苯那普利联合祛风除湿中药治疗慢性肾脏病3期风湿内扰证的前瞻性研究

Efficiency of Benazepril Combined with Wind Dispelling and Dampness Removing Chinese Herbs on Stage 3 Chronic Kidney Disease with Wind-dampness Syndrome:a Prospective Study

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DOI：

中文关键词: 慢性肾脏病慢性肾小球肾炎血管紧张素转换酶抑制剂苯那普利祛风除湿中药

英文关键词:chronic kidney disease chronic glomerulonephritis angiotensin-converting enzyme inhibitor Benazepril wind dispelling and dampness removing Chinese herbs

基金项目:国家“十一五”科技支撑计划(No.2006BAI04A07)

作者	单位
方一卿	浙江中医药大学附属广兴医院；杭州市中医院肾内科
鲁盈	浙江中医药大学附属广兴医院；杭州市中医院肾内科
王永钧	浙江中医药大学附属广兴医院；杭州市中医院肾内科
殷佳珍	浙江中医药大学附属广兴医院；杭州市中医院肾内科
涂晓	浙江中医药大学附属广兴医院；杭州市中医院肾内科
朱斌	浙江中医药大学附属广兴医院；杭州市中医院肾内科
袁博寒	浙江中医药大学附属广兴医院；杭州市中医院肾内科
陈佳韵	浙江中医药大学附属广兴医院；杭州市中医院肾内科
陈洪宇	浙江中医药大学附属广兴医院；杭州市中医院肾内科
周柳沙	浙江中医药大学附属广兴医院；杭州市中医院肾内科
毛俐婵	浙江中医药大学附属广兴医院；杭州市中医院肾内科
崔杏成	浙江中医药大学附属广兴医院；杭州市中医院肾内科
王旭强	浙江中医药大学附属广兴医院；杭州市中医院肾内科
张敏鸥	浙江中医药大学附属广兴医院；杭州市中医院肾内科
俞东容	浙江中医药大学附属广兴医院；杭州市中医院肾内科
王宇辉	浙江中医药大学附属广兴医院；杭州市中医院肾内科
童孟立	浙江中医药大学附属广兴医院；杭州市中医院肾内科
程晓霞	浙江中医药大学附属广兴医院；杭州市中医院肾内科

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中文摘要:

目的研究苯那普利与祛风除湿中药单用及联合应用治疗慢性肾脏病(chronic kidney disease,CKD)3期风湿内扰证患者的临床疗效和安全性,为CKD3期提供中西医有效治疗方案。方法将CKD3期中医辨证分为气阴(血)两虚、风湿内扰、肾络瘀痹、湿热内蕴4种证型,符合风湿内扰证挟或不挟其他3证为入组条件。采用前瞻性、双盲、随机对照研究,共入组60例原发性慢性肾小球肾炎(chronic glomerulonephritis,CGN)患者,随机分为3组。西医组(23例)给予苯那普利10mg/d口服;中医组(20例)给予辨证选方组合;联合组(17例)采用上述两药合用,总疗程24周。观察3组临床疗效及不良反应发生率。结果 3组患者中医证候均以风湿内扰挟气阴两虚、肾络瘀痹为多,其中中医组占75.0%,西医组占60.9%,联合组占82.4%。共54例患者完成整个试验,其中中医组19例,西医组19例,联合组16例。3组中医证候总有效率(分别为84.2%、78.9%、87.5%)比较,差异无统计学意义(P>0.05);西医疗效(总有效率分别为94.7%、94.7%、100.0%)比较,联合组明显高于其他两组(P<0.05)。西医组血肌酐(SCr)治疗24周/治疗前比值明显高于联合组(P<0.05),肾小球滤过率(estimate glomerular filtrationrate,eGFR)治疗24周/治疗前比值明显低于联合组(P<0.05),而中医组与联合组之间SCr和eGFR比值比较,差异无统计学意义。24h尿蛋白定量治疗24周/治疗前比值联合组均值和中位数均小于其他两组,无一例出现尿蛋白>2.0g/d。与试验药物相关的不良反应发生率西医组明显高于中医组(30.4%vs10.0%,P<0.05)。结论对于CGNCKD3期具有风湿内扰证患者使用苯那普利联合祛风除湿为主辨证组方中药具有良好的肾保护作用,延缓肾衰进展,提高临床总体疗效,患者耐受性好,不良反应少,是治疗CGNCKD3期的有效方法。

英文摘要:

Objective To observe the clinical efficiency and safety of Benazepril and wind dispelling and dampness removing Chinese herbs were singly or combined used in patients with stage 3 chronic kidney disease(CKD 3) ,and to provide effective integrative medicine methods for treatment of CKD 3.Methods The CKD 3 was allocated to qi and yin deficiency syndrome,inner disturbance of wind and damp syndrome,stasis in Shen meridian syndrome,and inner accumulation of damp and heat syndrome.Recruited were patients of inner disturbance of wind and damp syndrome accompanied or unaccompanied with the other 3 syndrome types.In the prospective,randomized,double blind controlled study,60 patients confirmed as primary chronic glomerulonephritis(CGN) were randomly assigned to 3 groups with a total course of treatment for 24 weeks.Patients in the Western medicine group(WM,23 cases) took Benazepril(10 mg/d) .Those in the Chinese medicine group(CM,20 cases) received treatment by syndrome typing.Those in the combination group(17 cases) used the two methods.The therapeutic efficacy and the occurrence of adverse reactions were observed in the 3 groups.Results The inner disturbance of wind and damp syndrome accompanied qi and yin deficiency syndrome and stasis in Shen meridian syndrome was most often seen in these patients.It accounted for 75.0% in the CM group,60.9% in the WM group,and 82.4% in the combination group.Totally 54 patients completed this trial.Of them,there were 19 in the CM group,19 in the WM group,and 16 in the combination group.There was no significant difference in the total effective rate of Chinese medicine syndrome among the 3 groups(84.2%,78.9%,and 87.5%,respectively) (P>0.05) .As for the total effective rate of WM,it was obviously higher in the combination group than in the WM group and the CM group(100.0%,94.7%,and 94.7%,respectively) (P<0.05) .The ratio(24 weeks of treatment/pre-treatment ratio) of serum creatinine(SCr) was obviously higher in the WM group than in the combination group(P<0.05) ,the estimate glomerular filtration rate(eGFR) (24 weeks of treatment/pre-treatment ratio) was obviously lower in the WM group than in the combination group(P<0.05) .There was no statistical difference in SCr and eGFR between the CM group and the combination group.The mean and median of 24 h urine protein ratio(24 weeks of treatment/pre-treatment ratio) were less in the combination group than in the other two groups.The urine protein greater than 2.0 g/d occurred in no case.The experimental drug-correlated adverse reaction rate was obviously higher in the WM group than in the CM group(30.4% vs 10.0%,P<0.05) .Conclusions As for CGN CKD 3 patients,treatment by Benazepril combined with wind dispelling and dampness removing Chinese herbs showed favorable renal protective effects.It delayed the progress of renal failure,significantly improve the overall clinical efficacy.It was an effective treatment method for CGN CKD 3 patients with good patient tolerance and less adverse reactions.

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