中医药综合治疗方案全程干预对糖尿病肾病终点事件的影响

目的观察中医综合治疗方案全程干预对糖尿病肾病(DN)发生终点事件的影响。方法采用多中心、分层、随机对照方法,将符合纳入标准的315例DN患者随机分为A组157例、B组158例,两组患者均给予基础治疗,A组辨证给予止消通脉宁颗粒剂、止消温肾宁颗粒剂、止消保肾宁颗粒剂;B组给予厄贝沙坦片及与以上颗粒剂外观一致的安慰剂。两组均以3个月为1个疗程,进行24个月随访观察,记录两组患者发生终点事件的例数及时间,采用生存分析方法对影响终点事件的因素进行分析。结果 A组发生终点事件7例(4.5%),B组21例(13.3%),两组患者终点事件发生率比较差异有统计学意义(P<0.01)。治疗方案、肾小球滤过率2项因素对DN终点事件发生有明显的影响作用。结论建立在饮食控制、降糖、降压、调脂等治疗基础上的中医药综合治疗方案可降低DN患者终点事件发生率。

Effect of the Whole Course Intervention Program of Combined Therapy of TCM on th e Endpoint Events of Diabetic Nephropathy

Objective To observe the effect of the whole course intervention program of combined therapy of TCM on the endpoint events of diabetic nephropathy(DN).Methods Multi-centered,stratified and randomized-controlled design was carried out.The selected 315DN patients were randomized into group A of 157cases and group B of 158cases.One kind of Chinese herbal granules was given to group A according to Chinese medical syndrome,while irbesartan and Chinese herbal placebo was given to group B.The treatment lasted for 3months and the follow-up time was 24months.All the factors influencing endpoint events were analyzed with survival analysis methods.Results There were 7cases endpoint events(4.5%)in group A and 21cases(13.3%)in group B.The rate of endpoint events was significantly different between two groups(P<0.01).The treatment program and glomerular filtration rate(GFR)influenced the incidence of endpoint events obviously.Conclusion On the basis of primary care including diet control,blood glucose control,blood pressure control and blood lipid control,the whole course intervention program of combined therapy of TCM for DN could reduce the rate of endpoint events.