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

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.

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.

Objective To summarize the treatment decision-making strategy and its long-term efficacy for advanced elderly patients with severe valvular heart disease and clear indications for surgery.Methods Clinical data of 196 patients aged 75 years and older firmly diagnosed as severe valvular heart diseases were retrospectively analyzed.The patients were divided into the surgical group (a mean age of 77.4±2.0 years,n=126)and the conservative group(a mean age of 80.5±5.0 years,n =70).Factors affecting therapeutic decision-making were analyzed,and the differences in a long-term survival were compared between the two groups.Results The most common reason for choosing conservative treatment was the recommendation of the doctor giving a preliminary diagnosis and worrying about the high-risk surgery for the patients(62.9％,44/70).Only 26(37.1％)patients in the conservative group were evaluated by cardiac surgeons,among whom 12 (17.1％)patients were considered to have surgical contraindications,and 14 (20.0％) patients themselves or their family members chose conservative treatment for the fear of surgical risks.Patients in the operation group were mainly from the outpatient department of cardiac surgery,and only 8 (6.3 ％)cases were referred from department of internal medicine.Logistic regression analysis showed that female,chronic renal insufficiency,advanced age,pneumonia and emergency hospital admissions were independent predictors for the conservative option(P ＜0.01),while patients with isolated aortic valve disease tended to receive surgical treatment.Overall 5-year survival was higher in the surgical group than in the conservative group (76.4％ vs.39.9％,P ＜ 0.01).Cox regression analysis disclosed that the conservative treatment option was the single risk factor for long-term survival in all series.Conclusions Many factors affect the process of therapeutic decision-making for patients with severe valvular heart diseases,and a multidisciplinary collaboration is the best way for the optimal treatment strategy for those patients.

OBJECTIVETo observe the regional homogeneity (ReHo) of resting-state brain function in the healthy subjects of gastric distention treated with acupuncture at the back- and front- points of the stomach, Weishu (BL 21) and Zhongwan (CV 12) and the correlation with gastric motility so as to explore the mechanism on the central integration of the front- and back- points of the stomach.

METHODSThe crossover test design was adopted. Twenty-four healthy subjects were assigned to a Weishu group, a Zhongwan group and a combined-point group separately, 8 cases in each one in each of the three times. Totally, 24 subjects were included in each group. Under the water load condition, the subjects received acupuncture at Weishu (BL 21), Zhongwan (CV 12) and the combined Weishu (BL 21) and Zhongwan (CV 12). Before and after each acupuncture, the resting-state brain functional magnetic resonance imaging (fMRI) scan and electrogastrogram (EGG) test were applied. The ReHo value was calculated in the collected fMRI imaging data. The changes in ReHo values were analyzed and compared before and after acupuncture in each group, as well as among the groups. The gastric motility was analyzed before and after acupuncture. Additionally, the correlative analysis was conducted between the gastric motility and ReHo changes before and after acupuncture.

RESULTS(1) After acupuncture, EGG amplitudes in the subjects of each group were lower remarkably as compared with those before acupuncture (all <0.01). The EGG frequencies were not different significantly as compared with those before acupuncture (all >0.05). The EGG amplitudes in the Weishu group and the Zhongwan group were higher than those in the combined-point group (both <0.05). (2) As compared with the conditions before acupuncture, acupuncture at the combined front- and the back- points as well as Weishu (BL 21) and Zhongwan (CV 12) separately all induced the changes in the brain ReHo. Acupuncture at the combined front- and the back- points significantly increased Reho values in the right inferior temporal gyrus, the left thalamus, the precuneus and the posterior cingulate gyrus (all <0.05) and remarkably reduced the ReHo values in the the middle temporal gyrus of the right temporal pole, sulcus calcarinus and precuneus (all <0.05). Compared with the single point groups, acupuncture at the combined front- and the back- points induced the increase of ReHo value in the posterior cingulate gyrus and the decrease of ReHo in the temporal pole (all <0.05). (3) The correlative analysis showed that the changes in the ReHo values in the posterior cingulate gyrus, the thalamus and the precuneus were positively correlated to the changes of the gastric motility amplitudes. The changes in the ReHo values in the temporal pole was negatively correlated to the changes of the gastric motility amplitudes.

CONCLUSIONAcupuncture at the combined back- and front- points of the stomach, as well as acupuncture at single Weishu (BL 21) and Zhongwan (CV 12) induce the ReHo changes in the different brain regions. Acupuncture at the combined back- and front- points of the stomach may induce the ReHo changes in some new brain regions as compared with the acupuncture at the single point. The thalamus, the posterior cingulate gyrus and the precuneus may be the the important integrated brain regions for acupuncture at the back- and the front- points in regulating the gastric motility. The effects of acupuncture at the back- and the front- points for the regulation of the gastric motility are closely related to the thalamus, the limbic system and the default network of the brain regions.

Acupuncture Points ; Acupuncture Therapy ; Brain ; diagnostic imaging ; physiology ; Cross-Over Studies ; Electroencephalography ; Gastrointestinal Motility ; Healthy Volunteers ; Humans ; Magnetic Resonance Imaging ; Stomach ; physiopathology

Objective To investigate the clinical characteristics,surgical experience and mid-term outcome of coronary artery bypass graft surgery in patients aged ≤ 40 years.Methods From Jan.,2009 to Dec.,2015,12 patients with median age of (37.9 ± 2.5) years (range 32-40 years,10 males) were diagnosed with coronary artery disease and underwent coronary artery bypass graft surgery at Zhongshan Hospital,Fudan University.The clinical characteristics included five cases with hypertension,three cases with diabetes mellitus,four cases with hyperlipemia,eight cases with smoking history,seven cases with myocardial infarction.Six cases had at least one branch totally occluded.Two cases once underwent percutaneous coronary intervention surgery and implanted with five and three stents respectively.The perioperative data and follow-up results were retrospectively analysed.Results There was no in-hospital death and no death during follow-up period.Surgical techniques included bilateral internal mammary arteries combined with radial artery were operated in six cases,bilateral internal mammary arteries combined with great saphenous vein in two cases,left internal mammary arteries combined with great saphenous vein in four cases,off-pump in nine cases and on-pump in three cases.The mean follow-up time was (47.8 ± 24.3) months.During the follow-up one case suffered with saphenous vein graft restenosis 5 years after the surgery and underwent percutaneous coronary intervention.Other cases were all alive and assessed New York Heart Association's function class Ⅰ-Ⅱ.Conclusions Younger patients usually suffer with severe coronary artery disease when diagnosed because they often have excellent compensative capacity and the pathogenesis is concealed.The mid-term results of coronary artery bypass graft surgery in patients aged ≤40 years are satisfactory.

Objective: To explore the inlfuence of diastolic iflling pattern on cardiac resynchronization therapy (CRT) in patients with ischemic cardiomyopathy.
Methods: A total of 61 patients with ischemic cardiomyopathy received CRT in our hospital from 2012-03 to 2014-03 were studied. According to pre-CRT diastolic iflling pattern, the patients were divided into 2 groups:Non-restrictive iflling (NRF) group, n=36 and RF group, n=25. All patients were followed-up for 12 months, based on NYHA classiifcation, CRT efifcacy was assessed by echocardiography;the endpoints included re-hospitalization for heart failure or cardiac death. Kaplan-Meier survival curve was used to assess the prognosis.
Results: ①NRF group had CRT response rate at 66.7%(24/36) which was higher than RF group 28.0%(7/25), (χ2=8.826, P=0.003);the post-operative NYHA classiifcation, LVEF, FS, LVEDV and LVESV were signiifcantly improved, all P<0.01.② RF group showed the improved post-operative NYHA classification, P<0.01, while no obvious changes of LVEF, FS, LVEDV at 6 months after operation, and LVESV increased than it was before, P<0.05. Signiifcant differences were observed between 2 groups at 6 months after operation, P<0.01. Logistic regression analysis indicated that diastolic iflling pattern was the independent impact factor for CRT response. There were 2 patients died during 12 months of follow-up period;the endpoints in RF group was 76.0%(19/25) which was higher than NRF group 44.4%(16/36), (χ2=5.213, P=0.022).
Conclusion: Diastolic iflling pattern affected CRT efifcacy in patients with ischemic cardiomyopathy;NRF patients were more beneifciary for CRT, while RF patients had lower response to CRT which associated to poor prognosis.

Objective To summarize and analyze the primary data from China Heart Transplant Registry in 2013 in order to explore the current status of heart transplantation in Chink Method Seventeen transplant centers have conducted 231 cases of heart transplantation in the year 2013.We analyzed the preoperative risk factors which impacted the survival of heart transplant recipients by using univariate and multivariate logistic regression analysis.And long-term survival of the 398 heart recipients from Beijing Fu Wai Hospital,who were followed up from June 2004 to December 2013 (follow-up rate was 100 ％) was calculated by the Kaplan-Meier method.The risk factors for long-term survival of heart transplant recipients were calculated by the COX survival analysis methods.Result The mean hospital stay of the 231 recipients was 24 days.There were 25 cases who died in hospital,and the total mortality was 10.8 ％ (25/231),while the average in-hospital mortality was 2.2 ％ in the three largest centers.By using the univariate and multivariate logistic regression analysis,we found that recipients positive PRA was the only preoperative risk factor which impacted the in-hospital mortality.(OR=12.435,95％ CI 1.369～ 112.938,P =0.025).The median follow-up time of the 398 heart transplant recipients from Beijing Fu Wai Hospital was 1383 days,and the 1-,3-,5-and 7-year survival rate was 94.7％,91.6％,88.0％ and 82.6％ respectively.The univariate and multivariate COX regression analysis revealed that preoperative primary diseases (coronary heart disease vs.cardiomyopathy,P ＜ 0.01),the history of chronic obstructive pulmonary disease (P ＜ 0.01),the preoperative total bilirubin level (P＜0.05) and serum creatinine level (P＜ 0.01) were risk factors affecting long-term postoperative survival.Conclusion In China the number of heart transplants has increased in 2013.The survival rate of recipients is high in large heart transplant centers.The integrity of registration data needs to be further improved in some centers.

Objective To investigate the treatment for scarred vocal folds by transplanting human amniotic epithelial cells (hAECs)and injecting collagenase as well as hyaluronic acid (HA) for the intervention of the extracellular matrix (EMC),to observe the growth,distribution of hAECs and to assess the abilities of them for scarred vocal fold regeneration.Methods The lamina propria was injured by localized resection in thirty-eight vocal folds of twenty rabbits.hAECs were isolated from human amnion and marked by Lenti-GFP.After the formation of vocal fold scarring,hAECs were transplanted into ten vocal folds,collagenase and HA were injected into ten vocal folds,all three were injected into ten vocal folds,none were injected into eight vocal folds,and two normal vocal folds were used as control.At 1 month and 2 months after the transplanting,the survival,the distribution and the cytoactive of hAECs were examined by immunofluorescence method.Meanwhile,at 1 month,2 months,3 months and 6 months after the operation,HE staining was performed for histopathological research,Masson trichrome staining and immunohistochemical staining were used for collagen and fibronectin respectively.Results After implanted into the scarred vocal folds,hAECs could survive in vocal fold lamina propria for two months.The immunofluorescence analysis showed the cytoactive of hAECs.Six months postoperatively,compared with that in the normal vocal folds,collagen in the untreated scarred vocal folds more increased and disorderly distributed ; the changes in other three groups were between the two groups above,but the group injected with all of hAECs,collagenase and HA was better than other two groups.Besides,the mean density of fibronectin in the scarred untreated control group was more significantly increased than that in the normal vocal folds;the changes in other three groups were between the two groups above,but the group injected with all of hAECs,collagenase and HA was better than other two groups.Conclusion The transplanting of hAECs and the interventions of EMC by injecting collagenase as well as HA have better abilities in rabbit scarred vocal fold reparation and regeneration by promoting ECM secretion,rational distribution and part ordering arrangement.

ObjectiveTo know the recent status of heart transplantation in Chinese multicenters.MethodsThe retrospectively data from 24 centers before 2010 (438 cases) and the data from China heart transplant Registry database between 2010 (149 cases from 15 centers)-2011(148 cases from 19 centers) were analyzed.Results In 2010,15 centers performed heart transplantation,including one large-scale center (60 transplants per year),3 moderate-scale centers (10 to 30 transplants per year),and 6 small-scale center (2-8 transplants per year).The rest 5 centers had one transplant per year each.In 2011,19 centers performed heart transplantation,including one large-scale center (52 transplants per year),3 moderate-scale centers (10 to 30 transplants per year),and 5 small-scale centers (2-8 transplants).The rest 8 centers had one transplant per year each.In 2010 and 2011,the median ages of heart transplant recipients were 44.6 and 42.9 years,respectively.Nonischemic cardiomyopathy was the leading indication for heart transplantation.The median donor age in 2010 and 2011was 30.2 and 30.8 years respectively.In 2010 and 2011,up to 99.3％ and 97.3％ of patients were treated with immune induction therapy,respectively.In 2010,the mortality at discharge was 10％,and that was 6％ in 2011.ConclusionAlthough total volume of heart transplants is still small in recent years,the discharge survival in China is similar to ISHLT report.