藏红花冻干泡腾片治疗原发性痛经气滞血瘀证的随机双盲对照临床研究  

A Randomized Double-Blind Controlled Clinical Study of Freeze-Dried Saffron Tablets in the Treatment of Primary Dysmenorrhea with Qi Stagnation and Blood Stasis Syndrome

作　　者：姚渊 谢琪 吴宗月 黄卫平 周洪伟[5] Yao Yuan;Xie Qi;Wu Zongyue;Huang Weiping;Zhou Hongwei(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Wangjing Hospital of China Academy of Chinese Medical Sciences,Beijing 100102,China;Fusui Airport Hospital District of Ruikang Hospital,Chongzuo 532199,China;Boji Medicial(Beijing)Co.,Ltd.,Beijing 100075,China;Traditional Chinese Medicine Data Center of Chinese Academy of traditional Chinese,Beijing 100700,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院望京医院,北京100102 [3]瑞康医院扶绥空港院区,崇左532199 [4]博济医药(北京)有限公司,北京100075 [5]中国中医科学院中医药数据中心,北京100700

出　　处：《世界科学技术-中医药现代化》2023年第11期3541-3547,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：中国中医科学院院级课题(Y201313):“病症结合”中医药真实世界临床科研方法学研究,负责人:谢琪

摘　　要：目的评价藏红花冻干泡腾片治疗气滞血瘀型原发性痛经的有效性及安全性,为其临床推广应用提供参考。方法采用前瞻性随机双盲安慰剂平行对照临床研究设计,纳入60例患者,区组随机分为治疗组与对照组,经过3个月洗脱期后,分别给予藏红花冻干泡腾片和安慰剂治疗2个月经周期,并连续随访2个月。结果对照组患者治疗前后无明显变化;治疗组患者治疗后症状明显减轻,与治疗前比较有显著差异;所有受试者均未出现不良反应。结论藏红花冻干泡腾片能够有效治疗气滞血瘀型原发性痛经,远期疗效和安全性较好,值得临床进一步深入研究。Objective To evaluate the efficacy and safety of saffron freeze-dried effervescent tablets in the treatment of primary dysmenorrhea of qi stagnation and blood stasis,and to provide reference for its clinical application.Methods A prospective,randomized,double-blind,placebo parallel controlled clinical trial was designed.60 patients were randomly divided into treatment group and control group.After 3 months of elution,the patients were treated with saffron freeze-dried effervescent tablets and placebo respectively for 2 menstrual cycles and were followed up for 2 months.Results There was no significant change in the control group before and after treatment,while the symptoms in the treatment group were significantly relieved after treatment,which were significantly different from those before treatment,and no adverse reactions occurred in all subjects.Conclusion Saffron freeze-dried effervescent tablets can effectively treat primary dysmenorrhea of qi stagnation and blood stasis with good long-term efficacy and safety,which is worthy of further clinical study.

关 键 词：原发性痛经 藏红花冻干泡腾片 气滞血瘀证 随机双盲对照 

分 类 号：R285.6[医药卫生—中药学]