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目的:观察狼疮静治疗系统性红斑狼疮(SLE)的远期临床疗效及作用,并进一步阐述其方剂组成规律,探索并丰富SLE中医药治疗体系。方法:运用回顾性、多中心试验方法,将300例活动性SLE患者随机分为治疗组和对照组,各150例。治疗组采用激素泼尼松加中药狼疮静联合治疗,对照组采用单纯激素治疗,两组疗程均为6个月。观察两组治疗前后24h尿蛋白量、免疫指标、狼疮活动评分的变化以及激素副作用的发生率、半年内的复发情况。结果:治疗后,治疗组对24 h尿蛋白量、红细胞沉降率(ESR)、血清补体C4含量的改善明显优于对照组(P<0.05),其余指标的改善程度无显著性差异;治疗组狼疮活动评分较对照组明显降低(P<0.05);随访中,治疗组的复发率及激素副作用发生率较对照组明显降低(P<0.05)。结论:狼疮静治疗SLE远期疗效显著,尤其在调节免疫、有效促进激素撤减、减轻西药的毒副作用、提高治疗效果等方面作用突出。
Objective: To observe the long-term clinical efficacy and effects of lupus static treatment of systemic lupus erythematosus (SLE) and further elaborate the rules of its prescription, to explore and enrich SLE Chinese medicine treatment system. Methods: A retrospective, multicenter trial of 300 patients with active SLE was randomly divided into treatment and control groups, 150 cases in each. Treatment group with hormone prednisone combined with traditional Chinese medicine lupus static treatment, the control group with simple hormone therapy, two courses of treatment were 6 months. The changes of 24 h urinary protein, immune index, lupus activity score and the incidence of hormone side effects and relapse within six months were observed before and after treatment. Results: After treatment, the improvement of 24 h urinary protein, erythrocyte sedimentation rate (ESR) and serum complement C4 content in the treatment group was significantly better than that in the control group (P <0.05), while the other indexes had no significant difference. The treatment group The score of lupus activity was significantly lower than that of the control group (P <0.05). At the follow-up, the relapse rate and the incidence of hormone side effects in the treatment group were significantly lower than those in the control group (P <0.05). Conclusion: Long-term curative effect of lupus static therapy on SLE is significant, especially in the regulation of immunity, effective promotion of hormone withdrawal, reducing the side effects of western medicine and improving the therapeutic effect.