【摘要】：[目的]探討與常規(guī)方案相比,強(qiáng)化方案化療是否能夠改善骨肉瘤患者的預(yù)后。[背景]20世紀(jì)80年代末,骨肉瘤患者的生存率隨新輔助化療在臨床中廣泛的推廣應(yīng)用而得到了極大的改善。目前在骨肉瘤治療方面雖然有很多臨床和基礎(chǔ)研究,但其療效卻沒有取得較大的改善和突破。部分學(xué)者認(rèn)為要提高患者的生存率,可以使用強(qiáng)化方案進(jìn)行化療。為此,我們進(jìn)行本項(xiàng)研究,旨在探討與常規(guī)方案化療相比,強(qiáng)化方案化療是否能夠改善骨肉瘤患者的預(yù)后。[方法]檢索 MEDLINE/PubMed,EMBASE,OVID,BIOSIS Previews,and Cochrane等數(shù)據(jù)庫(kù)中的相關(guān)研究。檢索時(shí)間為創(chuàng)刊至2016年10月。納入將骨肉瘤強(qiáng)化方案與常規(guī)方案化療進(jìn)行對(duì)比的隨機(jī)對(duì)照試驗(yàn)和臨床對(duì)照試驗(yàn),并對(duì)各項(xiàng)研究的循證證據(jù)等級(jí)進(jìn)行評(píng)價(jià)。從納入的文獻(xiàn)中提取研究對(duì)象的特征,干預(yù)措施,隨訪時(shí)間,結(jié)局預(yù)后等相關(guān)指標(biāo),通過(guò)Review Manager 5.3軟件對(duì)相關(guān)結(jié)局指標(biāo)進(jìn)行Meta分析,相關(guān)結(jié)果經(jīng)全面分析討論后得出最終結(jié)論。[結(jié)果]共納入12項(xiàng)研究(其中RCT8項(xiàng),CCT4項(xiàng)),4112例骨肉瘤患者。所有納入的研究均由兩名獨(dú)立的研究員采用PEDro質(zhì)量評(píng)分標(biāo)準(zhǔn)進(jìn)行評(píng)價(jià),得分在5-8之間。其中11項(xiàng)研究被認(rèn)為是高質(zhì)量的文獻(xiàn)研究(得分≥6分),1項(xiàng)研究的質(zhì)量相對(duì)較低(得分6分)。各項(xiàng)研究在方法學(xué)總體上是無(wú)明顯偏倚。Meta分析最終的結(jié)果顯示:強(qiáng)化方案化療組與常規(guī)方案化療組在3年無(wú)瘤生存率(OR,1.01; 95% CI,[0.74-1.37]; P=0.97),5 年無(wú)瘤生存率(OR, 1.00; 95% CI,[0.86-1.17]; P=0.97),5 年總生存率(OR, 1.04; 95% CI,[0.87-1.26]; P=0.64)及組織學(xué)反應(yīng)良好者所占的比率(OR, 1.12; 95% CI,[0.78-1.60]; P=0.55)上無(wú)明顯差異。數(shù)據(jù)的匯集分析結(jié)果顯示與常規(guī)方案化療組相比,強(qiáng)化方案化療組患者的局部復(fù)發(fā)率較低(OR,0.60; 95% CI,[0.42-0.85]; P=0.004)。[結(jié)論]輔助化療的應(yīng)用使骨肉瘤患者的預(yù)后得到了極大的改善。對(duì)化療藥物的組織反應(yīng)性是腫瘤細(xì)胞固有的生物學(xué)特性,與化療劑量和強(qiáng)度無(wú)關(guān),目前尚無(wú)確切的研究證據(jù)表明使用強(qiáng)化方案化療可以使骨肉瘤患者的遠(yuǎn)期生存率得到改善。鑒于強(qiáng)化方案化療會(huì)增加患者的毒副作用,且會(huì)給患者帶來(lái)更大的經(jīng)濟(jì)負(fù)擔(dān),因此提高骨肉瘤患者的生存率,強(qiáng)化方案似乎不是最佳的選擇。將來(lái)的研究重點(diǎn)應(yīng)致力于探索出一種有效的手段對(duì)骨肉瘤的敏感性進(jìn)行調(diào)控,或者研發(fā)新療效顯著且毒性溫和的藥物,在今后的臨床工作中,盡可能為患者選擇最佳,最有效的藥物,根據(jù)具體情況制定個(gè)體化化療方案,才能在骨肉瘤的生存率和生活質(zhì)量方面取得突破。
[Abstract]:Objective: to investigate whether intensive chemotherapy can improve the prognosis of osteosarcoma patients. Background: in the late 1980s, the survival rate of osteosarcoma patients improved greatly with the extensive application of neoadjuvant chemotherapy in clinical practice. Although there are many clinical and basic researches in the treatment of osteosarcoma, the curative effect has not been improved. Some scholars believe that intensive chemotherapy can be used to improve the survival rate of patients. Therefore, we conducted this study to investigate whether intensive regimen chemotherapy can improve the prognosis of patients with osteosarcoma compared with conventional regimen chemotherapy. [methods] the relevant research in MEDLINE/PubMed,EMBASE,OVID,BIOSIS Previews,and Cochrane and other databases was searched. The search time is from inception to October 2016. A randomized controlled trial and a clinical controlled trial were included to compare the enhanced osteosarcoma regimen with the conventional regimen, and the evidence-based evidence levels of each study were evaluated. The characteristics, intervention measures, follow-up time, outcome prognosis and other related indicators were extracted from the included literature. The final conclusions were obtained by Meta analysis of the relevant outcome indicators by Review Manager 5.3 software. [results] A total of 4112 patients with osteosarcoma were included in 12 studies (including RCT8 item CCT 4). All of the included studies were evaluated by two independent researchers using the PEDro quality score, with scores ranging from 5 to 8. Eleven of these studies were considered high quality literature studies (score 鈮，

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