百令胶囊对狼疮性肾炎患者临床疗效和感染率影响的多中心前瞻性研究

A Multicenter Prospective Study of the Effect of Bailing Capsules on Clinical Efficacy and Infection Rate in the Patients With Lupus Nephritis

目的:探讨百令胶囊对狼疮性肾炎(LN)患者临床疗效及感染率的影响。方法:将LN患者随机分成观察组和对照组,两组常规治疗相同,观察组给予百令胶囊(1g,tid)治疗,比较两组治疗1年后临床疗效、感染率及药物不良反应的差异。结果:治疗后,观察组补体C3和血白蛋白显著高于对照组,观察组尿蛋白、尿红细胞和SLEDAI显著低于对照组,差异均有统计学意义(P<0.05)。观察组有效率(89.71%)显著高于对照组(73.53%),差异有统计学意义P<0.05;观察组治疗1年的下呼吸道感染率(4.41%)和总感染率(26.47%)均显著低于对照组(分别为11.67%和44.12%),差异有统计学意义(P<0.05);观察组的不良反应发生率(45.59%)与对照组(39.71%)比较,差异无统计学意义(P>0.05)。结论:百令胶囊可提高LN患者的临床疗效,降低感染率,且不增加药物不良反应。

Objective： To explore the effect of Bailing Capsules on clinical efficacy and infection rate in the patients with lupus nephritis. Methods： The patients with lupus nephritis were randomly divided into the observe group and the control group. They all accepted the conventional treatment, but the patients in the observed group were given the treatment of Bailing Capsules（1g tid）. The difference of clinical efficacy, infection rate and adverse drug reactions were compared between the two groups after 1 year. Results： After treatment, the concentrations of C3 and serum albumin in the observe group were significantly higher than that in the control group after treatment for 1 year（P0.05）, and the concentration of urine protein, urine red blood cells and SLEDAI in the observe group was significantly lower than that in the control group after treatment for 1 year（P〈0.05）. The effective rate in the observe group（89.71%）was significantly higher than that in the control group（73.53%）（P〈0.05）. The lower respiratory tract infection rate and total infection rate during the 1 year follow up in the observe group（respectively 4.41% and 26.47%） were significantly lower than that in the control group（respectively 11.67% and 44.12%）（P〈0.05）. There＇s no significant difference of adverse drug reactions in the observe group（45.59%）and in the control group（39.71%）（P〈0.05）. Conclusions： Bailing Capsules could improve clinical efficacy and reduce the infection rate, but didn＇t increase in adverse drug reactions