Sheng Xiaohua, Dong Yang, Cheng Dongsheng, Wang Niansong, Guo Yongping
Department of Nephrology, Affiliated Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.
Ann Palliat Med. 2020 Nov;9(6):3885-3898. doi: 10.21037/apm-20-1799. Epub 2020 Nov 16.
Diabetic nephropathy (DN) is the main cause of end-stage renal failure (ESRF) in diabetic patients. Chinese medicine plays an extremely important role in controlling the symptoms of DN. At present, the efficacy and safety of Bailing capsules in the treatment of type 2 DN are still unclear. Therefore, the aim of this meta-analysis was to evaluate the clinical efficacy and safety of Bailing capsules in the treatment of type 2 DN.
A literature search on type 2 DN was conducted using Chinese and English databases. The Chinese databases searched were the CNKI database, Wanfang database, and Weipu database using the following search terms: Bailing capsule and DN. The English databases were PubMed, Embase, and Web of Science using the following search terms: type 2 diabetes mellitus, type II diabetes mellitus, and Bailing capsule. The quality of the literature was evaluated using RevMan 5.3 software. The meta-analysis was performed using the R3.5.1 software meta package.
Twenty-four articles with a total of 985 patients in the treatment group and 956 patients in the control group were found. The total effective rate of Bailing capsules in the treatment group was 1.24 times that of the control group [95% confidence interval (CI): 1.11-1.38]. Reductions in 24-h urine total protein, urine albumin excretion rate (UAER), serum creatinine (Scr), and blood urea nitrogen (BUN) levels before and after treatment in the treatment group were significantly lower than that of the control group, with standard mean differences (SMD) of 0.61 (95% CI: -1.01 to -0.22), -1.56 (95% CI: -2.34 to -0.78), -0.58 (95% CI: -0.89 to -0.27), and -0.73 (95% CI: -1.16 to -0.29), respectively. However, there was no significant change in serum potassium between the two groups (P>0.05). No publication bias was found in the metaanalysis (P>0.05).
For type 2 DN patients, the use of Bailing capsules in routine treatment demonstrated higher clinical efficacy and was found to improve the kidney function. However, high-quality randomized controlled trials are required to further explore the safety of Bailing capsules.
糖尿病肾病（DN）是糖尿病患者终末期肾衰竭（ESRF）的主要原因。中药在控制DN症状方面发挥着极其重要的作用。目前，百令胶囊治疗2型DN的疗效和安全性仍不明确。因此，本荟萃分析的目的是评估百令胶囊治疗2型DN的临床疗效和安全性。
使用中文和英文数据库对2型DN进行文献检索。检索的中文数据库为中国知网数据库、万方数据库和维普数据库，检索词为：百令胶囊和DN。英文数据库为PubMed、Embase和Web of Science，检索词为：2型糖尿病、II型糖尿病和百令胶囊。使用RevMan 5.3软件评估文献质量。使用R3.5.1软件的meta包进行荟萃分析。
共纳入24篇文章，治疗组985例患者，对照组956例患者。治疗组百令胶囊的总有效率是对照组的1.24倍[95%置信区间（CI）：1.11-1.38]。治疗组治疗前后24小时尿总蛋白、尿白蛋白排泄率（UAER）、血清肌酐（Scr）和血尿素氮（BUN）水平的降低幅度均显著低于对照组，标准平均差（SMD）分别为0.61（95%CI：-1.01至-0.22）、-1.56（95%CI：-2.34至-0.78）、-0.58（95%CI：-0.89至-0.27）和-0.73（95%CI：-1.16至-0.29）。然而，两组血清钾无显著变化（P>0.05）。荟萃分析未发现发表偏倚（P>0.05）。
对于2型DN患者，在常规治疗中使用百令胶囊显示出较高的临床疗效，并能改善肾功能。然而，需要高质量的随机对照试验来进一步探索百令胶囊的安全性。
