本文選題：來(lái)氟米特 + 甲氨蝶呤　； 參考：《福建醫(yī)科大學(xué)》2015年碩士論文

【摘要】：目的通過分析關(guān)于來(lái)氟米特與甲氨蝶呤聯(lián)合治療類風(fēng)濕性關(guān)節(jié)炎的臨床療效和安全性的隨機(jī)對(duì)照試驗(yàn),以期尋找高療效、低副反應(yīng)的聯(lián)合治療方案,為臨床治療提供依據(jù)。方法以類風(fēng)濕關(guān)節(jié)炎、來(lái)氟米特、甲氨蝶呤、隨機(jī)對(duì)照試驗(yàn)為關(guān)鍵詞(Rheumatoid Arthritis AND Leflunomide AND Methotrexate AND randomized controlled trials)在Pubmed、CNKI、萬(wàn)方、維普數(shù)據(jù)庫(kù)檢索自開庫(kù)~2014.12有關(guān)來(lái)氟米特聯(lián)合甲氨蝶呤治療類風(fēng)濕關(guān)節(jié)炎的隨機(jī)對(duì)照試驗(yàn)(RCT)。按照納入與排除標(biāo)準(zhǔn)進(jìn)行文獻(xiàn)篩選。對(duì)篩選得文獻(xiàn)進(jìn)行資料提取和質(zhì)量評(píng)價(jià)。采用Q檢驗(yàn)及異質(zhì)性定量分析對(duì)納入研究進(jìn)行異質(zhì)性分析,以ACR20、ACR50、ACR70達(dá)到率及改善率等為療效觀察指標(biāo),采用Rev Man5.2版軟件選擇對(duì)應(yīng)模型進(jìn)行Meta分析。結(jié)果所納入7項(xiàng)RCT試驗(yàn)合計(jì)716例,其中試驗(yàn)組(LEF+MTX)357例,對(duì)照組(MTX)359例。7項(xiàng)RCT質(zhì)量評(píng)價(jià)示除1篇外文文獻(xiàn)評(píng)價(jià)為7分高質(zhì)量文獻(xiàn)外,其余6篇納入文獻(xiàn)屬1-3分的低質(zhì)量文獻(xiàn)。Meta分析結(jié)果顯示治療6月后療效達(dá)ACR20的達(dá)到率上試驗(yàn)組與對(duì)照組差異有統(tǒng)計(jì)學(xué)意義[RR=1.75,95%CI(1.47,2.09),P0.00001];療效達(dá)ACR50差異有統(tǒng)計(jì)學(xué)意義[RR=1.86,95%CI(1.11,3.12),P=0.02];療效達(dá)ACR70差異有統(tǒng)計(jì)學(xué)意義[RR=2.96,95%CI(1.55,5.65),P=0.001];療效達(dá)改善以上的差異有統(tǒng)計(jì)學(xué)意義[RR=1.21,95%CI(1.05,1.39),P=0.008]。6項(xiàng)RCT詳細(xì)報(bào)道了副反應(yīng)發(fā)生情況,在副反應(yīng)發(fā)生率方面兩組差異無(wú)統(tǒng)計(jì)學(xué)意義[RR=1.03,95%CI(0.92,1.15),P=0.64]。敏感性分析示該評(píng)價(jià)系統(tǒng)穩(wěn)定性較好。結(jié)論由meta分析結(jié)果可知,LEF聯(lián)合MTX治療類風(fēng)濕性關(guān)節(jié)與單用MTX相比,在達(dá)到ACR20、ACR50、ACR70及達(dá)到改善的達(dá)到率上均優(yōu)于單用MTX。而在副反應(yīng)發(fā)生率方面兩組相當(dāng)。但由于本次meta分析受樣本量的限制、納入文獻(xiàn)質(zhì)量偏低及發(fā)表偏倚等的影響,對(duì)于應(yīng)用來(lái)氟米特與甲氨蝶呤聯(lián)合治療類風(fēng)濕性關(guān)節(jié)炎這一治療方案的療效仍需要設(shè)計(jì)更多隨機(jī)雙盲的藥物臨床試驗(yàn)來(lái)加以佐證,特別是具有較大樣本量的,由多中心聯(lián)合的隨機(jī)雙盲藥物臨床試驗(yàn)來(lái)加以驗(yàn)證。
[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.
【學(xué)位授予單位】：福建醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2015
【分類號(hào)】：R593.22

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