Norplant皮下埋植剂长期使用的有效性临床研究—八年经验

上海医科大学妇产科医院于１９８４年１０月至１９９３年１２月应用Ｎｏｒｐｌａｎｔ皮下埋植剂１６５７例（其中Ｎｏｒｐｌａｎｔ—Ⅰ型１３５６例，Ｎｏｒｐｌａｎｔ－Ⅱ３０１例）控制生育。１、３、５、６、７、８年的累积妊娠率分别为０、０．１、０．９、１．７、２．６、和３．３／１００妇女；妊娠率与最初埋植时的体重有关，体重重者妊娠率高。持续使用率分别为９７．１、８２．２、７３．５、４４．７、３４．３和１８．５／１００妇女。主要副反应为月经失调，是终止使用的主要原因；但总失血量不多，随着使用时间的延长，月经失调副反应逐渐减少。埋植剂的放置和取出技术易于掌握，在１６５７例使用中，未发生感染或其他并发症，使用安全。由于其妊娠率低，和不可能脱落及其高度可逆性，深为受术者欢迎。     

国产18甲基炔诺酮皮下埋植剂和Norplant的临床比较性研究—666例 …

本文旨在研究国产１８甲基炔诺酮皮下埋植剂避孕的有效性及其副反应，与Ｎｏｒｐｌａｎｔ作比较，６６６例对象经过４年观察，。国产组共姓４例妊娠，４年累积妊娠经为１．０７／１００妇女，年平均妊娠率为０．２７／１００妇女，４年累积的续用率为７６．６／１００妇女。与国外Ｎｏｒｐｌａｎｔ组比较，都无统计学差异。     

长期使用Norplant皮下埋植剂妇女血清左炔诺孕酮水平的测定

目的（１）测定ｏｒｐｌａｎｔ皮下埋植剂（１－１１年）的妇女血清左诺孕酮水平,预测其可能使用的最长有效期限;（２）观察长期（５年）用药后血清ＬＮＧ水平与受试者体重间相关性。方法 应用放射地测定血清中ＬＮＧ水平。结果 使用Ｎｏｒｐｌａｎｔ１、３、５年后,血清ＬＮＧ均值分别为１２７３．５μｍｏｌ／Ｌ、９２４．０ｐｍｏｌ／Ｌ和７３９．６ｐｍｏｌ／Ｌ。第５－７年血清ＬＮＧ均呈线性降低,第７－１０年,血清ＬＮ     

放置含铜宫内节育器的五年临床观察

对２００例放置金属宫内节育器（ＩＵＤ）失败的妇女，随机放置含铜ＭｕｌｔｉｌｏａｄＣｕ２５０ＩＵＤ（ＭＬＣｕ２５０）和ＶＣｕ２００ＩＵＤ（ＶＣｕ２００）各１００例。临床观察５年，随访率９７．５％。结果表明：ＭＬＣｕ２５０和ＶＣｕ２Ｏ０的５年累积脱落率为１．０／每百妇女（下同）、８．１；妊娠率为１２．０、４．１；因出血和疼痛取出率为６．０、６．１；继续存放率为８０．０、８１．７。ＭＬＣｕ２５０脱落率明显低于ＶＣｕ２００，两者比较，差异有非常显著意义。提示：ＭＬＣｕ２５０和ＣＶｕ２００５年存放率高，避孕效果好，两种ＩＵＤ均适合于放置金属ＩＵＤ失败者。ＭＬＣｕ２５０至少可使用５年，如增加其铜表面积，有可能使妊娠率进一步降低。     

“二日法”作为避孕措施的临床初试

目的:初步观察"二日法"在中国育龄妇女中使用的避孕效果。方法:对上海市黄浦区122对志愿使用"二日法"的育龄夫妇进行连续使用≥10个周期避孕情况的观察,随访资料用妇女年统计方法分析。结果:122例共使用1 414个妇女月。其中1例在使用的第11个月时意外妊娠;意外妊娠的Pearl指数为0.849。结论:初步观察的资料显示,"二日法"可以作为"知情选择"的避孕方法之一,但在推广前宜进一步开展扩大的临床有效性试验。     

含铜宫形器5年临床效果观察

含铜宫形器５年临床效果观察万开芳含铜宫形器是在宫形器取得脱落率低的效果基础上，为降低妊娠率，提高避孕效果，在宫形器内加入２００ｍｍ２铜丝制成的。我站１９８４年１２月～１９８５年６月应用含铜宫形器（宫铜器）２５４例，随访观察５年，现将结果报告如下。材料...     

稽留流产、葡萄胎妇女使用Billings法避孕效果观察

目的:观察稽留流产和葡萄胎妇女刮宫术后采用Billings法避孕的效果。方法:观察组46例,为我院住院治疗的稽留流产和葡萄胎行刮宫术后采用Billings法避孕者,同时随机抽取我院Billings门诊避孕的妇女92例为对照组,观察两组对象24个月内的停用率、续用率和意外妊娠率。结果:138例妇女共观察1501个妇女月,24个月内观察组除6例计划妊娠外,无停用和意外妊娠者,净累积续用率86.95%。对照组24个月内停用17例(18.47%),意外妊娠1例(1.08%),净累积续用率81.52%。结论:稽留流产、葡萄胎妇女采用Billings法避孕,效果良好,值得推荐应用。     

不同剂量米非司酮及合并双炔失碳酯用于紧急避孕的多中心随机临床研究

目的了解在无保护性交后９６小时内应用不同剂量米非司酮及与双炔失碳配伍用于紧急避孕的效果及其副反应。方法将无保护性交后９６小时内的２４００例健康育龄妇女随机分为４组（每组６００例）,分别予单次口服２５ｍｇ米非司酮、２５ｍｇ米非司酮加７．５ｍｇ双炔失碳酯、１０ｍｇ米非司酮加５ｍｇ双炔失碳酯及１０ｍｇ米非司酮。按Ｄｉｘｏｎ法推算避孕有效率。结果除２例接纳错误和１１例失访外,２３８７例妇女的总预期妊娠数为１７１．９例,实际妊娠３２例。４组的避孕有效率分别为８０．９％、８５．３％、９０．６％和６７．３％。１０ｍｇ米非司酮配伍５ｍｇ双炔失碳酯的避孕失败率０．７％,显著低于单次口服１０ｍｇ米非司酮者（２．２％）（Ｐ＜０．０５）。４组的诱导性出血发生率分别为９．２％、４．９％、３．４％和６．７％,配伍双炔失碳酯后诱导性出血发生率明显低于单次口服米非司酮者（Ｐ＜０．０１）。结论２５ｍｇ米非司酮或者１０ｍｇ米非司酮合并５ｍｇ双炔失碳酯为安全有效的紧急避孕方案,无严重副反应及对月经周期的明显干扰     

654例育龄妇女使用比林斯法一年的临床效果

目的: 观察比林斯法用于避孕的临床效果。方法:对2002年4月~2003年8月期间,654例自愿应用比林斯法避孕的育龄妇女,统计12月内的续用、停用、意外妊娠率。结果:654例妇女共观察了7 644个妇女月。1)12个月内的净累积续用率81.89%,停用率18.81%, 意外妊娠率0.98%;2) 654例中有7例意外妊娠,其中1例可能与方法学有关;3)经统计对象的年龄、文化程度与累积继续使用率、停用率和意外妊娠率间无相关性(P>0.05)。结论:比林斯法不仅简单、易接受、无副反应,而且在计划生育知情选择中连续使用率高,故可在全国有组织、有计划地培训教员和推广应用,为提高妇女的生殖健康服务。     

花式280与宫铜300宫内节育器临床效果比较

目的探讨花式280与宫铜300两种宫内节育器(IUD)规范应用1年的临床效果、可行性和可接受性。方法采用前瞻性研究方法,自2007年7月1日至2008年12月30日,在甘肃农村已婚育龄妇女中随机放置花式280与宫铜300各1070例,共2140例,1年末的随访率为100.00%。结果使用满12个月时,花式280和宫铜300的累积续用率分别为97.57/100妇女和97.66/100妇女,累计妊娠率分别为0.19/100妇女和0.47/100妇女,累计脱落和下移率分别为1.51/100妇女和1.69/100妇女,累计终止率分别为2.43/100妇女和2.34/100妇女,累计因症终止率分别为0.65/100妇女和0.37/100妇女。最常见的副反应为出血和疼痛。结论规范应用花式280与宫铜300可有效提高避孕方法的使用效果,两种IUD避孕效果好,值得进一步推广应用。     

A 10-year follow-up study of contraceptive Norplant implants.

OBJECTIVES: To evaluate the long-term efficacy and health problems associated with Norplant implants and re-implants after 5 full years of first implants. METHOD: From 1984 to 1988, 1657 women accepted first implants of Type I and Type II of Norplant, and 394 first acceptors had a re-implant, at a clinic for study. The clinical records and annual follow-up data of acceptors were analyzed. The life-table technique was the main method used. RESULTS: The continuation rates were very high. The cumulative pregnancy rates at 1, 3 and 5 full years of use were 0.0%, 0.1% and 0.7%, respectively. Users with heavier body weight had higher pregnancy rates. The rate of menstrual disturbances peaked at 73% after 3 months and consistently decreased to 20% at 5 years of use. Rates of menstrual disturbances associated with re-implants were much lower. CONCLUSION: Norplant is extremely effective and safe for long-term use.     

Norplant implants: the mechanism of contraceptive action

OBJECTIVE: To determine if fertilization occurs unnoticed among Norplant users who are ovulatory. DESIGN: Serial blood samples were obtained during 1 month from sexually active Norplant users experiencing regular menstrual bleeding patterns and a control group of noncontracepting women trying to conceive. The sequential blood samples were assayed for the presence of human chorionic gonadotropin (hCG). SETTING: All samples were obtained from women receiving contraceptive service and health care at the Center for Research and Services in Human Reproduction and Contraception, Santo Domingo, The Dominican Republic. Assays for hCG were performed at the Department of Biomedical Sciences, University of Tampere, Finland. PATIENTS, PARTICIPANTS: A total of 32 women using Norplant implants were enrolled in the treatment group, and 20 women of proven fertility who were attempting to conceive served as a control group. INTERVENTIONS: Duration of Norplant use was as follows: 4 in the 2nd year of use, 13 in the 3rd year, 11 in the 4th year, 3 in the 5th year, and 1 in the 7th year. MAIN OUTCOME MEASURE: The determination of pregnancy was based on the presence of hCG in the luteal phase, using a sensitive and specific immunoenzymatic assay that can detect dimeric hCG as early as 7 days after ovulation. RESULTS: Nine pregnancies were detected. All were in the control group trying to conceive. Six of these advanced to clinical pregnancies, and three did not proceed beyond the next expected menses. None of the Norplant users had evidence of hCG production, whether the observed cycles were anovulatory or ovulatory. The probability of finding no pregnancies in the ovulatory months at risk among Norplant users is between 1 in 50 and 1 in 150,000. The null hypothesis that Norplant users conceive at a natural rate can be rejected at the 0.05 level. CONCLUSION: Interruption of early pregnancy (menstrual abortion) does not play a role in the mechanism of action of Norplant contraceptive implants.     

国产长效皮下埋植避孕剂与Norplant多中心临床对比研究

目的 :观察两种国产皮下埋植避孕剂 I型、II型和 Norplant埋植剂的避孕效果、副反应和可接受性。方法 :采用前瞻性、随机分配原则的研究方法 ,在全国 1 0个临床中心开展本专题临床研究。统一研究方法 ,统一科研表格。每年随访一次 ,共随访 5年。结果 :共接收对象 2 999例。国产 型组 1 0 0 1例 , 型组 1 0 0 0例 ,Norplant组 998例。 5年随访率为 99.8%。 5年末 ,国产 型组 ,妊娠 3例 ,粗累积妊娠率 0 .4/1 0 0妇女。国产 型组 ,妊娠 5例 ,粗累积妊娠率 0 .7/1 0 0妇女。Norplant组无妊娠 ,三组间无统计学差异 ( P>0 .0 5 )。三组均无宫外孕发生。 5年末 ,三组共终止 82 2例。继续累积使用率 ,分别为 73.9,68.4和 75 .5 /1 0 0妇女。经 Log- Rankχ2 检验 ,三组无统计学意义 ( P>0 .0 5 )。月经问题是终止的主要原因。随埋植时间延长 ,月经出血模式正常比率明显增加。血红蛋白有上升趋势。 5年内未发生重大健康问题。结论 :国产皮埋剂 I型、II型和 Norplant是高效、长效、安全的节育方法     

The significance of bleeding patterns in Norplant implant users

The purpose of this study was to examine the bleeding patterns of 234 Norplant users during 5 years of use and to identify the bleeding patterns of users who conceived. During the first year of use, 26.6% of users had regular bleeding cycles, 66.3% had irregular cycles, and 7.1% were amenorrheic. By the fifth year of use, 62.5% of users had regular cycles, 37.5% had irregular cycles, and none had amenorrhea. Of the ten users who became pregnant, eight had regular menstrual cycles in the 6 months before the diagnosis of pregnancy, one had an irregular pattern, and one did not keep a bleeding record. None had amenorrhea. The 5-years cumulative pregnancy rate for patients with regular cycles was 17.4%; this was significantly higher (P less than .05) than the 5-year cumulative rates of 4.4% in users with irregular cycles and 0% in users with amenorrhea. This study indicates that during the first year of Norplant use, only 26.6% of users have regular cycles, but after the first year, 50-60% of users develop regular cycles. The bleeding patterns of women using Norplant improve after the first year of use, and those with regular cycles are at greatest risk for method failure.     

Norplant: reasons for discontinuation and side-effects.

OBJECTIVE: To study the side-effects and reasons for the discontinuation of Norplant. METHODS: The study was based on the analysis of the medical records of 265 Norplant users, who obtained Norplant from two clinics of the Family Planning Association of Pakistan and who were followed for 5 years. RESULTS: The most common reason (29.4%) for the discontinuation of Norplant was menstrual disturbances, followed by medical problems (4.1%), desire for more children (3.1%) and family problems (3.1%). The major side-effects were weight gain, breast tenderness, headache and dizziness. Only 7.7% of users mentioned any change in sexual behavior and 69.6% of the complaints leading to Norplant removal developed within 6 months of insertion. CONCLUSION: The extent and nature of the side-effects experienced by Pakistani women using Norplant are similar and comparable to those reported from other countries.     

国产18甲基炔诺酮皮下埋植剂和Norplant的临床比较性研究——666例4年报告

本文旨在研究国产18甲基炔诺酮皮下埋植剂避孕的有效性及其副反应,与Norplant作比较.666例对象经过4年观察.国产组共发生4例妊娠,4年累积妊娠率为1.07/100妇女,年平均妊娠率为0.27/100妇女,4年累积的续用率为76.6/100妇女.与国外Nor-Plant组相比较,都无统计学差异.两组副反应亦相似,主要均为月经失调,占终止者的半数以上.国产组的左旋18甲基炔诺酮的血药水平下降得较快,2年以后略低于Norplant组,但到48个月时仍在抑制排卵的血药水平.4年临床观察国产组与Norplant相似,都具有长效、高效、可逆、稳定的优点,是可供育龄妇女选用的新避孕法.     

Two-year prospective study in Colombia of Norplant implants

A clinical trial of levonorgestrel-releasing Norplant implants used for contraception was undertaken in two cities in Colombia. Through two years in which 389 women had accumulated 594 years of use, there were no pregnancies. In a comparison group of copper intrauterine device acceptors, the one-year pregnancy rate was 1.1 per 100. Menstrual disturbances associated with progestin-only administration were the principal side-effects, and the major reason for cessation of use. Continuation among users of the implants was at the same or at a higher rate than observed among users of the intrauterine device. Advantages and disadvantages of alternate sites for implant placement are discussed.     

使用Norplant皮下埋植剂阴道流血模型分析

上海医科大学妇产科医院自1984年引进Norplant,进行"中国妇女对Norplant可接受性研究"共观察1657例,木文对开始使用的548例对象的月经卡进行分析,目的是观察使用 Norplnt皮下埋植剂对象的阴道流血变化规律。结果显示使用 Norplant避孕的妇女阴道流血总和（包括滴血、流血和严重流血）的平均天数和滴血天数,在第1个90天的参考时限中分别为33．0天和21．5天;在第4个参考时限中分别为26．7和13．8天;到第20个参考时限分别降低至20．2和9．5天。闭经者在各个不同的参考时限分别占0．5～5．4％。结论是使用Norplant皮下埋植剂的妇女,总和的阴道流血天数随着使用时间的延长而逐渐减少。主要是"滴血"天数减少,而"流血"和"严重流血"的天数变化不大。