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精制桂枝茯苓胶囊治疗原发性痛经(血瘀证)的随机双盲对照临床试验 被引量:4

Random Double-blind Comparison Clinical Trial of Refining Guizhi Fuling Capsule for Essential Dysmenorrheal(Syndrome of Blood Stasis)
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摘要 目的:评价精制桂枝茯苓胶囊治疗原发性痛经(血瘀证)的安全性、有效性。设计:分层区组随机、双盲单模拟、阳性药平行对照、多中心试验,共入组病例240例,其中对照组120例,试验组120例。试验组:精制桂枝茯苓胶囊1粒+精制桂枝茯苓胶囊模拟剂2粒/次,3次/日,口服。对照组:桂枝茯苓胶囊3粒/次,3次/日,口服。从月经前7天开始,服药10天(经期服3天),连续服用3个月经周期,痊愈病例随访1个月经周期。结论:精制桂枝茯苓胶囊治疗原发性痛经(血瘀证)安全、有效。 Objective: evaluate safe, efficacy of refining Guizhi Fuling capsule for Essential Dysmenorrheal (Syndrome of Blood Stasis). Methods: delamination block random, double -blind single delamination, masculine parallel comparison, multicentre trial, 240 patients are divided into two groups,120 patients for control group, and 120 patients for experiment group. The patients belong to experiment group took refining Guizhi Fuling capsule 1 pill and refining Guizhi Fuling capsule simulation dose 2 pills for one time, PO. , three times a day. The patients belong to control group took refining Guizhi Fuling capsule 3 pills for one time, PO. , three times a day. The patients of 2 groups took drug for 10 days ( treatment for 3 days) from seventh day before the onset of menstruation, and keep the treatment for 3 menstruation, follow - up visit 1 menstruation to recovery patients, menstruation : the treatment of refining Guizhi Fuling capsule for Essential Dysmenorrheal( Syndrome of Blood Stasis) is safety and effective.
出处 《中华中医药学刊》 CAS 2007年第9期1810-1812,共3页 Chinese Archives of Traditional Chinese Medicine
基金 国家食品药品监督管理局新药临床观察项目(2005L00617)
关键词 精制桂枝茯苓胶囊 原发性痛经 血瘀证 随机 双盲单模拟 refining Guizlii Fuling capsule essential dysmenorrheal syndrome of blood stasis random double - blind
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参考文献3

  • 1[1]国家食品药品监督管理局.药品临床试验管理规范[S].2003 被引量:1
  • 2乐杰主编..妇产科学 第6版[M].北京:人民卫生出版社,2004:476.
  • 3张玉珍主编..中医妇科学[M].北京:中国中医药出版社,2002:422.

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