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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。
Objective: To explore the rule and safety of Tanreqing Injection in children and to provide reference for clinical application. Methods: A real-world study was conducted in children (≤14 years of age) admitted to hospital from July 2013 to January 2015 with demotrophic injection. The demographic information, clinical diagnosis, dosage, course of treatment, , Combination therapy and adverse reactions (ADR) incidence analysis. Results: A total of 1 062 children were treated with Tanreqing Injection, of which 613 were boys and 449 were girls, with 27 cases (2.54%) having adverse reactions. The patients were mainly used for bronchial pneumonia, bronchitis, upper respiratory tract infection and The upper respiratory tract-related surgery; combination medication accounted for 88.32%, the main combination for the antimicrobial drugs; by statistical analysis, different gender, different age groups, vehicle type, dilution ratio, combined medication ADR incidence was no significant difference; Allergy history, the number of days of use of ADR were statistically significant (P <0.05 and P <0.01, respectively). Conclusion: Tanreqing injection in clinical use of children, there is super-indications, non-standard administration, combined with more medication and other issues should be standardized clinical application to reduce or avoid the occurrence of ADR, to ensure the safety of patients medication.