【摘要】 目的 为临床合理应用痰热清注射液提供参考。方法 选取上海中医药大学附属曙光医院医院信息系统(HIS)中2020年1月至2023年12月的5 910例使用痰热清注射液患者的病历,统计患者的一般资料(年龄、性别、用药科室和过敏史),疾病信息(西医诊断、中医辨证),药物治疗情况(用法用量、溶剂及其剂量、给药途径、用药天数);依据药品说明书和诊疗指南,评价其临床应用合理性;根据《个例药品不良反应收集和报告指导原则》分析其安全性。采用巢氏病例对照研究的设计方法,通过单因素和Logistic多因素回归分析其药品不良反应(ADR)的危险因素。结果 5 910例患者中,符合药品说明书和指南推荐适应证的占90.56%,单次使用剂量符合要求的占99.85%,疗程合理率为96.53%,5.63%的患者使用痰热清注射液存在用药禁忌(主要是表寒证和肝肾功能衰竭患者)。44例(0.74%)患者发生ADR,主要累及消化系统和皮肤及其附件,经停药或对症处理后可缓解,发生时间以用药后3 d内较常见(63.64%)。患者发生ADR的危险因素包括过敏史[OR=3.515,95%CI(1.128,9.743),P=0.016],药液稀释倍数[OR=3.170,95%CI(1.329,7.565),P=0.009],用药天数[4～7 d:OR=6.376,95%CI(2.566,15.846),P <0.001;8～14 d:OR=16.787,95%CI(5.503,51.204)P <0.001]。结论 痰热清注射液临床使用中存在中医辨证不合理情况,ADR发生率与药品说明书一致,属“偶见”级ADR,需进一步开展多中心研究,以把握用药指征,确保安全、合理用药。更多还原

【Abstract】 Objective To provide a reference for the rational use of Tanreqing Injection in the clinic.Methods A total of 5 910 medical records of patients who used Tanreqing Injection from January 2020 to December 2023 in the hospital information system(HIS) of the Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine were selected. The patients′ general data(age,gender,medication department,allergy history),disease information(Western medicine diagnosis,Chinese medicine disease name and syndrome),and drug treatment status(dosage,solvent and dose,administration route,duration of medication) were collected and analyzed. The application rationality of Tanreqing Injection was evaluated based on the drug package insert and the diagnosis and treatment guidelines. The safety of Tanreqing Injection was analyzed according to the Guidelines for Collecting and Reporting Adverse Drug Reactions in Individual Cases. The design method of nested case-control study(NCCS) was adtoped and the risk factors of adverse drug reactions(ADRs) induced by Tanreqing Injection were analyzed by the univariate and Logistic multivariate regression analysis.Results Among the 5 910 patients,90. 56% of them had the recommended indications in the drug package insert and guidelines,99. 80% of them met the requirements for a single dose,and the reasonable treatment rate was 96. 53%. About 5. 63% of patients had contraindications to using Tanreqing Injection(mainly for those with surface cold syndrome and liver and kidney function failure). A total of 44 cases(0. 74%) of ADRs occurred,mainly affecting the digestive system,skin and its appendages. After drug withdrawal or symptomatic treatment,the symptoms were relieved,and the occurrence time was more common within 3 d after medication(63. 64%). The risk factors for ADRs included the history of allergies [OR = 3. 515,95%CI(1. 128,9. 743),P = 0. 016],dilution ratio of Tanreqing Injection [OR = 3. 170,95%CI(1. 329,7. 565),P = 0. 009],and duration of medication [4-7 d:OR = 6. 376,95%CI(2. 566,15. 846),P < 0. 001;8-14 d:OR = 16. 787,95%CI(5. 503,51. 204),P < 0. 001].Conclusion In the clinical use of Tanreqing Injection,there are cases of unreasonable traditional Chinese medicine syndrome differentiation,and the incidence of ADR is consistent with the drug instructions,which belongs to the "occasional" level of ADRs. Further multicenter research is needed to be carried out,in order to grasp the indications for medication and ensure safe and rational drug use.更多还原