Implanon use in Thai women above the age of 35 years

A prospective study of Implanon implant use in women older than 35 was conducted in Bangkok, Thailand. The purposes of this study were to evaluate the menstrual pattern and side effects of Implanon in 51 women followed for 6 months. Their mean age was 39.7 years. Most acceptors had completed primary school. No accidental pregnancies occurred in 6 months of use. The most common menstrual pattern in these acceptors was irregular bleeding followed by amenorrhea. The major side effect was irregular bleeding. There was no significant change in body weight, body mass index and diastolic blood pressure during the 6-month follow-up period, but systolic blood pressure declined. Implanon implant use is a safe and effective contraceptive method and should become another choice for contraception in women aged above 35 years who have contraindications for oral contraceptive use.     

Use of Norplant implants in the immediate postpartum period among asymptomatic HIV-1-positive mothers

A prospective cohort study of Norplant use in the immediate postpartum period among asymptomatic HIV-1-positive women was conducted in Bangkok, Thailand. The objectives of this study were to evaluate side effects and menstrual patterns of the Norplant system in this group. A total of 88 asymptomatic HIV-1-positive mothers were recruited for this study. All of them voluntarily accepted the use of the Norplant implant as a contraceptive method immediately postpartum. Their mean age was 24.9 years. Most of them had completed primary school. The follow-up period was 24 weeks. There were eight participants lost from the study because of loss of contact. Irregular bleeding was the most common menstrual pattern in these participants. The major side effects were headache, followed by hair loss. No subject terminated Norplant use during the study period. The Norplant implant appears to be safe and well tolerated in asymptomatic HIV-1-positive parturients when inserted immediately postpartum.     

NorplantR contraceptive subdermal implants: Two-year experience in Singapore

Norplant contraceptive implants are Silastic containing levonorgestrel implants. This study describes our two-year experience with 100 acceptors of Norplant implants in Singapore. No pregnancies occurred during the first two years of use. Desire for planned pregnancy and disruption of menstrual rhythm were the two main reasons for twenty implant removals during the two years. The continuation rate at the end of two years was 79%. The post-removal conception rate in women desiring pregnancy was 90% at the end of one year. It thus appears that the Norplant contraceptive system offers a highly effective, acceptable, reversible and safe method of contraception.     

三种皮下埋植避孕剂对农村妇女月经影响的比较性研究

采用随机方法在辽宁省北宁地区选择40岁以下健康经产妇女埋入国产Ⅰ型、Ⅱ型和Norplant皮埋剂各100例,按照统一标准随访,对于皮埋后主要副反应月经问题进行追踪观察和分析。结果:由于人们已经逐渐了解皮下埋植避孕法,尤其农村妇女对其引起不垫月经垫的出血的耐受力较强,主诉月经问题及月经日记分析的流血、滴血天数低于以往文献报道,主要是因平均滴血天数不同的原因。埋植者对月经稀发问题并不反对,对埋后闭经者约半数可接受。通过月经日记分析,在使用第一年约有70％妇女出现月经异常,与文献报道相符。对于典型的异常出血(包括年度内出现≥90天不出血者和出现持续出血≥14天者)对接受者体重并无影响,三组P>0.05。三组埋植者血红蛋白在正常范围内有增无减,至2年均有显著差异,P<0.01。本文提示皮下埋植后妇女可能改变既往传统的月经规律,只要不是长期不规则出血、出血期过长及出血过频较严重或过长的闭经则不必担心,也不需处置,良好的咨询及等待即可,一般可接受的异常出血对妇女健康并无影响,埋植剂一经取出,大部分在60天内恢复月经。     

DMPA use above the age of 35 in Thai women

A prospective study of depot-medroxyprogesterone acetate (DMPA) use in women aged above 35 years was conducted in Bangkok, Thailand. The objectives of the study were to evaluate efficacy, continuation rate, and side effects of DMPA use in these women. A total of 60 women were enrolled in a one-year clinical trial. Their mean age was 38 years. Most of them had completed primary school. No accidental pregnancies occurred throughout the 1-year use in this study. The continuation rate was 20%. Irregular bleeding was the major cause of termination. The major side effect was also irregular bleeding. Nevertheless, DMPA in older women is a safe and effective contraceptive. DMPA is a contraceptive akterbatuve fir women aged above 35 with contraindications to combination oral contraceptives.     

Statement on Norplant subdermal contraceptive implant system

At its September 1985 meeting, the International Medical Advisory Panel of the International Planned Parenthood Federation drafted a statement concerning Norplant, the subdermal contraceptive implant system developed by the Population Council. The statement, intended for use by physicians, administrators, and other health personnel in the field of family planning, summarizes current knowledge of this means of fertility control. Norplant is particularly recommended for women who seek longterm protection from pregnancy, but either may desire another child in the future or do not wish to undergo sterilization. Insertion during the 1st 7 days after menstruation onset, or immediately postabortion or postpartum (in nonbreastfeeding women), is advised. Capsules should be removed after 5 years of use. Annual pregnancy rates range from 0.2-1.3/100 women/year, with a cumulative pregnncy rate of 5 years of 2.6. The most frequently reported side effect is irregular menstrual bleeding, especially during the 1st year of use. Continuation rates are 60-90% at the end of the 1st year, and about 50% after 5 years. Counseling, especially regarding bleeding irregularities, is critical to continued acceptability. 40% of women who request Norplant removal in order to conceive become pregnant within 3 months of removal, and 76% achieve pregnancy within 1 year. Epidemiologic studies of the longterm safety of Norplant implants are under way. It is noted that program use of Norplant poses several managerial challenges. Formal training in insertion and removal techniques, as well as the risks and benefits of the method, must be planned and back-up and referral facilities identified. Since Norplant is a new delivery system, a carefully designed public information system is also important.     

Norplant contraceptive implants: a new contraceptive for women

This article summarizes current knowledge on the mechanism of action, side effects, and effectiveness of Norplant contraceptive implants. The most common side effect of the implant method is its disruption of the menstrual cycle, especially in the 1st few months of use. Long intervals without frank bleeding may occur and be misinterpreted as pregnancy in women who have not been counseled about this possibility. The average annual continuation rate was 84/100 in a study of 324 women from several countries who were followed for 5 years after Norplant implantation. The net cumulative pregnancy rate for the 5-year study period was 0.6/100. Reasons for method termination included menstrual problems, other medical problems (headache, depression, fatique), planning pregnancy, and other personal reasons (change in marital status, change in residence). To provide training for doctors, nurses, and counselors, the Population Council has established a network of 5 training institutions. Within the next few years, drug regulatory agencies are expected to approve use of Norplant implants in many countries. Although at present the method is available only in Finland and Sweden, Thailand and Indonesia are considering the method and clinical trials are underway in India, China, Brazil, and the US. A consulting committee of the World Health Organization has concluded that Norplant implants are a suitable contraceptive method for use in family planning programs.     

国产Ⅰ型、Ⅱ型埋植剂与Norplant使用第1年阴道出血模式的观察与比较

为了解两种国产埋植剂对阴道出血模式的影响,并与Norplant进行比较,对自1993年11月1日～1994年5月31日随机接受的857例埋植剂使用者记录的月经卡(其中国产Ⅰ型288份,国产Ⅱ型292份,Norplant277份),采用WHO推荐的参考时段法进行统计分析。结果:各项统计指标三组间差异均无显著意义;总出血天数和滴血天数各参考时段均有减少,自第3参考时段起差异有显著意义;各种出血类型的发生率三组间无差异,有基本正常出血类型的人数自第2参考时段明显增加,为30％～35％;出血不规则的发生率自第2参考时段明显减少,为34％～41％,但仍为各种异常出血的首位;再次使用埋植剂者的总出血天数和出血天数均少于首次使用者,差异有显著意义。初步认为两种国产埋植剂在使用后第1年中对阴道出血模式的影响与Norplant相似,阴道总出血天数随滴血天数的减少而缩短;与使用初期相比,使用三种埋植剂后三个月,有基本正常出血类型的人数明显增加,出血不规则的发生率明显减少,出血不规则是埋植剂使用后月经紊乱的主要表现;再次使用者的出血情况好于初次使用者。     

A five-year clinical evaluation of NORPLANT contraceptive subdermal implants in Bangladeshi acceptors

A non-comparative study of the Norplant contraceptive subdermal implant system was conducted in Dhaka, Bangladesh. The study was designed to evaluate the contraceptive efficacy, safety and overall acceptability of Norplant implants. Six hundred women were enrolled in the clinical trial, which began in 1985 at three study sites. Follow-up visits were scheduled at 1, 3, and 6 months after Norplant implant insertion, and every six months thereafter until removal or at the end of five years. There were no post-insertion pregnancies during Norplant implant use in this study. After five years of Norplant implant use, there was no clinically significant change in body weight, systolic or diastolic blood pressure. Less than 3% of the women ever reported having any significant medical problems such as migraine, respiratory or cardiac problems during the study. The gross cumulative continuation rate was 41.2 per 100 women at the end of five years. The two most frequently reported reasons for discontinuation during the study were menstrual problems and desired pregnancy. Of the women who completed the five-year user satisfaction questionnaire, the majority of the women (86.3%) planned to continue using contraception after study completion. Of these women, approximately one-third said they planned to use another Norplant set. The findings presented suggest that the Norplant system is a highly effective, safe and acceptable method among Bangladeshi women.     

国产皮下埋植剂多中心研究

目的:评价两种国产皮下埋植剂的避孕效果、副反应和继续使用率。方法:分两期进行。第一期为国产Ⅰ型、Ⅱ型皮下埋植剂与Norplant进行前瞻性临床对比研究,各100例,共300例。第二期为国产皮下埋植剂扩大临床应用,接受合格对象Ⅰ型999例,Ⅱ型998例,共1997例。随访5年。结果:5年随访率为99.5％。第一期国产Ⅰ型、Ⅱ型皮下埋植剂和Norplant的5年累计妊娠率分别为0/百妇女、1.0/百妇女、0/百妇女,5年继续使用率分别为77％、80％、80％,差异均无统计学意义(P>0.05)。主要副反应为月经紊乱,月经卡分析显示3种埋植剂的出血模型相似。第二期国产Ⅰ型、Ⅱ型皮下埋植剂5年累计妊娠率分别为0.20/百妇女,2.10/百妇女,5年继续使用分别为84.47％、82.28％。使用埋植剂6个月Ⅰ型和Ⅱ型月经问题主诉发生率分别为50.88％、57.16％,差异有显著意义(P<0.01),但随着使用时间延长,月经紊乱主诉发生率逐渐下降,两组间无差异。结论:5年研究表明两种国产皮下埋植剂的避孕效果、副反应发生率和继续使用率与Norplant相似,也是一种高效,长效的避孕制剂。国产皮下埋植剂Ⅱ型使用至第5年避孕失败率明显增加,建议国产Ⅱ型皮下埋植剂使用期限在3～4年为好。     

国产皮下埋植避孕方法多中心研究

本研究在全国11个省100个分中心对国产Ⅰ型和Ⅱ型皮下埋植剂进行临床多中心比较研究,共接收合格对象19673例,目前已完成二年随访。二年随访率94.29％,累计继续使用率分别为88.89,％(Ⅰ型)和89.93％(Ⅱ型),Ⅱ型显著高于Ⅰ型,二年累积妊娠率Ⅰ型和Ⅱ型分别为每百妇女0.0462和0.281,其间呈显著性差异。Ⅰ型埋植剂无异位妊娠发生,Ⅱ型埋植剂发生异位妊娠3例,发生率为0.163/1000妇女年。副反应的发生率有随时间增长而减少的趋势。主要副反应为月经失调,占副反应的90％以上。月经异常中月经频发、不规则出血和点滴出血的发生率高于月经稀发/量少和闭经。闭经和月经稀发/量少的发生率Ⅰ型高于Ⅱ型。二年观察中,因月经问题而终止使用者占总终止人数的78％,与月经问题有关的二年累积终止率Ⅰ型为每百妇女8.96,Ⅱ型为7.84,差别有显著性。二年观察研究表明,两种国产皮下埋植剂的副反应发生率和避孕效果以及二年的续用率与Norplant相似。     

Bleeding patterns of adolescents using a combination contraceptive injection for 1 year

PURPOSE: This prospective observational study evaluated the bleeding patterns of adolescents receiving a monthly injectable contraceptive containing norethisterone enanthate 50 mg plus estradiol valerate 5 mg. MATERIALS AND METHODS: The study enrolled 73 volunteers aged between 14 and 19 years; of these patients, 38 (52%) recorded their menstrual cycles during 1 year. RESULTS: After 1 year of using the contraceptive, most of the 38 women (71.1%) had adequate menstrual patterns (two to four bleeding episodes; none lasting 10 days or longer; with a range of bleeding-free intervals not exceeding 17 days), 23.7% reported prolonged bleeding episodes, 2.6% had irregular bleeding and 2.6% had amenorrhea. Only 1 of the 38 teenagers is known to have discontinued the method due to bleeding. Among these 38 adolescents, dissatisfaction with bleeding patterns was not a frequent reason given for discontinuation of the monthly injectable contraceptive.     

Norplant皮下埋植避孕150例临床研究

目的:探讨Norplant皮下埋植避孕的效果。方法:选择Norplant皮下埋植避孕妇女150例作为治疗组,以宫内节育环避孕妇女150例作为对照组,比较两组使用情况、避孕效果和月经紊乱情况。结果:5年后随访,治疗组因不适取出32例,取出率为21.33%,其余118例全部达到避孕效果,有效率100.00%;期间出现月经紊乱58例,发生率为49.15%;对照组因不适取出或自行脱出10例,取出率为6.67%,其余140例中达到避孕效果115例,有效率82.14%,出现月经紊乱33例,发生率为23.57%。两组避孕效果、月经紊乱和不适失败率比较均具有统计学差异(P<0.01)。结论:对生育期要求避孕妇女行皮下Norplant埋植避孕手术可达到有效的避孕效果,但月经紊乱发生率相对较高,宫内节育环避孕有效率较皮下Norplant埋植避孕手术低,但月经紊乱发生率亦较治疗组低。使用Norplant埋植避孕如何减少月经紊乱,仍是今后值得探讨的一个问题。     

狄波-普维拉长效避孕针在上海市育龄妇女中的应用

为验证每三个月注射一次的醋酸甲孕酮避孕针(狄波-普维拉),是否适于中国妇女应用,1995年10月起在上海市区(县)7家医院试用,共接纳451例,其中哺乳期208例,非哺乳对象243例,共使用3708妇女月,有效率100％,一年期因症停用率39％,因社会因素停用15.7％,早期副反应以滴血及少量不规则出血为主,后期闭经发生率上升,以90天为月经记录参照时期,第一至第四参照时期出血(滴血)过长,人数由65.8％降至23.3％,闭经人数由6.2％升至45.2％,未发生严重并发症;哺乳期或35岁以下妇女副反应发生率低于非哺乳或年龄≥35岁者(P<0.05),证明醋酸甲孕酮为高效、长效、安全、方便的避孕措施,尤其适宜于产后42天妇女使用,可减少产后早期及哺乳期人工流产,更适用于反复避孕失败的年轻妇女。     

Norplant

Norplant capsules and Norplant 2 rods contain levonorgestrel (LNG) that is released slowly for up to 2000 days. After removal the progestogen vanished from the blood stream within 96 hours, and fertility is restored in contrast to the pill contraceptives. Norplant provides a cervix barrier against spermatozoa. About 1/2 of women taking it had anovulation or luteinization of unruptured follicles. In ovulating women the midluteal progesterone values were clearly reduced. There have been some reports concerning the increased aggregation of thrombocytes and the decline of high density lipoprotein (HDL) cholesterol levels in Norplant users. Thrombosis, cerebro- and cardiovascular accidents have not been reported. A longterm prospective study of Norplant 2 users showed an unacceptably high rate of pregnancies after the 4th year, thus the rods have to be replaced after 3 years instead of 5 years. 23% of Norplant 2 and 41% of Norplant users had to resort to removal because of side effects. 54% of Norplant and 48% of Norplant 2 users halted use after 3 years because of menstrual disorders, irregular bleeding, depression, and mood changes. LNG has high affinity to sex hormone binding globulin (SHGB), and it is not active in bound form. The free LNG index was lower in women with unwanted pregnancies than in other women. In 1989 the Population Council reported on 7 phase-3 investigations involving 2470 women. Only 398 completed the 5-year observation period: the cumulative pregnancy rate was 3.5, there were 3 pregnancies among those with body weight of 50-60 kg and 8.6 pregnancies among those weighing 70 kg or more. There were 101 unwanted pregnancies, and 1 child was born with intersexual genitals. Endometrium biopsy or curettage is advised in the event of irregular bleeding especially in women over 40, and about 25% of Norplant users have undergone these procedures.     

Enhanced metabolism of levonorgestrel during phenytoin treatment in a woman with Norplant implants

A 26-year-old woman, treated with phenytoin for 10 years because of epilepsy, had Norplant subdermal implants inserted after a legal abortion. She became pregnant again after nine months of Norplant use. Her plasma levonorgestrel (LNG) levels were followed during one month during phenytoin treatment and then later during one month after discontinuation of phenytoin. During phenytoin treatment, plasma LNG levels were markedly below the levels found in healthy women with Norplant. There was a pronounced, statistically significant increase in plasma LNG levels after discontinuation of phenytoin. The plasma levels of sex hormone binding globulin were markedly above those found in normal healthy women during treatment with phenytoin and decreased significantly after cessation of phenytoin. The effects on the pharmacokinetics of LNG were reflected by effects on the menstrual cycle. During phenytoin treatment, the woman had regular ovulatory menstrual cycles. After cessation of phenytoin, her cycles became irregular and during the study period of one month, no signs of ovulation were found. It is concluded that treatment with phenytoin during use of Norplant subdermal implants enhances the metabolism of LNG to an extent where the contraceptive efficacy is endangered.     

WHO 86925 Norplant上市后监测(中国部分)

本课题研究目的是对Norplant皮下埋植剂潜在副作用进行监测,以进一步证实其安全性。对使用Norplant和IUD或绝育术的妇女进行比较随访研究。每半年随访一次,详细记录所有健康情况,共随访5年。随访率达99.9％。结果:Norplant组及对照组IUD和绝育术的5年继续使用率分别为76.25、80.89、98.10/100使用者。Norplant的5年累计妊娠率为0.6/100使用者,远低于IUD的8.11/100使用者,宫外孕发生率为0.46/1000妇女年,低于IUD的1.24/1000妇女年,但宫外孕和妊娠之比在Norplant组为31.6:100,远高于IUD的6.7:100,如发生妊娠,要警惕宫外孕的可能。月经问题是Norplant的主要终止使用原因,但使用5年者,其血红蛋白均值上升,和接收时相比P<0.001,而IUD使用5年者,其血红蛋白均值下降,和接收时相比P<0.01。在观察5年中胆囊炎胆石症、纤维囊性乳腺病在Norplant使用者中的发病率高于对照组,P<0.05～0.001,但未发现重大健康问题。Norplant使用5年是安全的。     

皮下埋植避孕剂用于临床避孕的疗效研究

目的:对皮下埋植剂避孕剂避孕的临床疗效及安全性进行研究,对其临床应用的前景进行展望。方法:对2007年4月～2008年4月在东台市计划生育指导站实行避孕术的妇女进行回顾性分析,选取98例符合标准者,观察组使用皮下埋植避孕剂进行避孕,对照组使用宫内节育器进行避孕。对两组研究对象避孕效果、术后阴道出血、月经情况、放置率、患者满意率等临床数据进行比较。结果:术后对患者随访5年,观察组有效率为97.9%,较对照组91.3%有优势。观察组出现不良反应4例,不良反应率为8.5%;对照组出现不良反应11例,不良发应率为23.9%,观察组不良反应率低于对照组(P<0.05)。观察组在放置率及患者满意率明显优于对照组。结论:皮下埋植避孕剂在临床避孕的使用中,具有避孕率高,不良发应少,放置率高等优势,受到临床医患的认可,适于推广使用。     

A randomized multicenter study comparing the efficacy and bleeding pattern of a single-rod (Implanon) and a six-capsule (Norplant) hormonal contraceptive implant.

To compare the contraceptive efficacy, tolerability, and bleeding patterns, 200 healthy female volunteers received, in an open, comparative, randomized, multicenter study in China, either a single-rod (Implanon) or a six-capsule (Norplant) contraceptive implant for 2 years with an optional extension of up to 4 years. Women were exposed to Implanon for 341.6 woman-years and Norplant for 329.1 woman-years. There were no pregnancies during the study. Per 90-day reference period, the median number of bleeding/spotting days with Implanon decreased from 33.5 in the first period to 19.0-21.5 days in the last year. Similarly, with Norplant, the median number of bleeding/spotting days decreased from 34.5 to 18.0-23.0 days, respectively. The number of bleeding/spotting episodes during year 1 was 2.0 per 90-day reference period with Implanon and 3.0 per period with Norplant (p < 0.05 for periods 1-4). For the remaining 90-day periods, there was no statistical difference between the two groups. In general, there was less frequent bleeding with Implanon compared with Norplant, whereas the incidences of amenorrhea and infrequent bleeding were higher with Implanon than with Norplant. The mean overall incidence of prolonged bleeding fell markedly during the study, from 66.0% in reference period 1 to 27.3% in period 16 with Implanon and from 69.0% to 21.7% with Norplant, respectively. The most common adverse events were related to disturbed bleeding patterns, which were also the major reasons for discontinuation (Implanon n = 8; Norplant n = 14). Normal menses returned in almost all subjects within 3 months after removal of the implants. Implanon was inserted in a mean time of 0.61 min and Norplant in 3.90 min (p < 0.001). Similarly, the mean time required to remove the implant was significantly shorter for Implanon than for Norplant (2.18 min vs 11.25 min, p < 0.001). The maximum time required for removal of the implant was 10 min for the Implanon group and 60 min for the Norplant group. In both groups, blood pressure and hemoglobin were not affected, whereas body weight tended to increase. It can be concluded that both contraceptive systems demonstrated excellent contraceptive efficacy and were well tolerated. Compared with Norplant, there was less frequent bleeding with Implanon, whereas the incidence of infrequent bleeding and amenorrhea was higher. Implanon was significantly quicker to insert and to remove than was the multiple capsule system.     

皮下埋植避孕剂临床多中心对比研究

对两种国产皮下埋植避孕剂与 Norplant 进行前瞻性临床对比研究,以了解在避孕效果、临床副反应及续用率方面有无差异。全国10个省市分别承担国产Ⅰ型、Ⅱ型和 Norplant 各100例,采用前瞻性、随机化的临床对比研究。根据统一的科研计划、记录表格和定期随访,资料集中统计和处理。共接收国产Ⅰ型1 001例,国产Ⅱ型1001例,Norplant 998例。一年时的随访率为99.3%,1年内避孕失败1例,因各种原因的终止率分别为每百名妇女3.9、3.7和3.9,因月经问题而终止者分别占总终止的79%、73%和77%,一年末的续用率分别为96.1%、96.3%和96.1%,三组之间均无差异。两种国产皮下埋植剂均为一种高效的避孕方法,副反应发生率、因症终止率和续用率均与 Norplant 相似,在全国不同地区、不同群体之间和 Norplant 一样具有较高的可接受性,可供广大育龄妇女选用。