小檗碱治疗代谢综合征合并肾损害的临床观察

Therapeutic Effect of Berberine on Metabolic Syndrome Combined with Renal Damage

目的:观察小檗治疗热盛证代谢综合征合并肾损害患者的临床疗效。方法:将20例代谢综合征合并肾损害热盛证的患者随机分为治疗组和对照组,治疗组10例给予盐酸小檗碱300 mg,3次/d治疗,对照组10例采用常规西药治疗,疗程8周,观察两组治疗前后中医热盛证证候积分、BMI、腰围、空腹血糖(FPG)、餐后2 h血糖(2HPG)、空腹胰岛素水平(FINS)、血脂(TG、HDL-C)、收缩压(SBP)、舒张压(DSP)、尿微量白蛋白/肌酐比值(U-m Alb/C)、血肌酐(Scr)、尿素氮(BUN)的变化及不良事件等安全性指标。结果:两组病人临床资料差异无统计学意义。(1)治疗8周后,治疗组BMI值、2HPG、TG较治疗前下降,治疗组下降显著,差异有统计学意义(P<0.05),治疗4周、8周之间差异有统计学意义(P<0.05)。对照组TG较治疗前下降显著,差异有统计学意义(P<0.05)。而在腰围、FINS、FPG、HDL-C、血压(包括收缩压及舒张压)等指标上两组治疗前后比较及组间比较差异均无统计学意义(均P>0.05)。(2)治疗8周后对照组和治疗组U-m Alb/C分别较治疗前下降(7.37±3.14)mg/mmol和(24.74±19.29)mg/mmol(均P<0.05)。两组下降幅度差异有统计学意义(P<0.05)。(3)对照组和治疗组热盛证积分分别下降(1.80±0.79)和(0.80±0.84)(P<0.05),两组证候积分下降幅度差异有统计学意义(P<0.05)。(4)治疗组中医症状有效率80%,对照组20%,两组比较差异有统计学意义(P<0.05)。(5)治疗8周中两组不良事件发生率差异无统计学意义,且均未发生严重不良事件。结论:小檗碱可以减少热盛证代谢综合征合并肾损害患者的尿蛋白,降低其BMI、餐后血糖及三酰甘油水平,同时明显改善中医热盛证临床症状,且无严重不良反应。

Objective：To observe the clinical effects of BBR（Berberine） on the treatment of metabolic syndrome combined with renal damage of heat hyperactivity syndrome. Methods： Twenty patients were assigned randomly into two groups ： treatment group in which 10 cases were treated with BBR（ ） , and control group, in which 10 canse were treated with basic treatment. The therapeutic course for both groups was 8 weeks. The indexes of efficacy, including heat syndrome scores, BMI, waist circumerence, fasting plasma glucose （FPG） , 2 h postprandial blood glucose （2HPG） , fasting insulin （FINS） , lipids （TG, HDL- C ） , systolic blood pressure （SBP） , diastolic blood pressure （DSP） , microalbuminuria / creatinine ratio （U -mAlb / C） and occurrence of adverse eventswere observed. Results ：There was no significant statistical difference between the two group s in aspects of baseline clinical figures. （ 1 ） After 8 weeks of treatment, In treatment group, BMI, 2HPG, TG than before treatment had statistical significance （ P 〈 0.05 ） , differences in treatment for 4 weeks, 8 weeks had statistical significance （ P 〈 0.05 ）. In control group, TG was significantly decreased compared with before treatment, there are significant differences （ P 〈 0.05 ）. There was no significant differences of waist circumference, FINS, FPG, HDL - C and blood pressure before and after treatment in two groups （P 〉 0. 05）. （2） After 8 weeks of treatment, the content of urine trace albumin/creatinine ratio significantly decreased by （7.37 ± 3.14 ） mg/mmol and （24.74 ± 19.29 ） mg/mmol respectively in the two groups, showing significant difference in comparing with baseline, and in comparison between groups （ P 〈 0.05 ）. （ 3 ） The seores of heat syndrome in the two groups decreased by（ 1. 80 ± 0.79 ） scores and （ 0.80 ± 0.84 ） scores respectively with significant difference as compared with base line （P 〈 0.05 ）, and in comparison between groups （P 〈 0. 05 ）. （4） The total effective rate of heat syndrome scores was 80% in the treatment group and 20% in the control group （ P 〈 0.05 ）. （5） No severe adverse event occurred during the treatment, and the occurrence in the two groups was similar. Conclusion：BBR can effectively decrease the proteinuria, reduced the level of BMI, postprandial blood glucose and triglyceride levels and improve clinical syndrome of patients of metabolic syndrome combined renal damage with heat syndrome type, and shows no serious adverse reaction.