Chinese Medical Journal最新文献

{"title":"Paroxetine alleviates dendritic cell and T lymphocyte activation via GRK2-mediated PI3K-AKT signaling in rheumatoid arthritis.","authors":"Tingting Liu, Chao Jin, Jing Sun, Lina Zhu, Chun Wang, Feng Xiao, Xiaochang Liu, Liying Lv, Xiaoke Yang, Wenjing Zhou, Chao Tan, Xianli Wang, Wei Wei","doi":"10.1097/CM9.0000000000003165","DOIUrl":"10.1097/CM9.0000000000003165","url":null,"abstract":"<p><strong>Background: </strong>G protein-coupled receptor kinase 2 (GRK2) could participate in the regulation of diverse cells via interacting with non-G-protein-coupled receptors. In the present work, we explored how paroxetine, a GRK2 inhibitor, modulates the differentiation and activation of immune cells in rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>The blood samples of healthy individuals and RA patients were collected between July 2021 and March 2022 from the First Affiliated Hospital of Anhui Medical University. C57BL/6 mice were used to induce the collagen-induced arthritis (CIA) model. Flow cytometry analysis was used to characterize the differentiation and function of dendritic cells (DCs)/T cells. Co-immunoprecipitation was used to explore the specific molecular mechanism.</p><p><strong>Results: </strong>In patients with RA, high expression of GRK2 in peripheral blood lymphocytes, accompanied by the increases of phosphatidylinositol 3 kinase (PI3K), protein kinase B (AKT), and mammalian target of rapamycin (mTOR). In animal model, a decrease in regulatory T cells (T regs ), an increase in the cluster of differentiation 8 positive (CD8 + ) T cells, and maturation of DCs were observed. Paroxetine, when used in vitro and in CIA mice, restrained the maturation of DCs and the differentiation of CD8 + T cells, and induced the proportion of T regs . Paroxetine inhibited the secretion of pro-inflammatory cytokines, the expression of C-C motif chemokine receptor 7 in DCs and T cells. Simultaneously, paroxetine upregulated the expression of programmed death ligand 1, and anti-inflammatory cytokines. Additionally, paroxetine inhibited the PI3K-AKT-mTOR metabolic pathway in both DCs and T cells. This was associated with a reduction in mitochondrial membrane potential and changes in the utilization of glucose and lipids, particularly in DCs. Paroxetine reversed PI3K-AKT pathway activation induced by 740 Y-P (a PI3K agonist) through inhibiting the interaction between GRK2 and PI3K in DCs and T cells.</p><p><strong>Conclusion: </strong>Paroxetine exerts an immunosuppressive effect by targeting GRK2, which subsequently inhibits the metabolism-related PI3K-AKT-mTOR pathway of DCs and T cells in RA.</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"441-451"},"PeriodicalIF":7.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845201/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neoadjuvant therapy with immune checkpoint inhibitors in combination with chemotherapy vs . chemotherapy alone in HER2(-) locally advanced gastric cancer: A propensity score-matched cohort study.","authors":"Gehan Xu, Tianjiao Liu, Jingyi Shen, Quanlin Guan","doi":"10.1097/CM9.0000000000003028","DOIUrl":"10.1097/CM9.0000000000003028","url":null,"abstract":"<p><strong>Background: </strong>This study aims to compare the efficacy between neoadjuvant immune checkpoint inhibitors (ICIs) plus chemotherapy vs . chemotherapy, and neoadjuvant triplet vs . doublet chemotherapeutic regimens in locally advanced gastric/esophagogastric junction cancer (LAGC).</p><p><strong>Methods: </strong>We included LAGC patients from 47 hospitals in China's National Cancer Information Database (NCID) from January 2019 to December 2022. Using propensity score matching (PSM), we retrospectively analyzed the efficacy between neoadjuvant ICIs plus chemotherapy vs . chemotherapy alone, and neoadjuvant triplet vs . doublet chemotherapeutic regimens. The primary study result was the pathologic complete response (pCR) rate. The secondary study results were disease-free survival (DFS) and overall survival (OS).</p><p><strong>Results: </strong>A total of 1205 LAGC patients were included. After PSM, the ICIs plus chemotherapy and the chemotherapy cohorts had 184 patients each, while the doublet and triplet chemotherapy cohorts had 246 patients each. The pCR rate (14.13% vs . 7.61%, χ2 = 4.039, P = 0.044), and the 2-year (77.60% vs . 61.02%, HR = 0.67, 95% con-fidence interval [CI] 0.43-0.98, P = 0.048) and 3-year (70.55% vs . 61.02%, HR = 0.58, 95% CI 0.32-0.93, P = 0.048) DFS rates in the ICIs plus chemotherapy cohort were improved compared to those in the chemotherapy cohort. No significant increase was observed in the OS rates at both 1 year and 2 years. The pCR rates, DFS rates at 1-3 years, and OS rates at 1-2 years did not differ significantly between the doublet and triplet cohorts, respectively. No differences were observed in postoperative complications between any of the group comparisons.</p><p><strong>Conclusions: </strong>Neoadjuvant ICIs plus chemotherapy improved the pCR rate and 2-3 years DFS rates of LAGC compared to chemotherapy alone, but whether short-term benefit could translate into long-term efficacy is unclear. The triplet regimen was not superior to the doublet regimen in terms of efficacy. The safety after surgery was similar between either ICIs plus chemotherapy and chemotherapy or the triplet and the doublet regimen.</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"459-471"},"PeriodicalIF":7.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845188/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study.","authors":"Chao Quan, Hongyu Zhou, Huan Yang, Zheng Jiao, Meini Zhang, Baorong Zhang, Guojun Tan, Bitao Bu, Tao Jin, Chunyang Li, Qun Xue, Huiqing Dong, Fudong Shi, Xinyue Qin, Xinghu Zhang, Feng Gao, Hua Zhang, Jiawei Wang, Xueqiang Hu, Yueting Chen, Jue Liu, Wei Qiu","doi":"10.1097/CM9.0000000000002990","DOIUrl":"10.1097/CM9.0000000000002990","url":null,"abstract":"<p><strong>Background: </strong>Disease-modifying therapies have been approved for the treatment of relapsing multiple sclerosis (RMS). The present study aims to examine the safety of teriflunomide in Chinese patients with RMS.</p><p><strong>Methods: </strong>This non-randomized, multi-center, 24-week, prospective study enrolled RMS patients with variant (c.421C>A) or wild type ABCG2 who received once-daily oral teriflunomide 14 mg. The primary endpoint was the relationship between ABCG2 polymorphisms and teriflunomide exposure over 24 weeks. Safety was assessed over the 24-week treatment with teriflunomide.</p><p><strong>Results: </strong>Eighty-two patients were assigned to variant ( n  = 42) and wild type groups ( n  = 40), respectively. Geometric mean and geometric standard deviation (SD) of pre-dose concentration (variant, 54.9 [38.0] μg/mL; wild type, 49.1 [32.0] μg/mL) and area under plasma concentration-time curve over a dosing interval (AUC tau ) (variant, 1731.3 [769.0] μg∙h/mL; wild type, 1564.5 [1053.0] μg∙h/mL) values at steady state were approximately similar between the two groups. Safety profile was similar and well tolerated across variant and wild type groups in terms of rates of treatment emergent adverse events (TEAE), treatment-related TEAE, grade ≥3 TEAE, and serious adverse events (AEs). No new specific safety concerns or deaths were reported in the study.</p><p><strong>Conclusion: </strong>ABCG2 polymorphisms did not affect the steady-state exposure of teriflunomide, suggesting a similar efficacy and safety profile between variant and wild type RMS patients.</p><p><strong>Registration: </strong>NCT04410965, https://clinicaltrials.gov .</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"452-458"},"PeriodicalIF":7.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845184/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139680744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early assessment of responsive neurostimulation for drug-resistant epilepsy in China: A multicenter, self-controlled study.","authors":"Yanfeng Yang, Penghu Wei, Jianwei Shi, Ying Mao, Jianmin Zhang, Ding Lei, Zhiquan Yang, Shiwei Song, Ruobing Qian, Wenling Li, Yongzhi Shan, Guoguang Zhao","doi":"10.1097/CM9.0000000000003292","DOIUrl":"10.1097/CM9.0000000000003292","url":null,"abstract":"<p><strong>Background: </strong>To evaluate the efficacy and safety of the first cohort of people in China treated with a responsive neurostimulation system (Epilcure TM , GenLight MedTech, Hangzhou, China) for focal drug-resistant epilepsy in this study.</p><p><strong>Methods: </strong>This multicenter, before-and-after self-controlled study was conducted across 8 centers from March 2022 to June 2023, involving patients with drug-resistant epilepsy who were undergoing responsive neurostimulation (RNS). The study was based on an ongoing multi-center, single-blind, randomized controlled study. Efficacy was assessed through metrics including median seizure count, seizure frequency reduction (SFR), and response rate. Multivariable linear regression analysis was conducted to explore the relationships of basic clinical factors and intracranial electrophysiological characteristics with SFR. The postoperative quality of life, cognitive function, depression, and anxiety were evaluated as well.</p><p><strong>Results: </strong>The follow-up period for the 19 participants was 10.7 ± 3.4 months. Seizure counts decreased significantly 6 months after device activation, with median SFR of 48% at the 6th month (M6) and 58% at M12 ( P  <0.05). The average response rate after 13 months of treatment was 42%, with 21% ( n  = 4) of the participants achieving seizure freedom. Patients who have previously undergone resective surgery appear to achieve better therapeutic outcomes at M11, M12 and M13 ( β  <0, P  <0.05). No statistically significant differences were observed in patients' scores of quality of life, cognition, depression and anxiety following stimulation when compared to baseline measurements. No serious adverse events related to the devices were observed.</p><p><strong>Conclusions: </strong>The preliminary findings suggest that Epilcure TM exhibits promising therapeutic potential in reducing the frequency of epileptic seizures. However, to further validate its efficacy, larger-scale randomized controlled trials are required.</p><p><strong>Registration: </strong>Chinese Clinical Trial Registry (No. ChiCTR2200055247).</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"430-440"},"PeriodicalIF":7.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845213/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142726453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gut microbiota and their metabolites in hemodialysis patients.","authors":"Junxia Du, Xiaolin Zhao, Xiaonan Ding, Qinqin Ren, Haoran Wang, Qiuxia Han, Chenwen Song, Xiaochen Wang, Dong Zhang, Hanyu Zhu","doi":"10.1097/CM9.0000000000003423","DOIUrl":"10.1097/CM9.0000000000003423","url":null,"abstract":"","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"502-504"},"PeriodicalIF":7.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845176/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142982823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of blinatumomab and chimeric antigen receptor T cells pre-haploidentical hematopoietic stem cell transplantation for pediatric Philadelphia chromosome negative B-cell acute lymphoblastic leukemia.","authors":"Guanhua Hu, Pan Suo, Lu Bai, Xiaohui Zhang, Yifei Cheng, Xiaojun Huang","doi":"10.1097/CM9.0000000000003396","DOIUrl":"10.1097/CM9.0000000000003396","url":null,"abstract":"","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"472-474"},"PeriodicalIF":7.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845181/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143000993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"p300 upregulates Ikur in atrial cardiomyocytes through activating NLRP3 inflammasome in hypertension.","authors":"Long Zeng, Panyue Liu, Fang Rao, Zhimin Du, Haiyin Xiao, Shenghuan Yu, Chunyu Deng, Mengzhen Zhang, Fangzhou Liu, Rui Zhu, Hai Deng, Shulin Wu, Yumei Xue, Xianhong Fang, Wei Wei","doi":"10.1097/CM9.0000000000003501","DOIUrl":"https://doi.org/10.1097/CM9.0000000000003501","url":null,"abstract":"<p><strong>Background: </strong>The nucleotide-binding oligomerization domain [NOD-], leucine-rich repeats [LRR-], and Pyrin domain-containing protein 3 (NLRP3) inflammasome plays an essential role in hypertension-related atrial fibrillation (AF). p300 is involved in cardiovascular inflammation. In this study, we aimed to investigate the role of p300 in NLRP3 inflammasome activation and its subsequent impact on the Ikur current in angiotensin II (Ang II)-induced HL-1 cells and Ang II-infused mice.</p><p><strong>Methods: </strong>Expression levels of p300, Kv1.5, and NLRP3 in left atrial appendage (LAA) tissues from AF and sinus rhythm (SR) patients were detected by Western blot. A hypertension mouse model was established in p300 knockout (p300-KO) mice via Ang II infusion, and AF incidence was assessed by electrocardiogram (ECG) after rapid atrial pacing. In vitro, the expression level of p300 in HL-1 cells was modulated by adenoviral overexpression, curcumin (an inhibitor of p300) treatment, and smal interfering RNA (siRNA) knockdown. NLRP3 inflammasome activation was evaluated by Western blot and enzyme-linked immunosorbent assay, and electrophysiological properties of HL-1 cells were analyzed using whole-cell patch-clamp recordings. Co-immunoprecipitation assays were performed to investigate the interaction between p300 and nuclear factor kappa B (NF-κB).</p><p><strong>Results: </strong>The expression levels of p300, Kv1.5, and NLRP3 were found to be significantly higher in the LAA tissue of AF patients compared to SR patients. p300-KO decreased AF incidence in Ang II-infused mice by impairing NLRP3 inflammasome activation. p300-OE facilitated NLRP3 inflammasome activation, which subsequently increased the Ikur density and shortened the action potential duration of HL-1 cells. Both curcumin (p300 inhibitor) and p300-siRNA treatments reversed Ang II-induced atrial electrical remodeling and NLRP3 inflammasome activation. Moreover, co-immunoprecipitation showed that p300 interacts with NF-κB to promote NLRP3 inflammasome activation.</p><p><strong>Conclusions: </strong>p300 participates in hypertension-induced AF susceptibility by interacting with NF-κB to activate the NLRP3 inflammasome, which subsequently upregulates the transmembrane current of Ikur in atrial cardiomyocytes.</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Associations of physical activity, sedentary behavior, and sleep with risk of incident Parkinson's disease: A prospective cohort study of 401,697 participants.","authors":"Haishan Jiao, Shuyi Huang, Wei Cheng, Jianfeng Feng, Jintai Yu","doi":"10.1097/CM9.0000000000003399","DOIUrl":"https://doi.org/10.1097/CM9.0000000000003399","url":null,"abstract":"<p><strong>Background: </strong>Physical activity, sedentary behavior (SB), and sleep duration are associated with brain health. Effects of those on developing Parkinson's disease (PD) are poorly investigated. This study aimed to examine the independent and joint associations of physical activity, SB, sleep with PD risk.</p><p><strong>Methods: </strong>We analyzed data on 401,697 participants from the UK Biobank cohort, which was enrolled in 2006-2010. Physical activities were measured based on a questionnaire. Sleep and SB time were defined through self-reported total number of hours. Models fitted with restricted cubic spline were conducted to test for linear and non-linear shapes of each association. Cox proportional hazards regression models were used to estimate the association of three modifiable behaviors.</p><p><strong>Results: </strong>Our analytic sample included 401,697 participants with 3030 identified cases of PD (mean age, 63 years; 62.9% male). PD risk was 18% lower in the high total physical activity group (95% CI, 0.75-0.90), 22% lower in the high leisure-time physical activity (LTPA) group (95% CI, 0.71-0.86) compared with the low level and 14% higher in the high sleep duration group (95% CI, 1.05-1.24) compared to moderate group. Total SB time was irrelevant with PD risk, while high TV viewing showed a 12% increase of PD risk compared to the low group (95% CI, 1.02-1.22). Low computer use (0 h/day) was associated with a 14% higher risk compared to 1 h/day use (95% CI, 1.04-1.26). Those associations were independent. A combination of 7 h/day sleep, moderate-to-high computer use, and moderate-to-vigorous intensity of LTPA showed lowest PD risk (HR, 0.70; 95% CI, 0.57-0.85).</p><p><strong>Conclusions: </strong>Physical activity, SB, and sleep were associated with PD risks separately. Our findings emphasize the possibility for changing these three daily activities concurrently to lower the risk of PD. These findings may promote an active lifestyle for PD prevention.</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448404","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Associations of total, domain-specific, and intensity-specific physical activity with all-cause and cause-specific mortality in China: A population-based cohort study.","authors":"Yalei Ke, Kexiang Shi, Derrick A Bennett, Jun Lv, Dianjianyi Sun, Pei Pei, Huaidong Du, Yiping Chen, Ling Yang, Xiangyang Zheng, Xiaoming Yang, Maxim Barnard, Junshi Chen, Zhengming Chen, Liming Li, Canqing Yu","doi":"10.1097/CM9.0000000000003485","DOIUrl":"https://doi.org/10.1097/CM9.0000000000003485","url":null,"abstract":"<p><strong>Background: </strong>Evidence of an association between physical activity (PA) and mortality has mainly focused on leisure-time physical activity (LTPA) and moderate-to-vigorous-intensity physical activity (MVPA). We aimed to assess the associations of total, domain-specific, and intensity-specific PA with all-cause and cause-specific mortality.</p><p><strong>Methods: </strong>We used baseline PA data from the China Kadoorie Biobank, including 482,067 participants aged 30-79 years from 10 areas in China. PA via self-report was quantified as a metabolic equivalent of task hours per day. Total PA was calculated by summing occupational, commuting, household, and leisure-time PA, and domain- and intensity-specific PAs were also calculated. Cox regression was used to estimate the associations of quintiles of different types of PA with all-cause and cause-specific mortality and adjust for potential confounders. Cause-specific mortalities were also examined in a competing risk analysis.</p><p><strong>Results: </strong>During a median follow-up of 12.1 years, 47,281 deaths occurred. Total PA was inversely associated with the risk of all-cause mortality, with a hazard ratio (HR) (95% confidence interval [95% CI]) of 0.69 (0.67-0.71) in the highest quintile as compared with the lowest quintile. Similar associations were observed for disease-specific mortality risks from cardiovascular disease, cancer, respiratory disease, diabetes, and nervous system disease, with HR (95% CI) for top vs. bottom quintile of PA of 0.68 (0.64-0.71), 0.80 (0.76-0.83), 0.39 (0.35-0.44), 0.44 (0.35-0.55), and 0.52 (0.38-0.73), respectively. In addition, the risk of all-cause mortality was lowered by 34%, 13%, 17%, and 30% for occupational PA, non-occupational PA, low-intensity PA, and MVPA, respectively, when comparing the highest quintile with the lowest quintile.</p><p><strong>Conclusions: </strong>PA was inversely associated with the risk of all-cause and cause-specific mortality, regardless of domain and intensity. Any PA can bring long-term beneficial health effects.</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vonoprazan-based quadruple therapy is non-inferior to esomeprazole-based quadruple therapy for Helicobacter pylori eradication: A multicenter, double-blind, randomized, phase 3 study.","authors":"Zhiqiang Song, Qin Du, Guoxin Zhang, Zhenyu Zhang, Fei Liu, Nonghua Lu, Liqun Gu, Shingo Kuroda, Liya Zhou","doi":"10.1097/CM9.0000000000003437","DOIUrl":"https://doi.org/10.1097/CM9.0000000000003437","url":null,"abstract":"<p><strong>Background: </strong>Owing to the high prevalence of antibiotic resistance in Helicobacter pylori (H. pylori) in China, bismuth-containing quadruple therapies have been recommended for H. pylori eradication. This study compared the efficacy and safety of quadruple regimens containing vonoprazan vs. esomeprazole for H. pylori eradication in a patient population in China.</p><p><strong>Methods: </strong>This was a phase 3, multicenter, randomized, double-blind study. Patients with confirmed H. pylori infection were randomized 1:1 to receive quadruple therapy for 14 days: amoxicillin 1000 mg and clarithromycin 500 mg after meals, bismuth potassium citrate 600 mg before meals, plus either vonoprazan 20 mg or esomeprazole 20 mg before meals, all twice daily. The primary outcome was the eradication rate of H. pylori, evaluated using a 13C urea breath test at 4 weeks after treatment. The non-inferiority margin was at 10%.</p><p><strong>Results: </strong>The study included 510 patients, 506 of whom completed the follow-up assessment. The primary analysis revealed eradication rates of 86.8% (210/242) and 86.7% (208/240) for vonoprazan and esomeprazole therapy, respectively (treatment difference: 0.1%; 95% confidence interval [CI]: -5.95, 6.17; non-inferiority P = 0.0009). Per-protocol analysis showed eradication rates of 87.4% for vonoprazan and 86.3% for esomeprazole (treatment difference: 1.2%; 95% CI: -5.03, 7.36; non-inferiority P = 0.0004). Vonoprazan and esomeprazole were well tolerated, with similar safety profiles.</p><p><strong>Conclusion: </strong>Vonoprazan was found to be well-tolerated and non-inferior to esomeprazole for eradicating H. pylori in patients from China.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT04198363.</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}