高强度聚焦超声治疗胰腺癌有效性和安全性的系统评价

Effectiveness and Safety of High-intensity Focused Ultrasound for Pancreatic Cancer: A Systematic Review

目的探讨高强度聚焦超声(HIFU)治疗胰腺癌的有效性和安全性,为其临床应用提供证据。方法计算机检索Pub Med、EMbase、h e Cochrane Library(2013年11期)、CBM、CNKI、VIP和Wan Fang Data数据库,纳入HIFU治疗胰腺癌的随机对照试验(RCT)和临床对照试验(CCT),检索时限均为从建库至2013年11月。由2名研究者按照纳入与排除标准筛选文献、提取数据和评价纳入研究的方法学质量后,使用Rev Man 5.0软件进行Meta分析。结果共纳入23个研究,包括19个RCT和4个CCT,其中14个研究报告了安全性。Meta分析结果显示:HIFU联合放化疗治疗胰腺癌在6个月生存率、12个月生存率、总有效率和临床受益率方面均优于单独三维适形放疗、吉西他滨、吉西他滨+顺铂、吉西他滨+5氟尿嘧啶治疗,且其差异有统计学意义(P<0.05)。HIFU联合放化疗治疗的不良反应主要是皮肤损伤和发热,其不良反应与对照组相当,差异无统计学意义(P>0.05)。结论HIFU联合放化疗治疗胰腺癌的有效性优于其他疗法,且不良反应较低。由于纳入研究的质量较低,不同程度降低了本研究结果的可靠性,因此尚需规范和统一胰腺癌的诊断和判效标准,提高临床研究设计和实施质量,为聚焦超声的临床应用生产高质量证据。

Objective To explore the effectiveness and safety of high intensity focused ultrasound （HIFU） in the treat ment of pancreatic cancer, so as to provide references for its clinical application. Methods PubMed, EMbase,The Cochrane Library （Issue 11, 2013）, CBM, CNKI, VIP and WanFang Data were systematically searched up to November 2013 for rand omized clinical trials （RCTs） and clinical controlled trials （CCTs） about HIFU in the treatment of pancreatic cancer. Accord ing to inclusion and exclusion criteria, two reviewers independently screened literature, extracted data, and assessed meth odological quality of included studies. Then meta-analysis was performed using RevMan 5.0. Results A total of 23 studies （19 RCTs and 4 CCTs） were included, of which 14 studies reported safety. The results of meta-analysis showed that： survival rates at the 64 month and the 124 month, overall efficacy and clinical benefit rate in the HIFU plus radiation and chemotherapy group were significantly higher than those in groups treated with three dimensional conformal radiation therapy （3D-CRT） （P〈0.05）, gemcitabine （GEM） （P〈0.05）, GEM plus cisplatin （DDP） （P〈0.05）, and GEM plus 5-fluorouracil （5-FU） （P〈0.05）. The adverse effects （mainly including skin damage and fever） in the HIFU plus radiation and chemotherapy group was similar to those in the control group with no significant difference （P〉0.05）. Conclusion Current evidence suggests that HIFU plus radiation and chemotherapy for pancreatic cancer is superior to other therapies with less adverse reaction. However, the poor quality of the included studies reduces the reliability of outcome to some extent. Thus, it is necessary to regulate and unify the criteria of diagnosis and outcome measures in the treatment of pancreatic cancer and improve the quality of study design and implementation in clinical studies, so as to provide high quality evidence for its clinical application.