喜炎平注射液在小儿肠道感染治疗中的不良反应及危险因素分析

Adverse reactions and their risk factors associated with Xiyanping Injection in the treatment of pediatric intestinal infections

摘要:

目的 分析喜炎平注射液在小儿肠道感染中的不良反应及危险因素。方法 对2020年8月—2024年8月达州市中西医结合医院200例使用喜炎平注射液治疗小儿肠道感染的病历资料进行回顾性分析，统计不良反应的发生率、发生时间、转归情况，并采用单因素分析和多因素一般Logistic回归模型评估其相关危险因素。结果 200例患儿中，64例患儿出现不良反应，不良反应发生率为32%，发生时间以用药后5 min内为主（39.06%）。不良反应临床表现中，皮肤及其附件20例（31.25%）、全身性损害15例（23.44%）、呼吸系统11例（17.19%）、中枢系统10例（15.63%）、胃肠系统5例（7.81%）和心血管系统3例（4.69%）。年龄< 3岁、用药超剂量、联合用药、静脉滴注给药、滴注速度80滴/min、溶媒为0.9%氯化钠注射液和有过敏史的患儿不良反应发生率均较高（P <0.05）。多因素一般Logistic回归分析结果显示：年龄< 3岁［O^R=3.083（95% CI：1.529，6.218）］、超剂量用药［O^R=2.528（95% CI：1.217，5.249）］、联合用药［O^R=2.654（95% CI：1.215，5.797）］、给药途径为静脉滴注［O^R=2.583（95% CI：1.174，5.684）］、滴注速度为80滴/min［O^R=2.037（95% CI：1.007，4.121）］、溶媒种类为0.9%氯化钠注射液［O^R=2.114（95% CI：1.053，4.247）］和有过敏史［O^R=3.062（95% CI：1.496，6.269）］均为患儿发生不良反应的危险因素（P <0.05）。结论 年龄、用药剂量、联合用药、给药途径、滴注速度、溶媒种类和过敏史是儿童使用喜炎平注射液治疗肠道感染时发生不良反应的主要危险因素。针对可能发生不良反应的高危儿童，医生应进行早期评估与监护，采取相应的预防措施，以确保喜炎平注射液的安全有效应用。

Abstract:

Objective To analyze the adverse reactions and their risk factors associated with Xiyanping Injection in the treatment of pediatric intestinal infections.Methods A retrospective analysis was conducted on the medical records of 200 children treated with Xiyanping Injection for intestinal infections at Dazhou Integrated TCM and Western Medicine Hospital from August 2020 to August 2024. The incidence, onset time and outcome of adverse reactions were analyzed. Univariable and multivariable Logistic regression analyses were used to evaluate the related risk factors.Results Among the 200 children, 64 (32%) experienced adverse reactions. The majority of the adverse reactions occurred within 5 minutes after administration (39.06%). Among the clinical manifestations of adverse reactions, 20 cases (31.25%) involved the skin and its appendages, 15 cases (23.44%) presented with systemic disorders, 11 cases (17.19%) affected the respiratory system, 10 cases (15.63%) involved the central nervous system, 5 cases (7.81%) were related to the gastrointestinal system, and 3 cases (4.69%) involved the cardiovascular system. A higher incidence of adverse reactions was observed in children under 3 years old, those administered with excessive doses, receiving combination therapy, undergoing intravenous infusion at a rate of 80 drops/min, using 0.9% sodium chloride injection as the solvent, and those with a documented history of allergies (P < 0.05). Multivariable Logistic regression analysis revealed that age < 3 years [O^R = 3.083 (95% CI: 1.529, 6.218) ], overdose administration [O^R = 2.528 (95% CI: 1.217, 5.249) ], combination therapy [O^R = 2.654 (95% CI: 1.215, 5.797) ], intravenous infusion [O^R = 2.583 (95% CI: 1.174, 5.684) ], infusion rate of 80 drops/min [O^R = 2.037 (95% CI: 1.007, 4.121) ], use of 0.9% sodium chloride injection as the solvent [O^R = 2.114 (95% CI: 1.053, 4.247) ], and a history of allergy [O^R = 3.062 (95% CI: 1.496, 6.269) ] were risk factors for adverse reactions (P < 0.05).Conclusion Age, dosage, combination therapy, route of administration, infusion rate, solvent type and history of allergy are the major risk factors for adverse reactions in children receiving Xiyanping Injection for intestinal infections. Early assessment and monitoring should be conducted for high-risk children, and appropriate preventive measures should be taken to ensure the safe and effective use of Xiyanping Injection.