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• 药品评价-临床研究 • 上一篇    下一篇

七味姜黄搽剂的临床运用与评价

翟烨,田文杨   

  1. 北京中医药大学东方医院,北京中医药大学东方医院
  • 收稿日期:2016-06-02 修回日期:2016-06-02 出版日期:2016-08-25 发布日期:2016-08-25

The Clinical Application and Systematic Evaluation On Qiwei Jianghuang Liniment

翟烨 and 田文杨   

  1. Dongfang Hospital Affiliated to Beijing University of Chinese Medicine,
  • Received:2016-06-02 Revised:2016-06-02 Online:2016-08-25 Published:2016-08-25

摘要: 该研究对七味姜黄搽剂的药理研究、临床有效性及安全性研究进行了回顾、分析。现有研究提示该药对痤疮、脂溢性皮炎有一定疗效;探索性研究提示过敏性皮肤疾病、体癣、股癣、足癣,斑秃等也有一定疗效,并提示该药可能引起局部刺痛、局部刺激等不良反应。但临床研究设计及药品的风险效益评估证据有待进一步细化,建议针对产品特点,开展设计良好的上市后临床研究,针对其最优势的适应症进一步开展高质量的临床研究,并加强安全性及与常见联合用药相互作用等研究,从而为优化临床用药方案、保障药品安全有效使用提供科学依据。

Abstract: We conclude that Qiwei Jianghuang liniment has certain therapeutic effects for acne and seborrhea by systematic review and analysis of the pharmacological research and clinical study on the efficacy and safety. It also have therapeutic effects on allergic skin disease, tinea corporis,tinea cruris,tinea pedis and alopecia areata.The post-marketing clinical studies also showed that it causes several adverse reactions, such as local pain and local irritation. Whereas, the design of current clinical study and the drug risk evaluation are insufficient. We propose that it is an appropriate way to provide further scientific proof and ensure rational efficacy drug use by conducting well-designed and good quality post-marketing clinical study on reevaluation the safety and efficacy according to the character of the product,the risk of interactions with other medications.