维药新药治疗带状疱疹临床研究指导原则(草案)
2017-01-24阿不都外力阿不都克里木斯拉甫艾白
阿不都外力?阿不都克里木++斯拉甫?艾白++王平山++吐尔逊?乌甫尔++玉苏甫?买提努尔
摘要:本研究针对带状疱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,将带状疱疹分为异常血液质型带状疱疹、异常胆液质型带状疱疹、异常黑胆质型带状疱疹共3型,建立带状疱疹的维医辨证分型标准,并对皮疹停发时间、皮疹干涸结痂时间、疼痛开始缓解时间、完全止痛时间、疼痛反弹发生率、后遗神经痛发生率、后遗神经痛痊愈时间进行评价,通过患者维医证候及生活质量的改善,观察其内环境的变化,建立带状疱疹的病证结合疗效判定标准。在此基础上,按照国家新药评审的技术要求和程序,研究制定维药新药治疗带状疱疹的临床研究指导原则(草案)。
关键词:带状疱疹;维医药;临床研究指导原则
DOI:10.3969/j.issn.1005-5304.2017.01.001
中图分类号:R291.5;275.921.2 文献标识码:A 文章编号:1005-5304(2017)01-0001-04
Clinical Research Guidelines for Treatment of Shingles with New Uyghur Medicine (Draft) Abuduwaili Abudukelimu1, Silafu Aibai2, WANG Ping-shan3, Tuerxun Wufuer1, Yusufu Maitinuer1, Muhamaiti Wusiman3, ZHANG Hong3, Tuerhong Aximu1, Refuhati Saimaiti1, BAI Lian-sheng3, LI Jin-feng3, Abudujilili Abuduaini2, LI Zhi-jian2, LI Gong-shu4, LIU Bing-lin4, PEI Xiao-jing4, ZHOU Bei4 (1. Xinjiang Uyghur Medicine Hospital, Urumqi 830049, China; 2. Institute of Xinjiang Traditional Uyghur Medicine, Urumqi 830049, China; 3. Xinjiang Uyghur Autonomous Region Food and Drug Administration, Urumqi 830002, China; 4. Center for Drug Evaluation, CFDA, Beijing 100045, China)
Abstract: This research conducted retrospective multi-center study on medical records of Uyghur Medicine diagnosis and treatment program of shingles, and collected information about demography, diagnostics, and therapeutics, efficacy evaluation and nursing to conclude and analyze the main syndromes and sub-disease performance. Shingles was divided into 3 types in Uyghur Medicine field: abnormal blood type shingles, abnormal bile liquid type shingles, and abnormal black choledochal type shingles. Uighur Medicine syndrome type standards of shingles were established. Rash suspended time, rash dry scab time, the pain start to ease time interval, time completely pain, pain bounce rate, the incidence of postherpetic neuralgia, and PHN recovery time were evaluated. Disease and syndrome clinical criteria of shingles were established by evaluating Uygur Medical symptoms improvement, improvement of patients life quality and the changes in patients internal environment. On this basis, in accordance with the technical requirements of the national medicine review, the research developed clinical research guidelines for the treatment of shingles with new Uyghur Medicine (draft).
Key words: shingles; Uyghur Medicine; clinical research guidelines
基金项目:新疆维吾尔自治区科技计划项目(201333101)
通讯作者:斯拉甫·艾白,E-mail:aibai@263.net
带状疱疹病毒(VZV)初次感染引起水痘,愈合后残留的病毒潜伏于脊神经后根及颅神经的神经节中,当VZV特异性的细胞免疫下降时,病毒重新复活而发生带状疱疹。带状疱疹发病的基本特点是:随着年龄的增加以及疾病、药物等对细胞免疫的损害,其发病率呈显著增长趋势。此病维吾尔医学称为“奈木拉”(NAMLA),机体的自然力和免疫力下降是带状疱疹发生和发展的主要原因。……