肿瘤靶向药物不良反应发生率的Meta分析

Meta-Analysis of the Incidence of Adverse Reactions to Tumor-targeted Drugs

目的探讨肿瘤患者使用靶向药物治疗后引发的不良反应发生率。方法从建库至2020年7月1日检索中国期刊全文数据库、中文期刊全文数据库、万方数据知识服务平台等数据库,获取现有的不同类型肿瘤靶向药物及不良反应发生率的相关文献,根据纳入和排除标准选取临床研究文献,采用ReviewManager 5.3软件对肿瘤靶向药物不良反应发生率进行Meta分析。结果共检索出相关文献568篇,通过浏览标题和摘要后筛选68篇文献精读,剔除重复研究和与结局指标无关的文献,最终纳入文献8篇,其中共568例受试者接受过药物不良反应评价。采用Cochrane风险偏倚评估工具对纳入的文献进行风险评估,本研究中偏倚检测提示无显著偏倚。Meta分析结果显示,分别有3篇文献、7篇文献、7篇文献的临床结局涉及到恶心呕吐、腹泻、皮肤不良反应,各结局研究间的异质性较显著,I2值分别为66%、53%、64%,故以随机效应模型(random effects models,REM)进行合并。Meta分析结果显示,上述结局合并发生率及其95%置信区间(95%CI)分别为7.26(2.94~17.91)、1.00(0.74~1.36)、1.01(0.76~1.33)。结论靶向药物可引发一定占比的肿瘤患者发生药物不良反应,应重视肿瘤靶向药物治疗引发的不良反应并对其严重性进行有效评估,提高肿瘤患者的生命质量和治疗依从性,继而提升疗效。

Objective To explore the incidence of adverse reactions induced by targeted drug therapy in tumor patients. Methods From the establishment of the database to July 1, 2020, Chinese periodicals full-text database, Chinese periodicals full-text database, Wanfang Data Knowledge Service Platform and other databases were searched to obtain existing literature on the incidence of different types of tumor-targeted drugs and adverse reactions. According to the inclusion and exclusion criteria, clinical research literature was selected, and the ReviewManager 5.3 software was used to conduct a Meta analysis of the incidence of tumor-targeted drug adverse reactions. Results A total of 568 related literature were searched, 68 literature were selected for intensive reading after reviewing the titles and abstracts, and repeated studies and literature unrelated to outcome indexes were excluded. Finally, a total of 8 literature were included, among which 568 subjects had received adverse drug reaction evaluation. The Cochrane risk bias assessment tool was used to assess the risk of the included literature, and the bias test in this study indicated that there was no significant bias. Meta-analysis results showed that there were 3 literature, 7 literature, and 7 literature with clinical outcomes related to nausea, vomiting, diarrhea, and skin adverse reactions. The heterogeneity among the outcome studies was significant, with I2 values of 66%, 53% and 64%, so random effects models(REM) were used for consolidation. The results of Meta analysis showed that the combined incidence of the above-mentioned outcomes and its 95% confidence interval(95% CI) were 7.26(2.94-17.91), 1.00(0.74-1.36), and 1.01(0.76-1.33), respectively. Conclusion From the Meta analysis in this paper, it is known that targeted drugs can cause a certain proportion of tumor patients to have adverse drug reactions. The adverse reactions caused by tumor targeted drug therapy should be paid attention to and their severity should be effectively evaluated to improve the quality of life of cancer patients, to improve the quality of life and treatment compliance of cancer patients, and then improve the efficacy.