维药新药治疗湿疹临床的研究指导的原则.docVIP

维药新药治疗湿疹临床的研究指导的原则 　　摘要：本研究针对湿疹维医诊疗方案进行多中心临床病历回顾性调查，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，将湿疹分为异常血液质型、紫色胆液质型、咸性黏液质型和异常黑胆液质型共4型，建立湿疹的维医辨证分型标准。分别于治疗前后对皮肤瘙痒程度、皮损形态及皮损面积积分进行评价，通过患者维医证候及生活质量的改善，观察患者内环境变化，建立湿疹的病证结合疗效评定标准。在此基础上，按照国家新药审评的技术要求和程序，研究制订维药新药治疗湿疹的临床研究指导原则。 　　关键词：湿疹；维医药；诊断技术和方法；临床研究指导原则 　　DOI：10.3969/j.issn.1005-5304.2015.05.041 　　中图分类号：R275.982.3；R291.5 文献标识码：A 文章编号：1005-5304（2015）05-0132-05 　　Abstract：Retrospective multi-center study on medical records of Uyghur medicine diagnosis and treatment program of eczema was done. Demography， diagnostics， therapeutics， efficacy evaluation and nursing data and other information were collated and analyzed. With analysis and summary of the primary and the secondary symptoms， eczema was divided into four types：blood corruption type （Ofunetlengen Kan Tiplik）， blue colored yellow bile type （Zenggereng Sapra Tiplik）， abnormal black bile type （Hayri Tabii Savda Hilitlik）， and salty phlegm type （Shor Belgem Hilitlik）. Uyghur Medicine syndrome differentiation and efficacy evaluation criteria were established. Skin itching， lesion shape， and lesion area integral of patients were scored before and after the treatment， respectively. According to the improvement in symptoms of Uyghur medicine syndrome and life quality of patients， and the internal environment change， evaluation criteria for the efficacy of disease symptom combination were established. On this basis， in accordance with the technical requirements of the national new medicine assessment technology， the study developed clinical research guidelines for the treatment of eczema with new Uyghur medicine. 　　Key words：eczema；Uyghur medicine；diagnostic technique and method；clinical research guideline 　　湿疹是最为常见的皮肤疾病。据统计，湿疹在发达国家儿童中的发病率高达30%，在成人中的发病率约为10%[1]；且有研究显示，由于经济快速增长、环境急剧变化，发展中国家湿疹的发病率有增高的趋势[2]。湿疹是由多种内外因素引起的真皮浅层及表皮炎症，临床上急性期皮损以丘疱疹为主、有渗出倾向，慢性期以苔藓样变为主，病情易反复发作。其病因尚不清楚，内部因素主要有慢性感染病灶、内分泌及代谢改变、血液循环障碍、神经精神因素、遗传因素等，其中遗传因素与个体易感性及耐受性有关；外部因素主要为由食物、吸入物、生活环境、动物皮毛、各种化学物质