Objective To investigate the effectiveness, safety and cost-effectiveness of leflunomide for rheumatoid arthritis, and formulate an evidence-based treatment plan for a patient with rheumatoid arthritis. Methods We searched the ACP Journal Club, The Cochrane Library (Issue 2, 2007) and MEDLINE (1990 to 2007), and critically appraised the available evidence. Results The available Level A (high quality) evidence showed that the efficacy and adverse events of leflunomide were comparable to those of methotrexate. The total cost of treating patients with leflunomide was significantly higher when compared to methotrexate. The combination of leflunomide and methotrexate in patients with active rheumatoid arthritis unresponsive to methotrexate monotherapy was less costly and more effective than the strategy excluding leflunomide. Given the current evidence, together with our clinical experience and the patient’s preference, methotrexate was administered to the patient. There was an inadequate response after 6 months of treatment. And then, adding leflunomide to methotrexate attained a remarkable response 3 months later. The patient is still being followed up. Conclusion treatment with leflunomide and methotrexate in RA patients can improve the clinical outcomes. Long-term efficacy and toxicity remain to be established.
Objective To evaluate the efficacy and safety of Leflunomide (LEF) in the treatment of Rheumatoid Arthritis (RA), so as to provide scientific proof for applying LEF in China. Methods Randomized controlled trials (RCTs) about the effect of LEF on patients with RA from January 1989 to January 2011 were searched from the following databases, CNKI, WanFang Data, MEDLINE, EMbase and CBM. After two reviewers independently screened the studies according to the inclusion and exclusion criteria, extracted the data and assessed the quality, the data were analyzed by RevMan 5.0 software. Results Among 3247 patients in 16 included RCTs, 1711 patients were in the LEF group, while the other 1536 patients were in the Methotrexate (MXT) group. The results of meta-analyses showed there was no significant difference in the efficacy between LEF and MXT (RR=1.03, 95%CI 0.94 to 1.11, Pgt;0.05), but a significant difference was found in the side reaction (RR=0.67, 95%CI 0.49 to 0.94, Plt;0.05). Conclusion Based on the current studies, Leflunomide is as effective as the commonly-used Methotrexate in the treatment of rheumatiod arthritis at present, much safer than Methotrexate, and thought as a safe and effective SAARD. For the quality restrictions of the included studies, more double blind RCTs with high quality are required to further assess the effects.
Objective To assess effectiveness and safety in rheumatoid arthritis （RA）patients treated with the indigenous leflunomide in comparison with Airohua produced by Cinkate Corp. Methods A double blind and double dummy randomized controlled trial was conducted in the outpatient clinic of rheumatology. Fifty-six Chinese RA patients were divided into two groups who received either indigenous Leflunomide or Airohua of 20 mg daily and the two matching placebo tablets of Airohua or indigenous Leflunomide with the constant dose of Oxaprozin （0.4 g, qd） in the first 6 weeks. Clinical and laboratory data were collected every 6 weeks during 24 weeks of follow-up. Results This study showed that the patients of both groups significantly improved on main variables except erythrocyte sedimentation rate （EXR） at the 12th week . The variables such as ESR, and the level of c-reaction protein in both groups at 24th week showed no statistical difference compared with those at the baseline. There were also no statistical difference in the clinical characteristics and laboratory findings between the two groups at the 12th week and 24th week （P 〉0. 05）. The effcacy of Airohua（37% ） was lower than that of indigenous Leflunomide（64% ） at the 12th week （P 〈0. 05 ） and slightly better than indigenous Leflunomide group at the 24 week （81.5% vs 77.3% , （ P 〉0. 05）. The administration of Airohua and indigenous leflunomide presented a similar pattern and frequency of adverse events. Serious adverse events such as interstitial pneumonitis, pulmonary infiltration, and liver impairment etc. were not reported in either group. Conclusions The study shows that the indigenous Leflunomide has a superior therapeutic effect. Its efficacy and safety are similar to Airohua in the treatment of acfive RA patients in China.
目的:观察来氟米特和雷公藤多甙联合治疗重症类风湿关节炎3个月后的疗效及不良反应。 方法:将46例重症类风湿关节炎随机分为治疗组和对照组各23例,治疗组接受国产来氟米特和雷公藤甙联合治疗,对照组接受甲氨喋呤和柳氮磺胺吡啶联合治疗,总疗程均为三个月。观察两组治疗前后各项临床和实验室指标的变化,并比较不良反应发生率。结果:治疗组与对照组比较各项临床和实验室指标的变化量及总有效率均无显著性差异,不良反应发生率亦无显著性差异。结论:国产来氟米特联合雷公藤多甙治疗重症类风湿关节炎安全有效。
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。