1.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
2.Adjustable "paper clip" techniques suturing the dorsal vein complex in radical prostatectomy
Yang CHEN ; Fangxing ZHANG ; Tianyu LI ; Chengyang LI ; Deyun LIU ; Haibiao YAN ; Zhanbin YANG ; Hua MI ; Linjian MO ; Naikai LIAO ; Shubo YANG ; Jiwen CHENG
Journal of Modern Urology 2023;28(8):707-712
【Objective】 To investigate the efficacy of the adjustable "paper clip" techniques in the suture of dorsal vein complex (DVC) and retention of urethral function in robot-assisted laparoscopic radical prostatectomy (RALRP). 【Methods】 A total of 30 cases of prostate cancer treated with RALRP were enrolled, all of which used the adjustable "paper clip" techniques. During operation, the DVC was sewed with barbed suture, and then a reverse suture was made through two sides of the prostatic ligaments. A Hem-o-lock was used to fasten the suture, which would be flexible to control the degree of tightness for the ligature. Perioperative and follow-up data of urinary continence and symptoms were collected and analyzed. 【Results】 All operations were successful. The estimated blood loss was (123.3±80.7) mL, 53.6% patients recovered continence in 1 month, and the continence rate increased to 92.9% and 96.3% at month 3 and 6. 92.9 of patients had no risk of incontinence 3 months after surgery. 【Conclusion】 The adjustable "paper clip" techniques have advantages in reducing blood loss, maintaining clear surgical field, preserving urethral function, and improving urinary continence.
3.Robotic urologic surgery using the KangDuo-Surgical Robot-01 system: A single-center prospective analysis.
Shengwei XIONG ; Shubo FAN ; Silu CHEN ; Xiang WANG ; Guanpeng HAN ; Zhihua LI ; Wei ZUO ; Zhenyu LI ; Kunlin YANG ; Zhongyuan ZHANG ; Cheng SHEN ; Liqun ZHOU ; Xuesong LI
Chinese Medical Journal 2023;136(24):2960-2966
BACKGROUND:
The KangDuo-Surgical Robot-01 (KD-SR-01) system is a new surgical robot recently developed in China. The aim of this study was to present our single-center experience and mid-term outcomes of urological procedures using the KD-SR-01 system.
METHODS:
From August 2020 to April 2023, consecutive urologic procedures were performed at Peking University First Hospital using the KD-SR-01 system. The clinical features, perioperative data, and follow-up outcomes were prospectively collected and analyzed.
RESULTS:
A total of 110 consecutive patients were recruited. Among these patients, 28 underwent partial nephrectomy (PN), 41 underwent urinary tract reconstruction (26 underwent pyeloplasty, 3 underwent ureteral reconstruction and 12 underwent ureterovesical reimplantation [UR]), and 41 underwent radical prostatectomy (RP). The median operative time for PN was 112.5 min, 157.0 min for pyeloplasty, 151.0 min for ureteral reconstruction, 142.5 min for UR, and 138.0 min for RP. The median intraoperative blood loss was 10 mL for PN, 10 mL for pyeloplasty, 30 mL for ureteral reconstruction, 20 mL for UR, and 50 mL for RP. All procedures were successfully completed without conversion, and there were no major complications in any patient. The median warm ischemia time of PN was 17.3 min, and positive surgical margin was not noted in any patient. The overall positive surgical margin rate of RP was 39% (16/41), and no biochemical recurrence was observed in any RP patient during the median follow-up of 11.0 months. The surgical success rates of pyeloplasty and UR were 96% (25/26) and 92% (11/12) during the median follow-up of 29.5 months and 11.5 months, respectively.
CONCLUSION
The KD-SR-01 system appears feasible, safe, and effective for most urological procedures, based on our single-center experience.
Male
;
Humans
;
Robotic Surgical Procedures/methods*
;
Robotics
;
Treatment Outcome
;
Retrospective Studies
;
Ureter/surgery*
;
Urologic Surgical Procedures/methods*
;
Laparoscopy/methods*
4.Application of EPID-based in vivo dose verification in dynamic intensity-modulated radiotherapy for lung and esophageal cancers
Jia FANG ; Wanli ZHU ; Chunyan DAI ; Xin YANG ; Hongjuan SUN ; Yingjie MEI ; Yanfang LIU ; Shubo DING
Chinese Journal of Radiological Medicine and Protection 2023;43(9):705-711
Objective:To investigate the factors affecting the accuracy of electronic portal imaging device (EPID)-based in vivo dose verification in radiotherapy for patients with lung and esophageal cancers, and to recommend the workflow and specifications for the application of the in vivo dose verification. Methods:This study randomly selected 32 patients who received radiotherapy for esophageal and lung cancers at the Department of Radiation Oncology, Jinhua Municipal Central Hospital from May to August 2022, including 14 lung cancer cases and 18 esophageal cancer cases. Using a uRT-linac 506c linear accelerator, these patients were treated according to the dynamic intensity-modulated radiotherapy (dIMRT) and EPID-based In vivo dose verification ( In vivo EPID) plans developed with the uRT-TPOIS planning system. The In vivo dose verification performed during the treatment included 238 fractions of In vivo EPID and 80 fractions of image-guided radiotherapy (IGRT) for the lung cancer cases, as well as 414 fractions of In vivo EPID and 105 fractions of IGRT for the esophageal cancer cases. The 2D γ passing rate for each irradiation field was obtained according to the set threshold value. Furthermore, fractioned irradiation fields with γ-passing rates below the threshold value were analyzed, and primary factors decreasing the γ-passing rate were further analyzed by combining the online CT images and 3D reconstruction-derived dose. Results:For lung and esophageal cancers, the mean γ-passing rates were 95.1% ± 5.7% and 96.5% ± 4.5%, respectively at 3 mm/5%; 91.5% ± 8.4% and 92.2% ± 4.9%, respectively at 3 mm/3%, and 79.1% ± 14.7% and 83.7% ± 8.2%, respectively at 2 mm/2%, indicating no statistically significant differences between two cancers ( P > 0.05). The average γ passing rate for beam orientations near 0°/180° (Group A) was higher than those near 90°/270° (Group B) 3 mm/5%: Z = -25.4, P < 0.05; 3 mm/3%: Z = -26.8, P < 0.05). The IGRT correction of setup errors significantly improved the γ passing rates (96.3% ± 5.1% and 96.4% ± 4.9%, respectively at 3 mm/5%, Z = -5.50, P < 0.05; 92.3% ± 8.0% and 91.3% ± 7.7%, respectively at 3 mm/3%, Z = -9.54, P < 0.05). The results of In vivo dose verification were affected by changes in the volumes and motion of tumors and normal tissues, radiotherapy positioning, and adequacy of pre-treatment preparation. Conclusions:EPID-based In vivo dose verification during radiotherapy can avoid incorrect irradiation. However, it is necessary to standardize the workflow of the EPID-based In vivo dose verification to avoid the decrease in the γ passing rate caused by artificial factors.
5.Initial clinical application of domestic endoscopic surgical robot system for partial nephrectomy
Xuesong LI ; Shubo FAN ; Shengwei XIONG ; Xiaofei DAI ; Kunlin YANG ; Zhihua LI ; Chang MENG ; Jie WANG ; Zheng ZHANG ; Lin CAI ; Cuijian ZHANG ; Zhongyuan ZHANG ; Wei YU ; Cheng SHEN ; Gang WANG ; Liqun ZHOU
Chinese Journal of Urology 2021;42(5):375-380
Objective:To evaluate the safety and effectiveness of Kangduo endoscopic surgical robot system for partial nephrectomy.Methods:Consecutive patients with stage T 1 renal tumor meeting the inclusion criteria from the Department of Urology, Peking University First Hospital from December 2020 to February 2021 were prospectively enrolled. All patients underwent partial nephrectomy with the Kangduo endoscopic surgical robot system after signing the informed consent. Clinical data including preoperative, perioperative and postoperative pathology and follow-up were collected. Results:Among the 26 patients, there were 16 males and 10 females, with a median age of 53(33-74) years, and a median body mass index of 25.99(20.90-32.91) kg/m 2. There were 12 cases of left kidney tumor and 14 cases of right kidney tumor. The median tumor diameter was 2.2(1.0-3.5) cm. The median time of warm ischemia was 17.7(7.1-29.2) minutes, and all of them were less than 30 minutes. The median docking time was 4.7(2.3-9.9) minutes, and the median time of robotic arm operation was 65.0 (37.0-155.0) minutes. The median National Aeronautics and Space Administration Task Load Index (NASA-TLX) score was 5.3 (2.0-28.0), and no instrument-related adverse events occurred intraoperatively. The median postoperative hospital stay was 4 (4-5) days. All tumor margins were negative on pathologic reports. No Clavien Ⅱ stage operative complications occurred in all patients during perioperative period and 1 month after the surgery. Conclusions:The partial nephrectomy using the kangduo endoscopic surgical robot system were completed successfully, and no instrument-related adverse events and complications occurred, showing that this surgical system used for partial nephrectomy is safe and effective.
6.Effect of polyethylene glycol combined with simethicone on Boston intestinal preparation scale score and tolerance in patients undergoing colonoscopy
Yang WANG ; Xiaoqin LI ; Siwen SHI ; Jun WANG ; Shubo ZHAO ; Jing WU ; Hong LIU ; Lihui LIU
Clinical Medicine of China 2021;37(5):411-415
Objective:To investigate the effect of polyethylene glycol combined with simethicone on boston bowel preparation scale(BBPS) score and tolerance in patients with colonoscopy.Methods:From January 2018 to January 2019, 220 patients who underwent colonoscopy in Beijing Shijitan Hospital Affiliated to Capital Medical University were selected as the research objects.According to different bowel preparation schemes, they were divided into control group and observation group, 110 cases in each group.In the control group, 4 bags of compound polyethylene glycol electrolyte powder were added with cold boiled water to prepare 4 L solution for intestinal preparation.Starting 6 hours before endoscopy, 1 L solution was taken every hour, and the interval from the last time to the beginning of colonoscopy was≤4 h. On the basis of the control group, the observation group was given 30 mL simethicone emulsion 4 hours before endoscopy on the basis of the control group.The BBPS score, intracavitary liquid volume score, total score, tolerance and adverse reactions were compared between the two groups.Results:The whole colon score (7.16±0.61), left colon score (2.89±0.62), transverse colon score (2.78±0.64) and right colon score (1.58±0.49), intestinal cavity fluid score (1.47±0.48) and total score (8.84±0.87) of the observation group were higher than those of the control group ((5.13±0.76), (2.23±0.86), (2.15±0.76), (1.14±0.16), (0.91±0.55), (7.11±1.04)), and the differences were statistically significant ( t=21.854, 6.532, 6.652, 8.957, 8.054, 13.380, all P<0.05). The tolerance of the observation group (90.00%(99/110)) was higher than that of the control group (81.81%(90/110)), but the difference was not statistically significant( χ 2=3.043, P=0.081). The incidence of abdominal distension in the observation group (1.82%(2/110)) was lower than that in the control group (8.18%(9/110)), the difference was statistically significant(χ 2=4.690, P<0.05), and there was no significant difference in the incidence of electrolyte disorder, nausea and vomiting, hypoglycemia or hunger, palpitation and chest tightness between the two groups (all P>0.05). Conclusion:The application of polyethylene glycol combined with Spanish silicone oil in intestinal preparation can improve the intestinal cleanliness of patients, but does not increase the tolerance of patients compared with polyethylene glycol alone, but significantly reduces the incidence of abdominal distension.
7.Hesitancy of parents towards vaccines in national immunization program in three regions in China: a cross-sectional study
Tianshuo ZHAO ; Hanyu LIU ; Hui ZHENG ; Bingfeng HAN ; Bei LIU ; Jiang LIU ; Chunyan ZHAO ; Xiaojing LI ; Shubo YANG ; Juan DU ; Ninghua HUANG ; Qingbin LU ; Yaqiong LIU ; Fuqiang CUI
Chinese Journal of Epidemiology 2021;42(9):1615-1620
Objective:To investigate the incidence and determinants of vaccine hesitancy towards national immunization program in China and understand the current status of parents' hesitancy to different vaccines used in national immunization program.Methods:A cross-sectional survey was conducted in Beijing, Sichuan and Gansu. The methods of proportional probability sampling and convenience sampling were used to select the eligible study subjects for questionnaire surveys.Results:A total of 3 592 parents were enrolled in the study, in whom 38.22% fully accepted all the vaccines, 59.35% agreed to let their children to receive all the vaccines but showed slight concern, and 2.42% had hesitancy to the vaccines. The vaccine with the most hesitancy was polio vaccine (0.89%), followed by diphtheria pertussis tetanus vaccine (0.70%) and hepatitis A vaccine (0.64%). The dominant reason for vaccine hesitancy was the risk-benefit perception of vaccination (31.03%), followed by the low awareness of the parents (21.84%) and the inconvenience caused by distance and time (21.84%).Conclusions:The incidence of vaccine hesitancy towards national immunization program was low in parents in China, but over 50% of the parents showed concern to the vaccines. It is essential to improve the service quality of national immunization program and strengthen the health education about the vaccination to reduce the incidence of vaccine hesitancy in parents.
8.Catalysis-based specific detection and inhibition of tyrosinase and their application
Yunwei QU ; Qing ZHAN ; Shubo DU ; Yang DING ; Bin FANG ; Wei DU ; Qiong WU ; Haidong YU ; Lin LI ; Wei HUANG
Journal of Pharmaceutical Analysis 2020;10(5):414-425
Tyrosinase is an important enzyme in controlling the formation of melanin in melanosome, and plays a key role in the pigmentation of hair and skin. The abnormal expression or activation of tyrosinase is associated with several diseases such as albinism, vitiligo, melanoma and Parkinson disease. Excessive deposition of melanin could cause diseases such as freckles and brown spots in the human body, and it is also closely related to browning of fruits and vegetables and insect molting. Detecting and inhibiting the activity of tyrosinase is of extraordinary value in the progress of diagnosis and treatment of these dis-eases. Therefore, many selective optical detection probes and small molecular inhibitors have been developed, and have made significant contributions to the basic and clinical research on these diseases. In this paper, the detection and inhibition of tyrosinase and their application in whitening products are reviewed, with special emphasis on development of fluorescent probes and inhibitors. Hopefully, this review will help design more efficient and sensitive tyrosinase probes and inhibitors, as well as shed light on novel treatment of diseases such as melanoma.
9.Association between Initial Chest CT or Clinical Features and Clinical Course in Patients with Coronavirus Disease 2019 Pneumonia
Zhe LIU ; Chao JIN ; Carol C. WU ; Ting LIANG ; Huifang ZHAO ; Yan WANG ; Zekun WANG ; Fen LI ; Jie ZHOU ; Shubo CAI ; Lingxia ZENG ; Jian YANG
Korean Journal of Radiology 2020;21(6):736-745
Objective:
To identify the initial chest computed tomography (CT) findings and clinical characteristics associated with the course of coronavirus disease 2019 (COVID-19) pneumonia.
Materials and Methods:
Baseline CT scans and clinical and laboratory data of 72 patients admitted with COVID-19 pneumonia (39 men, 46.2 ± 15.9 years) were retrospectively analyzed. Baseline CT findings including lobar distribution, presence of ground glass opacities, consolidation, linear opacities, and lung severity score were evaluated. The outcome event was recovery with hospital discharge. The time from symptom onset to discharge or the end of follow-up (for those remained hospitalized) was recorded. Data were censored in events such as death or discharge without recovery. Multivariable Cox proportional hazard regression was used to explore the association between initial CT, clinical or laboratory findings, and discharge with recovery, whereby hazard ratio (HR) values < 1 indicated a lower rate of discharge at four weeks and longer time until discharge.
Results:
Thirty-two patients recovered and were discharged during the study period with a median length of admission of 16 days (range, 9 to 25 days), while the rest remained hospitalized at the end of this study (median, 17.5 days; range, 4 to 27 days). None died during the study period. After controlling for age, onset time, lesion characteristics, number of lung lobes affected, and bilateral involvement, the lung severity score on baseline CT (> 4 vs. ≤ 4 [reference]: adjusted HR = 0.41 [95% confidence interval, CI = 0.18–0.92], p = 0.031) and initial lymphocyte count (reduced vs. normal or elevated [reference]: adjusted HR = 0.14 [95% CI = 0.03–0.60], p = 0.008) were two significant independent factors that influenced recovery and discharge.
Conclusion
Lung severity score > 4 and reduced lymphocyte count at initial evaluation were independently associated with a significantly lower rate of recovery and discharge and extended hospitalization in patients admitted for COVID-19 pneumonia.
10.Initial experience of ileal ureter replacement combined with augmentation cystoplasty in the treatment of ureteral stenosis with contracted bladder
Kunlin YANG ; Yuye WU ; Guangpu DING ; Yukun CAI ; Wei SHI ; Junsheng BAO ; Wenfeng GUAN ; Zi'ao LI ; Shubo FAN ; Wanqiang LI ; Lei ZHANG ; Xuesong LI ; Liqun ZHOU
Chinese Journal of Urology 2019;40(6):416-421
Objective To explore the availability and safety of ileal ureter replacement combined with ileal augmentation cystoplasty in treating ureteral stenosis with contracted bladder.Methods From August 2015 to November 2018,three patients who underwent ileal ureter replacement combined with augmentation cystoplasty were treated with ileal ureter replacement combined with augmentation cystoplasty.There were 1 male and 2 females with the age ranging from 34 to 55 years (mean 39 years).Two patients suffered from left ureter stenosis,and one patient had stenosis on the both sides.The length of the ureter stenosis ranged from 6 to 18 cm (mean 9.8 cm).The preoperative bladder capacity ranged from 60 to 150 ml (mean 103.3 ml).In the surgery,part of ileum was used to replace the ureter,and the distal intestine was made into U-shape to enlarge the bladder.Results All operation were completed successfully.The operation time ranged from 220 to 400 min (mean 303.0 min),and the blood loss ranged from 150 to 500 ml (mean 283.3 ml).Laparoscopic surgery was performed in 1 case and open surgery in 2 cases.Three weeks after the surgery,the bladder volume underwent cystography ranged from 300 to 400 ml (mean 360.0 ml).Three months after the surgery,the postvoid residual urine volume ranged from 20 to 50 ml (mean 33.3 ml).Postoperative frequency and urgency of urine were completely relieved in 1 case,alleviated in 2 cases.Flank pain was completely relieved in 1 case,and alleviated in 2 cases postoperatively.The serum creatinine of 2 patients mildly increased after the surgery,while 1 patient remained stable.For complications,1 patient had urinary infection,and 1 patient suffered from metabolic acidosis.Conclusions Ileal ureteral replacement combined with augmentation cystoplasty can be the choice of treatment for long segment ureteral stenosis and enlarge the bladder simultaneously.The postoperative complications and the kidney functions should be regularly followed up.

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