2017年 · 第97卷第19期

In order to adapt to the legal spirit of the General Principles of Civil Law of the People's Republic of China, the Law of the People's Republic of China on Practicing Physicians adopted by the Third Session of the Standing Committee of the Ninth National People's Congress on June 26, 1998, the Regulations on the Administration of Medical Institutions promulgated by the State Council on February 26, 1994, as well as administrative regulations and departmental rules, the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions, the Basic Standards of Medical Institutions (for Trial Implementation) and the Interim Provisions on the Scope of Practice in the Registration of Physicians, the medical technology management reform has been carried out at the national level, especially in order to implement the requirements of the reform of the administrative examination and approval system of the State Council, according to the Decision of the State Council on Cancelling Non-administrative License Examination and Approval Matters (Guofa [2015] No.27), the National Health and Family Planning Commission has decided to cancel the examination and approval of the third type of clinical application of medical technology. "Medical Technology with Restricted Clinical Application (2015 Edition)" is clearly put forward, with the purpose of strengthening the work measures of interim and post-event supervision after the non-administrative licensing approval of restricted medical technology, so as to ensure medical quality and patient safety.

Organized by the Medical Quality Division of the Medical Administration and Hospital Administration Bureau of the National Health and Family Planning Commission, sponsored by the Radioactive Particle Therapy Technology Expert Committee of Chinese Medical Doctors Association and the Particle Therapy Branch of the Minimally Invasive Cancer Therapy Professional Committee of China Anti-Cancer Association, and hosted by Zhongda Hospital affiliated to Southeast University, the Forum of the Radioactive Particle Implantation Therapy Technology Expert Committee was held in Nanjing in December 2016. The theme of this forum is: Dose and Quality, Technology and Quality. After the discussion at the meeting, a number of new views and ideas were produced, the current industry problems of radioactive particle therapy were pointed out, and the future development direction of the industry was put forward.

In recent years, Western countries such as the United States and the United Kingdom have successively launched national-level precision medicine research, and my country also launched a precision medicine program in 2016^[1]。 precision medicine is a medical model that fully considers the individual differences of patients in genes, environment and lifestyle to achieve the most effective disease treatment and prevention. Its core concept is to synthesize multi-dimensional data related to human health and disease prevention, and on this basis, treat and prevent diseases, improve population health, avoid excessive medical treatment, and better allocate medical resources. The focus of precision medicine research is to explore and interpret the pathogenesis of diseases with the help of new biological technologies and IT technologies, explore the differences in genes, environment and lifestyle of sick individuals to the greatest extent, complete deep integration with clinical data, and establish a knowledge system through advanced technologies such as artificial intelligence, predictive models and machine learning, so as to put forward new concepts, methods and schemes for the treatment and prevention of diseases^[2]。 In March 2016, precision medicine was officially included in the 13th Five-Year Plan and became one of the strategic directions for China's future medical development.

This specification is formulated in order to standardize the clinical application of radioactive particle implantation therapy technology and ensure medical quality and medical safety. This specification is the minimum requirement for medical institutions and their medical staff to carry out radioactive particle implantation therapy technology. The term "radioactive particle implantation therapy technology" mentioned in this specification refers to the radioactive particle implantation therapy technology of malignant tumors, and the application scope covered includes: radioactive particle implantation under the guidance of percutaneous imaging (ultrasound, CT, MRI, etc.) of solid tumors, endoscopic (including laparoscopy, thoracoscopy, natural tube endoscopy, etc.) radioactive particle implantation, cavity organ particle stent implantation, and radioactive particle implantation under direct surgical vision.

Members of the Expert Group:Zhang Fujun (Center for Medical Imaging and Minimally Invasive Cancer, Affiliated Cancer Hospital of Sun Yat-sen University); Wang Junjie (Department of Radiotherapy, Peking University Third Hospital); Guo Jinhe (Department of Radiology and Vascular Intervention, Zhongda Hospital affiliated to Southeast University); Zhang Jianguo (Department of Oral and Maxillofacial Surgery, Peking University Stomatological Hospital); Hu Xiaokun (Interventional Medicine Center, Affiliated Hospital of Qingdao University); Gai Baodong (Department of Gastrointestinal Surgery, China-Japan Friendship Hospital, Jilin University); Chai Shude (Department of Thoracic Surgery, Second Hospital of Tianjin Medical University); Teng Gaojun (Department of Radiology and Vascular Intervention, Zhongda Hospital affiliated to Southeast University); Li Yuliang (Department of Intervention, Second Hospital of Shandong University); Lu Ligong (Interventional Department, Zhujiang People's Hospital); Xiang Hua (Department of Interventional and Vascular Surgery, Hunan Provincial People's Hospital)

In 2009, the National Health Authority¹²⁵I seed implantation therapeutic technologies are included in the third category of medical technologies, and the radioactive¹²⁵I Particle Access and Application Management Specifications. In 2017, the National Health and Family Planning Commission aimed to further guarantee radioactivity¹²⁵I medical quality and safety of seed implantation therapy, will radioactive¹²⁵I Particle implantation therapy changed to restricted medical technology^[1]。 After more than ten years of development, radioactive¹²⁵I seed implantation plays an increasingly prominent role in multidisciplinary comprehensive treatment of tumor^[2,3]。 With the widespread application of this technology, radioactive¹²⁵The radiation protection of I particles has been paid more and more attention. At present, the state has not promulgated radioactive¹²⁵I Criteria for the management of radiation protection in particle wards.

A 56-year-old male was admitted to Guangzhou First People's Hospital on August 1, 2016 due to "sudden squeeze-like chest pain for 3 h". Body weight 62 kg. No previous drug or family allergy history. Physical examination at admission: body temperature 36.1 ℃, 19 breaths/min, 105 pulses/min, blood pressure 153/85 mmHg (1 mmHg =0.133 kPa). The mind was clear, there was no bleeding or rash on the skin and mucous membranes, the breathing sounds of both lungs were clear, no cardiopathological murmur was heard, the bilateral radial artery pulsed well, and the limbs were not swollen. The electrocardiogram showed a dorsal upward elevation of 0.2~0.5 mV in the ST segment of leads V1~ V5. Color ultrasound showed left atrial enlargement, mild mitral insufficiency, reduced anterior wall movement, and normal left ventricular systolic function. GRACE had a danger score of 101 and CRUSADE had a bleed score of 26. Emergency myocardial examination of three items: myoglobin 1 597.1 ng/ml, troponin I 80 ng/ml, creatine kinase MB isoenzyme Ⅱ 240.2 ng/ml. Hemoglobin 161 g/L, platelets 233×10⁹/L. Blood coagulation function was normal. Coronary heart disease diagnosed after admission: acute extensive anterior wall myocardial infarction. After admission, he was treated with aspirin 300 mg and clobigrel 300 mg oral loading. The patient refused direct interventional surgery due to poor economic conditions. After comprehensive evaluation, there was indication of thrombolysis, and thrombolytic therapy with alteplase was performed. The puncture vein of the right forearm failed. Instead, the puncture vein of the left forearm was successfully placed with an indwelling needle for thrombolysis. Before thrombolysis, 3 000 U of unfractionated heparin was given to heparinization. It was planned to give alteplase 100 mg (Boehringer Ingelheim Pharmaceuticals, Germany) for 90 minutes. First, 15 mg was intravenously injected, followed by continuous intravenous drip of 50 mg for 30 minutes, and the remaining 35 mg was continuously intravenously injected for 60 minutes. About 1 hour after the start of thrombolysis, the patient felt swelling in the right forearm, and soon blood blisters and blisters appeared (Figure 1), blood pressure was measured at 130/70 mmHg, alteplase was discontinued immediately, and local symptoms were further aggravated after 2 h (Figure 2), the right radial artery pulsed normally, the skin of the right hand was slightly cooler, and the circumference of the right forearm was 3~4 cm larger than that of the left forearm. Emergency ultrasound showed no hematoma, no abnormalities in arteries and veins, only thickening of subcutaneous tissue. Fibrinogen was 3.01 g/L before thrombolysis, which was undetectable the next day. Hemoglobin was 161 g/L before thrombolysis and 108 g/L on day 3. No bleeding was found in other parts such as the digestive tract, and no red blood cells were transfused. Monitor the patient's vital signs closely, raise the affected limb, drain by gravity, pierce large blood blisters with a sterile needle, cover with petrolatum oil gauze, then cover with sterile ordinary gauze block, and then apply magnesium sulfate wet compress for 1 d, then change to boric acid gauze block wet compress, take Willitan orally, and use sodium aescin intravenously. It began to improve after 1 d, and further improved on the 4th day. To Day 6 (Figure 3), the patient's bleeding performance improved significantly, and there was no chest pain attack after using the above hemostatic drugs. On the 9th day, the patient did not want to stay in hospital for too long due to poor economic conditions, and insisted on discharge. After 3 months of follow-up, the condition was good, the skin of the right upper limb completely healed, and the hemoglobin rose to 130 g/L.

With the increasing infertility rate (about 12.5% ~15%), assisted reproductive technology (ART) has become the first clinical choice to solve this problem. At the same time, there are also many problems such as low embryo implantation rate and birth rate (about 50% and 35% respectively), high congenital defect rate (0.5% ~1%), abnormal glucose metabolism, changes in DNA methylation pattern and changes in the expression of imprinted genes (such as H19), etc^[1]。 Embryos have very stringent requirements for in vitro culture environment, O₂Concentration, amino acid composition, mineral oil coverage, culture volume, culture density, temperature, humidity, pH value and artificial micromanipulation pressure may cause abnormal embryo development, among which light is also one of the important influencing factors^[2]。 In the natural state, female reproduction and embryo growth and development are completely protected from light, but ART means expose gametes and embryos to various wavelengths and intensities of light sources: microscope light source, indoor lighting and outdoor light, among which microscope light is the most serious influence^[3]。 It is of great significance and value to study and clarify the influence of light on early embryo development in ensuring embryo safety and offspring health. This article will summarize and discuss from the following aspects.