来氟米特与甲氨蝶呤联合治疗类风湿性关节炎的Meta分析

发布时间：2018-06-11 11:22

  本文选题：来氟米特 + 甲氨蝶呤　； 参考：《福建医科大学》2015年硕士论文

【摘要】：目的通过分析关于来氟米特与甲氨蝶呤联合治疗类风湿性关节炎的临床疗效和安全性的随机对照试验,以期寻找高疗效、低副反应的联合治疗方案,为临床治疗提供依据。方法以类风湿关节炎、来氟米特、甲氨蝶呤、随机对照试验为关键词(Rheumatoid Arthritis AND Leflunomide AND Methotrexate AND randomized controlled trials)在Pubmed、CNKI、万方、维普数据库检索自开库~2014.12有关来氟米特联合甲氨蝶呤治疗类风湿关节炎的随机对照试验(RCT)。按照纳入与排除标准进行文献筛选。对筛选得文献进行资料提取和质量评价。采用Q检验及异质性定量分析对纳入研究进行异质性分析,以ACR20、ACR50、ACR70达到率及改善率等为疗效观察指标,采用Rev Man5.2版软件选择对应模型进行Meta分析。结果所纳入7项RCT试验合计716例,其中试验组(LEF+MTX)357例,对照组(MTX)359例。7项RCT质量评价示除1篇外文文献评价为7分高质量文献外,其余6篇纳入文献属1-3分的低质量文献。Meta分析结果显示治疗6月后疗效达ACR20的达到率上试验组与对照组差异有统计学意义[RR=1.75,95%CI(1.47,2.09),P0.00001];疗效达ACR50差异有统计学意义[RR=1.86,95%CI(1.11,3.12),P=0.02];疗效达ACR70差异有统计学意义[RR=2.96,95%CI(1.55,5.65),P=0.001];疗效达改善以上的差异有统计学意义[RR=1.21,95%CI(1.05,1.39),P=0.008]。6项RCT详细报道了副反应发生情况,在副反应发生率方面两组差异无统计学意义[RR=1.03,95%CI(0.92,1.15),P=0.64]。敏感性分析示该评价系统稳定性较好。结论由meta分析结果可知,LEF联合MTX治疗类风湿性关节与单用MTX相比,在达到ACR20、ACR50、ACR70及达到改善的达到率上均优于单用MTX。而在副反应发生率方面两组相当。但由于本次meta分析受样本量的限制、纳入文献质量偏低及发表偏倚等的影响,对于应用来氟米特与甲氨蝶呤联合治疗类风湿性关节炎这一治疗方案的疗效仍需要设计更多随机双盲的药物临床试验来加以佐证,特别是具有较大样本量的,由多中心联合的随机双盲药物临床试验来加以验证。
[Abstract]:Objective to investigate the clinical efficacy and safety of leflunomide combined with methotrexate in the treatment of rheumatoid arthritis (RA). Methods rheumatoid arthritis, leflunomide, methotrexate, and rheumatoid Arthritis and methotrexate randomized controlled trials) were used as the key words in the pubmeda, CNKI, Wanfang, Wan-fang. A randomized controlled trial of leflunomide combined with methotrexate in the treatment of rheumatoid arthritis on April 12, 2014 was searched in Wiper database. According to the inclusion and exclusion criteria for literature screening. Data extraction and quality evaluation were carried out on the selected literature. Q test and quantitative analysis of heterogeneity were used to analyze the heterogeneity of the inclusion study. The ACR20 / ACR50 / ACR70 achievement rate and the improvement rate were taken as the therapeutic observation indexes, and the corresponding model was selected for Meta-analysis with the software Rev Man5.2. Results A total of 716 cases were included in 7 RCT tests, among which there were 357 cases of Lef MTX in the experimental group and 359 cases in the control group. The results of meta-analysis showed that there was a significant difference between the experimental group and the control group in ACR20 reaching rate after 6 months of treatment [RRR 1.755 ~ 95 CI 1.472.09m P0.00001], ACR50 was significantly different [RR1.8695CII 1.113.12P0.02], and there was no significant difference between the experimental group and the control group (P < 0.05). The results showed that there was a significant difference in ACR50 effect between the experimental group and the control group [RRR1.86995CI1.113.12P0.02], and the results showed that there was a significant difference between the experimental group and the control group. The difference of ACR70 was statistically significant [RRN 2.96 ~ 95CI 1.55 ~ 5.65% P0. 001], but there was significant difference in the improvement of curative effect [RRN 1.21 ~ 95CIN 1.05 ~ 1.39 P0. 008] .6 items of RCT reported the occurrence of side effects in detail. There was no significant difference in the incidence of side effects between the two groups. Sensitivity analysis shows that the stability of the evaluation system is good. Conclusion the results of meta analysis show that Lef combined with MTX in the treatment of rheumatoid joints is better than that of MTX alone in achieving ACR20 ACR50 ACR70 and improving the rate of ACR70. The incidence of side effects was similar between the two groups. However, due to the limitation of sample size in this meta analysis, the low quality of literature and publication bias were included in the analysis. The efficacy of a combination of flunomide and methotrexate in the treatment of rheumatoid arthritis still needs to be supported by more randomized, double-blind drug trials, especially those with large sample sizes. It was validated by a multicenter combined randomized double blind drug clinical trial.
【学位授予单位】：福建医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R593.22

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