中药注射剂在儿科临床应用的安全性评价研究

摘要

Objective To study the general pattern and characteristics of adverse drug reactions induced by traditional Chinese medicine injection to provide references for clinical rational use of drug .Methods 166 ADR/ADE reports of traditional Chinese medi-cine injection occurred in the past five years in Our hospital were analyzed using retrospective study method .Results 166 cases of pa-tients in male 122 cases,female 64 cases,involving 12 kinds of traditional Chinese medicine injections;Detoxification traditional Chi-nese medicine injection is the primary drug causing ADR /ADE;allergy is the highest incidence .80 ADRs caused by Tanreqing injec-tion are the largest number accounting for 43.01%.ADR/ADE mainly were skin allergies accounted for 58.72%.Conclusion the dosage for children in Package inserts of TCM injections should be further regulated , and ADR reporting and monitoring should be strengthened .Strictly follow the clinical principles and intensive care and timely treatment to ensure drug safety in children and improve the rational use of drug .%目的：了解中药注射剂在儿科应用引发不良反应/不良事件（ ADR/ADE）的特点和规律，评价其安全性，为临床合理应用提供参考。方法通过对我院近五年发生的166例儿科中药注射剂ADR/ADE进行回顾性统计分析。结果166例ADR/ADE中男性122例次，女性64例次，涉及中药注射剂12种，清热解毒类中药注射剂是致儿童ADR/ADE的主要药物；变态反应发生率最高，其中痰热清注射液引起ADR/ADE的例数最多，为80例次，占43.01％。所致ADR/ADE最常见的是皮肤及附件损害，占58.72％。结论中药注射剂说明书应进一步规范儿童用量，医院应高度重视儿科应用中药注射剂引起的ADR/ADE并加强ADR/ADE报告和监测工作，严格遵循中药注射剂临床使用基本原则，加强监护并及时处理，保障患儿用药安全，促进临床合理用药。