Kumar S, Prange A, Schulze J, Lettis S, Barnett A H
Department of Medicine, University of Birmingham and Birmingham Heartlands Hospital, UK.
Diabet Med. 1998 Sep;15(9):772-9. doi: 10.1002/(SICI)1096-9136(199809)15:9<772::AID-DIA677>3.0.CO;2-X.
The management of Type 2 diabetes mellitus with currently available oral agents may be complicated in the elderly by an increased frequency of side-effects. The effects of troglitazone, an insulin action enhancer, were studied in elderly patients with Type 2 diabetes in a double-blind, parallel-group, placebo-controlled trial. A total of 229 patients (41% male), mean age 75 (range 69-85) years, with two fasting capillary blood glucose values > or =7 and < or =15 mmol l(-1) (and within 4.0 mmol l(-1) of each other) and previously treated with either diet alone (30%) or oral hypoglycaemic agents, were randomized to placebo or troglitazone 400 mg once daily or 200 mg twice daily, or 800 mg once daily or 400 mg twice daily, for 12 weeks. After 12 weeks' treatment, fasting serum glucose was significantly lower in troglitazone-treated patients (troglitazone, adjusted geometric mean 9.4-10.4 mmol l(-1) vs placebo 12.7 mmol l(-1), p < 0.001). Adjusted geometric mean fructosamine was also lower in troglitazone-treated patients by 5 to 15% compared to placebo (P < 0.05 at all doses except 400 mg od). There was no significant difference between troglitazone doses for improvement in glycaemic control. Troglitazone lowered adjusted geometric mean fasting plasma insulin by 27-34% compared to placebo (P < 0.001) and insulin sensitivity (HOMA-S) improved by 9-15% in all troglitazone dose groups (p < 0.001). Troglitazone also lowered serum non-esterified fatty acids and triglyceride. Adverse event incidence in troglitazone-treated patients was similar to that in patients treated with placebo. No weight gain or symptomatic hypoglycaemia was recorded at any of the doses studied. Troglitazone is effective and well tolerated in elderly patients with Type 2 diabetes mellitus, providing improved glycaemic control in the absence of weight gain.
对于老年2型糖尿病患者而言,使用目前现有的口服药物进行治疗时,副作用发生频率增加可能会使治疗变得复杂。在一项双盲、平行组、安慰剂对照试验中,对胰岛素作用增强剂曲格列酮在老年2型糖尿病患者中的疗效进行了研究。共有229例患者(男性占41%),平均年龄75岁(范围69 - 85岁),空腹毛细血管血糖值有两个大于或等于7 mmol/L且小于或等于15 mmol/L(且两者相差在4.0 mmol/L以内),之前单独接受饮食治疗(30%)或口服降糖药治疗,被随机分为安慰剂组、曲格列酮400 mg每日一次组、200 mg每日两次组、800 mg每日一次组或400 mg每日两次组,治疗12周。治疗12周后,曲格列酮治疗组患者的空腹血糖显著降低(曲格列酮,校正几何平均数9.4 - 10.4 mmol/L,而安慰剂组为12.7 mmol/L,p < 0.001)。与安慰剂相比,曲格列酮治疗组患者的校正几何平均果糖胺也降低了5%至15%(除400 mg每日一次外,所有剂量组p < 0.05)。在血糖控制改善方面,曲格列酮各剂量组之间无显著差异。与安慰剂相比,曲格列酮使校正几何平均空腹血浆胰岛素降低了27% - 34%(P < 0.001),所有曲格列酮剂量组的胰岛素敏感性(HOMA - S)提高了9% - 15%(p < 0.001)。曲格列酮还降低了血清非酯化脂肪酸和甘油三酯。曲格列酮治疗组患者的不良事件发生率与安慰剂治疗组患者相似。在所研究的任何剂量下均未记录到体重增加或症状性低血糖。曲格列酮对老年2型糖尿病患者有效且耐受性良好,在不增加体重的情况下可改善血糖控制。