1.Simultaneous content determination of eleven ginsenosides in Fukang Tablets by UPLC-MS/MS
Si-Min XIE ; Jun-Fei CHEN ; Hao-Yu HUANG ; Li-Hong GU ; Jian-Ming LI
Chinese Traditional Patent Medicine 2024;46(9):2858-2863
AIM To establish a UPLC-MS/MS method for the simultaneous content determination of pseudoginsenoside F11 and ginsenosides Rf,Rg1,Re,Rb1,Rb2,Rb3,Rg2,Rg3,Rc,Rd.METHODS The analysis was performed on a 40℃ thermostatic Phenomenex Kinetex F5 column(2.1 mm×100 mm,1.7 μm),with the mobile phase comprising of acetonitrile-2 mmol/L ammonium formate flowing at 0.3 mL/min in a gradient elution manner,and electron spray ionization source was adopted in negative ion scanning with multiple reaction monitoring mode.RESULTS Eleven ginsenosides showed good linear relationships within their own ranges(r>0.9900),whose average recoveries were 97.40%-103.74%with the RSDs of 1.76%-3.48%.CONCLUSION This sensitive,practical and reproducible method can be used for the quality control of Ginseng Radix et Rhizoma in Fukang Tablets.
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.Efficacy and safefy of Polymyxin B treatment for neutropenic patients suffering from refractory Gram-negative bacterial bloodstream infection.
Meng ZHOU ; Hui Zhu KANG ; Cheng Yuan GU ; Yue Jun LIU ; Ying WANG ; Miao MIAO ; Jian Hong FU ; Xiao Wen TANG ; Hui Ying QIU ; Cheng Cheng FU ; Zheng Ming JIN ; Cai Xia LI ; Su Ning CHEN ; Ai Ning SUN ; De Pei WU ; Yue HAN
Chinese Journal of Hematology 2023;44(6):484-489
Objective: To assess the efficacy and safety of polymyxin B in neutropenic patients with hematologic disorders who had refractory gram-negative bacterial bloodstream infection. Methods: From August 2021 to July 2022, we retrospectively analyzed neutropenic patients with refractory gram-negative bacterial bloodstream infection who were treated with polymyxin B in the Department of Hematology of the First Affiliated Hospital of the Soochow University between August 2021 to July 2022. The cumulative response rate was then computed. Results: The study included 27 neutropenic patients with refractory gram-negative bacterial bloodstream infections. Polymyxin B therapy was effective in 22 of 27 patients. The median time between the onset of fever and the delivery of polymyxin B was 3 days [interquartile range (IQR) : 2-5]. The median duration of polymyxin B treatment was 7 days (IQR: 5-11). Polymyxin B therapy had a median antipyretic time of 37 h (IQR: 32-70). The incidence of acute renal dysfunction was 14.8% (four out of 27 cases), all classified as "injury" according to RIFLE criteria. The incidence of hyperpigmentation was 59.3%. Conclusion: Polymyxin B is a viable treatment option for granulocytopenia patients with refractory gram-negative bacterial bloodstream infections.
Humans
;
Polymyxin B/adverse effects*
;
Retrospective Studies
;
Gram-Negative Bacterial Infections/complications*
;
Fever/drug therapy*
;
Sepsis/drug therapy*
;
Anti-Bacterial Agents/therapeutic use*
;
Bacteremia/complications*
4.Repeated stellate ganglion blockade for the treatment of ventricular tachycardia storm in patients with nonischemic cardiomyopathy: a new therapeutic option for patients with malignant arrhythmias.
Chang CUI ; Xiao Kai ZHOU ; Yue ZHU ; You Mei SHEN ; Lin Dou CHEN ; Wei Zhu JU ; Hong Wu CHEN ; Kai GU ; Ming Fang LI ; Yin Bing PAN ; Ming Long CHEN
Chinese Journal of Cardiology 2023;51(5):521-525
Objectives: This study sought to describe our institutional experience of repeated percutaneous stellate ganglion blockade (R-SGB) as a treatment option for drug-refractory electrical storm in patients with nonischemic cardiomyopathy (NICM). Methods: This prospective observational study included 8 consecutive NICM patients who had drug-refractory electrical storm and underwent R-SGB between June 1, 2021 and January 31, 2022. Lidocaine (5 ml, 1%) was injected in the vicinity of the left stellate ganglion under the guidance of ultrasound, once per day for 7 days. Data including clinical characteristics, immediate and long-term outcomes, and procedure related complications were collected. Results: The mean age was (51.5±13.6) years. All patients were male. 5 patients were diagnosed as dilated cardiomyopathy, 2 patients as arrhythmogenic right ventricular cardiomyopathy and 1 patient as hypertrophic cardiomyopathy. The left ventricular ejection fraction was 37.8%±6.6%. After the treatment of R-SGB, 6 (75%) patients were free of electrical storm. 24 hours Holter monitoring showed significant reduction in ventricular tachycardia (VT) episodes from 43.0 (13.3, 276.3) to 1.0 (0.3, 34.0) on the first day following R-SGB (P<0.05) and 0.5 (0.0, 19.3) after whole R-SGB process (P<0.05). There were no procedure-related major complications. The mean follow-up was (4.8±1.1) months, and the median time of recurrent VT was 2 months. Conclusion: Minimally invasive R-SGB is a safe and effective method to treat electrical storm in patients with NICM.
Humans
;
Male
;
Adult
;
Middle Aged
;
Aged
;
Female
;
Stroke Volume
;
Stellate Ganglion/surgery*
;
Ventricular Function, Left
;
Cardiomyopathies/complications*
;
Tachycardia, Ventricular/therapy*
;
Treatment Outcome
;
Catheter Ablation
5.Expert consensus on the prevention and treatment of adverse reactions in subcutaneous immunotherapy(2023, Chongqing).
Yu Cheng YANG ; Yang SHEN ; Xiang Dong WANG ; Yan JIANG ; Qian Hui QIU ; Jian LI ; Shao Qing YU ; Xia KE ; Feng LIU ; Yuan Teng XU ; Hong Fei LOU ; Hong Tian WANG ; Guo Dong YU ; Rui XU ; Juan MENG ; Cui Da MENG ; Na SUN ; Jian Jun CHEN ; Ming ZENG ; Zhi Hai XIE ; Yue Qi SUN ; Jun TANG ; Ke Qing ZHAO ; Wei Tian ZHANG ; Zhao Hui SHI ; Cheng Li XU ; Yan Li YANG ; Mei Ping LU ; Hui Ping YE ; Xin WEI ; Bin SUN ; Yun Fang AN ; Ya Nan SUN ; Yu Rong GU ; Tian Hong ZHANG ; Luo BA ; Qin Tai YANG ; Jing YE ; Yu XU ; Hua Bin LI
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(7):643-656
6.Surveillance of suspected adverse events following immunization in Chongchuan District from 2008 to 2022
GU Hong ; HOU Xiaoyan ; QI Zhigang ; WU Ming
Journal of Preventive Medicine 2023;35(11):992-996
Objective :
To investigate the incidence of suspected adverse events following immunization(AEFI) in Chongchuan District, Nantong City, Jiangsu Province from 2008 to 2022, so as to provide insights into safety assessment of vaccines.
Methods:
The data on AEFI surveillance in Chongchuan District from 2008 to 2022 were collected through the National Immunization Program Information Management System of China, including demographics, history of vaccination, laboratory tests, incidence of AEFI and clinical characteristics. The epidemiological, clinical characteristics and reported incidence of AEFI were analyzed in Chongchuan District from 2008 to 2022 using a descriptive epidemiological method.
Results:
The reported incidence of AEFI in Chongchuan District from 2008 to 2022 appeared a tendency towards a decline (P<0.05), and the annual average reported incidence was 50.85/105. The incidence of AEFI associated with vaccines included in the national immunization program was significantly higher than that caused by vaccines that were not included in the national immunization program (74.67/105 vs. 20.35/105, P<0.05). General reaction was the predominant type of AEFI (1 937 cases, 44.21/105), and there were 274 cases with abnormal reactions (6.25/105) and 17 cases with coincident syndromes (0.39/105); however, no vaccine quality or vaccination accidents occurred. A high incidence rate was seen in AEFI associated with vaccines administered by subcutaneous (75.05/105) and intramuscular injection (47.40/105), and a low incidence rate was found in AEFI associated with vaccines administered orally (16.41/105). The five highest reported incidence rates of AEFI were found for the combined diphtheria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b vaccine (312.01/105), 7-valent pneumococcal polysaccharide-protein conjugate vaccine (292.14/105), inactivated Japanese encephalitis vaccine (248.37/105), Group ACYW135 meningococcal polysaccharide vaccine (240.67/105) and combined live vaccine for measles and rubella (229.31/105). The general reactions mainly included fever, redness and swelling and induration (1 878 cases, 96.95%), and abnormal reactions mainly included allergic skin rash (241 cases, 87.96%). In addition, 91.34% of AEFI occurred within 24 hours after vaccination, and 99.73% of cases with AEFI were cured during the 3-month follow-up.
Conclusions
The reported incidence of AEFI appeared a tendency towards a decline in Chongchuan District from 2008 to 2022. General reaction was the predominant type of AEFI, and all AEFI showed a good prognosis. The safety of vaccines was high in Chongchuan District from 2008 to 2022.
7.Clinical characteristics and long-term follow-up results of radiofrequency ablation for the treatment of ventricular tachycardia in patients with arrhythmogenic left ventricular cardiomyopathy.
Zhe WANG ; Lin Sheng SHI ; Hai Lei LIU ; Zi Dun WANG ; Xiao Hong JIANG ; Hong Wu CHEN ; Gang YANG ; Kai GU ; Wei Zhu JU ; Ming Long CHEN
Chinese Journal of Cardiology 2022;50(6):549-555
Objective: To investigate the acute and long-term outcome of catheter ablation for the treatment of ventricular tachycardia (VT) in patients with arrhythmogenic left ventricular cardiomyopathy (ALVC). Methods: This retrospective, cross-sectional study enrolled ALVC patients undergoing radiofrequency ablation for the treatment of VT at the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2018 and collected their clinical characteristics and intraoperative electrophysiological examination. Patients were followed up every 6 months after radiofrequency ablation until August 2021. Echocardiographic results and VT recurrence post radiofrequency ablation were analysed. Results: Totally 12 patients were enrolled (mean age: (42±15) years, 11 males(11/12)). The mean of left ventricular end diastolic diameter (LVDd) and left ventricular ejection fraction (LVEF) were (51±5)mm and (65±5)%, respectively. Twelve VTs were induced in 10 patients during the electrophysiological study, and the mean tachycardia cycle length was (293±65) ms. Three-dimensional substrate mapping revealed the diseased area at endocardial site in one patient, at epicardial sites in the other 11 patients (involved endocardial sites in 2 cases) with the basal part near the mitral annulus being the predilection for the substrate (10/11). After the catheter ablation at the endocardial and epicardial sites respectively, the complete procedure endpoint was achieved in all patients (VT cannot be induced post ablation). The median follow-up time was 65 (25, 123) months. One patient was lost to follow-up, and the other 11 patients survived without VT. No significant cardiac function deterioration was detected by the echocardiographic examination ((51±5)mm vs. (52±5)mm, P>0.05 for LVDd, (65±5)% vs. (60±6)%, P>0.05 for LVEF) at the end of follow-up. Conclusion: After radiofrequency ablation, the complete procedure endpoint is achieved in ALVC patients, and the catheter ablation provides long-term ventricular tachycardia control during the long-term follow-up.
Adult
;
Cardiomyopathies
;
Catheter Ablation
;
Cross-Sectional Studies
;
Follow-Up Studies
;
Humans
;
Male
;
Middle Aged
;
Pericardium/surgery*
;
Recurrence
;
Retrospective Studies
;
Stroke Volume
;
Tachycardia, Ventricular/surgery*
;
Treatment Outcome
;
Ventricular Function, Left
8.Relationship between the high sensitivity C-reactive protein and anxiety levels in hospitalized patients with cardiovascular-related diseases and hypertension
Qi LI ; Hong CAO ; Ming GU ; Jiang WAN ; Chuyun WANG ; Run YUAN ; Lin LI ; Xiang LI ; Jichun CHEN
Chinese Journal of Health Management 2022;16(5):303-307
Objective:To analyze the relationship between the high sensitivity C-reactive protein (hs-CRP) and anxiety levels in patients hospitalized with cardiovascular-related diseases and hypertension.Methods:A total of 221 patients hospitalized with cardiovascular-related diseases in the Fuwai Hospital were selected by a voluntary sampling method from September to December 2021. Participants were divided into hypertensive and non-hypertensive groups ( n=119 and n=102) based on the diagnosis of hypertension in their inpatient medical records. Anxiety levels were assessed using the Zung Self-Rating Anxiety Scale, and the levels of serum hs-CRP were estimated by automatic immunoanalyzer. Multivariate logistic regression was used to analyze the relationship between hs-CRP and anxiety. Results:In the hypertensive group, the risk of anxiety in patients with abnormal hs-CRP (>3 mg/L) was 4.239 times (95% CI: 1.569-11.748, P=0.005) higher than those in normal hs-CRP (≤3 mg/L). In turn, compared with patients without anxiety, those with anxiety had 3.878 times greater probability of experiencing abnormal hs-CRP (95% CI: 1.495-10.062, P=0.005), while those with mild anxiety and moderate to severe anxiety had 4.525 times (95% CI: 1.392-14.714, P=0.012) and 3.286 times (95% CI: 0.911-11.357, P=0.070) greater odds of experiencing abnormal hs-CRP, respectively. No similar significant association was seen in the non-hypertensive group. Conclusion:There is an interrelationship between elevated hs-CRP and anxiety in hospitalized patients with cardiovascular-related diseases and hypertension.
10.Safety and efficacy of left atrial appendage closure combined with patent foramen ovale closure for atrial fibrillation patients with patent foramen ovale.
Zhi Hong ZHAO ; Xiang SONG ; Sai Hua WANG ; Jun LUO ; Ying Biao WU ; Qian ZHU ; Ming FANG ; Qiang HUAN ; Xiao Gang ZHANG ; Bei TIAN ; Wei GU ; Luo Ning ZHU ; Shu Wen HAO ; Zhong Ping NING
Chinese Journal of Cardiology 2022;50(3):257-262
Objective: To analyze the safety and efficacy of combined left atrial appendage (LAA) and patent foramen ovale (PFO) closure in adult atrial fibrillation (AF) patients complicating with PFO. Methods: This study is a retrospective and cross-sectional study. Seven patients with AF complicated with PFO diagnosed by transesophageal echocardiography (TEE) in Zhoupu Hospital Affiliated to Shanghai University of Medicine & Health Sciences from June 2017 to October 2020 were selected. Basic data such as age, gender and medical history were collected. The atrial septal defect or PFO occluder and LAA occluder were selected according to the size of PFO, the ostia width and depth of LAA. Four patients underwent left atrial appendage closure(LAAC) and PFO closure at the same time. PFO closure was performed during a one-stop procedure of cryoablation combined with LAAC in 2 patients. One patient underwent PFO closure at 10 weeks after one-stop procedure because of recurrent transient ischemic attack (TIA). All patients continued to take oral anticoagulants. TEE was repeated 8-12 weeks after intervention. In case of device related thrombus(DRT), TEE shall be rechecked 6 months after adjusting anticoagulant and antiplatelet drug treatment. Patients were follow-up at 1, 3, 6, 12, 24 months by telephone call, and the occurrence of cardio-cerebrovascular events was recorded. Results: Among the 7 patients with AF, 2 were male, aged (68.0±9.4) years, and 3 had a history of recurrent cerebral infarction and TIA. Average PFO diameter was (3.5±0.8)mm. Three patients were implanted with Watchman LAA occluder (30, 30, 33 mm) and atrial septal defect occluder (8, 9, 16 mm). 2 patients were implanted with LAmbre LAA occluder (34/38, 18/32 mm) and PFO occluder (PF1825, PF2525). 2 patients were implanted with LACbes LAA occluder (24, 28 mm) and PFO occluder (PF2525, PF1825) respectively. The patients were followed up for 12 (11, 24) months after operation. TEE reexamination showed that the position of LAA occluder and atrial septal defect occluder or PFO occluder was normal in all patients. DRT was detected in 1 patient, and anticoagulant therapy was adjusted in this patient. 6 months later, TEE showed that DRT disappeared. No cardiovascular and cerebrovascular events occurred in all patients with AF during follow-up. Conclusions: In AF patients complicated with PFO, LAAC combined with PFO closure may have good safety and effectiveness.
Adult
;
Aged
;
Atrial Appendage/surgery*
;
Atrial Fibrillation/surgery*
;
Cardiac Catheterization/methods*
;
China
;
Cross-Sectional Studies
;
Foramen Ovale, Patent/surgery*
;
Humans
;
Male
;
Middle Aged
;
Retrospective Studies


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