浅谈中药注射剂与证候关联性——中药注射剂不良反应成因及对策思考

The correlation of TCM syndrome and TCM injection——the causes and countermeasures of adverse reactions of TCM injection

近来有关中药注射剂不良反应的报道和争议日渐增多,究其成因,除了不合理使用等人为因素和研制技术限制性因素外,缺乏中药注射剂中医证候关联性的循证依据,使中药注射剂使用的中医学属性或理念渐失亦是其重要因素之一。应着力研究复方主要活性物质或成分群与原方中医药特性的相关性,或建立适合中药新活性物质和成分群的新的中医理论及法则。可先行从中药注射剂与证候关联性评价等研究着手,分析出某一种中药注射剂所主病证中不同中医证候与疗效的关系度,进而明确此中药注射剂的最对应之中医证候以提高其临床疗效和用药安全性。

There are more and more reports about the adverse reactions of traditional Chinese medicine（TCM）injection, and the controversy on TCM injection becomes much more notable. In addition to the unreasonable use and technology defects, the lack of evidence-based correlation analysis on TCM injection and TCM syndrom contributes to the occurrence of its adverse effects, since TCM concepts and attributes used for guiding TCM injection application were lost. It is necessary to study the relationship between the main active substance or the composition group and the TCM characteristics of its original formula, or to establish a new theory and rule of TCM for the application of new active substances and composition groups. The evaluation study of correlation between TCM syndrome and TCM injection is more practical at present. The analysis should be made on the relationship between the efficacy and the different syndromes of TCM injection mainly treated disease. Consequently, the clinical efficacy and safety of TCM injection can be improved if its corresponding treated syndrome is clear.