TACE联合热学疗法治疗肝癌的系统评价和Meta分析
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摘要
背景：原发性肝癌有癌王之称,严重威胁着人类的健康,它具有起病隐匿,潜伏期长,高度恶性,生长迅速,侵袭力强,而且经治疗后肿瘤易复发、患者死亡率高等特点,其治疗一直是临床中的难点。肝癌出现症状时大多已失去手术机会,而且术后复发率高。经导管肝动脉碘油化疗栓塞术(transcatheter arterial chemoembolization,TACE)目前已广泛应用于临床,该技术是治疗中晚期肝癌的首选疗法之一,但其临床效果并不理想,为提高远期生存率并改善患者生活质量,协同TACE的肝癌综合疗法均在探讨中。
目的：系统评价肝动脉介入化疗栓塞术(TACE)联合热学疗法(氩氦刀、温热疗法以及高能聚焦超声)治疗原发性肝癌的疗效及安全性,为临床实践与进一步研究提供参考依据。
方法：计算机检索Cochrane Library、PubMed、EMBASE、Web of Science、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、中文科技期刊数据库(VIP)、数字化期刊全文数据库(WANFANG)八大数据库,同时辅以其他检索,收集所有TACE联合热学疗法对比单种疗法治疗原发性肝癌的随机对照试验(randomized controlled trials, RCTs)。由两位研究员按照研究计划书进行文献筛选和资料提取,参照Cochrane质量评价标准对纳入文献进行质量评价,并使用RevMan5.1软件进行Meta分析。
结果：初检出相关文献1407篇,经文献筛选后共纳入54篇RCT,除两篇SCI的英文文献外,其余均为中文文献,最终共纳入3969名患者。
(1)氩氦刀疗法纳入16篇RCT(1467例患者)。Meta分析结果显示：①联合组的总有效率、完全坏死率和0.5年、1年、1.5年、2年、2.5年生存率均明显好于TACE组,联合组复发率明显低于TACE组,联合组的AFP下降和Th细胞的上升较单纯TACE组更为明显,且其差异均有统计学意义(P<0.05)；联合组骨髓抑制发生率低于TACE组,但其差异尚无统计学意义(P>0.05)；联合组Th/Ts比值改善情况好于TACE组,但其差异处于统计学临界值(P=0.05)。②联合组的0.5年、1.5年、2年、2.5年生存率均明显好于单纯氩氦刀组,且其差异均有统计学意义(P<0.05)；联合组的AFP下降和Th细胞的上升较单纯氩氦刀组更为明显,且其差异均有统计学意义(P<0.05)。
(2)温热疗法纳入18篇RCT (979例患者)。Meta分析结果显示：TACE联合热疗组与单纯TACE组相比,其1、2年生存率、总有效率和生活质量改善率的差异均有统计学意义(P<0.05),联合组明显好于单纯FACE组；联合组骨髓抑制和消化道反应的发生率均低于对照组,但只有骨髓抑制发生率在两组间的差异有统计学意义(P<0.05)。
(3)高能聚焦超声疗法共纳入20篇RCT(1523例患者)。Meta分析结果显示：TACE与高能聚焦超声联合组的0.5年、1年、2年、3年、5年总生存率和总有效率均明显好于单独TACE组,且其差异均有统计学意义(P<0.05)。联合组白细胞下降、恶心呕吐、肝功损害的发生率均低于TACE组,但只有恶心呕吐发生率在两组间的差异有统计学意义(P<0.05)；联合组发热反应的发生率高于TACE组,且其差异有统计学意义(P<0.05)。
结论：相较于单纯TACE或单纯热学疗法的单种疗法,TACE与热学疗法的联合疗法能明显提高原发性肝癌患者的远期生存率和近期疗效,并有利于改善患者的生活质量以及抗肿瘤免疫机能,而且具有较好的临床安全性；但其长期疗效和安全性评价尚需大样本高质量的RCT进一步验证。
Background:Primary liver neoplasms (PLN) is known as the king of cancer, which is a serious threat to people's health in the world. It has the characteristic as following:hidden onset, long incubation period, highly malignant, rapid growth, strong aggressivity, and high recurrence and mortality rate after treatment of the tumor. Its treatment has been the difficulty in clinical. It's already lose the opportunity of surgery generally when symptoms of Liver cancer occured, and there is a high risk rate of the postoperative recurrence. Transcatheter arterial chemoembolization (TACE) has been used widely in clinical practice, which is one of the preferred therapies for locally advanced liver cancer, but its clinical effect is not ideal. In order to improve long-term survival rate and patients'quality of life, it is researching in the comprehensive therapies with TACE for patients with primary liver cancer.
Objective:To evaluate the clinical efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with Thermotics Therapy (Thermotherapy) for primary hepatic carcinomas, and to provide the reference for clinical practice and further research.
Methods:We searched foreign databases as Cochrane Library, PubMed, EMBASE, Web of Science and Chinese ones as CBM, CNK.1, VIP and Wanfang with computer and also retrieved other sources as supplying, such as tracing related references. All relevant randomized controlled trials (RCTs) were collected to compare combination therapy with TACE alone or Thermotherapy alone. Two investigators performed literature screening and data extraction according to the protocal independently. After quality evaluation of included studies had been finished according to the Cochrane criterion, meta-analyses were performed using the RevMan5.1software.
Results:A total of1407relevant literatures have been obtained through the preliminary retrieval, and a total of54RCTs were included after screening literatures. Besides two English papers of SCI, the rest are all Chinese literatures. A total of3969patients were included.
(1) Classified as argon-helium cryotherapy system (AHCS),16RCTs were included with1467patients involved. The results of meta-analysis showed:CD The total effective rate, complete necrosis rate,0.5-1-1.5-2-2.5-year survival rate, the decrease of AFP and the increase of Th cell in the combination therapy group were superior to TACE alone, recurrence rate in the combination group was lower than TACE alone; and there were all significant difference(P<0.05). The incidences of combination therapy was lower than TACE alone on the Myelosuppression, but there was no significant difference (P>0.05). The rate of Th/Ts was improved by combination therapy, but it was on the statistical critical value (P=0.05).②The0.5-1.5-2-2.5-year survival rate, the decrease of AFP and the increase of Th cell in the combination therapy group were superior to AHCS alone, and there were all significant difference(P<0.05).
(2) Classified as hyperthermia therapy (HT),18RCTs with979patients were included. Meta-analysis showed that comparing combination therapy with TACE alone, there were significant difference on the indicators of1-2-year survival rate, total effective rate and improvement rate of life quality (P<0.05), which were superior in the combination group. The incidences of combination therapy was lower than TACE alone on the indicators of Myelosuppression and Alimentary canal reactions, but there was statistically significant difference only on the incidence of Myelosuppression (P<0.05).
(3) Classified as high intensity focused ultrasou (HIFU), a total of20RCTs involving1523patients were included. Meta-analysis showed:The0.5-1-1.5-2-2.5-year overall survival rate and total effective rate in the combination therapy group were superior to TACE alone group, and there were all statistically significant difference (P<0.05). The incidences of combination therapy were lower than those of TACE alone on the indicators of Leukocytopenia, Nausea and Vomiting, Hepatic lesion, but there was statistically significant difference only on the indicator of Nausea and Vomiting (P<0.05). The incidence of fever was higher in the combination therapy group than the TACE alone group, and there was significant difference (P<0.05).
Conclusion:Compared with TACE or Thermotherapy alone, TACE combined with Thermotherapy can signally improve long-term survival rate and short-term curative effect, ameliorate the quality of life, and improve the anti-tumour immunity for PLN. Additionally, it's feasible and its safety can be accepted.But its long-term survival rate and more comprehensive security still needs to be further verified by more large sample and high quality RCTs.
目的：系统评价肝动脉介入化疗栓塞术(TACE)联合热学疗法(氩氦刀、温热疗法以及高能聚焦超声)治疗原发性肝癌的疗效及安全性,为临床实践与进一步研究提供参考依据。
方法：计算机检索Cochrane Library、PubMed、EMBASE、Web of Science、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、中文科技期刊数据库(VIP)、数字化期刊全文数据库(WANFANG)八大数据库,同时辅以其他检索,收集所有TACE联合热学疗法对比单种疗法治疗原发性肝癌的随机对照试验(randomized controlled trials, RCTs)。由两位研究员按照研究计划书进行文献筛选和资料提取,参照Cochrane质量评价标准对纳入文献进行质量评价,并使用RevMan5.1软件进行Meta分析。
结果：初检出相关文献1407篇,经文献筛选后共纳入54篇RCT,除两篇SCI的英文文献外,其余均为中文文献,最终共纳入3969名患者。
(1)氩氦刀疗法纳入16篇RCT(1467例患者)。Meta分析结果显示：①联合组的总有效率、完全坏死率和0.5年、1年、1.5年、2年、2.5年生存率均明显好于TACE组,联合组复发率明显低于TACE组,联合组的AFP下降和Th细胞的上升较单纯TACE组更为明显,且其差异均有统计学意义(P<0.05)；联合组骨髓抑制发生率低于TACE组,但其差异尚无统计学意义(P>0.05)；联合组Th/Ts比值改善情况好于TACE组,但其差异处于统计学临界值(P=0.05)。②联合组的0.5年、1.5年、2年、2.5年生存率均明显好于单纯氩氦刀组,且其差异均有统计学意义(P<0.05)；联合组的AFP下降和Th细胞的上升较单纯氩氦刀组更为明显,且其差异均有统计学意义(P<0.05)。
(2)温热疗法纳入18篇RCT (979例患者)。Meta分析结果显示：TACE联合热疗组与单纯TACE组相比,其1、2年生存率、总有效率和生活质量改善率的差异均有统计学意义(P<0.05),联合组明显好于单纯FACE组；联合组骨髓抑制和消化道反应的发生率均低于对照组,但只有骨髓抑制发生率在两组间的差异有统计学意义(P<0.05)。
(3)高能聚焦超声疗法共纳入20篇RCT(1523例患者)。Meta分析结果显示：TACE与高能聚焦超声联合组的0.5年、1年、2年、3年、5年总生存率和总有效率均明显好于单独TACE组,且其差异均有统计学意义(P<0.05)。联合组白细胞下降、恶心呕吐、肝功损害的发生率均低于TACE组,但只有恶心呕吐发生率在两组间的差异有统计学意义(P<0.05)；联合组发热反应的发生率高于TACE组,且其差异有统计学意义(P<0.05)。
结论：相较于单纯TACE或单纯热学疗法的单种疗法,TACE与热学疗法的联合疗法能明显提高原发性肝癌患者的远期生存率和近期疗效,并有利于改善患者的生活质量以及抗肿瘤免疫机能,而且具有较好的临床安全性；但其长期疗效和安全性评价尚需大样本高质量的RCT进一步验证。
Background:Primary liver neoplasms (PLN) is known as the king of cancer, which is a serious threat to people's health in the world. It has the characteristic as following:hidden onset, long incubation period, highly malignant, rapid growth, strong aggressivity, and high recurrence and mortality rate after treatment of the tumor. Its treatment has been the difficulty in clinical. It's already lose the opportunity of surgery generally when symptoms of Liver cancer occured, and there is a high risk rate of the postoperative recurrence. Transcatheter arterial chemoembolization (TACE) has been used widely in clinical practice, which is one of the preferred therapies for locally advanced liver cancer, but its clinical effect is not ideal. In order to improve long-term survival rate and patients'quality of life, it is researching in the comprehensive therapies with TACE for patients with primary liver cancer.
Objective:To evaluate the clinical efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with Thermotics Therapy (Thermotherapy) for primary hepatic carcinomas, and to provide the reference for clinical practice and further research.
Methods:We searched foreign databases as Cochrane Library, PubMed, EMBASE, Web of Science and Chinese ones as CBM, CNK.1, VIP and Wanfang with computer and also retrieved other sources as supplying, such as tracing related references. All relevant randomized controlled trials (RCTs) were collected to compare combination therapy with TACE alone or Thermotherapy alone. Two investigators performed literature screening and data extraction according to the protocal independently. After quality evaluation of included studies had been finished according to the Cochrane criterion, meta-analyses were performed using the RevMan5.1software.
Results:A total of1407relevant literatures have been obtained through the preliminary retrieval, and a total of54RCTs were included after screening literatures. Besides two English papers of SCI, the rest are all Chinese literatures. A total of3969patients were included.
(1) Classified as argon-helium cryotherapy system (AHCS),16RCTs were included with1467patients involved. The results of meta-analysis showed:CD The total effective rate, complete necrosis rate,0.5-1-1.5-2-2.5-year survival rate, the decrease of AFP and the increase of Th cell in the combination therapy group were superior to TACE alone, recurrence rate in the combination group was lower than TACE alone; and there were all significant difference(P<0.05). The incidences of combination therapy was lower than TACE alone on the Myelosuppression, but there was no significant difference (P>0.05). The rate of Th/Ts was improved by combination therapy, but it was on the statistical critical value (P=0.05).②The0.5-1.5-2-2.5-year survival rate, the decrease of AFP and the increase of Th cell in the combination therapy group were superior to AHCS alone, and there were all significant difference(P<0.05).
(2) Classified as hyperthermia therapy (HT),18RCTs with979patients were included. Meta-analysis showed that comparing combination therapy with TACE alone, there were significant difference on the indicators of1-2-year survival rate, total effective rate and improvement rate of life quality (P<0.05), which were superior in the combination group. The incidences of combination therapy was lower than TACE alone on the indicators of Myelosuppression and Alimentary canal reactions, but there was statistically significant difference only on the incidence of Myelosuppression (P<0.05).
(3) Classified as high intensity focused ultrasou (HIFU), a total of20RCTs involving1523patients were included. Meta-analysis showed:The0.5-1-1.5-2-2.5-year overall survival rate and total effective rate in the combination therapy group were superior to TACE alone group, and there were all statistically significant difference (P<0.05). The incidences of combination therapy were lower than those of TACE alone on the indicators of Leukocytopenia, Nausea and Vomiting, Hepatic lesion, but there was statistically significant difference only on the indicator of Nausea and Vomiting (P<0.05). The incidence of fever was higher in the combination therapy group than the TACE alone group, and there was significant difference (P<0.05).
Conclusion:Compared with TACE or Thermotherapy alone, TACE combined with Thermotherapy can signally improve long-term survival rate and short-term curative effect, ameliorate the quality of life, and improve the anti-tumour immunity for PLN. Additionally, it's feasible and its safety can be accepted.But its long-term survival rate and more comprehensive security still needs to be further verified by more large sample and high quality RCTs.
引文
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