Kennedy J E, Wu F, ter Haar G R, Gleeson F V, Phillips R R, Middleton M R, Cranston D
Department of Urology, Churchill Hospital, Oxford OX3 7LJ, UK.
Ultrasonics. 2004 Apr;42(1-9):931-5. doi: 10.1016/j.ultras.2004.01.089.
High-intensity focused ultrasound (HIFU) has been investigated as a tool for the treatment of cancer for many decades, but is only now beginning to emerge as a potential alternative to conventional therapies. In recent years, clinical trials have evaluated the clinical efficacy of a number of devices worldwide. In Oxford, UK, we have been using the JC HIFU system (HAIFU Technology Company, Chongqing, PR China) in clinical trials since November 2002. This is the first report of its clinical use outside mainland China. The device is non-invasive, and employs an extracorporeal transducer operating at 0.8-1.6 MHz (aperture 12-15 cm, focal length 9-15 cm), operating clinically at Isp (free field) of 5-15 KWcm(-2). The aims of the trials are to evaluate the safety and performance of the device. Performance is being evaluated through two parallel protocols. One employs radiological assessment of response with the use of follow-up magnetic resonance imaging and microbubble-contrast ultrasound. In the other, histological assessment will be made following elective surgical resection of the HIFU treated tumours. Eleven patients with liver tumours have been treated with HIFU to date. Adverse events include transient pain and minor skin burns. Observed response from the various assessment modalities is discussed.
几十年来,高强度聚焦超声(HIFU)一直作为一种癌症治疗工具进行研究,但直到现在才开始成为传统疗法的一种潜在替代方案。近年来,全球范围内的临床试验对多种设备的临床疗效进行了评估。在英国牛津,自2002年11月起,我们就在临床试验中使用JC HIFU系统(中国重庆海扶技术有限公司)。这是该设备在中国大陆以外地区临床应用的首份报告。该设备为非侵入性,采用体外换能器,工作频率为0.8 - 1.6兆赫兹(孔径12 - 15厘米,焦距9 - 15厘米),临床工作时在自由场的声强为5 - 15千瓦/平方厘米。试验目的是评估该设备的安全性和性能。通过两个平行方案对性能进行评估。一个方案采用后续磁共振成像和微泡造影超声对反应进行放射学评估。另一个方案是在对HIFU治疗的肿瘤进行选择性手术切除后进行组织学评估。截至目前,已有11例肝肿瘤患者接受了HIFU治疗。不良事件包括短暂疼痛和轻微皮肤灼伤。文中讨论了从各种评估方式观察到的反应。