基于真实世界研究的痰热清注射液儿童临床应用安全性分析

目的:探究痰热清注射液在儿童人群中的使用规律及安全性,为临床合理应用提供参考。方法:对2013年7月-2015年1月入院使用痰热清注射液的患儿(≤14岁)进行真实世界研究,对患儿的人口学信息、临床诊断、药物用法用量、疗程、溶媒、联合用药及不良反应(ADR)发生率进行总结分析。结果:使用痰热清注射液的儿童患者共1 062例,其中男童613例,女童449例,发生不良反应27例(2.54%);临床主要用于支气管肺炎、支气管炎、上呼吸道感染及上呼吸道相关的手术后;联合用药占88.32%,主要联合用药为抗菌药物;经统计分析,不同性别、不同年龄段、溶媒种类、稀释倍数、合并用药的ADR发生率无统计学差异;有无过敏史、使用天数的ADR发生率有统计学差异(分别为P<0.05和P<0.01)。结论:痰热清注射液在儿童的临床使用上,存在超适应证、给药不规范、联合用药较多等问题,应规范其临床应用,以减少或避免ADR发生,保障患者用药安全。

Analysis of clinical application of Tanreqing Injection in children based on real world research

OBJECTIVE To explore using rules and safety of Tanreqing Injection in pediatric population, provide reference for clinically reasonable application. METHODS From July 2013 to January 2015, children (under 14 years old) treated with Tanreqing Injection on admission were enrolled, registered and analyzed for demographic data, clinical diagnoses, drug dose, treatment course, solvent, combination of medication and adverse reactions (ADR). RESULTS A total of 1 062 cases including 613 boys and 449 girls were recorded; 27 cases of adverse reactions (2.54%) appeared; clinical diagnoses were mainly bronchial pneumonia, bronchitis, upper respiratory tract infection and operations of upper respiratory tract; combined medication accounted for 88.32%, main drugs combined were antibiotics. Statistical analysis showed no significant difference (P>0.05) in incidence rates of ADR between different genders, age groups, solvents and combined drugs. ADR including allergic history and treatment course had significant differences (P<0.05 and P<0.01). CONCLUSION Tanreqing Injection used in children has following problems, including use beyond indications, irregular medication, much drug combination. The clinical application should be standardized to reduce or avoid ADR, and guarantee safety for patients.