沙利度胺联合常规化疗用于晚期胃癌有效性与安全性的Meta分析
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篇名: 沙利度胺联合常规化疗用于晚期胃癌有效性与安全性的Meta分析
TITLE:
摘要: 目的:系统评价沙利度胺联合常规化疗用于晚期胃癌的有效性与安全性,为临床用药提供循证参考。方法:计算机检索PubMed、Embase、Cochrane 图书馆、中国期刊全文数据库、万方数字化期刊全文数据库、维普中文科技期刊数据库,收集沙利度胺联合常规化疗(观察组)对比常规化疗(对照组)用于晚期胃癌的随机对照试验(RCT),筛选文献、提取资料并按Cochrane系统评价员手册5.0风险评估工具评价文献质量后,采用Rev Man 5.3统计软件进行Meta分析。采用GRADE证据质量分级系统对结局指标的证据质量进行评价。结果:共纳入13项研究,共计761例患者。Meta分析结果显示,观察组患者总有效率[OR=1.72,95%CI(1.29,2.31),P=0.000 2]、完全缓解率[OR=1.90,95%CI(1.05,3.44),P=0.03]、疾病控制率[OR=2.66,95%CI(1.92,3.68),P<0.001]、生存质量改善率[OR=3.09,95%CI(1.82,5.24),P<0.001]、便秘发生率[OR=2.64,95%CI(1.74,4.01),P<0.001]均显著高于对照组,疾病进展率[OR=0.39,95%CI(0.28,0.54),P<0.001]、恶心呕吐发生率[OR=0.32,95%CI(0.18,0.56),P<0.001]均显著低于对照组。GRADE证据质量评价结果显示,总有效率、完全缓解率及白细胞减少、血小板减少、血红蛋白减少、肝功能异常发生率为高级证据推荐,疾病控制率为中级证据推荐,疾病进展率及周围神经炎、恶心呕吐、腹泻、便秘、手足综合征发生率为低级证据推荐,生存改善率为极低级证据推荐。结论:沙利度胺联合常规化疗用于晚期胃癌的疗效显著,可改善患者的生存质量,但可增加便秘的发生风险。
ABSTRACT: OBJECTIVE: To systematically evaluate the efficacy and safety of thalidomide combined with conventional chemotherapy in the treatment of advanced gastric cancer, and to provide evidence-based reference for clinical drug use. METHODS: Retrieved from PubMed, Embase, Cochrane library, CNKI, Wanfang database and VIP, RCTs about thalidomide combined with conventional chemotherapy (observation group) vs. conventional chemotherapy (control group) in the treatment of advanced gastric cancer were collected. After data extraction and quality evaluation of included literatures with Cochrane system evaluator manual 5.0 risk evaluation tool, Meta-analysis was conducted by using Rev Man 5.3 statistical software. The evidence qualities of outcome indexes were evaluated by using Grade evidence quality classification system. RESULTS: A total of 13 studies were included, involving 761 patients. Results of Meta-analysis showed that the total response rate [OR=1.72, 95%CI(1.29,2.31),P=0.000 2], complete remission rate [OR=1.90,95%CI(1.05,3.44),P=0.03], disease control rate [OR=2.66, 95%CI(1.92,3.68),P<0.001], improvement rate of survival quality [OR=3.09, 95%CI(1.82,5.24),P<0.001] and the incidence of constipation [OR=2.64, 95%CI(1.74,4.01),P<0.001] of observation group were significantly higher than those of control group, while disease progression rate [OR=0.39, 95%CI (0.28,0.54), P<0.001] and the incidence of nausea and vomiting [OR=0.32, 95%CI(0.18,0.56), P<0.001] of observation group were significantly lower than those of control group. Results of quality evaluation of Grade evidence showed that total response rate, complete remission rate, the incidence of leucopenia, thrombocytopenia, hemoglobin reduction and liver dysfunction were recommended for advanced evidence. Disease control was recommended for moderate-level evidence. The incidence of disease progression, peripheral neuritis, nausea and vomiting, diarrhea, constipation and hand-foot syndrome were recommended for low-level evidence. Improvement rate of survival was recommended for very low-level evidence. CONCLUSIONS: Thalidomide combined with conventional chemotherapy show significant therapeutic efficacy for advanced gastric cancer, can improve the quality of life but increase the risk of constipation.
期刊: 2019年第30卷第6期
作者: 张晓栋,白少雄,单贵刚,郭建昇
AUTHORS: ZHANG Xiaodong,BAI Shaoxiong,SHAN Guigang,GUO Jiansheng
关键字: 胃癌;晚期;常规化疗;沙利度胺;有效性;安全性;Meta分析
KEYWORDS: Gastric cancer; Advanced; Conventional chemotherapy; Thalidomide; Efficacy; Safety; Meta-analysis
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