维药新药治疗带状疱疹临床研究指导原则(草案)
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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)。
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).
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).
引文
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[3]张伊平,孙红红.复方甘草酸苷联合百癣夏塔热片治疗带状疱疹后遗神经痛62例临床观察[J].新疆医学,2012,42(12):54-55.
[4]中华医学会.临床诊疗指南:皮肤病与性病分册[M].北京:人民卫生出版社,2010:2-4.
[5]吐尔逊·乌甫尔.维吾尔医高等专科学校教材:皮肤病学[M].2版.乌鲁木齐:新疆人民卫生出版社,2005:3.
[6]《中国医学百科全书》编辑委员会.中国医学百科全书:维吾尔医学[M].上海:上海科学技术出版社,2005:52-53.
[7]国家中医药管理局.中医病证诊断疗效标准ZY/T001.2-94[S].南京:南京大学出版社,1994:112-116.