目的 系统评价安罗替尼联合化疗二线治疗小细胞肺癌（SCLC）患者的有效性和安全性。方法 计算机检索PubMed、Embase、Cochrane Library、中国生物医学文献数据库（CBM）、中国学术期刊全文数据库（CNKI）、维普生物医学数据库（VIP）和万方数据库（Wanfang Data），检索时限均从建库至2026年4月14日。搜集安罗替尼联合化疗治疗SCLC的临床研究。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后，采用R 4.4.2软件进行Meta分析。结果 共纳入14项研究，包括997例患者。Meta分析结果显示，与单纯化疗相比，联合治疗在总生存期（OS）[风险比（HR）＝0.81，95%置信区间（CI）（0.75，0.88），P＜0.000 1]、客观缓解率（ORR）[比值比（OR）＝2.78，95% CI（2.06，3.74），P＜0.000 1]和疾病控制率（DCR）[OR＝3.52，95% CI（2.51，4.95），P＜0.000 1]方面均显著优于对照组；在无进展生存期（PFS）方面，联合治疗组的风险更高，差异有统计学意义[HR＝1.17，95% CI（1.00，1.36），P＝0.043 8]。安全性方面，联合治疗组高血压的发生率显著高于对照组[OR＝7.13，95% CI（4.07，12.52），P＜0.000 1]；而两组在白细胞减少症[OR＝1.13，95% CI（0.68，1.87），P＝0.637 1]、血小板减少症[OR＝0.89，95% CI（0.51，1.55），P＝0.681 1]、胃肠道反应[OR＝1.21，95% CI（0.78，1.88），P＝0.400 6]及手足综合征[OR＝1.88，95% CI（0.99，3.56），P＝0.054 4]方面差异均无统计学意义。结论 当前证据表明，安罗替尼联合化疗可能显著改善SCLC患者的OS、ORR和DCR，但未能改善PFS，且高血压风险增加。为安罗替尼联合化疗作为SCLC二线治疗提供了新的循证依据，提示该方案在改善总体疗效方面具有潜在临床价值。

Objective To systematically evaluate the efficacy and safety of anlotinib combined with chemotherapy as second-line treatment for patients with small cell lung cancer (SCLC). Methods PubMed, Embase, Cochrane Library, CBM, China National Knowledge Infrastructure (CNKI), VIP and Wanfang Data databases were electronically searched to collect clinical studies on anlotinib combined with chemotherapy for SCLC from inception to April 14th, 2026. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was performed using R 4.4.2 software. Results A total of 14 studies involving 997 patients were included. Meta-analysis results showed that compared with chemotherapy alone, combination therapy significantly improved overall survival (OS) [HR = 0.81, 95% CI (0.75, 0.88), P<0.000 1], objective response rate (ORR) [OR = 2.78, 95% CI (2.06, 3.74), P<0.000 1] and disease control rate (DCR) [OR = 3.52, 95% CI (2.51, 4.95), P<0.000 1]; For progression-free survival (PFS), the combination therapy group had a statistically significantly worse outcome, with a higher risk of progression [HR = 1.17, 95% CI (1.00, 1.36), P= 0.043 8]. In terms of safety, the incidence of hypertension was significantly higher in the combination therapy group compared with the control group [OR = 7.13, 95% CI (4.07, 12.52), P<0.000 1]; While there were no significant differences between the two groups in leukopenia [OR = 1.13, 95% CI (0.68, 1.87), P= 0.637 1], thrombocytopenia [OR = 0.89, 95% CI (0.51,1.55), P= 0.681 1], gastrointestinal reactions [OR = 1.21, 95% CI (0.78, 1.88), P= 0.400 6] and hand-foot syndrome [OR = 1.88, 95% CI (0.99, 3.56), P= 0.054 4]. Conclusions Current evidence indicates that anlotinib in combination with chemotherapy may significantly improve OS, ORR, and DCR in SCLC patients; However, it does not improve PFS and is associated with a higher risk of hypertension. This study provides new evidence supporting the use of anlotinib combined with chemotherapy as a second-line treatment for SCLC, indicating that this regimen has potential clinical value in improving overall efficacy.

R974

国家卫生健康委能力建设和继续教育中心慢病管理研究课题（GWJJMB202510041001）