返回 
加入收藏
司美格鲁肽注射液相关不良反应的影响因素及风险预测模型研究
x
请在关注微信后，向客服人员索取文件
| 篇名： | 司美格鲁肽注射液相关不良反应的影响因素及风险预测模型研究 |
| TITLE： | Study on influencing factors and a risk prediction model for adverse drug reactions associated with Semaglutide injection |
| 摘要： | 目的 分析司美格鲁肽注射液相关不良反应（ADR）的影响因素，构建风险预测模型，为个体化治疗提供参考。方法对2024年4月－2025年12月因2型糖尿病和/或肥胖症或超重，且至少存在1种体重相关合并症、在我院就诊并首次使用司美格鲁肽注射液的患者进行为期6个月的随访，分析其相关ADR的发生情况。采用7∶3分层随机抽样将纳入患者分为训练集（216例）与验证集（93例），以是否发生ADR为因变量，在训练集中进行单因素分析；采用最小绝对收缩和选择算子（LASSO）回归分析，在训练集中筛选预测变量，并利用多因素Logistic回归分析筛选司美格鲁肽相关ADR发生的独立影响因素；基于所得多因素Logistic回归分析的回归系数构建风险预测模型并绘制列线图，通过受试者工作特征（ROC）曲线、决策曲线分析（DCA）、校准曲线在训练集和验证集中进行模型预测性能评估。结果共纳入309例患者，发生司美格鲁肽相关ADR的有165例（占53.40%）；发生时间为用药后的4.20（2.04，6.53）d，以消化系统不适最为常见；ADR多为轻至中度，因无法耐受ADR而停药的患者有15例（占4.85%）。基于训练集的单因素分析和LASSO回归分析共筛选出性别、糖尿病患病年限、基线空腹血糖（FBG）、基线糖化血红蛋白（HbA1c）、联用基础胰岛素、联用阿卡波糖、联用抗血小板药7个预测变量。多因素Logistic回归结果显示，女性、基线FBG≥11.1mmol/L、基线HbA1c≥9.0%、合用阿卡波糖是司美格鲁肽相关ADR发生的独立影响因素（比值比分别为2.11、18.11、0.11、0.10，P＜0.05）。所建风险预测模型的评估结果显示，训练集和验证集ROC曲线下面积分别为0.82、0.81；在对应阈值概率范围（0～0.80、0～0.75）内，使用该模型的临床净获益大于“全干预”或“无干预”策略；两数据集的原始校准曲线、偏倚校正曲线均与理想校准线重合（Hosmer-Lemeshow检验的P均大于0.05）。结论司美格鲁肽相关ADR多发生于治疗早期，以消化系统不适为主要临床表现；女性、基线FBG≥11.1mmol/L是ADR发生的独立危险因素，基线HbA1c≥9.0%、合用阿卡波糖则是其独立保护因素。所建风险预测模型的区分度、一致性、临床实用性较好，可用于临床上司美格鲁肽注射液相关ADR发生风险的预测。 |
| ABSTRACT： | OBJECTIVE To analyze the influencing factors of adverse drug reactions （ADRs） related to Semaglutide injection， construct a risk prediction model， and provide a reference for individualized treatment.METHODS Patients diagnosed with type 2 diabetes and/or obesity or overweight who also had at least one weight-related complication and were treated at our hospital for the first time with Semaglutide injection from April 2024 to December 2025 were followed up for 6 months to analyze the incidence of related ADRs. Using a 7∶3 stratified random sampling method， the enrolled patients were divided into a training set （216 cases） and a validation set （93 cases）. With the occurrence of ADRs as the dependent variable， univariate analysis was performed on the training set； the least absolute shrinkage and selection operator （LASSO） regression analysis was used to screen predictive variables in the training set， and multivariate Logistic regression analysis was employed to identify independent risk factors for the occurrence of semaglutide-related ADRs. A risk prediction model was constructed based on the regression coefficients obtained from the multivariate Logistic regression analysis， and a nomogram was generated. The predictive performance of the model was evaluated in both the training and validation sets using receiver operating characteristic （ROC） curves， decision curve analysis （DCA）， and calibration curves.RESULTS A total of 309 patients were enrolled， of whom 165 （53.40%） experienced semaglutide-related ADRs； the time to onset was 4.20 （2.04， 6.53） days after initiation of treatment， with gastrointestinal discomfort being the most common manifestation. ADRs were predominantly mild to moderate in severity， and 15 patients （4.85%） discontinued treatment due to intolerance of the ADRs. Univariate analysis and LASSO regression analysis based on the training set identified seven predictive variables： gender， duration of diabetes， baseline fasting blood glucose （FBG）， baseline glycated hemoglobin （HbA1c）， concomitant use of basal insulin， concomitant use of acarbose， and concomitant use of antiplatelet drugs. Results of multivariate Logistic regression analysis showed that female gender， baseline FBG≥11.1 mmol/L， baseline HbA1c≥9.0%， and concomitant use of acarbose were independent risk factors for the occurrence of semaglutide-related ADRs （odds ratios of 2.11， 18.11， 0.11， and 0.10， respectively； P ＜0.05）. Evaluation of the constructed risk prediction model showed that the areas under the ROC curves for the training and validation sets were 0.82 and 0.81， respectively； within the corresponding threshold probability ranges （0-0.80 and 0-0.75）， the clinical net benefit of using this model was greater than that of the “full intervention” or “no intervention” strategies. The unadjusted and bias-corrected calibration curves for both sets coincided with the ideal calibration curves （ P values for the Hosmer-Lemeshow test were all greater than 0.05）.CONCLUSIONS Semaglutide-related ADRs occur predominantly in the early stages of treatment， with gastrointestinal discomfort as the main clinical manifestation. Female gender and baseline FBG≥11.1 mmol/L are independent risk factors for ADRs， while baseline HbA1c≥9.0% and concomitant use of acarbose are independent protective factors. The developed risk prediction model demonstrates good discrimination， consistency and clinical utility， and can be used to predict the risk of ADRs associated with Semaglutide injection in clinical practice. |
| 期刊： | 2026年第37卷第20期 |
| 作者： | 黄娟娟；吕美怡；何海萍 |
| AUTHORS： | HUANG Juanjuan，LYU Meiyi，HE Haiping |
| 关键字： | 司美格鲁肽注射液;不良反应;影响因素;风险预测模型 |
| KEYWORDS： | Semaglutide injection;Adverse drug reactions;Influencing factors;risk prediction model |
| 阅读数： | 4 次 |
| 本月下载数： | 2 次 |
* 注：未经本站明确许可，任何网站不得非法盗链资源下载连接及抄袭本站原创内容资源!在此感谢您的支持与合作！
