【摘要】：[目的]探討與常規(guī)方案相比,強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)者認為要提高患者的生存率,可以使用強化方案進行化療。為此,我們進行本項研究,旨在探討與常規(guī)方案化療相比,強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)庫中的相關(guān)研究。檢索時間為創(chuàng)刊至2016年10月。納入將骨肉瘤強化方案與常規(guī)方案化療進行對比的隨機對照試驗和臨床對照試驗,并對各項研究的循證證據(jù)等級進行評價。從納入的文獻中提取研究對象的特征,干預(yù)措施,隨訪時間,結(jié)局預(yù)后等相關(guān)指標,通過Review Manager 5.3軟件對相關(guān)結(jié)局指標進行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項研究(其中RCT8項,CCT4項),4112例骨肉瘤患者。所有納入的研究均由兩名獨立的研究員采用PEDro質(zhì)量評分標準進行評價,得分在5-8之間。其中11項研究被認為是高質(zhì)量的文獻研究(得分≥6分),1項研究的質(zhì)量相對較低(得分6分)。各項研究在方法學(xué)總體上是無明顯偏倚。Meta分析最終的結(jié)果顯示:強化方案化療組與常規(guī)方案化療組在3年無瘤生存率(OR,1.01; 95% CI,[0.74-1.37]; P=0.97),5 年無瘤生存率(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。對化療藥物的組織反應(yīng)性是腫瘤細胞固有的生物學(xué)特性,與化療劑量和強度無關(guān),目前尚無確切的研究證據(jù)表明使用強化方案化療可以使骨肉瘤患者的遠期生存率得到改善。鑒于強化方案化療會增加患者的毒副作用,且會給患者帶來更大的經(jīng)濟負擔(dān),因此提高骨肉瘤患者的生存率,強化方案似乎不是最佳的選擇。將來的研究重點應(yīng)致力于探索出一種有效的手段對骨肉瘤的敏感性進行調(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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