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.
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
关键词
中西医结合治疗
难治性肾病综合征
临床研究
Treatment with integrated traditional Chinese and western medicine
Refractory nephrotic syndrom
Clinical trial