格列齐特控释片与普通片治疗2型糖尿病的临床疗效和生存质量比较

Comparison of efficacy and quality of life in type 2 diabetics treated with controlled-release-gliclazide and ordinary gliclazide tablets

目的对Ⅱ期随机对照临床试验中应用格列齐特控释片和格列齐特普通片治疗2型糖尿病的临床疗效和生存质量进行比较。方法48例符合入组标准的2型糖尿病患者随机分为两组各24例,A组予格列齐特控释片(30 mg)2片早餐前服用,安慰剂2片晚餐前服用;B组予格列齐特普通片(80 mg)和安慰剂各1片,每日2次(早餐前和晚餐前)服用。共治疗12周。所有患者均测定相关临床指标,并完成糖尿病患者生存质量特异性量表和简明健康状况调查表(SF36)。结果两组患者的空腹及餐后2 h静脉血糖和糖化血红蛋白均较治疗前显著降低(P<0．01),C肽水平明显升高(P<0．01),所有临床参数和生存质量参数组间比较差异均无统计学意义。两组患者SF36评分中躯体疼痛和社会功能治疗后均较治疗前显著改善(P<0．01)。A组和B组不良反应发生率分别为20．8％和8．3％,差异有统计学意义(P<0．05),均为轻度。结论格列齐特控释片治疗2型糖尿病的临床疗效和对生存质量的影响与格列齐特普通片相似。

Objective To assess clinical efficacy and quality of life （QOL） for patients of type 2 diabetes treated with controlled-release-gliclazide, as compared with those with ordinary gliclazide tablets, in a randomized controlled clinical trial stage Ⅱ. Methods Forty-eight eligible patients suffered from type 2 diabetes were randomly allocated to controlled-release-gliclazide group （group A） and ordinary gliclazide tablets group （group B ）, respectively. Patients in group A received two tablets of controlled-releasegliclazide （30 mg） before breakfast and two tablets of placebo before dinner every day. Patients in group B received one tablets of ordinary gliclazide （80 mg） and one tablets of placebo two times daily. All patients were treated for 12 weeks. Blood plasma levels of glucose, C peptide and glycosylated hemoglobin Alc （HbAlc） were measured for all patients. The patients were interviewed with a specific questionnaire of quality of life and 36-item short form for health survey （SF36）. Results Fasting and 2-hour postprandial plasma levels of glucose and HbA1c reduced significantly and the level of C-peptide increased significantly in both groups after treatment, as compared with those before treatment （ P 〈0. 01 ）. No significant difference in all clinical indicators and quality of life between the two groups was found after treatment. Scores of somatic pain and social function in SF36 improved significantly in both groups after treatment, as compared with those before treatment （P 〈 0. 01 ）. Rate of adverse reaction was significantly higher in group A （20. 8% ） than that in group B （8. 3%, P 〈0. 05）, but consequently no patients withdrew from the study. Conclusion Controlled-release-gliclazide had the similar effect on the patients with type 2 diabetes as ordinary gliclazide tablets did in improving their clinical manifestation and quality of life.