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.Recommendations for prescription review of antipyretic-analgesics in symptomatic treatment of children with fever
Xiaohui LIU ; Xing JI ; Lihua HU ; Yuntao JIA ; Huajun SUN ; Qinghong LU ; Shengnan ZHANG ; Ruiling ZHAO ; Shunguo ZHANG ; Yanyan SUN ; Meixing YAN ; Lina HAO ; Heping CAI ; Jing XU ; Zengyan ZHU ; Hua XU ; Jing MIAO ; Xiaotong LU ; Zebin CHEN ; Hua CHENG ; Yunzhu LIN ; Ruijie CHEN ; Xin ZHAO ; Zhenguo LIU ; Junli ZHANG ; Yuwu JIANG ; Chaomin WAN ; Gen LU ; Hengmiao GAO ; Ju YIN ; Kunling SHEN ; Baoping XU ; Xiaoling WANG
Chinese Journal of Applied Clinical Pediatrics 2022;37(9):653-659
Antipyretic-analgesics are currently one of the most prescribed drugs in children.The clinical application of antipyretic-analgesics for children in our country still have irrational phenomenon, which affects the therapeutic effect and even poses hidden dangers to the safety of children.In this paper, suggestions were put forward from the indications, dosage form/route, dosage suitability, pathophysiological characteristics of children with individual differences and drug interactions in the symptomatic treatment of febrile children, so as to provide reference for the general pharmacists when conducting prescription review.
3.Preventive and therapeutic effects of sanguinarine chloride on sodium arsenite-induced liver damage in mice
Heping YANG ; Mingfei YANG ; Aihua ZHANG ; Jia YU ; Sha CHENG ; Baofei SUN ; Chen YAN ; Zijiang YU ; Heng LUO
Journal of Environmental and Occupational Medicine 2022;39(8):913-918
Background Natural product sanguinarine chloride (SC) can significantly alleviate liver fibrosis and acute liver injury in mice, but whether it has a protective effect on mouse liver injury caused by sodium arsenite (SA) has not been studied. Objective To verify if SC may present preventive and therapeutic effects on SA-induced liver injury in mice. Methods A total of 140 SPF male Kunming mice were randomly divided into two sub-studies, which included a prevention sub-study and a treatment sub-study. In each sub-study, a blank group (normal saline), a model group (5 mg·kg−1 SA), and a positive control group (11.375 mg·kg−1 bicyclol and 182 mg·kg−1 glutathione), as well as SC low, medium, and high dose groups (25, 50, and 100 mg·kg−1) were arranged with 10 mice in each group. In the prevention sub-study, the blank group was given normal saline, the model group was given SA, and the other groups (the SC low, medium, and high dose groups and the positive control group) were given the corresponding treatment 30 min before gavage of SA, once a day, for 28 d. In the treatment sub-study, except for the blank group which was given normal saline, the other groups were given SA for 28 d, then the model group was given normal saline, and the other groups were given the corresponding treatment every day for 28 d. After the experiment, the mice were sacrificed to evaluate selected physiological and biochemical indicators in serum and liver tissue and to observe histopathological changes after HE staining. Results In either sub-study of preventive effect or treatment effect: compared with the blank group, body weight, liver weight, liver coefficient, as well as serum alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), malondialdehyde (MDA), glutathione peroxidase (GSH), and superoxide dismutase (SOD) among all SC groups were not significantly different (P>0.05); but compared with the model group, the SC groups showed increased body weight (P<0.01), decreased liver weight and liver coefficient (P<0.01), reduced ALT, AST, TBIL, and MDA (P<0.05 or P<0.01), and increased GSH and SOD with (P<0.05 or P<0.01) or without significance; compared with the positive control group, no differences were found in the above indicators (P>0.05). The result of histopathological evaluation showed that the SC groups had a clear liver lobule structure, neatly arranged hepatic cords, and less infiltration of inflammatory cells. Conclusion SC has both preventive and therapeutic effects on SA-induced liver injury in mice.
4.Acupuncture at sphenopalatine ganglion combined with conventional acupuncture for episodic cluster headache: a randomized controlled trial.
Feng-Lei ZAI ; Lai-Xi JI ; Jiang-Hui CHENG ; Ya-Ru CHEN ; Hong LIU
Chinese Acupuncture & Moxibustion 2022;42(6):603-607
OBJECTIVE:
To observe the clinical effect of acupuncture at sphenopalatine ganglion combined with conventional acupuncture for episodic cluster headache (CH).
METHODS:
One hundred and eighty patients with episodic CH were randomly divided into a combined group (60 cases, 3 cases dropped off),an acupuncture group (60 cases, 2 cases dropped off) and a sphenopalatine ganglion group (60 cases, 2 cases dropped off and 1 case was removed). The patients in the acupuncture group were treated with conventional acupuncture at Touwei (ST 8), Yintang (GV 24+), Yangbai (GB 14), Hegu (LI 4), etc., once a day, 6 times a week. The patients in the sphenopalatine ganglion group were treated with acupuncture at sphenopalatine ganglion, once every other day, 3 times a week. On the basis of the conventional acupuncture, the combined group was treated with acupuncture at sphenopalatine ganglion once every other day. Two weeks were taken as a course of treatment, and 3 courses of treatment were required in the 3 groups. The score of visual analogue scale (VAS), the number of headache attacks per week, the duration of each headache attack and the score of migraine-specific quality of life questionnaire version 2.1 (MSQ) were observed before and after treatment and in follow-up of 3 months after treatment. The clinical efficacy of each group was compared.
RESULTS:
After treatment and in follow-up, the VAS score of headache, the number of headache attacks per week, the duration of each headache attack, and each various scores and the total score of MSQ of each group were lower than those before treatment (P<0.01). Except that the number of headache attacks per week in the combined group was lower than the sphenopalatine ganglion group (P<0.01), other indexes in the combined group were lower than the other two groups (P<0.05, P<0.01). The total effective rate in the combined group was 93.0% (53/57), which was higher than 75.9% (44/58) in the acupuncture group and 73.7% (42/57) in the sphenopalatine ganglion group(P<0.05, P<0.01).
CONCLUSION
Acupuncture at sphenopalatine ganglion combined with conventional acupuncture could reduce the degree of pain in patients with episodic CH, reduce the number and duration of headache attacks, and improve the quality of life of patients. It is more effective than simple conventional acupuncture or acupuncture at sphenopalatine ganglion alone.
Acupuncture Points
;
Acupuncture Therapy
;
Cluster Headache/therapy*
;
Headache/therapy*
;
Humans
;
Quality of Life
;
Treatment Outcome
5.Visualizing Seizure Propagation in Freely-moving Mice via Miniature Two-photon Microscopy.
Zhuoran ZHANG ; Shihe JIANG ; Kaibin SHI ; Yan LI ; Wei-Na JIN ; Qiang LIU ; Ting ZHAO ; Heping CHENG ; Fu-Dong SHI
Neuroscience Bulletin 2022;38(12):1593-1597
Animals
;
Mice
;
Microscopy
;
Seizures
;
Brain
6.Evaluating the effectiveness of HIV/syphilis joint self-testing in promoting syphilis testing among men who have sex with men
Peizhen ZHAO ; Weibin CHENG ; Weiming TANG ; Heping ZHENG ; Bin YANG ; Cheng WANG
Chinese Journal of Epidemiology 2021;42(2):273-277
Objective:To evaluate the effectiveness of HIV/syphilis joint self-testing in promoting syphilis testing among men who have sex with men (MSM).Methods:In July 2019, the research participants were recruited through the Danlan website (https://www.danlan.org). Participants who met the selection criteria, and were randomly assigned into one of the three study groups (1∶1∶1) including HIV/syphilis joint self-testing group and lottery incentive self-testing group and control group. Self-test reagents were mailed to HIV/syphilis joint self-testing group and lottery incentive self-testing group, and the subjects in control group were encouraged to go to offline locations for testing. One month later, follow-up was conducted to evaluate the differences in the testing rates of syphilis among the three groups.Results:A total of 145 subjects were included in this study, including 48 in control group, 49 in HIV/syphilis joint self-testing group and 48 in lottery incentive self-testing group. During the follow-up period, the self-testing rate of syphilis was 74.4% (32/43) in HIV/syphilis joint self-testing group, 70.0% (28/40) in lottery incentive self-testing group and 36.4% (16/44) in control group. Multivariate logistic analysis revealed that the proportions of syphilis testing in HIV/syphilis joint self-testing group and lottery incentive self-testing group were 5.38 (95% CI: 2.06-14.04) times and 4.54 (95% CI: 1.75-11.74) times higher than that in control group during the follow-up period. Conclusions:HIV/syphilis joint self-testing and lottery-incentives-prompted self-testing significantly increased the testing rate of syphilis in MSM, respectively. HIV/syphilis joint self-testing is feasible for promotion.
7.Spatiotemporal distribution and related factors of congenital syphilis in Guangdong province from 2005 to 2017: a spatial panel data analysis
Shangqing TANG ; Wen CHEN ; Peizhen ZHAO ; Heping ZHENG ; Bin YANG ; Lishuo SHI ; Li LING ; Cheng WANG
Chinese Journal of Epidemiology 2021;42(4):620-625
Objective:To explore the spatiotemporal distribution and macro-related factors of congenital syphilis in Guangdong province and provide suggestions and recommendations for prevention.Methods:Yearly reported cases of syphilis and some influencing factor data of Guangdong province were collected from 2005 to 2017. The spatiotemporal distribution of congenital syphilis was described. Meanwhile, the spatial panel data model was constructed to analyze the relationship between the incidence rates of congenital syphilis and related factors.Results:From 2005 to 2017, 13 361 cases of congenital syphilis were reported in Guangdong province. The number of congenital syphilis cases rose to its highest point during 2005-2011. A slow downward trend followed. The peaks of incidence were observed from August to December. The incidence of the non-Pearl River Delta region has experienced a process of rising first and then decreasing. The spatial panel data model results showed that congenital syphilis had significant positive spatial autocorrelation ( P<0.001). The incidence of primary and secondary syphilis in women ( β=0.822, P<0.001), gross domestic product per capita ( β=3.511, P<0.001), net migrate rate ( β=0.215, P=0.047) and maternal system management rate ?(β=0.017, P=0.021) were all positively correlated with the incidence rates of congenital syphilis. Registered population density ( β=-1.167, P<0.001) and prenatal examination rate ( β=-0.038, P=0.031) was negatively correlated with congenital syphilis. Conclusions:The incidence of congenital syphilis was spatially aggregated in Guangdong province from 2005 to 2017. The intensity of prevention might be strengthened in cities with developed economies and high net migration rates, which have high risks of congenital syphilis. Controlling the incidence of primary and secondary syphilis in women and increasing the prenatal examination rate for pregnant women appears effective prevention measures of congenital syphilis.
8.Miniature Fluorescence Microscopy for Imaging Brain Activity in Freely-Behaving Animals.
Shiyuan CHEN ; Zichen WANG ; Dong ZHANG ; Aiming WANG ; Liangyi CHEN ; Heping CHENG ; Runlong WU
Neuroscience Bulletin 2020;36(10):1182-1190
An ultimate goal of neuroscience is to decipher the principles underlying neuronal information processing at the molecular, cellular, circuit, and system levels. The advent of miniature fluorescence microscopy has furthered the quest by visualizing brain activities and structural dynamics in animals engaged in self-determined behaviors. In this brief review, we summarize recent advances in miniature fluorescence microscopy for neuroscience, focusing mostly on two mainstream solutions - miniature single-photon microscopy, and miniature two-photon microscopy. We discuss their technical advantages and limitations as well as unmet challenges for future improvement. Examples of preliminary applications are also presented to reflect on a new trend of brain imaging in experimental paradigms involving body movements, long and complex protocols, and even disease progression and aging.
9.Clinical application of venous nutrition flap pedicled by medial plantar artery of the hallux on the medical aspect of the foot.
Lin JIAN ; Liang CHENG ; Zheng HEPING ; Lu HUA ; Zhang TIANHAO ; Wang ZHIJIANG ; Wan HUAJUN
Chinese Journal of Plastic Surgery 2015;31(3):179-182
OBJECTIVETo introduce the clinical application of venous nutrition flap pedicled by medial plantar artery of the hallux on the medical aspect of the foot.
METHODSBased on the anastomoses between the medial plantar artery of the hallux and the nutritional vein, the flap was designed with the perforator of medial plantar artery adjacent to the first metatarsal bone as the rotation point. The flap axis was along the vein at the medial aspect of the foot between rotation point and medial malleolus.
RESULTS5 cases were treated with primary healing and complete survival flaps. The patients were followed up for 1-12 months with good match of texture and color.
CONCLUSIONSThe venous nutrition flap pedicled by medial plantar artery of the hallux on the medical aspect of the foot can be transpositioned to repair the defect at forefoot.
Arteries ; Forefoot, Human ; Hallux ; blood supply ; Humans ; Metatarsal Bones ; Surgical Flaps ; blood supply ; Veins ; Wound Healing
10.The relationships between coping style, psychological capital and vocational selection anxiety in the female college graduates
Yanhong LUO ; Heping CHENG ; Taisheng CAI ; Gui CHEN
Chinese Journal of Behavioral Medicine and Brain Science 2015;24(7):647-649
Objective To examine the relationship of coping style,psychological capital and vocational selection anxiety for female college graduates.Methods A sample of 330 female college graduates filled out measures for the simplified coping styles questionnaire (SCSQ),Psychological Capital Questionnaire (PCQ) and vocational selection anxiety Questionnaire(VSAQ).Results Correlation analysis showed that except the self-efficacy and positive coping style collected with concerns about job prospects was not significant (r=-0.08-0.05,P>0.05),each dimensions of PCQ and SCSQ significantly correlated with the each dimensions of VSAQ (r=-0.44--0.13 or r=0.21-0.28,P<0.01).Regression analysis showed that negative coping style,resilience,hope and positive coping style could directly predict vocational selection anxiety.Psychological capital were the mediators between positive coping styles and vocational selection anxiety.Conclusion Coping styles and psychological capital are closely related to the female college graduates' vocational selection anxiety,using appropriate coping styles and improving mental ability can effectively reduce vocational selection anxiety.

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