Misconceptions in the application of HIFU in China need to be corrected urgently

1, scientific terminology should not be alienated: Niu Fengqi introduction, ultrasound is a more familiar diagnostic equipment, which uses low-intensity ultrasound. HIFU belongs to a therapeutic device, which uses high-intensity focused ultrasound, with the appropriate means of ultrasound focused on the body foci in the tiny area, so that the target tissue absorbs acoustic energy into heat, resulting in its temperature rose to 65 ~ 100 ℃, thus occurring in an instant! Coagulative necrosis is a non-invasive or minimally invasive thermal ablation treatment technology. However, this crystallization of modern science and technology, but derived from a number of non-scientific concepts and terms. The first is the term “ultrasound focused knife”. According to the authoritative definition in the Dictionary of Modern Chinese, “knife” refers to a tool for slicing, cutting, peeling, chopping, guillotining, or “something shaped like a knife”. However, the principle of HIFU tumor treatment is to let the pathological tissues undergo coagulative necrosis, not like traditional surgery to implement physical resection of the lesion; ultrasound treatment head or a single plane piezoelectric wafer plus acoustic lens, or a single concave wafer, or multiple wafers embedded in the inner side of the crown according to a certain law, the sound beam issued by the axis-symmetric dumbbell shape, focusing on the formation of the focal spot in the form of a grain of rice, no matter the physical object, or the acoustic field, Shape, none like a knife. That is to say, from the working principle and the appearance of the equipment, it is not actually a knife, called “focusing knife” or “ultrasonic knife” is somewhat irrelevant. Secondly, “Hai Fu” this translation. HIFU is an internationally recognized abbreviation, such as ultrasound, the most appropriate use of the original text, there is no need to engage in Chinese translation. Niu Fengqi said, it can be imagined, if the original must come to a “nationalization”, the B ultrasound will be translated as “must ultra” or “avoid ultra”, are incomprehensible and difficult to accept. Then there is the term “biological focal area”. According to the author’s explanation, the biological focal zone refers to the coagulation necrosis zone formed in the target tissue by one irradiation of HIFU. Niu Fengqi believes that, as a set of concepts that have correspondence and causality with focal spot and hot spot, it can be called “thermal necrosis body element” or “ablation spot” according to the substance, or “damage person” as it is called in foreign academic circles. “It is so clear and precise that there is no need to take another name. Moreover, focal spot is the concept of spatial distribution of energy in physics, while ablation spot refers to the spatial occupation of coagulated necrotic tissues, which alienates the term “focal domain” from the term “focal spot” in physics and “biology”, forcing a connection with “biology”. The term “focal domain” is alienated from the physical term “focal spot” and is associated with “biology”, which is difficult to agree with. 2, “leading”, “first” and slow to talk about Since the second International Conference on Therapeutic Ultrasound in August 2002, “China’s HIFU technology leading the world for 3 to 5 years”, “China’s HIFU technology is 3 to 5 years ahead of the world”, “pulling the world’s first” and other claims are very publicized. According to the quotes, the “leading” statement came from Professor L. Crum, chairman of the International Acoustics Conference, president of the Acoustical Society of America, and director of the Center for Industrial and Medical Ultrasound at the Institute of Applied Physics at the University of Washington. However, Niu Fengqi said he was fortunate to see the words of this international ultrasound authority recently, and the correct translation should be: “We are all surprised to find that in the field of clinical application of HIFU, China is three to five years ahead.” The difference is self-evident. It was also reported that China accounted for 10.5 of the 70 articles presented at the Third Annual International Conference on Therapeutic Ultrasound held in France in 2003. The specific distribution was as follows: biological effects and dosimetry: 3.5 out of 6; clinical effects in urological applications: 5 out of 14; interaction between air bubbles and therapeutic ultrasound: 1 out of 6; gene therapy and enhancement of drug delivery with ultrasound: 1 out of 7; ultrasound-based surveillance of ultrasound therapy: 0 out of 7; non-acoustic methods of surveillance of ultrasound therapy: 0 out of 5; and ultrasound therapy Modeling: 0 out of 8; Effects on blood vessels: 0 out of 6; Ultrasound therapy techniques: 0 out of 12. It can be seen that there is an obvious gap between the domestic research and development work on different aspects and levels of HIFU, both in terms of breadth and depth, compared with foreign countries. The so-called “leading” is actually limited to the clinical application, but also by the light of the relaxed management environment and rich clinical resources. Another country’s “focused ultrasound knife” is the “international first” reference, also inaccurate. Niu Fengqi corrected, it should be said that the commercial machine is indeed the first launched by China, but the scientific research machine is the first foreign countries, or else a large number of papers and data before the country’s intervention from where to come. 3, “solved the problem of therapeutic dosimetry,” some bias since the late 1990s, but also often in the media to see such publicity: relying on some kind of innovative “focal domain theory”, has “solved the problem of high intensity Focused ultrasound (HIFU) in vivo treatment dosimetry of this world problem”, and even “so that the ultrasound dose of human quantitative division”. Niu Fengqi this does not agree. According to the introduction, the dosimetry of ultrasound treatment is to study the quantitative relationship between the ultrasound sound field parameters and its biological effects. Sound field parameters include both spatial and temporal distribution of sound energy, including sound pressure, sound intensity of the quantitative level; biological effect refers to the role of ultrasound in the biological tissues under the state, function and structural changes. To link the two, it is necessary to clarify the exact mechanism of producing biological effects, and to establish a quantitative relationship between indirect physical factors (acoustic quantities), direct physical factors (thermodynamic or other quantities), physiological process parameters and parameters reflecting biological effects. It can be seen that it is not easy to solve the problem of therapeutic dosimetry of HIFU. Niu Fengqi talked about the fact that some researchers in China do pay attention to this topic. However, literature search shows that from 1990 to now, those who have really come up with standard theoretical and experimental research results are all foreign units and people. Its important work progress includes: entitled “Ultrasound – Focused Transducer – Definition and Measurement Methods of the Emission Field” of the IEC (International Electrotechnical Commission) document through the validation, becoming an official international standard; proposed to half the sound pressure maximum envelope range (-6dB beam area) spatially averaged sound intensity instead of the spatial peak sound intensity as the HIFU-specific parameters, and proposed the corresponding measurement method, the work has been the U.S. Food and Drug Administration (FDA) Center for Devices and Radiation Health experts included in the 1999 review report; proposed the rate of damage and the sound intensity, the depth of the target point (focal spot) is located, the acoustic attenuation coefficient of the passing through the tissue, the target tissue absorption coefficient – density -Specific heat, ambient temperature, and damage threshold temperature; the relationship between the diameter of the damage (ablation spot) and the diameter of the sound beam in the field-6dB, the damage rate, the rate of ultrasound energy accumulation, the blood perfusion, thermal diffusion, the density of the target tissue, and the irradiation time; the relationship between the length of the damage (ablation spot) and the length of the sound beam in the field-6dB, the damage rate, the rate of ultrasound energy accumulation, the blood perfusion, the thermal diffusion, and the exposure time. rate, blood perfusion, thermal diffusion, target tissue density, irradiation time, etc.; quantitative discussion of focused ultrasound surgery frequency optimization options, etc.. The content of HIFU therapy dosimetry in the ultrasound therapy monographs published in 2002 could not be compared with the level of the papers published in 1994. It is not known whether China has “solved this world problem”. Niu Fengqi appealed that the above are only some of the problems in the development of HIFU in China, hoping to arouse the attention of the competent authorities, academia and industry. Especially important is that we should not engage in self-hype, we should really collapse the heart, the work on HIFU to do a deep and detailed, so that it really becomes its own characteristics of the treatment of disease tools.