本文選題：索菲布韋 + 雷迪帕韋��； 參考：《昆明醫(yī)科大學(xué)》2017年碩士論文

【摘要】：[目的]通過(guò)Meta分析對(duì)比索菲布韋、雷迪帕韋聯(lián)合或者不聯(lián)合利巴韋林兩種治療方案對(duì)基因1型慢性丙型肝炎患者的安全性和療效。[方法]選擇 PubMed、SpringerLink、EMBASE、The Cochrane Library、Medline、Science Direct數(shù)據(jù)庫(kù)進(jìn)行檢索,時(shí)間從2013年12月至2016年11月,收集隨機(jī)對(duì)照試驗(yàn)中包含索菲布韋、雷迪帕韋兩聯(lián)組(LED+SOF)以及索菲布韋、雷迪帕韋、利巴韋林三聯(lián)組(LED+SOF+RBV)治療基因1型慢性丙型肝炎(CHC)患者對(duì)比的相關(guān)文獻(xiàn),并收集相關(guān)數(shù)據(jù),進(jìn)行質(zhì)量評(píng)價(jià),使用RevMan 5.0軟件對(duì)其進(jìn)行Meta分析。主要結(jié)局指標(biāo)持續(xù)病毒學(xué)應(yīng)答率(SVR12,既在治療結(jié)束后12周HCVRNA不可測(cè))、不良反應(yīng)發(fā)生率,次要結(jié)局指標(biāo)有病毒反彈和突破率、因不良反應(yīng)引起的停藥率以及5種常見不良反應(yīng)的發(fā)生率。[結(jié)果]納入了 7個(gè)研究,總共包括2626名基因1型CHC患者。1、比較LED+SOF組與LED+SOF+RBV組SVR12無(wú)明顯統(tǒng)計(jì)學(xué)差異(RR=1.00,95%CI 0.99～1.01,P=0.99),在亞組分析中 LED+SOF+RBV 組較 LED+SOF組治療 8 周(RR=1.00,95%CI0.96～1.05,P=0.87)、12 周(RR=0.99,95%CI 0.97～1.01,P=0.53)、24 周(RR=0.99,95%CI0.97～1.01,P=0.49)SVR12 無(wú)明顯升高,聯(lián)合或者不聯(lián)合RBV對(duì)于初治無(wú)肝硬化患者(RR=1.03,95%CI 0.99～1.07,P=0.20)和經(jīng)治有肝硬化患者(RR=0.99,95%CI 0.93～1.05,P=0.66)SVR12無(wú)明顯差異。2、比較LED+SOF組與LED+SOF+RBV組病毒反彈和突破率無(wú)明顯統(tǒng)計(jì)學(xué)差異(RR=1.35,95%CI 0.81～2.25,P=0.25)。在亞組分析中 LED+SOF+RBV 組較LED+SOF 組治療 8 周(RR=1.33,95%CI 0.58～3.02,P=0.50)、24 周(RR=1.51,95%CI0.25～9.05,P=0.65)病毒反彈和突破率無(wú)明顯升高,但LED+SOF組在治療12周的病毒反彈和突破率明顯大于LED+SOF+RBV組(RR=2.32,95%CI 1.02～5.25,P=0.04)。聯(lián)合或不聯(lián)合RBV對(duì)于初治無(wú)肝硬化患者(RR=0.87,95%CI 0.40～1.91,P=0.93)及經(jīng)治伴有肝硬化患者(RR=1.23,95%CI 0.50～3.03,P=0.66)在病毒反彈和突破發(fā)生率上無(wú)明顯差異。3、LED+SOF+RBV組較LED+SOF組不良反應(yīng)發(fā)生率明顯升高(RR=0.88,95%CI0.84～0.92,P=0.00001)。4、LED+SOF+RBV組與LED+SOF組在因不良反應(yīng)引起的停藥率上無(wú)明顯統(tǒng)計(jì)學(xué)差異(RR=0.67,95%CI 0.26-1.70,P=0.40)。5、LED+SOF組在疲乏、惡心、失眠、皮疹發(fā)生率上明顯小于LED+SOF+RBV組(疲乏:RR=0.60,95%CI0.41～0.86,P=0.006;惡心:RR=0.51,95%CI 0.41-0.62,P0.00001;失眠:RR=0.43,95%CI 0.30-0.60,P0.00001;皮疹:RR=0.36,95%CI0.27～0.49,P0.00001),在頭痛的發(fā)生率 LED+SOF 與LED+SOF+RBV治療組之間無(wú)明顯差異(RR=0.77,95%CI 0.59～1.02,P=0.07)。[結(jié)論]1.Meta結(jié)果顯示LED+SOF在治療基因1型慢性丙型肝炎患者的療效并不次于LED+SOF+RBV,且在不同治療時(shí)間、不同治療背景下療效相似,但在治療12周時(shí)加上RBV有利于減少病毒反彈和突破發(fā)生率。2.LED+SOF+RBV組的不良反應(yīng)發(fā)生率明顯高于LED+SOF組。
[Abstract]:[objective] to compare the safety and efficacy of sofebuvir combined with or without ribavirin in patients with chronic hepatitis C type 1 by Meta analysis. [methods] the Cochrane Library Direct database was selected to search the Cochrane Library Direct from December 2013 to November 2016. The randomized controlled trials included Sofibuvir, Redipravir, Sofibuvir and Redipavir. The relative literature of ribavirin triple group in the treatment of chronic hepatitis C type 1 (CHC1) patients was compared, and the relevant data were collected, the quality was evaluated, and Meta was analyzed by RevMan 5.0 software. The main outcome measure was persistent virological response rate (SVR12). After 12 weeks of treatment, HCVRNA was undetectable, the incidence of adverse reactions and secondary outcome indicators were virus rebound and breakthrough rate. The withdrawal rate due to adverse reactions and the incidence of 5 common adverse reactions. [results] included in seven studies, A total of 2626 patients with type 1 CHC were included. There was no significant difference in SVR12 between the LED SOF group and the LED SOF RBV group. In the subgroup analysis, there was no significant increase in RRN 1.00 ~ 95CI0.965P0.8712 weeks in the LED SOF RBV group as compared with that in the LED SOF group. There was no significant difference between RBV combined with or without RBV in the initial treatment of cirrhotic patients with or without liver cirrhosis. There was no significant difference between the two groups. There was no significant difference in the rate of virus rebound and breakthrough between the LED SOF group and the LED SOF RBV group. There was no significant difference in the rate of virus rebound and breakthrough between the LED SOF group and the LED SOF RBV group (RRR1.35 / 95CI 0.81 / 2.25P0. 25) and that in the meridian liver cirrhosis patients (CI 0.931.05 / 95) was not significantly different from that in the control group (P = 0.25), and there was no significant difference between the LED SOF group and the LED SOF RBV group in the rate of virus rebound and breakthrough. In the subgroup analysis, there was no significant increase in the rebound and breakthrough rate of the virus in the LED SOF RBV group compared with that in the LED SOF group at 8 weeks after treatment (CI 0.583.02 ~ 0.50), but the rate of virus rebound and breakthrough in the LED SOF group at 12 weeks was significantly higher than that in the LED SOF RBV group (RRN 2.3295 CI 1.025.250.45). There was no significant difference in the incidence of virus rebound and breakthrough in patients with or without liver cirrhosis treated with or without RBV. The incidence of adverse reactions in the SOF RBV group was significantly higher than that in the LED SOF group. The incidence of adverse reactions in the SOF RBV group was significantly higher than that in the LED SOF group, and the incidence of adverse reactions was significantly higher in the patients with cirrhosis than in the LED SOF group (CI 0.40 1.91P0.93) and the patients with liver cirrhosis treated with CI 0.500.2395% CI 0.503.03P0.66). The incidence of adverse reactions in the 3LED SOF RBV group was significantly higher than that in the LED SOF group. The incidence of adverse reactions in the SOF RBV group was significantly higher than that in the LED SOF group. The incidence of adverse reactions was significantly higher in the SOF RBV group than in the LED SOF group. There was no significant difference between LED SOF group and LED SOF group in drug withdrawal rate caused by adverse reactions. The incidence of nausea, insomnia and rash in the LED SOF RBV group was significantly lower than that in the LED SOF RBV group. There was no significant difference in the incidence of headache between the LED SOF group and the LED SOF RBV treatment group (RR0.7795CI 0.597.95CI 0.30-0.60P0.00001; RRR 0.3795CI 0.300.60P0.00001; the incidence of headache between the LED SOF group and the LED SOF RBV treatment group was 0.59795CI 0.59795CI 0.59795CI 0.592P0.00001). [conclusion] 1.Meta results showed that the efficacy of LED SOF in the treatment of chronic hepatitis C type 1 was not inferior to that of LED SOF RBV,. But after 12 weeks of treatment, the incidence of adverse reactions in LED SOF RBV group was significantly higher than that in LED SOF group.
【學(xué)位授予單位】：昆明醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R512.63

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