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不同剂量桂枝茯苓胶囊治疗原发性痛经疗效探索研究
引用本文:柳于介,萧伟,王振中,赵宾江,周忠明,姜惠中,金哲,魏绍斌,王喆,王东梅,夏亲华,林洁,王琪.不同剂量桂枝茯苓胶囊治疗原发性痛经疗效探索研究[J].中国中药杂志,2013,38(12):2019-2022.
作者姓名:柳于介  萧伟  王振中  赵宾江  周忠明  姜惠中  金哲  魏绍斌  王喆  王东梅  夏亲华  林洁  王琪
作者单位:江苏康缘药业股份有限公司, 江苏 连云港 222001;南京中医药大学, 江苏 南京 210023;江苏康缘药业股份有限公司, 江苏 连云港 222001;江苏康缘药业股份有限公司, 江苏 连云港 222001;江苏康缘药业股份有限公司, 江苏 连云港 222001;湖北中医药大学 附属医院, 湖北 武汉 430061;湖北中医药大学 附属医院, 湖北 武汉 430061;北京中医药大学 东方医院, 北京 100078;成都中医药大学 附属医院, 四川 成都610072;天津中医药大学 第一附属医院, 天津 300193;山东中医药大学 附属医院, 山东 济南 250011;江苏省中西医结合医院, 江苏 南京 210028;湖南中医药大学 第一附属医院, 湖南 长沙 410007;贵阳中医学院 第一附属医院, 贵州 贵阳 550001
基金项目:国家"重大新药创制"科技重大专项(2011ZX0910142-004)
摘    要:评价不同剂量桂枝茯苓胶囊治疗原发性痛经的临床有效性及安全性.将240例年龄18~30岁的原发性痛经患者按1∶1∶1的比例随机分为试验高剂量组、试验低剂量组和安慰剂组,每组各80例,连续治疗3个月经周期并随访3个月经周期,采用视觉模拟标尺法(VAS)对痛经疼痛程度进行比较.治疗期试验高剂量组、试验低剂量组、安慰剂组治疗期有效率分别为68.42%,67.57%,47.89%,试验组均优于安慰剂组(P<0.001);随访期试验高剂量组、试验低剂量组、安慰剂组有效率分别为73.68%,72.97%,53.52%,试验组均优于安慰剂组(P<0.005);治疗期试验高剂量组、试验低剂量组、安慰剂组疼痛持续时间分别下降57.88%,46.17%,30.40%;随访期试验高剂量组、试验低剂量组和安慰剂组疼痛持续时间分别下降67.93%,53.56%,47.46%,试验组疼痛持续时间下降率均优于安慰剂组,差异有显著性统计学意义(P<0.000 1),试验高剂量组疼痛持续时间下降率优于低剂量组,差异有统计学意义(P<0.05).试验高剂量组与低剂量组疗效呈现出一定的量效趋势,均无严重不良反应.桂枝茯苓胶囊高剂量组及低剂量组均能够显著缓解患者疼痛、改善患者症状,减少疼痛持续时间,对原发性痛经患者具有较好的总体治疗效果和远期治疗效应.

关 键 词:原发性痛经  桂枝茯苓胶囊  剂量探索  疼痛强度  疼痛持续时间
收稿时间:2012/11/8 0:00:00

Effects and safety of varying doses of Guizhi Fuling capsule in patients with primary dysmenorrhea: a multi-center, randomized, double-blind, placebo-controlled clinical study
LIU Yu-jie,XIAO Wei,WANG Zhen-zhong,ZHAO Bin-jiang,ZHOU Zhong-ming,JIANG Hui-zhong,JIN Zhe,WEI Shao-bin,WANG Zhe,WANG Dong-mei,XIA Qin-hu,LIN Jie and WANG Qi.Effects and safety of varying doses of Guizhi Fuling capsule in patients with primary dysmenorrhea: a multi-center, randomized, double-blind, placebo-controlled clinical study[J].China Journal of Chinese Materia Medica,2013,38(12):2019-2022.
Authors:LIU Yu-jie  XIAO Wei  WANG Zhen-zhong  ZHAO Bin-jiang  ZHOU Zhong-ming  JIANG Hui-zhong  JIN Zhe  WEI Shao-bin  WANG Zhe  WANG Dong-mei  XIA Qin-hu  LIN Jie and WANG Qi
Affiliation:Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;Nanjing University of Traditional Chinese Medicine, Nanjing 210023, China;Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;Affiliated Hospital of Hubei college of Traditional Chinese Medicine, Wuhan 430061, China;Affiliated Hospital of Hubei college of Traditional Chinese Medicine, Wuhan 430061, China;Dongfang Hospital of Beijing University of Chinese Medicine, Beijing 100078, China;Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China;First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250011, China;Jiangsu Province Hospital of Integrated Chinese and Western Medicine, Nanjing Medical University, Nanjing 210028, China;The First Affiliated Hospital, Hunan University of Traditional Chinese Medicine, Changsha 410007, China;The First Affiliated Hospital of Guiyang Traditional Chinese Medical College, Guiyang 550001, China
Abstract:To evaluate the effects and safety of varying doses of Guizhi Fuling capsule on treating primary dysmenorrhea. From August 2010 to March 2011, 240 subjects(aged 18-30) with primary dysmenorrheal, were enrolled in 8 sites. They were randomized into Guizhi Fuling capsule high dose group, low dose group and placebo control group, 80 cases in each group. These patients were treated for three consecutive menstrual cycles, then were followed up in another three consecutive menstrual cycles. Visual analogue scales(VAS) was used to determine the pain intensity. During the treatment, the high-, low-dose and placebo groups efficiency on pain relief are 68.42%, 67.57% and 47.89% respectively. Guzhi Fuling (included high- and low- dose group) significantly relieves the pain compared to placebo. In follow-up, Guzhi Fuling groups are still superior to the placebo group (73.68%, 72.97% and 53.52%). During the treatment, pain duration reduces 57.88% in high dose group, while 46.17% in low dose group, and 30.40% in placebo group. In follow-up, pain lasting time decrease 67.93%, 53.56% , 47.46%, respectively. Guizhi Fuling significantly reduces the pain duration compared to placebo and high-dose is better than low-dose. The efficacy of Guzhi Fuling (high- and low-dose) displays certain dosage-effect relationship. Among these group, no serious adverse event was reported. Guizhi Fuling capsule at high or low dose significantly relieves the pain, improves symptoms, reduces the duration of pain, and has a better overall treatment effect and long-term treatment effect in patients with primary dysmenorrhea.
Keywords:primary dysmenorrhea  Guizhi Fuling capsule  varying doses  pain intensity  pain duration
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