长春新碱联合低剂量环磷酰胺治疗系统性红斑狼疮的临床观察

目的评价长春新碱（VCR）联合低剂量环磷酰胺（CTX）治疗系统性红斑狼疮（SLE）的疗效和安全性。方法本研究为两个中心、随机、单盲、对照的临床试验。符合纳入和排除标准的50例SLE患者随机分为VCR＋CTX组（VCR1mg,12-24h内予CTX200-400mg,每3周1次）及单用CTX组（600-800mg/3周）,疗程24周,分别观察基线、12周、24周时各项指标及不良反应的发生情况,共41例患者完成试验。结果随访12周、24周与基线时相比及随访第24周与第12周相比,两组的SLEDAI、Cr显著下降（P〈0.05）,两组间变化均无差异（P〉0.5）;与基线值相比,随访第12周,VCR＋CTX组较CTX组BUN显著下降、PLT显著升高（P〈0.05）,随访第24周时,两组BUN均较基线、12周时显著下降（P〈0.05）,但PLT变化不明显（P〉0.5）。安全性方面,两组的不良反应发生率无差异（P〉0.05）。结论 VCR联合低剂量CTX可以有效改善SLE患者的症状,降低疾病活动度、改善肾功。两者联合安全性好,与CTX组相比,不良反应并未增加。

Clinical and experimental study of Vincristine and Cyclophosphamide in patients with Systemic lupus erythematosus

Objective To evaluate clinical efficacy and safety of VCR and CTX combination therapy.Methods In a randomized,single-blinded,controlled study,50 patients were randomly assigned to receive VCR plus CTX(VCR 1mg/3w+CTX 200-400mg/w) or CTX(600-800mg/3w).The clinical efficacy and safety were analyzed at baseline,12 and 24 weeks respectively.To study the change of indexes and adverse events.There were 41 patients from set up to finish.Results At week 12 and 24,SLEDAI,Cr significantly decreased in both VCR plus CTX group and CTX group compared to the baseline.Compared week 24 with week 12,SLEDAI,Cr significantly decreased in two group.Compared week 12 with the baseline,BUN significantly decreased in VCR plus CTX group than CTX group,but PLT significantly increased.At week 24,BUN significantly decreased in two groups,but PLT does not change significantly.The incidence of adverse events was not significantly higher in VCR plus CTX group than CTX group.Conclusion VCR plus CTX effectively reduces the symptoms,disease activity of SLE.VCR plus CTX is generally well tolerated by patients without significant increase in the rate of adverse events compared with CTX group.