早孕期阴道炎药物治疗后的妊娠结局

阴道用药通过宫颈或全身吸收可能造成胎儿畸形,有关这方面的研究不多。本研究的数据来自1980～1983COM PASS,这是由健康资料设计创建的数据库,包括全部参加Medicaid的处方和诊断书的计算机资料。比较早孕期间使用醚康唑(miconazole)、抗真菌Ⅰ(clotrimazole)、制霉菌素(nystatin)、杀念珠菌素(candici din)、复方氨基吖啶(aminacrine compóund)和甲硝咪唑(metronidazole)发生先天异常与未发生先天异常组,结果上述药物中没有对总的出生缺陷率或特殊的出生缺陷率(心血管缺陷、腭裂、脊柱裂)有显著的影响。又比较了早孕期用这些药物     

人工流产术后血绒毛膜促性腺激素(hCG)的消退

对156名正常早期妊娠人工流产术前及术后1、2、3周进行了血hCG测定与临床观察。平均术后17天hCG降至100 mlU/ml或以下。国产尿乳胶凝集抑制妊娠试验在人工流产术后14天应阴性,如仍为阳性,应考虑流产不全;或为阴性而仍有出血时应做血hCG定量测定。人工流产同时放宫内节育器者,出血天数较长,但不影响血hCG的消退。     

在临床科研中执行GCP的重要性

<正> 当今世界医学科技迅猛发展,日新月异。随着循证医学(ecidenci basedmedicine)的提出,对临床科研有了更高的要求,只有通过多中心随机前瞻性临床试验,才能得到科学、可信的数据,才能对医学的发展作出可靠的结论。因之要求临床科研的规范化,并借助GCP提高我们的科研水平。 我们参加计划生育临床科研已有近30年的时间,参加过我国最早减量18甲基炔诺酮的临床研究、众多部委攻关课题、WHO课题以及许多新的临床试验与验证。在过去的科研临床中,我们没有意     

雌二醇屈螺酮片治疗绝经后妇女绝经相关症状的多中心临床研究

Objective To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq)in treatment of menopausal symptoms among postmenopausal Chinese healthy women.Methods Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned for 16 weeks in this randomized multi-center double-blind placebo-controlled study.During the trial.the follow-up visits were conducted at week 4,8,12,16 of treatment and 2 weeks after treatment respectively.Height,weight,vital signs,hot flushes,other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit,while the clinical global impression scale Was assessed at 16 weeks as well.Results It showed that hot flushes were reduced significantly more in observation group than that in placebo group ( P＜0.01 ), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by - 0. 6± 0. 5 in observation group and - 0. 4 ± 0. 4 in placebo group from baseline respectively, which reached significant difference ( P ＜ 0. 05 ). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by - 0. 6± 0. 8 in observation group and -0. 3± 0.6 in placebo group from baseline respectively, which had no significant difference (P ＞ 0. 05 ).After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P ＜0. 01 ).During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48. 9% (87/178) in observation group and 10. 7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183 ). The level of serum potassium was in the normal range in observation group mostly. Meanwhile, the other adverse events rate was low. Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related. Conclusion Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmeuopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.     

雌二醇屈螺酮片治疗绝经后妇女绝经相关症状的多中心临床研究

Objective To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq)in treatment of menopausal symptoms among postmenopausal Chinese healthy women.Methods Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned for 16 weeks in this randomized multi-center double-blind placebo-controlled study.During the trial.the follow-up visits were conducted at week 4,8,12,16 of treatment and 2 weeks after treatment respectively.Height,weight,vital signs,hot flushes,other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit,while the clinical global impression scale Was assessed at 16 weeks as well.Results It showed that hot flushes were reduced significantly more in observation group than that in placebo group ( P＜0.01 ), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by - 0. 6± 0. 5 in observation group and - 0. 4 ± 0. 4 in placebo group from baseline respectively, which reached significant difference ( P ＜ 0. 05 ). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by - 0. 6± 0. 8 in observation group and -0. 3± 0.6 in placebo group from baseline respectively, which had no significant difference (P ＞ 0. 05 ).After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P ＜0. 01 ).During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48. 9% (87/178) in observation group and 10. 7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183 ). The level of serum potassium was in the normal range in observation group mostly. Meanwhile, the other adverse events rate was low. Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related. Conclusion Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmeuopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.     

Cu-Fix、LNG与Tcu380A的临床对比性研究

Ｃｕ－Ｆｉｘ、ＬＮＧ与Ｔｃｕ３８０Ａ的临床对比性研究张莉嘉翁梨驹丁俊英我院自１９９４年６月～１９９５年１月共接受２０～４０岁健康妇女１５１例，随机放置Ｃｕ－Ｆｉｘ５１例、ＬＮＧ５０例及Ｔｃｕ３８０Ａ５０例。观察比较三种宫内节育器（ＩＵＤ）的避孕效果、...     

米非司酮配伍前列腺素终止孕10～16周妊娠的临床观察

对米非司酮配伍卡前列甲酯栓(PG05)或米索前列醇(米索)用于120例孕10～16周妊娠妇女(随机分为四组)进行了终止妊娠效果的观察。对象一次或分次服米非司酮200mg后48小时,分别使用米索(Ⅰ、Ⅱ组)或PG05(Ⅲ、Ⅳ组),有效率分别为80.0％、80.0％、96.7％、100％。伍用PG05效果明显优于伍用米索。引流产时间分别为5.79、6.54、5.53、6.49小时,四组间无差异。Ⅲ、Ⅳ组副反应高于Ⅰ、Ⅱ组。结论:米非司酮200mg配伍PG05或米索是终止孕10～16周妊娠安全有效的方法。观察中PG05的效果高于米索,考虑可能与米索的剂量偏低有关。由于存在不全流产率较高及潜在的子宫破裂、宫颈裂伤危险,终止妊娠需加强监护。     

男性不育相关因素对夫精人工授精妊娠率的影响

目的探讨部分男性不育相关因素对精子质量和夫精宫腔内人工授精（AIH-IUI）妊娠率、流产率的影响。方法回顾性分析2006年1月至2009年6月在我院生殖医学中心接受治疗的153对不育夫妇,250个IUI周期,分别对男性不育年龄、不育类型和年限、体重指数（BMI）、吸烟情况、精液优化后活动精子（a＋b）计数进行分组统计少弱精子症接受IUI周期所占比率、周期妊娠率（PPR）、流产率,比较分析正常精子质量和少弱精子症IUI治疗PPR和流产率。结果总治疗周期250个,妊娠数35,PPR为13.6%,流产数16,流产率45.71%。治疗前检查精子质量位于正常范围周期97个,妊娠数13,PPR为13.4%,流产数3,流产率23.08%;少弱精子症夫妇97对,治疗周期153个,妊娠数21,PPR为13.73%,流产数13,流产率61.90%。男性相关因素：年龄、体重指数、不育年限、每日吸烟量对精液质量有不良影响,相同因素PPR正常精液质量组高于少弱精症组,流产率明显低于后者,存在统计学差异（P〈0.05）。精液优化前后对PPR和流产率均有影响,优化后获得妊娠的最小活动精子（a＋b）计数为4×106/ml。结论男性年龄、体重指数、不育时间、每日吸烟量影响精子质量和IUI结局。高龄、高体重指数、吸烟的少弱精子症男性对IUI结局有不良影响。选择合适的精液优化方法最大限度回收活动精子,可以获得良好妊娠结局。