1.Expert consensus on neoadjuvant PD-1 inhibitors for locally advanced oral squamous cell carcinoma (2026)
LI Jinsong ; LIAO Guiqing ; LI Longjiang ; ZHANG Chenping ; SHANG Chenping ; ZHANG Jie ; ZHONG Laiping ; LIU Bing ; CHEN Gang ; WEI Jianhua ; JI Tong ; LI Chunjie ; LIN Lisong ; REN Guoxin ; LI Yi ; SHANG Wei ; HAN Bing ; JIANG Canhua ; ZHANG Sheng ; SONG Ming ; LIU Xuekui ; WANG Anxun ; LIU Shuguang ; CHEN Zhanhong ; WANG Youyuan ; LIN Zhaoyu ; LI Haigang ; DUAN Xiaohui ; YE Ling ; ZHENG Jun ; WANG Jun ; LV Xiaozhi ; ZHU Lijun ; CAO Haotian
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(2):105-118
Oral squamous cell carcinoma (OSCC) is a common head and neck malignancy. Approximately 50% to 60% of patients with OSCC are diagnosed at a locally advanced stage (clinical staging III-IVa). Even with comprehensive and sequential treatment primarily based on surgery, the 5-year overall survival rate remains below 50%, and patients often suffer from postoperative functional impairments such as difficulties with speaking and swallowing. Programmed death receptor-1 (PD-1) inhibitors are increasingly used in the neoadjuvant treatment of locally advanced OSCC and have shown encouraging efficacy. However, clinical practice still faces key challenges, including the definition of indications, optimization of combination regimens, and standards for efficacy evaluation. Based on the latest research advances worldwide and the clinical experience of the expert group, this expert consensus systematically evaluates the application of PD-1 inhibitors in the neoadjuvant treatment of locally advanced OSCC, covering combination strategies, treatment cycles and surgical timing, efficacy assessment, use of biomarkers, management of special populations and immune related adverse events, principles for immunotherapy rechallenge, and function preservation strategies. After multiple rounds of panel discussion and through anonymous voting using the Delphi method, the following consensus statements have been formulated: 1) Neoadjuvant therapy with PD-1 inhibitors can be used preoperatively in patients with locally advanced OSCC. The preferred regimen is a PD-1 inhibitor combined with platinum based chemotherapy, administered for 2-3 cycles. 2) During the efficacy evaluation of neoadjuvant therapy, radiographic assessment should follow the dual criteria of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune RECIST (iRECIST). After surgery, systematic pathological evaluation of both the primary lesion and regional lymph nodes is required. For combination chemotherapy regimens, PD-L1 expression and combined positive score need not be used as mandatory inclusion or exclusion criteria. 3) For special populations such as the elderly (≥ 70 years), individuals with stable HIV viral load, and carriers of chronic HBV/HCV, PD-1 inhibitors may be used cautiously under the guidance of a multidisciplinary team (MDT), with close monitoring for adverse events. 4) For patients with a poor response to neoadjuvant therapy, continuation of the original treatment regimen is not recommended; the subsequent treatment plan should be adjusted promptly after MDT assessment. Organ transplant recipients and patients with active autoimmune diseases are not recommended to receive neoadjuvant PD-1 inhibitor therapy due to the high risk of immune related activation. Rechallenge is generally not advised for patients who have experienced high risk immune related adverse events such as immune mediated myocarditis, neurotoxicity, or pneumonitis. 5) For patients with a good pathological response, individualized de escalation surgery and function preservation strategies can be explored. This consensus aims to promote the standardized, safe, and precise application of neoadjuvant PD-1 inhibitor strategies in the management of locally advanced OSCC patients.
2.Mediating role of sleep quality between job burnout and depressive symptoms among Ningxia occupational population
Mengjun CHANG ; Shuangjie YU ; Jin JI ; Jiashu ZHU ; Ye LI ; Suzhen GUAN
Journal of Environmental and Occupational Medicine 2025;42(5):557-564
Background Job burnout and depressive symptoms are prevalent among occupational populations, with a close relationship between them. Sleep quality, as a potential mediating factor, significantly affects the mental health of workers. Objective To explore the relationship between job burnout, sleep quality, and depressive symptoms, and determine whether sleep quality mediates the relationship between job burnout and depressive symptoms. Methods From April 25 to May 1, 2024, this study employed cluster sampling to conduct a questionnaire survey among individuals engaged in various occupations across five cities in the Ningxia Hui Autonomous Region. The questionnaires included socio-demographic information, as well as the Chinese Maslach Burnout Inventory (CMBI), the Pittsburgh Sleep Quality Index (PSQI), and the Patient Health Questionnaire-9 (PHQ-9) for assessing burnout, sleep quality, and depressive symptoms, respectively. Out of the
3.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
4.Chemical constituents of butyl-phthalides from Ligusticum sinense.
Hang LIU ; Xue-Ming ZHOU ; Ting ZHENG ; Mei-Zhu WU ; Shuo FENG ; Ye LIN ; Xin-Ming SONG ; Ji-Ling YI
China Journal of Chinese Materia Medica 2025;50(2):439-443
Eight butyl-phthalides, senkyunolide K(1), senkyunolide N(2), butylphthalide(3), senkyunolide I(4), senkyunolide H(5),(Z)-butylidenephthalide(6),(Z)-ligustilide(7), and 3-butylidene-7-hydroxyphthalide(8) were isolated from the aerial part of Ligusticum sinense by column chromatography on silica gel column, ODS, Sephadex LH-20 and semi-preparative HPLC. Their structures were elucidated on the basis of spectroscopic and chemical data, especially NMR and MS. Compound 1 was a new butyl-phthalide and compounds 2-8 were isolated from the aerial part of L. sinense for the first time. Furthermore, the inhibitory activities of compounds 1-8 against the nitric oxide(NO) production induced by lipopolysaccharide(LPS) in mouse RAW264.7 macrophages in vitro were evaluated. The results showed that compounds 1-8 exerted inhibitory activities on NO production with IC_(50) of 19.34-42.16 μmol·L~(-1).
Animals
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Mice
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Nitric Oxide/biosynthesis*
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Ligusticum/chemistry*
;
Benzofurans/isolation & purification*
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Drugs, Chinese Herbal/isolation & purification*
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Macrophages/immunology*
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RAW 264.7 Cells
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Molecular Structure
5.Study the influencing factors on the therapeutic effect of glucocorticoid impact in the treatment of active thyroid-related eye diseases
Xiangying ZHU ; Li DING ; Bin YE ; Xiaozhen JI
Chinese Journal of Postgraduates of Medicine 2025;48(10):890-894
Objective:To analyze the influencing factors on the therapeutic effect of glucocorticoid impact in the treatment of active thyroid-related eye diseases.Methods:A total of 106 patients with thyroid-related eye disease admitted to Lishui People's Hospital from December 2020 to January 2024 were retrospectively selected, all of whom were treated with glucocorticoid impact therapy. According to the efficacy, they were divided into poor efficacy group (34 cases) and good efficacy group (72 cases), and relevant clinical data of the two groups were compared. Single factor and multiple factor Logistic regression were used to analyze the risk factors affecting the curative effect.Results:The proportion of smoking history in the poor efficacy group was higher than that in the good efficacy group:73.53% (25/34) vs. 29.17% (21/72), there was statistical difference ( χ2 = 18.50, P<0.01). The thyroid stimulating hormone (TSH) and lymphocyte (LYM) in the poor efficacy group were lower than those in the good efficacy group: (0.08 ± 0.02) mU/L vs. (0.10 ± 0.02) mU/L, 0.175 ± 0.028 vs. 0.192 ± 0.031;the free triiodothyronine (FT 3), free thyroxine (FT 4), tumor necrosis factor - α (TNF- α), interleukin (IL) -6, IL-8, neutrophil-to-lymphocyte ratio (NLR), degree of proptosis, and clinical activity score (CAS) were higher than those in the good efficacy group: (5.28 ± 1.21) pmol/L vs. (4.73 ± 1.03) pmol/L, (15.52 ± 2.35) pmol/L vs. (14.28 ± 2.31) pmol/L, (11.82 ± 2.11) ng/L vs. (10.05 ± 2.04) ng/L, (2.12 ± 0.21) ng/L vs. (1.96 ± 0.18) ng/L, (38.56 ± 4.35) ng/L vs. (35.46 ± 4.21) ng/L, 2.52 ± 0.41 vs. 1.67 ± 0.37, (17.42 ± 2.44) mm vs. (15.32 ± 2.27) mm, (4.34 ± 0.65) scores vs. (3.98 ± 0.63) scores, there were statistical differences ( P<0.05). Multiple Logistic regression analysis showed that smoking history, TSH, FT 3, FT 4, TNF-ɑ, IL-6, IL-8, LYM, NLR, exophthalmia and CAS score were all included in the regression equation, and they were all influential factors affecting the efficacy of glucocorticoid shock therapy for thyroid-related eye diseases ( P<0.05). Conclusions:In active thyroid-related eye disease patients receiving glucocorticoid impact therapy, the efficacy may be affected by many factors, and comprehensive intervention should be implemented according to the actual situation to further improve the efficacy.
6.Trends of Incidence and Mortality of Thyroid Cancer in Nanning Cancer Registration Areas from 2016 to 2020
Qiulan HUANG ; Lin YE ; Zhu LIANG ; Ji ZHOU ; Rongjian ZHU ; Xianyan TANG
China Cancer 2025;34(11):870-876
[Purpose]To analyze the trends of incidence and mortality of thyroid cancer in the cancer registration areas of Nanning City from 2016 to 2020.[Methods]The incidence and mor-tality data of thyroid cancer from 2016 to 2020 were collected from the Nanning cancer registries,and the the quality of data was assessed.The crude incidence/mortality rates,the age-standar-dized incidence/mortality rates by Chinese standard population(ASIRC,ASMRC)and world stan-dard population(ASIRW,ASMRW),the cumulative incidence/mortality rates(0~74 years old),and the age-specific incidence/mortality rates were calculated.The Joinpoint regression model was used to estimate the trends of incidence and mortality,expressed as average annual percentage change(AAPC).[Results]From 2016 to 2020,a total of 2 291 new cases of thyroid cancer were reported in Nanning cancer registries.The crude incidence rate was 7.70/105 with the ASIRC of 7.23/105 and ASIRW of 6.22/105,the cumulative incidence rate was 0.59%.The incidence was higher in female than that in male,and higher in urban areas than that in rural areas.The incidence rate of thyroid cancer began to rise sharply from the 20 years old and reached peak in the age group of 50~54 years old.The incidence rate in female remained at a high level in the age group of 30~59 years old,which was higher than that in male.A total of 121 deaths of thyroid cancer were re-ported with a crude mortality rate of 0.41/105,ASMRC of 0.32/105,ASMRW of 0.31/105 and cu-mulative mortality rate of 0.03%.The mortality rate was higher in female than that in male.The age-specific mortality rate for thyroid cancer showed a fluctuant upward trend after the 40 years old and peaked in the age group of 75~79 years old.The crude incidence rate and ASIRC showed an upward trend in whole population(AAPC=21.11%,t=3.25,P<0.05;AAPC=22.02%,t=3.39,P<0.05),in male(AAPC=19.45%,t=4.35,P<0.05;AAPC=19.81%,t=5.74,P<0.05)and urban areas(AAPC=30.62%,t=7.13,P<0.05;AAPC=32.38%,t=7.25,P<0.05).The crude mortality rate and ASMRC in urban areas(AAPC=43.06%,t=7.73,P<0.05;AAPC=47.63%,t=8.60,P<0.05)also showed an increasing trend.[Conclusion]The crude incidence rate and ASIRC of thyroid cancer in cancer registration areas of Nanning City showed an overall upward trend from 2016 to 2020,except in rural areas;while the rising trends of the crude mortality rate and ASMRC were only observed in urban areas.
7.Study the influencing factors on the therapeutic effect of glucocorticoid impact in the treatment of active thyroid-related eye diseases
Xiangying ZHU ; Li DING ; Bin YE ; Xiaozhen JI
Chinese Journal of Postgraduates of Medicine 2025;48(10):890-894
Objective:To analyze the influencing factors on the therapeutic effect of glucocorticoid impact in the treatment of active thyroid-related eye diseases.Methods:A total of 106 patients with thyroid-related eye disease admitted to Lishui People's Hospital from December 2020 to January 2024 were retrospectively selected, all of whom were treated with glucocorticoid impact therapy. According to the efficacy, they were divided into poor efficacy group (34 cases) and good efficacy group (72 cases), and relevant clinical data of the two groups were compared. Single factor and multiple factor Logistic regression were used to analyze the risk factors affecting the curative effect.Results:The proportion of smoking history in the poor efficacy group was higher than that in the good efficacy group:73.53% (25/34) vs. 29.17% (21/72), there was statistical difference ( χ2 = 18.50, P<0.01). The thyroid stimulating hormone (TSH) and lymphocyte (LYM) in the poor efficacy group were lower than those in the good efficacy group: (0.08 ± 0.02) mU/L vs. (0.10 ± 0.02) mU/L, 0.175 ± 0.028 vs. 0.192 ± 0.031;the free triiodothyronine (FT 3), free thyroxine (FT 4), tumor necrosis factor - α (TNF- α), interleukin (IL) -6, IL-8, neutrophil-to-lymphocyte ratio (NLR), degree of proptosis, and clinical activity score (CAS) were higher than those in the good efficacy group: (5.28 ± 1.21) pmol/L vs. (4.73 ± 1.03) pmol/L, (15.52 ± 2.35) pmol/L vs. (14.28 ± 2.31) pmol/L, (11.82 ± 2.11) ng/L vs. (10.05 ± 2.04) ng/L, (2.12 ± 0.21) ng/L vs. (1.96 ± 0.18) ng/L, (38.56 ± 4.35) ng/L vs. (35.46 ± 4.21) ng/L, 2.52 ± 0.41 vs. 1.67 ± 0.37, (17.42 ± 2.44) mm vs. (15.32 ± 2.27) mm, (4.34 ± 0.65) scores vs. (3.98 ± 0.63) scores, there were statistical differences ( P<0.05). Multiple Logistic regression analysis showed that smoking history, TSH, FT 3, FT 4, TNF-ɑ, IL-6, IL-8, LYM, NLR, exophthalmia and CAS score were all included in the regression equation, and they were all influential factors affecting the efficacy of glucocorticoid shock therapy for thyroid-related eye diseases ( P<0.05). Conclusions:In active thyroid-related eye disease patients receiving glucocorticoid impact therapy, the efficacy may be affected by many factors, and comprehensive intervention should be implemented according to the actual situation to further improve the efficacy.
8.Trends of Incidence and Mortality of Thyroid Cancer in Nanning Cancer Registration Areas from 2016 to 2020
Qiulan HUANG ; Lin YE ; Zhu LIANG ; Ji ZHOU ; Rongjian ZHU ; Xianyan TANG
China Cancer 2025;34(11):870-876
[Purpose]To analyze the trends of incidence and mortality of thyroid cancer in the cancer registration areas of Nanning City from 2016 to 2020.[Methods]The incidence and mor-tality data of thyroid cancer from 2016 to 2020 were collected from the Nanning cancer registries,and the the quality of data was assessed.The crude incidence/mortality rates,the age-standar-dized incidence/mortality rates by Chinese standard population(ASIRC,ASMRC)and world stan-dard population(ASIRW,ASMRW),the cumulative incidence/mortality rates(0~74 years old),and the age-specific incidence/mortality rates were calculated.The Joinpoint regression model was used to estimate the trends of incidence and mortality,expressed as average annual percentage change(AAPC).[Results]From 2016 to 2020,a total of 2 291 new cases of thyroid cancer were reported in Nanning cancer registries.The crude incidence rate was 7.70/105 with the ASIRC of 7.23/105 and ASIRW of 6.22/105,the cumulative incidence rate was 0.59%.The incidence was higher in female than that in male,and higher in urban areas than that in rural areas.The incidence rate of thyroid cancer began to rise sharply from the 20 years old and reached peak in the age group of 50~54 years old.The incidence rate in female remained at a high level in the age group of 30~59 years old,which was higher than that in male.A total of 121 deaths of thyroid cancer were re-ported with a crude mortality rate of 0.41/105,ASMRC of 0.32/105,ASMRW of 0.31/105 and cu-mulative mortality rate of 0.03%.The mortality rate was higher in female than that in male.The age-specific mortality rate for thyroid cancer showed a fluctuant upward trend after the 40 years old and peaked in the age group of 75~79 years old.The crude incidence rate and ASIRC showed an upward trend in whole population(AAPC=21.11%,t=3.25,P<0.05;AAPC=22.02%,t=3.39,P<0.05),in male(AAPC=19.45%,t=4.35,P<0.05;AAPC=19.81%,t=5.74,P<0.05)and urban areas(AAPC=30.62%,t=7.13,P<0.05;AAPC=32.38%,t=7.25,P<0.05).The crude mortality rate and ASMRC in urban areas(AAPC=43.06%,t=7.73,P<0.05;AAPC=47.63%,t=8.60,P<0.05)also showed an increasing trend.[Conclusion]The crude incidence rate and ASIRC of thyroid cancer in cancer registration areas of Nanning City showed an overall upward trend from 2016 to 2020,except in rural areas;while the rising trends of the crude mortality rate and ASMRC were only observed in urban areas.
9.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
10.Expedited program and utilization for anticancer drug approval in China and the United States
Qi ZHU ; Huiyao HUANG ; Anqi YU ; Xinyu MENG ; Ye LENG ; Hong FANG ; Ziwei LI ; Yu TANG ; Ji LI ; Ning LI
Chinese Journal of Oncology 2024;46(9):904-910
Objective:To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021.Methods:Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison.Results:Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, P=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, P=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, P=0.041) and breakthrough therapy (2.3% vs. 50.0%, P<0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. Conclusions:Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.


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