Objective To assess the efficacy and safety of Etanercept for Ankylosing spondylitis. Methods We searched The Cochrane Library (Issue 4. 2008), MEDLINE (1966 to September 2008), EMBASE (1974 to September 2008), CBM (1978 to 2008), CNKI (1994 to 2008), VIP (1989 to 2008), and Wanfang (1999 to 2008). The quality of included studies was critically evaluated. Data analyses were performed with The Cochrane Collaboration’s RevMan 5.0 software. Results Seven randomized controlled trials with total of 949 patients met the included criteria. The metaanalysis showed the effective rate of ASAS 20 or ASAS 50 receiving Etanercept was significantly higher than in patients receiving placebo, while no significant differences were noted between the Etanercept and placebo group in other indices. There was no statistical significance among different dosages. Patient Injection-site reaction rate for Etanercept was higher than that for placebo. No significant differences were observed in other adverse effects. Conclusions Etanercept is safe and effective for patients with Ankylosing spondylitis, however, some trials included in the review were of poor quality, so we needed the multi-center, large-scale randomized controlled trials of higher quality and the same course of treatment to confirm this.
目的:探讨甲氨蝶呤联合依那西普(MTX+ETA)和甲氨蝶呤联合来氟米特(MTX+LEF)治疗重度活动的类风湿关节炎(RA)的疗效差异。方法:收集重度活动的RA患者50例。A组24例,给予MTX 10mg/次,一周一次,口服,联合ETA 25mg/次,一周2次,皮下注射后病情缓解后依那西普减量为25mg/次,1周一次至随访结束;B组26例,给予MTX 10mg一周一次联合来氟米特20mg/d。两组随访时间为24周。定期随访其红细胞沉降率(ESR)、C反应蛋白(CRP)、DSA28评分、sharp评分、RF、ANA、ACR核心标准评定。结果:①A组在治疗半年前后其VAS评分、晨僵时间、关节肿痛个数、DSA28评分、HAQ、患者评分、医生评价、ESR、CRP方面改善明显,有统计学意义(Plt;0.05);B组在治疗半年前后其VAS评分、晨僵时间、关节肿痛个数、DSA28评分、HAQ、患者评分、医生评价方面改善明显,有统计学意义(Plt;0.05);A组和B组在治疗半年后在VAS评分、晨僵时间、关节触痛个数、DSA28评分、HAQ、患者评分、医生评价、ESR、CRP方面改善明显,有统计学意义(Plt;0.05)。②各组ACR20有效率逐步增加,在各随访期内两组的ACR20的达标率的差异无明显的统计学意义(Pgt;0.05);ACR50则在第4、20、24周,A组的达标率为12%、79%、87%与B组的8%、46%、50%差异有统计学意义(Plt;0.05);ACR70虽然在各期A组均高于B组,但差异均无差异性(Pgt;0.05)。③A组在第2、4、12周DSA28指数下降明显,跟前次随访指标的差异有统计学意义(Plt;0.05);B组在第16、24周DSA28指数下降明显,跟前次随访指标的差异有统计学意义(Plt;0.05);而A组与B组同期DSA28的比较发现,A组从第4周起各期DSA28分值均低于B组,且差异均有统计学意义(Plt;0.05)④两种治疗方案不良反应发生情况均低,且两组不良事件发生率差异无统计学意义。结论:ETA+MTX和LEF+MTX联合治疗重度活动的RA均是安全有效的,其中前者常常可以更早期的达到诱导缓解病情的目的。
ObjectiveTo compare the cost-effectiveness of etanercept combined with methotrexate to methotrexate plus placebo in the treatment of rheumatoid arthritis and to provide references for clinical practice.MethodsDecision tree model was developed to estimate the cost-effectiveness from the perspective of the health care system by TreeAge Pro 2016 software. The cost-effectiveness of the two treatments were compared by incremental analysis, and the robustness of the results were analyzed by sensitivity analysis.ResultsThe cost of etanercept combined methotrexate group in one year duration was ¥212 692, the effective rate (ACR50) was 66.4%; the cost of methotrexate combined with placebo group in one year duration was ¥572, the effective rate (ACR50) was 40.6%. The incremental cost-effectiveness ratio of two groups was ¥818 000/person, and the sensitivity analysis showed that the results were robust.ConclusionEtanercept combined methotrexate is significant more effective than methotrexat. But the cost of etanercept combined methotrexate is too high to afford and is not economical compared to methotrexate.