金水宝胶囊联合泼尼松治疗狼疮性肾炎的临床研究

Clinical study on Jinshuibao Capsules combined with prednisone in treatment of lupus nephritis

目的 探讨金水宝胶囊联合泼尼松治疗狼疮性肾炎的临床效果。方法 选取2018年6月-2020年12月河南科技大学第一附属医院收治的80例狼疮性肾炎患者,使用随机数字表法分成对照组和治疗组,每组各40例。对照组患者口服醋酸泼尼松片,1 mg/(kg·d),4~6周后逐步减量至最小维持量(<7.5 mg/d)。在对照组基础上,治疗组口服金水宝胶囊,1.98 g/次,3次/d。两组连续治疗6个月。观察两组患者临床疗效,比较治疗前后两组患者肾功能指标24 h尿蛋白定量(24h-Upro)、血清尿素氮(BUN)和肌酐(Cr)水平,系统性红斑狼疮疾病活动指数(SLEDAI)评分和36项健康调查简表(SF-36)总分,中性粒细胞与淋巴细胞比值(NLR),及血清高迁移率族蛋白B1(HMGB1)、白细胞介素-18(IL-18)和细胞间黏附分子-1(ICAM-1)水平。结果 治疗后,治疗组总有效率为92.5%,较对照组的75.0%显著提高(P<0.05)。治疗后,两组24 h-Upro和血清BUN、Cr水平均显著低于治疗前(P<0.05),且治疗组肾功能改善作用较对照组更明显(P<0.05)。治疗后,两组SLEDAI评分均显著降低,而SF-36总分则均显著升高(P<0.05),且治疗组SLEDAI和SF-36评分显著好于对照组(P<0.05)。治疗后,两组NLR和血清HMGB1、IL-18、ICAM-1水平显著低于治疗前(P<0.05),且治疗组明显低于对照组(P<0.05)。治疗期间,治疗组不良反应发生率明显低于对照组(12.5%vs32.5%,P<0.05)。结论 金水宝胶囊联合泼尼松治疗狼疮性肾炎的整体疗效确切,是保护患者肾功能、降低疾病活动度及改善生活质量的安全有效途径。

Objective To investigate the clinical effect of Jinshuibao Capsules combined with prednisone in treatment of lupus nephritis. Methods Patients(80 cases) with lupus nephritis in the First Affiliated Hospital of Henan University of Science and Technology from June 2018 to December 2020 were randomly divided into control and treatment group, and each group had 40 cases.Patients in the control group were po administered with Prednisone Acetate Tablets, 1 mg/(kg·d), and gradually reduced the amount to the minimum maintenance dose(< 7.5 mg/d) after 4 to 6 weeks. Patients in the treatment group were po administered with Jinshuibao Capsules on the basis of the control group, 1.98 g/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical evaluation was evaluated, the renal function indexes 24 h-Upro, serum BUN and Cr levels, and the scores SLEDAI and SF-36, NLR, and the levels of serum HMGB1, IL-18, and ICAM-1 in two groups before and after treatment were compared. Results After treatment, the clinical effective rate of the treatment group was 92.5%, which was significantly higher than 75.0% of the control group(P < 0.05). After treatment, the levels of 24 h-upro and serum BUN and Cr in two groups were significantly lower than those before treatment(P < 0.05), and the improvement of renal function in the treatment group was more obvious than that in the control group(P < 0.05). After treatment, the SLEDAI score in two groups were significantly decreased, while the total score of SF-36 were significantly increased(P < 0.05), and the scores of SLEDAI and SF-36 in the treatment group were significantly better than those in the control group(P < 0.05). After treatment, the concentrations of NLR, serum HMGB1, IL-18, and ICAM-1 levels in two groups were significantly lower than those before treatment(P < 0.05), and which in the treatment group were significantly lower than those in the control group(P < 0.05). During the treatment period, the adverse reaction rate in the treatment group was significantly lower than that in the control group(12.5% vs 32.5%, P < 0.05). Conclusion Jinshuibao Capsules combined with prednisone in treatment of lupus nephritis is a safe and effective way to protect patients’ renal function, reduce disease activity and improve quality of life.