Abstract
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。
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