国产Ⅰ、Ⅱ型皮下埋植剂的临床应用研究

目的:评价两种国产皮下埋植剂的避孕效果、副反应和续用率。方法:在安徽省16个计划生育服务站对国产Ⅰ型和Ⅱ型皮下埋植剂进行临床研究,按统一筛选标准接收研究对象(Ⅰ型456例,Ⅱ型513例),并完成24个月的随访。结果:两种埋植剂24个月仅国产Ⅰ型发生1例妊娠,累积妊娠率0.22/百妇女年;24个月累积续用率Ⅰ型为83.98/百妇女年,Ⅱ型为94.33/百妇女年;24个月时副反应主诉发生率国产Ⅰ型为39.2％,Ⅱ型为35.1％,两组之间无显著性差异。结论:两种国产皮下埋植避孕剂均高效、可接受性较好。     

GyneFixIN与r型、MLCu IUD的临床对照分析

目的:观察新型GyneFixIN IUD的临床效果。方法:采用对比性研究,以随机方法给556例健康育龄妇女放置三种不同IUD,其中GyneFix IN IUD 220例,r型IUD 220例,MLCu IUD 116例,于放置后6个月及1、2、3年进行随访。结果:GyneFix IN IUD使用3年妊娠率、脱落率、因症取出率和续用率分别为0.5％、0.9％、3.2％、94.5％。GyneFixINIUD脱落率明显低于MLCuIUD的11.3％(P<0.01),也低于r型IUD的4.2％,但无明显差异(P>0.05)。三种IUD续用率分别为94.5％、88.7％和82.4％,GyneFix IN IUD续用率高于MLCu IUD(P<0.05)。结论:CyneFixIN IUD具有脱落率低、续用率高、副反应小的优点,值得临床推广。     

置入MCu功能性宫内节育器1050例临床试验报告

目的:研究新型MCu功能性宫内节育器(MCuIUD)的临床效果及可接受性。方法:由四个临床中心自 1997年9月～1998年9月进行1 050例临床观察,其中有 109例与TCu220C进行了随机抽样对比观察,随访率>98％。结果:1 050例使用12个月妊娠率及脱落率均为0,续用率为99.62/百妇女。放置 MCuIUD与 TCu220C各 109例,观察 12个月,续用率分别为99.08/百妇女和88.07/百妇女;两组累积妊娠率分别为 0和2.75/百妇女;两组累积脱落率各为0和0.92/百妇女;两组因症取出症率为0.92/百妇女、7.34/百妇女,经统计学处理,P<0.05,有显著性差异。副反应发生率两组P<0.01,差异非常显著。结论:MCuIUD组临床效果优于 TCu220C组,其抗生育效果好、脱落率低、副反应小、安全、适应证较广泛,取得国内外IUD应用中前所未有的临床效果。该产品已获国家医疗器械注册证,它的广泛应用将给广大育龄妇女在选择新的避孕工具方面提供良好的机会。     

新型宫内节育器GyneFix、HCu280与TCu220的临床效果比较

目的:对比新型宫内节育器GyneFix、HCu280与TCu220型宫内节育器的临床使用效果。方法:无胎次区别于经后7天内随机放置GyneFix、HCu280和TC220宫内节育器,随访满1年。结果:放置GyneFix IUD的1年带器妊娠率为1.45/百妇女/年,脱落率为6.57/百妇女/年,因症取出率为2.39/百妇女/年,续用率为94.45/百妇女/年;放置Hcu280的1年带器妊娠率为0.96/百妇女/年,脱落率为3.52/百妇女/年,因症取出率为21.84/百妇女/年,续用率为84.55/百妇女/年;放置Tcu220的1年带器妊娠率为6.02/百妇女/年,脱落率为3.12/百妇女/年,因症取出率为22.50/百妇女/年,续用率为82.45/百妇女/年。结论:放置GyneFix无支架宫内节育器出血少,腹痛、续用率及避孕效果均高于Hcu280和Tcu220,是今后开发和推广使用的方向。     

去尾丝HCu280型花式IUD临床效果观察

目的:探讨放置去尾丝HCu280型花式宫内节育器(IUD)的临床效果,为推广使用提供科学依据。方法:21~45岁已婚已育且无放置IUD禁忌证妇女中,选择自愿放置去尾丝HCu280型花式IUD妇女200例为观察对象(HCu280IUD组),以选择放置TCu380AIUD妇女198例为对照(TCu380AIUD组),分别于放置后1、3、6和12个月进行随访,比较两组避孕效果、副作用主诉情况。结果:置器12个月HCu280IUD组和TCu380AIUD组带器妊娠率分别为每百妇女年0和0.5(P0.05);脱落率分别为每百妇年0.5和4.2(P0.05);与IUD使用相关终止率分别为每百妇女年3.5和9.6(P0.05);总终止率分别为每百妇女年4.0和10.1(P0.05);续用率分别为每百妇女年96.0和89.9。置器后1、3、6、12个月副作用主诉率,HCu280IUD组低于TCu380AIUD组。结论:HCu280型花式IUD避孕效果好,副作用主诉少,续用率高。     

规范知情选择对宫内节育器使用效果的影响

目的:探讨规范知情选择对放置宫内节育器(IUD)使用效果的影响,为改进服务提供科学依据。方法:对2011年10月~2012年9月在本服务站放置IUD的650例育龄妇女由医生进行规范知情选择(术前咨询、术后健康教育、术后1、3、6、12个月定期随访),并以一上年度在本站放置IUD的645例育龄使用情况进行对比,观察放置IUD术后感染率、因症取出率、脱落率、带器妊娠率及续用率。结果:术后复诊率、因症就诊率增加,因症取出率减少,续用率提高。结论:规范知情选择,可提高服务对象的依从性,减少IUD的因症取出率,提高IUD的使用率。     

Dillings自然避孕法的推广使用

观察300对育龄夫妇4516个妇女月连续使用Billings自然避孕法的避孕效果。用生命表法统计12个月和18个月时净累积停用率分别为14.57/百妇女和21.21/百妇女,续用率分别为85.43/百妇女和78.79/百妇女。因方法学本身引起的意外妊娠停用率较低,分别为1.02/百妇女和1.37/百妇女。本文认为除方法学意外妊娠外,其它原因引起的妊娠与使用者有关。只要进一步改进培训方法,调动受试者主观能动性和强调丈夫的合作,定能降低使用者引起的停用率,提高续用率。Billings自然避孕法效果可靠,无任何副作用,可进一步推广使用。     

宫型含药和宫型药铜IUD的临床研究

选择1600例健康妇女,放置宫型含药IUD和宫型药铜IUD各800例,进行1年的临床随访,并从每组抽取7例妇女测定放置前及放置后1、3、6、12个月的经血量进行比较研究。结果显示:宫型含药IUD的12个月累积妊娠卑、脱落率、因症取出率、续用率及副反应率分别是1.18/100妇女、0.94/100妇女、0.12/100妇女、97.76/100妇女、28.06％;宫型药铜IUD分别为0.25/100妇女、1.25/100妇女、0.13/100妇女、98.37/100妇女、30.07％。宫型含药IUD和宫型药铜IUD的经血量放置后均比放置前低(P<0.05)。可见两种IUD的事件率均较低,续用率较高,两者相比,宫型药铜的妊娠率又显著低于宫型含药IUD(P<0.05)。     

200例长效避孕针狄波—普维拉1年临床资料分析

<正> 为观察在中国妇女中大规模常规使用狄波—普维拉避孕针的使用有效率、续用率和停药原因,评价中国育龄妇女对该方法的可接受程度,为今后在我国引入该项节育技术提供经验和依据,1995年10月我们参加了由浙江医学科学院组织的引入性临床研究。本文报告200例用针1年的情况。 材料和方法 一、研究对象 对象的接纳与排除标准按课题统一规定,对象在决定是否愿意参加本项研究前均安排有详细的咨询并告知该药可能引起不规则出血或闭经,但不严重,且可随着用药时间的延长而有明显的改善。至1996年12     

放置MCu功能性宫内节育器60个月观察

目的追踪观察放置MCu功能性宫内节育器60个月的临床使用效果。方法Ⅰ组放置MCu功能性宫内节育器600例,Ⅱ组放置GT300型含铜宫腔形宫内节育器600例,追踪观察使用60个月的带器妊娠率、脱落率、因症取出率及续用率,于放置后1、3、6、12、24、36、48、60个月(1个月随访观察不纳入比较)各随访观察一次。结果放置满60个月时,MCu IUD和GT300 IUD的带器妊娠率分别为2.15/百妇女年、11.19/百妇女年;脱落率分别为0.17/百妇女年、8.96/百妇女年;因症取出率分别为1.52/百妇女年、11.15/百妇女年;续用率分别为92.67/百妇女年、60.33/百妇女年。两组差异均有统计学意义(p<0.05)。两组放置后3、6、12、24、36、48、60个月追踪观察副反应比较均有统计学意义(p<0.05)。结论 MCu IUD的使用效果好,5年续用率高,是比较理想的IUD,值得临床推广使用。     

A multicentered clinical trial of the long-acting injectable contraceptive Depo Provera in Chinese women

This study was an open trial where 1994 subjects each received Depo Provera injectable contraceptive every three months for one year and were observed a total of 20,294.3 woman months. At the time of observation, only one accidental pregnancy had occurred giving a use-effectiveness rate of 99.94% and a cumulative continuation rate of 72.87%. There were no significant adverse effects on weight and blood pressure. The main side effects were spotting, prolonged bleeding, and amenorrhea and these were also the main reasons of discontinuation. Complaints related to bleeding problems gradually decreased and complaints of amenorrhea increased with continued use. In lactating women, side effects occurrence rate was lower and continuation rate was higher in comparison with non-lactating women. Users did not report any effect on milk secretion. The results of this study confirm that Depo Provera is a very effective contraceptive method. With appropriate counseling and medical support, high acceptability and continuation rate can be achieved. Depo Provera is especially suitable for lactating women and could become a popular contraceptive method for lactating Chinese women.     

Forgettable contraception

The term “forgettable contraception” has received less attention in family planning than has “long-acting reversible contraception.” Defined here as a method requiring attention no more often than every 3 years, forgettable contraception includes sterilization (female or male), intrauterine devices, and implants. Five principal factors determine contraceptive effectiveness: efficacy, compliance, continuation, fecundity, and the timing of coitus. Of these, compliance and continuation dominate; the key determinants of contraceptive effectiveness are human, not pharmacological. Human nature undermines methods with high theoretical efficacy, such as oral contraceptives and injectable contraceptives. By obviating the need to think about contraception for long intervals, forgettable contraception can help overcome our human fallibility. As a result, all forgettable contraception methods provide first-tier effectiveness (≤2 pregnancies per 100 women per year) in typical use. Stated alternatively, the only class of contraceptives today with exclusively first-tier effectiveness is the one that can be started -- and then forgotten for years.     

Fertility regulation in nursing women: IV. Long-term influence of a low-dose combined oral contraceptive initiated at day 30 postpartum upon lactation and infant growth

The study was designed to test the long-term influence of a low-dose combined oral contraceptive upon lactation and infant growth when treatment was initiated at day 30 postpartum. The contraceptive tested contained ethinyl estradiol 0.03 mg and levonorgestrel 0.15 mg. Two control groups were formed by women who received an injectable placebo or a Copper T at day 30 postpartum. Women in the injectable placebo group received non-hormonal contraceptives at day 90 postpartum. An exacting list of requirements for admission and continuation in the study was applied to all groups. The oral contraceptive group had a significantly lower percentage of cases in full nursing from the 4th through the 10th postpartum month when compared to both control groups. The average absolute weight of infants in the oral contraceptive group was significantly lower at several ages when compared to the placebo group but not when compared to the Copper T group. No adverse side effects upon infant's health were detected. It was concluded that the oral contraceptive tested showed a moderate inhibitory influence upon lactation when treatment was initiated at the beginning of the second postpartum month.     

放置吉妮IUD 2312例临床使用效果调查分析

目的:评估吉妮固定式宫内节育器(吉妮IUD)在海南省育龄妇女中的使用效果,以便指导在全省推广应用吉妮IUD的工作。方法:对2312例放置吉妮IUD的妇女进行问卷调查,了解置器后的1、3、6、12个月等临床使用效果。结果:在调查全省2312例使用吉妮IUD的育龄妇女中,发生脱落41例,占1.77%;带器妊娠13例,占0.56%,节育有效率为99.44%;因症取出38例,占1.64%;按照置器期限,把2312例进行分组,即满1月组(374例)、3月组(494例)、6月组(419例)和12月组(1025例)等4组,各组续用率依次为98.66%、99.19%、95.94%和92.97%。结论:育龄妇女放置吉妮IUD的副作用小、脱落率低、续用率高、适应证宽和节育有效率高,是可供妇女选择的一种长效避孕措施,值得推广应用。     

Estimates of pregnancies averted through California's family planning waiver program in 2002

CONTEXT: During its first year of operation (1997-1998), California's family planning program, Family PACT, helped more than 750,000 clients to avert an estimated 108,000 pregnancies. Given subsequent increases in the numbers of clients served and contraceptive methods offered by the program, updated estimates of its impact on fertility are needed. METHODS: Claims data on contraceptives dispensed were used to estimate the number of pregnancies experienced by women in the program in 2002. Medical record data on methods used prior to enrollment were used to predict client fertility in the absence of the program. Further analyses examined the sensitivity of these estimates to alternative assumptions about contraceptive failure rates, contraceptive continuation and contraceptive use in the absence of program services. RESULTS: Almost 6.4 million woman-months of contraception, provided primarily by oral contraceptives (57%), barrier methods (19%) and the injectable (18%), were dispensed through Family PACT during 2002. As a result, an estimated 205,000 pregnancies-which would have resulted in 79,000 abortions and 94,000 births, including 21,400 births to adolescents-were averted. Changing the base assumptions regarding contraceptive failure rates or method use had relatively small effects on the estimates, whereas assuming that clients would use no contraceptives in the absence of Family PACT nearly tripled the estimate of pregnancies averted. CONCLUSION: Because all contraceptive methods substantially reduce the risk of pregnancy, Family PACT's impact on preventing pregnancy lies primarily in providing contraceptives to women who would otherwise not use any method.     

Mesigyna once-a-month combined injectable contraceptive: experience in Latin America

A phase III clinical study was carried out among 534 fertile Latin American women to evaluate cycle control, side effects, and contraceptive efficacy of a once-a-month combined injectable, Mesigyna, consisting of 50 mg norethisterone enanthate and 5 mg estradiol valerate. The pregnancy rate at 1 year was 0 per 100 woman-years for a total experience of 4688 woman-months. The overall discontinuation rate at one year was 17.9%. Discontinuation rate for bleeding problems was 5.1%. The Colombian women had a significant increase (p <0.001) in bleeding problems compared to other countries. The discontinuation rate for amenorrhea was 1.1%. There were no significant differences between the groups regarding discontinuation for other medical or non-medical reasons. Mean weight gain after one year of use was 1.02 kg. Mesigyna is an appropiate once-a-month injectable contraceptive for Latin American women since it is highly effective and its perception of normal menstrual bleeding is of importance in the Latin American population.     

两种国产皮下埋植避孕剂临床多中心比较研究

目的:对两种国产皮下埋植避孕剂的长期应用效果及副反应进行评价。方法:采用前瞻性临床多中心对比研究,共在5省58个分中心进行了7941例长达5年的临床应用和随访研究。结果:两种埋植剂5年的净累积妊娠率仅为0.257/百妇女(Ⅰ型)和1.569/百妇女(Ⅱ型),两者间有极显著差异;5年累积续用率高达76.23/百妇女(Ⅰ型)和77.98/百妇女(Ⅱ型);主诉副反应的发生率开始较高,随应用时间延长而逐年降低,由开始的近50％降至第5年时的15％左右,最主要的副反应是月经异常,占终止人数的74.8％,月经副反应发生率和因月经异常的停用率Ⅰ型埋植剂明显高于Ⅱ型。结论:两种国产皮下埋植避孕剂均是高效、长效、可接受性较好的新型避孕药。     

Discontinuation of oral contraceptives and depot medroxyprogesterone acetate among women with and without HIV in Uganda, Zimbabwe and Thailand

BackgroundWe examined hormonal contraceptive (HC) discontinuation and factors associated with discontinuation among HIV-uninfected women and the effect of HIV diagnosis on subsequent contraceptive use.Study DesignWe analyzed 4461 HIV-uninfected women from a prospective study of HC and HIV acquisition in Uganda, Zimbabwe and Thailand. Participants were ages 18–35 years, not pregnant, and using oral contraceptives (OCs) or injectable depot medroxyprogesterone acetate (DMPA) for at least 3 months before enrollment (median duration of OC and DMPA use before enrollment was 11.7 and 8.9 months, respectively). We compared the probability of OC and DMPA discontinuation using survival analysis and factors related to discontinuation using Cox regression. We also analyzed contraceptive patterns among 194 women who became infected with HIV.ResultsMedian duration of use after study enrollment was 15.6 months for OCs and 18.5 months for DMPA. Continuation rates for both methods were highest in Thailand. Factors associated with OC discontinuation included, nausea, breast tenderness, condom use, and no sex. Factors associated with DMPA discontinuation included young age, breast tenderness, nausea, irregular bleeding, high-risk sexual behaviors, partner risk, condom use, and no sex. Following an HIV diagnosis, 135 (98.5%) of 137 hormonal users continued HC and 14 (25%) of 57 nonusers began using HC.ConclusionsContraceptive continuation for OCs and DMPA was relatively high over 2 years. Young women, those reporting side effects, and those using condoms are more likely to discontinue and need ongoing contraceptive counseling. Many women receiving HIV-positive diagnoses desire effective contraception.     

Cervical mucus granulocyte macrophage colony stimulating factor and interleukin-2 soluble receptor in women using copper intrauterine contraceptive devices

The objectives of this study were to evaluate the bleeding patterns and clinical performance during the first 2 years of use of an intrauterine system releasing 20 microg/day of levonorgestrel (LNG-IUS, Mirena). Two-hundred-fifty-six women accepted use of Mirena from April 1998 through September 1998. The gross cumulative discontinuation rate due to pregnancy and expulsion were significantly higher in women who used the device because of heavy bleeding. There was one pregnancy at the 15th month of use after an inadvertent expulsion of the device. The continuation rate was 66.2 at the end of the second year. Forty-four percent of women reported amenorrhea at the 6th month of use. This rate maintained stability at 50% after 12 and 24 months of use. Spotting was present in 25% of the users at 6 months, decreasing to 8% and 11% at 18 and 24 months, respectively. Oligomenorrhea was described by one-quarter of women and was similar at each observation period. Removals due to menstrual bleeding problems were concentrated in the first 6 months of use and mostly due to amenorrhea or menorrhagia. In conclusion, LNG-IUS showed a high contraceptive efficacy and a good continuation rate up to 2 years. In addition, a reduction of blood loss was observed a few months after insertion.