在中国，甘精胰岛素100 U/mL与德谷胰岛素治疗2型糖尿病的Meta分析及成本效益分析
Meta-Analysis and Cost-Effectiveness Analysis of Insulin Glargine 100 U/mL Versus Insulin Degludec for the Treatment of Type 2 Diabetes in China.
作者信息
Su Wen, Li Chaoyun, Zhang Lei, Lin Ziyi, Tan Jun, Xuan Jianwei
机构信息
Health Economics Research Institute, Sun Yat-sen University, Guangzhou, China.
Health Economics and Outcome Research, Sanofi, Shanghai, China.
出版信息
Diabetes Ther. 2019 Oct;10(5):1969-1984. doi: 10.1007/s13300-019-00683-2. Epub 2019 Sep 3.
INTRODUCTION
To evaluate the efficacy and safety as well as the long-term cost-effectiveness of insulin glargine 100 U/mL (IGlar) versus insulin degludec (IDeg) for the treatment of type 2 diabetes mellitus (T2DM) from the Chinese healthcare system perspective.
METHODS
A systematic search of English and Chinese electronic databases for randomized controlled trials (RCTs) comparing IGlar with IDeg for the treatment of T2DM was performed, followed by a meta-analysis to compare the efficacy and safety of IGlar versus IDeg. The CORE Diabetes Model was used to estimate lifetime costs, quality-adjusted life years (QALYs) gained, and cost-effectiveness of IGlar versus IDeg. One-way and probabilistic sensitivity analyses were conducted to assess the underlying parameter uncertainty.
RESULTS
Six RCTs were included in the meta-analysis. The IGlar group showed a statistically significant decrease in glycated hemoglobin (HbA) from baseline compared to the IDeg group (mean difference [MD] 0.08%, 95% confidence interval [CI] 0.01-0.14%, P = 0.02). Body mass index (BMI) control was numerically better in the IGlar group than in the IDeg group (MD 0.07 kg/m, 95% CI - 0.01 to 0.14 kg/m, P = 0.08). In terms of hypoglycemia, the incidence of non-severe overall hypoglycemia was comparable between the IDeg and IGlar patient groups (P > 0.05), while the incidence of non-severe nocturnal hypoglycemia (relative risk [RR 0.79], 95% CI 0.70-0.90, P < 0.01) and the event rates of non-severe overall (RR 0.91, 95% CI 0.85-0.97, P < 0.01) and non-severe nocturnal hypoglycemia (RR 0.91, 95% CI 0.85-0.97, P < 0.01) were lower in the IDeg group. The incidences and event rates of both severe overall and nocturnal hypoglycemia were similar for the two groups (P > 0.05). The cost-effectiveness analysis showed that IGlar is the dominant treatment option compared with IDeg, with a lifetime savings of 1004 Chinese yuan in direct medical costs and a net gain of 0.015 QALYs per patient. Both one-way and probabilistic sensitivity analyses confirmed the robustness of the results.
CONCLUSIONS
IGlar is a cost-saving option with incremental effectiveness compared with IDeg for the treatment of T2DM in China.
FUNDING
Sanofi China.
引言
从中国医疗保健系统的角度评估100 U/mL甘精胰岛素（IGlar）与德谷胰岛素（IDeg）治疗2型糖尿病（T2DM）的疗效、安全性以及长期成本效益。
方法
系统检索英文和中文电子数据库，查找比较IGlar与IDeg治疗T2DM的随机对照试验（RCT），随后进行荟萃分析以比较IGlar与IDeg的疗效和安全性。使用CORE糖尿病模型估计终身成本、获得的质量调整生命年（QALY）以及IGlar与IDeg的成本效益。进行单向和概率敏感性分析以评估潜在参数的不确定性。
结果
荟萃分析纳入了6项RCT。与IDeg组相比，IGlar组糖化血红蛋白（HbA）从基线水平有统计学显著下降（平均差值[MD] 0.08%，95%置信区间[CI] 0.01 - 0.14%，P = 0.02）。IGlar组的体重指数（BMI）控制在数值上优于IDeg组（MD 0.07 kg/m²，95% CI -0.01至0.14 kg/m²，P = 0.08）。在低血糖方面，IDeg组和IGlar组患者的非严重总体低血糖发生率相当（P > 0.05），而IDeg组的非严重夜间低血糖发生率（相对风险[RR] 0.79，95% CI 0.70 - 0.90，P < 0.01）以及非严重总体（RR 0.91，95% CI 0.85 - 0.97，P < 0.01）和非严重夜间低血糖的事件发生率（RR 0.91，95% CI 0.85 - 0.97，P < 0.01）较低。两组严重总体和夜间低血糖的发生率及事件发生率相似（P > 0.05）。成本效益分析表明，与IDeg相比，IGlar是主要的治疗选择，每位患者终身可节省直接医疗成本1004元人民币，净增0.015个QALY。单向和概率敏感性分析均证实了结果的稳健性。
结论
在中国，对于T2DM的治疗，与IDeg相比，IGlar是一种具有成本节约且有效性增加的选择。
资助
赛诺菲中国。
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