PLoS One&Curr Med Res Opin：2型糖尿病降糖治疗的研究

近日，有2项针对我国2型糖尿病患者降糖治疗的大型研究成果发表在国外知名期刊上：

我国2型糖尿病患者 应用人胰岛素或增加肝癌风险

上海交通大学医学院附属上海市第六人民医院贾伟平教授等开展的一项队列研究提示，接受人胰岛素治疗的2型糖尿病患者罹患癌症的整体风险虽未额外增加，但肝癌风险明显升高，其全因死亡和癌症死亡风险也增加。(PLoS One. 2013,8:e53411)

研究者从上海糖尿病登记研究中纳入8774例从未接受胰岛素治疗的糖尿病患者，分入胰岛素治疗组和非胰岛素治疗组，接受随访至首次确诊癌症或死亡或至2011年7月31日。结果显示，胰岛素治疗组和非胰岛素治疗组分别确诊98例和170例癌症，发生率分别为78.6/万人年和74.3/万人年，两组的癌症发生风险无显着差异(校正RR=1.20，P=0.228)。与非胰岛素治疗组相比，胰岛素治疗组的肝癌风险显着升高(校正RR=2.84，P=0.028)，全因死亡(校正RR=1.89，P<0.0001)和癌症死亡(校正RR=2.16，P=0.001)风险亦升高。

研究者表示，尽管胰岛素组糖尿病患者的全因死亡和癌症死亡风险均较高，但其病情相对严重，因此应谨慎解读该研究结果。

我国2型糖尿病患者 格列美脲初始治疗安全有效

北京大学第一医院内分泌科高妍教授等公布的一项多中心、开放标签、单臂研究提示，对于我国2型糖尿病患者，格列美脲单药初始治疗可显着改善血糖水平，且其安全性良好。(Curr Med Res Opin 2013 Jan 10)

该研究入组391例2型糖尿病患者，给予格列美脲治疗16周，起始剂量为1 mg/d，根据受试者每次就诊时的空腹血糖(FPG)水平逐渐滴定至2 mg/d或4 mg/d。结果显示，应用格列美脲后，受试者的平均HbA1c水平从8.6%降至6.9%(P<0.001)，受试者中HbA1c水平<7%的比例高达60.9%。受试者的平均FPG和餐后2 h血糖水平分别降低2.3 mmol/L和4.4 mmol/L(P<0.001)，胰岛素抵抗指数HOMA-IR从2.5降至2.2(P=0.009)。研究期间，确诊低血糖的发生率为3.1%。

doi: 10.1371/journal.pone.0053411
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Cancer incidence and mortality in patients with type 2 diabetes treated with human insulin: a cohort study in shanghai

Gu Y, Wang C, Zheng Y, Hou X, Mo Y, Yu W, Zhang L, Hu C, Nan H, Chen L, Li J, Liu Y, Huang Z, Han M, Bao Y, Zhong W, Jia W.

AIM:The aim was to investigate the association between human insulin and cancer incidence and mortality in Chinese patients with type 2 diabetes. METHODS:We recruited 8,774 insulin-naïve diabetes patients from the Shanghai Diabetes Registry (SDR). The follow-up rate was 85.4%. All subjects were divided into the insulin use cohort (n = 3,639) and the non-insulin use cohort (n = 5,135). The primary outcome was the first diagnosis of any cancer. The secondary outcome was all-cause mortality. Cox proportional hazards model was used to estimate the relative risk (RR) of cancer and mortality. RESULTS:We observed 98 cancer events in the insulin use cohort and 170 in the non-insulin use cohort. Cancer incidence rates were 78.6 and 74.3 per 10,000 patients per year in the insulin users and the non-insulin users, respectively. No significant difference in cancer risk was observed between the two cohorts (adjusted RR = 1.20, 95% CI 0.89-1.62, P = 0.228). Regarding site-specific cancers, only the risk of liver cancer was significantly higher in the insulin users compared to that in the non-insulin users (adjusted RR = 2.84, 95% CI 1.12-7.17, P = 0.028). The risks of overall mortality (adjusted RR = 1.89, 95% CI 1.47-2.43, P<0.0001) and death from cancer (adjusted RR = 2.16, 95% CI 1.39-3.35, P = 0.001) were all significantly higher in the insulin users than in the non-insulin users. CONCLUSION:There was no excess risk of overall cancer in patients with type 2 diabetes who were treated with human insulin. However, a significantly higher risk of liver cancer was found in these patients. Moreover, insulin users showed higher risks of overall and cancer mortality. Considering that individuals treated with insulin were more likely to be advanced diabetic patients, caution should be used in interpreting these results.

DOI:10.1185/03007995.2013.765396
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Efficacy and safety of glimepiride as initial treatment in Chinese patients with Type 2 diabetes mellitus

Guo XH, Lv XF, Han P, Zhang XZ, Yang HZ, Duan WR, Gao Y.

Abstract Objective To investigate the efficacy and safety of glimepiride as initial mono-therapy in type 2 diabetes patients in China. Methods This is a multi-centre, open-label, single arm study. A total of 391 subjects were enrolled to receive glimepiride treatment for 16 weeks, the initiation dose was 1 mg/d, with titration to 2mg/d and 4mg/d according to the fasting blood glucose (FBG) level measured at each visit. The change in HbA1c, fasting plasma glucose (FPG), 2h postprandial blood glucose (2hPPG), HOMA-IR, weight, waist circumference and the incidence of hypoglycaemia were evaluated. An exploratory analysis was conducted to identify the potential population prone to achieve target glycemic control. Results HbA1c was reduced significantly from 8.6±1.6％ to 6.9±0.9％(P<0.001); 60.9% of the subjects achieved HbA1c <7% at study endpoint. The reduction in FPG and 2hPPG were 2.3mmol/L and 4.4mmol/L (P<0.001) respectively; Insulin resistance was improved significantly with HOMA-IR decreasing from 2.5±2.3 to 2.2±1.9 (P＝0.009). The incidence of confirmed hypoglycaemia (BG≤3.9mmol/L) was 3.1%. Conclusions Glimepiride treatment as initial mono-therapy could effectively improve blood glucose control in type 2 diabetic patients, with a favorable safety profile. Lack of control group was the major limitation of this study.

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