中西医结合疗法治疗阴虚内热、水瘀互结型狼疮性肾炎的临床随机对照研究

Integrated Chinese and western therapy for lupus nephritis of interior heat due to yin asthenia and mixture of water and stasis types: a randomized controlled trial

目的观察中西医结合疗法治疗阴虚内热、水瘀互结型狼疮性肾炎的临床疗效及安全性。方法将95例阴虚内热、水瘀互结型狼疮性肾炎患者随机分为对照1组(31例)、对照2组(31例)及治疗组(33例)。对照1组予环磷酰胺静脉滴注加泼尼松片口服;对照2组予自拟狼疮肾炎方加泼尼松片口服;治疗组同时予对照1组及对照2组的治疗措施。各组疗程均为1年,观察临床疗效以及中医证候积分、SLEDAI积分、24 h尿蛋白定量、血沉及免疫相关指标(Ig G、C3、C4)的变化情况,比较各组激素用量及安全性。结果1对照1组、对照2组及治疗组总有效率分别为80.65%、83.87%及96.88%,组间临床疗效比较差异有统计学意义(P<0.05)。2治疗前后组内比较,各组SLEDAL积分差异均有统计学意义(治疗组和对照2组组内P<0.01,对照1组组内P<0.05);组间治疗后比较,治疗组、对照2组与对照1组中医证候积分差异均有统计学意义(P<0.01)。3治疗前后组内比较,各组SLEDAI积分差异均有统计学意义(P<0.01);组间治疗后比较,治疗组与对照2组SLEDAI差异均有统计学意义,治疗组优于对照2组(P<0.05)。4治疗前后组内比较,各组24 h尿蛋白定量、血沉及免疫相关指标(Ig G、C3、C4)的差异均有统计学意义(P<0.01);组间治疗后比较,治疗组与对照1组、对照2组在24 h尿蛋白定量、血沉及补体C4方面差异有统计学意义(P<0.05),而治疗组与对照2组在Ig G、C3方面差异有统计学意义(P<0.05)。5治疗前后组内比较,各组激素用量差异均有统计学意义(P<0.01);组间治疗后比较,治疗组与对照2组激素用量差异有统计学意义,治疗组少于对照2组(P<0.05)。6不良反应发生率比较,对照1组与对照2组、治疗组差异均有统计学意义(P<0.05),而对照2组和治疗组差异无统计学意义(P>0.05),提示对照1组不良反应发生率高于对照2组、治疗组。结论中西医结合疗法治疗阴虚内热、水瘀互结型狼疮性肾炎可显著改善患者的临床症状及体征,减少激素的用量及用药不良反应。

Objective To observe the clinical efficacy and safety of integrated Chinese and western therapy in treating lupus nephritis of two types. Methods Ninetyfive cases of the two types were randomized into three groups： No. 1 control group in which 31 cases were treated by Cyclophosphamide Injection and Prednisone Tablets ; No. 2 control group in which 31 cases were treated by self-made formula and Prednisone Tablets; Treatment group in which 33 cases were treated by selfmade formula, Cyclophosphamide Injection and Prednisone Tablets, with the course of one year. The clinical efficacy, SLEDAI and TCM symptom scores as well as laboratory indicators were observed and analyzed. Results （1） The total effective rate was 80.65% in the No. 1 control group, was 83.87% in the No. 2 control group and 96.88% in the treatment groups, with a difference among these three groups （P 〈 0.05 ）. （2） In each group, there was a statistical difference in TCM symptom score between before and after treatment; after treatment, statistical difference was found among theses three groups （ P 〈 0.01 ）. （3） In each group, there was a statistical difference in SLEDAI score between before and after treatment （ P 〈 0. 01 ） ; after treatment, statistical difference was found between treatment group and No. 2 control group （P 〈 0.05 ）. （4） In each group, there were statistical differences in 24h urinary protein, ESR and relative immune indicators of IgG, C3 and C4 （P 〈 0.01 ） ; statistical differences were found in 24h urinary protein, ESR and C4 between treatment group and control groups （P 〈 0.05 ）, and with significantdifferences in IgG and C3 between treatment group and No.2control group （P 〈0. 05）. （5）Dosage of prednisone decreased within groups after treatment （P 〈0. 01） ; significant difference was found among these three groups after treament （ P 〈 0.05 ）. （6） There was significant difference in adverse event rate among these groups （ P 〈 0. 05 ）, but without significant difference between the treatment group and No. indicated that adverse event rate in No 2 control group （ P 〉 0.05 ）, which 1 control group was higher than that ofthe other two groups. Conclusion ntegrated Chinese and western therapy can improve the clinical symptoms and signs, reduce the dosage of hormone and toxic and adverse effects in patients with lupus nephritis.