第一、二、三代口服避孕药的发展和现状

<正> 复方口服避孕药(combined oral contraceptives,COCs)是使用甾体激素作为控制生育的方法,于20世纪50年代末问世以来,改变了整个节育技术和计划生育的形势。第一代甾体避孕药的诞生是20世纪计划生育领域的里程碑。70～80年代国际上又陆续合成雌激素效应更低、避孕效果更好的第二代和第三代口服复方短效雌、孕激素避孕药。我国于60年代和70年代先后合成了第一代孕激素炔诺酮和甲地孕酮以及第二代孕激素炔诺孕酮。避孕药的发展大致为:①降低雌、孕激素剂量以减少副反应,主要是对碳水化合物、蛋白、脂肪三大代谢的影响,从而减少对心血管、内分泌和肿瘤的影响。②合成不同类型、新的、具有高活性的孕激素如第二代的左炔诺孕酮和第三代的去氧孕烯(地索高诺酮)和孕二烯酮。③改变剂型:有口服短效、长效、和单方孕激素制剂,针剂和缓释     

我国短效口服避孕药安全性系统评估

目的:评估0、1、2号片、复方左炔诺孕酮单相片和复方左炔诺孕酮三相避孕片的安全性。方法:见“我国常用口服避孕药和宫内节育器系统评估的方法概述”(中国计划生育学杂志,2005年1期17页)。结果:共检索到83篇相关文献,入选20篇。与服药前相比,国产1、2号片和复方左炔诺孕酮单相片对妇女脂代谢的某些指标有影响。与IUD相比,1号片可升高妇女的舒张压。上述脂代谢和血压的改变均无临床意义。0、1号片可能增加心血管意外的风险,但这些影响都较小。结论:国产1、2号片和复方左炔诺孕酮单相片对使用者的脂代谢和血压改变有影响,0、1号片可能增加脑血管意外风险,考虑到心血管意外在年轻健康妇女(≤35岁)中发病率很低,且被评估的短效口服药的雌激素剂量≤35μg/片,故认为被评估的短效口服避孕药对年轻健康使用者心血管疾病的绝对风险很小。     

含有第三代孕激素成份的复方口服避孕药

第三代孕激素是在左旋18甲基炔诺酮的基础上研制产生,包括地索高诺酮、孕二烯酮及肟炔诺酯。主要特点为具有很强的孕激素效能而雄激素活性很小,因之这类复方口服避孕药配方中的甾体剂量减少而避孕效果不变,副反应发生率降低,对脂代谢变化无不利影响。目前已有大量临床观察资料,妊娠率均小于1/100妇女年,周期控制良好。     

国产探亲避孕药的评估

目的:评估我国5种探亲避孕药的有效性、副反应、安全性及可接受性。方法:检索相关文献并对纳入评估系 统的探亲避孕药进行数据分析。结果:共检索到50篇相关文献,11篇文献被纳入本评估,其中4篇为无对照的临床 试验,7篇为一期临床试验。根据有限的资料分析,探亲避孕片1号及53号探亲抗孕片早期服用方案的避孕失败率 在3.5～16.4/100妇女年之间。一期临床试验显示服用53号探亲抗孕片后并不能完全抑制排卵。53号探亲抗孕片 还可能抑制乳汁分泌。未检索到探亲避孕片1号及53号探亲抗孕片现用方案及炔诺孕酮速效避孕片、左炔诺孕酮速 效避孕片和炔诺酮探亲丸临床资料。结论:建议在较短时间内逐渐停止使用探亲避孕药。如果需要保留部分探亲避 孕药,需要对其有效性、副反应、安全性重新进行研究。     

孩子误服避孕药有无影响

孩子误服避孕药有无影响误服避孕药对孩子的身体有何影响，多与所服避孕药的种类、性质和其剂量大小有关。众所周知，常用的口服避孕药有短效和长效两种。短效口服避孕药是由孕激素和雌激素制成的复方糖衣片剂，每日服用则起到抑制排卵的目的。长效口服避孕药是由炔雌醚和...     

中国避孕药发展编年表(二)

三、长效避孕药序号品名主要成份新药证书或鉴定生产批准证书国家首次收购时间生产上市或停产时间生产企业炔诺孕酮炔雌醚片(复方长效18一甲口服避孕片、复方甲基炔诺孕酮长效避孕片)每片含炔诺孕酮12mg,炔雌醚3mg(77)国计育办字第28号请安排生产的函,京卫药准字(1996)第101248号1978北京制药厂(北京双鹤药业股份有限公司)每片含炔诺孕酮12mg,炔雌醚3mg苏卫药(80)第19号(生产批复),苏卫药准字(82)2463一l号京卫药准字(94)第016号,京卫药准字(19%)第103040号苏卫药准字(82)2463一l号1977年试产1994年停产1979年生产2(洲洲)年停产1994年生产20…     

我国短效口服避孕药有效性、常见副反应和续用率的系统评估

目的:评估0、1、2号片、复方左炔诺孕酮单相片和复方左炔诺孕酮三相片的有效性、常见副反应和续用率。方法:见“我国常用口服避孕药和宫内节育器系统评估的方法概述”(中国计划生育学杂志2005年1期17页)。结果:共检索到10篇相关文献,4篇入选。在比较1号片、复方左炔诺孕酮单相片和复方左炔诺孕酮三相片的随机对照临床试验中,3组6个月累计妊娠率均小于1.1每百妇女,6个月累计续用率均大于80每百妇女,且3组相似。复方左炔诺孕酮三相片点滴出血、月经延长和缩短发生率均低于1号片,其它常见副反应发生率三者相似。在一项0号片的现况调查中,妊娠的发生率为0,突破性出血达16%以上。未检索到有关2号片有效性和续用率的文献。结论:1号片、复方左炔诺孕酮单相片和复方左炔诺孕酮三相片的有效性及续用率相近;1号片的常见副反应发生率高于复方左炔诺孕酮三相片。现有的资料不足以对0、2号片的有效性和续用率进行系统评估。     

复方左炔诺孕酮用于紧急避孕的临床观察

目的探讨复方左炔诺使用于紧急避孕时的临床反应并加以观察。方法选取200例无保护性性交在72小时内要求紧急避孕的妇女,随机将这些妇女分成A组和B组,分别为100例,A组患者服用4片复方左炔诺孕酮,相隔12个小时后再服用复方左炔诺孕酮4片;B组患者口服1片左炔诺孕酮,间隔12小时后再口服1片。两组研究对象会被定期随访,一直到她们月经来潮为止,与此同时还要观察其避孕效果和副作用与可接受性。结果使用经典方法(Dixon)来计算预期的妊娠数量,两组最后实际上各有1例对象妊娠,A组为83.2%的避孕效果,B组为84.2%的避孕效果,两组百分比在统计学上没有显著差异。结论在避孕效果上复方左炔诺孕酮和左炔诺孕酮的效果相等。     

避孕药事

短效避孕药 关键词:安全 容易漏服 避孕率近100％ 很多人分不清长效、短效、紧急避孕药的区别,以为只要是避孕药都对身体有害.实际上短效避孕药是妇科医生比较推荐的常规避孕方式,因为它的剂量很小,人体能很快代谢掉. 短效口服避孕药是由雌激素和孕激素配制而成的复方药物,通过抑制排卵、阻止精子穿透、抗着床等机制达到避孕的目的,从而实现接近100％的高效避孕.     

新型口服避孕药可能增加血栓风险

<正>对服用任何复方口服避孕药(含有雌激素与孕激素)的妇女来说,其血栓的总体风险仍然相对较低,每1万名服用药物的妇女中,每年额外增加6~14例病例。但近日,英国一项大型研究表明,服用新型口服避孕药的人群发生血栓的风险更高。静脉血栓栓塞(VTEs)在服用雌激素药物的妇女中更为常见,如果血栓移动并运行到心脏、大脑或肺部则有可能是致命的。新型复方避孕药包括孕激素屈螺酮、去氧孕烯、孕二烯酮或环丙孕酮,与包括左炔诺孕酮与炔诺酮在内的老款药物相比,新型     

Once-a-month contraceptive pills in China: a review of available evidence

OBJECTIVE: A review of evidence was conducted to assess the safety, effectiveness and continuation of once-a-month contraceptive pills. METHODS: Papers were identified by electronic searches in Chinese and international databases and manual searches of Chinese journals and index of family planning literature. Data on pharmacokinetics, clinical performance and laboratory examinations were extracted from 17 papers of mixed quality on pills containing quinestrol 3 mg and norgestrel 12 mg (Quin-Ng) or levonorgestrel 6 mg (Quin-Lng) used by women in China. RESULTS: Quin-Lng pills gave steady-state serum levels of ethinylestradiol between 0.20-0.25 and 0.15 ng/mL. The 1-year perfect use pregnancy rate was 1.1 per 100 women-years. Nausea and increased leukorrhea were common; bleeding control was good. Hypertension developed in 5.8% of Quin-Ng pill users during the first year of use. For Quin-Ng and Quin-Lng once-a-month pills, 1 year continuation rates were 73.6 and 82.1 per 100, respectively. CONCLUSIONS: Lack of good quality data prevents confident assessment of the safety and efficacy of once-a-month pills. Short-term safety information indicates a high incidence of bothersome side effects and hypertension. The high monthly estrogen and progestogen doses raise questions about the safety of the once-a-month pills.     

Serum lipids in Chinese patients using oral contraceptive pills

Eighty-four Chinese patients attending the Family Planning Association of Hong Kong for contraception with oral contraceptive pills were randomized into 2 groups. The first group received pills containing 0.15 mg levonorgestrel and 0.03 mg ethinyl oestradiol. The second group received pills containing 0.15 mg desogestrel and 0.03 mg ethinyl oestradiol. Blood was taken after overnight fast before the use of pills for assay of serum total lipids, triglycerides, total cholesterol and high density lipoprotein cholesterol (HDL-C). The tests were repeated at 1 month, 3 months and 6 months after the use of pills. There was a significant increase in the serum total lipids in the levonorgestrel group but not in the desogestrel group. The serum triglycerides showed a significant increase in the desogestrel group but not in the levonorgestrel group. There was no significant change in the serum total cholesterol levels in both groups. There was a significant decrease in the HDL-C in the levonorgestrel group but there was no significant change in the desogestrel group.     

紧急避孕药系统评估

目的:评估两种(0.75mg双剂、1.5mg单剂)左炔诺孕酮(LNG)及两种低剂量(10mg、25mg)米非司酮(MFP)紧急避孕方案的有效性和副作用。方法:通过电子及手工检索方式检索相关文献,筛选出其中的随机对照临床试验,提取信息并进行Meta分析。结果:共检索到63篇相关文献,其中28篇纳入本评估。结果显示,两种剂量LNG方案有效性及副反应的发生率均相似。在服用紧急避孕药后无性生活的对象中,25mgMFP与10mgMFP(方法失败率)相似,然而25mgMFP总失败率(在所有对象中计算出的失败率)略低于10mgMFP,但差别没有统计学意义。25mgMFP方案恶心发生率比10mgMFP方案略高。10mgMFP方案与单剂1.5mgLNG方案总失败率相似,而前者方法失败率略低。25mgMFP方案方法失败率与总失败率均略低于单剂及双剂LNG方案,但差别无统计学意义。MFP紧急避孕方案月经延迟的发生率比LNG方案高,而后者点滴出血的发生率比前者高。无保护性生活后越早接受紧急避孕,失败率越低。结论:两种LNG方案和两种MFP方案有效性和副反应发生基本相似,由于LNG为传统避孕药物,其安全性已被证实,并为非处方药,故优先推荐使用LNG方案,单剂1.5mgLNG方案更为方便。     

Minimum effectiveness of the levonorgestrel regimen of emergency contraception

The standard method for estimating the effectiveness of emergency contraceptive pills (ECPs) uses external data to calculate the proportion of expected pregnancies averted by the treatment. Because these data may not be applicable to ECP study populations, this approach could result in substantial overestimation of effectiveness. We used data from two published randomized trials of the levonorgestrel and Yuzpe ECP regimens to calculate the minimum effectiveness of the levonorgestrel regimen. Conservatively assuming that the Yuzpe regimen was entirely ineffective in these trials, we estimate that the levonorgestrel regimen prevented at least 49% of expected pregnancies (95% confidence interval: 17%, 69%). Because physiologic data suggests that the Yuzpe regimen does, in fact, have some efficacy, the effectiveness of the levonorgestrel regimen is likely to be higher than our minimum estimate.     

Biphasic versus triphasic oral contraceptives for contraception

Side effects caused by oral contraceptives discourage compliance with and continuation of oral contraceptives. A suggested disadvantage of biphasic oral contraceptive pills compared to triphasic oral contraceptive pills is an increase in breakthrough bleeding. We examined this potential disadvantage by conducting a systematic review comparing biphasic oral contraceptives with triphasic oral contraceptives in terms of efficacy, cycle control, and discontinuation because of side effects.We included randomized, controlled trials comparing any biphasic oral contraceptive with any triphasic oral contraceptive when used to prevent pregnancy. Only two trials of limited quality met our inclusion criteria. Larranaga compared two biphasic and one triphasic pills, each containing levonorgestrel and ethinyl estradiol. No important differences emerged, and the frequency of discontinuation because of medical problems was similar with all three pills. Percival-Smith compared a biphasic pill containing norethindrone (Ortho 10/11) with a triphasic pill containing levonorgestrel (Triphasil) and another triphasic pill containing norethindrone (Ortho 7/7/7). The biphasic pill had inferior cycle control compared with the levonorgestrel triphasic pill.The available evidence is limited and of poor quality; the internal validity of these trials is questionable. Given that caveat, the biphasic pill containing norethindrone was associated with inferior cycle control compared with the triphasic pill containing levonorgestrel. This suggests that the choice of progestin may be more important that the phasic regimen in determining bleeding patterns.     

《中国计划生育学杂志》创刊15年学术论文作者群分析

目的:通过对《中国计划生育学杂志》创刊以来学术论文作者、地区、机构分布情况的统计分析,了解科技人员合作类型及特点、核心作者及高产机构,为客观评价我国计划生育科技队伍现状提供科学依据。方法:对1992～2006年学术论文进行文献计量学统计分析。结果:15年来发文2998篇,论文合作度为3.15,合作率为74.75%;仅发表1篇论文作者1987人;核心作者55人,发文331篇。发文主要集中在中部及沿海发达地区,北京地区发文355篇,居第1位;发文在20篇以上高产机构15个;计划生育系统科研院(所)及技术指导中心发文728篇(24.28%),技术服务机构1069篇(35.66%);妇幼卫生机构584篇(19.48%),医学院校及附属医院417篇(13.91%),科研机构114篇(3.60%)。在全国计划生育科研院(所)中,国家人口计生委科研所、上海市计划生育科研所发文量最多。结论:该刊论文作者分布广泛,拥有一支实力雄厚、对刊物影响力较大、造诣较深的活跃核心作者。但论文合作程度不高,各地区计划生育科技研究力量分布极不均衡,提示特别应加强西北部及东北部地区的科研力量培养和关注。     

Faculty statement from the CEU on a new publication: WHO Selected Practice Recommendations for Contraceptive Use Update. Missed pills: new recommendations

The World Health Organisation Selected Practice Recommendations for Contraceptive Use (WHOSPR) was first published in 2002 and provides evidence-based recommendations on how to use contraception effectively. The WHOSPR was adapted for UK use by the Faculty of Family Planning and Reproductive Heath Care (FFPRHC). The UK version is available on the FFPRHC website (www.ffprhc.org). Extensive field experience with the first edition of the WHOSPR highlighted to the WHO the need for revised recommendations for missed combined oral contraceptive pills (COCs). The WHOSPR was updated in 2004 and revised guidance on missed pills published. This guidance is now available on the WHO website (www.who.int/reproductive-health). The FFPRHC endorses the new recommendations from WHO on missed COCs for the following reasons: There is new evidence on which to base guidance. The WHOSPR follow a published and rigorous process for assessing the available evidence. The recommendations were developed by an international expert panel, with UK representation. Field experience shows a need for simple, harmonised guidance. This Statement summarises the revised WHOSPR evidence-based 'missed pill rules' in formats which we hope clinicians will find useful. We recognise that different individuals favour different styles for the presentation of information. Thus, both tabular and flow chart styles of summary are provided; these convey the same information but in different ways. The FFPRHC considers that the following statements may also serve as useful aides memoir for the 'missed pill rules': Whenever a woman realises that she has missed pills, the essential advice is 'just keep going'. She should take a pill as soon as possible and then resume her usual pill-taking schedule. Also, if the missed pills are in week three, she should omit the pill-free interval. Also, a back-up method (usually condoms) or abstinence should be used for 7 days if the following numbers of pills are missed: 'Two for twenty' (ie if two or more 20 microgram ethinylestradiol pills are missed). 'Three for thirty' (ie if three or more 30-35 microgram ethinylestradiol pills are missed). The fpa (Family Planning Association) has produced a revised COC user information sheet to reflect these changes; available from April 2005.