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| 更舒颗粒治疗绝经综合征肝肾阴虚证Ⅲ期临床研究 |
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闫颖1, 王惠津1, 王洪珍2, 陈立怀3, 石玲4, 宋殿荣5, 赵瑞华6, 魏绍斌7, 陈莹8, 钟成梁1, 张立伟2, 李颖2, 毕富玺1
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1.天津中医药大学第一附属医院妇科, 天津 300193;2.通化万通药业股份有限公司, 通化 134000;3.长春中医药大学附属医院妇科, 长春 130021;4.辽宁中医药大学第二附属医院妇科, 沈阳 110000;5.天津中医药大学第二附属医院妇科, 天津 300150;6.中国中医科学院广安门医院妇科, 北京 100053;7.成都中医药大学附属医院妇科, 成都 610072;8.辽宁中医药大学附属医院妇科, 沈阳 110032
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| 摘要: |
| [目的] 以更年安片为阳性对照药物,证实更舒颗粒治疗绝经综合征肝肾阴虚证有效性和安全性。[方法] 试验采用分层随机、双盲、阳性药平行对照、多中心的临床研究方法,将符合绝经综合征诊断标准480例患者分为2组,试验组360例,剔除0例,脱落10例;对照组120例,剔除1例,脱落9例。试验口服更舒颗粒及更年安片模拟药,对照组口服更年安片及更舒颗粒模拟药,疗程均为14 d。[结果] 疾病疗效的FAS分析结果,更舒颗粒试验组总显效率为58.1%、更年安片对照组为38.7%,差异有显著性意义;中医证候疗效的FAS分析结果,试验组临床痊愈率14.2%,总显效率52.5%,总有效率95.8%;阳性对照组临床痊愈率1.7%,总显效率24.4%,总有效率84.0%,差异均有统计学意义(P=0.000)。非劣效检验结果显示:试验组疗效非劣于对照组。[结论] 更舒颗粒治疗女性绝经综合征安全有效。 |
| 关键词: 更舒颗粒 绝经综合征 临床试验 |
| DOI：10.11656/j.issn.1672-1519.2015.09.07 |
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| Phase III clinical study on the treatment of menopause syndrome by Gengshu particles discriminated as deficiency of liver-yin and kidney-yin |
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YAN Ying1, WANG Hui-jin1, WANG Hong-zhen2, CHEN Li-huai3, SHI Ling4, SONG Dian-rong5, ZHAO Rui-hua6, WEI Shao-bin7, CHEN Ying8, ZHONG Cheng-liang1, ZHANG Li-wei2, LI Ying2, BI Fu-xi1
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1.Department of Gynecology, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;2.Wantong Pharmacy Group Corporation, Tonghua 134000, China;3.Department of Gynecology, The Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun 130021, China;4.Department of Gynecology, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110000, China;5.Department of Gynecology, The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China;6.Department of Gynecology, Guanganmen Hospital of Chinese Academy of Traditional Chinese Medicine, Beijing 100053, China;7.Department of Gynecology, The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China;8.Department of Gynecology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China
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| Abstract: |
| [Objective] Regarding gengnianan tablets as positive control drug,to confirm the effect of gengshu particles for of menopausal syndrome of liver and kidney yin deficiency. [Methods] The test used the method of stratified random, double-blind, positive drug parallel controlled, multi center, we adopt 480 patients of menopausal syndrome and divided into 2 groups, 360 for the test group, in which 0 cases were excluded, 10 were lost to follow up; 120 were in the control group, in which 1 were excluded, 9 were lost to follow up. The patients of test group oral Gengshu particles analog with simulation of Gengnianan tablets, The patients of control group oral Gengnianan tablets along with simulation of Gengshu particles. The course of treatment was 14 days. [Results] FAS analysis results of the curative effect of disease, the test group total effective was 58.1%, and 38.7% for the control group, there was significant difference. FAS analysis results of the efficacy of traditional Chinese medicine(TCM) syndrome. The clinical cure rate of the test group was 14.2%, and of all the total effective rate was 52.5%, total effective rate was 95.8%. The positive control group, the cure rate was 1.7%. The total effective rate was 24.4%, and of all the total efficiency of 84%. The differences were statistically significant (P=0.000). Non inferiority test results show that: the efficacy of the test group is non inferior to the control group. [Conclusion] Gengshu particles are more safe and effective in the treatment of menopause syndrome. |
| Key words: Gengshu particle menopause syndrome clinical trial |
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