Objective To explore the possible anti-inflammatory mechanism of peroxisome proliferators-activated receptor（PPAR） gamma-agonists by investigating the effects of Rosiglitazone on the expression of phosphorylation of signal transducer and activator of transcription 6（p-STAT6） and the secretion of interleukin（IL）-4 in T-lymphocytes from patients with acute asthma.Methods Peripheral blood T-lymphocytes from 10 healthy volunteers（group A） and 10 patients with acute asthma were isolated，purificated and cultured.T-lymphocytes from the asthma patients were divided into a control group（group B） and a Rosiglitazone treated group（group C）.Rosiglitazone was added with a single dose of 10-4 mol/L at 0 hour of cultrue.After cultured for 48 hours，the concentration of IL-4 in supernatant of each groups were detected by ELISA.The express of p-STAT6 in the T-lymphocytes were determined by Western blot and immunohistochemical techniques.Results The levels of IL-4 were increased markedly in group B than those in group A and group C[（170.34±9.05）pg/mL vs（76.82±7.06）pg/mL and（123.59±8.70）pg/mL，both Plt;0.01]，and which in group C was significantly lower than group A（Plt;0.01）.The levels of p-STAT6 in T lymphocytes were increased markedly in group B than in group A and C[Western blot：（6.28±0.19 vs 3.07±0.18 and 4.12±0.16；immunohistochemistry：（36.58%±7.41）% vs（11.39±4.02）% and（23.92±5.8）%，all Plt;0.01），and which in group C were significantly higher than that in group B（both Plt;0.01）.There was a positive correlation between the level of p-STAT6 and IL-4（Plt;0.01）.Conclusion The levels of p-STAT6 and IL-4 in T-lymphocytes of patients with acute asthma were suppressed by Rosiglitazone in vitro.
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 Diabetes 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 software. 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 therapeutic effect 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 significant 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 suffering 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.
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 thiazolidinediones for metabolic syndrome.Methods Up through 2007, we searched The Cochrane Library, MEDLINE, EMbase, the China Biological Medicine Database, VIP and CMAC. We also handsearched relevant literature. Randomized controlled trials about usingthiazolidinedioes to treat metabolic syndrome were included. Two reviewers independently extracted the data from the eligible studies and evaluated the quality of the included studies. Meta-analysis was performed for the results ofhomogeneous studies using RevMan 4.2.9 software. Results Ten randomized control trials involving 1,183 patients with metabolic syndrome met the inclusion criteria. Meta-analysis was not carried out because of apparent heterogeneity. Five trials compared rosiglitazone and placebo, which of single study reported CVD events at the end of 9 month follow-up. The results suggested that no significant differences were found between the two groups in occurrence of CVD events (RR=0.50, 95%CI 0.25 to 1.00), such as myocardial infarction and urgent vessel revascularization after coronary stent implantation, in the patients with metabolic syndrome, while rosiglitazone significantly decreased the proportion of metabolic syndrome (RR=4.0, 95%CI 1.63 to 9.82) and HOMA-index (WMD=-0.80, 95%CI -0.90 to -0.70) as compared with placebo. Pioglitazone did not affect TG, significantly decreased HOMA-index (WMD=0.02, 95%CI 0.01 to 0.03), and increased HDL-c (WMD=0.02, 95%CI 0.01 to 0.03), compared with placebo. Pioglitazone plus glimepirde was better than rosiglitazone plus glimepiride in TG and HDL-c improvement, with no significant differences in improving BP, FPG, PPG, HbA1c, and HOMA-index for both treatments. The combination of rosiglitazone with metformin was similar to pioglitazone-metformin combination in improving FPG, PPG, HbA1c and HOMA-index, whereas pioglitazone plus metformin was superior to rosiglitazone plus metformin in improving TG and HDL-c. No differences between rosiglitazone-metformin combination and glimepirde-metformin combination were observed in improving FPG, PPG, and HbA1c, but rosiglitazone plus metformin significantly lowered HOMA-index and SBP/DBP more than glimepirde plus metformin. The results of included trails revealed that rosiglitazone and pioglitazone had no favorable effects on BMI and WC or resulted in weight gain. The adverse drug reactions for thiazolidinediones were mild to moderate, and well tolerated. Conclusion The results suggest that thiazolidinediones produce positive effects on blood glucose level and insulin sensitivity in the absence of favorable obesity effects or resulting in weight gain. Pioglitazone favorably affects HDL-c. Thiazolidinediones show a certain effect on decreasing the proportion of metabolic syndrome, but the therapeutic effect on BP is uncertain. Overall there is insufficient evidence to recommend the use of thiazolidinediones for metabolic syndrome due to low methodological quality, small sample size, and limited number of trials. More high-quality, largescale randomized controlled trials are required.
目的 观察罗格列酮钠对血糖控制未达标的2型糖尿病（T2DM）合并与不合并非酒精性脂肪肝（NAFL）患者的降糖疗效和安全性。 方法 2009年1月－2011年1月60例仅用磺脲类和二甲双胍治疗血糖控制未达标的T2DM患者，按合并和不合并NAFL分为观察组和对照组各30例，两组均在原口服降糖药基础上联合加用国产罗格列酮钠4 mg 1次/d，治疗共3个月，观察治疗前后的血糖、胰岛素、糖化血红蛋白（HbA1c）、体质量指数（BMI）、血脂、肝功、血压水平以及药物不良反应，并比较治疗后的血糖达标率。 结果 两组患者治疗后的空腹血糖（FPG）、餐后2 h血糖（2hPG）、HbA1c、空腹胰岛素、甘油三酯和极低密度脂蛋白胆固醇均较治疗前下降，高密度脂蛋白胆固醇较治疗前升高（P＜0.05），而丙氨酸转氨酶、总胆固醇、低密度脂蛋白胆固醇及血压无明显变化（P＞0.05），但观察组治疗后的FPG和2hPG均较对照组下降更明显（P＜0.01），且血糖达标率为73.3%，显著高于对照组的46.7%（P＜0.05），同时观察组餐后2 h胰岛素（2hINS）水平在治疗前后均明显高于对照组而且治疗后有显著下降（P＜0.01），但对照组治疗后2hINS虽然也有下降但无统计学意义（P＞0.05）。观察组治疗前后BMI无明显变化，但对照组治疗后BMI有明显的升高（P＜0.05）。结论 国产罗格列酮钠片对血糖控制未达标的T2DM合并和不合并NAFL患者均有进一步降低血糖、HbA1c以及改善血脂的作用，但对T2DM合并NAFL的患者的降糖疗效更显著，未见加重肝功能损坏，不良反应小，可作为此类患者联合用药的一种选择。
【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。
目的:比较罗格列酮钠片与二甲双胍片分别联合胰岛素治疗2型糖尿病的疗效和安全性。方法:40例单用胰岛素控制血糖不理想的2型糖尿病患者,随机分为A组,太罗组(罗格列酮钠片)(21例);B组,二甲双胍组(19例),进行为期16周的对照观察。结果:两组治疗后空腹及餐后2小时血糖及糖化血红蛋白(HbA1c)均呈有意义的下降(Plt;0.05),从下降幅度的百分率统计,太罗组下降幅度明显高于二甲双胍组。结论:太罗联合胰岛素治疗对于血糖的控制明显优于二甲双胍联合胰岛素治疗。