[关键词]
[摘要]
目的 评估雷公藤多苷(TGT)治疗糖尿病肾病(DKD)的效益与风险。方法 建立TGT治疗DKD效益与风险的多准则决策分析模型。检索数据库中TGT治疗DKD相关试验的文献。按照纳入排除标准筛选文献,从纳入的文献中提取效益与风险指标。利用RevMan 5.4软件对效益、风险指标数据进行合并,采用摇摆赋权法赋予权重,再利用Hiview3软件计算不同用药条件下的效益值、风险值及效益-风险总值。采用敏感性分析验证模型稳定性,并通过蒙特卡洛模拟优化本研究结果。结果 共纳入23篇随机对照试验,结果显示,TGT 60 mg·d-1和120 mg·d-1 2项用药方案的效益-风险总值分别为54、58; TGT用药疗程3、6、12个月3组用药方案的效益-风险总值分别为52、54、47,可见TGT治疗DKD的效益-风险结果受其日剂量、用药疗程因素的影响。结论 TGT日剂量120 mg用于治疗DKD的效益风险总值较60 mg更高;用药疗程方面,3个月和6个月的效益风险总值近似,然而12个月的效益风险总值最低,表明长期使用TGT存在潜在安全风险,医生在临床用药决策过程中需充分权衡效益与风险。
[Key word]
[Abstract]
Objective Tripterygium Glycoside Tablets (TGT) has been clinically listed as an important drug for reducing proteinuria and stabilizing renal function. This study aims to evaluate the benefits and risks of TGT in the treatment of diabetic kidney disease (DKD). Methods To develop a multi-criteria decision analysis model of the benefits and risks of TGT for DKD. Literature on trials related to TGT for DKD was searched in the database. Literature was screened according to the inclusion and exclusion criteria, and benefit and risk indicators were extracted from the included literature. The data of benefit and risk indicators were combined using RevMan 5.4 software, and weights were assigned using the swing assignment method, and then Hiview3 software was used to calculate the benefit value, risk value, and total benefit-risk value under different medication conditions. Sensitivity analysis was used to verify the stability of the model and Monte Carlo simulation was used to optimize the results of this study. Results A total of 23 RCTs were included. The results show that the total benefit-risk values of TGT 60 mg·d-1 and TGT 120 mg·d-1 are 54 and 58 respectively; the total benefit-risk values of TGT treatment course of 3, 6 and 12 months were 52, 54 and 47 respectively. It can be seen that the benefitrisk result of TGT in the treatment of DKD is affected by factors such as its daily dose and medication course. Conclusion The total benefit-risk value of TGT at a daily dose of 120 mg for the treatment of diabetic nephropathy was higher than that of 60 mg. Regarding the duration of dosing, the total benefit-risk values of 3 and 6 months were similar, however, the total benefit-risk value of 12 months was the lowest, indicating that there are potential safety risks associated with the long-term use of TGT, and that physicians need to adequately weigh the benefits against the risks in the process of clinical decision-making on the use of the medication.
[中图分类号]
R969.4
[基金项目]
江苏省药学会-恒瑞医院药学基金课题(H02332)