螺旋断层放疗系统治疗肿瘤的快速卫生技术评估

Helical Tomotherapy for Cancer Treatment:A Rapid Health Technology Assessment

目的快速评估螺旋断层放射治疗系统（helical tomotherapy，HT）治疗肿瘤的有效性、安全性和适用性，为政府卫生政策制定者提供当前可得的最佳决策证据。方法计算机检索PubMed、EMbase、The Cochrane Library、CNKI、WanFangData、VIP和CBM，同时检索相关专业网站。由2位评价者根据纳入与排除标准独立筛选文献、提取资料和评价质量后，行描述性分析。结果①最终纳入150个研究，其中卫生技术评估（HTA）4个、临床对照试验（CCT）18个和观察性研究127个。②4个HTA全文发表于2006-2009年，证据数量较少，质量较低；纳入的145个原始研究结果显示，HT主要用于14类肿瘤的治疗，治疗肿瘤总体毒性较低，生存率较高。虽纳入研究质量均低，但前列腺癌、头颈部癌、鼻咽癌、宫颈癌、肺癌和肝癌研究证据较多，累计样本量较大，其疗效和安全性结果可靠。③Clinicaltrials．gov上已注册56个HT相关临床试验，多为欧美国家注册，其中9个研究已完成，但尚未公布研究结果。结论当前证据显示HT安全性高，临床疗效较好，但上述结论仍需开展更多高质量长随访研究加以验证。该设备不仅购置、维护和使用费用较高，对操作者的技术、培训和资质要求也高。建议政府根据我国的肿瘤流行病学特征、卫生资源配置、疾病负担和医疗卫生服务水平等因素综合评估后，减少购置数量，合理配置，高效使用；同时立项资助高质量长周期随访研究，生产本土化证据，不断指导和完善科学决策。

Objective To rapidly review the effectiveness, safety, costs and applicability of helical tomotherapy （HT）, so as to provide currently-available best evidence for decision makers of government health policies. Methods We elec- tronically searched databases including PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, VIP, CBM and other relevant professional websites. Two reviewers independently screened literature according to the inclusion and ex- clusion criteria, extracted data, assessed quality, and then performed descriptive analysis. Results a） We finally included 150 studies, encompassing 5 health technology assessments （HTAs）, 18 clinical controlled trials （CCTs）, and 127 observa- tional studies, b） Four included HTAs were published during 2006-2009, providing fairly less evidence of low quality and the results of 145 primary studies showed that： HT was mainly used in the treatments of 14 types of cancer, with relatively low total toxicity and high survival rates. Although the quality of the included studies was poor, there was much evidence about prostate cancer, head and neck cancer, nasopharynx cancer, cervical cancer, lung cancer and liver cancer, with ac- cumulatively enough sample size and fairly reliable results in HT＇s efficacy and safety. And c） a total of 56 clinical trials had bee registered in Clinicaltrials.gov, most of which were registered by the occident; among them, 9 had been come to the end, yet without results published. Conclusion Current evidence of this study showed that, HT is safe and effective in clinic. But the abovementioned conclusion needs to be verified by conducting more high quality studies with long-term follow-up. The costs of HT in procurement, maintenance and application are high; and the skills, training and qualifica- tion of operators are required. We suggest that the procurement of HT should be reduced; it should be allocated rationally and effectively used after comprehensive assessment in China＇s cancer epidemiology characteristics, health resource allo-cation, disease burden, medical service level, etc.; and also high quality studies with long-term follow-up should be finan- cially supported on the basis of establishing projects, so as to provide local evidence and consistently guide and improve scientific decision making.