罗格列酮治疗2型糖尿病伴原发性高血压患者效果的Meta分析

Rosiglitazone in Treating Type 2 Diabetes Mellitus with Essential Hypertension Patients:A Meta-analysis

目的系统评价罗格列酮治疗2型糖尿病(T2DM)伴高血压的疗效及安全性。方法计算机检索Cochrane图书馆(2009年第4期)、PubMed(1970～2010.5)、CBM(1978～2010.5)、CNKI(1996～2010.5)、万方数据库(1999～2010.5)、VIP数据库(1996～2010.5)、Google Scholar;手工检索《中华糖尿病杂志》等相关杂志,并进行参考文献追查,收集联用罗格列酮(试验组)与不联用罗格列酮(对照组)比较治疗T2DM伴高血压患者的随机对照试验(RCT)。由两位研究者按照纳入与排除标准独立进行资料提取,并根据Cochrane Handbook 5.0评价纳入研究质量后,采用RevMan 5.0软件进行Meta分析。结果共纳入10个RCT,合计738例患者,其中英文1篇,中文9篇。纳入研究质量评分均为C级。Meta分析结果显示:与对照组比较,罗格列酮组能更有效地降低血压[SBP:WMD=–17.83 mmHg,95%CI(–27.63,–8.02);DBP:WMD=–7.81 mmHg,95%CI(–10.18,–5.44)]、血糖[FBG:WMD=–1.66 mmol/L,95%CI(–3.08,–0.23);PBG:WMD=–2.38 mmol/L,95%CI(–4.12,–0.64)]、甘油三酯[WMD=–0.29 mmol/L,95%C(I–0.43,–0.14)]、低密度脂蛋白胆固醇[WMD=–0.76 mmol/L,95%C(I–1.02,–0.50)]和胰岛素[FINS:WMD=–7.06 mU/L,95%C(I–9.47,–4.65);PINS:WMD=–98.86 mU/L,95%C(I–116.38,–81.34)]、糖化血红蛋白[WMD=–0.75%,95%CI(–1.07,–0.42)]和胰岛素抵抗指数[WMD=–1.61,95%CI(–2.18,–1.05)];且罗格列酮组能更有效地提高高密度脂蛋白胆固醇[WMD=0.21 mmol/L,95%CI(0.12,0.30)]和胰岛素敏感指数[WMD=1.64,95%CI(1.48,1.80)];罗格列酮组治疗高血压的有效性高于对照组[OR=9.35,95%CI(4.76,18.35)];在胆固醇水平[WMD=–0.22 mmol/L,95%CI(–0.55,0.10)]、体质指数[WMD=–0.26 kg/m2,95%CI(–0.86,0.33)]、心率[WMD=0.50 bpm,95%CI(–4.98,5.98)]和尿蛋白排泄率[WMD=–16.00 mg/24 h,95%CI(–37.90,5.90)]4个指标上,两组差异无统计学意义。此外,对于水肿[OR=3.01,95%C(I0.62,14.54)]、胃肠不适[OR=1.19,95%C(I0.63,2.24)]、头疼乏力[OR=9.79,95%CI(0.51,186.95)]和贫血[OR=2.38,95%CI(0.09,59.90)]等不良反应发生率,两组差异也无统计学意义。结论罗格列酮组较对照组在治疗2型糖尿病伴高血压患者时能更有效地降低血压、血糖、血脂水平,降低胰岛素抵抗和提高β细胞功能。

Objective To assess the efficacy and safety of rosiglitazone in treating type 2 diabetes mellitus（T2DM） with essential hypertension（HBP）.Methods Such databases as the Cochrane Library（Issue 4,2009）,PubMed（1970 to May 2010）,CBM（1978 to May 2010）,CNKI（1996 to May 2010）,WanFang Database（1999 to May 2010）,VIP（1996 to May 2010）,and Google Scholar were searched on computer,and the relevant journals such as Chinese Journal of Dia-betes Mellitus were also hand researched to investigate references and collect randomized controlled trials（RCTs） about rosiglitazone（experimental group） compared with non-rosiglitazone（control group） in treating T2DM with HBP.The data were extracted according to the inclusion and exclusion criteria by two reviewers independently,the quality of the included studies was assessed according to the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0,and meta-analysis was conducted by using RevMan 5.0 so ware.Results Among 10 RCTs involving 738 patients,one was in English from Greece,while nine were in Chinese.The average score quality of the included studies was in C level.The results of meta-analyses showed that the experimental group was more effective than the control group in lowering blood pressure levels（SBP： WMD= –17.83 mmHg,95%CI –27.63 to –8.02;DBP： WMD=–7.81 mmHg,95%CI –10.18 to –5.44）,blood glucose levels（FBG： WMD= –1.66 mmol/L,95%CI –3.08 to –0.23;PBG： WMD= –2.38 mmol/L,95%CI – 4.12 to –0.64）,triglyceride（TG） levels（WMD= –0.29 mmol/L,95%CI –0.43 to –0.14）,low-density lipoprotein cholesterol（LDL-C） levels（WMD= –0.76 mmol/L,95%CI –1.02 to –0.50）,insulin levels（FINS： WMD= –7.06 mU/L,95%CI –9.47 to –4.65;PINS： WMD= –98.86 mU/L,95%CI –116.38 to –81.34）,glycosylated hemoglobin（HbA1c） levels（WMD=–0.75%,95%CI –1.07 to –0.42）,and insulin resistance index（HOMA-IR）（WMD= –1.61,95%CI –2.18 to –1.05）;the experimental group was more effective than the control group in increaseing the high-density lipoprotein cholesterol levels（HDL-C）（WMD=0.21 mmol/L,95%CI 0.12 to 0.30）,and insulin sensitivity index（ISI）（WMD=1.64,95%CI 1.48 to 1.80）;the thera-peutic e ect for hypertension was greater in the experimental group than in the control group（OR=9.35,95%CI 4.76 to 18.35）;there were no significant differences in cholesterol levels（TC）（WMD= –0.22 mmol/L,95%CI –0.55 to 0.10）,body mass index（BMI）（WMD= –0.26 kg/m2,95%CI –0.86 to 0.33）,heart rates（HR）（WMD=0.50 bpm,95%CI –4.98 to 5.98）,and urine albumin excretion（UAE）（WMD= –16.00mg/24h,95%CI –37.90 to 5.90）;additionally,there were also no sigfinicant differences in adverse reactions between the two groups,such as edema（OR=3.01,95%CI 0.62 to 14.54）,gastro-intestinal discomfort（OR=1.19,95%CI 0.63 to 2.24）,headache and fatigue（OR=9.79,95%CI 0.51 to 186.95）,and anemia（OR=2.38,95%CI 0.09 to 59.90）.Conclusion To treating patients su ering from T2DM with HBP,the rosiglitazone is much effective than the control group in lowering blood pressure,blood glucose and lipid,reducing insulin resistance and improving β-cell function.