1.Effect analysis of titanium wire-absorbable suture dual line combined firm stitching technique in costal cartilage framework shaping for congenital microtia auricular reconstruction
Jianwen QU ; Yang JIA ; Zhen KONG ; Chunli ZHANG ; Lin LIN ; Bo PAN ; Chuan LI
Chinese Journal of Medical Aesthetics and Cosmetology 2025;31(1):30-35
Objective:To investigate the effect of titanium wire-absorbable suture dual line combined firm stitching technique in costal cartilage framework shaping for auricular reconstruction in congenital microtia patients.Methods:A retrospective study was conducted on 120 patients with congenital microtia who underwent auricular reconstruction surgery at the Plastic Surgery Hospital of Chinese Academy of Medical Sciences and Peking Union Medical College from January 2020 to December 2021. Among these, 86 were male and 34 were female, with an age range of 6-15 (8.5±2.1) years. All patients underwent auricular reconstruction using the expanded skin flap method, and the titanium wire-absorbable suture dual line combined firm stitching technique was used to construct a multi-layer three-dimensional autologous costal cartilage framework. Postoperative follow-up was conducted for 1 to 3 years to evaluate the morphology, stability, patient satisfaction, and occurrence of adverse reactions.Results:Of the 120 patients, 119 (99.2%) achieved primary healing. The reconstructed auricles were lifelike with clear substructures, and the long-term shape of the auricles remained stable without significant deformation. One patient developed a local skin infection and ulceration, leading to exposure of the cartilage framework, which was successfully repaired using a temporal fascia flap and free skin graft. A total of 85.8% (103/120) of the patients were satisfied with the postoperative results, 13.3% (16/120) rated the outcome as average, and 0.8% (1/120) were dissatisfied. No cases of hematoma or flap necrosis were observed in any of the patients.Conclusion:The costal cartilage framework, constructed using the titanium wire-absorbable suture dual line combined firm stitching technique, demonstrates good clinical effects for auricular reconstruction with no severe adverse reactions.
2.Effect analysis of titanium wire-absorbable suture dual line combined firm stitching technique in costal cartilage framework shaping for congenital microtia auricular reconstruction
Jianwen QU ; Yang JIA ; Zhen KONG ; Chunli ZHANG ; Lin LIN ; Bo PAN ; Chuan LI
Chinese Journal of Medical Aesthetics and Cosmetology 2025;31(1):30-35
Objective:To investigate the effect of titanium wire-absorbable suture dual line combined firm stitching technique in costal cartilage framework shaping for auricular reconstruction in congenital microtia patients.Methods:A retrospective study was conducted on 120 patients with congenital microtia who underwent auricular reconstruction surgery at the Plastic Surgery Hospital of Chinese Academy of Medical Sciences and Peking Union Medical College from January 2020 to December 2021. Among these, 86 were male and 34 were female, with an age range of 6-15 (8.5±2.1) years. All patients underwent auricular reconstruction using the expanded skin flap method, and the titanium wire-absorbable suture dual line combined firm stitching technique was used to construct a multi-layer three-dimensional autologous costal cartilage framework. Postoperative follow-up was conducted for 1 to 3 years to evaluate the morphology, stability, patient satisfaction, and occurrence of adverse reactions.Results:Of the 120 patients, 119 (99.2%) achieved primary healing. The reconstructed auricles were lifelike with clear substructures, and the long-term shape of the auricles remained stable without significant deformation. One patient developed a local skin infection and ulceration, leading to exposure of the cartilage framework, which was successfully repaired using a temporal fascia flap and free skin graft. A total of 85.8% (103/120) of the patients were satisfied with the postoperative results, 13.3% (16/120) rated the outcome as average, and 0.8% (1/120) were dissatisfied. No cases of hematoma or flap necrosis were observed in any of the patients.Conclusion:The costal cartilage framework, constructed using the titanium wire-absorbable suture dual line combined firm stitching technique, demonstrates good clinical effects for auricular reconstruction with no severe adverse reactions.
3.A survey on the management status and indicators of pathogen detection rate before antimicrobial treatment of inpatients in 265 medical institu-tions in Guangdong Province
Jia-jin CHEN ; Zhen-feng ZHONG ; Shi-yun WANG ; Ting HUANG ; Shu-xian CHEN ; Chen ZHU ; Yi-nan LI ; Li-li PENG ; Yuan-chun MO ; Min-shan CHEN ; Wei-qing LIN ; Xiu-juan QU ; Fang YU ; Zhi-xing LI ; Shu-mei SUN
Chinese Journal of Infection Control 2024;23(12):1499-1507
Objective To evaluate the management and indicators of pathogen detection before antimicrobial treat-ment for inpatients in second level and above medical institutions(MIs)in Guangdong Province,and provide direc-tion and decision-making basis for the improvement of pathogen detection quality in the region.Methods The ma-nagement status,information system functions,and pathogen detection rate indicators of secondary and above MIs in 21 cities in Guangdong Province was surveyed through online questionnaire surveys and system submission.A baseline survey on sentinel monitoring MIs was conducted from July 15th to August 8th,2023.From November 7th to 30th,a baseline survey on non-sentinel monitoring MIs was launched.Surveys on indicator information of all MIs were completed from January 15th to 30th,2024.Results A total of 265 MIs were surveyed,and the proportions of establishing special working groups(83.98%),developing special action improvement plans(79.01%),estab-lishing pathogen detection rate management systems(91.71%),and developing management assessment plans(76.80%)of tertiary MIs were all higher than that of secondary MIs,differences were all statistically significant(all P<0.05).The proportion of tertiary MIs with various information system functions was higher than that of secondary MIs(all P<0.05).The pathogen detection rate(61.07%)before antimicrobial treatment and health-care-associated infection(HAI)diagnosis-related pathogen detection rate(88.00%)of inpatients in tertiary MIs were both higher than those in secondary MIs(both P<0.05).Among different types of MIs,pathogen detection rate before antimicrobial treatment of inpatients in maternal and child health MIs was higher than that in other types of MIs.HAI diagnosis-related pathogen detection rate in other specialized hospitals was the highest,and pathogen detection rate before combined use of key antimicrobial treatment in traditional Chinese medicine hospitals was the lowest,differences were all statistically significant(all P<0.05).Conclusion Tertiary MIs have more advantages in management strategies and information technology construction than secondary MIs,secondary MIs need more guidance and support.Monitoring and analysis of pathogen detection rate indicators in MIs of different levels and types should be strengthened through special actions.
4.Psychosocial and behavioral problems of children and adolescents across five cities in Northern China
Minjun LI ; Shaoli LI ; Feiyong JIA ; Wenli WANG ; Yunjing ZHAO ; Hanyu DONG ; Junting LIU ; Wenquan NIU ; Nan PENG ; Xia QU ; Jialu GU ; Lijun ZHOU ; Bo ZHOU ; Jianhong WANG ; Lin WANG
Chinese Journal of Preventive Medicine 2024;58(12):1967-1975
Objective:The objective of this research is to study the prevalence and risk factors of psychosocial and behavioral problems in children and adolescents of different ages and genders to provide a scientific foundation for more targeted psychological interventions and social support in the future.Methods:From April 21 to May 31, 2023, a cross-sectional survey was conducted using a stratified random sampling method in five cities (Beijing City, Changchun City, Baicheng City, Shenyang City, Hohhot City) across four provinces in Northern China (Beijing, Jilin, Liaoning, Inner Mongolia). The study was conducted using an online questionnaire among children and adolescents aged 6-16 years. Self-made social and life characteristics questionnaire and Achenbach Child Behavior Check List (CBCL) (for parent) was utilized to investigate the prevalence of psychosocial and behavioral problems and relative influencing factors. Using stepwise regression analysis to screen potential factors affecting the psychosocial and behavioral health of children and adolescents and logistic regression analysis was employed to analyze the risk factors associated while controlling for confounding variables.Results:A total of 10 492 questionnaires were distributed in this study. Among the 8 593 valid questionnaires collected, there were 4 385 males (51.03%) and 4 208 females (48.97%). The sample consisted of 3 348 children aged 6-11 years old and 5 245 children aged 12-16 years old. Out of these participants, 688 individuals (8.01%) were detected positive. In the 6-11 age group, 1 762 boys were assessed, revealing 142 positive cases (8.06%), while 1 586 girls were assessed, with 84 positive cases (5.30%). In the 12-16 age group, 2 623 boys were evaluated, resulting in 237 positive cases (9.04%), and 2 622 girls were evaluated, with 225 positive cases (8.58%). Overall, boys had a higher prevalence rate than girls did, with older age groups showing higher rates compared to younger ones. Logistic regression analysis identified six significant risk factors: parent-child conflict ( OR=4.207, 95% CI: 3.583-4.940), irregular diet patterns( OR=1.862, 95% CI: 1.566-2.213), parental mental illness history( OR=5.381, 95% CI: 2.673-10.83), sleep disorders( OR=4.664, 95% CI: 4.194-5.187), and excessive screen exposure( OR=1.863, 95% CI: 1.577-2.200) were found to be risk factors; whereas having more close friends ( OR=0.510, 95% CI: 0.431-0.603) acted as a protective factor. Conclusions:Psychosocial and behavioral problems in children and adolescents will change with social conditions, with continuous attention required to prevent risk factors. Precise intervention and integral support should be implemented by families, schools and society to provide more accurate protection for children and adolescents.
5.Efficacy and safety of eltrombopag in the treatment of primary immune thrombocytopenia: real-world data from a single medical center
Xifeng DONG ; Yalan LI ; Nianbin LI ; Weinan LIN ; Ting WANG ; Huaquan WANG ; Lijuan LI ; Wen QU ; Limin XING ; Hong LIU ; Yuhong WU ; Guojin WANG ; Jia SONG ; Jing GUAN ; Xiaoming WANG ; Zonghong SHAO ; Rong FU
Chinese Journal of Hematology 2024;45(3):271-276
Objective:This study aimed at investigating the efficacy and safety of eltrombopag in the treatment of adult primary immune thrombocytopenia (ITP) and evaluated the factors influencing its efficacy and side effects.Methods:A total of 198 patients with adult ITP who were admitted to Tianjin Medical University General Hospital between January 2018 and March 2022 were retrospectively analyzed. The efficacy of each starting dose of eltrombopag was evaluated, and adverse events were analyzed. The factors influencing efficacy were investigated, including sex, age, adult ITP type, platelet antibodies, and combined drug treatments.Results:Of the 198 patients, 70 males and 128 females with a median age of 45 years (18-88 years) were included; 130 (65.7%) had newly diagnosed adult ITP, 25 (12.6%) had persistent adult ITP, and 43 (21.7%) had chronic adult ITP. The bleeding event scores at baseline were assessed; 84.3% had scores of<4 and 15.7% had scores of ≥4. The eltrombopag response rate (initial response) at 6 weeks was 78.8% (complete response [CR]: 49.0%; CR1: 14.6%; CR2: 15.2%). The median response time to eltrombopag was 7 (7, 14) days. The initial response rates to 25, 50, and 75 mg eltrombopag were 74.1%, 85.9%, and 60.0%, respectively ( P=0.031). The initial response rate to the 50 mg dose was significantly higher than that of the 25-mg and 75-mg doses. Two patients received 100 mg as the starting dose, and their initial response was 0. Regarding dose adjustment, 70.7% of the patients remained on the starting dose, 8.6% underwent dose adjustment to 50 mg, and 6.1% underwent dose adjustment to 75 mg. Another two patients underwent dose adjustment to 100 mg. After dose adjustment, the persistent response rates were 83.6%, 85.3%, and 85.7% for the 25-, 50-, and 75-mg doses, respectively, with no significant difference. After dose adjustment, the sustained efficacy rate for the 100-mg dose (4 patients) was 100.0%. After 6 weeks of treatment with eltrombopag, the overall bleeding score of patients with ITP decreased. The number of patients with a score of ≥4 decreased to 0, the number of patients with a score of<4 decreased, and there was no significant change in the number of patients with a score of 1-2. The most common adverse event associated with eltrombopag was impaired liver function (7.7%). No thrombosis events or other adverse events were observed. ITP type and number of megakaryocytes significantly affected the initial response to eltrombopag. The initial response rates to eltrombopag for newly diagnosed adult ITP, persistent adult ITP, and chronic adult ITP were 85.3%, 56.0%, and 76.2%, respectively ( P=0.003). For megakaryocytes, the initial response rates were 61.8%, 87.1%, and 84.3% ( P=0.009) for the decreased, normal, and increased megakaryocyte groups, respectively. Conclusion:Eltrombopag, as a second-line or higher treatment for adult ITP, has a rapid onset of action and good safety. The initial response rate is significantly higher with a dose of 50 mg than with a dose of 25 mg. Patients with newly diagnosed ITP and those with normal or increased megakaryocyte numbers have a higher initial response rate to eltrombopag.
6.Psychosocial and behavioral problems of children and adolescents across five cities in Northern China
Minjun LI ; Shaoli LI ; Feiyong JIA ; Wenli WANG ; Yunjing ZHAO ; Hanyu DONG ; Junting LIU ; Wenquan NIU ; Nan PENG ; Xia QU ; Jialu GU ; Lijun ZHOU ; Bo ZHOU ; Jianhong WANG ; Lin WANG
Chinese Journal of Preventive Medicine 2024;58(12):1967-1975
Objective:The objective of this research is to study the prevalence and risk factors of psychosocial and behavioral problems in children and adolescents of different ages and genders to provide a scientific foundation for more targeted psychological interventions and social support in the future.Methods:From April 21 to May 31, 2023, a cross-sectional survey was conducted using a stratified random sampling method in five cities (Beijing City, Changchun City, Baicheng City, Shenyang City, Hohhot City) across four provinces in Northern China (Beijing, Jilin, Liaoning, Inner Mongolia). The study was conducted using an online questionnaire among children and adolescents aged 6-16 years. Self-made social and life characteristics questionnaire and Achenbach Child Behavior Check List (CBCL) (for parent) was utilized to investigate the prevalence of psychosocial and behavioral problems and relative influencing factors. Using stepwise regression analysis to screen potential factors affecting the psychosocial and behavioral health of children and adolescents and logistic regression analysis was employed to analyze the risk factors associated while controlling for confounding variables.Results:A total of 10 492 questionnaires were distributed in this study. Among the 8 593 valid questionnaires collected, there were 4 385 males (51.03%) and 4 208 females (48.97%). The sample consisted of 3 348 children aged 6-11 years old and 5 245 children aged 12-16 years old. Out of these participants, 688 individuals (8.01%) were detected positive. In the 6-11 age group, 1 762 boys were assessed, revealing 142 positive cases (8.06%), while 1 586 girls were assessed, with 84 positive cases (5.30%). In the 12-16 age group, 2 623 boys were evaluated, resulting in 237 positive cases (9.04%), and 2 622 girls were evaluated, with 225 positive cases (8.58%). Overall, boys had a higher prevalence rate than girls did, with older age groups showing higher rates compared to younger ones. Logistic regression analysis identified six significant risk factors: parent-child conflict ( OR=4.207, 95% CI: 3.583-4.940), irregular diet patterns( OR=1.862, 95% CI: 1.566-2.213), parental mental illness history( OR=5.381, 95% CI: 2.673-10.83), sleep disorders( OR=4.664, 95% CI: 4.194-5.187), and excessive screen exposure( OR=1.863, 95% CI: 1.577-2.200) were found to be risk factors; whereas having more close friends ( OR=0.510, 95% CI: 0.431-0.603) acted as a protective factor. Conclusions:Psychosocial and behavioral problems in children and adolescents will change with social conditions, with continuous attention required to prevent risk factors. Precise intervention and integral support should be implemented by families, schools and society to provide more accurate protection for children and adolescents.
7.A survey on the management status and indicators of pathogen detection rate before antimicrobial treatment of inpatients in 265 medical institu-tions in Guangdong Province
Jia-jin CHEN ; Zhen-feng ZHONG ; Shi-yun WANG ; Ting HUANG ; Shu-xian CHEN ; Chen ZHU ; Yi-nan LI ; Li-li PENG ; Yuan-chun MO ; Min-shan CHEN ; Wei-qing LIN ; Xiu-juan QU ; Fang YU ; Zhi-xing LI ; Shu-mei SUN
Chinese Journal of Infection Control 2024;23(12):1499-1507
Objective To evaluate the management and indicators of pathogen detection before antimicrobial treat-ment for inpatients in second level and above medical institutions(MIs)in Guangdong Province,and provide direc-tion and decision-making basis for the improvement of pathogen detection quality in the region.Methods The ma-nagement status,information system functions,and pathogen detection rate indicators of secondary and above MIs in 21 cities in Guangdong Province was surveyed through online questionnaire surveys and system submission.A baseline survey on sentinel monitoring MIs was conducted from July 15th to August 8th,2023.From November 7th to 30th,a baseline survey on non-sentinel monitoring MIs was launched.Surveys on indicator information of all MIs were completed from January 15th to 30th,2024.Results A total of 265 MIs were surveyed,and the proportions of establishing special working groups(83.98%),developing special action improvement plans(79.01%),estab-lishing pathogen detection rate management systems(91.71%),and developing management assessment plans(76.80%)of tertiary MIs were all higher than that of secondary MIs,differences were all statistically significant(all P<0.05).The proportion of tertiary MIs with various information system functions was higher than that of secondary MIs(all P<0.05).The pathogen detection rate(61.07%)before antimicrobial treatment and health-care-associated infection(HAI)diagnosis-related pathogen detection rate(88.00%)of inpatients in tertiary MIs were both higher than those in secondary MIs(both P<0.05).Among different types of MIs,pathogen detection rate before antimicrobial treatment of inpatients in maternal and child health MIs was higher than that in other types of MIs.HAI diagnosis-related pathogen detection rate in other specialized hospitals was the highest,and pathogen detection rate before combined use of key antimicrobial treatment in traditional Chinese medicine hospitals was the lowest,differences were all statistically significant(all P<0.05).Conclusion Tertiary MIs have more advantages in management strategies and information technology construction than secondary MIs,secondary MIs need more guidance and support.Monitoring and analysis of pathogen detection rate indicators in MIs of different levels and types should be strengthened through special actions.
8.Incidence and prognosis of olfactory and gustatory dysfunctions related to infection of SARS-CoV-2 Omicron strain: a national multi-center survey of 35 566 population.
Meng Fan LIU ; Rui Xia MA ; Xian Bao CAO ; Hua ZHANG ; Shui Hong ZHOU ; Wei Hong JIANG ; Yan JIANG ; Jing Wu SUN ; Qin Tai YANG ; Xue Zhong LI ; Ya Nan SUN ; Li SHI ; Min WANG ; Xi Cheng SONG ; Fu Quan CHEN ; Xiao Shu ZHANG ; Hong Quan WEI ; Shao Qing YU ; Dong Dong ZHU ; Luo BA ; Zhi Wei CAO ; Xu Ping XIAO ; Xin WEI ; Zhi Hong LIN ; Feng Hong CHEN ; Chun Guang SHAN ; Guang Ke WANG ; Jing YE ; Shen Hong QU ; Chang Qing ZHAO ; Zhen Lin WANG ; Hua Bin LI ; Feng LIU ; Xiao Bo CUI ; Sheng Nan YE ; Zheng LIU ; Yu XU ; Xiao CAI ; Wei HANG ; Ru Xin ZHANG ; Yu Lin ZHAO ; Guo Dong YU ; Guang Gang SHI ; Mei Ping LU ; Yang SHEN ; Yu Tong ZHAO ; Jia Hong PEI ; Shao Bing XIE ; Long Gang YU ; Ye Hai LIU ; Shao wei GU ; Yu Cheng YANG ; Lei CHENG ; Jian Feng LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(6):579-588
Objective: This cross-sectional investigation aimed to determine the incidence, clinical characteristics, prognosis, and related risk factors of olfactory and gustatory dysfunctions related to infection with the SARS-CoV-2 Omicron strain in mainland China. Methods: Data of patients with SARS-CoV-2 from December 28, 2022, to February 21, 2023, were collected through online and offline questionnaires from 45 tertiary hospitals and one center for disease control and prevention in mainland China. The questionnaire included demographic information, previous health history, smoking and alcohol drinking, SARS-CoV-2 vaccination, olfactory and gustatory function before and after infection, other symptoms after infection, as well as the duration and improvement of olfactory and gustatory dysfunction. The self-reported olfactory and gustatory functions of patients were evaluated using the Olfactory VAS scale and Gustatory VAS scale. Results: A total of 35 566 valid questionnaires were obtained, revealing a high incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain (67.75%). Females(χ2=367.013, P<0.001) and young people(χ2=120.210, P<0.001) were more likely to develop these dysfunctions. Gender(OR=1.564, 95%CI: 1.487-1.645), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), oral health status (OR=0.881, 95%CI: 0.839-0.926), smoking history (OR=1.152, 95%CI=1.080-1.229), and drinking history (OR=0.854, 95%CI: 0.785-0.928) were correlated with the occurrence of olfactory and taste dysfunctions related to SARS-CoV-2(above P<0.001). 44.62% (4 391/9 840) of the patients who had not recovered their sense of smell and taste also suffered from nasal congestion, runny nose, and 32.62% (3 210/9 840) suffered from dry mouth and sore throat. The improvement of olfactory and taste functions was correlated with the persistence of accompanying symptoms(χ2=10.873, P=0.001). The average score of olfactory and taste VAS scale was 8.41 and 8.51 respectively before SARS-CoV-2 infection, but decreased to3.69 and 4.29 respectively after SARS-CoV-2 infection, and recovered to 5.83and 6.55 respectively at the time of the survey. The median duration of olfactory and gustatory dysfunctions was 15 days and 12 days, respectively, with 0.5% (121/24 096) of patients experiencing these dysfunctions for more than 28 days. The overall self-reported improvement rate of smell and taste dysfunctions was 59.16% (14 256/24 096). Gender(OR=0.893, 95%CI: 0.839-0.951), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), history of head and facial trauma(OR=1.180, 95%CI: 1.036-1.344, P=0.013), nose (OR=1.104, 95%CI: 1.042-1.171, P=0.001) and oral (OR=1.162, 95%CI: 1.096-1.233) health status, smoking history(OR=0.765, 95%CI: 0.709-0.825), and the persistence of accompanying symptoms (OR=0.359, 95%CI: 0.332-0.388) were correlated with the recovery of olfactory and taste dysfunctions related to SARS-CoV-2 (above P<0.001 except for the indicated values). Conclusion: The incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain is high in mainland China, with females and young people more likely to develop these dysfunctions. Active and effective intervention measures may be required for cases that persist for a long time. The recovery of olfactory and taste functions is influenced by several factors, including gender, SARS-CoV-2 vaccination status, history of head and facial trauma, nasal and oral health status, smoking history, and persistence of accompanying symptoms.
Female
;
Humans
;
Adolescent
;
SARS-CoV-2
;
Smell
;
COVID-19/complications*
;
Cross-Sectional Studies
;
COVID-19 Vaccines
;
Incidence
;
Olfaction Disorders/etiology*
;
Taste Disorders/etiology*
;
Prognosis
9.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone
10.Heterozygous CARD9 mutation favors the development of allergic bronchopulmonary aspergillosis.
Xia XU ; Haiwen LU ; Jianxiong LI ; Jielin DUAN ; Zhongwei WANG ; Jiawei YANG ; Shuyi GU ; Rongguang LUO ; Shuo LIANG ; Wei TANG ; Fengying ZHANG ; Jingqing HANG ; Juan GE ; Xin LIN ; Jieming QU ; Xinming JIA ; Jinfu XU
Chinese Medical Journal 2023;136(16):1949-1958
BACKGROUND:
Previous research demonstrated that a homozygous mutation of g.136372044G>A (S12N) in caspase recruitment domain family member 9 ( CARD9 ) is critical for producing Aspergillus fumigatus -induced ( Af -induced) T helper 2 (T H 2)-mediated responses in allergic bronchopulmonary aspergillosis (ABPA). However, it remains unclear whether the CARD9S12N mutation, especially the heterozygous occurrence, predisposes the host to ABPA.
METHODS:
A total of 61 ABPA patients and 264 controls (including 156 healthy controls and 108 asthma patients) were recruited for sequencing the CARD9 locus to clarify whether patients with this heterozygous single-nucleotide polymorphisms are predisposed to the development of ABPA. A series of in vivo and in vitro experiments, such as quantitative real-time polymerase chain reaction, flow cytometry, and RNA isolation and quantification, were used to illuminate the involved mechanism of the disease.
RESULTS:
The presence of the p.S12N mutation was associated with a significant risk of ABPA in ABPA patients when compared with healthy controls and asthma patients, regardless of Aspergillus sensitivity. Relative to healthy controls without relevant allergies, the mutation of p.S12N was associated with a significant risk of ABPA (OR: 2.69 and 4.17 for GA and AA genotypes, P = 0.003 and 0.029, respectively). Compared with patients with asthma, ABPA patients had a significantly higher heterozygous mutation (GA genotype), indicating that p.S12N might be a significant ABPA-susceptibility locus ( aspergillus sensitized asthma: OR: 3.02, P = 0.009; aspergillus unsensitized asthma: OR: 2.94, P = 0.005). The mutant allele was preferentially expressed in ABPA patients with heterozygous CARD9S12N , which contributes to its functional alterations to facilitate Af -induced T H 2-mediated ABPA development. In terms of mechanism, Card9 wild-type ( Card9WT ) expression levels decreased significantly due to Af -induced decay of its messenger RNA compared to the heterozygous Card9S12N . In addition, ABPA patients with heterozygous CARD9S12N had increased Af -induced interleukin-5 production.
CONCLUSION
Our study provides the genetic evidence showing that the heterozygous mutation of CARD9S12N , followed by allele expression imbalance of CARD9S12N , facilitates the development of ABPA.
Humans
;
Aspergillosis, Allergic Bronchopulmonary/complications*
;
Aspergillus fumigatus/genetics*
;
Asthma/genetics*
;
Aspergillus
;
Mutation/genetics*
;
CARD Signaling Adaptor Proteins/genetics*

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