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作 者:于之恒 陈恳[1] 刘维[1] 翟所迪[1,3] YU Zhi-heng;CHEN Ken;LIU Wei;ZHAI Suo-di(Department of Pharmacy,Peking'University Third Hospital,Beijing 100191,China;Department of Pharmaceutical Administration and Clinical Pharmacy,School of Pharmaceutical Sciences,Peking University,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China)
机构地区:[1]北京大学第三医院药剂科,北京100191 [2]北京大学药学院药事管理与临床药学系,北京100191 [3]北京大学医学部药物评价中心,北京100191
出 处:《中华男科学杂志》2018年第11期1029-1035,共7页National Journal of Andrology
摘 要:目的:了解国内中成药治疗特发性男性不育的临床研究现状。方法:计算机检索中国知网、万方及SinoM ed,检索时限为2001年1月至2017年5月发表于学术期刊的相关文献,纳入考察特发性男性不育患者使用中成药治疗的随机对照试验(RCT)、队列研究、病例对照研究及病例系列研究,统计文献发表情况并进行分析。结果:共纳入307篇文献,其中243篇(79%)为RCT,57篇(19%)为病例系列研究,7篇(2%)为回顾性队列研究。涉及146种学术期刊、51个中成药。文献发表数量呈逐年增长趋势。文献作者来自于29个省、直辖市或自治区,排名前5位的分别为广东、广西、河南、北京和江苏。纳入研究主要评价了药物的有效性和安全性,研究数量最多的前5位药物分别是五子衍宗丸、复方玄驹胶囊、生精胶囊、黄精赞育胶囊和六味地黄丸,其中涉及五子衍宗丸研究的文献有114篇(37. 13%)。发表文献最多的学术期刊是中国男科学杂志。结论:国内中成药治疗男性不育的研究发展迅速,但仍存在地域发展不均衡、样本量少、研究质量低、药师参与度不足等局限性。Objective: To survey the current status of clinical studies on patent Traditional Chinese Medicine( TCM) for idiopathic male infertility in China. Methods: Using the keywords " oligospermia", " azoospermia", " asthenozoospermia", " infertility" and " sperm",we searched China National Knowledge Internet( CNKI),Wanfang Database and SinoM ed for randomized clinical trials( RCT),cohort studies,case-control studies and case series studies focusing on the treatment of male idiopathic infertility using TCM from January 2001 to May 2017. Two individual reviewers screened the literature,extracted the information separately,recorded the titles,authors,related institutions and regions,journals and years of publication,medication studied,and outcomes. The collected data was analyzed using Microsoft Excel and SPSS. Results: Totally,307 publications were included in this study,including 243 RCTs( 79%),57 case series studies( 19%) and 7 retrospective cohort studies( 2%). Fifty one patent TCM and in 146 journals were involved. The number of publications gradully increased from 2001 to 2017. The authors were from 243 institutions in 29 provinces,independent municipalities or autonomous regions,mostly in Guangdong,Guangxi,Henan,Beijing and Jiangsu. Majority of the studies focused on the evaluation of the efficacy and safety of the drugs,among which the most studied medication Wuziyanzong Pills( 114/307,37. 13%),Fufangxuanju Capsules,Shengjing Capsules,Huangjingzanyu Capsules,and Liuweidihuang Pills. Chinese Journal of Andrology had the highest number of publications. Conclusion: A rapid progress has been achieved in China in the studies of patent TCM for the treatment of male infertility. However,limitatiors stiu exist,ragarding inbalance among regions,low sample sizes,low quality of studies,poor involvement of phamacisis.
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