中药治疗小儿遗尿症临床研究技术要点  

Key point of clinical research of treating enuresis in children with traditional Chinese medicine

作　　者：戎萍[1] 赵玉生[1] 马融[1] 胡思源[1] 钟成梁[1] 赵金生[2] 

机构地区：[1]天津中医药大学第一附属医院,天津300193 [2]天津中医药大学,天津300193

出　　处：《中华中医药杂志》2012年第8期2052-2056,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：儿科中药新药临床评价研究技术平台规范化建设(No.2011ZX09302-006-03)~~

摘　　要：为相关临床医师、临床科研者及学者提供关于中药治疗小儿遗尿症的临床研究技术要点的参考,使中药治疗小儿遗尿症的临床试验更趋于规范化。本研究从临床定位与试验目的;试验总体设计;诊断标准;中医诊断与辨证;病例纳入标准;排除病例标准;对照药物的选择;疗程、观察时点及随访;有效性评价;安全性指标;合并治疗;试验的质量控制等方面进行归纳和分析,并提出相应的建议。Providing reference of key point of clinical research of treating enuresis in children with traditional Chinese drugs and natural drug for clinical researchers,making the research of treating enuresis in children with traditional Chinese drugs and natural drug tend to standardization.We proposed some research suggestions and analyzed and induced some key points that current research including trial objective,trial overall design,diagnostic criteria,diagnosis and syndrome differentiation of traditional Chinese medicine（TCM）,inclusion criteria,exclusion criteria,the election of control drugs,treating period,observing time and follow-up,effectiveness evaluation,safe indicator,treating of complication,and quality control.

关 键 词：中药新药 小儿遗尿症 临床研究 

分 类 号：R272[医药卫生—中医儿科学]