1.Preliminary study on an improved method for constructing internal quality control framework of ELISA
Youbin DUAN ; Rui WANG ; Le CHANG ; Changwen QIU ; Zhiqiang LI ; Gengrui CHEN ; Jingjuan YANG ; Qing HE ; Lunan WANG
Chinese Journal of Blood Transfusion 2026;39(1):103-108
Objective: To propose an improved method for constructing the internal quality control (IQC) framework for ELISA assays and validate its efficacy by statistically analyzing IQC data from nine blood center laboratories. Methods: 1) IQC data was collected from nine blood centers and analyzed using a domestic HBsAg ELISA detection kit as an example. 2) Differences between IQC values across batches within Blood Center 1 were assessed. 3) Statistical analyses were performed on batch usage, number of batches used, days of use, number of QC points, batch-specific means, and coefficients of variation (CV) across all nine centers. 4) Using the improved construction method for IQC framework, provisional and permanent frames were established for batches within Blood Center 1 and Blood Center 9, followed by outlier determination. Results: 1) Statistically significant differences were observed in IQC data between batches within Blood Center 1 (P<0.01). It is recommended that both the control material/reagents and the control chart framework be replaced simultaneously. 2) There were substantial differences among 9 blood centers regarding the control material/reagent lot numbers used, the number of QC runs per batch, and the QC values for identical lots. Therefore, individual laboratories should establish their own IQC chart frameworks. 3) The improved IQC framework construction method for ELISA assays is as follows: provisional frames are established via frame-shifting, using the pre-experimental mean and cumulative coefficient of variation (CV) from the preceding batch. For batches used >20 days with >20 QC points, permanent frames are constructed by aggregating in-control data accumulated over ≥20 days with ≥20 points to calculate cumulative mean and standard deviation. The provisional and permanent frames constructed by this method identified all 26 extreme outliers across Blood Centers 1 and 9 as out-of-control. Among the 218 general outliers, 10 were classified as normal by the provisional frames, while the remainder were designated as warnings or out-of-control. This method effectively monitors assay stability. Conclusion: Based on the statistical analysis of IQC practices across blood centers of varying scales, combined with the inherent characteristics of ELISA assays and the batch-to-batch instability of reagents/QC materials, it is recommended to reconstruct QC charts upon lot changes. The proposed method—utilizing frame-shifting for provisional frames and establishing permanent frames based on cumulative data—is applicable to blood center laboratories of differing sizes and effectively monitors the stability of the ELISA assay process.
2.Mechanism of action of Qingre huatan huoxue decoction against atherosclerosis based on macrophage polarization
Huaping ZHONG ; Qicheng ZHU ; Zhengwei ZOU ; Zhengyi HE ; Heping XIE ; Xu CHEN ; Zhisheng DUAN ; Tian XIAO
China Pharmacy 2026;37(4):438-443
OBJECTIVE To explore the mechanism of action of Qingre huatan huoxue decoction against atherosclerosis (AS)based on macrophage polarization. METHODS Using atorvastatin served as the positive control, the drug-containing serum of the Qingre huatan huoxue decoction was prepared to treat RAW264.7 macrophages. Macrophage viability, apoptosis rate, and the fluorescence intensities of CD86 and CD206 were measured, along with the levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β). Apolipoprotei n E-deficient (ApoE -/- ) mice (AS model mice) fed with a high-fat diet were randomly assigned to model group, atorvastatin group (2.6 mg/kg), and low-, medium- and high-dose groups of Qingre huatan huoxue decoction (90, 180, 360 mg/kg), respectively. C57BL/6J mice fed with a standard diet served as the normal control group, with 10 mice per group. The treatment group mice were administered the corresponding drugs intragastrically, once daily, for 8 consecutive weeks. Serum levels of TNF-α and IL-1β were measured in all groups. Lipid deposition in the aorta (assessed by the percentage of plaque in the entire aorta and aortic root) and morphological changes in the aortic root were observed. Expression levels of CD86 and CD206 in aortic tissue, as well as the protein expression levels of inducible nitric oxide synthase (iNOS), arginase-1 (Arg-1), AMP-activated protein kinase (AMPK), phosphorylated AMPK (p-AMPK), and peroxisome proliferator-activated receptor γ (PPAR-γ) in aortic tissues were all detected. RESULTS Cell experiment results showed that, at concentrations of 5-100 μg/mL, the drug-containing serum of the Qingre huatan huoxue decoction significantly increased RAW264.7 cell viability ( P <0.05). The drug-containing serum of the Qingre huatan huoxue decoction at concentrations of 10, 50, and 100 μg/mL, along with atorvastatin, significantly reduced apoptosis rates, CD86 fluorescence intensity, and TNF-α and IL-1β levels in RAW264.7 cells, while markedly enhancing CD206 fluorescence intensity ( P <0.05). Animal experiment results showed that, compared with the model group, all dosage groups of Qingre huatan huoxue decoction and the atorvastatin group showed significantly reduced/down-regulated levels of TNF-α and IL-1β in serum, along with decreased aortic total and root plaque percentages, CD86 expression, and iNOS protein expression. CD206 expression and Arg-1, p-AMPK/AMPK, PPAR-γ protein expression were significantly up-regulated ( P <0.05). Pathological morphology of the aorta showed varying degrees of improvement. CONCLUSIONS The formula of Qingre huatan huoxue decoction exerts its anti-AS effects by regulating macrophage polarization, increasing the proportion of M2 macrophages, thereby effectively inhibiting AS plaque formation and reducing inflammatory responses.
3.Network meta-analysis of the efficacy and safety of dual amoxicillin-based regimens for Helicobacter pylori eradication
Ziwen SONG ; Xinmiao YUAN ; Liyuan LUO ; Yufang HE ; Lingshu YANG ; Yixu HUANG ; Jianpeng SHE ; Peihan WEI ; Sihan GUO ; Fei DUAN
China Pharmacy 2026;37(8):1074-1079
OBJECTIVE To evaluate the efficacy and safety of amoxicillin combined with proton pump inhibitor (PPI) or potassium-competitive acid blocker (P-CAB) for Helicobacter pylori (Hp) eradication. METHODS Randomized controlled trial (RCTs) on amoxicillin combined with PPI or P-CAB for Hp eradication were retrieved from PubMed, Embase, the Cochrane Library, Web of Science, CNKI, Wanfang, and VIP data. The search time frame was from database inception to September 5, 2025. After literature screening, data extraction, and quality assessment, a network meta-analysis was performed using Stata 17.0 software. RESULTS A total of 12 RCTs involving 5 515 patients were included, encompassing 8 therapeutic regimens: PPI combined with high-dose amoxicillin for 14 days (TR1), PPI combined with low-dose amoxicillin for 14 days (TR2), P-CAB combined with high-dose amoxicillin for 7 days (TR3), P-CAB combined with high-dose amoxicillin for 14 days (TR4), P-CAB combined with high-dose amoxicillin for 10 days (TR5), P-CAB combined with low-dose amoxicillin for 7 days (TR6), P-CAB combined with low-dose amoxicillin for 14 days (TR7), and P-CAB combined with low-dose amoxicillin for 10 days (TR8). The network meta-analysis results showed that, in terms of intention-to-treat Hp eradication rates, the eradication rates of TR5 and TR4 were significantly higher than those of TR3, TR8, TR6 and TR1 ( P <0.05). The surface under the cumulative ranking curve (SUCRA) values from highest to lowest were: TR4 (89.7%)>TR5 (82.3%)>TR7 (71.5%)> TR2 (48.6%)>TR1 (43.9%)>TR8 (28.7%)>TR3 (22.7%)>TR6 (12.6%). Regarding safety, the incidence of adverse reactions in TR3 and TR5 was significantly lower than that in TR1 ( P <0.05). The SUCRA values from highest to lowest were: TR1 (91.3%)>TR4 (79.8%)>TR5 (55.0%)>TR7 (50.9%)>TR8 (41.3%)>TR2 (36.4%)>TR3 (27.6%) >TR6 (17.7%). CONCLUSIONS Although the regimen of P-CAB combined with high-dose amoxicillin for 14 days demonstrates the best efficacy, the combination of P-CAB with high-dose amoxicillin for 10 days exhibits a better balanced profile in terms of both efficacy and safety.
4.Spatiotemporal clustering characteristics and epidemiological trends of typhus fever in Baoshan City, Yunnan Province, 2005‒2023
Tianren LU ; Lijuan ZHAO ; Lizhong DUAN ; Kai HE ; Na WANG ; Zongqi JIANG ; Zhijie ZHANG ; Dongsheng HUANG
Shanghai Journal of Preventive Medicine 2026;38(4):274-279
ObjectiveTo analyze the incidence and spatiotemporal distribution of typhus fever in Baoshan City, Yunnan Province from 2005 to 2023, to identify high-risk populations and regions, so as to provide a scientific basis for optimizing the allocation of local prevention and control resources and developing targeted intervention measures. MethodsData of typhus fever cases in Baoshan City from 2005 to 2023 were obtained from the Infectious Disease Information Management System of the Chinese Center for Disease Control and Prevention. Descriptive epidemiological methods were used to analyze the temporal, spatial and demographic distribution of typhus fever cases. Spatial clustering was assessed using spatial dynamic window scan statistics (circular and elliptical windows), flexible spatial scan statistics, and local spatial autocorrelation methods (including local Moran’s I, local Geary’s C, and Getis-Ord Gi*). Retrospective spatiotemporal scan statistics were employed to detect spatiotemporal clusters. ResultsA total of 1 099 typhus fever cases were reported in Baoshan City from 2005 to 2023. The incidence rate peaked at 6.31/ 100 000 in 2007, followed by a decline until reaching its lowest level at 0.21/100 000 in 2015 , and subsequently rebounded during 2016‒2023. The highest proportion of cases was among children under 10 years of age (31.12%), and the top three occupations of cases were farmers, students, and children, accounting for 88.62% of all cases. Cases occurred predominantly between June and September each year. The incidence was relatively high in Jiucheng Town (62.58/100 000), Yaoguan Town (57.15/100 000), and Dianyang Town (46.81/100 000) of Shidian County. Spatial clustering analyses indicated that high-risk areas were mainly located in the southern part of Baoshan City, showing a south-to-north trend. Spatiotemporal scan analyses identified five clusters, with the most likely cluster centered around Yaoguan Town, covering ten towns (subdistricts) during the period 2007‒2010. ConclusionThe incidence of typhus fever in Baoshan City exhibits a clear seasonal and spatial clustering pattern, with peak incidence occurring in summer and autumn. Spatially, cases are primarily distributed in the southern part of Baoshan City, and high-risk clusters exhibit a south-to-north trend. Farmers, students, and children are the high-risk groups.
5.Uptake of HIV-related health services among cross-border couples in Dehong Dai and Jingpo Autonomous Prefecture
Runhua YE ; Yuanyuan HAN ; Qunbo ZHOU ; Lin LI ; Yuecheng YANG ; Lifen XIANG ; Renhai TANG ; Jibao WANG ; Yingying DING ; Na HE ; Song DUAN
Shanghai Journal of Preventive Medicine 2026;38(8):614-619
ObjectiveTo investigate the current status of HIV-related health service uptake among cross-border couples (Chinese husbands and Myanmar wives) in Dehong Dai and Jingpo Autonomous Prefecture (hereinafter referred to as Dehong Prefecture), and to provide evidence for optimizing HIV prevention and control strategies in border areas. MethodsA cross-sectional survey was conducted from September 2022 to September 2023 among 14 662 cross-border couples (Chinese husbands and Myanmar wives) in Dehong Prefecture. Data on sociodemographic characteristics, HIV/AIDS knowledge awareness, and utilization of HIV-related health services within the past year were collected. Multivariable logistic regression was used to analyze factors associated with HIV testing uptake among husbands and wives. ResultsA total of 29 324 individuals (14 662 couples) were included. The overall awareness rate of HIV/AIDS was 82.09%, with the rate among husbands significantly higher than that among wives (85.17% vs. 79.01%, P<0.001). Overall, 94.98% of participants had received at least one HIV-related health service, and the HIV testing rate in the past year was 65.52%. Multivariable logistic regression analysis showed that, compared with participants married for 0‒3 years, those married for 4‒10 years and ≥11 years were more likely to have received HIV testing. The corresponding ORs were 1.344 (95%CI: 1.187‒1.521) and 1.381 (95%CI: 1.211‒1.574) among husbands, and 1.308 (95%CI: 1.155‒1.481) and 1.344 (95%CI: 1.178‒1.533) among wives, respectively. Compared with those holding a marriage certificate, those possessing a border marriage registration certificate were positively associated with HIV testing uptake, with ORs of 1.710 (95%CI: 1.575‒1.857) among husbands and 1.700 (95%CI: 1.565‒1.847) among wives. Compared with illiterate participants, those with primary school education showed lower testing rates, with ORs of 0.738 (95%CI: 0.650‒0.837) among husbands and 0.827 (95%CI: 0.766‒0.891) among wives. Additionally, a history of sexually transmitted diseases (OR=3.656, 95%CI: 1.243‒15.589) and participation in the New Rural Cooperative Medical Scheme (OR=1.51, 95%CI: 1.179‒1.935) were independently associated with higher testing rates among husbands. ConclusionThe overall utilization of HIV-related health services among cross-border couples in Dehong Prefecture is satisfactory, but significant gender disparities exist, with foreign wives showing lower rates of knowledge awareness and lower proportions obtaining such knowledge through certain channels compared with their Chinese husbands. Couples with shorter marriage duration, those with primary school education, and those not included in the border marriage registration system are vulnerable groups with lower HIV testing uptake. Future interventions should prioritize cross-border marriage families at the early stage of entry and in the newly married period. Based on the border marriage registration management system and primary healthcare networks, health education and HIV testing services targeting foreign spouses should be strengthened to improve service accessibility and equity.
6.Outcome Framing and Expression Style in Sleep Health Messages for Students in Medical and Health-Related Disciplines
Hong KANG ; Daiyun HE ; Yizhen WEI ; Ying XIA ; Lu WANG ; Shengnan YE ; Jixiaoyu CHEN ; Wenli DUAN
Medical Journal of Peking Union Medical College Hospital 2026;17(5):1397-1406
To compare psychological reactance, intention to adopt sleep-management recommendations, and intention to use sleep-support resources among students in medical and health-related disciplines exposed to sleep health messages with different outcome frames and expression styles, and to provide evidence for the design of sleep health information materials. A 2×2 between-subject randomized message experiment was conducted. A total of 320 students in medical and health-related disciplines were included in the analysis. The questionnaire system randomly presented each participant with one of four sleep health messages combining gain versus loss framing with autonomy-supportive versus controlling expression. All main measures were assessed immediately after message exposure. Intention to adopt sleep-management recommendations was the primary outcome, and the main effect of expression style was the primary effect; a 2×2 analysis of variance was performed, with marginal mean differences reported. The six items assessing intention to use sleep-support resources were secondary outcomes and were analyzed separately using 2×2 linear models with Holm adjustment; generalized estimating equations(GEE) were used as an aggregate supplementary analysis. The statistical mediation relationship involving psychological reactance was examined exploratorily using bootstrap analysis. For the primary outcome, the marginal mean difference between autonomy-supportive and controlling expression was 0.661 points(95% CI: 0.530-0.791; The estimated difference associated with expression style is larger than that associated with outcome framing. Autonomy-supportive expression is associated with greater intention to adopt sleep-management recommendations and greater intention to use each sleep-support resource. The statistical mediation relationship involving psychological reactance provides a clue for understanding this difference.
7.Exploration on Mechanism of Shengjiang Pingchuan Zhike Pills Against Cough Variant Asthma by Modulating AMPK/mTOR/ULK1 Signaling Pathway Based on Transcriptomics
Baotang LU ; Jiao DU ; Min BAI ; Tengfei HE ; Le LI ; Yongqiang DUAN ; Changxi ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(22):169-179
ObjectiveTo investigate the mechanism by which Shengjiang Pingchuan Zhike pills (SPZP) alleviate airway injury in the rat model of cough variant asthma (CVA) via regulating autophagy through activating the adenosine monophosphate-activated protein kinase (AMPK)/mammalian target of rapamycin (mTOR)/Unc-51-like autophagy activating kinase 1 (ULK1) signaling pathway based on transcriptomics, thus providing experimental evidence for the clinical application of SPZP. MethodsForty SPF-grade SD rats were enrolled in the present study and randomly via the random number table method assigned into four groups: a blank group, a model group, a SPZP (2 160 mg·kg-1·d-1) group, and a positive drug (montelukast sodium, MTL, 0.9 mg·kg-1·d-1)group, with 10 rats in each group. After one week of adaptive feeding, the rat model of cough variant asthma (CVA) was established by two-week sensitization with ovalbumin (OVA) and aluminium hydroxide, followed by capsaicin atomization challenge. Rats in the blank group received an equal volume of normal saline during modeling. Upon successful modeling, rats in the SPZP group and positive drug group were administrated with SPZP suspension and MTL solution, respectively, while those in the blank and model groups received the same dose of normal saline by gavage. The whole intervention lasted for 21 consecutive days. After the intervention, general behaviors of rats in each group were observed. Pulmonary function indicators were subsequently detected. Hematoxylin-eosin (HE) staining was performed to visualize the pathological morphology of the lung tissue, and periodic acid-Schiff (PAS) staining was adopted to evaluate airway mucus secretion. Transcriptomic sequencing was conducted to screen differentially expressed genes in the lung tissue across groups. The levels of inflammatory cytokines including interleukin (IL)-4, IL-5, immunoglobulin E (IgE), and interferon-γ (IFN-γ) in the bronchoalveolar lavage fluid (BALF) were quantified by enzyme-linked immunosorbent assay (ELISA). Immunofluorescence staining was used for detecting the co-localization of autophagy-related protein Beclin-1 and phosphorylated mammalian target of rapamycin (p-mTOR). Transmission electron microscopy was employed to count autophagosomes and observe mitochondrial morphological changes in the lung tissue. Western blot assay was utilized to measure the expression levels of AMPK/mTOR/ULK1 axis-related proteins, including AMPK, phosphorylated adenosine monophosphate-activated protein kinase (p-AMPK), mTOR, phosphorylated mammalian target of rapamycin (p-mTOR), ULK1, and phosphorylated Unc-51-like autophagy activating kinase 1 (p-ULK1) as well as the autophagy biomarkers Beclin-1 and selective autophagy adaptor protein p62 in lung specimens. ResultsCompared with the blank group, the model group exhibited markedly elevated cough frequency accompanied by wheezing and stridor, dull fur, poor mental activity, diminished motor activity, accelerated respiratory rate, and weakened sensory response and mobility to external stimuli, accompanied by a declining tendency of body mass. Meanwhile, the model group exhibited decreased dynamic lung compliance, increased airway resistance (P<0.01), severe pathological damage and excessive mucus secretion in the lung tissue (P<0.01), and elevated levels of IL-4, IL-5, and IgE and declined level of IFN-γ in the BALF (P<0.01). Ultrastructural observation revealed damaged mitochondrial morphology and a sharp reduction in the number of autophagosomes in the lung tissue. In addition, the expression of p-AMPK, p-ULK1, and Beclin-1 were downregulated, whereas p-mTOR and p62 were highly expressed (P<0.05, P<0.01) in the model group. Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses demonstrated significant enrichment of AMPK, mTOR, and autophagy-related pathways. Compared with the model group, both the positive drug group and SPZP group obtained visible improvements in general behavioral manifestations and obvious recovery of pulmonary function indicators (P<0.05), alleviated pulmonary pathological lesions and suppressed excessive airway mucus secretion (P<0.05), recovered levels of inflammatory cytokines in the BALF (P<0.05), restored mitochondrial morphology, increased autophagosomes, upregulated expression levels of p-AMPK, p-ULK1, and Beclin-1, and downregulated expression levels of p-mTOR and p62 (P<0.05). ConclusionSPZP can effectively ameliorate airway inflammation and improve the pulmonary function in the rat model of CVA by activating the AMPK/mTOR/ULK1 signaling pathway, enhancing autophagy in the lung tissue, and inhibiting excessive airway mucus secretion and immune inflammatory imbalance.
8.Mid-long term follow-up reports on head and neck rhabdomyosarcoma in children
Chao DUAN ; Sidou HE ; Shengcai WANG ; Mei JIN ; Wen ZHAO ; Xisi WANG ; Zhikai LIU ; Tong YU ; Lejian HE ; Xiaoman WANG ; Chunying CUI ; Xin NI ; Yan SU
Chinese Journal of Pediatrics 2025;63(1):62-69
Objective:To analyze the clinical characteristics of children with head and neck rhabdomyosarcoma (RMS) and to summarize the mid-long term efficacy of Beijing Children′s Hospital Rhabdomyosarcoma 2006 (BCH-RMS-2006) regimen and China Children′s Cancer Group Rhabdomyosarcoma 2016 (CCCG-RMS-2016) regimen.Methods:A retrospective cohort study. Clinical data of 137 children with newly diagnosed head and neck RMS at Beijing Children′s Hospital, Capital Medical University from March 2013 to December 2021 were collected. Clinical characteristic of patients at disease onset and the therapeutic effects of patients treated with the BCH-RMS-2006 and CCCG-RMS-2016 regimens were compared. The treatments and outcomes of patients with recurrence were also summarized. Survival analysis was performed by Kaplan-Meier method, and Log-Rank test was used for comparison of survival rates between groups.Results:Among 137 patients, there were 80 males (58.4%) and 57 females (41.6%), the age of disease onset was 59 (34, 97) months. The primary site in the orbital, non-orbital non-parameningeal, and parameningeal area were 10 (7.3%), 47 (34.3%), and 80 (58.4%), respectively. Of all patients, 32 cases (23.4%) were treated with the BCH-RMS-2006 regimen and 105 (76.6%) cases were treated with the CCCG-RMS-2016 regimen. The follow-up time for the whole patients was 46 (20, 72) months, and the 5-year progression free survival (PFS) and overall survival (OS) rates for the whole children were (60.4±4.4)% and (69.3±4.0)%, respectively. The 5-year OS rate was higher in the CCCG-RMS-2016 group than in BCH-RMS-2006 group ((73.0±4.5)% vs. (56.6±4.4)%, χ2=4.57, P=0.029). For the parameningeal group, the 5-year OS rate was higher in the CCCG-RMS-2016 group (61 cases) than in BCH-RMS-2006 group (19 cases) ((57.3±7.6)% vs. (32.7±11.8)%, χ2=4.64, P=0.031). For the group with meningeal invasion risk factors, the 5-year OS rate was higher in the CCCG-RMS-2016 group (54 cases) than in BCH-RMS-2006 group (15 cases) ((57.7±7.7)% vs. (30.0±12.3)%, χ2=4.76, P=0.029). Among the 10 cases of orbital RMS, there was no recurrence. In the non-orbital non-parameningeal RMS group (47 cases), there were 13 (27.6%) recurrences, after re-treatment, 7 cases survived. In the parameningeal RMS group (80 cases), there were 40 (50.0%) recurrences, with only 7 cases surviving after re-treatment. Conclusions:The overall prognosis for patients with orbital and non-orbital non-parameningeal RMS is good. However, children with parameningeal RMS have a high recurrence rate, and the effectiveness of re-treatment after recurrence is poor. Compared with the BCH-RMS-2006 regimen, the CCCG-RMS-2016 regimen can improve the treatment efficacy of RMS in the meningeal region.
9.Current status and prospects of single-incision laparoscopic cholecystectomy
Xingyu WANG ; Jian DUAN ; Jinlan HE ; Zhe QING ; Hui ZHANG ; Xudong ZHU ; Jiafeng JI
International Journal of Surgery 2025;52(8):559-563
Single-incision laparoscopic cholecystectomy (SILC) represents a significant evolution in minimally invasive surgery, designed to accomplish cholecystectomy via a single umbilical incision. This approach seeks to reduce abdominal wall trauma while optimizing cosmetic outcomes. SILC is a safe and feasible minimally invasive technique for cholecystectomy under defined conditions; however, its broader adoption will require further evidence-based research and the establishment of standardized protocols to support its widespread implementation. When performed by skilled surgeons in carefully selected patients, SILC demonstrates clinical outcomes comparable to those of conventional multiport laparoscopic cholecystectomy, with notable improvements in incision aesthetics. Nonetheless, the technique is limited by a constrained operative field and a protracted learning curve. In response, continuous advancements in instrumentation and procedural modifications have propelled the further development and clinical integration of SILC. Drawing on current literature and clinical experience, this review delineates the technical characteristics, current clinical applications, primary benefits, and prevailing challenges associated with SILC.
10.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
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Proton Pump Inhibitors/therapeutic use*
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Acute Coronary Syndrome/microbiology*
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Female
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Gastrointestinal Microbiome/drug effects*
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Male
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Middle Aged
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Histamine H2 Antagonists/therapeutic use*
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Aged
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Single-Blind Method

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