1.Expression of two biomarkers in ventricular remodeling in elderly patients with hypertension combined with HFmrEF
Haiying LIU ; Wei ZHAN ; Meng WANG ; Zhiquan QU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2024;26(7):737-741
Objective To investigate the expression changes in serum brain natriuretic peptide(BNP)and N-terminal pro-B-type natriuretic peptide(NT-proBNP)in ventricular remodeling in elderly hypertensive patients with heart failure with mildly reduced ejection fraction(HFmrEF).Methods A total of 288 elderly hypertensive patients admitted to our department from January 2022 to January 2024 were enrolled,and then divided into heart failure with preserved ejection fraction(HFpEF)group(88 cases),HFmrEF group(54 cases),heart failure with reduced ejection fraction(HFrEF)group(62 cases),and control group(simple hypertension,84 cases).The BNP and NT-proBNP levels and ventricular remodeling indicators were compared among all groups.Ventricular remodeling indicators included left ventricular posterior wall thickness(LVPWT),interventricular septum thickness(IVST),left ventricular end-diastolic diameter(LVEDD),maximum mitral flow velocity in early left ventricular diastolic period(E)/maximum mitral flow velocity in late left ventricular diastolic period(A),left ventricle mass index(LVMI)and left ventricular ejection fraction(LVEF).Results Significant differences were observed in the LVPWT,IVST,LVEF,LVEDD,E/A,LVMI,BNP and NT-proBNP levels among above four groups(P<0.01).The LVPWT,IVST,LVEDD,LVMI,BNP and NT-proBNP levels were obvi-ously higher,and LVEF and E/A were notably lower in the HFpEF,HFmrEF and HFrEF groups than the control group(P<0.05).Multivariate logistic regression analysis showed that BNP and NT-proBNP were risk factors for ventricular remodeling in patients with hypertension combined with HFmrEF(P<0.01).Spearman correlation analysis indicated that BNP and NT-proBNP levels were positively correlated with LVPWT,IVST,LVEDD and LVMI(r=0.387,P=0.001,r=0.523,P=0.001,r=0.417,P=0.001,r=0.364,P=0.001;r=0.421,P=0.001,r=0.603,P=0.001,r=0.316,P=0.000,r=0.286,P=0.001),but negatively with LVEF and E/A(r=-0.437,P=0.001,r=-0.624,P=0.001;r=-0.687,P=0.001,r=-0.592,P=0.001).ROC curve analysis revealed that the AUC value of BNP and NT-proBNP levels in predicting ventricu-lar remodeling in patients with hypertension combined with HFmrEF was 0.906 and 0.881(P<0.01),their best cut-off value was 1205.07 and 2016.13 ng/L,the sensitivity was 96.8%and 90.3%,and the specificity was 92.3%and 87.0%,respectively.Conclusion Abnormal levels of BNP and NT-proBNP are associated with ventricular remodeling in elderly patients with hyper-tension combined with HFmrEF,and they can be used as biomarkers for the diagnosis of ventric-ular remodeling in the patients.
2.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
3.A prospective multicenter clinical trial of extralevator abdominoperineal excision for locally advanced low rectal cancer.
Zhenjun WANG ; Qun QIAN ; Yong DAI ; Zhiquan ZHANG ; Jinshan YANG ; Fei LI ; Xiaobin LI ; Jiagang HAN ; Congqing JIANG ; Jinbo JIANG ; Baoju QI ; Zuojun LIU ; Zhigang GAO ; Yanfu DU ; Yong YANG ; Guanghui WEI ; Hao QU ; Minzhe LI ; Huachong MA ; Bingqiang YI
Chinese Journal of Surgery 2014;52(1):11-15
OBJECTIVETo demonstrate the feasibility of extralevator abdominoperineal excision (ELAPE) for locally advanced low cancer in China.
METHODSA prospective multicenter clinical trial was carried out by 7 general hospitals across China from August 2008 to October 2011. A total of 102 patients underwent ELAPE for primary locally advanced low rectal cancer. There were 60 male and 42 female patients. The patients' characteristics, complications and prognosis were recorded.
RESULTSAll patients underwent the ELAPE procedure successfully. The median operating time was 180 minutes (range 110-495 minutes) and median intraoperative blood loss was 200 ml (range 50-1000 ml). The rates of sexual dysfunction, perineal complications, urinary retention, and chronic perineal pain were 40.5%, 23.5%, 18.6% and 13.7%, respectively. Chronic perineal pain was associated with coccygectomy (12 months postoperatively, t = 8.06, P < 0.01), and the pain might gradually ease over time. Reconstruction of pelvic floor with biologic mesh was associated with lower rate of perineal dehiscence (χ(2) = 13.502, P = 0.006) and overall perineal wound complications (χ(2) = 5.836, P = 0.016) compared with primary closure. A positive circumferential margin (CRM) was demonstrated in 6 (5.9%) patients, and intraoperative perforations occurred in 4 (3.9%) patients. All CRM involvement and intraoperative perforation located at anteriorly and anterolaterally. The local recurrence was 4.9% at a median follow-up of 35 months (range, 18-58 months).
CONCLUSIONSELAPE performed in the prone position for low rectal cancer leads to a reduction in CRM involvement, intraoperative perforations, and local recurrence, but it might result in a little high rate of perineal wound related complications. Reconstruction of pelvic floor with biologic mesh might lower the rate of perineal wound complications.
Adult ; Aged ; Digestive System Surgical Procedures ; methods ; Female ; Humans ; Male ; Middle Aged ; Perineum ; surgery ; Postoperative Complications ; Prognosis ; Prospective Studies ; Rectal Neoplasms ; surgery ; Treatment Outcome

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