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引用本文:黄志平,俞慧群,赵昕,张俊锋,高捷,张幸国,方强.替吉奥治疗胃癌的循证评价[J].中国现代应用药学,2020,37(21):2644-2648.
HUANG Zhiping,YU Huiqun,ZHAO Xin,ZHANG Junfeng,GAO Jie,ZHANG Xingguo,FANG Qiang.Evidence-based Evaluation on Tegafur-gimeracil-oteracil Potassium in the Treatment of Gastric Cancer[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(21):2644-2648.
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替吉奥治疗胃癌的循证评价
黄志平1, 俞慧群2, 赵昕2, 张俊锋2, 高捷2, 张幸国1, 方强1
1.浙江大学医学院附属第一医院, 杭州 310031;2.宁波市北仑区人民医院, 浙江 宁波 315800
摘要:
目的 系统评价替吉奥治疗胃癌合理性。方法 查询国内外替吉奥的最新版药品说明书、权威指南和诊疗规范,收集替吉奥的全部适应证。计算机检索Micromedex、GIN、NGC、PubMed、Dynamed、Uptodate、CBM、CNKI、Epistemonikos、Embase、Cochrane Library、万方数据库,检索时间均限定至2020年1月10日,收集替吉奥治疗胃癌研究文献,对该药治疗胃癌的有效性和安全性进行系统性评价。结果 替吉奥在FDA说明书中提及联合顺铂治疗晚期胃癌,在NMPA说明书提及用于不能切除的局部晚期或转移性胃癌。查询数据库共有5篇指南和8篇系统评价关注了替吉奥治疗胃癌的有效性和安全性。根据指南AGREE II评分,纳入的5篇指南有2篇提及证据级别和推荐级别质量较高,推荐替吉奥用于胃癌D2清扫术后的辅助治疗;3篇质量较低,仅提及替吉奥可用于胃癌辅助化疗。根据AMSTAR评分,纳入的8篇系统评价质量总体为中等,但按照GRADE工具方法,对纳入的系统评价进行结局指标的证据等级评分,结果显示整体证据等级为不高。结论 替吉奥可推荐用于胃癌D2清扫s术后的辅助治疗,在进展期/晚期胃癌患者中,替吉奥疗效尚可,不亚于其他胃癌治疗药物,且化疗相关恶心、呕吐、纳差等胃肠道反应小,骨髓抑制风险低。因此推荐含替吉奥的联合用药方案在进展期/晚期胃癌化疗时优先考虑。
关键词:  替吉奥  胃癌  循证评价
DOI:10.13748/j.cnki.issn1007-7693.2020.21.014
分类号:R969.3
基金项目:全国超说明书用药管理工作项目(中华医学会临床药学分会)
Evidence-based Evaluation on Tegafur-gimeracil-oteracil Potassium in the Treatment of Gastric Cancer
HUANG Zhiping1, YU Huiqun2, ZHAO Xin2, ZHANG Junfeng2, GAO Jie2, ZHANG Xingguo1, FANG Qiang1
1.The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310031, China;2.Beilun District People's Hospital, Ningbo 315800, China
Abstract:
OBJECTIVE To systematically evaluate the rationality of tegafur-gimeracil-oteracil potassium in the treatment of gastric cancer. METHODS Check the latest edition of medicine instruction, the authority of the drug guide and rules of diagnosis and treatment, so as to collect all the indications of tegafur-gimeracil-oteracil potassium. Micromedex, GIN, NGC, PubMed, Dynamed, Uptodate, CBM, CNKI, Epistemonikos, Embase, Cochrane Library and Wanfang database were searched from database foundation to 2020 January 10. Research literatures of tegafur-gimeracil-oteracil potassium in the treatment of gastric cancer were collected and the efficacy and safety of the drug for the treatment of gastric cancer were evaluated systematically. RESULTS Tegafur-gimeracil-oteracil potassium mentioned in the FDA's instructions for the treatment of advanced gastric cancer combined with cisplatin, and NMPA's instructions for the treatment of unresectable local advanced or metastatic gastric cancer. There were 5 guidelines and 8 systematic reviews in the query database, which focused on the efficacy and safety of tegio in the treatment of gastric cancer. According to the AGREE II score of the guidelines, 2 of the 5 included guidelines mentioned the level of evidence and the level of recommendation had high quality, and recommended that tegafur-gimeracil-oteracil potassium be used for adjuvant treatment after D2 gastric cancer resection; 3 were of low quality, only mentioned that tegafur-gimeracil-oteracil potassium could be used for adjuvant chemotherapy of gastric cancer. According to AMSTAR score, the overall quality of the 8 systematic evaluations was moderate, but according to GRADE tool method, the evidence grade of the outcome index of the included systematically evaluation was scored, and the result showed that the overall evidence grade was not high. CONCLUSION Tegafur-gimeracil-oteracil potassium can be recommended as an adjuvant treatment for gastric cancer after D2 dissection. In patients with advanced gastric cancer, tegafur-gimeracil-oteracil potassium is as effective as other gastric cancer drugs. What's more, chemotherapy-related malignant, vomiting, anorexia, and other gastrointestinal reactions are mild, and the risk of bone marrow suppression is low. It is recommended that the combination regimen containing tegafur-gimeracil-oteracil potassium is given priority in chemotherapy for advanced gastric cancer.
Key words:  tegafur-gimeracil-oteracil potassium  gastric cancer  evidence-based evaluation
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