1.Fibroblast activation protein targeting radiopharmaceuticals: From drug design to clinical translation.
Yuxuan WU ; Xingkai WANG ; Xiaona SUN ; Xin GAO ; Siqi ZHANG ; Jieting SHEN ; Hao TIAN ; Xueyao CHEN ; Hongyi HUANG ; Shuo JIANG ; Boyang ZHANG ; Yingzi ZHANG ; Minzi LU ; Hailong ZHANG ; Zhicheng SUN ; Ruping LIU ; Hong ZHANG ; Ming-Rong ZHANG ; Kuan HU ; Rui WANG
Acta Pharmaceutica Sinica B 2025;15(9):4511-4542
The activation proteins released by fibroblasts in the tumor microenvironment regulate tumor growth, migration, and treatment response, thereby influencing tumor progression and therapeutic outcomes. Owing to the proliferation and metastasis of tumors, fibroblast activation protein (FAP) is typically highly expressed in the tumor stroma, whereas it is nearly absent in adult normal tissues and benign lesions, making it an attractive target for precision medicine. Radiolabeled agents targeting FAP have the potential for targeted cancer diagnosis and therapy. This comprehensive review aims to describe the evolution of FAPI-based radiopharmaceuticals and their structural optimization. Within its scope, this review summarizes the advances in the use of radiolabeled small molecule inhibitors for tumor imaging and therapy as well as the modification strategies for FAPIs, combined with insights from structure-activity relationships and clinical studies, providing a valuable perspective for radiopharmaceutical clinical development and application.
2.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
INTRODUCTION:
Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:
In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:
A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:
Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION
ClinicalTrials.gov , NCT07034222.
Humans
;
Alzheimer Disease/drug therapy*
;
Male
;
Female
;
Aged
;
Middle Aged
;
Cognitive Dysfunction/drug therapy*
;
Aged, 80 and over
;
Amyloid beta-Peptides/metabolism*
;
Biomarkers
;
East Asian People
3.Study on Intervention of Liuwei Dihuang Capsules on Intestinal Flora of Type 2 Diabetes Mellitus with Yin Deficiency Syndrome
Dechao SONG ; Xingzhong FENG ; Xiaoyu CHEN ; Xiaolong RONG ; Huijuan GAO ; Jingni XU ; Aijia SHEN ; Xiaoqi QI ; Jing LIU ; Shidong WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(8):139-145
Objective To explore the clinical efficacy of Liuwei Dihuang Capsules for type 2 diabetes mellitus(T2DM)with yin deficiency syndrome and the effects on intestinal flora and inflammatory factors.Methods Totally 60 patients of T2DM with yin deficiency syndrome in Dongzhimen Hospital of Beijing University of Chinese Medicine from September 2022 to June 2023 were selected as the study objects,and were divided into control group and observation group according to the method of block randomization,with 30 cases in each group.Both groups received basic treatment.The control group was given a simulated agent of Liuwei Dihuang Capsules,while the observation group was given Liuwei Dihuang Capsules.The treatment course for both groups was 4 weeks.Clinical efficacy,blood glucose levels[fasting plasma glucose(FPG),2-hour postprandial plasma glucose(2 hPG),glycated albumin(GA)],serum insulin levels[fasting insulin(FINS)and insulin resistance index(HOMA-IR)],changes in gut microbiota,and serum inflammatory cytokine levels[interleukin(IL)-6,tumor necrosis factor(TNF)-α]of both groups were compared.Results The total effective rate of the observation group(76.67%)was better than that of the control group(50.00%)(P<0.05).Compared with before treatment,the FPG,2 hPG,GA,FINS and HOMA-IR decreased in the observation group,while the FPG,2 hPG and FINS decreased in the control group(P<0.05);after treatment,the Shannon index of the observation group increased after treatment(P<0.05),and the diversity of the microbiota increased;the abundance of the microbial communities such as Coprococcus 3,Cutibacterium,Pseudomonas,Faecalibaculum,Dubosiella and Mucispirillum significantly increased(P<0.05);the abundance of Sphingomonas,Corynebacterium 1,Ileibacterium,Ruminiclostridium and other microbiota communities significantly decreased(P<0.05).Compared with before treatment,the levels of IL-6 and TNF-α in both groups were significantly reduced after treatment(P<0.01,P<0.05).After treatment,the levels of IL-6 and TNF-α in the observation group were significantly lower than those in the control group(P<0.05).Conclusion Liuwei Dihuang Capsules can effectively reduce blood glucose levels in patients of T2DM with yin deficiency syndrome,improve insulin resistance,increase gut microbiota diversity,increase beneficial bacterial abundance,reduce harmful bacterial abundance,and alleviate inflammatory cytokine levels.
4.The clinical outcome of debridement antibiotic and implant retention combined with myocutaneous flap transfer for chronic implant-associated infection
Qiyuan BAO ; Junxiang WEN ; Zhusheng ZHANG ; Zhuochao LIU ; Yuchen FU ; Rong WAN ; Yaoqi YANG ; Yuhui SHEN ; Weibin ZHANG
Chinese Journal of Orthopaedics 2025;45(10):647-653
Objective:To evaluate the clinical efficacy of a novel surgical approach of debridement, antibiotics, and implant retention (DAIR) with flap transfer, for treating chronic implant infections in bone tumor patients.Methods:A retrospective review was conducted on nine consecutive patients [6 males, 3 females; median age 35(27, 51) years, range 9-71] who underwent a modified procedure of DAIR plus flap transfer between November 2022 and January 2024. The cohort included six cases of chronic periprosthetic joint infection and three cases of chronic plate and screw infection. Tumor diagnoses included seven primary malignant tumors (osteosarcoma=5, undifferentiated pleomorphic sarcoma of bone=1, synovial sarcoma=1) and two bone metastasis of renal cell carcinoma. The procedure involved wide, radical debridement, meticulous removal of biofilm from implants and surrounding soft tissue, followed by the transfer of a well vascularized musculocutaneous flap to fully envelope the contaminated interface. Pre-operative clinicopathological data, surgical details, postoperative complications and infection recurrence were analyzed.Results:The median interval between initial implantation and debridement was 10.0(3.3, 14.8) months. Median follow-up after debridement was 15.9(15.4, 18.2) months. All nine surgeries were completed as planned: six musculocutaneous flaps, two fasciocutaneous flaps and one muscle-only flap. Implants were preserved in six patients; two required subsequent removal for recurrent infection, and one patient later underwent amputation for tumor recurrence. Infection-free implant survival at 3, 6 and 12 months was 88.9%, 87.5% and 87.5%, respectively. Major complications included one donor-site hematoma, one donor-site sensory deficit and one wound healing delay. All the complications were well management. Both reinfections occurred in proximal tibial prostheses, likely due to limited flap coverage options and local anatomical constraints.Conclusion:Although reinfections happened in two cases DAIR with flap transfer provides promising short-term infection control in patients with chronic implant-associated infections following bone tumor surgery.
5.Epidemiological characteristics and related factors of multimorbidity of common diseases among children and adolescents aged 7-18 years in Guangdong Province
Meng LI ; Shaojun SHEN ; Qiuxia CHEN ; Rong LIU ; Xiao YANG ; Chengshu YANG ; Yi XING ; Yabin QU
Chinese Journal of Preventive Medicine 2025;59(3):277-285
Objective:To investigate the multimorbidity of myopia and obesity, as well as myopia and malnutrition, among children and adolescents aged 7-18 in Guangdong Province and analyze their epidemiological characteristics and related factors.Methods:A stratified random cluster sampling method was used to select 274 939 children and adolescents aged 7-18 from 21 cities in Guangdong Province in 2023. Physical examination information such as height, weight, distance vision, and diopter, as well as questionnaire survey information on dietary behavior, physical activity, screen behavior, sleep time, etc., were collected to analyze the current status and trends of multimorbidity between myopia and obesity, myopia and malnutrition. The multivariate logistic regression model was used to analyze the related factors of multimorbidity.Results:The multimorbidity rates of myopia and obesity, myopia and malnutrition in children and adolescents aged 7-18 in Guangdong Province in 2023 were 4.43% and 6.40%, respectively. The multimorbidity rates for males were 5.44% and 6.88%, respectively, which were higher than those for females, about 3.31% and 5.88% (both P<0.001). The multimorbidity rates of urban students were 5.03% and 6.73%, respectively, which were higher than those of county students at 4.03% and 6.18% (both P<0.001). The multimorbidity rates of myopia and obesity, myopia and malnutrition increased with the increase of academic stage (all P<0.001). The multimorbidity rates of myopia and obesity, as well as myopia and malnutrition, fluctuated with age, with the first decrease occurring at the age of 12. The multivariate logistic regression analysis showed that compared to children and adolescents aged 7-18 who had daily after-school tutoring <2 hours, daily screen time <2 hours, did not consume sugary drinks every day, sleep time that could meet health requirements daily, and exercised≥60 minutes of moderate-to vigorous-physical activity ≥60 minutes for at least 3 days per week, those who had daily after-school tutoring ≥2 hours ( OR=1.18, 95% CI: 1.11-1.26), daily screen time ≥2 hours ( OR=1.09, 95% CI: 1.02-1.16), consumed sugary drinks every day ( OR=1.20, 95% CI: 1.11-1.30), daily sleep time that could not meet the health requirements ( OR=1.16, 95% CI: 1.09-1.23), and no exercise per week ( OR=1.09, 95% CI: 1.01-1.18) had a higher risk of multimorbidity of myopia and obesity. Compared to children and adolescents who exercised≥60 minutes of moderate-to vigorous-physical activity ≥60 minutes for at least 3 days per week, those who exercised <3 days per week ( OR=1.20, 95% CI: 1.17-1.34) had a higher risk of multimorbidity of myopia and malnutrition. Conclusion:The multimorbidity rates of myopia and obesity, as well as myopia and malnutrition, in children and adolescents aged 7-18 in Guangdong Province are relatively low and fluctuate with age. Physical activity, screen time, consumption of sugary drinks, and sleep time may be associated with these multimorbidities.
6.Efficacy of revision surgery for hiatal hernia with gastroesophageal reflux disease after sleeve gastrectomy
Chongwen ZHAN ; Lili LIU ; Qiwei SHEN ; Bo XU ; Xiaojian FU ; Yikai SHAO ; Rong HUA ; Qiyuan YAO
Chinese Journal of General Surgery 2025;34(4):668-675
Background and Aims:Gastroesophageal reflux disease(GERD)is a common complication following sleeve gastrectomy(SG),particularly in patients with concomitant hiatal hernia,where symptoms tend to be more persistent and refractory,significantly impairing postoperative quality of life.This study aimed to evaluate the efficacy of laparoscopic hiatal hernia repair combined with gastroesophageal fixation in SG patients with severe GERD and hiatal hernia,providing clinical reference for revisional surgical strategies.Methods:The clinical data of 9 patients with severe GERD after SG who underwent laparoscopic hiatal hernia repair and gastroesophageal fixation at Huashan Hospital,Fudan University,between January 2023 and June 2024 were retrospectively analyzed.GerdQ scores,proportion of endoscopically confirmed reflux esophagitis,and proton pump inhibitor(PPI)usage were compared before and after surgery.Surgical parameters and follow-up outcomes were also recorded.Results:All patients successfully completed the surgery without major intraoperative complications,and the mean postoperative hospital stay was 5.22 d.After a mean follow-up period of 15.27 months,the GerdQ score significantly decreased from 11.67±2.00 to 7.22±1.48.The proportion of patients with GerdQ score≥8 decreased from 100.00%to 44.44%,and the rate of endoscopically confirmed GERD dropped from 88.89%to 11.11%;PPI use also significantly declined,with all differences reaching statistical significance(all P<0.05).Conclusion:Laparoscopic hiatal hernia repair combined with gastroesophageal fixation can effectively alleviate reflux symptoms in SG patients with coexisting hiatal hernia,demonstrating favorable short-term efficacy and high safety.This approach may be a preferable surgical option for selected patients.
7.Association of Body Mass Index with All-Cause Mortality and Cause-Specific Mortality in Rural China: 10-Year Follow-up of a Population-Based Multicenter Prospective Study.
Juan Juan HUANG ; Yuan Zhi DI ; Ling Yu SHEN ; Jian Guo LIANG ; Jiang DU ; Xue Fang CAO ; Wei Tao DUAN ; Ai Wei HE ; Jun LIANG ; Li Mei ZHU ; Zi Sen LIU ; Fang LIU ; Shu Min YANG ; Zu Hui XU ; Cheng CHEN ; Bin ZHANG ; Jiao Xia YAN ; Yan Chun LIANG ; Rong LIU ; Tao ZHU ; Hong Zhi LI ; Fei SHEN ; Bo Xuan FENG ; Yi Jun HE ; Zi Han LI ; Ya Qi ZHAO ; Tong Lei GUO ; Li Qiong BAI ; Wei LU ; Qi JIN ; Lei GAO ; He Nan XIN
Biomedical and Environmental Sciences 2025;38(10):1179-1193
OBJECTIVE:
This study aimed to explore the association between body mass index (BMI) and mortality based on the 10-year population-based multicenter prospective study.
METHODS:
A general population-based multicenter prospective study was conducted at four sites in rural China between 2013 and 2023. Multivariate Cox proportional hazards models and restricted cubic spline analyses were used to assess the association between BMI and mortality. Stratified analyses were performed based on the individual characteristics of the participants.
RESULTS:
Overall, 19,107 participants with a sum of 163,095 person-years were included and 1,910 participants died. The underweight (< 18.5 kg/m 2) presented an increase in all-cause mortality (adjusted hazards ratio [ aHR] = 2.00, 95% confidence interval [ CI]: 1.66-2.41), while overweight (≥ 24.0 to < 28.0 kg/m 2) and obesity (≥ 28.0 kg/m 2) presented a decrease with an aHR of 0.61 (95% CI: 0.52-0.73) and 0.51 (95% CI: 0.37-0.70), respectively. Overweight ( aHR = 0.76, 95% CI: 0.67-0.86) and mild obesity ( aHR = 0.72, 95% CI: 0.59-0.87) had a positive impact on mortality in people older than 60 years. All-cause mortality decreased rapidly until reaching a BMI of 25.7 kg/m 2 ( aHR = 0.95, 95% CI: 0.92-0.98) and increased slightly above that value, indicating a U-shaped association. The beneficial impact of being overweight on mortality was robust in most subgroups and sensitivity analyses.
CONCLUSION
This study provides additional evidence that overweight and mild obesity may be inversely related to the risk of death in individuals older than 60 years. Therefore, it is essential to consider age differences when formulating health and weight management strategies.
Humans
;
Body Mass Index
;
China/epidemiology*
;
Male
;
Female
;
Middle Aged
;
Prospective Studies
;
Rural Population/statistics & numerical data*
;
Aged
;
Follow-Up Studies
;
Adult
;
Mortality
;
Cause of Death
;
Obesity/mortality*
;
Overweight/mortality*
8.Epidemiological characteristics and related factors of multimorbidity of common diseases among children and adolescents aged 7-18 years in Guangdong Province
Meng LI ; Shaojun SHEN ; Qiuxia CHEN ; Rong LIU ; Xiao YANG ; Chengshu YANG ; Yi XING ; Yabin QU
Chinese Journal of Preventive Medicine 2025;59(3):277-285
Objective:To investigate the multimorbidity of myopia and obesity, as well as myopia and malnutrition, among children and adolescents aged 7-18 in Guangdong Province and analyze their epidemiological characteristics and related factors.Methods:A stratified random cluster sampling method was used to select 274 939 children and adolescents aged 7-18 from 21 cities in Guangdong Province in 2023. Physical examination information such as height, weight, distance vision, and diopter, as well as questionnaire survey information on dietary behavior, physical activity, screen behavior, sleep time, etc., were collected to analyze the current status and trends of multimorbidity between myopia and obesity, myopia and malnutrition. The multivariate logistic regression model was used to analyze the related factors of multimorbidity.Results:The multimorbidity rates of myopia and obesity, myopia and malnutrition in children and adolescents aged 7-18 in Guangdong Province in 2023 were 4.43% and 6.40%, respectively. The multimorbidity rates for males were 5.44% and 6.88%, respectively, which were higher than those for females, about 3.31% and 5.88% (both P<0.001). The multimorbidity rates of urban students were 5.03% and 6.73%, respectively, which were higher than those of county students at 4.03% and 6.18% (both P<0.001). The multimorbidity rates of myopia and obesity, myopia and malnutrition increased with the increase of academic stage (all P<0.001). The multimorbidity rates of myopia and obesity, as well as myopia and malnutrition, fluctuated with age, with the first decrease occurring at the age of 12. The multivariate logistic regression analysis showed that compared to children and adolescents aged 7-18 who had daily after-school tutoring <2 hours, daily screen time <2 hours, did not consume sugary drinks every day, sleep time that could meet health requirements daily, and exercised≥60 minutes of moderate-to vigorous-physical activity ≥60 minutes for at least 3 days per week, those who had daily after-school tutoring ≥2 hours ( OR=1.18, 95% CI: 1.11-1.26), daily screen time ≥2 hours ( OR=1.09, 95% CI: 1.02-1.16), consumed sugary drinks every day ( OR=1.20, 95% CI: 1.11-1.30), daily sleep time that could not meet the health requirements ( OR=1.16, 95% CI: 1.09-1.23), and no exercise per week ( OR=1.09, 95% CI: 1.01-1.18) had a higher risk of multimorbidity of myopia and obesity. Compared to children and adolescents who exercised≥60 minutes of moderate-to vigorous-physical activity ≥60 minutes for at least 3 days per week, those who exercised <3 days per week ( OR=1.20, 95% CI: 1.17-1.34) had a higher risk of multimorbidity of myopia and malnutrition. Conclusion:The multimorbidity rates of myopia and obesity, as well as myopia and malnutrition, in children and adolescents aged 7-18 in Guangdong Province are relatively low and fluctuate with age. Physical activity, screen time, consumption of sugary drinks, and sleep time may be associated with these multimorbidities.
9.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.
10.The clinical outcome of debridement antibiotic and implant retention combined with myocutaneous flap transfer for chronic implant-associated infection
Qiyuan BAO ; Junxiang WEN ; Zhusheng ZHANG ; Zhuochao LIU ; Yuchen FU ; Rong WAN ; Yaoqi YANG ; Yuhui SHEN ; Weibin ZHANG
Chinese Journal of Orthopaedics 2025;45(10):647-653
Objective:To evaluate the clinical efficacy of a novel surgical approach of debridement, antibiotics, and implant retention (DAIR) with flap transfer, for treating chronic implant infections in bone tumor patients.Methods:A retrospective review was conducted on nine consecutive patients [6 males, 3 females; median age 35(27, 51) years, range 9-71] who underwent a modified procedure of DAIR plus flap transfer between November 2022 and January 2024. The cohort included six cases of chronic periprosthetic joint infection and three cases of chronic plate and screw infection. Tumor diagnoses included seven primary malignant tumors (osteosarcoma=5, undifferentiated pleomorphic sarcoma of bone=1, synovial sarcoma=1) and two bone metastasis of renal cell carcinoma. The procedure involved wide, radical debridement, meticulous removal of biofilm from implants and surrounding soft tissue, followed by the transfer of a well vascularized musculocutaneous flap to fully envelope the contaminated interface. Pre-operative clinicopathological data, surgical details, postoperative complications and infection recurrence were analyzed.Results:The median interval between initial implantation and debridement was 10.0(3.3, 14.8) months. Median follow-up after debridement was 15.9(15.4, 18.2) months. All nine surgeries were completed as planned: six musculocutaneous flaps, two fasciocutaneous flaps and one muscle-only flap. Implants were preserved in six patients; two required subsequent removal for recurrent infection, and one patient later underwent amputation for tumor recurrence. Infection-free implant survival at 3, 6 and 12 months was 88.9%, 87.5% and 87.5%, respectively. Major complications included one donor-site hematoma, one donor-site sensory deficit and one wound healing delay. All the complications were well management. Both reinfections occurred in proximal tibial prostheses, likely due to limited flap coverage options and local anatomical constraints.Conclusion:Although reinfections happened in two cases DAIR with flap transfer provides promising short-term infection control in patients with chronic implant-associated infections following bone tumor surgery.

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