益气养肾汤治疗IgA肾病气阴两虚证临床研究

摘要

Objective:To observe the curative effect and safety of Yiqi Yangshen decoction which was adopted to cure the sickness of Qiyinliangxu of IgA nephropathy, by taking Angiotensin converting enzyme inhibitor ( Lotensin) as reference medicine. Methods:The 90patients with Qiyinliangxu of IgA nephropathy was randomly organized into two groups-the treatment group and the reference group. The patients in the treatment group was given Yiqi Yangshen decoction. The patients in the reference group was given Lotensin(benazepril hydrochloride, Beijing Novartis Pharma Ltd production)10 mg once a day. The treatment takes 12 weeks for both groups. Results:The safety index and adverse drug react of U-Pro, the TCM scores, Scr、BUN、Ccr and liver function was observed after 12 weeks. The total effect of treatment group was better than that of reference group (P<0. 01). U-Pro of both groups was ob-viously better than before treatment(P<0. 05). The different between two groups had statistical significance (P<0. 05). It had sta-tistical meaning that result of treatment group is better that of reference group. The TCM scores of both two groups showed obviously than baseline (P<0. 05). The different between two groups had statistical significance (P<0. 05). The TCM scores of accompanied symptom of both two groups declined obviously than before treatment. But the different between two groups had no statistical signifi-cance (P<0. 05). Scr、BUN of two groups had no statistical difference (P<0. 05). The difference of the incidence of adverse events with two groups has no statistical significance. And no sever adverse effect happened. Conclusion:Yiqi yangshen decoction is able to decline proteinuria of IgA nephropathy patients with Qiyinliangxu. The curative effect of The TCM scores is better than Lotensin and no adverse effect was found-well safety.%目的：：以血管紧张素转化酶抑制剂洛汀新为阳性对照药,观察益气养肾汤治疗IgA肾病气阴两虚证的疗效及安全性。方法：将90例IgA肾病气阴两虚证患者随机分为治疗组和对照组各45例,治疗组采用益气养肾汤治疗,对照组给予洛汀新(盐酸贝那普利片,北京诺华制药有限公司生产)10 mg,每日1次。两组均治疗12周,比较治疗前后24 h尿蛋白定量,中医证候积分,血肌酐、尿素氮、肌酐清除率及肝功能等安全性指标及不良反应。结果：治疗组总体疗效明显优于对照组(P<0.01)。两组24 h尿蛋白定量较治疗前均明显下降(P<0.05),治疗组更显著,两组差异有统计学意义(P<0.05),有统计学意义。两组中医主症积分均较基线明显下降(P<0.05),两组下降幅度差异有统计学意义(P<0.05)。两组中医兼症积分较治疗前均明显下降(P<0.05),但组间差异无统计学意义(P>0.05)。两组的血肌酐、尿素氮等生化指标无明显变化(P>0.05)。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：益气养肾汤可以显著降低IgA肾病气阴两虚证患者蛋白尿,明显改善患者中医证候疗效,作用优于洛汀新,且无严重不良反应,安全性好。