Objective To assess the effects and safety of sitagliptin combined with metformin in treating type 2 diabetes mellitus. Methods The Cochrane Library, PubMed, EMbase, CNKI, WanFang Data, VIP and CBM were searched to collect the randomized controlled trials (RCTs) on sitagliptin combined with metformin in treating Type 2 diabetes mellitus (T2DM) from inception to November, 2012. References of included studies were also retrieved. Two reviewers independently screened studies according to exclusion and inclusion criteria, extracted data, and assessed the methodological quality. Then, meta-analysis was performed using RevMan 5.1 software. Results 7 RCTs involving 2 917 patients were included. The results of meta-analysis showed that, compared with metformin alone, sitagliptin combined with metformin effectively improved HbA1c levels (WMD= –0.62%, 95%CI –0.76 to –0.47, Plt;0.000 1) and fasting plasma glucose levels (WMD= –0.7 mmol/L, 95%CI –1.03 to –0.37, Plt;0.000 01), and increased insulin sensitivity and β-cell function. But there was no significant difference between the two groups in the incidences of gastrointestinal reactions and hypoglycemia. Conclusion Compared with using metformin alone, sitagliptin combined with metformin can improve glycemic control, enhance insulin sensitivity and better β-cell function more effectively and both have a similar effect on weight lose, but there is no significant difference he incidences of gastrointestinal reactions and hypoglycemia. The above conclusion should be verified by more large-scale high-quality studies in future due to the limitations of the methodological quality and sample size of the included studies.
Objective To evaluate the efficacy and safety of rosiglitazone versus metformin in treating polycystic ovary syndrome (PCOS). Methods Randomized controlled trials (RCTs) about rosiglitazone versus metformin in treating PCOS were retrieved on computer in MEDLINE, The Cochrane Library, EMbase, EBSCO, CBM, CNKI, Chinese Medical Association Journal Database and VIP from the date of their establishment to December 2010. The trials were screened according to the inclusion and exclusion criteria by two reviewers independently, the data were extracted, the methodological quality was assessed, and finally meta-analysis was conducted with Stata 11.0 software. Results A total of six RCTs involving 286 PCOS patients were included. The results of meta-analyses showed that there was no significant difference between rosiglitazone and metformin in improving PCOS patients’ insulin sensitivity (SMD= –0.14, 95%CI –0.46 to 0.19, P=0.412) and lowering androgen levels (SMD=0.05, 95%CI –0.26 to 0.36, P=0.747). However, the effect of rosiglitazone was inferior to metformin in lowing patients’ weight with a significant difference (SMD=0.34, 95%CI 0.11 to 0.58, P=0.004). The rosiglitazone showed a lower incidence rate of adverse reaction compared with metformin. Conclusion Compared with metformin, the rosiglitazone is eqully effective in improving PCOS patients’ insulin sensitivity and lowering androgen levels, and has a lower incidence rate of adverse reaction although it is inferior to metformin in lowing patients’ weight. So rosiglitazone is more applicable for the patients who are of underweight or cannot tolerate the gastrointestinal side effects induced by metformin. There is no enough evidence for this conclusion due to the small sample size and limited number of RCTs. More high-quality, large-sample and multicentered RCTs are required to guide clinical treatment and benefit patients.
Objectives To assess the efficacy and safety of metformin plus rosiglitazone in treating type 2 diabetes mellitus. Methods Based on the principles and methods of Cochrane systematic reviews, we searched the CochraneLibrary (2008, 4 issue), PubMed (1966 to October 19, 2008), Embase (1974 to October 19, 2008), China BiomedicalLiterature Database (1978 to October 12, 2008), China Journal Fulltext Database (1994 to October 12, 2008), ChineseScientific Journals Full text Database (1989 to October 12, 2008). Randomized controlled trials (RCTs) of Metforminplus roziglitazone versus metformin for type 2 diabetes were included. We assessed the quality of the included RCTsaccording to the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1. The Cochrane Collaboration’s software RevMan 5.0 was used for meta-analysis. Results Twelve RCTs totaling 3020 patients were included. Metaanalysis showed that Glycosylated hemoglobin levels [WMD= – 0.48%, 95%CI (– 0.74, – 0.22), P=0.000 3], fasting plasma glucose levels [WMD= – 1.03mmol/L, 95%CI (– 1.85, – 0.75), Plt;0.000 01], insulin sensitivity, and β-cell function improved significantly with metformin plus rosiglitazone therapy. Compared with the metformin monotherapy group, patients treated with metformin plus rosiglitazone had more edema events [RR= 3.27, 95%CI (1.80, 5.91), Plt;0.000 1] and lower gastro-intestinal events [RR= 0.82, 95%CI (0.71, 0.94), P=0.004]. We found no statistically significant effect on body weight, the percentage of patients with at least one adverse event, and hypoglycemia events. Conclusions Current evidence demonstrates that combination treatment with metformin plus rosiglitazone improves glycemic control, insulin sensitivity, and cells function more effectively than with metformin monotherapy. Side effects of two types of therapy have differences in performance.
Objective To evaluate the efficacy and safety of metformin for metabolic syndrome. Methods We searched The Cochrane Library, MEDLINE, EMBASE, China Biological Medicine Database, VIP, and CMAC up to the year of 2007. Handsearches and additional searches were also conducted. Randomized controlled trials of metformin for metabolic syndrome were included. Two reviewers independently extracted data from eligible studies and evaluated the quality of included studies. Meta-analysis was performed for the results of homogeneous studies by The Cochrane Collaboration’s software RevMan 4.2.9. Results Six trials involving a total of 2442 patients with metabolic syndrome were included. Meta-analysis was not performed due to the apparent heterogeneity. Metformin, compared with placebo, exhibited more favorable effects in reducing the proportion of patients with metabolic syndrome (RR 1.27, 95% CI 1.01 to 1.60), the proportion of patients with low HDL-c (RR 1.61, 95%CI 1.16 to 2.23), wide waist circumference (RR 1.64, 95%CI 1.06 to 2.55), and high FPG (RR 1.55, 95%CI 1.17 to 2.05). Metformin was also more effective in improving FPG and insulin sensitivity. The addition of metformin to atenolol plus nitrendipine was superior to atenolol plus nitrendipine alone in reducing the proportion of patients with high TG (RR 5.57, 95%CI 1.56 to 19.84), abdominal obesity (RR 14.47, 95%CI 3.34 to 62.61), and IGT (RR 16.51, 95%CI 6.06 to 45.0). Compared with low-fat diet therapy, metformin was superior in improving FPG, 2-hour postload plasma glucose, and insulin sensitivity. No differences were observed between metformin and acarbose in the reduction of TG and FPG, but metformin was less effective than acarbose in improving 2-hour postload plasma glucose. No adverse drug reactions were reported. Conclusion Metformin has beneficial effects in reducing the incidence of high FPG, IGT, and abdominal obesity. It also proved beneficial in reducing the prevalence of metabolic syndrome and increasing insulin sensitivity. The therapeutic effects of metformin on blood pressure, obesity, and lipid profile are uncertain. There is insufficient evidence to recommend the use of metformin in the treatment of metabolic syndrome due to low methodological quality, small sample size, and limited number of trials. More high quality, large-scale randomized controlled trials are required.
Objective To formulate an evidence-based treatment plan for a patient with gestational diabetes mellitus. Methods Based on the clinical questions raised from a real-life patient of gestational diabetes mellitus, we searched ACP Journal Club (1991 to Dec. 2006), The Cochrane Library (Issue 4, 2006), MEDLINE (1966 to Dec. 2006) and Chinese Biological Medical Database (1980 to Dec. 2006) for systematic reviews, randomized controlled trials, cohort and case-control studies. We used the following keywords: gestational diabetes, metformin, and pregnancy complication. The quality of the included studies was assessed.Results One meta-analysis (from MEDLINE) and two randomized controlled trials (from the Cochrane Central Register of Controlled Trials) were included. These studies concluded that there was no clear evidence on the benefits of metformin for gestational diabetes. Based on the current evidence, integrated with clinical expertise and the patient’s values, metformin was not used for this patient. Instead, intensive dietary control, blood glucose control, and appropriate exercise were administered. After this individual treatment, the patient gave birth to a healthy baby in 39+4 Weeks. Conclusion The appropriate management for gestational diabetes mellitus has been formulated with the approach of evidence-based medicine. Large-scale, methodologically-sound trials are required.
目的 采用液相色谱-串联质谱法测定人血浆中二甲双胍的浓度。 方法 血浆样品用乙腈（含0.1%甲酸）沉淀蛋白后用二氯甲烷反洗后进行分析。使用Agilent C8（75 mm×4.6 mm，3.5 μm）色谱柱。流动相：A泵：5 mmol/L醋酸铵（三乙胺调pH值至7.5），B泵：乙腈。线性梯度洗脱，流速0.4 mL/min。采用电喷雾离子源，多反应离子监测。用于定量分析的离子对二甲双胍为130.2/71.1，内标吗啉胍为172.2/60.2。 结果 线性范围为50～2 000 ng/mL，最低定量限为50 ng/mL，预处理回收率为81.7%～98.0%，二甲双胍的基质效应＜9.97%，日内和日间相对标准偏差均＜5.2%。 结论 液相色谱-串联质谱法快速、简便、灵敏度高，是一种适用于人血浆中药物浓度的测定及药物动力学和生物利用度研究的方法。
【摘要】 目的 观察单用二甲双胍与二甲双胍联合阿卡波糖对2型糖尿病（type 2 diabetes mellitus，T2DM）降糖作用的临床疗效。 方法 对2010年1—10月就诊有典型易饥多食的T2DM患者45例，随机分为二甲双胍组20例和二甲双胍联合阿卡波糖25例，疗程12周。 结果 二甲双胍组与二甲双胍联合阿卡波糖组治疗后对患者的饥饿感和食量改善差异有统计学意义（Plt;0.05），空腹及餐后血糖差异（Plt;0.01）、空腹血糖达标比例差异（Plt;0.01）、餐后血糖达标比例差异（Plt;0.05）均有统计学意义。 结论 二甲双胍联合阿卡波糖能显著改善T2DM患者的食欲及食量，从而明显降低空腹及餐后血糖。【Abstract】 Objective To observe and compare the clinical affects and curative effects between using metformin and metformin plus acarbose in the treatment of type 2 diabetes mellitus (T2DM). Methods From January to October 2010, 45 T2DM patients with common symptoms of easy-starving and overeating were randomized into two groups and treated for 12 weeks with either metformin (n=20) or metformin plus acarbose (n=25). Results After the treatment, significant differences were found between the two groups in the improvement on patients’ sense of starving and quantity of eating (Plt;0.05), fasting and postprandial blood glucose (Plt;0.01), up-to-standard rate of fasting blood glucose (Plt;0.01), and up-to-standard rate of postprandial blood glucose (Plt;0.05). Conclusion The combination of metformin and acarbose can substantially improve the appetite and quantity of eating for patients with T2DM, hence significant reductions of fasting and postprandial blood glucose level can be feasibly achieved.
【摘要】 目的 探讨二甲双胍致不良反应的一般规律和特点。 方法 检索1994年-2011年中国期刊全文数据库中二甲双胍所致不良反应个案报道的文献，得到符合条件的文献29篇共33例，进行统计分析。 结果 33例不良反应主要表现为内分泌系统（48.5%），皮肤及附件（18.2%），变态反应（15.2%），消化系统（9.1%），神经系统（6.1%）等。 结论 临床上应重视二甲双胍引起的不良反应，用药时应加强对患者的监护，以减少严重药物不良反应的发生。【Abstract】 Objective To investigate the characteristics and the general pattern of the adverse drug reactions (ADR) induced by metformin. Methods The ADR induced by metformin reported in domestic medical journals during 1994-2008 were retrieved by means of CNKI. A total of 29 related literatures involving 33 cases, and a related database was established for statistical analysis. Results The main clinical manifestation represented as endocrine system (48.5%), lesion of skin and its appendants (18.2%), allergic reactions (15.2%), digestive system (9.1%), nervous system (6.1%) and so on. Conclusion It is necessary to pay attention to ADR induced by metformin and strengthen observation during medication in order to reduce serious ADR.
【摘要】 目的 观察罗格列酮加二甲双胍联合治疗对2型糖尿病患者的降糖作用和安全性以及对胰岛素抵抗的影响。 方法 对2007年8月-2008年5月收治的2型糖尿病患者53例采用自身前后对照研究，48例符合入选条件的患者，接受罗格列酮加二甲双胍为期12周治疗。试验开始和结束日测定患者空腹血糖（fast plasma glucose，FPG）、血清胰岛素（serum insulin，FINS）、总胆固醇（total cholesterol，TC）、甘油三酯（triglyceride，TG）、高密度脂蛋白胆固醇（high-density lipoprotein cholesterol，HDL-C）和糖化血红蛋白（glycosylated hemoblobin，HbA1c）以及标准餐后2 h血糖（postprandial 2 hours blood glucose，2hPPG）和胰岛素（postprandial 2 hours insulin，2hPINS）。胰岛素敏感性采用HOMA2模型公式评价。 结果 12周时FPG、FINS、2hPINS、 HbA1c均较治疗前基线时下降，分别为（8.16±2.37） mmol/L与（6.57±1.90） mmol/L，（8.84±8.07） mU/L与（7.28±6.84） mU/L，（26.87±3.13） mU/L与（20.18±13.25） mU/L，7.60%±1.71%与6.79%±1.82%，差异有统计学意义（Plt;0.05）。胰岛素抵抗指数显著低于治疗前（2.77±0.90与3.74±1.61，Plt;0.05）。其余代谢参数变化差异无统计学意义（Pgt;0.05）。 结论 罗格列酮加双胍类药物联合治疗2型糖尿病能有效降2型糖尿病患者的血糖水平，提高胰岛素敏感性，不增加体重，无低血糖发生，是一种安全有效的治疗方案。【Abstract】 Objective To observe the effect and security of rosiglitazone plus metformin in patients with type 2 diabetes mellitus, and the effect on insulin resistance. Methods Forty-eight cases suitable for this study were accepted and compared from August 2007 to May 2008. Patients accepted rosiglitazone plus metformin for 12 weeks. Fasting plasma glucose (FPG), serum insulin (FINS), total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), glycosylated hemoglobin (HbA1c), postprandial 2 hours blood glucose and postprandial 2 hours insulin were determined at the first and last day of this study. HOMA 2 model formula evaluation was used in testing insulin sensitivity. Results After a 12-weeks’ treatment, FPG, FINS, 2hPINS, and HbA1c of patients were lower than those before treatment [(8.16±2.37) mmol/L vs (6.57±1.90) mmol/L; (8.84±8.07) mU/L vs (7.28±6.84) mU/L; (26.87±19.31) mU/L vs (20.18±13.25) mU/L; 7.60%±1.71% vs 6.79%±1.82%; Plt;0.05)]. Insulin resistance index was lower than that after treatment (2.77±0.90 vs 3.74±1.61, Plt;0.05). Other metabolic related parameter had no statistical difference (Pgt;0.05). Conclusion Rosiglitazone plus metformin treatment of type 2 diabetes mellitus is effective both in reducing in blood glucose levels and improving insulin sensitivity, and without gain weight, incidence of hypoglycemia. It is a safe and effective option.
目的:罗格列酮(RGZ)联合二甲双胍治疗初诊2型糖尿病(T2DM)的临床疗效和安全性。方法:40例初诊2型糖尿病联用罗格列酮和二甲双胍进行12周的治疗,测定治疗前后空腹血糖(FBG)、餐后2小时血糖(PPG)、糖化血红蛋白(HbA1c)、胰岛素、C-肽、甘油三脂、体重指数(BMI),胰岛素抵抗指数(IR)、血常规、肝、肾功能等。 结果:治疗前后对照,空腹及餐后血糖、胰岛素、甘油三脂、IRI降低,具有显著差异性(Plt;0.001),体重指数变化不大(Pgt;0.05),未发生肝肾功能损害。结论:罗格列酮联合二甲双胍治疗2型糖尿病,明显改善胰岛素抵抗,降糖疗效确切。