Liu Wei, Yu Jiangyi, Yan Qianhua, Wang Lijuan, Li Nan, Xiong Wei
The First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, Jiangsu 210023, P.R. China.
Department of Endocrinology and Metabolism, Jiangsu Province Hospital of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu 210023, P.R. China.
Exp Ther Med. 2018 Sep;16(3):2545-2553. doi: 10.3892/etm.2018.6449. Epub 2018 Jul 17.
The purpose of this meta-analysis was to evaluate the evidence of the clinical efficacy and safety of sitagliptin in diabetic patients with incipient nephropathy. PubMed, Ovid, Cochrane library, Chinese National Knowledge Infrastructure, and Wanfang databases were searched in September 2017 to identify randomized controlled trials (RCTs) of sitagliptin in diabetic patients with incipient nephropathy. Study selection, data extraction and study quality assessment were performed independently by two investigators, while disagreements were resolved by a third reviewer. The treatment effect was estimated by calculating the mean difference (MD) or standard mean difference (SMD). Heterogeneity was assessed with the χ and I tests. Additionally, risk of bias graphs and summaries were used to assess the quality of the included trials. Thirteen RCTs were included in this review; their results suggested that sitagliptin has obvious advantages in lowering the 24-hour urinary albumin excretion [MD, -25.71; 95% confidence interval (CI), -30.75 to -20.66; P<0.00001], serum cystatin C (MD, -0.59; 95% CI, -0.64 to -0.54; P<0.00001), inflammation (MD, -0.81; 95% CI, -1.20 to -0.42; P<0.0001), and total cholesterol (MD, -0.13; 95% CI, -0.22 to -0.03; P=0.009). However, sitagliptin did not appear to influence serum creatinine, fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin A1c, or triglyceride levels, although these results may have been influenced by biases in the included trials. The most common adverse effects of sitagliptin were gastrointestinal tract reaction and hypoglycemia, although these symptoms resolved quickly. Sitagliptin appears to be effective in reducing proteinuria, ameliorating renal function, and producing an anti-inflammatory effect in patients with early-stage diabetic nephropathy. The present analysis provides important guidance for the clinical application of sitagliptin.
本荟萃分析的目的是评估西他列汀在早期肾病糖尿病患者中临床疗效和安全性的证据。于2017年9月检索了PubMed、Ovid、Cochrane图书馆、中国知网和万方数据库，以确定西他列汀在早期肾病糖尿病患者中的随机对照试验（RCT）。由两名研究人员独立进行研究选择、数据提取和研究质量评估，分歧由第三位审阅者解决。通过计算平均差（MD）或标准化平均差（SMD）来估计治疗效果。用χ²和I²检验评估异质性。此外，使用偏倚风险图和总结来评估纳入试验的质量。本综述纳入了13项RCT；其结果表明，西他列汀在降低24小时尿白蛋白排泄量[MD，-25.71；95%置信区间（CI），-30.75至-20.66；P<0.00001]、血清胱抑素C（MD，-0.59；95%CI，-0.64至-0.54；P<0.00001）、炎症（MD，-0.81；95%CI，-1.20至-0.42；P<0.0001）和总胆固醇（MD，-0.13；95%CI，-0.22至-0.03；P=0.009）方面具有明显优势。然而，西他列汀似乎并未影响血清肌酐、空腹血糖、餐后血糖、糖化血红蛋白A1c或甘油三酯水平，尽管这些结果可能受到纳入试验中偏倚的影响。西他列汀最常见的不良反应是胃肠道反应和低血糖，尽管这些症状缓解迅速。西他列汀似乎对早期糖尿病肾病患者减少蛋白尿、改善肾功能和产生抗炎作用有效。本分析为西他列汀的临床应用提供了重要指导。
