在肥胖的胰岛素依赖型2型糖尿病患者中添加苯氟雷司。

Leutenegger M, Bauduceau B, Brun J M, Guillon-Metz F, Martin C, Nicolino-Peltier C, Richard J L, Vannereau D

Hôpital R. Debré, Reims, France.

Diabetes Metab. 1998 Feb;24(1):55-61.

To determine the effect of benfluorex on glycaemic control in obese insulin-requiring Type 2 diabetes, 76 patients (aged 53.8 +/- 12.8 years) receiving insulin (> or = 0.5 IU/kg) and an appropriate low-calorie diet were evaluated after a 1-month run-in followed by a 3-month double-blind treatment period (3 tablets daily) with benfluorex (B; n = 37) vs placebo (P; n = 39). At inclusion, the B and P groups respectively did not differ in body weight (80.9 +/- 10.3 vs 77.2 +/- 9.1 kg), body mass index (BMI) (30.1 +/- 4.6 vs 29.0 +/- 2.3 kg/m2) or fasting blood glucose (11.22 +/- 4.33 vs 10.35 +/- 4.42 mmol/l). However, daily insulin dose and HbA1c levels were higher in the B group (59.9 +/- 18.6 vs 50.4 +/- 12.8 IU, p = 0.012; and 7.72 +/- 1.60 vs 6.96 +/- 1.27%, p = 0.025, respectively). After 3 months of treatment, the decrease in daily insulin dose was greater in the B group (8.7 +/- 10.1 vs 2.7 +/- 8.1 IU; p = 0.032), with a decrease in HbA1c (-0.73 +/- 1.74%, p = 0.026), vs no change in the P group (+0.01 +/- 1.65%, NS) and a tendency towards a greater decrease in fasting blood glucose (-1.43 +/- 5.41 vs +0.42 +/- 3.78 mmol/l respectively). Body weight and BMI were also lower in the B group (1.77 ñ 2.27 vs 0.21 ñ 2.68 kg, p = 0.013; and 0.64 +/- 0.84 vs 0.07 +/- 1.07 kg/m2, p = 0.019, respectively) in parallel with the decrease in insulin dose. Triglycerides decreased in the B group vs an increase in the P group (-0.54 +/- 2.04 vs +0.21 +/- 0.70 mmol/l p = 0.06). Total cholesterol decreased within the B group (-0.47 +/- 1.01 mmol/l; p = 0.013) and vs the P group (intergroup p = 0.006). Adverse events were reported in 11 patients in the B group vs 5 in the P group (NS), causing dropout in only one case (intercurrent illness, P group). Addition of benfluorex in obese insulin-requiring Type 2 diabetes thus enhances glycaemic control and lowers both daily insulin requirement and body weight. Benfluorex + insulin is a valid alternative for obese patients who remain poorly controlled despite insulin or who require high doses of insulin.

为确定苯氟雷司对肥胖的需用胰岛素治疗的2型糖尿病患者血糖控制的影响，对76例患者（年龄53.8±12.8岁）进行了评估，这些患者接受胰岛素治疗（≥0.5IU/kg）并采用适当的低热量饮食，经过1个月的导入期后，进入为期3个月的双盲治疗期（每日3片），其中37例患者服用苯氟雷司（B组），39例患者服用安慰剂（P组）。纳入时，B组和P组在体重（80.9±10.3 vs 77.2±9.1kg）、体重指数（BMI）（30.1±4.6 vs 29.0±2.3kg/m²）或空腹血糖（11.22±4.33 vs 10.35±4.42mmol/L）方面无差异。然而，B组的每日胰岛素剂量和糖化血红蛋白（HbA1c）水平较高（分别为59.9±18.6 vs 50.4±12.8IU，p = 0.012；以及7.72±1.60 vs 6.96±1.27%，p = 0.025）。治疗3个月后，B组每日胰岛素剂量的减少幅度更大（8.7±10.1 vs 2.7±8.1IU；p = 0.032），HbA1c降低（-0.73±1.74%，p = 0.026），而P组无变化（+0.01±1.65%，无统计学意义），且空腹血糖有更大幅度降低的趋势（分别为-1.43±5.41 vs +0.42±3.78mmol/L）。与胰岛素剂量的减少相一致，B组的体重和BMI也较低（分别为1.77±2.27 vs 0.21±2.68kg，p = 0.013；以及0.64±0.84 vs 0.07±1.07kg/m²，p = 0.019）。B组甘油三酯降低，而P组升高（-0.54±2.04 vs +0.21±0.70mmol/L，p = 0.06）。B组总胆固醇降低（-0.47±1.01mmol/L；p = 0.013），且与P组相比也降低（组间p = 0.006）。B组有11例患者报告了不良事件，P组有5例（无统计学意义），仅1例导致退出研究（并发疾病，P组）。因此，在肥胖的需用胰岛素治疗的2型糖尿病患者中加用苯氟雷司可增强血糖控制，降低每日胰岛素需求量和体重。对于尽管使用胰岛素但控制不佳或需要高剂量胰岛素的肥胖患者，苯氟雷司+胰岛素是一种有效的替代方案。