蘇金單抗治療風(fēng)濕性關(guān)節(jié)炎有效性和安全性的Meta分析
發(fā)布時(shí)間:2018-06-05 19:22
本文選題:關(guān)節(jié)炎 + 類風(fēng)濕。 參考:《中國全科醫(yī)學(xué)》2017年29期
【摘要】:目的系統(tǒng)評價(jià)蘇金單抗治療風(fēng)濕性關(guān)節(jié)炎(RA)的有效性和安全性。方法計(jì)算機(jī)檢索Pub Med、Medline、EMBase、Web of Science、the Food and Drug Administration(FDA)Website、Clinical Trials Website、Cochrane Library、中國知網(wǎng)、萬方數(shù)據(jù)知識服務(wù)平臺(tái)、維普網(wǎng)等數(shù)據(jù)庫中關(guān)于蘇金單抗治療RA有效性和安全性的隨機(jī)對照試驗(yàn)(RCT),檢索時(shí)間從建庫至2016-08-31。進(jìn)行資料提取及質(zhì)量評價(jià),采用Rev Man 5.2及Stata 12.0軟件對數(shù)據(jù)進(jìn)行Meta分析。結(jié)果共納入6篇RCT,903例患者。Meta分析結(jié)果顯示,蘇金單抗組ACR20率[RR=1.56,95%CI(1.31,1.87),P0.000 01]、ACR50率[RR=2.11,95%CI(1.51,2.93),P0.000 01]、ACR70率[RR=2.75,95%CI(1.39,5.43),P=0.004]較對照組升高。蘇金單抗組疾病活動(dòng)性評分28(DAS28)-C反應(yīng)蛋白(CRP)[加權(quán)均數(shù)差(WMD)=-0.48,95%CI(-0.67,-0.29),P0.000 01]、DAS28-紅細(xì)胞沉降率(ESR)[WMD=-0.43,95%CI(-0.69,-0.16),P=0.001]、健康評估問卷殘疾指數(shù)(HAQ-DI)[WMD=-0.16,95%CI(-0.24,-0.08),P=0.000 1]較對照組降低。蘇金單抗組嚴(yán)重不良反應(yīng)事件發(fā)生率[RR=1.97,95%CI(1.10,3.52),P=0.02]、消化道功能紊亂發(fā)生率[RR=1.81,95%CI(1.15,2.86),P=0.01]較對照組升高。Egger檢驗(yàn)結(jié)果提示,蘇金單抗組與對照組比較,納入研究間不存在發(fā)表偏倚風(fēng)險(xiǎn)(P=0.205)。結(jié)論現(xiàn)有證據(jù)表明蘇金單抗治療RA安全有效。然而,由于納入研究樣本量較小,有必要進(jìn)一步開展高質(zhì)量、大樣本RCT評價(jià)其療效和安全性。
[Abstract]:Objective to evaluate the efficacy and safety of Sujin McAb in the treatment of rheumatoid arthritis (RA). Methods Pub Medline was used to search Pub Medline for randomized controlled trials on the efficacy and safety of Sujin McAb in the treatment of RA. The search time ranged from the construction of the database to 2016-08-31. Rev Man 5.2 and Stata 12.0 were used to analyze the data by Meta. Results the results of meta-analysis showed that the ACR20 rate of the Sujin McAb group [RRRN 1.5695 CIQ 1.31 1.87 P0.00001] ACR50 was higher than that of the control group [RRR2.11995 CI 1.51 + 2.93P0.00001] ACR70 [RRR2.75-95CIT 1.395.43Pn4] was higher than that of the control group (P < 0.05), but it was higher than that of the control group (P < 0.05), and the ACR50 rate was higher than that in the control group. The results showed that the ACR70 rate in the Sujin McAb group was higher than that in the control group (P < 0.05), and the ACR50 rate was higher than that in the control group. The disease activity score of 28(DAS28)-C reaction protein (28(DAS28)-C) in Su Jin McAb group was lower than that in the control group (WMD-0.169CI-0.249CI-0.248CI-0.248P0.0001) [WMD-0.43C95CI-0.69- 0.16P0.001] [WMD-0.1695CI-0.249CI-0.249CI-0.248P0.000000] and the health assessment disability index (HAQ-DI) was lower than that in the control group (WMD-0.1695CI-0.249CI-0.248P0.0001). The incidence of severe adverse events in the Sujin McAb group [RRN 1.97-95CII 1.101.103.52P0. 02], the incidence of gastrointestinal dysfunction [RRRN 1.81CIMA 1.152.86C P0.01] was higher than that in the control group. The results of Egger test showed that there was no risk of publishing bias between the two groups. The results of Egger test showed that there was no risk of publishing bias between the two groups. Conclusion the available evidence shows that Sujin McAb is safe and effective in the treatment of RA. However, due to the small sample size, it is necessary to further develop high quality and large sample RCT to evaluate its efficacy and safety.
【作者單位】: 西南醫(yī)科大學(xué)藥學(xué)院;西南醫(yī)科大學(xué)附屬醫(yī)院藥劑科;西南醫(yī)科大學(xué)臨床醫(yī)學(xué)院;成都外國語學(xué)校;
【分類號】:R593.22
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