1.Therapeutic results of three-dimensional aortic valve anatomic repair for regurgitant bicuspid aortic valve
Jun LI ; Chunsheng WANG ; Zheng ZUO ; Hao LAI ; Lili DONG ; Kai ZHU ; Junyu ZHAI ; Yongxin SUN ; Wenjun DING ; Tao HONG
Chinese Journal of Surgery 2024;62(11):1024-1031
Objective:To explore the surgical technique and results of three-dimensional aortic valve anatomic repair for bicuspid aortic valve (BAV) with aortic regurgitation (AR).Methods:This is a retrospective case series study. From August 2021 to December 2023, 130 consecutive patients with BAV-AR underwent aortic valve anatomic repair at the Department of Cardiothoracic Surgery, Zhongshan Hospital, Fudan University,and the data were retrospectively analyzed. There were 115 males and 15 females, aged (38.6±11.7) years (range: 15 to 67 years). All patients received modified aortic root reconstruction, to do three-dimensional root remodeling, including the basal ring, sinus of Valsalva and sino-tubular junction simultaneously. Perioperative and follow-up data were collected and analyzed. Comparisons between groups were performed using independent samples t-test, Wilcoxon paired signed-rank test, or χ2 test. Results:No patient transferred to valve replacement during the operation. The cardiopulmonary bypass time ( M(IQR)) was 109(34) minutes (range:67 to 247 minutes), and the aortic cross-clamp time was 76(26) minutes (range: 32 to 158 minutes). Preoperative transesophageal echocardiography showed 123 patients (94.6%) presented with moderate or severe regurgitation. Immediately postoperative transesophageal echocardiography showed no regurgitation in 22 patients (16.9%), trace regurgitation in 81 patients (62.3%) and mild regurgitation in 27 patients (20.8%). Follow up was completed in all patients, with a follow-up of 5.5(9.4) months (range: 0.1 to 27.6 months). No mortality was observed during follow-up. Echocardiography was obtained in 112 patients at the latest follow-up, including no regurgitation in 4 patients (3.6%), trace regurgitation in 58 patients (51.8%), mild regurgitation in 45 patients (40.2%), moderate regurgitation in 4 patients (3.6%), and severe regurgitation in 1 patient (0.9%). Conclusion:For patients with BAV-AR who have good valve quality and no severe aortic sinus dilation, the recent outcomes of three-dimensional anatomical repair technique, focusing on overall remodeling of the aortic root, are satisfactory.
2.Therapeutic results of three-dimensional aortic valve anatomic repair for regurgitant bicuspid aortic valve
Jun LI ; Chunsheng WANG ; Zheng ZUO ; Hao LAI ; Lili DONG ; Kai ZHU ; Junyu ZHAI ; Yongxin SUN ; Wenjun DING ; Tao HONG
Chinese Journal of Surgery 2024;62(11):1024-1031
Objective:To explore the surgical technique and results of three-dimensional aortic valve anatomic repair for bicuspid aortic valve (BAV) with aortic regurgitation (AR).Methods:This is a retrospective case series study. From August 2021 to December 2023, 130 consecutive patients with BAV-AR underwent aortic valve anatomic repair at the Department of Cardiothoracic Surgery, Zhongshan Hospital, Fudan University,and the data were retrospectively analyzed. There were 115 males and 15 females, aged (38.6±11.7) years (range: 15 to 67 years). All patients received modified aortic root reconstruction, to do three-dimensional root remodeling, including the basal ring, sinus of Valsalva and sino-tubular junction simultaneously. Perioperative and follow-up data were collected and analyzed. Comparisons between groups were performed using independent samples t-test, Wilcoxon paired signed-rank test, or χ2 test. Results:No patient transferred to valve replacement during the operation. The cardiopulmonary bypass time ( M(IQR)) was 109(34) minutes (range:67 to 247 minutes), and the aortic cross-clamp time was 76(26) minutes (range: 32 to 158 minutes). Preoperative transesophageal echocardiography showed 123 patients (94.6%) presented with moderate or severe regurgitation. Immediately postoperative transesophageal echocardiography showed no regurgitation in 22 patients (16.9%), trace regurgitation in 81 patients (62.3%) and mild regurgitation in 27 patients (20.8%). Follow up was completed in all patients, with a follow-up of 5.5(9.4) months (range: 0.1 to 27.6 months). No mortality was observed during follow-up. Echocardiography was obtained in 112 patients at the latest follow-up, including no regurgitation in 4 patients (3.6%), trace regurgitation in 58 patients (51.8%), mild regurgitation in 45 patients (40.2%), moderate regurgitation in 4 patients (3.6%), and severe regurgitation in 1 patient (0.9%). Conclusion:For patients with BAV-AR who have good valve quality and no severe aortic sinus dilation, the recent outcomes of three-dimensional anatomical repair technique, focusing on overall remodeling of the aortic root, are satisfactory.
3.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
4.Trends in incidence of malignant tumors in Yongkang City from 2013 to 2019
YING Liya ; ZHU Hongting ; HU Hao ; HU Chunsheng ; ZHANG Feng
Journal of Preventive Medicine 2023;35(11):970-974
Objective :
To investigate the trends in incidence of malignant tumors in Yongkang City, Zhejiang Province from 2013 to 2019, so as to provide insights into formulation of the malignant tumor control strategy.
Methods:
Data pertaining to the incidence of malignant tumors from 2013 to 2019 were captured from the Zhejiang Chronic Disease Monitoring Information System. Based on the International Classification of Diseases 10th Revision (ICD-10) and data from the national population census, the constituent ratio, crude incidence and Chinese population-standardized incidence of malignant tumors were estimated, and the trends in incidence of malignant tumors were investigated using annual percent change (APC).
Results:
The annual mean crude incidence and Chinese population-standardized incidence of malignant tumors were 356.75/105 and 226.97/105, which both appeared an overall tendency towards a rise (APC=5.887% and 4.815%, both P<0.05). The crude incidence of malignant tumors appeared a tendency towards a rise among both men (APC=3.860%, P<0.05) and women (APC=8.534%, P<0.05) from 2013 to 2019, and the Chinese population-standardized incidence of malignant tumors appeared a tendency towards a rise among women (APC=8.392%, P<0.05). The largest increase in the crude incidence of malignant tumors was seen among women at ages of 15 to 44 years (APC=11.599%, P<0.05). In addition, the Chinese population-standardized incidence of lung cancer, colorectal cancer and thyroid cancer all showed a tendency towards a rise among men (all P<0.05), and the Chinese population-standardized incidence of lung cancer and thyroid cancer both appeared a tendency towards a rise among women (both P<0.05).
Conclusions
The incidence of malignant tumors showed a tendency towards a rise in Yongkang City from 2013 to 2019, and the elderly and young females are high-risk populations for malignant tumors. Lung cancer, thyroid cancer and colorectal cancer are cancers that should be given a high priority.
5.Analysis of iodine nutritional level of residents in iodine adequate areas of Henan Province in 2020
Zhiwei HAN ; Yanli TENG ; Jingya HENG ; Lin ZHU ; Heming ZHENG ; Xiaofeng LI ; Chunsheng YUAN ; Li ZHANG ; Gan CHEN ; Jin YANG
Chinese Journal of Endemiology 2023;42(4):305-309
Objective:To investigate the iodine nutritional level of residents in iodine adequate areas in Henan Province, and provide basis for making policy of targeted guidance and rational iodine supplementation.Methods:In the 156 counties of Henan Province in 2020, one township was selected from each location (east, west, south, north and middle) in each county; one school was selected from each township; 40 children aged 8-10 years in the school and 20 pregnant women in the township were selected to collect their urine and salt samples to test urine and salt iodine levels. One third of the counties were selected to examine the thyroid gland of children. Individuals lived in villages with water iodine between 40 and 100 μg/L were included in the study.Results:In iodine adequate areas, a total of 2 097 salt samples were collected from children and tested, the consumption rate of qualified iodized salt was 93.6% (1 962/2 097). A total of 2 096 urine samples were collected from children and tested, and the median urinary iodine was 288.0 μg/L. The goiter rate of children was 0.7% (5/723). A total of 1 068 salt samples from pregnant women were tested, and the consumption rate of qualified iodized salt was 93.0% (993/1 068). A total of 1 068 urine samples from pregnant women were tested, with a median urinary iodine 232.7 μg/L. Stratified by water iodine (40-59, 60-79, 80-100 μg/L), the median urinary iodine of children was 273.8, 288.6, and 305.9 μg/L, respectively, statistically significantly different between groups ( H = 15.79, P < 0.001); the goiter rate of children was ≤2%, and the difference between groups was statistically significant (χ 2 = 7.31, P = 0.026); but the median urinary iodine of pregnant women was not significantly different ( H = 1.82, P = 0.402). Under different water iodine conditions, there was no significant difference in urinary iodine levels in children and pregnant women between the high salt iodine concentration group (≥21 mg/kg) and the low salt iodine concentration group (< 21 mg/kg, P > 0.05). Conclusions:The iodine nutrition level of children in iodine adequate areas in Henan Province is relatively high, and the iodine nutrition of pregnant women is appropriate. The goiter rate of children is at a relatively low level. Continuous surveillance should be conducted to comprehensively evaluate the iodine nutrition level. Various measures will be taken by regions and populations.
6.Application of aortic root repair in acute type A aortic dissection with aortic sinus involvement
Chengkai HU ; Zheng FU ; Jiawei GU ; Jun LI ; Yongxin SUN ; Kai ZHU ; Hao LAI ; Chunsheng WANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2022;38(4):204-209
Objective:To evaluate the outcomes of aortic root repair in acute type A aortic dissection (ATAAD) with aortic sinus involvement.Methods:The clinical data of patients with ATAAD involving the aortic sinus and an aortic root diameter of ≤45 mm who were treated from January 1, 2015, to December 31, 2016, were collected. Patients were divided into group A (involvement of one aortic sinus or part of one aortic sinus) and group B (involvement of more than one aortic sinus). The effectiveness of aortic root repair in ATAAD with sinus involvement was analyzed by comparing the preoperative imaging characteristics and postoperative results between the two groups.Results:The study cohort comprised 155 patients, including 100 patients in group A and 55 in group B. There were no differences between the two groups in baseline characteristics, aortic root diameter, 30-day mortality, and complication rates. During an average follow-up of(49.1±14.6) months, there was no difference between the two groups in the survival rate (92.0% vs. 89.5%, P=0.61). The aortic root diameter at follow-up showed no progressive expansion compared with preoperatively in either of the two groups[(38.1±3.6) mm vs. (37.9±3.5)mm, P=0.92, A; (38.4±4.1) mm vs. (38.3±3.6) mm, P=0.74, B]; furthermore, there was no difference between the two groups in aggravation of aortic regurgitation. Conclusion:Aortic root repair achieves satisfactory medium-term outcomes in ATAAD with more than one aortic sinus involved, but the long-term outcomes need to be evaluated.
7.Establishment of large animal model of bicuspid aortic valve
Quanlin YANG ; Huan LIU ; Yan SHAN ; liming ZHU ; Xiaoning SUN ; Ye YANG ; Wenshuo WANG ; Lai WEI ; Chunsheng WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2022;29(11):1485-1491
Objective To discuss the feasibility of establishment of animal model of "functional" bicuspid aortic valve with swine and observe its effect on the wall shear stress inside the aorta. Methods Four common Shanghai White Swine with body weight between 50 kg to 55 kg were selected. Under general anesthesia and cardiopulmonary bypass, the aortic transverse incision approach was used, continuous suture with 6-0 polypropylene to align the left and right coronary valve leaflets to create a bicuspid valve morphology. After the operation, echocardiography was used to observe the aortic valve morphology and the hemodynamic changes of the aortic valve orifice. The effect on the wall shear stress inside the aorta was studied with 4D-Flow magnetic resonance imaging (MRI). Results A total of 4 swine "functional" bicuspid aortic valve models were established, with a success rate of 100.0%. Echocardiography showed that the blood flow velocity of the aortic valve orifice was faster than that before the operation (0.96 m/s vs. 1.80 m/s). 4D-Flow MRI showed abnormally increased wall shear stress and blood flow velocity in the aorta of the animal models. After the surgery, in model animals, the maximal wall shear stress inside the ascending aorta was greater than 1.36 Pa, and the maximum blood flow velocity was greater than 1.4 m/s. Conclusion Establishment of the animal model of "functional" bicuspid aortic valve in swine is feasible, scientific and reliable. It can be used in researches on evaluating the pathophysiological changes.
8.Effects of chemotherapy dose intensity on short-term efficacy in patients with advanced colon cancer: a study based on real-world data
Xuelei CHU ; Yun MAO ; Peng XUE ; Linlu LI ; Meichi CHEN ; Chunsheng YUAN ; Xiaoyan QIN ; Shijie ZHU
Journal of International Oncology 2022;49(7):408-415
Objective:To investigate the effects of different chemotherapy dose intensity on the short-term efficacy and adverse reactions of patients with advanced colon cancer.Methods:A real-world database of patients with advanced colon cancer in Wangjing Hospital of China Academy of Chinese Medical Sciences and China-Japan Friendship Hospital from January 2017 to December 2020 was established, including 105 patients treated with the same chemotherapy regimen for two consecutive cycles. The patients were grouped according to the average relative dose intensity (ARDI) of chemotherapy, and the population differences, treatment regimens, short-term efficacy and adverse reactions of different chemotherapy dose intensities were evaluated. The receiver operating characteristic (ROC) curve was used to analyze the predictive value of ARDI for short-term efficacy.Results:There were 31 patients in the high dose intensity group (ARDI≥80%) , 34 patients in the medium dose intensity group (80%
9.Epidemic status of drinking water-borne endemic fluorosis of Henan Province in 2018
Yang LIU ; Bo YU ; Chunsheng YUAN ; Xinbo ZHU ; Guoqiang HOU ; Xiaohong LI ; Heming ZHENG
Chinese Journal of Endemiology 2021;40(4):290-294
Objective:To understand the status of drinking water-borne endemic fluorosis in Henan Province, so as to provide scientific basis for improving prevention and control strategies.Methods:Ten counties (districts, referred to as counties) were selected from drinking water-borne endemic fluorosis areas of Henan Province in 2018. Three villages in each project county were selected according to the disease status of mild, moderate and severe conditions, and the operation status of water improvement projects, water fluoride content and dental fluorosis among children aged 8 to 12 years in each diseased village were monitored.Results:Totally 30 villages were surveyed, all of which were in the water improvement projects; a total of 25 water improvement projects were monitored, all of them were in normal operation, and the water fluoride exceeding standard rate was 28.00% (7/25), the qualified rate of water fluoride in the water improvement projects was 72.00% (18/25). Among them, 21 villages were in normal operation and the water fluoride in the water improvement projects met national standard. In which the detection rate of dental fluorosis among children aged 8 to 12 years was 36.71% (606/1 651), the index of dental fluorosis was 0.74, and the epidemic intensity was extremely mild. Water fluoride of water improvement projects in 9 villages exceeded the national standard, where the detection rate of dental fluorosis among children aged 8 to 12 years was 43.57% (261/599), the index of dental fluorosis was 0.78, and the epidemic intensity was extremely mild. The detection rate of dental fluorosis among children in the villages where the water fluoride of water improvement projects exceeded the national standard was higher than that in the villages where the water fluoride of water improvement projects met the national standard (χ 2=8.752, P < 0.01). Conclusions:The excessive fluorine content in the water of water improvement projects is still serious, and the epidemic is still severe. It is necessary to strengthen the scientific demonstration of the water improvement project construction and the project acceptance upon completion, so as to prevent unqualified projects from being put into use. We will carry out regular water quality monitoring and promptly rectify projects with water quality exceeding the standards.
10.Analysis of monitoring results of drinking water-borne endemic fluorosis areas of Henan Province in 2019
Chunsheng YUAN ; Bo YU ; Jiajun MA ; Xiaohong LI ; Guoqiang HOU ; Xinbo ZHU ; Heming ZHENG
Chinese Journal of Endemiology 2021;40(9):733-737
Objective:To understand the prevention and control progress of drinking water-borne endemic fluorosis in Henan Province, to evaluate the effects of prevention and control measures, and provide a basis for adjusting prevention and control strategies.Methods:In 2019, a general survey was conducted in all registered drinking water-borne endemic fluorosis villages in Henan Province to monitor the basic conditions of water improvement, the fluoride content of drinking water and the prevalence of dental fluorosis in children aged 8-12 years. The control compliance (water fluoride content qualified and the detection rate of dental fluorosis of children ≤30%) status of the villages was analyzed, and calculate the compliance rate.Results:A total of 17 504 drinking water-borne endemic fluorosis villages were monitored, among them, 17 352 villages with water improvement and 152 villages without water improvement, with a water improvement rate of 99.1%. Among the 3 685 water improvement projects constructed, 3 448 were in normal operation, and the normal operation rate was 93.6%. There were 13 526 villages with qualified drinking water fluoride content, and the qualified rate of water fluorine was 77.3%; the actual beneficiary population was 11 011 000, and the population benefit rate was 90.1%. The qualified rate of water fluoride in the villages with and without water improvement was 77.9% (13 512/17 352) and 9.2% (14/152), respectively; the qualified rate of water fluoride in the villages with water improvement was significantly higher than that in the villages without water improvement (χ 2=400.58, P < 0.05). A total of 498 527 children of 8 to 12 years old were examined, 68 972 cases of dental fluorosis were detected, the detection rate of dental fluorosis was 13.84%, and the dental fluorosis index was 0.3. The number of villages meeting the control standard was 12 488, and the compliance rate was 71.3%. Conclusions:In Henan Province, the water improvement projects in the drinking water-borne endemic fluorosis areas have been basically implemented, and the disease has been effectively controlled. However, there is still a certain gap with the target of the "13th Five-Year Plan on National Prevention and Control of Endemic Diseases", and timely rectification is needed to ensure the effectiveness of the water improvement projects.


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