1.Comparative analysis of diagnostic criteria for occupational radiation diseases between China and the International Labour Organization
Ru XUE ; Jingyi LI ; Jinxin JU ; Erdong CHEN
Journal of Environmental and Occupational Medicine 2026;43(5):651-655
The diagnosis of occupational radiation diseases, with the diagnostic criteria as main technical basis, has always been one of the emphases of China's occupational health work. This study compared the diagnostic standards for occupational radiation diseases between China and the International Labour Organization (ILO) across three aspects—types, classifications/grades, and diagnostic dose requirements—categorizing the diseases into tissue reactions and stochastic effects. ① For tissue reactions, 8 types are included both in China and ILO standards, 13 unique to China's standards, and 4 unique to the ILO standards; significant differences exist in classifaton/grading; China's standards are either consistent with or stricter (i.e., requiring higher diagnostic dose values) than the ILO standards. ② For stochastic effects (radiation-induced cancer), 12 types were included in both standards; China's standards provide more comprehensive coverage for certain malignancies (e.g., bone cancer); while 5 types were unique to the ILO standards have, some (e.g. salivary gland cancer) are primarily observed in non-occupational populations. Overall, China’s standards include more disease types and maintain more stringent diagnostic dose requirements. However, specific discrepancies require further deliberation during future revisions. Finally, based on these results, recommendations were provided for basic research and the evaluation of Chinese diagnostic criteria.
2.Comparative analysis of diagnostic criteria for occupational radiation diseases between China and the International Labour Organization
Ru XUE ; Jingyi LI ; Jinxin JU ; Erdong CHEN
Journal of Environmental and Occupational Medicine 2026;43(5):651-655
The diagnosis of occupational radiation diseases, with the diagnostic criteria as main technical basis, has always been one of the emphases of China's occupational health work. This study compared the diagnostic standards for occupational radiation diseases between China and the International Labour Organization (ILO) across three aspects—types, classifications/grades, and diagnostic dose requirements—categorizing the diseases into tissue reactions and stochastic effects. ① For tissue reactions, 8 types are included both in China and ILO standards, 13 unique to China's standards, and 4 unique to the ILO standards; significant differences exist in classifaton/grading; China's standards are either consistent with or stricter (i.e., requiring higher diagnostic dose values) than the ILO standards. ② For stochastic effects (radiation-induced cancer), 12 types were included in both standards; China's standards provide more comprehensive coverage for certain malignancies (e.g., bone cancer); while 5 types were unique to the ILO standards have, some (e.g. salivary gland cancer) are primarily observed in non-occupational populations. Overall, China’s standards include more disease types and maintain more stringent diagnostic dose requirements. However, specific discrepancies require further deliberation during future revisions. Finally, based on these results, recommendations were provided for basic research and the evaluation of Chinese diagnostic criteria.
3.Expert Consensus on Classification of Hand Degloving Injures and Emergency Repair of Avulsion Skin
Jihui JU ; Gang ZHAO ; Yongjun RUI ; Xin WANG ; Weiyang GAO ; Xiaoheng DING ; Qingtang ZHU ; Xianyou ZHENG ; Yongqing XU ; Shanlin CHEN ; Juyu TANG ; Lei XU ; Jianxi HOU ; Huaqiao WANG ; Jingyi MI ; Haifeng SHI ; Shusen CUI ; Chunlin HOU ; Liqiang GU
Chinese Journal of Microsurgery 2025;48(2):121-134
Hand degloving injury represents one of the most severe forms of hand trauma, characterised by challenging treatment and a complex prognostic outcome. It is crucial to effectively utilise the degloved tissues in emergency or primary repair of a hand degloving injury. This consensus provides a comprehensive review of the existing literature on definition, classification, emergency assessment, debridement, judgment of skin viability, in situ repair of the degloved skin, and adjunctive treatment for degloving injury of hand. Based on conclusion of both domestic and international experiences, this expert consensus on the classification of hand degloving injury and the emergency repair with the avulsed skin is established, aiming to provide a guidance to surgeons on standardised treatment strategy and improve the management of hand degloving injury.
4.Evidence-based guideline for diagnosis and early fixation of severe open tibiofibular fractures (version 2025)
Yongjun RUI ; Yongqing XU ; Qingtang ZHU ; Xin WANG ; Zhao XIE ; Shanlin CHEN ; Jingyi MI ; Xianyou ZHENG ; Juyu TANG ; Xiaoheng DING ; Aixi YU ; Tao SONG ; Jianxi HOU ; Jian QI ; Xinyu FAN ; Jun FEI ; Lin GUO ; Xingwen HAN ; Weixu LI ; Aiguo WANG ; Yun XIE ; Tao XING ; Meng LI ; Baoqing YU ; Yan ZHUANG ; Xiaoqing HE ; Tao SUN ; Pengcheng LI ; Jihui JU ; Hongxiang ZHOU ; Haidong REN ; Guangyue ZHAO ; Gang ZHAO ; Yongwei WU ; Jun LIU ; Yunhong MA ; Yapeng WANG
Chinese Journal of Trauma 2025;41(11):1021-1034
Severe open tibiofibular fractures account for approximately 28.1% of all open fractures. Among them, Gustilo-Anderson type IIIB/C fractures present significant clinical challenges due to associated bone and soft tissue defects, high infection rates, and risk of amputation. Inadequate preoperative assessment may lead to suboptimal emergency surgical planning or intraoperative complications. Historically, external fixation was often preferred, but this approach has been associated with limitations such as restricted joint mobility, delayed bone union, joint stiffness, and disuse osteoporosis, resulting in poor functional recovery. With advancements of debridement techniques, standardization of antibiotic use, and popularization of early soft tissue coverage, early internal fixation has gained broader acceptance. Nevertheless, controversies persist regarding the choice of fixation method, timing of definitive fixation, use of reamed versus unreamed intramedullary nailing, and necessity of fibular fixation. To standardize the diagnosis and early management of severe open tibiofibular fractures, reduce complication rates, and improve functional recovery, the Society of Microsurgery of the Chinese Medical Association organized a panel of domestic experts to develop the Evidence-based guideline for the diagnosis and early fixation of severe open tibiofibular fractures ( version 2025), using evidence-based methodology. The guidelines provided 12 recommendations covering diagnostic and early fixation strategies of severe open tibiofibular fractures, aiming to provide clinicians with scientifically grounded and standardized guidance.
5.An analysis of the application of the principles of standardized document expression in drafting radiological health standards
Jingyi LI ; Ru XUE ; Jinxin JU ; Erdong CHEN
Chinese Journal of Radiological Health 2025;34(2):279-282
High-quality standard drafting is the foundation for ensuring the effective implementation of radiological health standards. Based on the current standard drafting requirements and the practices in drafting and reviewing radiological health standards in recent years, this article analyzed and discussed the connotations of three principles of standardized document expression, including consistency, coordination, and usability, as well as their application in standard drafting. This article summarized the important considerations during drafting and provided reasonable suggestions, which can be used as a reference for standardization professionals.
6.Evidence-based guideline for diagnosis and early fixation of severe open tibiofibular fractures (version 2025)
Yongjun RUI ; Yongqing XU ; Qingtang ZHU ; Xin WANG ; Zhao XIE ; Shanlin CHEN ; Jingyi MI ; Xianyou ZHENG ; Juyu TANG ; Xiaoheng DING ; Aixi YU ; Tao SONG ; Jianxi HOU ; Jian QI ; Xinyu FAN ; Jun FEI ; Lin GUO ; Xingwen HAN ; Weixu LI ; Aiguo WANG ; Yun XIE ; Tao XING ; Meng LI ; Baoqing YU ; Yan ZHUANG ; Xiaoqing HE ; Tao SUN ; Pengcheng LI ; Jihui JU ; Hongxiang ZHOU ; Haidong REN ; Guangyue ZHAO ; Gang ZHAO ; Yongwei WU ; Jun LIU ; Yunhong MA ; Yapeng WANG
Chinese Journal of Trauma 2025;41(11):1021-1034
Severe open tibiofibular fractures account for approximately 28.1% of all open fractures. Among them, Gustilo-Anderson type IIIB/C fractures present significant clinical challenges due to associated bone and soft tissue defects, high infection rates, and risk of amputation. Inadequate preoperative assessment may lead to suboptimal emergency surgical planning or intraoperative complications. Historically, external fixation was often preferred, but this approach has been associated with limitations such as restricted joint mobility, delayed bone union, joint stiffness, and disuse osteoporosis, resulting in poor functional recovery. With advancements of debridement techniques, standardization of antibiotic use, and popularization of early soft tissue coverage, early internal fixation has gained broader acceptance. Nevertheless, controversies persist regarding the choice of fixation method, timing of definitive fixation, use of reamed versus unreamed intramedullary nailing, and necessity of fibular fixation. To standardize the diagnosis and early management of severe open tibiofibular fractures, reduce complication rates, and improve functional recovery, the Society of Microsurgery of the Chinese Medical Association organized a panel of domestic experts to develop the Evidence-based guideline for the diagnosis and early fixation of severe open tibiofibular fractures ( version 2025), using evidence-based methodology. The guidelines provided 12 recommendations covering diagnostic and early fixation strategies of severe open tibiofibular fractures, aiming to provide clinicians with scientifically grounded and standardized guidance.
7.Expert Consensus on Classification of Hand Degloving Injures and Emergency Repair of Avulsion Skin
Jihui JU ; Gang ZHAO ; Yongjun RUI ; Xin WANG ; Weiyang GAO ; Xiaoheng DING ; Qingtang ZHU ; Xianyou ZHENG ; Yongqing XU ; Shanlin CHEN ; Juyu TANG ; Lei XU ; Jianxi HOU ; Huaqiao WANG ; Jingyi MI ; Haifeng SHI ; Shusen CUI ; Chunlin HOU ; Liqiang GU
Chinese Journal of Microsurgery 2025;48(2):121-134
Hand degloving injury represents one of the most severe forms of hand trauma, characterised by challenging treatment and a complex prognostic outcome. It is crucial to effectively utilise the degloved tissues in emergency or primary repair of a hand degloving injury. This consensus provides a comprehensive review of the existing literature on definition, classification, emergency assessment, debridement, judgment of skin viability, in situ repair of the degloved skin, and adjunctive treatment for degloving injury of hand. Based on conclusion of both domestic and international experiences, this expert consensus on the classification of hand degloving injury and the emergency repair with the avulsed skin is established, aiming to provide a guidance to surgeons on standardised treatment strategy and improve the management of hand degloving injury.
8.Efficacy and safety of adalimumab originator and biosimilars in the treatment of Crohn′s disease
Xiaohui LI ; Jingyi JU ; Qinglu YANG ; Pengyun YIN ; Jiaolan YANG ; Cui ZHANG ; Changqin LIU ; Zhanju LIU ; Xiaomin SUN
Chinese Journal of Digestion 2025;45(3):177-181
Objective:To evaluate the efficacy and safety of adalimumab (ADA) originator and biosimilars in the treatment of Crohn′s disease (CD).Methods:From January 2020 to January 2023, the clinical data of 73 patients who were diagnosed as CD and received ADA treatment at the Department of Gastroenterology, the Tenth People′s Hospital of Tongji University were retrospectively analyzed. Among them, 30 patients received ADA originator treatment (National Medicine Approval Number SJ20181019; originator group), 23 patients received biosimilar A treatment (Medicine Medicine Approval Number S20190038; biosimilar A group), and 20 patients received biosimilar B (Medicine Medicine Approval Number S20190043; biosimilar B group). At 12 and 48 weeks after treatment, the clinical data of clinical remission (Crohn′s disease activity index(CDAI) score <150), clinical response (CDAI score decreased ≥ 70 from baseline), endoscopic remission (simple endoscopic score for Crohn′s disease (SES-CD) ≤ 2 or Rutgeerts score ≤ 1), endoscopic response (SES-CD decreased > 50% from baseline), and adverse drug reaction (ADR) were collected. Chi-square test or Fisher′s exact test was used for statistical analysis.Results:After 12 weeks of ADA treatment, the overall clinical remission rate was 69.9% (51/73), which of the biosimilar A group was 69.6% (16/23), the biosimilar B group was 75.0% (15/20), and the originator group was 66.7% (20/30). The overall clinical response rate was 83.6% (61/73), which of the biosimilar A group was 82.6% (19/23), the biosimilar B group was 80.0% (16/20), and the originator group was 86.7% (26/30). The overall endoscopic remission rate was 42.5% (31/73), which of the biosimilar A group was 52.2% (12/23), the biosimilar B group was 45.0% (9/20), and the originator group was 33.3% (10/30). The overall endoscopic response rate was 63.0% (46/73), which of the biosimilar A group was 73.9% (17/23), the biosimilar B group was 70.0% (14/20), and the originator group was 50.0% (15/30). And in the above data, there were no statistically significant differences among the 3 groups (all P>0.05). After 48 weeks of treatment, the overall clinical remission rate was 54.2% (32/59), which of the biosimilar A group was 8/18, the biosimilar B group was 9/15, and the originator group was 57.7% (15/26). The overall clinical response rate was 71.2% (42/59), which of the biosimilar A group was 10/18, the biosimilar B group was 12/15, and the originator group was 76.9% (20/26). The overall endoscopic remission rate was 25.4% (15/59), which of the biosimilar A group was 5/18, the biosimilar B group was 3/15, and the originator group was 26.9% (7/26). The overall endoscopic response rate was 40.7% (24/59), which of the biosimilar A group was 7/18, the biosimilar B group was 5/15, and the originator group was 46.2% (12/26). And in the above data, there were no statistically significant differences among the 3 groups (all P>0.05). The overall incidence of ADR was 32.9% (24/73), which of the biosimilar A group was 30.4% (7/23), the biosimilar B group was 30.0% (6/20), and the originator group was 36.7% (11/30); and there was no statistically significant difference among the 3 groups ( P=0.847). Conclusion:ADA biosimilars A and B demonstrate comparable efficacy and safety to the originator medication in the treatment of CD.
9.Efficacy and safety of adalimumab originator and biosimilars in the treatment of Crohn′s disease
Xiaohui LI ; Jingyi JU ; Qinglu YANG ; Pengyun YIN ; Jiaolan YANG ; Cui ZHANG ; Changqin LIU ; Zhanju LIU ; Xiaomin SUN
Chinese Journal of Digestion 2025;45(3):177-181
Objective:To evaluate the efficacy and safety of adalimumab (ADA) originator and biosimilars in the treatment of Crohn′s disease (CD).Methods:From January 2020 to January 2023, the clinical data of 73 patients who were diagnosed as CD and received ADA treatment at the Department of Gastroenterology, the Tenth People′s Hospital of Tongji University were retrospectively analyzed. Among them, 30 patients received ADA originator treatment (National Medicine Approval Number SJ20181019; originator group), 23 patients received biosimilar A treatment (Medicine Medicine Approval Number S20190038; biosimilar A group), and 20 patients received biosimilar B (Medicine Medicine Approval Number S20190043; biosimilar B group). At 12 and 48 weeks after treatment, the clinical data of clinical remission (Crohn′s disease activity index(CDAI) score <150), clinical response (CDAI score decreased ≥ 70 from baseline), endoscopic remission (simple endoscopic score for Crohn′s disease (SES-CD) ≤ 2 or Rutgeerts score ≤ 1), endoscopic response (SES-CD decreased > 50% from baseline), and adverse drug reaction (ADR) were collected. Chi-square test or Fisher′s exact test was used for statistical analysis.Results:After 12 weeks of ADA treatment, the overall clinical remission rate was 69.9% (51/73), which of the biosimilar A group was 69.6% (16/23), the biosimilar B group was 75.0% (15/20), and the originator group was 66.7% (20/30). The overall clinical response rate was 83.6% (61/73), which of the biosimilar A group was 82.6% (19/23), the biosimilar B group was 80.0% (16/20), and the originator group was 86.7% (26/30). The overall endoscopic remission rate was 42.5% (31/73), which of the biosimilar A group was 52.2% (12/23), the biosimilar B group was 45.0% (9/20), and the originator group was 33.3% (10/30). The overall endoscopic response rate was 63.0% (46/73), which of the biosimilar A group was 73.9% (17/23), the biosimilar B group was 70.0% (14/20), and the originator group was 50.0% (15/30). And in the above data, there were no statistically significant differences among the 3 groups (all P>0.05). After 48 weeks of treatment, the overall clinical remission rate was 54.2% (32/59), which of the biosimilar A group was 8/18, the biosimilar B group was 9/15, and the originator group was 57.7% (15/26). The overall clinical response rate was 71.2% (42/59), which of the biosimilar A group was 10/18, the biosimilar B group was 12/15, and the originator group was 76.9% (20/26). The overall endoscopic remission rate was 25.4% (15/59), which of the biosimilar A group was 5/18, the biosimilar B group was 3/15, and the originator group was 26.9% (7/26). The overall endoscopic response rate was 40.7% (24/59), which of the biosimilar A group was 7/18, the biosimilar B group was 5/15, and the originator group was 46.2% (12/26). And in the above data, there were no statistically significant differences among the 3 groups (all P>0.05). The overall incidence of ADR was 32.9% (24/73), which of the biosimilar A group was 30.4% (7/23), the biosimilar B group was 30.0% (6/20), and the originator group was 36.7% (11/30); and there was no statistically significant difference among the 3 groups ( P=0.847). Conclusion:ADA biosimilars A and B demonstrate comparable efficacy and safety to the originator medication in the treatment of CD.
10.Construction and application of the project approval evaluation system for traditional Chinese medicine prepara-tion in medical institutions
Xiaoyu JU ; Liang ZHAO ; Yue ZHAO ; He TANG ; Jingyi ZHANG ; Junxue LI ; Yurun XUE ; Shengjiang GUAN ; Jie CHENG
China Pharmacy 2024;35(10):1168-1173
OBJECTIVE To establish the project approval evaluation system for traditional Chinese medicine (TCM) preparations in medical institutions guided by new drug conversion, to improve the success rate of approval for TCM preparations in medical institutions and lay the foundation for the later drug conversion. METHODS Research and development team used the literature research method and brainstorming method to list and organize relevant elements of project evaluation and determine the initial indicator system. Experts were consulted using the Delphi method to confirm the evaluation index. The weights were calculated based on the proportion of importance scores for each indicator and assigned specific scores to each item. The indicator system was used to evaluate 31 TCM preparations applied for filing by various departments of our hospital from April to July 2023. RESULTS After two rounds of 17 experts’ consultation, the final TCM preparation system included five primary indicators, i.e. theoretical basis, clinical research foundation, pharmaceutical foundation, prescription, and clinical value, as well as 17 secondary indicators including prescription source, traditional Chinese medicine theory, clinical positioning and so on. Human experience was considered as the item which would be rejected as one vote. Based on the above indicator system, our hospital further improved the filing and project approval process for TCM preparations in medical institutions. Among the 31 TCM preparations applied for filing by various departments from April to July 2023, 8 TCM preparations with a score ≥65 were selected for development. CONCLUSIONS The evaluation system is objective, comprehensive, and highly operable. It is suitable for the selection of TCM preparations in medical institutions before research and development.

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