雷珠单抗用于糖尿病性白内障术后患者药品不良事件的系统性分析

Systemic analysis of adverse drug events in patients with diabetes complicated by cataract treated with rizumab after surgery

目的 探讨雷珠单抗注射液在糖尿病性白内障术后患者中相关药品不良反应(ADR)的发生情况。方法 通过电子病历系统和随访记录收集2021年8月至2023年6月新疆四七四医院眼科接受雷珠单抗注射液治疗的75例糖尿病性白内障术后患者的病历资料。分析ADR发生率、具体ADR情况及发生时间,并对比有无发生ADR患者间临床特征差异。结果 75例接受雷珠单抗注射液治疗患者中,发生ADR者38例(50.67%),有无发生ADR患者间性别构成(χ^(2)=0.644,P=0.422)以及年龄分布(χ^(2)=1.415,P=0.702)差异无统计学意义;1、2级ADR35例(46.67%),3、4级ADR3例(4.00%),其中10例(13.33%)同时出现累及多个系统的ADR,其中咳嗽2例、恶心5例、过敏反应(皮疹、荨麻疹、瘙痒和红斑)2例、动脉血栓栓塞1例。最常见的ADR是眼压升高19例,其次是结膜出血10例,3、4级ADR为视网膜撕裂或脱落2例、动脉血栓栓塞1例;75例患者,60 min ADR发生率为30.67%(23/75),38例ARD中,前60 min,占比60.53%(23/38),予以对症治疗后均可缓解。结论 约1/2糖尿病性白内障术后患者在接受雷珠单抗治疗后出现ADR。尽管大多数ADR为1、2级轻微反应,但仍有部分患者出现了严重的3、4级ADR,包括视网膜撕裂或脱落以及动脉血栓栓塞。这提示在临床实践中应严格监控患者的反应情况,并在用药后60 min内特别注意ADR的发生。对症治疗可以有效缓解ADR,但预防和管理严重ADR仍是未来研究的方向。

Objective To investigate the occurrence of related adverse drug reactions(ADR)of rizumab injection in patients after diabetic cataract surgery.Methods A retrospective collection of medical records was conducted through an electronic medical record system and follow-up records of 75 patients receiving rizumab injection treatment after diabetic cataract surgery in Department of Ophthalmology of Xinjiang 474 Hospital from August 2021 to June 2023.The incidence of ADR,specific ADR and occurrence time were analyzed,and the differences in clinical characteristics were compared between the patients with ADR and those without.Results Among the 75 patients treated with rizumab injection,38(50.67%)experienced ADRs.There were no significant differences in gender composition(χ^(2)=0.644,P=0.422)and age distribution(χ^(2)=1.415,P=0.702)between the patients with ADR and those without.There were 35 patients(46.67%)with grade 1 and 2 ADRs,and 3(4.00%)with grade 3 and 4 ADRs.Among these,10 patients(13.33%)presented with ADRs affecting multiple systems,including 2 of cough,5 of nausea and 2 of allergic reactions(rash,urticaria,itching,and erythema)and 1 of arterial thromboembolism.The most common ADR was increased intraocular pressure in 19 patients,followed by conjunctival hemorrhage in 10.Grade 3 and 4 ADRs included 2 of retinal tear or detachment and 1 of arterial thromboembolism.For the 75 patients,the ADR incidence rate within 60 minutes was 30.67%(23/75).Among the 38 ADR cases,23 occurred within the first 60 minutes,accounting for 60.53%(23/38).All symptoms were alleviated after symptomatic treatment.Conclusion Approximately half of diabetic cataract patients experienced ADRs after receiving rizumab.Despite most ADR having grade 1 and 2 mild reactions,some patients develop severe grade 3 and 4 ADRs including retinal tear or detachment and arterial thromboembolism.This indicates that patient response should be strictly monitored in clinical practice and special attention should be paid to ADR within 60 minutes after medication.Symptomatic treatment can be effective in providing ADR relief and the prevention and management of severe ADR is still a key direction for future research.