盐酸考来维仑联合其他降糖药物治疗2型糖尿病疗效和安全性的Meta分析
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篇名: 盐酸考来维仑联合其他降糖药物治疗2型糖尿病疗效和安全性的Meta分析
TITLE:
摘要: 目的:系统评价盐酸考来维仑联合其他降糖药物治疗2型糖尿病的疗效和安全性,为临床治疗2型糖尿病提供循证参考。方法:计算机检索PubMed、Embase、Medline、Cochrane图书馆、中国期刊全文数据库、中文科技期刊数据库、万方数据,检索时限为各数据库建库起至2019年7月,收集盐酸考来维仑联合其他降糖药物(试验组)对比安慰剂或其他降糖药物(对照组)治疗2型糖尿病疗效和安全性的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取后,采用Cochrane系统评价员手册5.1.0进行质量评价,采用Rev Man 5.3统计软件对糖化血红蛋白水平、空腹血糖水平、低密度脂蛋白胆固醇水平、总体不良反应发生率、低血糖发生率和胃肠道不良反应发生率等指标进行Meta分析。结果:共纳入11项RCT,合计2 625例患者。Meta分析结果显示,试验组患者糖化血红蛋白水平[MD=-0.37,95%CI(-0.51,-0.22),P<0.001]、空腹血糖水平[MD=-0.47,95%CI   (-0.88,-0.07),P=0.02]和低密度脂蛋白胆固醇水平[MD=-0.38,95%CI(-0.49,-0.28),P<0.001]均低于对照组,差异均有统计学意义。在安全性方面,试验组患者总体不良反应发生率[OR=1.24,95%CI(1.06,1.45),P=0.007]和胃肠道不良反应发生率[OR=1.78,95%CI(1.05,3.02),P=0.03]均高于对照组,差异均有统计学意义,两组患者低血糖发生率比较,差异无统计学意义[OR=1.03,95%CI(0.62,1.72),P=0.90]。结论:盐酸考来维仑联合其他降糖药物使用可有效降低2型糖尿病患者的糖化血红蛋白水平、空腹血糖水平和低密度脂蛋白胆固醇水平,但使用时应注意胃肠道等不良反应的发生。
ABSTRACT: OBJECTIVE: To systematically review the efficacy and safety of colesevelam hydrochloride combined with other hypoglycemic drugs in the treatment of T2DM, and to provide evidence-based reference for clinical treatment of T2DM. METHODS: Retrieved from PubMed, Embase, Medline, Cochrane Library, CJFD, VIP and Wanfang database during database establishement-Jul. 2019, randomized controlled trials (RCT) about the efficacy and safety of colesevelam hydrochloride combined with other hypoglycemic drugs (trial group) vs. placebo or other hypoglycemic drugs (control group) in the treatment of T2DM were collected. After extracting data from clinical studies that met the inclusion criteria, the quality of the studies was evaluated by Cochrane System Evaluator Manual 5.1.0. Meta-analysis was conducted by using Rev Man 5.3 statistical software in respects of the levels HbA1c, FPG, LDL-C, the incidence of total ADR, incidence of hypoglycemia and incidence of gastrointestinal ADR. RESULTS: A total of 11 RCTs were included, involving 2 625 patients. Results of Meta-analysis showed that HbA1c levels [MD=-0.37, 95%CI(-0.51, -0.22),P<0.001], FPG level [MD=-0.47, 95%CI(-0.88, -0.07), P=0.02] and LDL-C level [MD=-0.38, 95%CI(-0.49, -0.28), P<0.001] in trial group were significantly lower than control group, with statistical significance. In terms of safety, the incidence of total ADR [OR=1.24, 95%CI(1.06, 1.45), P=0.007] and gastrointestinal ADR [OR=1.78,95%CI(1.05, 3.02),P=0.03] in trial group were significantly higher than control group, with statistical significance. There was no significant difference in the incidence of hypoglycemia [OR=1.03, 95%CI(0.62,1.72),P=0.90]. CONCLUSIONS: Colesevelam hydrochloride combined with other hypoglycemic drugs can effectively reduce the levels of HbA1c, FPG and LDL-C in T2DM patients, but attention should be paid to the occurrence of gastrointestinal ADR.
期刊: 2019年第30卷第21期
作者: 于琦,贾晨晨,贾鹏丽,贺培凤
AUTHORS: YU Qi,JIA Chenchen,JIA Pengli,HE Peifeng
关键字: 盐酸考来维仑;2型糖尿病;疗效;安全性;Meta分析
KEYWORDS: Colesevelam hydrochloride; Type 2 diabetes mellitus; Efficacy; Safety; Meta-analysis
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