帕夫林治疗系膜增生性肾炎的临床研究

Efficacy and safety of Pafulin in treatment of mesangial proliferative nephritis

目的 观察白芍总苷（TGP）制剂帕夫林治疗系膜增生性肾炎（MsPGN）患者的疗效、作用特点及安全性.方法 选取经肾穿刺确诊的原发性MsPGN患者109例,按随机数字表法分为TGP组51例和雷公藤多苷组58例,TGP组给予TGP0.6～1.2g/d,分2次口服;雷公藤多苷组给予雷公藤多苷片30～60mg/d,分3次口服;观察治疗前和治疗12周后24h尿蛋白量、尿红细胞、肝肾功能及不良反应发生率.结果 治疗12周后,TGP组和雷公藤多苷组分别有52.9％和39.7％的患者获得临床缓解,总有效率分别为86.3％和84.5％,两组间差异无统计学意义（P＞0.05）.雷公藤多苷组发生肝功能异常13例（22 .4％）,经期紊乱9例（15. 5％）,血白细胞或血小板下降7例（12 .0％）,TGP组仅有8例（15 .7％）发生便溏、腹泻,两组间不良反应发生率比较差异有统计学意义（P＜0.01）.TGP能显著降低24h尿蛋白量和尿红细胞,治疗前后的差异有统计学意义（P＜0.05或0.01）.12周后,TGP组继续治疗并随访,最长96周,结果显示TGP有一定的时效和量效趋势.结论 TGP能有效降低MsPGN尿蛋白、尿红细胞,提高临床缓解率,疗效与雷公藤多苷相当,但不良反应发生率显著低于雷公藤多苷,安全性良好;TGP的疗效存在一定的时效和量效性,因此长程的TGP治疗方案有利于MsPGN获得良好的治疗效果.

Objective To observe the efficacy and safety of Pafulin capsule（total glycosides of peony,TGP） in treatment of mesangial proliferative nephritis （MsPGN）.Methods One hundred and nine patients with primary MsPGN were enrolled in the study from January 2008 to September 2012.Patients were randomly assigned to receive TGP capsule 0.6～1.2g/d （TGP group,n=51）or Ripterygium wilfordii glycosides tablets（TW） 30～60mg/d （control group,n=58）for 12 weeks.The proteinuria,hematuria,liver and kidney function were examined before and after treatment and adverse events were documented in both groups.Results There were 52.9％ and 39.7 ％ of clinical alleviate rate,and 86.3％ and 84.5 ％ of total effective rate in TGP and control groups,respectively （P ＞0.05）.However,in control group there were 13 cases （22.4％） of abnormal liver function,9 cases of menstrual disorder （15.5％）,7 cases （12％） of declined white blood cells or blood platelets; while in TGP group only 8 cases had loose stools and diarrhea （15.7％）.There was significant difference in adverse events rate between TGP and control groups （P＜ 0.01）.Compared to pre-treatment,the 24h urinary protein excretion and red blood cells were significantly reduced in TGP group after treatment （P＜0.05 or 0.01）.The long-term follow-up showed that the efficacy of TGP were maintained presenting a time and dose dependent manner.Conclusion TGP presents same efficacy as TW in treatment of MsPGN and has a lower adverse effects than TW.