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.     

复方甾体长效口服避孕药对妇女血脂影响的前瞻性研究

本文对36例育龄妇女随机服用左旋18甲基炔诺酮6mg或消旋18甲基炔诺酮12mg与炔雌醚3mg配伍的长效口服避孕药,观察脂代谢的变化。于服药前、服药后6、12周期及停药后1、6周期系统观察血清总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(IDL—C)、低密度脂蛋白胆固醇(LDL—C)及载脂蛋白APOA—I与APOB的变化。结果表明:随服药周期的延长,两种避孕药均使血清TC、TG、HDL—C、APOA—I、APOB升高,停药后逐渐下降,半年时趋近于服药前水平。两种药对血脂的影响无差异。     

18甲基炔诺酮阴道环的临床观察

本文介绍108例妇女使用释放左旋18甲基炔诺酮20微克/天阴道环一年的临床效果和副反应。每100例妇女使用一年的净累积率为:妊娠率3.7,脱落率4.6,与阴道环有关的停用率26.9,持续使用率71.2。副反应主要为月经紊乱,但随使用时间的延长而逐步改善。本文有20例首进行月经血量,血红蛋白和铁蛋白测定。使用阴道环后第一月,经血量略有增加,此后有下降趋势,血红蛋白浓度在放环后第6和第12月有明显增加(P<0.05)。     

应用4种口服避孕药与节育用阴道环妇女的代谢和临床效果比较

作者报道了服用4种口服避孕药(OC)和放置阴道环(CVR)的110名妇女代谢和临床副反应比较的结果。其中100名妇女随机分为4组分别服用下列1种OC:(1)炔雌醚50μg+炔诺酮1 mg(Ortho Novum(1/50));(2)炔雌醇50μg+炔诺酮1mg(Ovcon);(3)炔雌醇35μg+炔诺酮1mg(Neocon);(4)炔雌醇30μg+dl-18甲基炔诺酮150μg(Lo-Ovral),另有10名妇女使用含dl-18甲基炔诺酮和雌二醇的阴道环(CVR)。所有服药者于每周期第五天起每天服药1片,直至第二十八天。所有CVR使用者亦于月经第五天起将CVR自行置于阴道内,3周后取出,并作窥阴器检查。研究持续6个月。所有研究对象为17～33岁有生育力的妇女,平     

女用长效口服避孕药——复方炔雌醚对子代生长发育的影响

<正> 复方炔雌醚是六十年代末由我国配伍制成的女用长效口服避孕药。每片含炔雌醚2mg,氯地孕酮6mg,18-甲基炔诺酮6mg,每月服一片,避孕一个月,七十年代初开始实验室与临床研究,迄今已历时15年之久。此药有抑制排卵的作用,其避孕效率按妇女年计算达97.06%,多数人在停药3～6个月内恢复排卵,生育功能迅速恢复。有部份服药妇女受孕后继续妊娠,分娩了相当数量的子代。为了研究药物的安全性及阐明药物对后代的影响,本文于1984～1985年收集上海地区曾服此药的妇女所生育的子代236名进行了生长发育并各系统的检查。     

18-甲基炔诺酮抗家兔排卵作用机理的初步分析

本实验使用家兔诱导排卵动物模型,分别观察了消旋18-甲基炔诺酮和左旋18-甲基炔诺酮对于用铜盐、由PMSG和hCG以及由LH-RH诱导的家兔排卵的影响。实验分三组:一组于实验第1～3天皮下注射雌二醇(每只100μg/天),第4天经耳缘静脉注射1%醋酸酮(0.4ml/kg),24小时后处死并检查排卵点。二组于实验第1～2天皮下注射雌二醇,第4天皮下注射一次LH-RH(12.5μg/只),48小时后处死并观察和记数排卵点。三组于实验第2天皮下注射PMSG(12.5u),第4天经耳缘静脉注射50iuhCG,48小时后处死并检查排卵点。各组中的实验组于第1～4天肌肉注射消旋18-甲基炔诺酮或左旋18-甲基炔诺酮(每只8mg/天)对照组给予等量溶媒。结果表明,两种18-甲基炔诺酮皆明显抑制由铜盐诱导的家兔排卵,抗排卵率分别为83.3%和66.7%。然而,两者对于由LH-RH和由PMSG与hCG诱导的家兔排卵皆无明显影响。以上结果提示,消旋18-甲基炔诺酮和左旋18-甲基炔诺酮的抗排卵作用可能是通过干扰下丘脑LH-RH的释放而实现的,并非由于在垂体水平拮抗LH-RH的作用或在性腺水平上拮抗促性腺激素作用的结果。     

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。     

新型铜Flaxigard宫内节育器与TCu380A宫内节育器的临床对比研究

目的　了解新型铜FlaxigardIUD(CuFixIUD)的避孕效果和副反应 ,以TCu380AIUD为对照组进行临床实验。方法　采用前瞻性、随机分配原则 ,共接收 2 0 0例受试者。结果　 12个月内两组无一例发生妊娠 ,脱落率为每百妇女 10 2和 1 0 ,有明显统计学意义 (P <0 0 5 )。累积使用率为每百妇女 88 8和 97 0 ,两组无统计学意义 (P >0 0 5 )。 2 4个月时累积使用率两组分别为每百妇女 88 8和 93 0 ,36个月时随访率为 10 0 %。妊娠率两组分别为每百妇女 1 0和 3 0 ,因症取出率为每百妇女 2 0和 5 0。最常见的副反应为出血和疼痛。累积使用率分别为每百妇女 85 7和 89 0 ,两组无统计学意义 (P >0 0 5 )。结论　新型铜FlaxigardIUD为一种低妊娠率、高效和长效的IUD。TCu380A仍不失为一种高效、低副反应的IUD。     

每周口服米非司酮避孕的临床研究

目的:研究每周一次口服米非司酮25mg或50mg用于常规避孕的可行性。方法:志愿参加避孕研究的健康妇女共33例,随机分为二组,自月经d2-3口服米非司酮,每例观察6个周期。A组(16例)每周口服米非司酮25mg;B组(17例)每周口服50mg。另在A组、B组中各选2例,每例服药前1个周期及服药后2-6个周期间,于黄体中期各取子宫内膜共2次作自身对照,测定子宫内膜形态学改变,应用免疫组化法检测基质金属蛋白酶(MMP)-9和MMP-26的表达。结果:A组共服药50个周期,1例妊娠,4例闭经,1例妇女经量极少;B组共服药81个周期,无1例妊娠,5例闭经,4例经期仅点滴出血。服药后与服药前比较内膜明显变薄,主要表现为基质和腺体发育不同步,大部分腺上皮分泌活动不明显。与对照周期相比,服药后二组MMP-9和MMP-26在子宫内膜腺上皮和基质细胞的表达均显著降低。结论:每周一次口服米非司酮(25mg或50mg)妇女的月经周期改变较大,临床避孕效果理想。每周口服50mg米非司酮可能是比较合适的剂量。但闭经率较高,且闭经的出现不可预测,妇女对其的可接受性较差。     

三种低剂量、复方口服避孕药的临床比较性研究

本文应用随机化双盲法,对三种低剂量含雌、孕甾体激素避孕药(含18-甲基炔诺酮及炔雌醇的复方三相制剂,含18-甲基炔诺酮150μg及炔雌醇30μg的固定剂量制剂,含炔诺酮600μg及炔雌醇35μg的Ⅰ号避孕药)进行比较性研究。共收集合格健康育龄妇女279例;其中复方三相制剂96例,固定剂量制剂93例,Ⅰ号避孕药90例。按生命表法统计,其6个月的每百妇女累积续用率:复方三相制剂82.3,左旋18-甲基炔诺酮/炔雌醇固定剂量制剂81.6,Ⅰ号避孕药80.9,三组间在统计学上无显著差别。副反应的发生率,三组间亦甚相似。有关出血类型:在复方三相制刺中月经周期较为规则,滴血最为少见,行经期长度亦较少受影响。研究证实复方三相制剂是一种有效的低剂量口服避孕药,值得进一步研究。     

黄体早期服用低剂量米非司酮作为妇女常规避孕方法的初步研究

目的:探讨米非司酮用于妇女常规避孕的可行方法。方法:共74例自愿受试人员,于规律月经第15日开始,口服米非司酮5 mg,按疗程递减顺序分别为A组(研究Ⅰ期)每日1次连服4天,B组(研究Ⅱ期)每日1次连服3天,C组(研究Ⅲ期)隔日1次共服2天,观察避孕效果及月经周期改变情况,对可能月经推迟3天及以上者行尿HCG、B超等检查排除早孕。结果:A组43例受试125周期,122例次月经如期来临,3例次月经推迟6~9天,尿HCG、B超等检查阴性,有效率100.0%,月经正常率97.6%。B组68例(A组43例+新入受试25例)受试286周期,282例次月经如期来临,4例次月经推迟5~8天,尿HCG、B超等检查阴性,有效率100.0%,月经正常率98.6%。C组6例(新入受试人员)受试12周期,9例次月经推迟6~9天,尿HCG、B超等检查阴性,有效率100.0%,月经正常率25.0%。A、B两组共获411受试周期,避孕有效率均达100.0%,月经正常率98.3%;C组月经周期正常率显著低于A、B组(P0.01),研究暂时终止。A、B两组避孕效果及对月经的影响差异无统计学意义(P0.05)。结论:黄体早期(内膜分泌期早期)阶段短程、小剂量应用米非司酮有较好的避孕效果,且对月经周期无明显的影响,月经规律者可用于每月的常规性避孕。初步研究认为较佳的剂量-时效关系为米非司酮5mg/d连用3天。     

激素补充治疗对绝经后妇女血液流变学的影响

目的探讨不同剂量结合雌激素(倍美力)配伍安宫黄体酮(MPA)的连续联合方案对绝经后妇女血液流变学的影响,以便更合理地为绝经后妇女的激素补充治疗提供指导和咨询.方法将60例绝经1～4年的健康妇女随机分为3组,A、B组分别口服结合雌激素0.625mg/d或0.3mg/d配伍MPA2mg/d,加复方碳酸钙(钙尔奇-D)600mg/d;C组口服复方碳酸钙600mg/d,为期半年,对比3组用药前、后以及用药后各组间血液流变学各项指标的变化.结果治疗前3组血液流变学各项指标比较,差异无显著性(P＞0.05).用药后,A组的全血高切粘度从(5.23±0.37)毫帕@秒(mPa@s)降至(5.03±0.43)mPa@s(P＜0.05),血浆粘度从(1.66±0.19)mPa@s降至(1.58±0.15)mPa@s(P＜0.05),红细胞变形能力从(4.76±0.32)mPa@s降至(4.54±0.34)mPa@s(P＜0.05),有明显改善.B组全血高切粘度从(5.10±0.30)mPa@s降至(4.87±0.30)mPa@s(P＜0.05),红细胞变形能力从(4.65±0.34)mPa@s降至(4.43±0.29)mPa@s(P＜0.05),也有明显改善.C组各项指标无明显变化.治疗后,A组血浆粘度及纤维蛋白原水平低于C组(P＜0.05);B组全血高切粘度、全血低切粘度及血浆粘度低于C组(P＜0.05).血栓弹力图于治疗前及治疗后各组间比较及治疗前后自身对比,差异无显著性(P＞0.05).结论两种剂量结合雌激素配伍MPA连续联合方案,均可降低血浆粘度、提高红细胞变形能力、改善微循环.     

The comparison of bleeding patterns with high-dose and low-dose hormone replacement therapy in postmenopausal women.

Our objective was to compare vaginal bleeding patterns with lower doses of conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA), in a randomized, double-blind, placebo-controlled trial. A total of 112 healthy, postmenopausal women were divided into three groups. Group A received CEE 0.625 mg/day plus MPA 2.5 mg/day; group B received CEE 0.3 mg/day, plus MPA 1.25 mg/day; and another group received placebo. All medications were continued for 13 months and bleeding data were analyzed in each group. The percentage of patients who experienced no bleeding in cycle one was 45.2% in group B. These values were significantly greater than the figure for group A (18.2%) and lower than in the placebo group (66.7%). A linear trend between time since menopause and cumulative amenorrhea was observed in cases in group B and the placebo group in all cycles (p < 0.05). This finding was significant in only cycle 13 in group A. In conclusion, a higher rate of amenorrhea was observed with a lower-dose regimen of CEE/MPA, which may be the appropriate regimen.     

低剂量与标准剂量结合雌激素联合天然孕酮或地屈孕酮治疗围绝经期综合征的疗效观察

目的:研究低剂量结合雌激素(CEE)与标准剂量CEE联合天然孕酮或地屈孕酮治疗围绝经期综合征的疗效比较。方法:本试验为单中心、前瞻性随机对照试验,2014年2月至2015年12月招募绝经早期有子宫、有绝经相关症状的妇女(共107例完成试验),随机分为3组:A组35例(低剂量CEE+天然孕酮)、B组37例(标准剂量CEE+天然孕酮)、C组35例(标准剂量CEE+地屈孕酮),采用连续序贯方案治疗12个周期,在第3、6、9、12周期结束后记录改良Kupperman评分,计算有效率,用药前与用药后抽血测定卵泡刺激素(FSH)、雌二醇(E2)。结果:在治疗3个周期后,改良Kupperman评分值均显著性下降(P均0.01),3组间的完全缓解率、显效率差异均无统计学意义,但B组有效率(89.2%)显著高于A组(60%,P=0.024)和C组(61.9%,P=0.035)。治疗结束后,3组的完全缓解率、显效率、有效率差异均无统计学意义(P0.05)。治疗结束后与治疗前比,3组的FSH值均有显著性降低(P0.001),E2值均显著性升高(P0.001)。治疗结束后,3组FSH值比较差异无统计学意义(P=0.26);E2值A组显著低于B组(P=0.002)及C组(P=0.004),B组与C组比较差异无统计学意义(P=0.832)。不良反应主要为阴道不规则流血和乳房胀痛,A、B、C组阴道不规则流血的发生率分别为20.91%、39.51%、19.99%,B组显著高于A与C组(PAB=0.034,PBC=0.015),A组与C组比较差异无统计学意义;乳房胀痛的发生率A、B、C组分别为30.22%、37.46%、68.06%,A、B两组差异无统计学意义,C组显著高于A、B组(PAC=0.008,PBC=0.002)。结论:低剂量雌激素补充已可满足大部分患者缓解围绝经期综合征的需求,加用天然孕酮比加用地屈孕酮对围绝经期症状的缓解作用更显著。     

The comparison of bleeding patterns with high-dose and low-dose hormone replacement therapy in postmenopausal women

Our objective was to compare vaginal bleeding patterns with lower doses of conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA), in a randomized, double- blind, placebo-controlled trial. A total of 112 healthy, postmenopausal women were divided into three groups. Group A received CEE 0.625 mg/day plus MPA 2.5 mg/day; group B received CEE 0.3 mg/day, plus MPA 1.25 mg/day; and another group received placebo. All medications were continued for 13 months and bleeding data were analyzed in each group. The percentage of patients who experienced no bleeding in cycle one was 45.2% in group B. These values were significantly greater than the figure for group A (18.2%) and lower than in the placebo group (66.7%). A linear trend between time since menopause and cumulative amenorrhea was observed in cases in group B and the placebo group in all cycles (p <?0.05). This finding was significant in only cycle 13 in group A. In conclusion, a higher rate of amenorrhea was observed with a lower-dose regimen of CEE/MPA, which may be the appropriate regimen.     

结合雌激素对绝经后妇女血液流变学影响的探讨

目的 探讨不同剂量结合雌激素对绝经后妇女血液流变学及临床症状的影响。方法 将66例绝经后妇女分为三组,其中A组每日服用CEE 0.625 mg+ 安宫黄体酮(MPA)2 mg+ 钙尔奇 D 600 mg,B纽每日服用CEE 0.3 mg+MPA 2mg+钙尔奇D 600 mg,C组为对照组,每日单用钙尔奇D 600 mg,观察治疗前后血液流变学及Kupgermn评分的变化。结果 A组血浆粘度、纤维蛋白原明显低于对照组,B组全血高切粘度、低切粘度和血浆粘度明显低于对照组。两组用雌激素后,与自身对照,全血高切粘度和红细胞变形能力均明显改善,两组更年期症状均明显改善,A组阴道出血率54.5％,明显高于B组。结论 结合雌激素加孕激素可以改善绝经后妇女血液流变学指标,每日结合雌激素0.3 mg加安宫黄体酮2 mg与CEE 0.625 mg加MPA 2 mg效果相似。     

黄体期个体化雌激素补充方案对IVF-ET治疗结局的影响

目的:探讨黄体期个体化添加不同剂量雌激素对体外受精-胚胎移植(IVF-ET)胚胎种植率和临床妊娠率的影响。方法:回顾性分析104个长方案控制性促排卵(COH)IVF-ET周期,根据其移植日血清E2水平下降幅度分为4组,A组:E2下降<30%,12个周期,单用黄体酮进行黄体期支持;B组:E2下降30%-39%,18个周期,黄体期支持采用黄体酮+3mg/d雌激素;C组:E2下降40%-49%,16个周期,D组:E2下降≥50%,58个周期,C组、D组患者黄体期支持采用黄体酮+4mg/d雌激素。结果:各组的取卵数目、受精率、卵裂率、优质胚胎数、内膜厚度和移植胚胎数相比差异均无显著性(P>0.05)。A组、B组、C组间胚胎种植率和临床妊娠率无统计学差异;而D组与其余3组比,胚胎种植率和临床妊娠率显著下降(P<0.05)。结论:①在长方案COH的IVF-ET中,当移植日血清E2水平下降幅度≥30%时黄体期支持补充雌激素可以改善胚胎种植率和临床妊娠率;②E2下降幅度大的患者可能需要增加雌激素的添加剂量。     

Anaerobic vaginosis: treatment with tinidazole vaginal tablets

A prospective randomized trial comprising 90 patients was undertaken to evaluate three different regimens of tinidazole in the treatment of anaerobic vaginosis. Each group consisted of 30 women. The three regimens were: (A) oral tinidazole (150 mg X 2) for 7 days, (B) same oral treatment as above but also the partner received 500 mg X 2 for 4 days, and (C) intravaginal tinidazole (500 mg) at bedtime for 2 weeks. After clinical diagnosis and treatment the patients were reassessed at 1 and 3 months. The overall cure rate was significantly (p less than 0.05) higher in group C than in the other groups. After 3 months, 70% of the cases in group C were asymptomatic, while in the other groups the rate was 42 and 43%, respectively. The intrauterine contraceptive device (IUCD) played an important role in the etiology of relapses and also in the decreased cure rates particularly seen in groups A and B. Among the women in group C using an IUCD, 80% were cured, while in groups A and B only 30 and 29% were cured. All regimens were well tolerated. The treatment of anaerobic vaginosis with vaginal tinidazole was effective and particularly useful if an IUCD was in concurrent use.     

Cognitive function variations in postmenopausal women treated with continuous,combined HRT or tibolone. A comparison

OBJECTIVE: To compare cognitive function in postmenopausal women receiving continuous hormone replacement therapy and those receiving tibolone. STUDY DESIGN: This was a 6-month, prospective, single-blind, single center, randomized study. A total of 50 healthy, postmenopausal women were enrolled. In the end, 40 women completed the 6-month follow-up. One group (23 subjects) received conjugated equine estrogens (CEE), 0.625 mg/d, and medroxyprogesterone acetate (MPA), 5 mg/d. The other group (17 subjects) received tibolone, 2.5 mg/d. Their serum estradiol levels and Cognitive Abilities Screening Instrument (CASI) and Mini-Mental State Examination (MMSE) scores were obtained before starting and after 3 and 6 months of treatment. RESULTS: There was a significant increase in the serum estradiol level in the CEE + MPA group, especially after 3 months of treatment, but there was no increase in the estradiol level in the tibolone group. The CASI and MMSE scores of the CEE + MPA group and the tibolone group after 3 and 6 months of treatment showed no significant difference between the two groups apart from the MMSE at the 3-month follow-up. We saw an increasing trend in CASI and MMSE scores after treatment in both groups; however, the increases were not statistically significant. The rate of increase of both CASI and MMSE scores in the CEE + MPA group was greater than in the tibolone group, though the difference was not significant. CONCLUSION: This preliminary study demonstrated that both CEE + MPA and tibolone can preserve cognitive function and may be able to prevent cognitive decline in postmenopausal women during short-term treatment. Our results also show that continuous, combined CEE + MPA seems to be marginally more effective than tibolone in improving cognitive processes; however, long-term study is needed to follow-up such effect.     

Hormone replacement therapy: effect of progestin dose and time since menopause on endometrial bleeding

OBJECTIVE: To analyze the effects of two continuous combined hormone replacement regimens on bleeding profiles in postmenopausal women, based on progestin dose and time since the patient's last spontaneous menstrual period. METHODS: A randomized, double-masked, multicenter trial was conducted in 1724 women recruited from 99 sites. Six hundred seventy-eight women received a continuous regimen of oral conjugated equine estrogens (CEE), 0.625 mg/day, combined with medroxyprogesterone acetate (MPA), 2.5 or 5.0 mg/day, for 1 year. RESULTS: After 1 year, no bleeding was reported by over 89% of women. More women in the 5.0 mg/day MPA group than in the 2.5 mg/day MPA group reported no bleeding (93.8% versus 89.5%; P<.089). Of those women who had had their last menstrual period 3 years ago or less, a significantly higher percentage in the 5.0 mg/day MPA group (72.4%) did not experience bleeding after three cycles compared with the 2.5 mg group (59.0%; P<.001). Although the percentage of patients without bleeding was also higher in the 5.0 mg/day MPA group after six cycles and 1 year, the differences between groups were not statistically significant. Of the women who had their last menstrual period more than 3 years ago, 94.7% of those in the 5.0 mg/day MPA group and 90.7% of those in the 2.5 mg/day MPA group reported no bleeding at 1 year. CONCLUSION: A continuous combined regimen of CEE plus 5.0 mg MPA may be more suitable for women closer to the onset of menopause or for women starting therapy who are unwilling to tolerate irregular bleeding. The improved bleeding profile with CEE and 5.0 mg/day MPA is likely to enhance compliance with hormone replacement therapy.