[關鍵詞]
[摘要]
目的 評估雷公藤多苷(TGT)治療糖尿病腎?。―KD)的效益與風險。方法 建立TGT治療DKD效益與風險的多準則決策分析模型。檢索數(shù)據(jù)庫中TGT治療DKD相關試驗的文獻。按照納入排除標準篩選文獻,從納入的文獻中提取效益與風險指標。利用RevMan 5.4軟件對效益、風險指標數(shù)據(jù)進行合并,采用搖擺賦權法賦予權重,再利用Hiview3軟件計算不同用藥條件下的效益值、風險值及效益-風險總值。采用敏感性分析驗證模型穩(wěn)定性,并通過蒙特卡洛模擬優(yōu)化本研究結果。結果 共納入23篇隨機對照試驗,結果顯示,TGT 60 mg·d-1和120 mg·d-1 2項用藥方案的效益-風險總值分別為54、58; TGT用藥療程3、6、12個月3組用藥方案的效益-風險總值分別為52、54、47,可見TGT治療DKD的效益-風險結果受其日劑量、用藥療程因素的影響。結論 TGT日劑量120 mg用于治療DKD的效益風險總值較60 mg更高;用藥療程方面,3個月和6個月的效益風險總值近似,然而12個月的效益風險總值最低,表明長期使用TGT存在潛在安全風險,醫(yī)生在臨床用藥決策過程中需充分權衡效益與風險。
[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.
[中圖分類號]
R969.4
[基金項目]
江蘇省藥學會-恒瑞醫(yī)院藥學基金課題(H02332)