背景:糖尿病肾病(DN),作为糖尿病的常见并发症之一,以持续的蛋白尿为特征,肾小球滤过率下降,动脉血压升高.目前,血必净注射液广泛应用于DN的治疗。然而,很少发表关于血必净注射液干预DN的系统评价和荟萃分析.为了更系统、客观地评价血必净注射液干预DN的临床疗效,我们进行了系统评价和荟萃分析来验证.
目的:系统评价血必净注射液联合前列地尔治疗糖尿病肾病的临床疗效。
方法:我们搜索了中国国家知识基础设施(CNKI),中国生物医学数据库(SinoMed),维普数据库(VIP),万方数据库,PubMed,科克伦图书馆,Embase,WebofScience和其他计算机数据库,检索自数据库建立至2022年的国内外血必净注射液联合前列地尔治疗DN的随机对照试验。主要结局指标包括血糖、次要结局指标包括血脂,肾功能,尿蛋白,和安全。两名评估人员独立筛选了文献,提取数据并评估纳入研究的偏倚风险。采用RevMan5.3软件进行数据分析。
结果:共纳入14项随机对照试验,包括1233例,治疗组618例,对照组615例。荟萃分析结果表明,与对照组相比,治疗组能有效降低空腹血糖[均差[MD]=-1.90,95%CI(-2.40,-1.40),P<.00001],糖化血红蛋白A1c[MD=-2.38,95%CI(-2.51,-2.25),P<.00001],餐后2h血糖[MD=-2.92,95%CI(-3.95,-1.89),P<.00001],三酰甘油[MD=-1.08,95%CI(-1.66,-0.50),P=.0003],总胆固醇[MD=-1.17,95%CI(-1.39,-0.95),P<.00001],低密度脂蛋白胆固醇[MD=-1.19,95%CI(-1.60,-0.78),P<.00001],高密度脂蛋白胆固醇[MD=0.32,95%CI(0.23,0.42),P<.00001],血清肌酐[MD=-42.95,95%CI(-57.46,-28.43),P<.00001],血尿素氮[MD=-2.24,95CI(-2.62,-1.86),P<.00001],血β2微球蛋白[SMD=-1.49,95%CI(-1.70,-1.28),P<.00001],尿β2微球蛋白[SMD=-0.81,95%CI(-1.04,-0.58),P<.00001],24小时尿蛋白定量[MD=-0.20,95%CI(-0.26,-0.14),P<.00001],尿白蛋白排泄率[SMD=-1.15,95%CI(-1.38,-0.93),P<.00001].
结论:血必净注射液联合前列地尔治疗DN较常规西药治疗更具优势。
BACKGROUND: Diabetes nephropathy (DN), as one of the common complications of diabetes, is characterized by persistent albuminuria, decreased glomerular filtration rate, and elevated arterial blood pressure. At present, Xuebijing injection is widely used in the treatment of DN. However, few systematic reviews and meta-analysis related to Xuebijing injection intervention in DN were published. In order to more systematically and objectively evaluate the clinical efficacy of Xuebijing injection intervention in DN, we conducted systematic reviews and meta-analysis to verify it.
OBJECTIVE: The purpose of the research was to systematically evaluate the clinical efficacy of Xuebijing injection combined with alprostadil in the treatment of diabetic nephropathy.
METHODS: We searched the China National Knowledge Infrastructure (CNKI), China Biomedical Database (SinoMed), Weipu Database (VIP), Wanfang Database, PubMed, The Cochrane Library, Embase, Web of Science and other databases by computer, and searched the randomized controlled trials of Xuebijing injection combined with alprostadil in the treatment of DN at home and abroad from the establishment of the database to 2022. The main outcome indicators included blood glucose, and the secondary outcome indicators included blood lipid, renal function, urinary protein, and safety. Two evaluators independently screened the literature, extracted the data and evaluated the risk of bias in the included studies. RevMan 5.3 software was used to analyze the data.
RESULTS: A total of 14 randomized controlled trials were included, including 1233 cases, 618 cases in the treatment group and 615 cases in the control group. The results of meta-analysis demonstrated that compared with the control group, the treatment group could effectively reduce fasting plasma glucose [mean difference [MD] = -1.90, 95% CI (-2.40, -1.40), P < .00001], glycosylated hemoglobin A1c [MD = -2.38, 95% CI (-2.51, -2.25), P < .00001], 2h postprandial blood glucose [MD = -2.92, 95% CI (-3.95, -1.89), P < .00001], triacylglycerol [MD = -1.08, 95% CI (-1.66, -0.50), P = .0003], total cholesterol [MD = -1.17, 95% CI (-1.39, -0.95), P < .00001], low-density lipoprotein cholesterol [MD = -1.19, 95% CI (-1.60, -0.78), P < .00001], high-density lipoprotein cholesterol [MD = 0.32, 95% CI (0.23, 0.42), P < .00001], serum creatinine [MD = -42.95, 95% CI (-57.46, -28.43), P < .00001], blood urea nitrogen [MD = -2.24, 95%CI (-2.62,-1.86), P < .00001], blood β2 microglobulin [SMD = -1.49, 95% CI (-1.70, -1.28), P < .00001], urine β2 microglobulin [SMD = -0.81, 95% CI (-1.04, -0.58), P < .00001], 24-hour urinary protein quantification [MD = -0.20, 95% CI (-0.26, -0.14), P < .00001], urinary albumin excretion rate [SMD = -1.15, 95% CI (-1.38, -0.93), P < .00001].
CONCLUSIONS: Xuebijing injection combined with alprostadil has more advantages in treating DN compared to routine Western medicine.