金匮肾气丸联合他克莫司和甲泼尼龙治疗狼疮性肾炎的临床研究

目的探讨金匮肾气丸联合他克莫司胶囊和甲泼尼龙片治疗狼疮性肾炎的临床疗效。方法选取2015年2月—2018年2月在三亚市人民医院确诊并接受治疗的98例狼疮性肾炎患者为研究对象,将所有患者采用数字表法随机分为对照组和治疗组,每组各49例。对照组患者口服甲泼尼龙片,1 mg/(kg·d),连续治疗4～8周后根据患者病情逐渐减少剂量;同时口服他克莫司胶囊,初始期剂量为2 mg/次,2次/d,间隔12 h餐后服用,血谷浓度维持在5～8 ng/mL,连续治疗4～8周后,维持期剂量为1 mg/次,2次/d,血谷浓度维持在2～5 ng/mL。治疗组在对照组基础上口服金匮肾气丸,5 g/次,2次/d。两组患者均连续治疗6个月。观察两组的临床疗效,比较两组的肾功能指标、血清因子水平。结果治疗后,对照组和治疗组的总有效率分别为81.63%、93.87%,两组比较差异有统计学意义(P0.05)。治疗后,两组患者尿素氮、血肌酐、24h尿蛋白定量水平均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后,治疗组患者肾功能指标显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者补体C3、血红蛋白、血清白蛋白水平均显著升高,血清胱抑素C水平显著降低,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后,治疗组患者血清因子水平显著优于对照组,两组比较差异具有统计学意义(P0.05)。结论金匮肾气丸联合他克莫司胶囊和甲泼尼龙片治疗狼疮性肾炎具有较好的临床疗效,可保护肾功能,改善血清因子水平,安全性较高,具有一定的临床推广应用价值。

Clinical study on Jinkui Shenqi Pills combined with tacrolimus and methylprednisolone in treatment of lupus nephritis

Objective To investigate the clinical effect of Jinkui Shenqi Pills combined with Tacrolimus Capsules and Methylprednisolone Tablets in treatment of lupus nephritis. Methods Patients (98 cases) with lupus nephritis in Sanya People''s Hospital from February 2015 to February 2018 were randomly divided into control and treatment groups, and each group had 49 cases. Patients in the control group were po administered with Methylprednisolone Tablets, 1 mg/(kg·d), after 4 - 8 weeks of continuous treatment, the dose was gradually reduced according to the patient''s condition. And patients in the control group were also po administered with Tacrolimus Capsules, starting dosage 2 mg/time, twice daily, taking after meals at 12 h intervals, valley concentration was maintained at 5 - 8 ng/mL, after 4 - 8 weeks of continuous treatment, maintenance dose of 1 mg/time, valley concentration was maintained at 2 - 5 ng/mL. Patients in the treatment group were po administered with Jinkui Shenqi Pills on the basis of the control group, 5 g/time, twice daily. Patients in two groups were treated for 6 months. After treatment, the clinical efficacies were evaluated, and the renal function indexes and serum factor levels in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 81.63% and 93.87%, respectively, and there was difference between two groups (P<0.05). After treatment, the levels of urea nitrogen, serum creatinine, and 24 h urinary protein quantification in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the renal function indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, the levels of complement C3, hemoglobin, and Serum Albumin in two groups were significantly increased, but he levels of serum cystatin C in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the serum factor levels in the treatment group were significantly better than those in the control group, with significant difference between two groups (P<0.05). Conclusion Jinkui Shenqi Pills combined with Tacrolimus Capsules and Methylprednisolone Tablets has clinical curative effect in treatment of lupus nephritis, can protect renal function, and improve serum factor level, with good safety, which has a certain clinical application value.