中药注射剂致输液性静脉炎不良反应的危险因素分析

目的探讨中药注射剂致输液性静脉炎的危险因素。方法采用病例对照研究的方法,分别选取中药注射剂致输液性静脉炎患者为观察组和非输液性静脉炎患者为对照组,每组63例,按照患者的基本情况(性别、年龄、过敏史、免疫性疾病)、用药情况(用药剂量、输液种类、合并用药、溶媒体积、累积输液时间)和输液操作(规范化无菌输液操作、从配制到输液时间)等进行调查,通过组间单因素χ~2分析和组内多因素Logistic分析进行危险因素分析。结果两组患者年龄、过敏史、免疫性疾病、用药剂量、合并用药、累积输液时间、规范化输液操作和从配制到输液时间比较差异有统计学意义(P<0.05),进一步采用组内多因素Logistic分析发现,年龄(>65岁)、过敏史、免疫性疾病、用药剂量(>标准剂量)、合并用药、累积输液时间(>6 d)、规范化无菌输液操作和从配制到输液时间(>1 h)是中药注射剂致输液性静脉炎的独立危险因素,其OR值分别为1.72、4.20、1.61、1.92、0.08、5.00、0.56、0.38。结论规范化无菌输液操作是预防中药注射剂致输液性静脉炎的关键因素,同时应更关注高龄、过敏史、伴有免疫性疾病、合并多种药物、累积输液时间长的患者,保证临床用药安全。

Risk factors of infusion phlebitis caused by traditional Chinese medicine injections

Objective To explore the correlation of traditional Chinese medicine (TCM) injections with infusion phlebitis and analyze the risk factors of TCM injection-related infusion phlebitis.Methods The case control study was performed in observation group and control group,which were divided according to whether there was infusion phlebitis caused by TCM injection,63 cases in each group.The basic information (gender,age,history of allergy and immunological diseases),drug use (dosage and kinds of infusion,combined medication,solvent volume,cumulative time of infusion) and infusion operation (standardized sterile infusion operation,time from preparation to infusion) of the patients were investigated.The risk factors were analyzed by single factor x2 analysis and multiple factors Logistic analysis.Results There were significant differences in age,history of allergy,immune diseases,medication dosage,combined medication,cumulative infusion time,standardized infusion operation and the time from preparation to infusion between the two groups (P ＜ 0.05).The multiple factors Logistic analysis of the above factors showed that age (＞ 65 years old),history of allergy,immune disease,dosage (over standard dose),combined medication,cumulative infusion time (＞ 6 d),standardized sterile infusion operation and time from preparation to infusion (＞ 1 h) were independent risk factors of infusion phlebitis induced by TCM injections.The OR value was 1.72,4.20,1.61,1.92,0.08,5.00,0.56 and 0.38,respectively.Conclusion Standardized aseptic infusion operation is the key factor to prevent the infusion phlebitis caused by TCM injection;meanwhile,the patients with old age,allergic history,immune diseases,combined medication and longer time of cumulative infusion should be paid more attention to ensure the safety of clinical medication.