甲泼尼龙联合环磷酰胺和他克莫司对狼疮性肾炎患者的疗效及安全性分析

Clinical effect and safety of methylprednisolone combined with cyclophosphamide and tacrolimus respectively in patients with lupus nephritis

目的研究甲泼尼龙分别联合环磷酰胺与他克莫司对狼疮性肾炎患者的疗效及安全性。方法选取2015年3月-2018年3月在榆林市第二医院就诊的80例狼疮性肾炎患者为研究对象,随机分为对照组39例和观察组41例。所有患者均给予甲泼尼龙治疗,在此基础上对照组患者给予注射用环磷酰胺治疗,剂量为0.5 g/m^2,不超过9 g,1次/2周;观察组患者给予他克莫司胶囊治疗,诱导期初始剂量为4 mg/d,2次/d,间隔12 h,餐后2 h服用,监测血药谷浓度,维持在5~8 ng/mL,连续治疗4~8周后,维持期剂量保持2 mg/d,血药谷浓度维持在2~5 ng/mL。比较两组患者的临床疗效,治疗前后的相关临床指标变化情况以及治疗期间的不良反应发生情况。结果治疗后,观察组患者的总有效率为87.80%,显著高于对照组的66.67%,两组比较差异有统计学意义(P<0.05)。治疗前两组各项指标差异不显著,治疗后两组24 h尿蛋白量、血清抗核抗体(ANA)阳性率、血清肌酐(SCr)、红斑狼疮活动指数评分(SLEDAI)均降低,补体C3水平升高,同组治疗前后比较差异有统计学意义(P<0.05);且观察组变化显著优于对照组,组间差异有统计学意义(P<0.05)。治疗期间,观察组不良反应总发生率为7.32%,显著低于对照组的17.95%(P<0.05)。结论甲泼尼龙联合他克莫司治疗狼疮性肾炎疗效显著,能有效改善患者的相关临床指标,且具有较高的安全性,值得在临床推广使用。

Objective To investigate the clinical effect and safety of methylprednisolone combined with cyclophosphamide and tacrolimus respectively in patients with lupus nephritis. Methods Selected 80 cases of patients with lupus nephritis who were treated in The Second Hospital of Yunlin from March 2015 to March 2018, divided into observation group(41 cases) and control group(39 cases) randomly. All patients were treated with methylprednisolone, patients in the control group were treated with Cyclophosphamide for Injection at a dose of 0.5 g/m^2, no more than 9 g, once/2 weeks. Patients in the observation group were treated with Tacrolimus Capsules at an initial dose of 4 mg/d, twice daily, 12 h apart, 2 hours after meal, and the blood trough concentration was monitored to maintain at 5 - 8 ng/mL for 4 - 8 consecutive treatments. The maintenance dose was maintained at 2 mg/d and the blood trough concentration was maintained at 2 - 5 ng/mL. Clinical effects, changes of related clinical indicators before and after treatment and the adverse reactions occur during treatment were compared between two groups. Results After treatment, the total effective rate of the observation group was 87.80%, which was significantly higher than 66.67% in the control group(P < 0.05). There were no significant differences in the indicators of two groups before the treatment, and the 24 h urine protein amount, ANA positive rate, Scr, and SLEDAI scores were decreased after the treatment, and the level of C3 were increased,and there were differences in the same group(P < 0.05). And the changes in observation group were significantly better than control group, and there were differences between two groups(P < 0.05). The incidence of adverse reactions in the observation group during treatment was 7.32%, which was significantly lower than 17.95% in the control group(P < 0.05). Conclusion Methylprednisolone combined with tacrolimus was effective in treatment of lupus nephritis, which can effectively improve the related clinical indicators of patients, and has a higher safety, is worthy of clinical application.