1.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
2.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
3.Expert consensus on surgical treatment and rehabilitation for competitive sports athletes returning to sports after anterior cruciate ligament injury (version 2025)
Kai HUANG ; Lunhao BAI ; Qing BI ; Hong CHEN ; Jiwu CHEN ; Xuesong DAI ; Wenyong FEI ; Weili FU ; Zhizeng GAO ; Lin GUO ; Yinghui HUA ; Jingmin HUANG ; Suizhu HUANG ; Xuan HUANG ; Jian LI ; Qiang LI ; Shuzhen LI ; Yanlin LI ; Yunxia LI ; Zhong LI ; Ning LIU ; Yuqiang LIU ; Wei LU ; Hongbin LYU ; Haile PAN ; Xiaoyun PAN ; Chao QI ; Weiliang SHEN ; Luning SUN ; Jin TANG ; Zimin WANG ; Bide WANG ; Ru WANG ; Shaobai WANG ; Licheng WEI ; Weidong XU ; Yongsheng XU ; Jizhou YANG ; Liang YANG ; Rui YANG ; Hongbo YOU ; Tengbo YU ; Jiakuo YU ; Bing YUE ; Hua ZHANG ; Hui ZHANG ; Qingsong ZHANG ; Xintao ZHANG ; Jiajun ZHAO ; Lilian ZHAO ; Qichun ZHAO ; Song ZHAO ; Jiapeng ZHENG ; Jiang ZHENG ; Zhi ZHENG ; Jingbin ZHOU ; Jinzhong ZHAO
Chinese Journal of Trauma 2025;41(4):325-338
With the rapid development of competitive sports, the incidence of anterior cruciate ligament (ACL) injury is on the rise. Such injuries may shorten athletes′ career and lead to other long-term adverse consequences. Although athletes generally recover well after ACL reconstruction, many still struggle to return to their pre-injury performance levels. Advances in the understanding of ACL anatomy and injury mechanisms, along with the evolution of surgical techniques and rehabilitation methods, have provided more individualized and tailored options for athletes following ACL injuries. However, there is currently no consensus in China regarding surgical and rehabilitation strategies for competitive athletes aiming to return to sports after ACL injuries. To this end, the Sports Medicine Committee of the Chinese Research Hospital Association and the Editorial Board of the Chinese Journal of Trauma jointly formulated the Expert consensus on surgical treatment and rehabilitation for competitive sports athletes returning to sports after anterior cruciate ligament injury ( version 2025), and presented 14 recommendations covering surgical indications, preoperative rehabilitation, surgical timing, surgical strategies and postoperative rehabilitation strategies, aiming to improve the surgical treatment and rehabilitation system for ACL injuries in competitive athletes and facilitate their return to high-level sports performance after injury.
4.Environmental Temperature and the Risk of Hand, Foot, and Mouth Disease Transmission in the Yangtze River Region of China.
Yan Qing YANG ; Min CHEN ; Jin LI ; Kai Qi LIU ; Xue Yan GUO ; Xin XU ; Qian LIANG ; Xing Lu WU ; Su Wen LEI ; Jing LI
Biomedical and Environmental Sciences 2025;38(3):290-302
OBJECTIVE:
To assess health equity in the Yangtze River region to improve understanding of the correlation between hand, foot, and mouth disease (HFMD) and socioeconomic factors.
METHODS:
From 2014-2016, data on HFMD incidence, population statistics, economic indicators, and meteorology from 26 cities along the Yangtze River were analyzed. A multi-city random-effects meta-analysis was performed to study the relationship between temperature and HFMD transmission, and health equity was assessed with respect to socio-economic impact.
RESULTS:
Over the study period, 919,458 HFMD cases were reported, with Shanghai (162,303) having the highest incidence and Tongling (5,513) having the lowest. Males were more commonly affected (male-to-female ratio, 1.49:1). The exposure-response relationship had an M-shaped curve, with two HFMD peaks occurring at 4 °C and 26 °C. The relative risk had two peaks at 1.30 °C (1.834, 95% CI: 1.204-2.794) and 31.4 °C (1.143, 95% CI: 0.901-1.451), forming an M shape, with the first peak higher than the second. The most significant impact of temperature on HFMD was observed between -2 °C and 18.1 °C. The concentration index (0.2463) indicated moderate concentration differences, whereas the Theil index (0.0418) showed low inequality in distribution.
CONCLUSION
The incidence of HFMD varied across cities, particularly with changes in temperature. Economically prosperous areas showed higher risks, indicating disparities. Targeted interventions in these areas are crucial for mitigating the risk of HFMD.
Female
;
Humans
;
Male
;
China/epidemiology*
;
Cities/epidemiology*
;
Hand, Foot and Mouth Disease/transmission*
;
Incidence
;
Risk Factors
;
Temperature
5.Asian consensus on normothermic intraperitoneal and systemic treatment for gastric cancer with peritoneal metastasis
Zhenggang ZHU ; Kitayama Joji ; Hyung-Ho Kim ; Jimmy Bok-Yan So ; Hui CAO ; Lin CHEN ; Xiangdong CHENG ; Jiankun HU ; Imano Motohiro ; Ishigami Hironori ; Ye Seob Jee ; Jong-Han Kim ; Yasuhiro Kodera ; Han LIANG ; Xiaowen LIU ; Sheng LU ; Yiping MOU ; Mingming NIE ; Won Jun Seo ; Yanong WANG ; Dan WU ; Zekuan XU ; Yamaguchi Hironori ; Chao YAN ; Zhongyin YANG ; Kai YIN ; Yonemura Yutaka ; Wei-Peng Yong ; Jiren YU ; Jun ZHANG ; Asian Gastric Cancer NIPS Treatment Collaborative Group ; Shanghai Anticancer Association, Committee of Peritoneal Tumor
Journal of Surgery Concepts & Practice 2025;30(4):277-294
Gastric cancer with peritoneal metastasis (GCPM) is a common and lethal manifestation of advanced gastric cancer, with a median survival of only 5-11 months. This consensus was developed by 30 experts from Asia (China, Japan, Korea, and Singapore) using the Delphi method and the GRADE evidence grading system. A total of 29 statements were formulated, covering the diagnosis and assessment of GCPM, indications for laparoscopic exploration and NIPS (normothermic intraperitoneal and systemic treatment), treatment regimens, prevention and management of complications, criteria for conversion surgery, and postoperative intraperitoneal therapy. The consensus aims to standardize clinical practice and improve the prognosis of patients with GCPM.
6.Multicenter retrospective study of transoral robotic surgery for supraglottic laryngeal cancer
Kai XU ; Lei TAO ; Yan WANG ; Faya LIANG ; Chengzhi XU ; Lanlan DENG ; Xin ZOU ; Xiang LU ; Xiaoming HUANG ; Ping HAN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(3):266-271
Objective:To explore the safety, effectiveness, and short-term outcomes of transoral robotic surgery (TORS) for supraglottic laryngeal cancer.Methods:A retrospective analysis was conducted on patients with supraglottic laryngeal cancer who underwent TORS at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Eye Ear Nose and Throat Hospital of Fudan University, and the First Affiliated Hospital of China Medical University between January 2018 and April 2024. Data on operative time, intraoperative blood loss, postoperative hospital stay, perioperative tracheostomy, nasogastric feeding, complications, and short-term follow-up were analyzed. Statistical analysis was performed using Python.Results:A total of 27 patients with supraglottic laryngeal cancer were included from the four centers, including 24 males and 3 females, with a median age of 66 (65, 68) years [ M( Q1, Q3), same below]. There were 26 cases of squamous cell carcinoma and 1 case of adenoid cystic carcinoma.The TNM staging included T1 in 10 cases (37.04%), T2 in 13 cases (48.15%), and T3 in 4 cases (14.81%); N0 in 14 cases (51.85%), N1 in 7 cases (25.93%), and N2 in 6 cases (22.22%). The Da Vinci Si system was used in 23 cases, and the Da Vinci Xi in 4 cases. The robotic surgical time was 53 (30, 58) min. Concurrent neck dissection was performed in 25 cases, neoadjuvant therapy was given preoperatively in 8 cases (29.63%), and postoperative radiotherapy was administered in 13 cases (48.15%). Tracheostomy was performed in 11 cases (40.74%). Nasogastric tube placement was required in 23 cases (85.19%), with a median duration of 16 (12, 21) days. The postoperative hospital stay was 9.19±4.07 days. The median follow-up time was 12 (3, 30) months. Local recurrence occurred in 2 cases. The 3-year overall survival rate was 100%, and the 3-year disease-free survival rate was 94.1%. Conclusion:With appropriate patient selection, TORS for supraglottic laryngeal cancer demonstrates satisfactory short-term outcomes, thereby offering advantages in safety, efficacy, and minimal invasiveness, which can be considered a new treatment option for this condition.
7.Multicenter study on the efficacy of transoral robotic surgery for malignant tongue base tumors
Ming SONG ; Chengzhi XU ; Kai XU ; Faya LIANG ; Huijun YANG ; Chunping WU ; Shuwei CHEN ; Lanjun CAI ; Ping HAN ; Longjuan CHU ; Changding HE ; Xing ZHANG ; Liang ZHOU ; Yan WANG ; Xiaoming HUANG ; Xiang LU ; Ankui YANG ; Lei TAO
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(3):278-284
Objective:To evaluate the clinical efficacy of transoral robotic surgery (TORS) in the treatment of malignant tongue base tumors.Methods:A multicenter study was conducted to collect and analyze the clinical data of patients with malignant tongue base tumors who underwent TORS at five otolaryngology-head and neck surgery centers in China, including Eye Ear Nose and Throat Hospital of Fudan University, Sun Yat-sen University Cancer Center, Tongji Hospital of Huazhong University of Science and Technology, Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and the First Affiliated Hospital of China Medical University between January 2017 and January 2023. Among the patients, 38 were males and 11 were females, with a mean age of 59.0±8.8 years. Baseline characteristics, complications, and follow-up data were compared between groups. Independent sample t-tests or Mann-Whitney U tests was used for comparisons of continuous variables; chi-square tests or Fisher′s exact tests was applied for categorical variables. Survival analysis was performed using the Kaplan-Meier method to calculate overall survival and disease-free survival, and differences between groups were compared using the log-rank test. Results:Among the 49 patients, 41 (83.7%) were diagnosed with squamous cell carcinoma (SCC), with a p16 positive rate of 51.2% (21/41). There were no statistically significant differences between the p16-positive group ( n=21) and the p16-negative group ( n=20) in age, sex, or postoperative bleeding (all P>0.05). However, there was a significant difference in TNM stage between the two groups ( χ2=14.556, P=0.020), with the p16-positive group predominantly in stage I (66.7%) and the p16-negative group primarily in stages Ⅲ and Ⅳ (40.0% and 30.0%, respectively). The postoperative tracheotomy rate was 30.6% (15/49), and the incidence of postoperative bleeding was 6.1% (3/49). The 1-year and 3-year overall survival rates were 98.0% and 92.5%, respectively, while, the 1-year and 3-year disease-free survival rates were 89.2% and 84.9%, respectively. No significant differences were observed between the p16-positive and p16-negative groups in 3-year overall survival (100% vs. 83.8%, χ2=1.093, P=0.518) or 3-year disease-free survival (68.2% vs. 88.9%, χ2=2.161, P=0.382). Conclusion:TORS for malignant tongue base tumors demonstrates high clinical safety and favorable oncological outcomes.
8.Multicenter retrospective analysis of transoral robotic surgery for parapharyngeal space neoplasm
Lei TAO ; Xiaoming HUANG ; Xiang LU ; Ming SONG ; Longjuan CHU ; Huijun YANG ; Liang ZHOU ; Chengzhi XU ; Chunping WU ; Faya LIANG ; Kai XU ; Ankui YANG ; Xing ZHANG ; Shuwei CHEN ; Yan WANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(3):285-291
Objective:To investigate the efficacy and feasibility of transoral robotic surgery (TORS) for resection of tumors in the parapharyngeal spaces.Methods:The clinical data of 57 patients who underwent TORS for parapharyngeal space tumors from September 2018 to February 2024 were retrospectively analyzed. These patients were treated at five medical institutions: The First Affiliated Hospital of China Medical University, Eye & ENT Hospital of Fudan University, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Sun Yat-sen University Cancer Center. The patients were 28 males and 29 females, aged 17-77 years (median age, 47 years). The pathological types, locations, and sizes of the tumors, operation time, intraoperative bleeding volumes, postoperative hospital stays, and postoperative complications were evaluated. The data were analyzed using SPSS 27.0 software.Results:Postoperative pathological examination revealed 11 types of benign tumors. Among 57 cases, 27 cases had their tumors in the prestyloid spaces, predominantly with pleomorphic adenoma ( n=17), and 30 cases in the retrostyloid spaces, predominantly with schwannoma ( n=22). The tumor volumes ranged from 0.6 to 130.1 cm3, the intraoperative bleeding volumes ranged from 5 to 1 000 ml, the operation time ranged from 20 to 390 min, and the postoperative hospital stays ranged from 2 to 25 days. The total costs for individual cases were 36 000-100 000 yuan, with the highest cost in the case suffering from cerebrovascular accident. Four patients(7.0%) had tracheotomy and 36(63.2%) had nasogastric tube placement. Among the 57 patients, 5 had postoperative cavity effusion, 2 had wound dehiscence, 2 had cerebrovascular accidents, 1 had Horner syndrome, and 2 had other complications. The patients were followed up for 1-67 months, with only 1 patient with intracranial and extracranial communication relapsed. Conclusion:TORS is a safe and feasible approach for treating parapharyngeal space tumors, offering advantages such as minimal invasiveness, reduced blood loss, and faster recovery. It is suitable for parapharyngeal space tumors of various pathological types and locations. The postoperative complications are manageable, with favorable long-term follow-up results and low recurrence rates.
9.Expert consensus on surgical treatment and rehabilitation for competitive sports athletes returning to sports after anterior cruciate ligament injury (version 2025)
Kai HUANG ; Lunhao BAI ; Qing BI ; Hong CHEN ; Jiwu CHEN ; Xuesong DAI ; Wenyong FEI ; Weili FU ; Zhizeng GAO ; Lin GUO ; Yinghui HUA ; Jingmin HUANG ; Suizhu HUANG ; Xuan HUANG ; Jian LI ; Qiang LI ; Shuzhen LI ; Yanlin LI ; Yunxia LI ; Zhong LI ; Ning LIU ; Yuqiang LIU ; Wei LU ; Hongbin LYU ; Haile PAN ; Xiaoyun PAN ; Chao QI ; Weiliang SHEN ; Luning SUN ; Jin TANG ; Zimin WANG ; Bide WANG ; Ru WANG ; Shaobai WANG ; Licheng WEI ; Weidong XU ; Yongsheng XU ; Jizhou YANG ; Liang YANG ; Rui YANG ; Hongbo YOU ; Tengbo YU ; Jiakuo YU ; Bing YUE ; Hua ZHANG ; Hui ZHANG ; Qingsong ZHANG ; Xintao ZHANG ; Jiajun ZHAO ; Lilian ZHAO ; Qichun ZHAO ; Song ZHAO ; Jiapeng ZHENG ; Jiang ZHENG ; Zhi ZHENG ; Jingbin ZHOU ; Jinzhong ZHAO
Chinese Journal of Trauma 2025;41(4):325-338
With the rapid development of competitive sports, the incidence of anterior cruciate ligament (ACL) injury is on the rise. Such injuries may shorten athletes′ career and lead to other long-term adverse consequences. Although athletes generally recover well after ACL reconstruction, many still struggle to return to their pre-injury performance levels. Advances in the understanding of ACL anatomy and injury mechanisms, along with the evolution of surgical techniques and rehabilitation methods, have provided more individualized and tailored options for athletes following ACL injuries. However, there is currently no consensus in China regarding surgical and rehabilitation strategies for competitive athletes aiming to return to sports after ACL injuries. To this end, the Sports Medicine Committee of the Chinese Research Hospital Association and the Editorial Board of the Chinese Journal of Trauma jointly formulated the Expert consensus on surgical treatment and rehabilitation for competitive sports athletes returning to sports after anterior cruciate ligament injury ( version 2025), and presented 14 recommendations covering surgical indications, preoperative rehabilitation, surgical timing, surgical strategies and postoperative rehabilitation strategies, aiming to improve the surgical treatment and rehabilitation system for ACL injuries in competitive athletes and facilitate their return to high-level sports performance after injury.
10.Multicenter retrospective study of transoral robotic surgery for supraglottic laryngeal cancer
Kai XU ; Lei TAO ; Yan WANG ; Faya LIANG ; Chengzhi XU ; Lanlan DENG ; Xin ZOU ; Xiang LU ; Xiaoming HUANG ; Ping HAN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(3):266-271
Objective:To explore the safety, effectiveness, and short-term outcomes of transoral robotic surgery (TORS) for supraglottic laryngeal cancer.Methods:A retrospective analysis was conducted on patients with supraglottic laryngeal cancer who underwent TORS at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Eye Ear Nose and Throat Hospital of Fudan University, and the First Affiliated Hospital of China Medical University between January 2018 and April 2024. Data on operative time, intraoperative blood loss, postoperative hospital stay, perioperative tracheostomy, nasogastric feeding, complications, and short-term follow-up were analyzed. Statistical analysis was performed using Python.Results:A total of 27 patients with supraglottic laryngeal cancer were included from the four centers, including 24 males and 3 females, with a median age of 66 (65, 68) years [ M( Q1, Q3), same below]. There were 26 cases of squamous cell carcinoma and 1 case of adenoid cystic carcinoma.The TNM staging included T1 in 10 cases (37.04%), T2 in 13 cases (48.15%), and T3 in 4 cases (14.81%); N0 in 14 cases (51.85%), N1 in 7 cases (25.93%), and N2 in 6 cases (22.22%). The Da Vinci Si system was used in 23 cases, and the Da Vinci Xi in 4 cases. The robotic surgical time was 53 (30, 58) min. Concurrent neck dissection was performed in 25 cases, neoadjuvant therapy was given preoperatively in 8 cases (29.63%), and postoperative radiotherapy was administered in 13 cases (48.15%). Tracheostomy was performed in 11 cases (40.74%). Nasogastric tube placement was required in 23 cases (85.19%), with a median duration of 16 (12, 21) days. The postoperative hospital stay was 9.19±4.07 days. The median follow-up time was 12 (3, 30) months. Local recurrence occurred in 2 cases. The 3-year overall survival rate was 100%, and the 3-year disease-free survival rate was 94.1%. Conclusion:With appropriate patient selection, TORS for supraglottic laryngeal cancer demonstrates satisfactory short-term outcomes, thereby offering advantages in safety, efficacy, and minimal invasiveness, which can be considered a new treatment option for this condition.

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