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.Assessment of the clinical effect of aortic endovascular remodeling device (AERD) for type A aortic dissection
Zhenyuan XU ; Haiyue WANG ; Chen LU ; Yu LIU ; Peng YANG ; Hongwei ZHANG ; Zhenghua XIXO ; Wei MENG ; Jia HU
Chinese Journal of Thoracic and Cardiovascular Surgery 2024;40(6):324-330
Objective:To investigate the early and mid-term outcomes of aortic endovascular remodeling device (AERD) for Stanford type A aortic dissection (TAAD) in type Ⅱhybrid surgery, and to evaluate its clinical efficacy.Methods:46 patients with TAAD, including 14 females and 32 males, participated in the single-center clinical trial of West China Hospital of Sichuan University and underwent type II hybrid surgery (Bentall / ascending aorta replacement + AERD implantation) from February 2021 to October 2023. The safety and efficacy of AERD in type Ⅱ hybrid surgery for TAAD were estimated by clinical indicators (postoperative mortality, cardiovascular and cerebrovascular accidents, paraplegia, ischemia), and blood flow condition (volume of the true and false lumen, and suprachial branches).Results:Three patients (6.52%) died during the follow-up period, and the operation-related mortality was 4.35% (2/46). The remaining 43 patients were followed up for an average of (25.53±9.60) months. There were two cases (4.35%) of stroke after the operation, and paraplegia, acute renal insufficiency, and other severe complications were not noticed. The blood flow of the superior branch of the aortic arch was unobstructed, and there was no significant difference in the blood flow of the branch before the operation and at each follow-up time point. Compared to the pre-operation, the true lumen volume of the stent part increased by 59.0% and the false lumen volume decreased by 82.4%.Conclusion:AERD is a safe and effective alternative in type II hybrid surgery for acute TAAD, which is helpful in improving perioperative and short- and long-term survival rates and clinical outcomes.
3.Reintervention for distal residual dissection after proximal repair of acute aortic dissection: experience of aortic endovascular remodeling device
Wenfan LI ; Chen LU ; Peng YANG ; Yu LIU ; Haiyue WANG ; Wei MENG ; Zhenghua XIAO ; Jia HU
Chinese Journal of Thoracic and Cardiovascular Surgery 2024;40(6):339-344
Objective:To analyzed the 3-year follow-up results in a single center to evaluate the mid-term clinical efficacy of aortic endovascular remodeling device(AERD).Methods:From January 2019 to June 2019, 18 patients with residual aortic dissection after proximal repair of acute aortic dissection were treated with AERD in our heart center of West China Hospital of Sichuan University. They were followed up for 3 years after surgery and underwent vascular enhanced CT review. The primary outcome of our study included all-cause mortality and stent-related mortality. Secondary outcome included branch patency rate, reoperation rate and the incidence of serious adverse events. Morphological measures assessed the effectiveness of AERD in treating residual distal dissection.Results:17 patients completed the 3-year follow-up, and 1 was lost to follow-up. There was no stent-related death, branch artery occlusion, or new serious adverse events. 12 patients completed vascular enhanced CT review, the true lumen was significantly expanded and the false lumen was reduced considerably at 3-year follow-up, true lumen volume, (52.39±22.32)cm 3 vs. (74.34±14.64) cm 3( P<0.01), false lumen volume(50.42±25.44) cm 3 vs. (32.32±31.75)cm 3( P<0.01). Increased true lumen diameter and area ( P<0.001) and decreased false lumen diameter( P<0.001) were significantly different from those before operation, especially in the level below the renal artery and 5 cm below the renal artery. Conclusion:The mid-term effect of AERD in treating distal residual dissection is satisfactory, and it promoted positive distal aorta remodeling with safety and effectiveness.
4.Study on the correlation between abnormal menstrual cycle and intestinal microbiome in female rhesus monkeys
Minxue XIE ; Chen ZHAO ; Yuchen YAN ; Zhenghua PEN ; Jiaochun LI ; Yinzhen TAN ; Xuefu WANG ; Chaowu ZHANG ; Wu YANG ; Yuan ZHAO
China Modern Doctor 2024;62(17):1-6,12
Objective Using healthy female reproductive-age rhesus macaques as the research subjects,we explored the correlation between menstrual cycle abnormalities and gut microbiota composition by using 16S rRNA metagenomic sequencing.Methods Twenty-seven healthy female rhesus macaques were divided into regular menstrual and irregular menstrual groups.Fecal samples were collected at follicular phase(FP),ovulation phase(OP)and luteal phase(LP)of the two groups.The structure and diversity of bacterial flora in different physiological periods were analyzed and compared between the two groups.Results At the phylum level,Firmicutes,Bacteroidetes,and Proteobacteria dominated the sample flora in the follicular,luteal,and ovulatory phases of the rhesus macaques in both the regular and irregular groups,with a combined percentage of more than 98% .At the genus level,the genus Prevotella_9,Ruminococcaceae_UCG-002,Lactobacillus,Prevotella_2,Phascolarctobacterium,Ruminococcaceae_UCG-005,Streptococcus,Blautia,Prevotellaceae_NK3B31_group,Rikenellaceae_RC9_gut_group were dominant.In the luteal phase the percentage of Firmicutes was higher in the regular group than in the irregular group,while the opposite was true for Bacteroidetes.Spirochaetes were higher in the regular group than in the irregular group at all 3 stages(P<0.05).Conclusion There were some differences in intestinal microbial composition between the two groups of macaques with regular and irregular menstrual cycles,which provided some reference for the study of intestinal bacteria and ovulation disorders.
5.Advances in therapeutic drug monitoring of invasive fungal disease
Yuting CHEN ; Zhenghua WU ; Guorong FAN
China Pharmacy 2024;35(20):2565-2570
Invasive fungal disease (IFD) is a deep infectious disease with an overall increasing incidence in patients with hematologic malignancies. Triazoles, polyenes, echinocandins echinocandin antifungal drugs, 5-fluorocytosine and Compound sulfamethoxazole are the main drugs used in the clinical treatment of IFD. Therapeutic drug monitoring for IFD prevention and treatment is helpful to optimize treatment outcomes and reduce adverse effects. In this paper, the effective plasma concentration ranges of the above 5 types of drugs are systematically summarized, and the correlation between the plasma concentration of antifungal drugs and the efficacy and adverse reactions is reviewed. Solid phase extraction combined with ultra-performance chromatography-tandem mass spectrometry is a promising detection method in this research field.
6.Lateral septum adenosine A2A receptors control stress-induced depressive-like behaviors via signal-ing to hypothalamus and habenula
Muran WANG ; Peijun LI ; Zewen LI ; SILVA S.da BEATRIZ ; Wu ZHENG ; Zhenghua XIANG ; Yan HE ; Tao XU ; CORDEIRO CRISTINA ; Lu DENG ; Yuwei DAI ; Mengqian YE ; Zhiqing LIN ; Jianhong ZHOU ; Xuzhao ZHOU ; Fenfen YE ; CUNHA A RODRIGO ; Jiangfan CHEN ; Wei GUO
Chinese Journal of Pharmacology and Toxicology 2023;37(7):547-548
Depressive disorder ranks as a major bur-den of disease worldwide,yet the current antidepressant medications are limited by frequent non-responsiveness and significant side effects.The lateral septum(LS)is thought to control of depression,however,the cellular and circuit substrates are largely unknown.Here,we identified a subpopulation of LS GABAergic adenosine A2A receptors(A2AR)-positive neurons mediating depres-sive symptoms via direct projects to the lateral habenula(LHb)and the dorsomedial hypothalamus(DMH).Activa-tion of A2AR in the LS augmented the spiking frequency of A2AR-positive neurons leading to a decreased activation of surrounding neurons and the bi-directional manipula-tion of LS-A2AR activity demonstrated that LS-A2ARs are necessary and sufficient to trigger depressive pheno-types.Thus,the optogenetic modulation(stimulation or inhibition)of LS-A2AR-positive neuronal activity or LS-A2AR-positive neurons projection terminals to the LHb or DMH,phenocopied depressive behaviors.Moreover,A2AR are upregulated in the LS in two male mouse mod-els of repeated stress-induced depression.This identifica-tion that aberrantly increased A2AR signaling in the LS is a critical upstream regulator of repeated stress-induced depressive-like behaviors provides a neurophysiological and circuit-based justification of the antidepressant poten-tial of A2AR antagonists,prompting their clinical transla-tion.
7.Cochlear electrode array misplacement into the superior semicircular canal: a case report and literature review.
Chen SUN ; Zhenghua HUANG ; Yingxue MA ; Ye GU ; Qi LI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2023;37(4):310-312
Electrode array misplacement is a rare complication of cochlear implant. This article reports an 11-year-old boy who was mistakenly implanted the cochlear electrode array into the superior semicircular canal during the initial cochlear implant. After the diagnosis was confirmed, he underwent a second cochlear implant and the electrode array were successfully implanted into the cochlea. This article conducted a systematic review of the literature on electrode array misplacement, and the causes of electrode array misplacement were analyzed from different implantation position.
Male
;
Humans
;
Child
;
Electrodes, Implanted
;
Reoperation
;
Cochlea
;
Cochlear Implantation
;
Cochlear Implants/adverse effects*
;
Semicircular Canals/surgery*
8.Prevalence of psoriatic arthritis in Chinese population with psoriasis: A multicenter study conducted by experienced rheumatologists.
Hua ZHANG ; Miao CHEN ; Ran CUI ; Xia LI ; Kexiang YAN ; Lihong CHEN ; Zhenghua ZHANG ; Ning YU ; Xinling BI ; Hui DENG ; Yangfeng DING ; Qiong HUANG ; Sheng-Ming DAI
Chinese Medical Journal 2023;136(12):1439-1447
BACKGROUND:
Reports on the prevalence of psoriatic arthritis (PsA) among Chinese patients with psoriasis are very limited. This study, conducted by rheumatologists, estimated the prevalence of PsA in a large number of Chinese patients with psoriasis.
METHODS:
Consecutive patients with a confirmed diagnosis of psoriasis attending nine dermatology clinics in five hospitals were recruited. All psoriasis patients were asked to complete a questionnaire comprising 16 questions to identify possible cases of PsA. All patients with one or more positive answers to the questionnaire were evaluated by two experienced rheumatologists.
RESULTS:
A total of 2434 psoriasis patients, including 1561 males and 873 females, were enrolled. Both the questionnaire and rheumatologists' examinations were completed in the dermatology clinics. The results identified 252 patients with PsA, comprising 168 males and 84 females. The overall prevalence of PsA among psoriasis patients was 10.4% (95% confidence interval [95% CI], 9.1%-11.7%). By sex, the prevalence was 10.8% (95% CI, 9.2%-12.5%) for males and 9.6% (95% CI, 7.7%-11.9%) for females and there was no significant sex difference in the prevalence of PsA (P = 0.38). Of the 252 PsA patients, 125 (49.6%, 95% CI, 41.3%-59.1%) were newly diagnosed by rheumatologists. Consequently, the prevalence of undiagnosed PsA among psoriasis patients was 5.2% (95% CI, 4.4%-6.2%).
CONCLUSION
The prevalence of PsA in the Chinese population with psoriasis is about 10.4%, which is almost double that of previous reports in the Chinese population, but lower than that in Caucasians.
Humans
;
Female
;
Male
;
Arthritis, Psoriatic/epidemiology*
;
Rheumatologists
;
Prevalence
;
East Asian People
;
Psoriasis/epidemiology*
9.Treatment of trochanter fractures in total hip arthroplasty with ventral compression steel wire tension band
Jiajing YE ; Zhong ZHU ; Zhenghua HONG ; Lingjun JIANG ; Haizhao WU ; Shouli WANG ; Haixiao CHEN ; Zhongyi CHEN
Chinese Journal of Orthopaedics 2022;42(5):297-305
Objective:To evaluate the various wire tension belt ventral compression wiring technologiesfor treating several types of femoral greater trochanter fractures in total hip replacement, according to the different types of greater trochanter of femur fractures.Methods:From March 2013 to June 2019, a total of 1 280 cases of primary total hip arthroplasty were completed in our hospital, 21 patients with greater trochanter fractures were identified in total hip replacement. There were 11 males and 10 females with an average age of 65.81±6.45 years (range 42-76 years). All of them were unilateral. There were 11 cases on the left and 10 cases on the right. There were 11 cases of osteoarthritis secondary to hip dysplasia, 4 cases of hip osteoarthritis, 4 cases of aseptic necrosis of femoral head and 2 cases of femoral neck fracture. Different wire tension belt ventral compression wiring technologies were used for each fracture type. Harris hip function score, Parker activity score, and visual analogue scale (VAS) score of hip pain were evaluated during follow-up. X-ray films were taken to evaluate the fracture healing, prosthesis position, loosening and dislocation.Results:Three new fracture types were proposed: A transverse fracture from the greater trochanter tip to the base (4 cases); B oblique fracture from the greater trochanter tip to the base (according to the fracture line direction, type B was further divided into types B1 (4 cases) and B2 (6 cases); and C fracture line from the greater trochanter to subtrochanteric plane (7 cases). Among the 21 patients, one died at an early stage, two were lost during follow-up, and 18 were followed up for an average of 30.7±7.6 months. In 18 patients, the mean operation time was 110.0±20.0 min, and the mean intraoperative blood loss was 356.9±115.7 ml. The patients' Harris score was 35.26±5.52 at the preoperative, 65.7±6.42 at the 3 months after operation, and 87.75±6.21 at the final follow-up. The difference was statistically significant ( F=377.23, P<0.001). The patients' Parker score was 2.17±0.98 at the preoperative, 5.94±1.11 at the 3 months after operation,and 8.01±0.77 at the final follow-up. The difference was statistically significant ( F=170.96, P<0.001). The patients' VAS score was 6.22±1.11 at the preoperative, 2.61±0.92 at the 3 months after operation, and 1.28±0.67 at the final follow-up. The difference was statistically significant ( F=139.71, P<0.001). Deep vein embolism, heterotopic ossification was noted in one and another patient, respectively. The patient with non-union refused reoperation and had a broken steel wire, lower-limb limp, and no notable pain at the 12-month follow-up examination. Radiographs of 17 patients showed good location of the femoral prosthesis and no chronic pain. Conclusion:Different types of greater trochanter fractures in total hip arthroplasty were proposed, using different wire tension belt ventral compression wiring technologies for the various types of femoral greater trochanter fractures during total hip replacement can improve clinical outcomes.
10.Risk Factors of Vascular Invasion in Patients with Resectable Gastric Cancer
Yihuan QIAO ; Jipeng LI ; Le CHEN ; Zhenghua DU ; Yuan GUO
Cancer Research on Prevention and Treatment 2022;49(2):123-127
Objective To explore the risk factors for vascular invasion and its influence on prognosis of resectable gastric cancer patients by analyzing the clinicopathological features. Methods We retrospectively analyzed the data of 1077 patients with stage Ⅰ-Ⅲ gastric cancer who underwent surgical resection. According to whether vascular invasion occurred, they were divided into LVI positive group (

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