前瞻性试验中电磁热疗的临床证据现状

T. Ohguri
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引用次数: 5

摘要

1990年4月,日本政府批准使用健康保险支付电磁热疗结合放射治疗的费用。1996年4月,除联合放疗外,电磁热疗被批准用于临床。然而,医疗保险中热疗的既定医疗报酬点很少,而且由于盈利能力下降,往往禁止电磁热疗的广泛使用。基于meta分析和III期研究的I级证据表明,电磁热疗联合放疗在头颈癌、乳腺癌、恶性黑色素瘤、非小细胞肺癌、宫颈癌、直肠癌和膀胱癌的局部控制率和/或肿瘤缓解率方面得到认可。在高级别肉瘤和肝癌患者中也发现了电磁热疗联合化疗的一级证据。在宫颈癌、直肠癌和高级别肉瘤患者中,基于一级证据的总生存率得到了改善。近年来,基于II期研究的热疗联合化疗或放化疗有了可喜的结果。本文简要概述了基于前瞻性试验(包括正在进行的试验)修订电磁热疗医疗报酬点的临床证据和未来展望。
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Current Status of Clinical Evidence for Electromagnetic Hyperthermia on Prospective Trials
Japanese Government approved the use of health insurance to cover the costs of electromagnetic hyperthermia in combination with radiotherapy in April 1990. In April 1996, electromagnetic hyperthermia was approved for clinical uses other than combination with radiotherapy. However,the established medical remuneration points of hyperthermia in health insurance were scarce, and tend to prohibit widespread use of electromagnetic hyperthermia due to the decreased profitability. Level I evidence based on meta-analysis and phase III study for electromagnetic hyperthermia in combination with radiotherapy was recognized in following various disease;head and neck cancer, breast cancer,malignant melanoma,non-small cell lung cancer,cervical cancer,rectal cancer and bladder cancer for local control rate and/or tumor response rate. Level I evidence for electromagnetic hyperthermia in combination with chemotherapy was also seen in patients with high-grade sarcoma and liver cancer. Improvements of the overall survival rate base on the level I evidence were confirmed in patients with cervical cancer, rectal cancer and high-grade sarcoma. In recent years, promising results for hyperthermia in combination with chemotherapy or chemoradiotherapy based on phase II study were reported. A brief overview of the clinical evidence and future perspective to revise the medical remuneration points for electromagnetic hyperthermia based on prospective trials including ongoing trials is provided in this article.
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