卡培他滨超说明书用药治疗胰腺癌的指南质量评价

Quality assessment on clinical practice guidelines for off-label drug use of capecitabine for treatment of pancreatic cancer

目的:使用指南研究与评价工具AGREEⅡ评价卡培他滨超说明书用药用于治疗胰腺癌的指南,为临床治疗胰腺癌提供相关依据。方法:制定卡培他滨治疗胰腺癌指南的纳入标准和检索策略,检索Epistemonikos、PubMed、Embase、Cochrane Library、美国国立指南文库(NGC)、CBM、万方和CNKI等数据库。按纳入标准纳入有关卡培他滨治疗胰腺癌的指南,提取和描述指南AGREEⅡ评价信息,使用AGREEⅡ评价纳入指南质量,使用组内相关系数(ICC)进行评价员间一致性检验。分析比较不同指南推荐内容的共识和差异。结果:共纳入6篇指南,分别来自美国、中国、欧洲、西班牙。检索时限为建库到2018年3月20日。指南质量经AGREEⅡ评价评分显示:6大领域(范围和目的、制定指南的参与人员、制定的严谨性、清晰性与可读性、应用性、编辑的独立性)的平均分分别为54%,22.67%,21.67%,55.5%,12.17%,27.33%。结论:纳入研究的卡培他滨治疗胰腺癌的超说明书用药相关指南证据等级较低,整体质量有待提高。不建议将卡培他滨用于胰腺癌的治疗,临床如需使用,建议签署知情同意书后使用。

OBJECTIVE The aim of this study was to assess the quality of clinical practice guidelines for off-label drug use of capecitabine for treatment of pancreatic cancer by using the Appraisal of Guidelines for Research and EvaluationⅡ(AGREEⅡ)instrument,and to provides relevant evidence for the clinical treatment of pancreatic cancer.METHODS The inclusion criteria and the search strategy for guidelines for clinical treatment of pancreatic cancer were established;and then,Epistemonikos,PubMed,Embase,Cochrane Library,CBM,Wanfang and CNKI database were searched.The related guidelines of capecitabine for treatment of pancreatic cancer were included under the established inclusion criteria,and the information on the AGREEⅡinstrument for the guidelines were extracted and described.Subsequently,quality of the included guidelines was assessed with the AGREEⅡinstrument,and inter-assessor consistency was tested through intraclass correlation coefficient(ICC).The consensus and difference between the contents recommended in the various guidelines were analyzed.RESULTS A total of 6 guidelines identified from the United States,China,Europe,Spain was included.Each database retrieval time is limited to March 20,2018.The AGREEⅡinstrument rated them among 6 domains(scope and purpose,participants,guideline rigorousness,clarity,readability,applicability and independence)in which average scores were 54%,22.67%,21.67%,55.5%,12.17%and 27.33%,respectively.CONCLUSION The guidelines for off-label drug use of capecitabine for treatment of pancreatic cancer included in this study has a low level of evidence,and their overall quality is still to be improved.Capecitabine is not recommended for treatment of pancreatic cancer,and so,if clinically necessary,we suggest the it should be used after signing a patient’s written informed consent.