CAJ | 학술논문

目的：评价那格列奈联合二甲双胍治疗2型糖尿病（T2DM）的疗效和安全性。方法：全面检索那格列奈联合二甲双胍与单用二甲双胍比较治疗T2DM的随机对照试验（RCT）。根据Cochrane Handbook 5.1.0进行质量评价，并采用RevMan 5.2软件进行Meta分析。结果：共纳入6个RCT，1402例患者。Meta分析结果显示：那格列奈联合二甲双胍组在空腹血糖（FPG）[MD =–1.00，95%CI（–1.46，–0.54），P <0.0001]、餐后2小时血糖（2 hPG）[MD =–2.37，95%CI（–3.99，–0.75），P =0.004]、糖化血红蛋白（HbA1c）[MD =–1.19，95%CI（–2.07，–0.31），P =0.008]方面较单用二甲双胍组能更有效地改善血糖水平。那格列奈联合二甲双胍组的低血糖发生率高于单用二甲双胍组[OR =2.14，95%CI（1.11，4.12），P =0.02]。两组在胃肠道不良反应发生率方面差异无统计学意义。结论：那格列奈联合二甲双胍在控制血糖方面优于二甲双胍，但低血糖反应发生率高于二甲双胍。受纳入文献的方法学质量和样本量限制，上述结论的可靠性仍需更多大样本、高质量的研究予以证实。
목적：평개나격렬내연합이갑쌍고치료2형당뇨병（T2DM）적료효화안전성。방법：전면검색나격렬내연합이갑쌍고여단용이갑쌍고비교치료T2DM적수궤대조시험（RCT）。근거Cochrane Handbook 5.1.0진행질량평개，병채용RevMan 5.2연건진행Meta분석。결과：공납입6개RCT，1402례환자。Meta분석결과현시：나격렬내연합이갑쌍고조재공복혈당（FPG）[MD =–1.00，95%CI（–1.46，–0.54），P <0.0001]、찬후2소시혈당（2 hPG）[MD =–2.37，95%CI（–3.99，–0.75），P =0.004]、당화혈홍단백（HbA1c）[MD =–1.19，95%CI（–2.07，–0.31），P =0.008]방면교단용이갑쌍고조능경유효지개선혈당수평。나격렬내연합이갑쌍고조적저혈당발생솔고우단용이갑쌍고조[OR =2.14，95%CI（1.11，4.12），P =0.02]。량조재위장도불량반응발생솔방면차이무통계학의의。결론：나격렬내연합이갑쌍고재공제혈당방면우우이갑쌍고，단저혈당반응발생솔고우이갑쌍고。수납입문헌적방법학질량화양본량한제，상술결론적가고성잉수경다대양본、고질량적연구여이증실。
Objective:To evaluate the efficacy and safety of nateglinide combined with metformin for type 2 diabetes mellitus (T2DM).Methods: The randomized controlled trials (RCTs) about nateglinide combined with metformin compared with metformin alone in treating T2DM were searched. The quality of the included studies was assessed according to the Cochrane Handbook of version 5.1.0 for systematic reviews, and meta-analysis was conducted by using RevMan 5.2 software.Results: According to the inclusion criteria, six RCTs were included consisting of 1402 patients. Meta-analysis showed that the effects of nateglinide combined with metformin in improving blood glucose levels were better than that of metformin alone in respect of FPG [MD =–1.00, 95%CI (–1.46,–0.54),P < 0.000 1]; 2 hPG [MD =–2.37, 95%CI (–3.99,–0.75),P = 0.004]; HbA1c [MD=–1.19, 95%CI (– 2.07,–0.31),P = 0.008]. The occurrence rate of hypoglycemia of nateglinide combined with metformin was higher than that of metformin alone [OR = 2.14, 95%CI (1.11, 4.12),P = 0.02]. There was no significant difference in gastrointestinal discomfort between the two groups.Conclusion: Compared with metformin alone, nateglinide combined with metformin could improve glycemic control but increase the rate of hypoglycemia. The above conclusion should be verified by more large scale, high quality studies in future due to the limitations of the methodological quality and sample size of the included studies.