Gong Xue

3月28日上午7點，山東省腫瘤醫院質子臨床研究中心地下一層的治療室里，3名患者正在接受質子放射治療。儘管腫瘤類型、病情進展、身體素質大不相同，但治療他們疾病的卻來自同一種能量——核能。

When people think of "nuclear", they often associate it with nuclear power plants, nuclear submarines, nuclear reactors, etc. At present, nuclear medicine has become a major application area of nuclear technology. As one of the most advanced cancer radiotherapy technologies in the world, proton therapy is closely related to nuclear medicine. At the end of 1200, China's first proton therapy system approved to use superconducting cyclotron and 0-degree rotation frame was settled in Shandong Provincial Cancer Hospital. Up to now, the system has treated nearly 0 patients, covering nasopharyngeal cancer, esophageal cancer, lung cancer, breast cancer, prostate cancer, hepatobiliary cell carcinoma, pediatric tumors and other types.

“現在對2號室進行質子束流轟擊。”7點15分，質子主控室內，隨著醫生發出指令，質子束精確地照射到患者腫瘤部位。據介紹，當質子抵達癌細胞后，會迅速沉積，釋放出最大能量，就像一把鋒利的“質子刀”，“擊碎”癌細胞DNA螺旋，進而抑制其生長、分裂。

Treatment Room of Proton Center, Shandong Cancer Hospital.

In this "nuclear explosion" that occurs inside the cell, the shock wave is precisely limited to the sub-millimeter level, which realizes the "directional blasting" of cancer cells and protects the surrounding normal tissues to the greatest extent. This not only means that the spread of the tumor is effectively suppressed, but also promotes a significant reduction in complications, so that the quality of life of cancer patients is greatly improved.

"Compared to conventional radiotherapy, the safety of proton radiation therapy is obvious. Based on our clinical experience, oral mucosal reactions, skin reactions, and radiation damage to various organs are significantly reduced in most proton radiation therapy patients. Research data show that the incidence of long-term side effects such as cardiotoxicity, pulmonary fibrosis, and radiation brain injury is also greatly reduced through proton therapy. Zhu Jian, deputy director of the Department of Radiophysical Technology, introduced.

7點半，來自淄博的8歲患者笑笑(化名)被推出治療室。因為罹患腦膠質瘤，她的頭圍比成年人還要大一圈。“這是笑笑接受質子治療的第15天，沒有出現不適的感覺，也沒出現口幹、咽痛等副作用。”笑笑媽媽說。

How should innovative medical devices such as proton therapy systems be subject to scientific and strict quality supervision?

3月25日上午，濟南市市場監管局監管人員孫愷和同事來到質子中心，進行監督檢查。 “質子治療系統像是一座建築物，它由多個大型設備組成，我們就身在其中。所以，對這裡的檢查也需要採用具有特定性、針對性的手段和方法。”孫愷介紹，“按照省葯監局要求，我們每季度開展一次檢查，確保有關制度落實執行到位。”

Heavy ion radiotherapy is also the world's cutting-edge cancer treatment technology. "Compared with protons, heavy ions are more 'lethal' to cancer cells, and their physical quality and biological effects are greater than those of protons, which can destroy the double helix of nuclear DNA of cancer cells and make them lose their ability to replicate." Zhu Jian revealed that at present, the heavy ion and neutron therapy project of the second phase of the proton center project is accelerating, and it is expected to complete the infrastructure work by the end of this year, start the installation and commissioning of the equipment next year, and submit the registration declaration. In the future, patients will be able to receive heavy ion therapy without leaving Shandong.

"The provincial drug regulatory department relies on the medical device innovation Shandong service station of the Medical Device Review Center of the State Food and Drug Administration to carry out a series of precise services and guidance for innovative medical device products, and will work together with medical institutions to help more innovative medical devices with clinical value accelerate the listing and promote the high-quality development of the nuclear drug industry in our province." The relevant person in charge of the Provincial Food and Drug Administration said. (Wang Heying)