1.Determination of Three Kinds of Cannabinoids in Cannabis UsingUltra-high Performance Liquid Chromatography-Tandem MassSpectrometry and Analysis of Phenotype of Cannabis
Weilai SUN ; Xiaoyu ZHENG ; Yanbiao ZHAO ; Linghua ZENG ; Lisheng GAO ; Hui ZHENG ; Yao LIU
Chinese Journal of Analytical Chemistry 2017;45(7):1052-1058
An analytical method of ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC/PDA-QDa) for the qualitative and quantitative analysis of Δ9-tetrahydrocannabinol (Δ9-THC), cannabidiol (CBD), and cannabinol (CBN) in confiscated cannabis was developed.The seized cannabis was extracted in methanol by sonication.The binary mobile phase consisted of methanol (containing 0.1% formic acid) and water.After centrifugation, the supernatant was separated on Waters UPLC BEH C18 column (50 mm×2.1 mm, 1.7 μm) with isocratic elution at a flow rate of 0.2 mL/min.The three cannabinoids were analyzed by photodiode array (PDA) detector at 220 nm and confirmed by mass spectrometer QDa.The correlation coefficient of standard curve for the three cannabinoids in linearity range was not less than 0.999, as well as the recoveries were 82%-102% with the relative standard deviations (RSD) of 0.36%-4.12% at three spiked levels.The method is specific, easy, quick and suitable for confirmation of the cannabinoids in seized cannabis.Cannabis plants in different areas were classified by their chemical phenotype as drug-type or fiber-type plants, taking into account the phenotypic index Δ9-THC, (Δ9-THC+CBN)/CBD, or the Δ9-THC/CBD and the (Δ9-THC+CBN)/CBD ratios.The analysis of the original composition of plant material is necessary for the detection and the quality control of cannabis plants.
2.An epidemiological survey on reproductive track infection and the investigation on syndromic approach on vaginal discharge.
Min LIU ; Guang ZENG ; Linghua ZHANG ; Zhiqiang LIU ; Shiqin LI
Chinese Journal of Epidemiology 2002;23(6):422-426
OBJECTIVETo investigate the reproductive track infection (RTI) situation and risk factors for cervical infection (Neisseria gonorrhoeae or Chlamydia trachomatis) among different kinds of women of childbearing age in Shenzhen city, China. To assess the feasibility of the syndromic approach for vaginal discharge.
METHODSThe survey was administrated to 4,744 eligible women in Shenzhen city during October 2001 and April 2002. The subjects included three different kinds of population: 3,895 cases of general population, 438 STD/gynecological clinic outpatients and 411 people with high risk behavior. Gynaecologic examination and RTI laboratory diagnosis were performed for each subject. PCR method-based test was used to detect the Neisseria gonorrhoeae and Chlamydia trachomatis infection. Standardized questionnaire were designed to collect the information about RTI related behaviors, and history of marriage and child bearing, et al. The risk factors, symptoms and signs of cervical infection were analyzed. Syndromic approach was established and its feasibility was assessed.
RESULTS27.6% of women in Shenzhen were infected with at least one kind of RTI, including 5.0% with cervical infection. The risk factors for cervical infection were: individuals having had new sex partner within last 3 months (OR = 1.6, 95% CI: 1.1 - 2.4), having had the experience of abortion (OR = 1.6, 95% CI: 1.1 - 2.4), aged 25 or less (OR = 1.6, 95% CI: 1.1 - 2.4) and never using condom during sex intercourse (OR = 1.7, 95% CI: 1.1 - 2.4). The sensitivity of syndromic approach of risk assessment and signs for cervical infection among general population was 63.8%, while specificity was 55.1% with the positive predictive value 7.0%.
CONCLUSIONSRTI infection was common among all three kinds of childbearing women in Shenzhen city. The prevalence of RTI was the highest among high risk population, followed by STD/gynecological clinic outpatients. The efficacy of syndromic approach for cervical infection in general population was not ideal.
China ; epidemiology ; Female ; Genital Diseases, Female ; epidemiology ; etiology ; Humans ; Risk Assessment ; Risk Factors ; Uterine Cervical Diseases ; epidemiology ; Vaginal Discharge ; epidemiology ; etiology
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