Researchers have pinpointed why mutations that cause Rett Syndrome (RTT)--among the leading causes of mental retardation in females--specifically target the brain rather than other body tissues. They said their findings yield important insight into the origin and course of the disease.
RTT has been especially puzzling because girls with the disorder develop normally through the first 6 to 18 months of life. But then they lose motor skills and speech, their heads cease normal growth, and they begin to show irregular breathing, obsessive hand-wringing, and autistic behaviors.
Researchers had traced the RTT's cause to mutations in the gene for methyl-CpG-binding protein 2 (MeCP2)--a protein found in tissues throughout the body that regulates many target genes by repressing their activity. The gene for MeCP2 is found on the X chromosome, which is why females, with two X chromosomes, are far more likely to suffer from RTT than are males.
In their new studies, reported in the October 19, 2006, issue of the journal Neuron, published by Cell Press, Michael Greenberg and colleagues tackled a central mystery of the disorder: why mutations in the MeCP2 gene specifically produce neural pathology. They also sought to understand why the pathology of RTT does not appear until well into infant development.
In experiments with rats and mice, the researchers identified a particular site, called S421, on the MeCP2 protein that is the trigger site for activating MeCP2 during its normal function. MeCP2 is activated by a process called phosphorylation, in response to neuronal activity, as when the brain receives sensory experience, they found. Without such activation, as occurs when MeCP2 is "crippled" by a mutation affecting S421, the protein does not function properly.
Particularly significant was the researchers' finding that MeCP2 is selectively phosphorylated at the S421 site only in the brain. This specificity explains why mutations affecting that site target brain development, they said.
The researchers' experiments showed that mutating the MeCP2 gene specifically at the S421 site disrupts normal growth of interconnections, called dendrites, among neurons. Such growth is necessary for the brain to wire itself normally in response to experience. Dendrites are the structures that form one side of the contacts, called synapses, among neurons.
"In this study, we identify an important missing link in the synaptic hypothesis of RTT by identifying S421 as a major site of activity-dependent modification on MeCP2 that is required for the maturation of neuronal connectivity, thereby providing a potential mechanism by which experience-dependent stimuli might regulate MeCP2 function," concluded the researchers.
They wrote that "These findings suggest a key role for the activity-dependent regulation of MeCP2 in the maturation of neuronal connectivity and provide a new framework for understanding how mutations in MeCP2 lead to the deregulation of these processes in RTT."
The researchers include Zhaolan Zhou, Elizabeth J. Hong, Sonia Cohen, Hsin-yi Henry Ho, Wen G. Chen, Yingxi Lin, Eric C. Griffith, and Michael E. Greenberg of Children's Hospital Boston and Harvard Medical School in Boston, Massachusetts; Wen-ning Zhao and Charles J. Weitz of Harvard Medical School in Boston, Massachusetts; Lauren Schmidt, Erin Savner, Linda Hu, and Judith A.J. Steen of Children's Hospital Boston in Boston, Massachusetts.
This work was supported by the Rett Syndrome Research Foundation (M.E.G.), National Institutes of Health grants (NS048276,M.E.G.; NS43491, C.J.W.), the NIH Medical Scientist Training Program (S.C.), the Damon Runyon Cancer Research Foundation (H.-y.H.H), the Fannie and John Hertz Foundation (E.J.H.), and the Helen Hay Whitney Foundation (E.C.G., Z.Z.).
Zhou et al.: "Brain-Specific Phosphorylation of MeCP2 Regulates Activity-Dependent Bdnf Transcription, Dendritic Growth, and Spine Maturation." Publishing in Neuron 52, 255??"269, October 19, 2006. DOI 10.1016/j.neuron.2006.09.037 neuron/
Contact: Heidi Hardman
Cell Press
четверг, 29 декабря 2011 г.
четверг, 22 декабря 2011 г.
Kaiser Daily Women's Health Policy Report Highlights Women's Health Policy Issues Related To 2006 Elections
The following highlights recent election-related news on women's health issues.
Connecticut: Although Gov. M. Jodi Rell (R) supports abortion rights, NARAL Pro-Choice Connecticut recently chose not to endorse her bid for re-election in part because of her lack of support for legislation that would require hospitals to provide rape survivors access to emergency contraception and because of the voting record of her running mate, the AP/Stamford Advocate reports. According to gubernatorial candidate John DeStefano's (D) campaign, Rell's running mate, former state Rep. Michael Fedele (R), in 1998 voted for a failed amendment to a measure that would have classified performing a late-term abortion as a class D felony, punishable by up to five years in prison. NARAL Pro-Choice Connecticut Executive Director Carolyn Treiss said that Fedele did not return the group's candidate questionnaire for the November election, adding in a statement, "It concerns us Gov. Rell did not take the issue of women's reproductive freedom into account when selecting a running mate." Rell said that Fedele supports abortion rights, adding, "A lot of people feel very strongly on the 'partial-birth' abortion, but Mike has always been pro-choice." Rell also said she is proud of her record on women's issues, including supporting legislation allowing women to stay in the hospital longer after a mastectomy and increasing access to mammograms (Haigh, AP/Stamford Advocate, 10/3).
Iowa: Gubernatorial candidates Jim Nussle (R) and Chet Culver (D) on Monday during their first televised debate discussed abortion rights and human embryonic stem cell research issues, the Des Moines Register reports (Beaumont, Des Moines Register, 10/3). Nussle, a U.S. representative, last year voted against a bill (HR 810) that would have expanded federal funding for embryonic stem cell research and in July voted to sustain President Bush's veto of the measure, saying he opposes giving federal funding to research using human embryos. Culver, Iowa's secretary of state, has said if elected, he would call for the repeal of a 2002 state law that bans multiple forms of stem cell research and would call for the allocation of $10 million to create an Iowa Center for Regenerative Medicine at the University of Iowa Hospital and Clinics (Kaiser Daily Women's Health Policy Report, 7/25). Culver also has said he supports abortion rights and would veto any legislation seeking to place limitations on the procedure. Campaign staff for Nussle has said he would sign a bill banning abortion in the second and third trimesters of pregnancy if elected (Kaiser Daily Women's Health Policy Report, 9/8). Nussle on Monday also said Iowa should approve a law requiring minors seeking abortion to obtain consent from their parents (Glover, AP/Charles City Press, 10/3). Culver said that his position on abortion rights is with the "mainstream in the state" and that Nussle's is an "extreme position." Nussle said, "I do not have an extreme position unless you believe that it's extreme to protect unborn life" (Gearino, Sioux City Journal, 10/5).
Ohio: Secretary of State and gubernatorial candidate J. Kenneth Blackwell (R) in a meeting before the Columbus Dispatch editorial board said medical science has advanced to the point at which choosing to save the life of a pregnant woman or aborting the fetus is "no longer the dilemma the medial profession had to deal with," the Dispatch reports. U.S. Rep. Ted Strickland, the Democratic gubernatorial candidate, who supports abortion rights and also attended the meeting, said "every physician I've talked with" has said that Blackwell's statement "is flat out wrong," adding that Blackwell has "nuanced" his position from opposing all abortions during the Republican primary to now allowing it to save the life of the pregnant woman. Blackwell said that he has not changed his position. He also said that if his daughter were raped, the "more traumatic choice for that young woman, in this case my daughter," would be to undergo an abortion rather than to carry the pregnancy to term. Strickland said, "It ought to be her choice" (Hallett/Niquette, Columbus Dispatch, 10/3).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
четверг, 15 декабря 2011 г.
West Australian Women: Drinking Before, And During, Pregnancy
* In a survey of non-indigenous West Australian women, 79.8 percent reported drinking alcohol in the three months before becoming pregnant.
* Nearly half of the women (46.7%) surveyed reported that their pregnancy was unplanned.
* More than half (58.7%) drank alcohol during pregnancy despite recommendations of abstinence.
Complications due to drinking during pregnancy can range from the very serious Fetal Alcohol Syndrome to the less severe and possibly greater-occurring Fetal Alcohol Spectrum Disorders. The timing of alcohol consumption, its frequency, the beverage size and type, all appear to be crucial elements of identifying risk. A new survey has found that nearly 80 percent of non-Indigenous West Australian women consumed alcohol during the three months before pregnancy; nearly half had not planned their pregnancies; and more than half drank alcohol during pregnancy despite recommendations of abstinence.
Results are published in the February issue of Alcoholism: Clinical & Experimental Research.
"There is a lack of information as it relates to the measurement of alcohol consumption during the periconceptional period of pregnancy," said Lyn Colvin, a researcher at the Telethon Institute for Child Health Research at The University of Western Australia and corresponding author for the study. "In particular, information on specific alcoholic beverage consumed, frequency, timing during pregnancy, and volume in standard drinks are rare."
Colleen O'Leary, a research associate at the Telethon Institute for Child Health Research, concurs. "The most vulnerable period for the fetus is during the first trimester," she said, "although there is potential risk to the baby from drinking throughout pregnancy. It is important to know how much alcohol women are drinking both during the periconceptional period and throughout pregnancy, as well as more about the relationship between alcohol consumption during the periconceptional period and unplanned pregnancy. This information is important for women and men, policy makers and researchers."
Researchers analyzed data from a survey of 4,839 women 12 weeks after delivery. The women had agreed to participate in the 1995 - 1997 West Australian Pregnancy and Infancy Survey, created from a 10-percent random sample of all non-Indigenous women giving birth in Western Australia. Each participant was asked questions about alcohol consumption during four time periods: the periconceptional period, and each trimester of pregnancy. Questions were designed to measure the volume and type of alcoholic beverage consumed, as well as frequency of consumption.
* Nearly 80 percent reported drinking alcohol in the three months before becoming pregnant.
"Of those 3,860 women consuming alcohol in the three months before pregnancy," said Colvin, "the majority (55.6%) drank more than one type of alcoholic beverage. Once pregnant, the majority (65.5%) drank only one type of alcoholic beverage."
* Nearly half of the women (46.7%) surveyed had not planned their pregnancy.
"These data are in agreement with other Australian studies, and studies from the United States and Britain," said O'Leary. "It is concerning, however, that with the range of contraceptive options available to women that such a high proportion of pregnancies are unplanned." Furthermore, she added, the women who had planned their pregnancies were significantly less likely to drink alcohol during the first trimester than women who did not plan their pregnancy. "This would indicate that many pregnancies may be exposed to high levels of alcohol during the periconceptional period, prior to pregnancy awareness."
* More than half of the women (58.7%) drank alcohol during pregnancy despite the recommendation at the time of the study (1995-1997) of abstinence.
"It is interesting to note that the number of women who consumed alcohol during the 2nd trimester (42.4%) was similar to the number during the 1st trimester (42.1%)," said Colvin. "This probably indicates that the pregnant women were unaware of the recommendation of abstinence."
"Until 2001," added O'Leary, "the Australian guideline for alcohol consumption during pregnancy was abstinence. However, to my knowledge, there was no health promotion campaign in WA to educate women of this policy during or prior to the period these data were collected. Furthermore, a survey of health professionals conducted in WA during 2002 - 2003 found that fewer than half of health professionals surveyed routinely provided information to pregnant women about alcohol consumption during pregnancy."
'Despite what initially appears alarming, said Colvin, "it is actually encouraging that many women who drank alcohol reduced their consumption in the first trimester of pregnancy. With appropriate information, they and others may be able to further reduce or abstain from consuming alcohol when they are pregnant or might soon become pregnant. The challenge is to develop effective health promotion messages to reach women of child-bearing age before they consider pregnancy so they can make informed decisions." She added that involving health-promotion practitioners, medical practitioners and obstetricians would be key.
Both Colvin and O'Leary were concerned about "binge" drinking among women of childbearing age. "The findings that 14.2 percent of women surveyed consumed five or more standard drinks per occasion during the three months prior to pregnancy, and that almost half of the pregnancies were unplanned pregnancies, indicate that many women may have exposed their babies to high levels of alcohol before they were aware of their pregnancy," said O'Leary. In addition, she observed, "the percentage of Australian teenagers who binge drink has increased over the past decade since these data were collected. We need to find ways to reduce the very culture of binge drinking which is particularly concerning in young people as this is when drinking patterns are established."
O'Leary spoke of the need to educate both men and women. "We need to be careful how we frame our health-promotion messages since many women may have consumed alcohol prior to pregnancy awareness and unintentionally exposed their baby to alcohol," she said. "It is important not to generate undue fear and/or guilt. In addition, it is important not to place all the responsibility onto women alone: both women and men need to know about the risks to the baby from the consumption of alcohol during pregnancy; and many women and men need to take better precautions to prevent unplanned pregnancies."
Alcoholism: Clinical & Experimental Research (ACER) is the official journal of the Research Society on Alcoholism and the International Society for Biomedical Research on Alcoholism. Co-authors of the ACER paper, "Alcohol Consumption During Pregnancy in Non-Indigenous West Australian Women," were: Jan Payne, Deborah E. Parsons, and Carol Bower of the Telethon Institute for Child Health Research at The University of Western Australia; and Jennifer J. Kurinczuk of the National Perinatal Epidemiology Unit at the University of Oxford. The study was funded by the Health Promotion Foundation of Western Australia.
Contact:
Lyn Colvin, M.P.H.
Colleen O'Leary, M.P.H.
Telethon Institute for Child Health Research
Alcoholism: Clinical & Experimental Research
* Nearly half of the women (46.7%) surveyed reported that their pregnancy was unplanned.
* More than half (58.7%) drank alcohol during pregnancy despite recommendations of abstinence.
Complications due to drinking during pregnancy can range from the very serious Fetal Alcohol Syndrome to the less severe and possibly greater-occurring Fetal Alcohol Spectrum Disorders. The timing of alcohol consumption, its frequency, the beverage size and type, all appear to be crucial elements of identifying risk. A new survey has found that nearly 80 percent of non-Indigenous West Australian women consumed alcohol during the three months before pregnancy; nearly half had not planned their pregnancies; and more than half drank alcohol during pregnancy despite recommendations of abstinence.
Results are published in the February issue of Alcoholism: Clinical & Experimental Research.
"There is a lack of information as it relates to the measurement of alcohol consumption during the periconceptional period of pregnancy," said Lyn Colvin, a researcher at the Telethon Institute for Child Health Research at The University of Western Australia and corresponding author for the study. "In particular, information on specific alcoholic beverage consumed, frequency, timing during pregnancy, and volume in standard drinks are rare."
Colleen O'Leary, a research associate at the Telethon Institute for Child Health Research, concurs. "The most vulnerable period for the fetus is during the first trimester," she said, "although there is potential risk to the baby from drinking throughout pregnancy. It is important to know how much alcohol women are drinking both during the periconceptional period and throughout pregnancy, as well as more about the relationship between alcohol consumption during the periconceptional period and unplanned pregnancy. This information is important for women and men, policy makers and researchers."
Researchers analyzed data from a survey of 4,839 women 12 weeks after delivery. The women had agreed to participate in the 1995 - 1997 West Australian Pregnancy and Infancy Survey, created from a 10-percent random sample of all non-Indigenous women giving birth in Western Australia. Each participant was asked questions about alcohol consumption during four time periods: the periconceptional period, and each trimester of pregnancy. Questions were designed to measure the volume and type of alcoholic beverage consumed, as well as frequency of consumption.
* Nearly 80 percent reported drinking alcohol in the three months before becoming pregnant.
"Of those 3,860 women consuming alcohol in the three months before pregnancy," said Colvin, "the majority (55.6%) drank more than one type of alcoholic beverage. Once pregnant, the majority (65.5%) drank only one type of alcoholic beverage."
* Nearly half of the women (46.7%) surveyed had not planned their pregnancy.
"These data are in agreement with other Australian studies, and studies from the United States and Britain," said O'Leary. "It is concerning, however, that with the range of contraceptive options available to women that such a high proportion of pregnancies are unplanned." Furthermore, she added, the women who had planned their pregnancies were significantly less likely to drink alcohol during the first trimester than women who did not plan their pregnancy. "This would indicate that many pregnancies may be exposed to high levels of alcohol during the periconceptional period, prior to pregnancy awareness."
* More than half of the women (58.7%) drank alcohol during pregnancy despite the recommendation at the time of the study (1995-1997) of abstinence.
"It is interesting to note that the number of women who consumed alcohol during the 2nd trimester (42.4%) was similar to the number during the 1st trimester (42.1%)," said Colvin. "This probably indicates that the pregnant women were unaware of the recommendation of abstinence."
"Until 2001," added O'Leary, "the Australian guideline for alcohol consumption during pregnancy was abstinence. However, to my knowledge, there was no health promotion campaign in WA to educate women of this policy during or prior to the period these data were collected. Furthermore, a survey of health professionals conducted in WA during 2002 - 2003 found that fewer than half of health professionals surveyed routinely provided information to pregnant women about alcohol consumption during pregnancy."
'Despite what initially appears alarming, said Colvin, "it is actually encouraging that many women who drank alcohol reduced their consumption in the first trimester of pregnancy. With appropriate information, they and others may be able to further reduce or abstain from consuming alcohol when they are pregnant or might soon become pregnant. The challenge is to develop effective health promotion messages to reach women of child-bearing age before they consider pregnancy so they can make informed decisions." She added that involving health-promotion practitioners, medical practitioners and obstetricians would be key.
Both Colvin and O'Leary were concerned about "binge" drinking among women of childbearing age. "The findings that 14.2 percent of women surveyed consumed five or more standard drinks per occasion during the three months prior to pregnancy, and that almost half of the pregnancies were unplanned pregnancies, indicate that many women may have exposed their babies to high levels of alcohol before they were aware of their pregnancy," said O'Leary. In addition, she observed, "the percentage of Australian teenagers who binge drink has increased over the past decade since these data were collected. We need to find ways to reduce the very culture of binge drinking which is particularly concerning in young people as this is when drinking patterns are established."
O'Leary spoke of the need to educate both men and women. "We need to be careful how we frame our health-promotion messages since many women may have consumed alcohol prior to pregnancy awareness and unintentionally exposed their baby to alcohol," she said. "It is important not to generate undue fear and/or guilt. In addition, it is important not to place all the responsibility onto women alone: both women and men need to know about the risks to the baby from the consumption of alcohol during pregnancy; and many women and men need to take better precautions to prevent unplanned pregnancies."
Alcoholism: Clinical & Experimental Research (ACER) is the official journal of the Research Society on Alcoholism and the International Society for Biomedical Research on Alcoholism. Co-authors of the ACER paper, "Alcohol Consumption During Pregnancy in Non-Indigenous West Australian Women," were: Jan Payne, Deborah E. Parsons, and Carol Bower of the Telethon Institute for Child Health Research at The University of Western Australia; and Jennifer J. Kurinczuk of the National Perinatal Epidemiology Unit at the University of Oxford. The study was funded by the Health Promotion Foundation of Western Australia.
Contact:
Lyn Colvin, M.P.H.
Colleen O'Leary, M.P.H.
Telethon Institute for Child Health Research
Alcoholism: Clinical & Experimental Research
четверг, 8 декабря 2011 г.
Ovarian Cancer Screening Does Not Appear To Reduce Risk Of Ovarian Cancer Death
In a clinical trial that included nearly 80,000 women, those who received ovarian cancer screening did not have a reduced risk of death from ovarian cancer compared to women who received usual care, but did have an increase in invasive medical procedures and associated harms as a result of being screened, according to a study in the June 8 issue of JAMA, a theme issue on cancer. The study is being published early online to coincide with its presentation at the American Society of Clinical Oncology 2011 Annual Meeting.
In the United States, ovarian cancer is among the 5 leading causes of cancer death in women. Most women with ovarian cancer are diagnosed with advanced stage disease, which has a 5-year survival of only 30 percent. The recognition that early detection of ovarian cancer may have the potential to improve prognosis prompted the development of randomized controlled trials to evaluate the efficacy of transvaginal ultrasound and serum cancer antigen 125 (CA-125) as screening tools to reduce ovarian cancer mortality, according to background information in the article.
Saundra S. Buys, M.D., of the University of Utah Health Sciences Center, Salt Lake City, and colleagues examined the ovarian cancer-specific mortality results from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial to evaluate the effect of screening for ovarian cancer. The randomized controlled trial included 78,216 women, ages 55 to 74 years, assigned to undergo either annual screening (n = 39,105) or usual care (n = 39,111) at 10 screening centers across the United States between November 1993 and July 2001. The intervention group was offered annual screening with CA-125 for 6 years and transvaginal ultrasound for 4 years. Participants and their health care practitioners received the screening test results and managed evaluation of abnormal results. The usual care group was not offered annual screening with CA-125 for 6 years or transvaginal ultrasound but received their usual medical care. Participants were followed up for a maximum of 13 years for cancer diagnoses and death until February 28, 2010.
Through the follow-up period, 212 ovarian cancer cases were diagnosed in the intervention group and 176 cases in the usual care group. There were 118 deaths caused by ovarian cancer in the intervention group and 100 deaths in the usual care group. Analysis of data indicated that the difference in survival between the intervention and usual care groups was not statistically significant.
"All-cause mortality (excluding deaths from ovarian, colorectal, and lung cancer) was similar in the 2 study groups; there were 2,924 deaths in the intervention group and 2,914 deaths in the usual care group. Mortality rates for the major causes of death were generally similar between the 2 study groups," the authors write.
Of 3,285 women with false-positive results, 1,080 underwent surgery (32.9 percent for oophorectomy [surgical removal of one or both ovaries]) as part of the diagnostic workup. Of these 1,080 women, 163 (15 percent) experienced a total of 222 distinct major complications, which yielded a rate of 20.6 complications per 100 surgical procedures. A total of 1,771 women in the intervention group (7.7 percent) and 1,304 in the usual care group (5.8 percent) reported oophorectomy, with women in the intervention group having a higher rate of oophorectomy than women in the usual care group.
Regarding the outcomes of this trial, the researchers suggest that although the screening tests as used in this study did not reduce mortality, it is possible if used differently that CA-125 and transvaginal ultrasound may have the potential to be beneficial. For example, assessing the changes in CA-125 over time rather than a single CA-125 value as used in this study may allow detection of cancers at an earlier stage when cure is possible. However, there is no evidence from other clinical trials to support this approach at this time. The authors also suggest that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. "Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening. In contrast, more ovarian cancers were diagnosed in the screened group than in the usual care group (212 vs. 176), suggesting that some of the additional cancers detected by screenings were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their life-limes (i.e., overdiagnosis)."
"We conclude that annual screening for ovarian cancer as performed in the PLCO trial with simultaneous CA-125 and transvaginal ultrasound does not reduce disease-specific mortality in women at average risk for ovarian cancer but does increase invasive medical procedures and associated harms," the authors write.
JAMA. 2011;305[22]2295-2303.
In the United States, ovarian cancer is among the 5 leading causes of cancer death in women. Most women with ovarian cancer are diagnosed with advanced stage disease, which has a 5-year survival of only 30 percent. The recognition that early detection of ovarian cancer may have the potential to improve prognosis prompted the development of randomized controlled trials to evaluate the efficacy of transvaginal ultrasound and serum cancer antigen 125 (CA-125) as screening tools to reduce ovarian cancer mortality, according to background information in the article.
Saundra S. Buys, M.D., of the University of Utah Health Sciences Center, Salt Lake City, and colleagues examined the ovarian cancer-specific mortality results from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial to evaluate the effect of screening for ovarian cancer. The randomized controlled trial included 78,216 women, ages 55 to 74 years, assigned to undergo either annual screening (n = 39,105) or usual care (n = 39,111) at 10 screening centers across the United States between November 1993 and July 2001. The intervention group was offered annual screening with CA-125 for 6 years and transvaginal ultrasound for 4 years. Participants and their health care practitioners received the screening test results and managed evaluation of abnormal results. The usual care group was not offered annual screening with CA-125 for 6 years or transvaginal ultrasound but received their usual medical care. Participants were followed up for a maximum of 13 years for cancer diagnoses and death until February 28, 2010.
Through the follow-up period, 212 ovarian cancer cases were diagnosed in the intervention group and 176 cases in the usual care group. There were 118 deaths caused by ovarian cancer in the intervention group and 100 deaths in the usual care group. Analysis of data indicated that the difference in survival between the intervention and usual care groups was not statistically significant.
"All-cause mortality (excluding deaths from ovarian, colorectal, and lung cancer) was similar in the 2 study groups; there were 2,924 deaths in the intervention group and 2,914 deaths in the usual care group. Mortality rates for the major causes of death were generally similar between the 2 study groups," the authors write.
Of 3,285 women with false-positive results, 1,080 underwent surgery (32.9 percent for oophorectomy [surgical removal of one or both ovaries]) as part of the diagnostic workup. Of these 1,080 women, 163 (15 percent) experienced a total of 222 distinct major complications, which yielded a rate of 20.6 complications per 100 surgical procedures. A total of 1,771 women in the intervention group (7.7 percent) and 1,304 in the usual care group (5.8 percent) reported oophorectomy, with women in the intervention group having a higher rate of oophorectomy than women in the usual care group.
Regarding the outcomes of this trial, the researchers suggest that although the screening tests as used in this study did not reduce mortality, it is possible if used differently that CA-125 and transvaginal ultrasound may have the potential to be beneficial. For example, assessing the changes in CA-125 over time rather than a single CA-125 value as used in this study may allow detection of cancers at an earlier stage when cure is possible. However, there is no evidence from other clinical trials to support this approach at this time. The authors also suggest that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. "Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening. In contrast, more ovarian cancers were diagnosed in the screened group than in the usual care group (212 vs. 176), suggesting that some of the additional cancers detected by screenings were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their life-limes (i.e., overdiagnosis)."
"We conclude that annual screening for ovarian cancer as performed in the PLCO trial with simultaneous CA-125 and transvaginal ultrasound does not reduce disease-specific mortality in women at average risk for ovarian cancer but does increase invasive medical procedures and associated harms," the authors write.
JAMA. 2011;305[22]2295-2303.
четверг, 1 декабря 2011 г.
Low Complication Profile For Pelvic Floor Repair - New Restorelle™ Series Demonstrates Near Zero Mesh Erosion Rate
Mpathy Medical, a rapidly growing medical device company which specializes in restoring pelvic health to women, today announced the findings of a retrospective cohort study carried out by Red Alinsod, MD, FACOG, FACS, ACGE, Laguna Beach, CA. This study demonstrates a low complication profile for Restorelle™, the company's pelvic floor restoration product line, which is constructed with its ultra lightweight Smartmesh™.
In a series of 201 patients and 360 total mesh implantsi, carried out from November 2005 to October 2008, the results report that the use of Restorelle™ is associated with a 0.28% erosion rate and a 99.5% cure rate based on POP-Q assessment of the enrolled patients. The follow up time for this series ranged from 36 months to 2 months, resulting in a mean follow up of 22 months. Important factors regarding patient quality of life were measured and included:
-- No new occurrence of dyspareunia (painful intercourse) attributable to prolapse repair.
-- Non-palpability of the mesh throughout - neither the patient nor partner could feel the implant postoperatively in uncomplicated repairs.
-- 93% patients reporting that their quality of life was "good" or "very good" postoperatively compared to "poor" or "fair" preoperatively.
"The results from this substantial series clearly demonstrate the low complication profile associated with Mpathy Medical's ultra lightweight mesh material when used to surgically manage pelvic organ prolapse," stated Dr. Red Alinsod, South Coast Urogynecology, Laguna Beach, CA. "I have been extremely pleased with the fully functional and restored anatomy which Restorelle™ products help me to deliver to my patients. I have consistently been able to achieve these positive results without my patients or their partners experiencing dyspareunia, which was often present after using previous surgical solutions."
The Food and Drug Administration recently issued a public health notification which reported serious complications associated with transvaginal placement of mesh in the repair of urinary stress incontinence (USI) and pelvic organ prolapse (POP). This announcement came following over 1,000 reports of adverse events associated with mesh from nine manufacturers. These complications ranged from issues that negatively affect the patient's quality of life, such as dispareunia or narrowing of the vaginal wall, to more serious problems that can include chronic pain and require additional surgery to correct.
"We are pleased to share the results from Dr. Alinsod's study," stated Ian Stevens, Chief Executive Officer, Mpathy Medical. "We believe that the recent FDA announcement raises important issues relating to the use of mesh for this type of surgery. We are very confident that Smartmesh™ is the right solution for women and their surgeons, since it is the only product which has been designed specifically with the female anatomy and physiology in mind."
To review the abstract from Dr. Alinsod's series, click here.
Facts on Pelvic Health Conditions:
-- The prevalence of USI and POP increases with ageii.
-- USI affects approximately 1 in 4 women while POP affects up to half of all women over the age of 50.
-- Approximately 20% of women who have symptoms of POP also experience USI.
-- Approximately 200,000 procedures are performed each year to correct USI and POPiii.
-- Women who are obese have a 40-75% increased risk of POPiv.
-- Many women who suffer from USI or POP are unaware of the procedures that are available to correct these problems. A recent study indicated 2/3 of women were not aware of sling procedures to treat USIv.
-- Depression is a common resulting factor of pelvic health conditions. The risk of depression is 40% higher for incontinent women. Women with severe incontinence are 80% more likely to experience depressionvi.
About Mpathy Medical
Mpathy Medical is a rapidly growing medical device company which has developed and brought to market a range of surgical solutions used to restore pelvic health to women. Mpathy Medical's core product lines - Minitape® and Restorelle™ - are used by surgeons specializing in urogynecology, gynecology, and urology to treat female urinary stress incontinence and pelvic organ prolapse. Founded in 2003 by a surgeon, Dr. James Browning, Mpathy Medical supplies the only mesh solutions designed specifically for the female anatomy and physiology. The mesh - branded Smartmesh™ - is a physiologically compatible, ultra lightweight polypropylene mesh which encourages superior collagen growth and works in concert with the patient's own natural tissue for optimum safety and results. The company is headquartered in Glasgow, Scotland with US operations in Raynham, MA and has received 510(k) clearance to market by the FDA in the US and CE marking in the UK for all its medical devices. To learn more about Mpathy Medical, visit www.mpathymedical.
i Many patients received a multi-compartment vaginal repair; therefore, requiring more than one piece of Restorelle™ mesh.
ii Nygaard, I. et al (2008). Prevelance of Symptomatic Pelvic Floor Disorders in US Women. Journal of American Medical Association; 300, 1311-1316.
iii American Urogynecologic Society.
iv American Urogynecologic Society.
v American Academy of Gynecologic Laparoscopists.
vi Nygaard, I. et al (2003). Urinary Stress Incontinence and Depression in Middle-Aged United States Women. The American College of Obstetricians and Gynecologists; 101,149-156.
In a series of 201 patients and 360 total mesh implantsi, carried out from November 2005 to October 2008, the results report that the use of Restorelle™ is associated with a 0.28% erosion rate and a 99.5% cure rate based on POP-Q assessment of the enrolled patients. The follow up time for this series ranged from 36 months to 2 months, resulting in a mean follow up of 22 months. Important factors regarding patient quality of life were measured and included:
-- No new occurrence of dyspareunia (painful intercourse) attributable to prolapse repair.
-- Non-palpability of the mesh throughout - neither the patient nor partner could feel the implant postoperatively in uncomplicated repairs.
-- 93% patients reporting that their quality of life was "good" or "very good" postoperatively compared to "poor" or "fair" preoperatively.
"The results from this substantial series clearly demonstrate the low complication profile associated with Mpathy Medical's ultra lightweight mesh material when used to surgically manage pelvic organ prolapse," stated Dr. Red Alinsod, South Coast Urogynecology, Laguna Beach, CA. "I have been extremely pleased with the fully functional and restored anatomy which Restorelle™ products help me to deliver to my patients. I have consistently been able to achieve these positive results without my patients or their partners experiencing dyspareunia, which was often present after using previous surgical solutions."
The Food and Drug Administration recently issued a public health notification which reported serious complications associated with transvaginal placement of mesh in the repair of urinary stress incontinence (USI) and pelvic organ prolapse (POP). This announcement came following over 1,000 reports of adverse events associated with mesh from nine manufacturers. These complications ranged from issues that negatively affect the patient's quality of life, such as dispareunia or narrowing of the vaginal wall, to more serious problems that can include chronic pain and require additional surgery to correct.
"We are pleased to share the results from Dr. Alinsod's study," stated Ian Stevens, Chief Executive Officer, Mpathy Medical. "We believe that the recent FDA announcement raises important issues relating to the use of mesh for this type of surgery. We are very confident that Smartmesh™ is the right solution for women and their surgeons, since it is the only product which has been designed specifically with the female anatomy and physiology in mind."
To review the abstract from Dr. Alinsod's series, click here.
Facts on Pelvic Health Conditions:
-- The prevalence of USI and POP increases with ageii.
-- USI affects approximately 1 in 4 women while POP affects up to half of all women over the age of 50.
-- Approximately 20% of women who have symptoms of POP also experience USI.
-- Approximately 200,000 procedures are performed each year to correct USI and POPiii.
-- Women who are obese have a 40-75% increased risk of POPiv.
-- Many women who suffer from USI or POP are unaware of the procedures that are available to correct these problems. A recent study indicated 2/3 of women were not aware of sling procedures to treat USIv.
-- Depression is a common resulting factor of pelvic health conditions. The risk of depression is 40% higher for incontinent women. Women with severe incontinence are 80% more likely to experience depressionvi.
About Mpathy Medical
Mpathy Medical is a rapidly growing medical device company which has developed and brought to market a range of surgical solutions used to restore pelvic health to women. Mpathy Medical's core product lines - Minitape® and Restorelle™ - are used by surgeons specializing in urogynecology, gynecology, and urology to treat female urinary stress incontinence and pelvic organ prolapse. Founded in 2003 by a surgeon, Dr. James Browning, Mpathy Medical supplies the only mesh solutions designed specifically for the female anatomy and physiology. The mesh - branded Smartmesh™ - is a physiologically compatible, ultra lightweight polypropylene mesh which encourages superior collagen growth and works in concert with the patient's own natural tissue for optimum safety and results. The company is headquartered in Glasgow, Scotland with US operations in Raynham, MA and has received 510(k) clearance to market by the FDA in the US and CE marking in the UK for all its medical devices. To learn more about Mpathy Medical, visit www.mpathymedical.
i Many patients received a multi-compartment vaginal repair; therefore, requiring more than one piece of Restorelle™ mesh.
ii Nygaard, I. et al (2008). Prevelance of Symptomatic Pelvic Floor Disorders in US Women. Journal of American Medical Association; 300, 1311-1316.
iii American Urogynecologic Society.
iv American Urogynecologic Society.
v American Academy of Gynecologic Laparoscopists.
vi Nygaard, I. et al (2003). Urinary Stress Incontinence and Depression in Middle-Aged United States Women. The American College of Obstetricians and Gynecologists; 101,149-156.
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