1.Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients: A 12-week randomized placebo-controlled phase III trial with long-term extension
Chen YU ; Songmei GENG ; Bin YANG ; Yunhua DENG ; Fuqiu LI ; Xiaojing KANG ; Mingye BI ; Furen ZHANG ; Yi ZHAO ; Weili PAN ; Zhongwei TIAN ; Jinhua XU ; Zhenghua ZHANG ; Nan YU ; Xinsuo DUAN ; Shuping GUO ; Qing SUN ; Weiquan LI ; Juan TAO ; Zhijun LIU ; Yuanyuan YIN ; Gang WANG
Chinese Medical Journal 2024;137(10):1190-1198
Background::There is a need for effective and safe therapies for psoriasis that provide sustained benefits. The aim of this study was to assess the efficacy and safety of tildrakizumab, an anti-interleukin-23p19 monoclonal antibody, for treating moderate-to-severe plaque psoriasis in Chinese patients.Methods::In this multi-center, double-blind, phase III trial, patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned (1:1) to receive subcutaneous tildrakizumab 100 mg or placebo at weeks 0 and 4. Patients initially assigned to placebo were switched to receive tildrakizumab at weeks 12, 16, and every 12 weeks thereafter. Patients in the tildrakizumab group continued with tildrakizumab at week 16, and every 12 weeks until week 52. The primary endpoint was the Psoriasis Area and Severity Index (PASI 75) response rate at week 12.Results::At week 12, tildrakizumab demonstrated significantly higher PASI 75 response rates (66.4% [73/110] vs. 12.7% [14/110]; difference, 51.4% [95% confidence interval (CI), 40.72, 62.13]; P <0.001) and Physician’s Global Assessment (60.9% [67/110] vs. 10.0% [11/110]; difference, 49.1% [95% CI, 38.64, 59.62]; P <0.001) compared to placebo. PASI 75 response continued to improve over time in both tildrakizumab and placebo-switching to tildrakizumab groups, reaching maximal efficacy after 28 weeks (86.8% [92/106] vs. 82.4% [89/108]) and maintained up to 52 weeks (91.3% [95/104] vs. 87.4% [90/103]). Most treatment-emergent adverse events were mild and not related to tildrakizumab. Conclusion::Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.Trial registration::ClinicalTrials.gov, NCT05108766.
2.The prognostic value of myocardial infarct size measured by cardiovascular magnetic resonance in patients with acute ST-segment elevation myocardial infarction
Shiru ZHANG ; Ruixue LI ; Yundi JIAO ; Nan ZHANG ; Weili DUAN ; Zhijun SUN ; Zhaoqing SUN
Chinese Journal of Internal Medicine 2021;60(8):751-756
Objective:To investigate the prognostic value of infarct size (IS) in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (PCI).Methods:A total of 104 patients with acute STEMI who underwent primary PCI treatment in Shengjing Hospital of China Medical University from February 2017 to November 2018 were included in the present study. All patients underwent cardiovascular magnetic resonance (CMR) within one week after primary PCI treatment. The subjects were followed up for two years. Major adverse cardiac events (MACE) included new onset congestive heart failure and/or recurrent nonfatal myocardial infarction and/orcardiac death. The optimal IS cutoff value for MACE was determined by receiver operating character (ROC) curve. Based on the IS cutoff value, the patients were divided into the high IS group and the low IS group. Clinical characteristics between the two groups were compared. A cox regression model was used to analyze the prognostic value of IS in acute STEMI patients treated with primary PCI for the adverse events.Results:The IS cutoff value determined by ROC curve was 13.55%. 50 patients were in the high IS group (IS≥13.55%) and 54 patients were in the low IS group (IS<13.55%). More female patients [14 cases (28.0%) vs. 6 cases (11.1%)] were in the IS group, and a higher proportion of patients in the high IS group had anterior myocardial infarction [27 cases (54.0%) vs. 16 cases (29.6%)] or microvascular obstruction [32 cases (64.0%) vs. 16 cases (29.6%)]. White blood cell counts [11.25(8.90, 13.38) ×10 9/L vs. 9.25(7.58, 11.00) ×10 9/L], troponin I levels [50.63(16.56, 76.30)μg/L vs. 16.58(2.66, 38.42)μg/L] and brain natriuretic peptide levels [178.10(79.70, 281.95)μg/L vs. 79.60(42.83, 183.90)μg/L] in the high IS group were higher than those in the low IS group ( P<0.05), and left ventricular ejection fraction [(45.15±10.65)% vs. (51.95±12.91)%] in the high IS group was lower than that in the low IS group ( P<0.05). Multivariate Cox regression analyses showed that IS was independently associated with the risk of cardiac death in patients with acute STEMI two years after primary PCI( P=0.033, HR=1.075, 95% CI1.006-1.148). Every 1% increase in IS was associated with a 7.5% increase in cardiac death. Conclusions:Infarct size, measured by CMR within one week after primary PCI, is strongly associated with cardiac death in patients with acute STEMI two years after primary PCI. IS could be used as an index for the prognosis of patients with acute STEMI.
3.Study on the factors of short-term prognosis of very elderly patients with acute coronary syndrome after interventional therapy
Nan ZHANG ; Yundi JIAO ; Sitong LIU ; Jiake WU ; Zongyu WEN ; Weili DUAN ; Zhijun SUN ; Zhaoqing SUN
Chinese Journal of Postgraduates of Medicine 2021;44(1):11-15
Objective:To investigate the characteristics of short-term prognostic factors in very elderly patients with acute coronary syndrome (ACS).Methods:A total of 2 912 ACS patients admitted to Shengjing Hospital of China Medical University from January 1, 2010 to October 31, 2014 and treated with percutaneous coronary intervention (PCI) were enrolled and divided into two groups according to age: very elderly group (≥75 years, 480 cases) and control group (< 75 years, 2 432 cases). The clinical data and coronary artery lesions of the included patients were detected. Major cardiovascular adverse events (MACE) occurred within 30 d after discharge were followed up and recorded. The short-term prognostic factors in very elderly patients with ACS were analyzed by Logistic regression.Results:Compared with control group, the percentage of hypertension, global registry of acute coronary events (GRACE) score, high density lipoprotein cholesterol, N-terminal pro-brain natriuretic peptide, the left main lesion ratio and Gensini score in very elderly group were higher, while the percentage of men, number of smoking, hyperlipidemia proportion, red blood cell count, white blood cell count, blood platelet count, albumin, and long term oral administration of aspirin, clopidogrel, statins, angiotensin receptor inhibitor after discharge were lower, and the differences were statistically significant ( P<0.01 or<0.05). During the follow-up period, the all-cause mortality in very elderly group was higher than that in control group: 2.5%(12/480) vs. 0.9% (21/2 432), and the difference was statistically significant ( P<0.01). Multivariate analysis showed that oral angiotensin converting enzyme inhibitor was a protective factor for elderly ACS patients after discharge ( OR = 0.046, 95% CI 0.006 to 0.383, P = 0.004). The receiver operating characteristic curve analysis showed that Gensini score ≥ 87.75 scores was a threshold value for all-cause mortality. The all-cause mortality ratio in high Gensini score (≥ 87.75 scores) group was higher than that in low Gensini score (<87.75 scores) group: 6.6% (9/137) vs. 0.9% (3/343), and the difference was statistically significant ( P<0.01). Conclusions:Very elderly patients with ACS have their own characteristics from both clinical history and prognostic factors. Patients with Gensini score of ≥ 87.75 scores should be closely observed, and drug treatment during hospitalization should be intensified if necessary. Follow-up should be strengthened for such patients, and oral drug treatment should be continued after discharge.
4.Clinical analysis of skeletal malocclusion, axial inclination in patients with short root anomaly of the maxillary central incisors
YANG Yang ; YU Zhishuang ; DUAN Xiaoyuan ; WU Weili ; DENG Yi ; YAO Ji
Journal of Prevention and Treatment for Stomatological Diseases 2020;28(6):367-371
Objective :
To investigate the prevalence and distribution of skeletal malocclusion and axial inclination of the maxillary central incisors in short root anomaly (SRA) patients in Kunming city, to provide some reference and guidance for SRA patients′ clinical diagnosis and treatment and prevention in SRA patients.
Methods:
A total of 1 000 cases were randomly selected from the CBCT database of patients admitted to the author′s hospital from January 2011 to July 2019, and a retrospective analysis was performed. A total of 27 patients with SRA were diagnosed (SRA group).The control group, consisted of 100 randomly selected patients from non-SRA patients. According to the clinical data and cephalometric data, skeletal malocclusion was divided into three subgroups: Class I skeletal malocclusion, Class II skeletal malocclusion and Class Ⅲ skeletal malocclusion. Additionally, the axial inclination of the central incisors was divided into three subgroups: the lingual inclination group, labial inclination group and normal inclination group. The two groups each according to sex, skeletal malocclusion and types of axial inclination of the maxillary central incisors were discussed.
Results :
The prevalence rate of SRA in the selected population was 2.7%, and the prevalence of SRA in females was 3.67% (21/572) , which was higher than that in males by 1.4% (6/428), and was significantly different between sexes (χ2=4.562, P=0.033). There was a significant difference between SRA patients and control group in terms of skeletal malocclusion (χ2=8.710, P=0.013). Class Ⅲ skeletal malocclusion was the main type of skeletal malocclusion in SRA. There was a significant difference between SRA patients and control group in terms of the axial inclination of the maxillary central incisors (χ2=16.75,P<0.001). Lingual inclination of the maxillary central incisors was the main type of axial inclination of the maxillary central incisors in SRA.
Conclusion
There is a certain correlation between class Ⅲ skeletal malocclusion and lingual inclination of the maxillary central incisors and SRA, and the root-crown ratio and root shape of these patients should be evaluated before orthodontics are implemented.
5.Effectiveness and feasibility of health management cloud platform for people with high-risk of coronary heart disease
Weili SHI ; Yingshuai ZHAO ; Mingyan LI ; Yong WANG ; Xiaoyu LIU ; Hongyan DUAN ; Liuyi WANG
Chinese Journal of Health Management 2020;14(5):420-424
Objective:To evaluate the effectiveness and feasibility of health management based on cloud platform for population with high-risk of coronary heart disease (CHD).Methods:In this study, self-control method was used to study the high-risk group of CHD in two community outpatient clinics in Jinshui District, Zhengzhou through cloud platform. One year later, the clinical indicators, the degree of mastering CHD prevention knowledge andthe medicine compliance of the group were evaluated. Finally, the feasibility and acceptance of cloud platform management were evaluated through questionnaire survey.Results:A total of 272 people were enrolled intothe group. After one year of cloud platform management, the blood lipid, uric acid, homocysteine and fasting blood glucose in the group weresignificantly improved (all P<0.05), but the glycosylated hemoglobin was not significantly reduced [(6.4±1.2)% vs.(6.3±1.1)%, P>0.05]. The degree of mastering CHD prevention knowledgewas significantly improved, and the medicine compliance was not significantly improved [(5.0±1.6) vs. (5.0±1.5), P>0.05]. Questionnaire survey showed that 228 (83.8%) of the patients had a high acceptance of cloud platform management, and 208 (76.5%) of the group wanted to continue to use cloud platform for health management. Conclusions:Health management based on cloud platform can improve the clinical index control of the high-risk population of CHD, and help the high-risk population to master the relevant knowledge of CHD prevention. Some functions of cloud platform need to be further improved.
6.Efficacy of minimally invasive pulmonary surfactant administration in preterm infants with neonatal respiratory distress syndrome: a multicenter clinical trial
Huiqiang LIU ; Xiaomei TONG ; Tongyan HAN ; Hui ZHANG ; Ming GUO ; Xuefeng ZHANG ; Xinjian LIU ; Xiang ZHANG ; Mingtao ZHANG ; Fang LIU ; Lisha BAO ; Jun ZHENG ; Xiuying TIAN ; Qi GAO ; Wanxian ZHANG ; Yang DUAN ; Fuqiang SUN ; Wei GUO ; Ling LI ; Min XIAO ; Weili LIU ; Rui JIANG
Chinese Journal of Pediatrics 2020;58(5):374-380
Objective:To explore the feasibility and safety of minimally invasive surfactant administration (MISA) in preterm neonates with respiratory distress syndrome (NRDS).Methods:In this multicenter prospective randomized controlled trial, 92 preterm infants with gestation age ≤30 weeks and diagnosed with NRDS were enrolled in 8 level Ⅲ neonatal intensive care units (NICU) in Beijing-Tianjin-Hebei Region from 1 st July 2017 to 31 st December 2018. They were randomly assigned to minimally invasive surfactant administration (MISA) group or endotracheal intubation surfactant administration (EISA) group according to random number generated by computer. Infants in both groups received calf pulmonary surfactant preparation at a dose of 70-100 mg/kg. The data of demography, perinatal situation, medication administration, complications, clinical outcomes in the two groups were compared with Chi-square test, Student′s t-test, Mann-Whitney U test or Fisher′s exact test. Results:Among the 92 preterm infants, 53 were males, 39 were females; 47 were in the MISA group (25 males), and 45 were in the EISA group (28 males). The gestational age and birth weight were (29.5±1.2) weeks and (1 271±242) g in all patients, (29.5±1.4) weeks and (1 285±256) g in the MISA group, and (29.6±0.9) weeks and (1 255±227) g in the EISA group. The duration of surfactant infusion and the length of whole procedure in the MISA group were significantly longer than that in the EISA group (60 (18, 270) s vs. 50 (30, 60) s, Z=3.009, P=0.003; 90 (60, 300) s vs. 60 (44, 270) s, Z=3.365, P=0.001). For the outcomes, the incidence of hemodynamically significant patent ductus arteriosus (hsPDA) and bronchopulmonary dysplasia (BPD) were lower in the MISA group than in the EISA group (36% (17/47) vs. 67% (30/45), χ 2=8.556, P=0.003; 26% (12/47) vs. 47% (21/45), χ 2=4.464, P=0.035). Conclusions:Minimally invasive surfactant administration is applicable in preterm infants ≤30 weeks gestational age with NRDS. Although the length of whole procedure is longer than route endotracheal administration, the benefit of decreasing the incidences of hsPDA and BPD outweighs this demerit.
7. Interpretation for diagnosis of Yersiniosis
Xin WANG ; Zhihai CHEN ; Lu RAN ; Ran DUAN ; Shuai QIN ; Hui WANG ; Ming ZENG ; Fengcai ZHU ; Changjun BAO ; Lan WANG ; Weili LIANG ; Fengqin LI ; Zhentao QING ; Hua CHUN ; Huaiqi JING
Chinese Journal of Epidemiology 2019;40(9):1048-1051
Yersiniosis is one of the "other infectious diarrhea" of the notifiable infectious diseases and also an important food-borne disease. However, it lacked the basis or standard for diagnosis. The Chinese Preventive Medicine Association coordinated experienced researchers from National Institute for Communicable Disease Control and Prevention, China CDC and other institutes to produce the group standard entitled "Diagnosis of Yersiniosis" (T/CPMA 005-2019). Based on the principle of "legality, scientificity, advancement, and feasibility" , the standard gives a clear definition for Yerisiniosis, stipulates diagnosis basis, principles and main differential diagnosis and provides two informative appendixes for epidemiological and clinical characteristics and a normative appendix for laboratory detection. The standard provides accurate basis and methods of Yersiniosis diagnosis for hospitals and CDCs at all levels in China. It will solve the problems that Yersiniosis cannot be clearly diagnosed for clinical cases and in the outbreaks.
8.Impact of Intracoronary Administration of Eptifibatide on Coronary No-reflow and Myocardium Perfusion in Patients With Acute Myocardial Infarction
Ling XUE ; Weili WU ; Xiaoqian JIA ; Haiwei XUE ; Jinsheng DUAN ; Jun PAN ; Xuezhe LI ; Xianghua FU
Chinese Circulation Journal 2016;31(9):862-865
Objective: To evaluate the impact of intracoronary administration of eptifibatide oncoronary no-reflow and myocardium perfusion in patients with ST-elevation myocardial infarction (STEMI) at percutaneous coronary intervention (PCI). Methods: A total of 80 STEMI patients with emergent PCI were randomly divided into 2 groups: Eptifibatide group, the patients received intracoronary administration of eptiifbatide and Control group, the patients received the same volume of normal saline.n=40 in each group. The baseline condition, post-operative vascular recanalization, changes of platelet aggression at pre- and post-medication were compared between 2 groups. Echocardiography was examined at immediately and 24 weeks after operation;myocardial infusion imaging was examined at l week after operation. All patients were followed-up for 24 weeks to observe the incidence of major adverse cardiovascular events (MACE). Results: Compared with Control group, Eptifibatide group showed increased ratios of post-operative TIMI grade 3 (72.5%vs 92.5%) and myocardium perfusion (70.0% vs 90.0%), bothP<0.05; decreased post-operative and 2h post-medicinal platelet aggression and they were both lower than Control group at the same period, allP<0.05. Eptiifbatide group had obviously improved LVEDD and LVEF at 24-week than 1-week after PCI and they were both superior to Control group, allP<0.05. There were 7 (17.5%) patients in Eptiifbatide group and 7 (7.5%) in Control group suffering from small bleeding events, P>0.05; no severe bleeding eventand no in-hospital thrombocytopeniaoccurred. MACE occurrence rates during 24-week follow-up period were 12.5% vs 22.5%, P>0.05. Conclusion: Intracoronary administration of eptiifbatide in STEMI patients at emergent PCI could effectively improve coronary blood lfow,increase myocardium perfusion and enhance cardiac function without severe bleeding events.
9.Investigation on invasion situation of cardinal ligament in stage ⅠA2- ⅡA2 cervical cancer and its risk factors analysis
Kaixian DENG ; Weili LI ; Chunlin CHEN ; Ping LIU ; Donglin LI ; Weidong ZHAO ; Bin LING ; Hui DUAN ; Liling WANG ; Kexin MO ; Weifeng ZHANG ; Yunlu LIU
Chongqing Medicine 2016;45(12):1641-1644
Objective To investigate the invasion situation of cardinal ligaments(CL) in stage Ⅰ A2 - ⅡA2 cervical cancer and to find the high risk clinicopathological factors affecting its invasion .Methods The retrospective analysis was performed on the clinicopathological data in 2 982 patients with cervical cancer treated by operation extracted in 5 hospitals from January 2004 to De‐cember 2014 .Results (1) Totally 855 cases according with the research condition were included .The CL invasion was found in 20 cases(2 .3% ) .No CL invasion occurred in the stage ⅠA2 ,the CL invasion rate in the stage ⅠB1 was 1 .7% ,in the stage ⅠB2 was 1 .2% ,in the stage ⅡA1 was 5 .7% and in the stage ⅡA2 was 2 .9% .With the increase of FIGO staging ,the CL invasion rate had no significant increase(P=0 .269) .(2) The infiltration rate of left CL and right CL had no statistical difference among the stageⅠA2- ⅡA2(P=1 .000) .And the invasion rate of the left CL with different FIGO stages had no statistical difference(P=0 .286) , while the right one had statistical difference(P=0 .005) ,in which the highest was in the stage ⅡA1 (4 .3% ) .(3)The univariate a‐nalysis found that lymph‐vascular invasion ,cervical stroma infiltration depth ,pelvic lymph node metastasis ,uterus body infiltration and vaginal fornix infiltration were the risk factors of CL invasion(P<0 .01);the further multivariate analysis determined that the invasion of uterine body(OR=11 .858) ,pelvic lymph node metastasis(OR=6 .359 ,) ,vaginal fornix infiltration(OR=6 .012 ,) were the risk factors for CL invasion(P<0 .05) .Conclusion The invasion rate of CL invasion in early stage cervcial cancer is low .The invasion of uterine body ,pelvic lymph node metastasis and vaginal fornix filtration are the risk factors for CL invasion in the stageⅠA2- ⅡA2 cervical cancer .
10.Determination of Pharmacokinetic Parameters of P-methoxybenzyl Alcohol from Gastrodiae Rhizoma in Plasma of Rats by HPLC
Xiaohua DUAN ; Weili WANG ; Shuang WU ; Hanwen YAN ; Lisong LIU ; Qing LIN
Chinese Journal of Information on Traditional Chinese Medicine 2015;(6):99-102
Objective To determine the pharmacokinetic parameters of P-methoxybenzyl alcohol from Gastrodiae Rhizoma in plasma of rats by HPLC. Methods Gavage and intravenous injection were employed for administration. HPLC was used to determine the concentrations of P-methoxybenzyl alcohol from Gastrodiae Rhizoma in plasma of rats in different time points. The pharmacokinetic parameters were computed by DAS3.0. Results The linear range of P-methoxybenzyl alcohol in plasma was 0.63-321.17 μg/mL, r 2=0.994 5. Intra-day accuracy, inter-day accuracy, absolute recovery and stability were in specified range. Conclusion The method is simple and accurate for the determination of the pharmacokinetic parameters of P-methoxybenzyl alcohol from Gastrodiae Rhizoma in plasma of rats.


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