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Received:February 11, 2023 Published Online:June 20, 2023
Received:February 11, 2023 Published Online:June 20, 2023
中文摘要: 目的 采用Meta分析方法对安罗替尼治疗广泛期小细胞肺癌（ES-SCLC）的疗效及安全性进行系统评价。 方法 检索PubMed、Embase、Cochrane Library、知网、万方、维普、中国生物医学文献数据库，查阅自建库至2022年11月公开发表的研究安罗替尼治疗ES-SCLC的全部文献。由另外2名研究员负责独立按照纳排标准进行筛选文献和提取资料后,使用RevMan 5.4软件进行数据的Meta分析。 结果 共纳入6项随机对照试验进行分析研究，合计302例患者。Meta分析提示安罗替尼能明显延长ES-SCLC的无进展生存期（HR=0.12，95%CI：0.07~0.21，P<0.01），提高客观缓解率（RR=1.48，95%CI：1.15~1.91，P<0.01），改善KPS评分（MD=9.18，95%CI：4.35~14.02，P<0.01），降低NSE值（MD=-8.20，95%CI：-9.15~-7.25，P<0.01）。安全性方面：安罗替尼组相较于对照组，不良反应发生风险增高，但差异无统计学意义（RR=1.11，95%CI：0.91~1.35，P=0.31），高血压发生率（RR=6.63，95%CI：2.44~16.44，P<0.01）及皮疹发生率（RR=3.55，95%CI：1.43~8.78，P<0.01）均高于对照组；其余不良反应如乏力（RR=1.06，95%CI：0.74~1.52，P=0.74）、腹泻（RR=2.28，95%CI：0.56~9.24，P=0.25）、蛋白尿（RR=1.75，95%CI：0.53~5.73，P=0.36）两组比较差异均无统计学意义。 结论 与安慰剂或空白对照相比，安罗替尼能提高ES-SCLC患者的远期生存和近期疗效，改善生活质量，降低NSE值，其发生高血压及皮疹的风险较高，其余一些不良反应如乏力、腹泻、蛋白尿的发生率与安慰剂/空白对照组相近，患者总体用药耐受程度较好。
中文关键词: 安罗替尼 小细胞肺癌, 广泛期 酪氨酸激酶抑制剂 神经元特异性烯醇化酶 高血压 皮疹
Abstract:Objective To systematically evaluate the efficacy and safety of anlotinib in the treatment of extensive-stage small cell lung cancer (ES-SCLC) by meta-analysis. Methods PubMed, Embase, Cochrane Library, CNKI, Wanfang Data, VIP Database, China Biology Medicine disc were searched for the full literature on studies of anlotinib for the treatment of ES-SCLC published from database establishment to November 2022. Other 2 investigators were responsible for screening the literature and extracting data independently according to the inclusion and exclusion criteria. Revman 5.4 software was used for meta-analysis of the data. Results A total of 6 RCTs were included for analysis studies, with a total of 302 patients. Meta analysis suggested that anlotinib significantly prolonged progression free survival of ES-SCLC (HR=0.12, 95%CI: 0.07 to 0.21, P<0.01) , improved objective response rate (RR=1.48, 95%CI: 1.15 to 1.91, P<0.01) , improved KPS score (MD=9.18, 95%CI: 4.35 to 14.02, P<0.01) , and decreased neuron-specific enolase (NSE) value (MD=-8.20, 95%CI: -9.15 to -7.25, P<0.01) . Compared to control group, the anlotinib group was associated with a higher risk of adverse events (RR=1.11, 95%CI: 0.91 to 1.35, P=0.31) , but without significant difference, while the incidence of hypertension (RR=6.63, 95%CI: 2.44 to 16.44, P<0.01) and rash (RR=3.55, 95%CI: 1.43 to 8.78, P<0.01) increased in anlotinib group. There was no significant difference in the remaining adverse effects, such as fatigue (RR=1.06, 95%CI: 0.74 to 1.52, P=0.74) , diarrhea (RR=2.28, 95%CI: 0.56 to 9.24, P=0.25) , and proteinuria (RR=1.75, 95%CI: 0.53 to 5.73, P=0.36) . Conclusion Anlotinib can raise long-term survival and short-term outcomes, improve quality of life, and reduce NSE values in ES-SCLC patients compared with placebo or blank controls, but it has a higher risk of developing hypertension and rash. The risk of remaining adverse effects such as fatigue, diarrhea, and proteinuria occurred are similar between placebo/blank controls and anlotimib treatment. The patients have a good medication tolerance.
keywords: Anlotinib Small cell lung cancer, extensive stage Tyrosine kinase inhibitors Neuro-specific enolase Hypertension Rash
文章编号： 中图分类号：R734.2 文献标志码：A
基金项目:国家重点研发计划 (2018YFC1705101); 国家自然科学基金 (82174453); 北京市自然科学基金 (7222270)
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