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黄体酮阴道凝胶与黄体酮栓治疗功能失调性子宫出血多中心随机单盲平行对照临床试验 被引量:3

Single-blind randomized controlled multicenter clinical trial on progesterone vaginal gel versus progesterone suppository in the treatment of dysfunctional uterine bleeding
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摘要 目的评价黄体酮阴道凝胶治疗功能失调性子宫出血的疗效和安全性。方法用随机单盲平行对照临床试验,试验组61例,对照组65例,分别于月经周期第15天开始,隔日1次分别给予黄体酮阴道凝胶和黄体酮栓剂,治疗3个月经周期。分别于每次月经来潮干净后3~7天,随访上个月经周期的经期、经量、周期、痛经和白带变化,第3周期月经第25~28天,进行子宫内膜病理学检查。结果治疗3个月经周期后,试验组和对照组均能明显缩短月经经期,减少月经量和血块,对痛经有较好疗效,其临床有效率分别为83.61% 和 73.85%。2组疗效比较无显著性差异(P>0.05)。2组药物不良反应发生率分别为3.28%和4.62%。结论黄体酮阴道凝胶治疗功能失调性子宫出血安全有效。 Objective To evaluate the efficacy and safety of progesterone vaginalgel compared with progesterone suppository. Methods A single-blind randomizedcontrolled clinical trail was conducted every other day from the 15th of themenorrhea, the test group of 61 cases were given progesterone vaginal gel and thecontrol group of 65 cases were given progesterone suppository for three periods,respectively. In every 3~7 day after menorrhea, menstrual duration, amount offlow, interval between periods, dysmenorrhea and leucorrhea of last period wereobserved. The pathology of endometrium were examed in the 25th^28th of thethird menorrhea. Results After three periods treatment, the menstrual durationswere shortened obviously, the amount of flow and clots were decreased,dysmenorrhea was alleviated. The efficacy rate of test group was 83.61% and whichof control group was 73.85%. There was no significant statistic difference betweenthese two groups (P>0.05). The rate of adverse reactions of progesterone vaginalgel and progesterone suppository were 3.28%, 4.62%, respectively. Conclusion Itis suggested that progesterone vaginal gel has advantage of effectiveness andsafety in the treatment of dysfunctional uterine bleeding.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2004年第4期243-246,共4页 The Chinese Journal of Clinical Pharmacology
关键词 黄体酮阴道凝胶 黄体酮栓剂 功能失调性子宫出血 progesterone vaginal gel progesterone suppository dysfunctionaluterine bleeding
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  • 1Cicinelli E,de Ziegler D,Galantino P,et al.Twice-weekly transdermal estradiol and vaginal progesterone as continuous combined hormone replacement therapy in postmenopausal women:a 1-year prospective study[J].Am J Obstet Gynecol,2002;187:556-560.
  • 2Penzias AS.Luteal phase support[J].Fertil Steril,2002 ;77:318-323.
  • 3Propst AM,Hill JA,Ginsburg ES,et al.A randomized study comparing crinone 8% and intramuscular progesterone supplementation in vitro fertilization-embryo transfer cycles[J].Fertil Steril,2001 ;76:1144-1149.
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