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:探討甲氨蝶呤聯合依那西普(MTX+ETA)和甲氨蝶呤聯合來氟米特(MTX+LEF)治療重度活動的類風濕關節炎(RA)的療效差異。方法:收集重度活動的RA患者50例。A組24例,給予MTX 10mg/次,一周一次,口服,聯合ETA 25mg/次,一周2次,皮下注射后病情緩解后依那西普減量為25mg/次,1周一次至隨訪結束;B組26例,給予MTX 10mg一周一次聯合來氟米特20mg/d。兩組隨訪時間為24周。定期隨訪其紅細胞沉降率(ESR)、C反應蛋白(CRP)、DSA28評分、sharp評分、RF、ANA、ACR核心標準評定。結果:①A組在治療半年前后其VAS評分、晨僵時間、關節腫痛個數、DSA28評分、HAQ、患者評分、醫生評價、ESR、CRP方面改善明顯,有統計學意義(Plt;0.05);B組在治療半年前后其VAS評分、晨僵時間、關節腫痛個數、DSA28評分、HAQ、患者評分、醫生評價方面改善明顯,有統計學意義(Plt;0.05);A組和B組在治療半年后在VAS評分、晨僵時間、關節觸痛個數、DSA28評分、HAQ、患者評分、醫生評價、ESR、CRP方面改善明顯,有統計學意義(Plt;0.05)。②各組ACR20有效率逐步增加,在各隨訪期內兩組的ACR20的達標率的差異無明顯的統計學意義(Pgt;0.05);ACR50則在第4、20、24周,A組的達標率為12%、79%、87%與B組的8%、46%、50%差異有統計學意義(Plt;0.05);ACR70雖然在各期A組均高于B組,但差異均無差異性(Pgt;0.05)。③A組在第2、4、12周DSA28指數下降明顯,跟前次隨訪指標的差異有統計學意義(Plt;0.05);B組在第16、24周DSA28指數下降明顯,跟前次隨訪指標的差異有統計學意義(Plt;0.05);而A組與B組同期DSA28的比較發現,A組從第4周起各期DSA28分值均低于B組,且差異均有統計學意義(Plt;0.05)④兩種治療方案不良反應發生情況均低,且兩組不良事件發生率差異無統計學意義。結論:ETA+MTX和LEF+MTX聯合治療重度活動的RA均是安全有效的,其中前者常常可以更早期的達到誘導緩解病情的目的。
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.