Objective To investigate the occurrence of adverse reactions of traditional Chinese medicine injection and its influencing factors.Methods A total of 200 cases were treated with Shuanghuanglian injection at our hospital from January,2015 to December,2017 and were retrospectively analyzed.The incidence of adverse reactions of Shuanghuanglian injection and its influencing factors were analyzed.Results A total of 25 cases of adverse reactions occurred in 200 patients who received double-linked injection.The incidence was 12.5％.Univariate analysis showed that the adverse reactions of Shuanghuanglian injection occurred because of age,BMI index,history of drug allergy,history of allergy,abnormal liver and kidney function,cardiovascular disease,pregnancy or lactation,TCM differentiation of medication,dispensing time,dosage,hourly dose,drip rate,vehicle,route of administration,drug concentration,contraindications,and combination therapy (all P ＜ 0.05).The results of multivariate analysis showed that age,history of drug allergy,abnormal liver and kidney function,TCM syndrome differentiation medication,dispensing time,drip rate,and combination therapy were independent influencing factors of adverse reactions of Shuanghuanglian injection (all P ＜ 0.05).Conclusion Shuanghuanglian injection has a high incidence of adverse reactions,which is mainly related to age,drug allergy history,abnormal liver and kidney function,TCM syndrome differentiation,drug dispensing time,drip rate,and combination therapy.Clinical intervention for these factors should be taken to reduce the incidence of adverse reactions.%目的 探讨中药注射剂不良反应发生情况及其影响因素.方法 选择2015年1月至2017年12月在本院采用双黄连注射液进行治疗的200例病例进行回顾性分析,对双黄连注射液不良反应发生率及其影响因素进行分析.结果 使用双黄连注射液的200例患者不良反应共发生25例,发生率为12.5％.单因素分析结果显示,双黄连注射液不良反应的发生与年龄、BMI指数、药物过敏史、过敏史、肝肾功能异常、心血管疾病、妊娠期或哺乳期用药、中医辩证用药、配药时间、用药剂量、每小时给药量、滴速、溶媒、用药途径、药物浓度、禁忌用药、联合用药有关(均P＜0.05).多因素分析结果显示:年龄、药物过敏史、肝肾功能异常、中医辩证用药、配药时间、滴速、联合用药为双黄连注射液不良反应发生的独立性影响因素(均P＜ 0.05).结论 双黄连注射液不良反应发生率较高,其主要与年龄、药物过敏史、肝肾功能异常、中医辩证用药、配药时间、滴速、联合用药有关,临床上应注意对上述因素进行干预以降低不良反应的发生.
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