1.Impact of short-term proton pump inhibitors vs . histamine-2 receptor antagonists on gut microbiota in patients with acute coronary syndrome: A multicenter randomized trial.
Chen CHEN ; Huizhu LIANG ; Meibo HE ; Ruqiao DUAN ; Yu GUAN ; Fangfang WANG ; Liping DUAN
Chinese Medical Journal 2025;138(5):542-552
BACKGROUND:
Several randomized controlled studies have suggested that the prophylactic use of proton pump inhibitors (PPIs) in intensive care unit (ICU) patients could not reduce the incidence of gastrointestinal bleeding (GIB) and may increase adverse events such as intestinal infection and pneumonia. Gut microbiota may play a critical role in the process. PPIs have been widely prescribed for GIB prophylaxis in patients with acute coronary syndrome (ACS). This study aimed to determine the short-term effects of PPI and histamine-2 receptor antagonist (H2RA) treatment on gut microbiota of ACS patients.
METHODS:
The study was designed as a single-blind, multicenter, three-parallel-arm, randomized controlled trial conducted at three centers in Beijing, China. We enrolled ACS patients at low-to-medium risk of GIB and randomized (2:2:1) them to either PPI ( n = 40), H2RA ( n = 31), or control group ( n = 21). The primary outcomes were the alterations in gut microbiota after 7 days of acid suppressant therapy. Stool samples were collected at baseline and 7 days and analyzed by 16S ribosomal RNA (rRNA) gene sequencing.
RESULTS:
There were no significant changes in the diversity of gut microbiota after the short-term use of acid suppressants, but the abundance of Fusobacterium significantly increased and that of Bifidobacterium significantly decreased, especially in PPI users. In addition, the abundance of some pathogenic bacteria, including Enterococcus and Desulfovibrio, was significantly elevated in the PPI users. The fecal microbiota of the PPI users included more arachidonic acid metabolism than that of control group.
CONCLUSIONS:
PPIs may increase the risk of infection by adversely altering gut microbiota and elevating arachidonic acid metabolism, which may produce multiple proinflammatory mediators. For ACS patients at low-to-medium risk of GIB, sufficient caution should be paid when acid-suppressant drugs are prescribed, especially PPIs.
REGISTRATION
www.chictr.org.cn (ChiCTR2000029552).
Humans
;
Proton Pump Inhibitors/therapeutic use*
;
Acute Coronary Syndrome/microbiology*
;
Female
;
Gastrointestinal Microbiome/drug effects*
;
Male
;
Middle Aged
;
Histamine H2 Antagonists/therapeutic use*
;
Aged
;
Single-Blind Method
2.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
INTRODUCTION:
Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:
In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:
A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:
Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION
ClinicalTrials.gov , NCT07034222.
Humans
;
Alzheimer Disease/drug therapy*
;
Male
;
Female
;
Aged
;
Middle Aged
;
Cognitive Dysfunction/drug therapy*
;
Aged, 80 and over
;
Amyloid beta-Peptides/metabolism*
;
Biomarkers
;
East Asian People
3.Research progress of radical chemoradiotherapy combined with immunotherapy in locally advanced esophageal carcinoma
Huizhu CHEN ; Jiayan CHEN ; Xianshu GAO
Clinical Medicine of China 2024;40(4):241-248
Radical chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal carcinoma, but its efficacy needs to be further improved, and combined immunotherapy is a potential direction to solve this issue. At present, the combination of radical radiotherapy and chemotherapy with immunotherapy mainly includes three modes: induction chemotherapy combined with immunotherapy before radiotherapy and chemotherapy, concurrent immunotherapy during radiotherapy and chemotherapy, and immune maintenance therapy after radiotherapy and chemiotherapy. A number of phase I and Ⅱ clinical trials have shown that radiotherapy and chemotherapy combined with immunotherapy can be tolerated by patients with good clinical efficacy, and more research data and long-term follow-up results are expected. At the same time, the adverse reactions caused by immunotherapy still deserve attention. Finding the optimal combination therapy mode, screening the patient population suitable for the treatment mode, and predicting and identifying serious adverse reactions as early as possible are the directions that need to be explored continuously.
4.A cross-sectional investigation on the detection of colorectal cancer and adenoma in adults under colonoscopy in Shihezi in recent ten years
Yuanmao XIE ; Miaomiao LUO ; Mengzhen SHI ; Xueping WANG ; Huizhu CHEN ; Yang LI ; Yixiu LIN ; Weigang CHEN
Chinese Journal of Digestive Endoscopy 2022;39(6):472-478
Objective:To investigate the change of the detection rate of colorectal cancer (CRC), colorectal adenoma and advanced adenoma in adults under colonoscopy in Shihezi in the past ten years.Methods:Data of patients who completed colonoscopy in the First Affiliated Hospital of Shihezi University School of Medicine from January 1, 2010 to December 31, 2019 were investigated. The medical records were collected by consulting the electronic medical record system, including the age and sex of patients and the location, quantity, size and pathological type of lesions. The detection rates, including the overall detection rate in the past 10 years, those in the first 5 years (from 2010 to 2014) and the second 5 years (from 2015 to 2019) of colorectal adenomas, advanced colorectal adenomas and CRC, were studied.Results:A total of 50 645 cases were included, 14 931 cases were excluded by the exclusion criteria, and finally a total of 35 714 cases were included in the data analysis. The 10-year overall detection rates of colorectal adenoma, advanced colorectal adenoma and CRC were 17.65% (6 302/35 714), 4.45% (1 589/35 714) and 3.71% (1 324/35 714), respectively. The overall detection rates of colorectal adenoma and advanced colorectal adenoma in the second 5 years were higher respectively than those in the first 5 years [20.33% (4 565/22 457) VS 13.10% (1 737/13 257), 4.69% (1 053/22 457) VS 4.04% (536/13 257)]. The overall detection rate of CRC in the second 5 years [3.30% (741/22 457)] was lower than that in the first 5 years [4.40% (583/13 257)].Conclusion:Compared with 2010 to 2014, the detection rate of colorectal adenoma in Shihezi area in 2015 to 2019 increased significantly, the detection rate of advanced colorectal adenoma increased slightly, and the detection rate of CRC decreased slightly. Therefore, the detection and resection of colorectal adenoma by colonoscopy may be important in reducing the incidence of CRC.
5.Application of ultrasound-guided peripherally inserted central catheter in very/extremely low birth weight infants
Lili ZUO ; Yimei REN ; Jie ZHOU ; Huizhu LI ; Sisi ZHUANG ; Shudong CUI ; Xiaoqing CHEN
Chinese Journal of Neonatology 2021;36(5):20-23
Objective:To study the clinical application of ultrasound-guided puncture and catheter tip positioning in peripherally inserted central catheter (PICC) among very/extremely low birth weight infants (VLBWI/ELBWI).Method:From January 2019 to August 2020, VLBWI/ELBWI admitted to NICU of our hospital and received PICC were prospectively enrolled in the study. Based on the last digit of medical record number was odd or even, the infants were assigned into ultrasound group and X-ray group. In the ultrasound group, puncture and catheter tip positioning were performed at bedside guided by ultrasound, while in the X-ray group, these procedures were performed empirically. The differences of catheterization procedure duration, first-time success rate, the visibility of catheter tip, primary dislocation rate, secondary dislocation rate and complication rate were compared between the two groups using SPSS 25.0.Result:A total of 118 premature infants were enrolled, including 57 cases in ultrasound group (50 cases VLBWI and 7 cases ELBWI) and 61 cases in X-ray group (54 cases VLBWI and 7 cases ELBWI). The catheterization procedure duration [(23.2±7.1) min vs. (34.1±7.5) min], first-time success rate (93.0% vs. 65.6%), the visibility of catheter tip (96.5% vs. 83.6%), primary dislocation rate (7.0% vs. 24.6%) and complication rate (7.0% vs. 21.3%) in ultrasound group were all better than X-ray group ( P<0.05). For ELBWI, the above five indexes in the ultrasound group were better than the X-ray subgroup ( P<0.05). For VLBWI, only the catheterization procedure duration and first-time success rate were better in the ultrasound group than the X-ray group ( P<0.05). Conclusion:Ultrasound-guided PICC catheterization in VLBWI/ELBWI is convenient and accurate, which can improve success rate, reduce radiation exposure and repeated catheterization injury. Timely tracking and adjustment of the catheter under ultrasound can reduce complications after catheterization. This technique is worth popularizing among VLBWI/ELBWI.
6.Detection rate of pathogens from sputum, blood, and bronchoalveolar lavage fluid samples in acquired immunodeficiency syndrome patients complicated with pulmonary infection
Ya TIAN ; Yu WANG ; Yajie WANG ; Chen CHEN ; Zhen CHEN ; Huizhu WANG ; Fujie ZHANG
Chinese Journal of Infectious Diseases 2019;37(6):343-346
Objective To study the detection rate of pathogens from sputum , blood, and bronchoalveolar lavage fluid ( BALF ) samples in acquired immunodeficiency syndrome ( AIDS ) patients complicated with pulmonary infection.Methods Seventy-three hospitalized AIDS patients complicated with pulmonary infection in Beijing Ditan Hospital , Capital Medical University were enrolled from February 2018 to September 2018.Blood, sputum and BALF samples were collected.Blood samples were cultured to detect anaerobic bacteria, aerobic bacteria, fungi and mycobacteria.Antigen agglutination method was applied in blood samples to detect cryptococcus neoformans.The sputum samples were tested for Mycobacterium tuberculosis by acid-fast staining and were cultured to detect bacteria and fungi.The sputum samples were observed under microscope for sporotrichosis and fungal spores.The BALF samples were cultured to detect bacteria and fungi. The BALF samples were tested for Mycobacterium tuberculosis by polymerase chain reaction amplification and acid-fast staining.Pneumocystis were detected in BALF samples by methenamine silver staining method .The BALF samples were observed under a microscope for sporotrichosis and fungal spores .The detection rate of pathogens from blood, sputum and BALF samples were compared.Chi-square test was conducted for statistical analysis.Results In 73 AIDS patients complicated with pulmonary infection , the pathogen detection rates in blood, sputum and BALF samples were 8 (11.0%), 23 ( 31.5%) and 48 (65.8%), respectively.The difference was statistically significant ( F =48.513, P <0.01 ).The detection rate in BALF samples was significantly higher than that in blood or sputum samples ( χ2 =43.349 and 17.136, respectively, both P<0.01).The detection rate in sputum samples was significantly higher than that in blood (χ2 =9.215, P<0.05). The highest detection rates of pathogens in blood , sputum and BALF samples were Talaromyces marneffei 4.1%(3), viridans group streptococci 16.4%(12) and 35.6%(26), respectively.Conclusions The detection rate of pathogens in BALF samples from AIDS patients complicated with pulmonary infection is the highest , followed by sputum and blood samples.
7.Application of Quality Control Circle in Improving the Process Efficiency of Automatic Dispensation Ma-chine before Dispensing
Zhuoqian CAI ; Huizhu SONG ; Hua YANG ; Jiagang CHEN
China Pharmacy 2017;28(13):1801-1804
OBJECTIVE:To improve the process efficiency of automatic dispensation machine before dispensing. METHODS:After building quality control circle(QCC)in the hospital inpatient,according to the steps of QCC,the key links and factors that affect process efficiency of automatic dispensation machine before dispensing were found out,corresponding countermeasures were developed based on causes,then it was evaluated by process time and other indexes in dispensing before and after the development of QCC. RESULTS:The 2 links(removing the drug packaging,manually counting and developing add-drug list)with the longest time before dispensing improved work efficiency by setting add-drug quantity and variety truly,timing checking dispensation medi-cine,timely counting dispensation medicine drug list,strengthening training and other methods,process time of automatic dispensa-tion machine before dispensing was shortened from 179.8 min(before)to 119.2 min(after)(shortened by 33.7%),target achieve-ment rate was 168.5%;and QCC staff showed positive growth in means, responsibility, team cohesion, and other aspects (increase rate were 15%-81%). CONCLUSIONS:QCC shows obvious effect on improving process efficiency of automatic dispen-sation machine before dispensing.
8.Distribution and drug resistance characteristics of pathogens for infection after lung transplantation from 2010 to 2016
Xiaojun CAI ; 复旦大学附属华山医院 ; Huizhu SONG ; Zheng JIAO ; Yi LU ; Zhidong ZANG ; Xiuhong ZHANG ; Jingyu CHEN
Chinese Journal of Organ Transplantation 2017;38(9):513-519
Objective To investigate the pathogen distribution and drug resistance condition in patients after lung transplantation so as to guide the reasonable use of antibiotics.Methods The clinical specimens from 242 lung transplantation patients in Wuxi People's Hospital between Jan.2010 to Dec.2016 were retrospectively analyzed.Among the 242 patients,182 were males and 60 were females with the average age of (52 ± 15) years old.Automatic analysis instrument VITEK-2 was applied for pathogen detection and K-B method was used to test drug resistance.Results From 2373specimens,1005 strains of pathogens were isolated and the detection rate was 42.35% (1005/2373),in which gram-negative bacteria accounted for 81.79% (822/1005).The specimens mainly resulted from sputum (76.19 %) and bronchoalveolar lavage (19.76 %).Among those strains,acinetobacter baumannii (28.76%),pseudomonas aeruginosa (16.62%),klebsiella pneumonia (14.33%),escherichia coli (5.57%) and Stenotrophomonas maltophilia (4.88%) ranked the top five species.Acinetobacter baumannii strains were highly resistant to most of antibiotic agents,with the drug resistant rate from 59.52% to 100%,except cefperazone-sulbactam (< 50%).Pseudomonas aeruginosa strains were highly resistant to cefazolin,ceftriaxone,cefotetan,ampicillin,ampicillinsulbactam with the resistance rate of 80.24%-98.80%,while compared to other anibiotics with the resistance rate less than 50%.Stenotrophomonas maltophilia strains with intrinsic drug resistance to imipenem were sensitive to trimethoprim-sulfamethoxazole,cefperazone-sulbactam,piperacillintazobactam,levofloxacin,ciprofloxacin with the drug resistance rate of 12.24%,14.29%,32.65%,16.33% and 18.37% respectively.Klebsiella Klebsiella pneumoniae and escherichia coli,whose resistant rate to ceftazidime,cefperazone-sulbactam,piperacillin-tazobactam,aztreonam,amikacin and tobramycin was all less than 50%,were highly sensitive to imipenem,with the resistance rate of 24.31% and 7.14% respectively.Gram-positive bacteria were accounted for 9.35%,mainly Staphylococcus aureus,Staphylococcus haemolyticus and Staphylococcus epidemics,and drug resistant rate of them to vancomycin was all less than 20.00%.Fungi were accounted for 8.86%,mainly Candida albicans and Filamentous fungi,whose drug resistance rate to 5 antifungal drugs was less than 20.00%.The drug resistance rate of C.glabrata strains and C.krusei strains to fluconazole was 80.00% and 100.00%,respectively.Conclusion The incidence of gram-negative bacteria infection and multiple bacterial strain infection in patients after lung transplantation is very high and the nonfermentation bacteria are highly resistant to multiple antibiotics.So,the rational antibiotics' use inclinical practice should be based on drug sensitivity results in order to improve the lung transplant recipients' survival rate.
9.Analysis of the Relationship of HPLC Fingerprint of Zhizi Jinhua Pills with Its in vitro Antioxidant Activity
Shuai CHEN ; Huizhu WANG ; Jianfei XUE ; Fangli ZHONG ; Lingli LI
China Pharmacy 2016;27(22):3077-3080
OBJECTIVE:To establish fingerprint of Zhizi jinhua pills(ZZJHW)and analyze the relationship of it with in vitro antioxidant activity,in order to provide the basis for the quality control of them. METHODS:HPLC method was adopted. The sep-aration was performed on a Sinochrom ODS-BP C18(200 mm×4.6 mm,5 μm)column with mobile phase consisted of 0.2% acetic acid(containing 3 mmol/L sodium heptanesulfonate solution)-acetonitrile(gradient elution)at the detection wavelength of 254 nm and flow rate of 0.8 ml/min. The column temperature was controlled at 38 ℃,and injection volume was 10 μl. The“Chromato-graphic Fingerprint Similarity Evaluation System for TCM”(2012.130723 edition) issued by Chinese Pharmacopoeia Commission was used to evaluate the similarity of the 12 batches of ZZJHW using baicalin as reference peak so as to attribute the common peak of fingerprint. DPPH free radical scavenging assay was used to investigate the in vitro antioxidant activity of 12 batches of ZZJHW,and the relationship between its fingerprint and antioxidant activity was studied. RESULTS:The fingerprint of 12 batches of ZZJHW was established and the similarity between the fingerprint of ZZJHW with their reference fingerprint were all above 0.9 (except S1,S2,S3,S12). 30 common peaks were marked,all of which were assigned to the herbs. Antioxidant experiment result showed the differences in the antioxidant capacity among different batches of ZZJHW;spectrum effect relationship showed that 13 common peaks were positively related with oxidation activity and 17 common peaks negatively related with it;among known com-ponents,oxidation activity components were mainly from Lonicera japonica,Scutellaria baicalensis and Rheum palmatum. CON-CLUSIONS:The spectrum effect relationship of established fingerprint with its antioxidant activity can provide reference for the quality control of ZZJHW.
10.Related factors of serum vitamine D level in 4-15-year-olds children in southwest Zhejiang
Huizhu LI ; Huafu WANG ; Guiai ZHENG ; Jiaqi CHEN ; Houxing LEI ; Huisu FAN ; Jihong SHI ; Yan HUANG
Chinese Journal of Clinical Nutrition 2016;24(2):110-114
Objective To investigate vitamin D ( VD) level and its influencing factors in 4-15-year-old children in southwest of Zhejiang province, so as to guide intervention strategy for improving VD level. Methods A total of 2 620 4 -15-year-old healthy children who visited Lishui People's Hospital for regular physical check-up between January and December 2014 were divided into 4 age groups, namely 4 -6 years (kindergarten), 7 -9 years (lower grades in primary school), 10 -12 years (higher grades in primary school), and 13-15 years (junior middle school).We randomly selected 200 children from each age group using a random number table.A survey using self-developed questionnaire was conducted to obtain information regarding diet, exposure to sunlight, and VD supplement.Serum 25-( OH) D level was measured with electro-chemiluminescence.VD nutritional status and composition, diet, sunlight exposure, VD supplement were com-pared among the groups.Results In southwest Zhejiang, the mean VD level in primary and middle school students was ( 24.76 ±8.39 ) μg/L, clinical deficiency rate was 31.5%, subclinical deficiency rate was 45.0%, and only 23.5% reached the appropriate level, which was even lower ( 14.5%) in junior middle school students.The VD deficiency rate elevated significantly along with the growth of age (P=0.036).The level of VD was positively correlated with sunlight exposure and VD supplementation, and showed significant in-ter-group differences ( all P<0.05 ) .Conclusions The nutritional status of VD is unfavorable and sunlight exposure insufficient in primary and middle school students in southwest Zhejiang province.We should encour-age students to take more outdoor activities and increase sunlight exposure to improve their VD nutritional sta-tus.Children >7 years should be given more attention to in the intervention of increasing sunlight exposure. Students with difficulties in getting adequate sunlight exposure need VD supplements.

Result Analysis
Print
Save
E-mail