摘要
目的 分析司美格鲁肽药物不良反应的临床表现及相关影响因素,以期为临床治疗提供参考.方法 收集2022年1月-2023年12月在重庆市第九人民医院内分泌科就诊并接受司美格鲁肽治疗的597例患者临床资料.根据患者使用司美格鲁肽后是否发生不良反应,将患者分为有反应组(n=177)和无反应组(n=420).收集患者姓名、年龄、性别、身体质量指数(BMI)、用药目的、司美格鲁肽维持剂量、电话,通过门诊随访或电话随访患者,详细记录患者用药后的任何不适症状.结果 司美格鲁肽引起的不良反应最常见累及的器官/系统为消化系统,占比为82.48％.在177例发生不良反应患者中,有18例(10.16％)患者因该药所致胃肠道不良反应不能耐受而停止用药;有7例(3.95％)患者因该药所致不良反应相关症状持续不缓解而住院治疗;有2例(1.12％)患者因该药所致严重腹泻诱发基础疾病加重而死亡.比较2组患者临床资料,结果显示2组患者的BMI水平,超说明书用药人数比例以及用药 目的方面差异存在统计学意义(P＜0.05).Logistic回归分析结果显示:低BMI、患2型糖尿病、超说明书用药是患者服用司美格鲁肽后发生不良反应的影响因素(P＜0.05).结论 司美格鲁肽胃肠道不良反应发生率较高,同时,其还可能增加胆囊结石形成风险.建议临床使用司美格鲁肽应严格遵循适应证用药,用药前应对患者的消化系统及甲状腺状况进行评估,且用药过程中应密切关注其用药初期及长期不良反应的发生情况.
Abstract
Objective To analyze the clinical manifestations and related influencing factors of adverse drug reactions(ADRs)to semaglutide,providing references for clinical treatment.Methods Clinical data from 597 patients treated with semaglu-tide at the Endocrinology Department of Chongqing Ninth People's Hospital from January 2022 to December 2023 were col-lected.Patients were assigned to two groups based on the occurrence of ADRs:the reaction group(n=177)and the non-re-action group(n=420).Data on patient's name,age,gender,body mass index(BMI),purpose of medication,semaglutide maintenance dose,and follow-up details or telephone calls were collected.Any discomfort post-medication was recorded thoroughly through outpatient or telephone follow-ups.Results The most common organ/system affected by semaglutide ADRs was the digestive system,accounting for 82.48％of cases.Among the 177 patients with ADRs,18 patients(10.16％)discontinued the drug due to intolerable ADRs,7 patients(3.95％)required hospitalization due to persistent ADR-related symptoms,and 2 patients(1.12％)died due to exacerbation of underlying diseases triggered by severe diarrhe-a.Significant differences between the two groups were observed in BMI levels,off-label drug use,and purpose of medication(P＜0.05).Multivariate logistic regression analysis revealed that low BMI,type 2 diabetes,and off-label drug use were factors influencing the occurrence of ADRs to semaglutide(P＜0.05).Conclusion Gastrointestinal ADRs are common with semaglutide,and it may also increase the risk of gallstone formation.It is recommended that semaglutide be used strictly ac-cording to indications,with an evaluation of the patient's digestive system and thyroid status before administration,and close monitoring of early and long-term ADRs during treatment.
基金项目
重庆市卫生健康委医学科研项目(2023WSJK031)
维普
万方数据