甲磺酸阿帕替尼递增式给药治疗晚期胃癌有效性和安全性的系统评价  

Systematic Review of Efficacy and Safety of Apatinib Mesylate in the Treatment of Advanced Gastric Cancer

作　　者：郑子恢[1] 张田 赵紫楠[1] 李琼[1] 李文英[1] 张白歌 马琳[1] 金鹏飞[1] ZHENG Zihui;ZHANG Tian;ZHAO Zinan;LI Qiong;LI Wenying;ZHANG Baige;MA Lin;JIN Pengfei(Dept.of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Gerontology,Chinese Academy of Medical Sciences,Assessment of Clinical Drugs Risk and Individual Application Key Laboratory(Beijing Hospital),Beijing 100730,China)

机构地区：[1]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730

出　　处：《中国医院用药评价与分析》2021年第6期705-710,717,共7页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：北京市自然科学基金(No.7113164)。

摘　　要：目的:系统评价甲磺酸阿帕替尼递增式给药治疗晚期胃癌的有效性和安全性。方法:计算机检索the Cochrane Library、Pub Med、EMBase、中国知网、万方数据库和中国生物医学文献数据库,纳入从建库至2021年2月发表的甲磺酸阿帕替尼递增式给药治疗晚期胃癌的随机对照试验(研究组患者采用递增式给药方案口服甲磺酸阿帕替尼;对照组患者按照药品说明书推荐常规剂量口服甲磺酸阿帕替尼),经文献筛选、提取资料并评价纳入研究的偏倚风险后,采用Rev Man 5.4软件进行荟萃分析(Meta分析)。结果:共纳入6篇文献,包括521例患者(研究组患者261例,对照组患者260例)。Meta分析结果显示,有效性方面,研究组患者的完全缓解率(OR=2.32,95%CI=1.38~3.91,P=0.002)、部分缓解率(OR=1.68,95%CI=1.16~2.43,P=0.006)、缓解率(OR=2.76,95%CI=1.80~4.23,P <0.000 01)、进展率(OR=0.38,95%CI=0.23~0.62,P=0.000 1)和疾病控制率(OR=2.68,95%CI=1.64~4.40,P <0.000 1)均显著优于对照组,差异均有统计学意义;安全性方面,研究组患者的蛋白尿发生率(RD=-0.06,95%CI=-0.12~-0.00,P=0.04)、手足综合征发生率(OR=0.26,95%CI=0.16~0.43,P <0.000 01)、胃肠道反应发生率(OR=0.22,95%CI=0.13~0.37,P <0.000 01)、消化道出血发生率(OR=0.26,95%CI=0.11~0.64,P=0.003)、肝功能异常发生率(RD=-0.07,95%CI=-0.13~-0.01,P=0.02)和高血压发生率(RD=-0.07,95%CI=-0.13~-0.00,P=0.04)均显著低于对照组,差异均有统计学意义。结论:现有证据表明,甲磺酸阿帕替尼递增式给药治疗晚期胃癌安全、有效,较常规给药方式有明显优势。结果证据受纳入研究的数量和质量限制,上述结论有待更多高质量研究予以验证。OBJECTIVE: To systematically evaluate the efficacy and safety of increasing dose of apatinib mesylate in the treatment of advanced gastric cancer. METHODS: The Cochrane Library,Pub Med,EMBase,CNKI,Wanfang database and CBM database were retrieved to collect the randomized controlled trial of increasing dose of apatinib mesylate in the treatment of advanced gastric cancer( the study group received apatinib mesylate orally with an incremental dosing regimen, while the control group was given apatinib mesylate orally at the regular dose recommended in the drug instructions),the retrieval time was from the establishment of the databe to Feb. 2021. After literature screening,data extraction and evaluation of the risk of bias in the included literature,RevMan 5. 4 software was used for Meta-analysis. RESULTS: Totally 6 literature were collected,including 521 patients( with 261 patients in the study group and 260 patients in the control group). Meta-analysis results showed that the complete remission rate( OR = 2. 32,95% CI = 1. 38-3. 91,P = 0. 002) and partial remission rate( OR = 1. 68,95% CI = 1. 16-2. 43,P =0. 006),remission rate( OR = 2. 76,95% CI = 1. 80-4. 23,P < 0. 000 01),progression rate( OR = 0. 38,95% CI =0. 23-0. 62,P = 0. 000 1) and disease control rate( OR = 2. 68,95% CI = 1. 64-4. 40,P < 0. 000 1) in the study group were significantly better than those in the control group,the differences were statistically significant. The incidence of urinary protein( RD =-0. 06,95% CI =-0. 12--0. 00,P = 0. 04),the incidence of hand-foot syndrome( OR =0. 26,95% CI = 0. 16-0. 43,P < 0. 000 01),the incidence of gastrointestinal reaction( OR = 0. 22,95% CI = 0. 13-0. 37,P < 0. 000 01),the incidence of gastrointestinal bleeding( OR = 0. 26,95% CI = 0. 11-0. 64,P = 0. 003),the incidence of abnormal liver function( RD =-0. 07,95% CI =-0. 13--0. 01,P = 0. 02) and the incidence of hypertension( RD =-0. 07,95% CI =-0. 13--0. 00,P = 0. 04) in the study group were significantly lower than those in the control group,and the differe

关 键 词：甲磺酸阿帕替尼 递增式给药 晚期胃癌 META分析 随机对照试验 

分 类 号：R979.1[医药卫生—药品]