TACE联合靶向治疗药物治疗中晚期肝癌的临床疗效的Meta分析

Meta-Analysis on the Clinical Efficacy of Transcatheter Arterial Chemoembolization Combined with Targeted Therapy in the Treatment of Middle and Advanced Liver Cancer

摘要: 分析经动脉化疗栓塞(TACE)联合靶向治疗药物索拉菲尼(Sorafenib)和单独TACE治疗中晚期肝癌的临床疗效及不良反应。方法：检索PubMed、Embase、考克兰图书馆、中国期刊全文数据库及万方数据库，收集TACE和索拉菲尼联合治疗中晚期肝癌相关的随机对照试验(Randomized Controlled Trial, RCT)，检索时间跨度均从建库至2023年8月。由2位评价者按照纳入与排除标准独立筛选文献、提取资料并评价纳入研究的偏倚风险后，按照Cochrane系统评价方法完成数据提取和文献质量评估。采用RevMan 5.3软件进行Meta分析。结果：在检索分析后有7篇RCT入组，共920例患者，其中观察组为TACE联合sorafenib治疗组有464例，TACE单独治疗组为对照组有456例，这些患者的客观缓解率(ORR)在TACE+索拉菲尼组和TACE组分别为55.8%和44.5%差异有统计学意义(P = 0.0008)；而且TACE + 索拉菲尼组比单独TACE治疗组有更高的1年、2年生存率；TACE + 索拉菲尼的并发症中包括厌食症、贫血、脊髓抑制、腹泻腹痛、恶心呕吐、疲惫、发热、手足口症、高血压、体重减轻等，有些学者认为在TACE + 索拉菲尼的治疗方案中，索拉菲尼的使用加重了患者的不良反应，但和TACE单独治疗组相比，在TACE + 索拉菲尼治疗组中出现的更多不良反应如手足口症和腹泻，在对症治疗后患者可以明显改善，而胃肠道反应、发热、乏力等基础不良反应的病例数与对照组并无明显差异。

Abstract: Objective: To analyze the clinical efficacy and adverse reactions of transcatheter chemoembolization (TACE) combined with Sorafenib and TACE alone in the treatment of primary liver cancer. Methods: PubMed, Embase, Cochrane Library, China Journal Full-text Database and Wanfang Database were searched to collect the Randomized Controlled trials (RCTS) related to the combination of TACE and Sorafenib in the treatment of primary liver cancer. The retrieval time span is from database con-struction to August 2023. Two evaluators independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and evaluated the risk of bias in the included studies. Data extraction and literature quality assessment were completed according to the Cochrane systematic evaluation method. Meta-analysis was performed using RevMan 5.3 software. Results: Seven RCTS were included after retrieval analysis, including a total of 920 patients, includ-ing 464 patients in the observation group treated with TACE combined with Sorafenib, and 456 pa-tients in the control group treated with TACE alone. The objective response rate (ORR) of these pa-tients was 55.8% in the TACE + Sorafenib group and 44.5% in the TACE group (P = 0.0008). Moreo-ver, the TACE + Sorafenib group had higher 1-year and 2-year survival rates than the TACE group alone. Complications of TACE + Sorafenib include anorexia, anemia, spinal cord depression, diarrhea, abdominal pain, nausea and vomiting, fatigue, fever, hand, foot and mouth disease, hypertension, weight loss, etc. Some scholars believe that in the treatment regimen of TACE + Sorafenib, the use of sorafenib worsens the adverse reactions of patients, and compared with conventional treatment alone group, in the TACE + Sorafenib treatment group, there were more adverse reactions such as hand, foot and mouth disease and diarrhea, which could be significantly improved after sympto-matic treatment, while there was no obvious difference in the number of cases of gastrointestinal reaction, fever, fatigue and other basic adverse reactions from the control group.