基于文献的临床评价规范性研究——以痰热清注射液治疗小儿支气管肺炎为例

Normalizing Study of Clinical Evaluation Based on Literature

目的:梳理探讨痰热清注射液治疗小儿支气管肺炎的临床评价标准及指标等内容,为临床评价研究规范性提出相关建议。方法:以"痰热清"、"小儿支气管肺炎"为主题词检索CNKI、万方数据库,依据纳入排除标准进行文献筛选,并对文献中的临床诊断、疗效评价与中医证候等内容进行统计分析。结果:纳入分析的46篇文献中,35篇(76.09%)有明确的西医诊断依据,仅4篇(8.70%)有明确的中医诊断依据,9篇(19.57%)明确描述中医证候分型;疗效评价方面,仅14篇(30.43%)文献有明确的疗效评价标准;另外关于疗效评价指标的选择也各不相同,46篇文献中出现频率在80%以上的分别为:总有效率、体温、咳嗽咳痰和肺部啰音。结论:痰热清注射液治疗小儿支气管肺炎的临床研究存在诊断依据、疗效评价标准和指标不明确、不统一的现象,为提高临床研究的规范性,需建立统一的临床路径和诊疗指南。

Objective： To provide reference for clinical research of standardization by analyzing clinical evaluation of the studies on tanreqing injection in treatment of children with bronchial pneumonia. Methods： Taking ＂tanreqing＂ and＂ infantile bronchopneumonia＂ as the key words according to the related standard of literature to search CNKI and Wanfang database, and analyzing the diagnostic criteria, effective evaluation criteria, syndrome classification etc. Results ：46 studies were included. There are 35 （76.09%） studies including clear western medicine diagnosis criteria,4 （8.70%）studies including clear Traditional Chinese Medicine diagnosis criteria, 9 （ 19. 57% ） stud- ies including Syndrome classification. About the curative effect evaluation, only 14（30. 43% ） studies has the definite curative effect e- valuation standard, in addition, the choice of curative effect evaluation indexes are different in the studies. The frequency above 80% are total effective rate, body temperature, cough and expectoration and lung sounds, respectively. Conclusion： Based on tanreqing injection in treatment of children with bronchial pneumonia, Diagnostic criteria, effect evaluation and syndrome classification are lack of unified stand- ard. In order to improve the standardization of the clinical research, it is necessary to establish a unified clinical pathway and guidelines.