摘要
目的 评价以清热解毒、活血化瘀为治疗原则的中药协定方对 2型糖尿病尿白蛋白排泄率(UAER)的干预作用和安全性。方法 采用随机、单盲、安慰剂对照研究。将 71例 2型糖尿病患者随机分成中药协定方治疗组和安慰剂 (对照 )组 ,观察治疗前和治疗 2 4周后UAER和甲襞微循环等指标 ,并随访血糖、血脂、血压、体脂参数 ,观察药物的不良反应。结果 治疗 2 4周后 ,治疗组UAER中位数较治疗前下降 3.8mg/ 2 4h(P =0 .0 0 0 ) ,对照组无明显改变 (P =0 .76 7)。UAER异常者中 ,治疗组UAER中位数下降 36 .2mg/ 2 4h(P =0 .0 0 1) ,对照组无明显改变 (P =0 .6 38)。治疗组治疗后流态积分、襻周积分和总积分均显著降低 (P值分别为0 .0 0 0、0 .0 2 0和 0 .0 0 7) ,对照组无明显改变 (P值分别为 0 .5 0 8、0 .116和 0 .0 83)。治疗组和对照组的不良事件发生率分别为 18.92 %和 2 0 .5 8% ,两组差异无显著性 ,其中以胃肠道反应为主 ,占不良事件的 85 .71% ,但多数可以耐受。结论 中药协定方治疗 2型糖尿病患者 2 4周后显著改善了UAER和甲襞微循环检测定量指标 ,提示该协定方有保护肾脏和改善微循环的作用 。
Objective To evaluate the effect and safety of traditional Chinese medicine(CTM) prescription on urine albumin excreting rate of type 2 diabetes.Methods 71 type 2 diabetes patients were randomly and single-blindly divided into treated group and control group. The parameters as albumin excreting rate (UAER)、microcirculation nail bed flow before and after the trail and its influences on blood body fat, blood glucose, lipid and adverse effects were observed.Results At the end of the trail, the treated group showed decrease of UAER level ( 3.8 mg/ 24 h,P= 0.000), the control group showed no significant change (P= 0.767). 30 patients demonstrated UAER levels higher than 30 mg/ 24 h( 42.3%). After treatment, the median level of UAER decreased significantly to 36.2 mg/ 24 h,(P= 0.001). No significant change was shown in the control group (P= 0.638). These results suggested the CTM therapy effectively reduced the UAER in type 2 diabetes. The microcirculatory flow score, loop circumambience score and the total score of the treated group decreased significantly (P= 0.000, 0.020, 0.007 respectively), no significant change(P= 0.508, 0.116, 0.083 respectively) was seen in the control group. The frequently adverse effects in the treated group and the control group were 18.92% and 20.58%, respectively, no significant difference was observed. The main adverse effects were gastrointestinal ( 85.71%) and could be tolerated.Conclusion The results indicated that type 2 diabetes patients showed significantly improvement in UAER and microcirculatory nail bed flow after TCM therapy safly and tolerably.
出处
《上海医学》
CAS
CSCD
北大核心
2004年第7期466-469,共4页
Shanghai Medical Journal
基金
上海市科学技术发展基金资助项目 ( 0 0 40 190 2 6)
关键词
中药协定方
2型糖尿病
尿白蛋白排泄率
干预作用
甲襞微循环
Type 2 diabetes
Traditional chinese medicine
Urine albumin excreting rate (UAER)
Microcirculation nail bed flow
