肾病Ⅱ号方治疗IgA肾病单纯性血尿的有效性和安全性研究

Efficacy and Safety of Shenbing Decoction Ⅱ for IgA Nephropathy Simple Hematuria

目的评价肾病Ⅱ号方治疗IgA肾病单纯性血尿的有效性和安全性。方法以随机、开放研究方法,纳入IgA肾病单纯性血尿患者60例,按随机数表法分为对照组和干预组。在低盐低脂优质蛋白饮食基础上,对照组给予血尿安胶囊,干预组给予肾病Ⅱ号方,干预3周。主要疗效评价包括临床总有效率、中医证候积分、尿红细胞计数等,次要疗效评价包括肾功能、生存质量等。结果共50例患者完成临床试验,干预组的临床总有效率为88%(22/25),对照组为96%(24/25),但两组差异无统计学意义(χ^(2)=1.133,P=0.287)。与治疗前相比,治疗后对照组血清白细胞介素6(IL-6)、肿瘤坏死因子α(TNF-α)水平显著降低(P<0.05),干预组血清单核细胞趋化蛋白1(MCP-1)、TNF-α水平显著降低(P<0.05)。治疗后干预组在生理机能、躯体疼痛、一般健康状况、精神健康、社会功能、精力、健康变化等生存质量维度的得分显著高于对照组(P<0.05)。两组均无不良事件发生。结论肾病Ⅱ号方治疗IgA肾病单纯性血尿的临床疗效与血尿安胶囊接近,能降低患者中医证候积分、尿红细胞计数、D-二聚体,改善患者生存质量、降低血清MCP-1和TNF-α的水平,且具有较好的安全性。

ObjectiveThe efficacy and safety of Shenbing DecoctionⅡfor IgA nephropathy simple hematuria were assessed.MethodsSixty patients with IgA nephropathy simple hematuria were randomly divided into control group and intervention group in a randomized,open-access trial.Based on low-salt,low-fat and high-quality protein diet,patients in the control group were treated with Xueniaoan capsules and those in the intervention group were treated with Shenbing DecoctionⅡrespectively,both for 3 weeks.The main efficacy evaluation included total clinical effective rate,Traditional Chinese medicine syndrome score,urinary red blood cell count,and so on.The secondary efficacy evaluation included the changes of renal function and quality of life.ResultsFifty patients completed the trial.The total clinical effective rate of the intervention group was 88%and that of the control group was 96%.There was no significant difference between the two groups(χ^(2)=1.133,P=0.287).After treatment,the serum levels of IL-6 and TNF-αin the control group were significantly lower than those before treatment(P<0.05),and the levels of MCP-1 and TNF-αin the intervention group were significantly lower than those before treatment(P<0.05).After treatment,the scores of physical functioning,bodily pain,general health,mental health,social functioning,vitality and reported health transition in the intervention group were significantly higher than those in the control group(P<0.05).There was no adverse event in both groups.ConclusionThe clinical efficacy of Shenbing DecoctionⅡin the treatment of IgA nephropathy simple hematuria is similar to that of Xueniaoan capsules.It can reduce the patients’TCM syndrome score,urinary red blood cell count,D-dimer,improve the patients’quality of life,reduce serum MCP-1 and TNF-αlevels,and has good safety.