肾乐胶囊治疗IgA肾病肺脾气虚证患者的前瞻性多中心随机对照临床研究

Prospective, Multi-centered, Randomized and Controlled Trial on Effect of Shenle Capsule in Treating Patients with IgA Nephropathy of Fei-Pi Qi-Deficiency Syndrome

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中文关键词: 肾乐胶囊 IgA肾病福辛普利脾肺气虚证

英文关键词:Shenle Capsule IgA nephropathy fosinopril Pi-Fei qi-deficiency syndrome

基金项目:国家“十五”科技攻关项目(No .2001BA701A14a);国家自然科学基金“创新研究群体”项目(No .30121005);北京市“针对重大疾病的创新药物”研究(No .D0204003041031);北京市国际合作项目

作者	单位
陈香美	解放军总医院全军肾脏病研究所暨重点实验室
陈以平	上海中医药大学附属龙华医院肾科
周柱亮	北京军区281医院肾科
陈建	南京军区福州总医院肾科
魏日胞	上海中医药大学附属龙华医院肾科
邓跃毅	第三军医大学大坪医院肾科
何亚妮	北京中日友好医院
李平	解放军总医院全军肾脏病研究所暨重点实验室
李建军	解放军总医院全军肾脏病研究所暨重点实验室
罗健华	解放军总医院全军肾脏病研究所暨重点实验室

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中文摘要:

目的以血管紧张素转化酶抑制剂福辛普利为对照,观察中药复方肾乐胶囊治疗IgA肾病(IgAnephropathy,IgAN)脾肺气虚证的疗效及安全性。方法采用前瞻性、多中心、双盲双模拟、随机对照试验设计方案。70例IgA肾病脾肺气虚证患者,随机分为肾乐胶囊组(36例)和福辛普利组(34例),治疗12周,观察24h尿蛋白定量、血肌酐、中医证候积分等疗效指标及肝功能和不良事件等安全性指标。结果与治疗前比较,治疗12周后,两组患者24h尿蛋白定量明显下降,白蛋白水平明显升高,中医症状显著改善(P<0·05或P<0·01),血清总胆固醇、甘油三酯、肾功能无明显变化(P>0·05),两组间各个指标比较差异无统计学意义。按中医疗效标准判断,福辛普利组总有效率为82·4%,肾乐胶囊组为83·3%;按西医疗效标准判断,福辛普利组总有效率为58·8%,肾乐胶囊组为66·7%,两组中医和西医总有效率比较差异无统计学意义。未发现严重不良事件。结论中药肾乐胶囊与阳性对照药福辛普利相似,也可以有效降低IgA肾病脾肺气虚证患者的蛋白尿,改善患者临床症状,耐受性良好。

英文摘要:

ObjectiveTo observe the effect and safety of Chinese compound Shenle Capsule (SC) in treating IgA nephropathy patients of Fei-Pi qi-deficiency syndrome (FPQD). Methods A prospective, multi-centered, randomized, double-blinded,double-mimetic, controlled trial was conducted in 70 IgA nephropathy patients of FPQD syndrome, who were randomly assigned to two groups treated with SC and fosinopril respectively for 12 weeks. The changes of TCM syndrome score, 24 h urine protein quantity (UP), serum creatinine (SCr), hepatic function before and after treatment and the adverse reaction were observed. Results Compared with those before treatment, the level of UP and the TCM syndrome scores decreased significantly in both groups (P<0.05 or P<0.01), while the level of albumin increased significantly after treatment, and the level of total cholesterol, triglycerid and renal function remained unchanged (P>0.05). There was no significant difference in all the above parameters between the two groups. According to the curative criterion for Chinese medicine and Western medicine, the total effective rate was 83.3% and 66.7% respectively in the SC treated patients, 82.4% and 58.8% respectively in the fosinopril treated patients, showing insignificant difference between them. In addition, no severe adverse event was found. Conclusion SC treatment showed effects similar to that of fosinopril in reducing proteinuria and improving TCM syndrome in IgA nephropathy patients of FPQD syndrome, and could be well tolerated by patients.

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