大剂量甲氨蝶呤不同输注方案治疗骨肉瘤疗效和安全性的Meta分析
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篇名: 大剂量甲氨蝶呤不同输注方案治疗骨肉瘤疗效和安全性的Meta分析
TITLE:
摘要: 目的:系统评价大剂量(>500 mg/m2)甲氨蝶呤不同输注方案治疗骨肉瘤的疗效和安全性,为临床治疗提供循证参考。方法:计算机检索Medline、Embase、clinicaltrials.gov、中国期刊全文数据库、万方数据和中国生物医学文献数据库,检索时限为自建库起至2018年3月纳入大剂量甲氨蝶呤不同输注方案(不同剂量和输注时间)治疗骨肉瘤的疗效和安全性的观察性研究和随机/非随机对照试验,进行资料提取并采用纽卡斯尔-渥太华量表、Cochrane系统评价员手册5.1.0和非随机对照试验方法学评价指标进行质量评价后,采用Rev Man 5.3软件对血药浓度(c)、相关毒性(如肝毒性发生率、血液毒性发生率)进行Meta分析或描述性分析。结果:共纳入5项研究,合计310例患者。Meta分析结果显示,8 g/m2组患者c0 h[MD=-240.11,95%CI(-271.47,-208.75),P<0.001]、c24 h[MD=-0.09,95%CI(-0.11,0.08),P<0.001]、c48 h[MD=-0.07,95%CI(-0.10,-0.05),P<0.001]、c72 h[MD=  -0.05,95%CI (-0.06,-0.03),P<0.001]以及肝毒性发生率[OR=0.26,95%CI(0.10,0.67),P<0.005]均显著低于10 g/m2组患者;描述性分析结果显示,均给予8 g/m2时,输注时间为2、4 h患者的c24 h显著低于输注6 h患者,8 g/m2组患者白细胞减少和血小板减少的发生率显著低于10 g/m2组患者。结论:用大剂量甲氨蝶呤治疗骨肉瘤时,适当降低给药剂量(如8 g/m2)和适当延长输注时间(如6 h)可能获得较理想的疗效和安全性。
ABSTRACT: OBJECTIVE: To systematically evaluate the efficacy and safety for different infusion schemes of large-dose (>500 mg/m2) of methotrexate in the treatment of osteosarcoma, and to provide evidence-based reference for clinical treatment. METHODS: Retrieved from Medline, Embase, clinicaltrials.gov, CJFD, Wanfang database and CBM database, observational studies and randomized/non-randomized controlled trials about therapeutic efficacy and safety for different infusion schemes (different doses and infusion time) of large-dose of methotrexate in the treatment of osteosarcoma were included during the establishment of the database to Mar. 2018. After data extraction and quality evaluation with methodological evaluation index of the Newcastle-Ottawa scale, Cochrane 5.1.0 bias risk evaluation tool and non-randomized controlled trials, Meta-analysis or descriptive analysis for blood drug concentration (c), related toxicity (e.g. incidence of hepatotoxicity, incidence of hemotoxicity) were performed by using Rev Man 5.3 software. RESULTS: Totally 5 studies were included, involving 310 cases. Results of Meta-analyses indicated c0 h [MD=-240.11, 95%CI(-271.47, -208.75), P<0.001], c24 h [MD=-0.09, 95%CI (-0.11, 0.08), P<0.001], c48 h [MD=-0.07, 95%CI (-0.10, -0.05), P<0.001], c72 h [MD=-0.05, 95%CI (-0.06, -0.03), P<0.001] and the incidence of liver toxicity [OR=0.26, 95%CI (0.10, 0.67), P<0.005] in 8 g/m2 group were significantly lower than 10 g/m2 group. Results of descriptive analysis showed that when both groups were given 8 g/m2, c24 h of patients with 2 and 4 h infusion time was significantly lower than that of patients with 6 h infusion time. The incidence of leukopenia and thrombo- cytopenia in 8 g/m2 group was significantly lower than 10 g/m2 group. CONCLUSIONS: In the treatment of osteosarcoma with high-dose of methotrexate, appropriate dosage reduction (e.g. 8 g/m2) and appropriate prolongation of infusion time   (e.g. 6 h) may lead to a better efficacy and safety.
期刊: 2019年第30卷第13期
作者: 黄振城,宋再伟,赵荣生
AUTHORS: HUANG Zhencheng,SONG Zaiwei,ZHAO Rongsheng
关键字: 大剂量;甲氨蝶呤;骨肉瘤;输注方案;疗效;安全性;Meta分析
KEYWORDS: High-dose; Methotrexate; Osteosarcoma; Infusion schemes; Efficacy; Safety; Meta-analysis
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