中西医结合治疗难治性肾病综合征:随机、双盲、单模拟、多中心临床研究  

Treatment of refractory nephrotic syndrome with integrated traditional Chinese and western medicine:a randomized,double-blind,single-simulated,multi-center clinical trial

作　　者：魏连波 洪钦国[2] 汤水福[2] 龙海波[3] 于淑军 史伟[5] 周伟东[3] 张春花 罗月中[2] 吴金玉[5] 肖炜[6] 隋淑梅[7] 王明[8] 吕佩佳 谢丹丹[6] 邹小虎 

机构地区：[1]南方医科大学深圳医院中医科,深圳518021 [2]广州中医药大学第一附属医院肾内科,510504 [3]南方医科大学珠江医院肾内科,广州510280 [4]威海市中医院肾内科,264200 [5]广西中医药大学第一附属医院肾内科,530023 [6]南方医科大学中医药学院,广州510515 [7]黑龙江省中医研究院,黑龙江150036 [8]南方医科大学珠江医院中医科,广州510280 [9]南方医科大学中西医结合医院肾内科,广州510315

出　　处：《中华肾病研究电子杂志》2017年第5期219-223,共5页Chinese Journal of Kidney Disease Investigation（Electronic Edition）

基　　金：广东省"211工程"三期重点学科建设项目;粤发改社[2009]431号

摘　　要：目的分析中西医结合治疗难治性肾病综合征的临床疗效及安全性。方法在中国临床试验中心注册(Chi CTR-TRC-12002539),采用多中心、随机、单盲、2∶1基础对照的研究方法,选取全国9家三甲医院,共有120例患者入选。试验组采用基础治疗(糖皮质激素及环磷酰胺)加中药辨证组方治疗;对照组采用基础治疗加安慰剂治疗,疗程为3个月。定期监测24 h尿蛋白量、血清白蛋白、肾功能、中医证候评分及不良反应。采用SPSS 20.0软件进行数据分析。结果:治疗后,临床疗效方面,试验组总有效率89.39%,对照组总有效率63.64%,差异有统计学意义(χ~2=7.824,P=0.005);中医证候疗效方面,试验组总有效率为93.94%,对照组总有效率72.73%,差异有统计学意义(χ~2=6.918,P=0.009)。治疗过程中试验组库欣综合征、消化道反应、感染等不良反应发生率低于对照组,差异有统计学意义(χ~2=7.666,P=0.006;χ~2=5.088,P=0.024;χ~2=5.227,P=0.022)。结论中西医结合治疗可有效提高难治性肾病综合征的临床疗效,改善临床症状,并可有效减少免疫抑制剂的副作用。Objective This study aimed to assess the clinical efficacy and safety of the treatment of refractory nephrotic syndrome with integrated traditional Chinese and western medicine. Methods The study was a prospective,randomized,double-blind,2 ∶ 1 basic-control,multi-center clinical trial,with120 patients recruited from 7 hospitals in China. The test group was administered with traditional Chinese medicine（ TCM） particles on the base of prednisone and cyclophosphamide treatment for 3 months,while the control group was administered with placebo using the same method. The 24-hour urinary protein,serum albumin,serum creatinine,TCM syndrome score and adverse reactions were monitored timely. SPSS 20. 0 software was used for data analysis. Results At 3 months,the total effective rate was 89. 39% and63. 64% for the test and the control,respectively,the difference of which was of statistical significance（ χ~2= 7. 824,P = 0. 005）. The total effective rate of TCM syndromes was 93. 94% and 72. 73% for the test and the control,respectively,the difference of which was also of statistical significance（ χ~2= 6. 918,P =0. 009）. The incidence of Cushing＇ s syndrome,digestive tract reactions,and infections in the test group were lower than in the control group,the difference of which was of statistical significance（ χ~2= 7. 666,P =0. 006; χ~2= 5. 088,P = 0. 024; χ~2= 5. 227,P = 0. 022）. Conclusion Treatment with integrated traditional Chinese and western medicine effectively improved the clinical efficacy of refractory nephrotic syndrome,improved the clinical symptoms,and reduced the side effects of immunosuppressive agents.

关 键 词：中西医结合治疗 难治性肾病综合征 临床研究 

分 类 号：R692[医药卫生—泌尿科学]