狼疮Ⅱ号胶囊辅助治疗中度活动性系统性红斑狼疮36例疗效观察

Clinical study on Effect of LangChuangⅡcapsule in Treating Active Systemic Lupus Erythematosus of Middling degree as Adjuvant Treatment

目的 观察中药狼疮Ⅱ号胶囊(由山茱萸、生地、丹皮、青蒿等组成)辅助激素治疗中度活动性系统性红斑狼疮(SLE)的疗效和安全性。方法 将72例活动性SLE患者随机分为两组(各36例),对照组用糖皮质激素治疗,治疗组在西药治疗基础上加狼疮Ⅱ号胶囊治疗,疗程12周,观察比较两组的活动指标(SLEDAI)、中医临床疗效、糖皮质激素用量计分。结果 ①SLE活动性指标:治疗组临床痊愈率、好转率分别为24.24%、63.64%;对照组分别为13.34%、60.00%,组间比较无显著性差异(p>0.05)。②中医临床证候疗效评价:治疗组临床痊愈率、显效率分别为27.78%、38.89%;对照组分别为13.89%、22.22%;两组总疗效有显著性差异(p<0.05)。③两组ITT意图治疗分析(intention-to-treat analysis):SLE活动性指标的组间比较,亦无显著性差异(p>0.05),中医临床证候总疗效有显著性差异(p<0.05)。④治疗组治疗后激素用量计分逐渐减少,对照组治疗第8周激素用量计分出现反弹,12周后两组激素用量计分减少组间比较有显著性差异(p<0.05)。⑤两组均未发现任何不良反应。结论 中药狼疮Ⅱ号胶囊治疗活动型SLE安全有效,且可减少激素用量。

Objective To observe the effectiveness and safety of herbal medicine LangChuangⅡcapsule in treating active systemic lupus erythematosus of middling degree as adjuvant treatment.Methods A randomized blinded controlled clinical trail was Adopted in the study.72 cases were randomlydivided into two groups (36 cases of each group),the control group treated with glucocorticoid(GC),thetreatment group were treated by western conventional treatment plus LangChuang Ⅱ capsule,the course oftreatment lasted twelve weeks .The SLEDAI ,therapeutic effect of Chinese medical clinical symptom ,dosage of GC and adverse reaction of two groups were comparatively observed.Results After twelve weeksof treatemt ①integral of SLEDAI: the clinical cure rate and the improved rate in the treatment groupwas 24.24%、63.64% and13.34%、60.00% in the control group.The statistical analysis showed that thetotal effect of two groups had no difference(p>0.05). ②Therapeutic effect of Chinese medicalclinical symptom: the clinical cure rate in the treatment group and the control group was 27.78%、13.89% , the remarkably effective rate was 38.89%、22.22%. The statistical analysis showed that the totaleffect of two groups had a significant difference(p<0.05). ③Intention-to-treat analysis:Thestatistical analysis showed that the total effect of SLEDAI had no difference(p>0.05),and Also showeda significant difference in therapeutic effect of Chinese medical clinical symptom (p<0.05). ④Dosageof GC:in the treatment group ,the dosage of GC reducued gradually after treatment,but in the controlgroup ,after eight weeks of treatment the dosage of GC rebounded.After twelve weeks, The statisticalanalysis showed that the the dosage of GC had a significant difference between two groups(p<0.05).Conclusions The LangChuangⅡcapsule was a safe and effective herbal medicine in treating activesystemic lupus erythematosus of middling degree,It may help the dosage of GC reducued firmly.