Abstract

Objective: Thermal treatment (TT), defined as treatment using supra-physiological body temperatures (39–45 C), somewhat resembles fever in terms of temperature range, one of the first natural barriers for the body to fight exposure to external pathogens.

Methods: Whole-body thermal treatment (WBTT) consists of heating up the complete body to a temperature range of 39 to 45 C. Despite the recognized therapeutic potential of hyperthermia, the broad clinical use of WBTT has been limited by safety issues related to medical devices and procedures used to achieve WBTT, in particular adequate control of the body temperature. To circumvent this, a sophisticated medical device was developed, allowing long-term temperature controlled WBTT (41.5 C for up to 8 h). Technical feasibility and tolerability of the WBTT procedure (including complete anesthesia) were tested using female Aachen minipig. Optical fiber temperature sensors inserted in multiple organs were used and demonstrated consistent monitoring and control of different organs temperature over an extended period of time.

Results: Clinical evaluation of the animals before, during and after treatment revealed minor clinical parameter changes, but all of them were clinically acceptable. These changes were limited and reversible, and the animals remained healthy throughout the whole procedure and follow-up. In addition, histopathological analysis of selected key organs showed no thermal treatment-related changes.

Conclusion: It was concluded that WBTT (41.5 C for up to 8 h) was well tolerated and safe in female Aachen minipigs. Altogether, data supports the safe clinical use of the WBTT medical device and protocol, enabling its implementation into human patients suffering from life-threatening diseases.

摘要

目的：热处理（TT）定义为使用超生理温度（39-45 C）进行的治疗，在温度范围上有点类似于发烧，这是人体抵御暴露于外部病原体的最早自然障碍之一。

方法：全身热处理（WBTT）包括将整个身体加热到39至45 C的温度范围。尽管热疗具有公认的治疗潜力，但WBTT的广泛临床应用受到与医疗相关的安全性问题的限制。用于实现WBTT的设备和程序，尤其是对体温的充分控制。为了避免这种情况，开发了一种先进的医疗设备，可以对WBTT进行长期温度控制（41.5 C，长达8小时）。使用雌性亚琛小型猪测试了WBTT手术的技术可行性和耐受性（包括完全麻醉）。使用了插入多个器官的光纤温度传感器，并证明了在较长的时间内对不同器官温度的一致监控。

结果：对动物进行治疗前，治疗中和治疗后的临床评估显示，临床参数有微小变化，但所有动物均在临床上可以接受。这些变化是有限的和可逆的，并且动物在整个过程和随访过程中保持健康。此外，对选定关键器官的组织病理学分析未显示与热处理相关的变化。

结论：结论：对于雌性亚琛小型猪，WBTT（41.5 C，长达8 h）具有良好的耐受性和安全性。总之，数据支持WBTT医疗设备和协议的安全临床使用，使其能够在遭受威胁生命的疾病的人类患者中实施。