维药新药治疗慢性前列腺炎的临床研究指导原则(草案)  

Clinical research guidelines on the treatment of chronic prostatitis with traditional Uyghur Medicine new drugs(Draft)

作　　者：斯拉甫.艾白 买尼沙.买买提 阿里甫.恩提 王平山 阿布都外力.阿布都克里木 李攻戍[4] 刘炳林[4] 裴小静[4] 唐健元[4] 李治建 阿布都吉力力.阿布都艾尼 

机构地区：[1]新疆维吾尔自治区维吾尔医药研究所,乌鲁木齐830049 [2]新疆维吾尔自治区维吾尔医医院,乌鲁木齐830049 [3]新疆维吾尔自治区食品药品监督管理局,乌鲁木齐830002 [4]国家食品药品监督管理总局药品审评中心,北京100045

出　　处：《中药药理与临床》2015年第3期202-205,共4页Pharmacology and Clinics of Chinese Materia Medica

基　　金：新疆维吾尔自治区科技计划项目(201133126)

摘　　要：本文针对慢性前列腺炎维医诊疗方案进行多中心临床病历回顾性调查研究,收集人口学、诊断学、治疗学、疗效评价、护理学资料等信息,进行整理研究。归纳分析其主症和次症表现,将慢性前列腺炎分为咸味粘液质型、腐败的血液质型和蓝色胆液质型等3型,依次建立了慢性前列腺炎的维医辨证分型标准。并根据患者主观症状量化以期更客观评价症状改善程度的NIHCPSI系统,同时考虑维吾尔医证候症状的改善,使患者内环境恢复到疾病发作前的状态,建立了此病的病症结合疗效评定标准。在此基础上,按照国家新药审评的技术要求和程序,研究制订了维药新药治疗慢性前列腺炎的临床研究指导原则。In this paper, retrospective multi-center study on medical records of Uyghur Medicine diagnosis and treatment program of chronic prosta- titis was done and demographic, diagnostic, therapeutic, efficacy evaluation and nursing data and other information collected were collated and analyzed. Chronic prostatitis, of which the main symptoms and secondary symptoms being analyzed, was divided into three different types ： Xor Balgham Type, Ofunatlangan Kan Type, Zanggarrang Sapra Type and Uyghur Medicine differentiation standard of chronic prostati- tis was successively established. According to the quantified subjective symptoms of the patients and the National Institutes of Health Chronic Prostatitis Symptom Index （NIH-CPSI）, also considering Uyghur Medicine syndrome symptom improvement which can restore the internal en- vironment of the body as well as before the disease, evaluation criteria on the effect of disease and syndrome combination was established. On this basis, in accordance with the technical requirements of the national drug review, the study developed clinical research guidelines for the treatment of chronic prostatitis with Uyghur Medicine new drugs.

关 键 词：慢性前列腺炎 维医药 诊断技术和方法 临床研究指导原则 

分 类 号：R29[医药卫生—民族医学]