摘要
[背景与目的]原发性肝癌,特别是肝细胞癌(HCC),是临床常见的恶性肿瘤之一。在我国,肝癌的发病率和死亡率甚高。当前关于HCC治疗的循证医学证据存在不完善或尚有争议的临床议题,亟待解决。本研究旨在通过收集、复习有关HCC治疗的高质量临床研究文献,寻找当前存在与这些治疗相关的、具有争议性的或需要更新的研究题目,通过循证医学的方法学进行研究分析。
[方法]数据库检索HCC领域的随机对照试验(RCT)以及Meta-分析或系统评价(SR),检索时间为2011年12月。阅读检索获得的各文献研究的摘要,并分类归纳HCC病因、诊断、预防、治疗、预后等方面的一级证据文献,重点对HCC治疗的RCT和Meta-分析或SR研究进行复习总结。
[结果]当前有关HCC治疗的临床一级证据相对匮乏。我们在279篇HCC治疗的RCT中初步明确了“HCC根治治疗后辅助治疗疗效”(第1项)和“经肝动脉治疗HCC后预防性抗生素使用必要性”(第2项)的研究题目,并分别对这两个题目实施数据库检索筛查、数据统计分析及质量评价等Meta-分析流程。第1项研究纳入27项RCT,结果显示：HCC根治治疗后使用化疗、动脉内照射或硫酸乙酰肝素类似物PI-88的辅助治疗不能改善患者的无肿瘤复发生存期和总生存期；而辅助干扰素和过继免疫治疗却具有一定的治疗有效性；辅助维生素治疗的疗效尚需进一步验证；其它辅助治疗手段可能有益于患者预后,但其结果仅基于小样本的单个RCT。第2项研究共纳入4个临床试验,结果显示：HCC经肝动脉治疗后发生感染的几率极小；抗生素使用组与不使用组在治疗后发热、血白细胞计数和血清C反应蛋白水平变化、住院时间等观察指标上无统计学差异。
[结论]HCC的预后差,有关其治疗的临床RCT研究相对较少。HCC根治术后患者的预后差。辅助干扰素治疗可有效改善患者的无肿瘤复发生存期和总生存期,但其应用需考虑严重不良反应的发生风险；当前不建议联合系统化疗和经肝动脉化疗的方案作为HCC根治后的辅助治疗；其它辅助治疗手段在改善患者预后方面仅获得了有限的收益。因此,HCC根治治疗后各种辅助治疗手段的价值及意义有待设计良好的大宗临床试验进一步进行评价论证。经肝动脉治疗HCC后可不需要常规使用抗生素预防感染,但对于罹患感染高风险的患者,预防性抗生素的使用需权衡利弊、谨慎对待。
Background and aims:Primary liver cancer, particularly hepatocellular carcinoma (HCC), is one of the most common malignances worldwide. In china, the morbidity and mortality of HCC are high. Given the lacking of evidence-based clinical studies or controversial issues in trials of therapies for HCC, the aim of the current study was twofold: to review available high-quality clinical studies in HCC, from these to locate some potential questions that are either controversial or require further evaluation; and to solve these questions by using meta-analytic methods.
Methods:Several databases were searched for randomized controlled trials (RCTs) and meta-analysis or systematic reviews (SR) in HCC. This was conducted in December,2011. The retrieved articles were scanned and were categorized into several study groups with regard to etiology, diagnosis, prevention, and treatment and prophylaxis of HCC.
Results:The absence of high-quality evidence of interventions is main challenge in HCC clinical research. From279RCTs of intervention, two study topics were indentified, which were then entitled as "Adjuvant therapy after potentially curative treatment for HCC"(The first study) and "Antibiotic prophylaxis in transarterial therapy of HCC"(The second study). We performed meta-analysis for either of the two topics following criteria recommended by Cochrane handbook for systematic reviews of interventions. The first study included27RCTs and the results demonstrated that adjuvant chemotherapy, internal radiation therapy and heparanase inhibitor PI-88therapy failed to improve recurrence-free or overall survival, while interferon therapy or adoptive immunotherapy showed promising results. The findings of adjuvant vitamin analogue therapy need to be further examined. Cancer vaccine therapy and radioimmunotherapy may confer survival benefits after radical surgery, which were however tested in small-scale and preliminary settings. The results of the meta-analysis of the second study involving4clinical trials showed that the incidence of infection after transarterial procedure of HCC was rare. The rate of patients developing fever, changes in peripheral white blood cell counts or serum C-reactive protein levels, and the mean length of hospital stay showed no significant inter-group differences between antibiotic and no antibiotic treatment.
Conclusions:The prognosis of patients with HCC is poor, and there are few RCTs of therapy that are available for meta-analytic evaluation. Adjuvant IFN therapy can improve both RFS and OS, but the benefits of using this agent should be weighed against side effects. Combination of systemic and transhepatic arterial chemotherapy is not recommended for HCC after potentially curative treatment. Other adjuvant therapies produce limited success for survival. Further RCTs with proper design are required to establish the role of adjuvant therapies for HCC. Routinely use of prophylactic antibiotics against post-procedure infection in patients undergoing transarterial therapy of HCC may be unnecessary. However, a more judicious use of antibiotics is recommended for patients with increased risk of infection.
引文
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