痰热清注射液综合评价研究

Comperhensive evaluation research of Tanreqing injection

目的 以临床常用痰热清注射液为例,探索中成药综合评价的内容和方法,为中成药的临床合理使用、中成药价值的研究开发以及药品相关决策提供依据,推动安全、有效、合理的用药。方法 基于系统检索文献和药品生产企业提供的研究资料,利用循证医学和药物经济学等基本方法,从药学特性、有效性、安全性、经济性、适宜性、可及性和创新性等方面对痰热清注射液进行评价。结果 痰热清注射液有效成分和在说明书适应症上的药理作用明确,临床疗效肯定,安全性良好,药品质量有保障。在其他中药注射剂方案对比中部分适应症的有效性和经济性结果并不一致。结论 痰热清注射液的临床证据已形成一定的体系,但在不同临床应用中的药理机制挖掘、临床扩展应用中的有效性和安全性、个体精准用药还需要更深入的研究。

To conduct the comprehensive evaluation of Tanreqing injection, we attempt to provide evidences for clinical use, value development and decision-making of the traditional Chinese medicine(TCM) injection systematically. Methods Using literature review, expert surveys and related research data, Tanreqing injection was analyzed from various aspects, including pharmaceutical characteristics, effectiveness, security, economy, suitability, accessibility and innovation. Results Tanreqing injection has demonstrated reliable results in most dimension, while controversial results reported in efficiency and economy comparing with other TCM injection treatments. Conclusion The evidence of Tanreqing injecton is considerable, but higher-quality research on pharmacological mechanism and individual treatment is required.