人参皂苷联合强的松治疗系统性红斑狼疮的前瞻性随机双盲对照试验

Efficacy of ginsenosides combined with prednisone in patients with systemic lupus erythematosus:a prospective,randomized,double-blind,placebo-controlled trial

背景:糖皮质激素治疗系统性红斑狼疮(systemic lupus erythematosus,SLE)的副作用一直是临床医生关注的焦点,我们的前期研究表明人参皂苷可以增强地塞米松的临床疗效。目的:探讨人参皂苷联合强的松对SLE中医证候积分和临床疗效的影响。设计、场所、对象和干预措施:所有病例均为上海长海医院风湿免疫科的门诊及住院SLE患者。采用随机、双盲、对照的方法,60例SLE患者在常规强的松治疗的基础上分别给予人参皂苷胶囊和安慰剂胶囊。疗程为3个月。主要结局指标:观察治疗前后SLE患者的中医证候积分和临床总体疗效。结果:治疗组28例,对照组27例纳入结果分析。治疗组总有效率为89.28%,与对照组总有效率66.67%相比,差异有统计学意义(P<0.05)。两组中医证候积分均较治疗前下降(P<0.01),治疗组治疗前后中医证候积分差值与对照组比较,差异有统计学意义(P<0.05)。治疗组的症状改善程度亦优于对照组(P<0.05)。结论:人参皂苷联合强的松可以显著提高SLE的临床治疗有效率,更好地改善SLE患者的临床症状。

Background：The side effects of glucocorticoid in treatment of systemic lupus erythematosus （SLE） have been the focus of debate,and our preliminary study indicates that ginsenosides can enhance the efficacy of dexamethasone.Objective：To observe the effects of ginsenosides combined with prednisone in SLE patients.Design,setting,participants and interventions：A total of 60 SLE patients from Department of Rheumatology and Immunology,Changhai Hospital,Second Military Medical University,were randomly divided into treatment group and control group,with 30 patients in each group.Patients in the treatment group were given routine treatment with prednisone plus ginsenosides,while those in the control group were given routine treatment with prednisone plus placebo.They were all treated for 3 months.Main outcome measures：After three-month treatment,syndrome score in traditional Chinese medicine （TCM）,total response rate and symptom improvement rate were measured and evaluated.Results：Twenty-eight cases in treatment group and twenty-seven cases in control group were included in analysis.The total response rates in the treatment group and control group were 89.28% and 66.67% respectively,and there was a significant difference between the two groups （P0.05）.After treatment,the TCM syndrome scores in the two groups were lower than those before treatment （P0.01）,and prednisone plus ginsenosides was better in decreasing the TCM syndrome score than prednisone plus placebo （P0.05）.The symptoms were improved in the treatment group as compared with the control group （P0.05）.Conclusion：Prednisone combined with ginsenosides can increase the clinical effective rate and improve the clinical symptoms of SLE patients.