他克莫司联合激素诱导治疗弥漫增生性狼疮性肾炎的临床研究

目的 探讨他克莫司联合激素诱导治疗弥漫增生性狼疮性肾炎的疗效和安全性.方法 将38例弥漫增生性狼疮性肾炎患者按随机数字表法分为研究组和对照组,每组19例,分别采用他克莫司联合激素治疗和环磷酰胺联合激素治疗,观察两组治疗前后的实验室指标变化以及用药期间的不良反应.结果 两组治疗9个月后的狼疮疾病活动性指数、尿蛋白定量、尿沉渣红细胞计数和抗dsDNA阳性率较治疗前均显著下降,差异有统计学意义(P＜0.05);而血清白蛋白、C3和C4较治疗前均显著升高,差异有统计学意义(P＜0.05);研究组尿蛋白定量较对照组下降更为显著,而血清白蛋白升高则更为显著,差异均有统计学意义(P＜0.05).研究组的有效率为94.7%(18/19),显著高于对照组的68.4%(13/19),差异有统计学意义(P＜0.05);研究组获得完全缓解、部分缓解的时间均显著短于对照组,差异有统计学意义(P＜0.05).两组均未发生因药物不良反应严重而停药者,研究组一过性血肌酐升高、糖代谢异常的发生率均高于对照组,而感染和一过性肝酶升高发生率则低于对照组.研究组未出现月经紊乱和血白细胞减少者,但上述不良反应的发生率组问比较差异均无统计学意义(P＞0.05).结论 他克莫司是诱导治疗弥漫增生性狼疮性肾炎的一种有效的免疫抑制剂,起效快,不良反应轻.

Abstract：

Objective To investigate the efficacy and safety of tacrolimus combined with glucocorticoid for inductive therapy of diffuse proliferative lupus nephritis. Methods Thirty-eight patients with diffuse proliferative lupus nephritis were randomly divided into study group (19 cases) and control group (19 cases) ,and they received the treatment of tacrolimus combined with glucocorticoid and cyclophosphamide combined with glucocorticoid respectively. The changes of laboratory tests and adverse reactions before and after treatment were observed. Results After treatment for 9 months, the systemic lupus erythematosus disease activity index, urinary protein quantitation, urinary sediment RBC count and anti-dsDNA positive rate in two groups were significantly decreased than those before treatment (P ＜0.05). While serum albumin, complement C3 and G4 levels were significantly increased than those before treatment (P＜0.05). Urinary protein quantitation in study group decreased more significantly than that in control group, while serum albumin increased more significantly than that in control group, and the differences were statistically significant(P＜ 0.05). The effective rate in study group[94.7%(18/19)] was significantly higher than that in control group[68.4%(13/19)](P＜ 0.05). The duration to obtain complete remission and partial remission in Emaii:mashangminpl@163.comstudy group was significantly shorter than that in control group(P＜ 0.05). Nobody withdrawed from the study due to serious side effects of drug. The incidence rate of transient increase in SCr and abnormal glucose metabolism in study group was higher than that in control group, and the incidence of infection and elevated liver enzymes was lower than that in control group. In addition, menstrual disorders and reduction of blood WBC did not occur in study group, but the incidence rate of side effects between two groups had no significant difference (P＞ 0.05). Conclusion Tacrolimus is an effective immunosuppressant for inductive therapy of diffuse proliferative lupus nephritis with quick response and less adverse effects.

Efficacy of tacrolimus combined with glucocorticoid for inductive therapy of diffuse proliferative lupus nephritis

Objective To investigate the efficacy and safety of tacrolimus combined with glucocorticoid for inductive therapy of diffuse proliferative lupus nephritis. Methods Thirty-eight patients with diffuse proliferative lupus nephritis were randomly divided into study group (19 cases) and control group (19 cases) ,and they received the treatment of tacrolimus combined with glucocorticoid and cyclophosphamide combined with glucocorticoid respectively. The changes of laboratory tests and adverse reactions before and after treatment were observed. Results After treatment for 9 months, the systemic lupus erythematosus disease activity index, urinary protein quantitation, urinary sediment RBC count and anti-dsDNA positive rate in two groups were significantly decreased than those before treatment (P ＜0.05). While serum albumin, complement C3 and G4 levels were significantly increased than those before treatment (P＜0.05). Urinary protein quantitation in study group decreased more significantly than that in control group, while serum albumin increased more significantly than that in control group, and the differences were statistically significant(P＜ 0.05). The effective rate in study group[94.7%(18/19)] was significantly higher than that in control group[68.4%(13/19)](P＜ 0.05). The duration to obtain complete remission and partial remission in Emaii:mashangminpl@163.comstudy group was significantly shorter than that in control group(P＜ 0.05). Nobody withdrawed from the study due to serious side effects of drug. The incidence rate of transient increase in SCr and abnormal glucose metabolism in study group was higher than that in control group, and the incidence of infection and elevated liver enzymes was lower than that in control group. In addition, menstrual disorders and reduction of blood WBC did not occur in study group, but the incidence rate of side effects between two groups had no significant difference (P＞ 0.05). Conclusion Tacrolimus is an effective immunosuppressant for inductive therapy of diffuse proliferative lupus nephritis with quick response and less adverse effects.