1.Effect of Optimized New Shengmai Powder (优化新生脉散方) on Exercise Tolerance in Patients with Chronic Heart Failure of Qi Deficiency,Blood Stasis and Fluid Retention Syndrome:A Randomized,Double-Blind,Placebo-Controlled Trial
Xianliang WANG ; Jingyi ZHANG ; Zhao GE ; Tongzuo LIU ; Maozhe ZHANG ; Shuai WANG ; Zhiqiang ZHAO ; Yingfei BI ; Ruijuan ZHOU ; Ying ZHENG ; Jingyuan MAO
Journal of Traditional Chinese Medicine 2026;67(4):425-431
ObjectiveTo evaluate the effects and safety of the optimized new Shengmai Powder (优化新生脉散方) on exercise tolerance in patients with chronic heart failure (CHF) of qi deficiency, blood stasis, and fluid retention syndrome. MethodsA randomized, double-blind, placebo-controlled trial was conducted. A total of 78 CHF patients with qi deficiency, blood stasis, and fluid retention syndrome were recruited and randomly assigned to a treatment group (39 cases) and a control group (39 cases). On the basis of conventional western medical therapy, patients in the treatment group additionally received the optimized new Shengmai Powder granules, while the control group was given an oral placebo of optimized new Shengmai Powder granules. Patients in both groups took 30.6 g each time, twice a day, mixed with water for administration, with a total treatment course of 4 weeks. The primary outcomes were 6-minute walk distance (6MWD) and peak oxygen uptake (Peak VO2) measured by cardiopulmonary exercise testing. Secondary outcomes included New York Heart Association (NYHA) functional classification, B-type natriuretic peptide (BNP) levels, cardiac function indexes including left ventricular ejection fraction (LVEF), left ventri-cular end-systolic diameter (LVESD) and left ventricular end-diastolic diameter (LVEDD), Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores, and scores of four diagnostic information of traditional Chinese medicine (TCM). All indicators were assessed once before and after treatment respectively. Safety indicators were evaluated, and adverse events during the trial were recorded. ResultsAll patients in both groups were included in the full ana-lysis set (FAS) and safety set (SS). Compared with baseline, the 6MWD and Peak VO₂ of cardiopulmonary exercise test in the treatment group significantly increased after treatment, while the MLHFQ scores, serum BNP levels and scores of TCM four diagnostic information significantly decreased, and the NYHA cardiac function grade significantly improved (P<0.01). After treatment, the 6MWD and Peak VO₂ of cardiopulmonary exercise test, as well as their changes from baseline in the treatment group were higher than those in the control group; the MLHFQ scores, serum BNP levels and scores of TCM four diagnostic information in the treatment group were lower than those in the control group; and the improvement of NYHA cardiac function grade in the treatment group was superior to that in the control group (P<0.01). There was no statistically significant differences in all indicators after treatment in the control group (P>0.05). The incidence of adverse events was 5.1% (2/39) in the treatment group and 2.6% (1/39) in the control group, with no statistically significant difference between groups (P>0.05). ConclusionOn the basis of conventional western medicine treatment, the addition of the optimized new Shengmai Powder can further improve exercise tolerance, cardiac function and quality of life in patients with CHF of qi deficiency, blood stasis and fluid retention syndrome, and show good safety.
2.Analysis of the potential disease burden of occupational polycyclic aromatic hydrocarbons exposure-associated lung cancer in China from 1990 to 2021
Jingyuan ZHAO ; Yang LIU ; Nan SHANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2025;43(6):430-434
Objective:To assess the disease burden of lung cancer associated with occupational exposure to polycyclic aromatic hydrocarbons (PAHs) in China from 1990 to 2021 using the 2021 Global Burden of Disease (GBD) data.Methods:In July 2024, data on occupational PAHs exposure-associated lung cancer from 1990 to 2021 were extracted from the GBD database, including mortality rates, age-standardized mortality rates, number of deaths, disability-adjusted life years (DALYs) rates, age-standardized DALYs rates, and number of DALYs for different genders and ages. Descriptive statistics were used to analyze trends in lung cancer mortality rates, age-standardized mortality rates, DALYs rates, and age-standardized DALYs rates over different years, genders, and ages. Joinpoint regression models were used to calculate the annual percent change (APC) and average annual percent change (AAPC), and to identify change points and trends in different periods within the data.Results:From 1990 to 2021, the mortality rate of lung cancer associated with occupational PAHs exposure increased from 0.085 per 100000 to 0.259 per 100000, and the age-standardized mortality rate increased from 0.107 per 100000 to 0.162 per 100000. The DALYs rate increased from 2.746 per 100000 to 7.389 per 100000, and the age-standardized DALYs rate increased from 3.330 per 100000 to 4.679 per 100000. The number of lung cancer deaths and DALYs both peaked in the 65-69 age group. Joinpoint regression analysis showed significant upward trends in mortality, age-standardized mortality, DALYs rate, and age-standardized DALYs rate from 1990 to 2021, with AAPCs of 3.655%, 1.382%, 3.256%, and 1.108%, respectively (all P<0.001). From 2016 to 2021, both the mortality rate and age-standardized mortality rate increased, with APCs of 4.163% and 1.735%, respectively. From 2015 to 2021, the DALYs rate increased (APC: 3.137%), and from 2016 to 2021, the age-standardized DALYs rate also rose (APC: 1.578%). For females, both mortality and DALYs rates increased from 2015 to 2021 (APCs: 6.269% and 5.426%, respectively). Among males, the mortality rate increased from 2018 to 2021 (APC: 3.477%) . Conclusion:From 1990 to 2021, the disease burden of lung cancer related to occupational PAHs exposure in China has significantly increased, particularly among the elderly population. Public health policies should enhance screening and prevention efforts targeting the high-risk populations.
3.Development and evaluation of a health management model for the elderly in rural areas
Jingyuan ZHAO ; Nan SHANG ; Pei WANG ; Tian LI
Chinese Journal of Health Management 2025;19(12):1007-1012
Objective:To develop a health management model tailored for the elderly population in rural areas and to evaluate its effectiveness.Methods:This before-and-after controlled intervention study was conducted from January 2024 to June 2024 in rural areas of Jiaocheng County, Shanxi Province. A multi-stage stratified random sampling method was used to include 5 000 permanent residents aged ≥65 years. A baseline health survey was first conducted to collect multidimensional data, including demographic characteristics, chronic disease information, cognitive and psychological scales, sleep quality, and health service utilization. Using the comprehensive health index as the outcome variable, seven machine learning models, including LightGBM, were constructed to identify key factors influencing health status and explore intervention pathways. Subsequently, under the framework of a "five-level linkage+shared database, " comprehensive interventions such as health communication, integrated medical and elderly care, and dynamic follow-ups were implemented. Differences in major health indicators were compared before and after the 6-month intervention.Results:At baseline, the prevalence rates of hypertension, diabetes, and coronary heart disease were 58.2%, 24.8%, and 16.1%, respectively. The rate of cognitive impairment was 36.9%, and the positive rates for depression and anxiety were 27.3% and 17.4%, respectively. Machine learning analysis showed that the Naive Bayes model had the best predictive performance (area under the curve=0.966), with key influencing factors including number of follow-ups, number of health lectures, and medical check-up frequency. After six months of intervention, systolic blood pressure decreased from (142.95±15.84) to (138.37±17.20) mmHg (1 mmHg=0.133 kPa), fasting glucose from (6.43±1.26) to (6.09±1.40) mmol/L, and MMSE scores increased from (25.04±3.28) to (25.71±3.29) points. The positive rates of anxiety and depression declined from 17.4% to 12.8% and 27.3% to 20.6%, respectively. Follow-up compliance improved from 76.5% to 80.5%, and health record completeness from 69.8% to 75.8% (all P<0.001). Conclusions:The integrated health management model based on the"five-level linkage+shared database,"incorporating health education and the integration of medical and elderly care, effectively improves chronic disease control and enhances cognitive and psychological health among older adults in rural areas of Shanxi Province. This model also strengthens service adherence and management efficiency.
4.Application effect of intelligent management process of health management (examination) institutions in Shanxi Province
Shanshan GE ; Jingyuan ZHAO ; Caizheng YANG ; Jiahui DING
Chinese Journal of Health Management 2025;19(8):617-624
Objective:To evaluate the application effect of intelligent management of health management (examination) institutions in Shanxi Province.Methods:In this study, a cross-sectional study was adopted. In October 2023, through convenient sampling, 300 health management (examination) institutions in Shanxi Province were investigated according to the four regions of northern Shanxi, central Shanxi, southern Shanxi and southeastern Shanxi, and the application information of intelligent management in the whole process from January to December 2022 was collected. According to the evaluation indicators in the documents of the National Health and Wellness Commission, six indicators were analyzed, including the completion rate of health questionnaire, the integrity of physical examination files, the filing rate of physical examination cycle, the evaluation rate of cardiovascular risk diseases, the re-examination rate of patients with chronic diseases (blood pressure, blood lipid and blood glucose indicators) and the follow-up rate of important abnormal results.Results:The completion rates of health questionnaires in northern Shanxi, central Shanxi, southern Shanxi and southeastern Shanxi were 54.9%, 84.2%, 93.2% and 98.2% ( χ 2=225 050.17, P<0.001), and the filing rates of health checkups in various regions were 89.1%, 94.7%, 94.0% and 94.5% ( χ 2=10 254.02, P<0.001). The filing rates of physical examination cycles in each region were 21.8%, 23.4%, 24.3% and 24.7% ( χ 2=734.15, P<0.001), and the assessment rates of cardiovascular risk diseases in each region were 84.5%, 85.4%, 80.2% and 86.2% ( χ 2=4 627.99, P<0.001). The reexamination rates of patients with chronic diseases (blood pressure, blood lipid and blood glucose indicators) in different regions were 38.8%, 39.7%, 39.3% and 39.5% ( χ 2=24.24, P<0.001), and the follow-up rates of important abnormal results were 81.7%, 84.1%, 82.9% and 83.9% ( χ 2=255.02, P<0.001). Conclusion:Shanxi health management (examination) institutions have achieved certain results in the application of intelligent management in the whole process, but there is still much room for improvement in the filing of physical examination cycle and re-examination of chronic diseases.
5.The role of radiotherapy in combined immunotherapy and chemotherapy as first-line treatment for oligometastatic non-small cell lung cancer
Yaowen ZHANG ; Jingyuan WEN ; Chenyu WANG ; Xinyu CHENG ; Heming ZHANG ; Linzhi JIN ; Runchuan REN ; Xiaohan ZHAO ; Wenbin SHEN
Chinese Journal of Radiological Medicine and Protection 2025;45(2):91-100
Objective:To evaluate the therapeutic value of radiotherapy in combined immunotherapy and chemotherapy as first-line treatment for patients with oligometastatic non-small cell lung cancer (NSCLC).Methods:A retrospective analysis was conducted on data from 195 NSCLC patients who lacked epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations and were treated at the Anyang Tumor Hospital and the Fourth Hospital of Hebei Medical University from January 2019 to December 2021. These patients consisted of 166 male and 29 female cases, aged from 28 to 85 years, with an average age of (61.4 ± 9.3) years. These patients were divided into two groups, with each group receiving the radiotherapy and combined immunotherapy and chemotherapy (the radiotherapy and combination group, n = 60) and combined immunotherapy and chemotherapy only (the combination group, n = 135). Then, propensity score matching (PSM) was performed to analyze the differences in prognosis between both groups before and after PSM, as well as the short-term efficacy and adverse reactions after PSM. Results:For the 195 NSCLC patients, the median follow-up time was 31.8 months, with median overall survival (OS) and median progression-free survival (PFS) recorded at 23.8 months and 9.2 months, respectively. The radiotherapy and combination group exhibited enhanced 1-, 2-, and 3-year survival rates of 78.5%, 55.9%, and 45.1%, respectively, significantly higher than the combination group (48.3%, 35.6%, and 26.6%, respectively, χ2 = 14.65, P < 0.001). Similarly, the radiotherapy and combination group displayed 1-, 2-, and 3-year PFS rates of 51.9%, 29.5%, and 22.7%, respectively, exceeding those of the combination group (30.0%, 24.5%, and 16.9%, respectively, χ2=6.09, P=0.014). After PSM, the radiotherapy and combination group manifested an objective response rate (ORR) of 60.0% (33/55) and a disease control rate (DCR) of 89.1% (49/55), which were 16.4% (9/55) and 56.4% (31/55), respectively for the combination group. These results suggested that the radiotherapy and combination group demonstrated significantly higher ORR and DCR ( χ2 = 22.18, 14.85, P<0.001). After PSM, the radiotherapy and combination group yielded 1-, 2-, and 3-year survival rates of 70.9%, 52.3%, and 41.9%, respectively, significantly than the combination group (43.6%, 29.8%, and 27.1%, respectively, χ2=8.95, P=0.003). The radiotherapy and combination group exhibited 1-, 2-, and 3-year PFS rates of 47.3%, 27.3%, and 18.7%, respectively, significantly higher than the combination group (23.6%, 17.6%, and 15.4%, respectively, χ2 = 6.71, P = 0.010). Multivariate Cox regression analysis revealed that independent factors affecting OS included clinical stage, treatment regimen, number of immunotherapy cycles, and treatment efficacy ( HR = 1.88, 2.11, 0.23, 1.79, P < 0.05). Similarly, independent factors affecting PFS consisted of treatment regimen, number of immunotherapy cycles, and treatment efficacy ( HR = 1.62, 0.37, 3.42, P <0.05). There were no statistical differences in the incidence of grade ≥ 2 bone marrow suppression (18.2% vs. 12.7%) and grade ≥ 2 pneumonia (21.8% vs. 14.5%) between both groups ( P>0.05). Conclusions:Introducing radiotherapy into combined immunotherapy and chemotherapy as first-line treatment for oligometastatic NSCLC can optimize both local and systemic disease control and significantly improve patient prognosis without increasing treatment-related adverse reactions.
6.Scleromitrion diffusum reverses epithelial-mesenchymal transi-tion of gastric mucosa in rats with gastric precancerous lesions.
Luping MA ; Xin ZUO ; Weikai ZHU ; Jiyan LI ; Yanyan ZHAO ; Jingyuan ZHANG ; Hui SHEN
Journal of Zhejiang University. Medical sciences 2025;54(3):342-349
OBJECTIVES:
To investigate the effect of Scleromitrion diffusum on gastric mucosal epithelial-mesenchymal transition (EMT) in rats with gastric precancerous lesion.
METHODS:
Fifty SD rats were randomly divided into blank control group (n=11), model control group (n=13), Scleromitrion diffusum (SD) group (n=13) and vitase group (n=13). Gastric precancerous lesion animal model was prepared by 1-methyl-3-nitro-1-nitrosoguanidine complex polyfactor method, and the drugs were administrated by gavage once a day for 6 weeks. The pathological changes of gastric mucosa were observed with hematoxylin and eosin staining, the expression of EMT marker proteins were detected with immunohistochemical staining and Western blotting.
RESULTS:
Compared with the model control group, the gastric mucosal injury was significantly attenuated in the Scleromitrion diffusum group, the mucosal tissue structure gradually recovered, the saccular expansion area was reduced, and the inflammatory infiltration was ameliorated. The expression of epithelial cadherin was higher, and the expression of neural cadherin and vimentin in the Scleromitrion diffusum group were lower than those of model control group (all P<0.05).
CONCLUSIONS
Scleromitrion diffusum can ameliorate gastric mucosal injury in rats with gastric precancerous lesion by reversing the EMT.
Animals
;
Rats
;
Rats, Sprague-Dawley
;
Epithelial-Mesenchymal Transition/drug effects*
;
Precancerous Conditions/metabolism*
;
Gastric Mucosa/metabolism*
;
Stomach Neoplasms/drug therapy*
;
Male
;
Cadherins/metabolism*
7.WNK1 Alleviates Chloride Efflux-Induced NLRP3 Inflammasome Activation and Subsequent Neuroinflammation in Early Brain Injury Following Subarachnoid Hemorrhage.
Panpan ZHAO ; Huimiao FENG ; Xinyu ZHOU ; Jingyuan ZHOU ; Fangbo HU ; Taotao HU ; Yong SUN
Neuroscience Bulletin 2025;41(9):1570-1588
The nod-like receptor family pyrin domain containing 3 (NLRP3) inflammasome plays a crucial role in the prognosis of subarachnoid hemorrhage (SAH). WNK1 kinase negatively regulates NLRP3 in various inflammatory conditions, but its role in early brain injury (EBI) after SAH remains unclear. In this study, we used an in vivo SAH model in rats/mice and AAV-WNK1 intraventricular injection to investigate its neuroprotective mechanisms. WNK1 expression was significantly reduced in SAH patient blood and SAH model brain tissue, correlating negatively with microglial activation. AAV-WNK1 alleviated brain edema, neuronal necrosis, behavioral deficits, and inflammation by inhibiting NLRP3 inflammasome activation. In hemin-stimulated BV-2 cells, WNK1 overexpression reduced NLRP3 activation and inflammatory cytokines. Chloride counteracted WNK1's inhibitory effects, and WNK1 suppressed P2X7R-induced NLRP3 activation. Mechanistically, WNK1 functioned via the OXSR1/STK39 pathway. These findings highlight WNK1 as a key regulator of intracellular chloride balance and neuroinflammation, presenting a potential therapeutic target for SAH treatment.
Animals
;
NLR Family, Pyrin Domain-Containing 3 Protein/metabolism*
;
Subarachnoid Hemorrhage/complications*
;
Inflammasomes/metabolism*
;
Rats
;
Mice
;
Neuroinflammatory Diseases/metabolism*
;
WNK Lysine-Deficient Protein Kinase 1/genetics*
;
Male
;
Humans
;
Chlorides/metabolism*
;
Mice, Inbred C57BL
;
Rats, Sprague-Dawley
;
Brain Injuries/metabolism*
;
Microglia/metabolism*
;
Protein Serine-Threonine Kinases
8.Exploration of factors influencing abnormal iodine nutrition and pregnancy outcome in pregnant women during pregnancy based on thyroid function and thyroid autoantibody analysis
Yanping JIANG ; Wei YUAN ; Shuqiong WANG ; Yongli YAO ; Wei LUO ; Kang SONG ; Xiaoxia FAN ; Lijun LIN ; Ya'nan LI ; Yanling XIE ; Lingling ZHAO ; Beibei WANG ; Fang DANG ; Jingyuan WANG ; Wenyan MA ; Peiyun FAN
The Journal of Practical Medicine 2025;41(16):2549-2555
Objective To analyze the factors influencing iodine nutritional status in pregnant women dur-ing pregnancy,based on thyroid function and thyroid autoantibody levels,and to explore the association between iodine nutritional abnormalities and pregnancy outcomes.Methods A total of 838 pregnant women who underwent routine prenatal checkups at Qinghai Provincial People's Hospital between January 2021 and June 2023 were pro-spectively enrolled in this study.All participants were followed until delivery.Seven cases were lost to follow-up,resulting in a final sample size of 831 participants.Among them,276 were in the first trimester,384 in the second trimester,and 171 in the third trimester.Data on urinary iodine concentration(UIC),urinary creatinine(UCr),thyroid function indicators,and thyroid autoantibodies were collected.Based on their iodine nutritional status,the participants were categorized into either the iodine-sufficient group or the iodine-abnormal group(including iodine-deficient,iodine-hyper-sufficient,and iodine-excessive subgroups).This study analyzed the iodine nutritional sta-tus of pregnant women during different gestational periods,compared thyroid function indices,prevalence of thy-roid diseases,and the positivity rates of thyroid peroxidase antibody(TPOAb),thyroglobulin antibody(TGAb),and thyroid-stimulating hormone receptor antibody(TRAb)among different iodine status groups.Additionally,ad-verse pregnancy outcomes were compared across groups.Multivariate logistic regression analysis was conducted to identify risk factors associated with iodine abnormalities during pregnancy,and a predictive model was developed to assess its potential predictive value.Results Among the 831 pregnant women included in the study,373 cases(44.89%)exhibited iodine sufficiency,while 458 cases(55.11%)presented with iodine abnormalities,including 282 cases of iodine deficiency,144 cases of iodine hypersufficiency,and 32 cases of iodine excess.No statistically significant differences were observed in the iodine nutritional status across different trimesters(P>0.05).The se-rum level of thyroid-stimulating hormone(TSH)was significantly higher in the iodine abnormal group compared to the iodine sufficient group(P<0.05).Additionally,the iodine abnormal group demonstrated higher positivity rates of TPOAb alone,TGAb,and TRAb,as well as increased incidence of thyroid dysfunction and total adverse pregnancy outcomes compared to the iodine sufficient group(all P<0.05).These adverse indicators were also sig-nificantly elevated in the iodine-deficient,iodine super-sufficient,and iodine overdose subgroups compared to the iodine sufficient group(P<0.05).Elevated serum TSH levels and the presence of TPOAb,TGAb,and TRAb were identified as risk factors for iodine abnormalities during pregnancy(P<0.05).The predictive model con-structed for identifying iodine abnormalities in pregnant women demonstrated an area under the curve(AUC)of 0.876,with a sensitivity of 72.27%and a specificity of 89.01%.Conclusions The prevalence of iodine nutritional abnormalities among pregnant women during pregnancy was high,with most cases presenting iodine deficiency.These abnormalities were associated with thyroid function,thyroid autoimmunity,and pregnancy outcomes,but showed no significant correlation with gestational age.Furthermore,the prediction model developed based on iden-tified risk factors demonstrated effective performance in predicting iodine nutritional abnormalities during preg-nancy.
9.Effect of the treatment sequence of chemoradiotherapy combined with immunotherapy as first-line therapy on the prognosis of patients with stage III non-small cell lung cancer
Shuguang LI ; Jinrui XU ; Luanying WU ; Jingyuan WEN ; Xiaohan ZHAO ; Chunyang SONG ; Ke YAN ; Youmei LI ; Shuchai ZHU ; Wenbin SHEN
Chinese Journal of Radiation Oncology 2025;34(12):1191-1198
Objective:To investigate the impact of different treatment sequences of immunotherapy combined with chemoradiotherapy (CRT) as the first-line therapy on the prognosis of patients with stage III non-small cell lung cancer (NSCLC).Methods:Clinical data of 112 patients with stage III NSCLC treated at the Fourth Hospital of Hebei Medical University from January 2019 to December 2021 were retrospectively collected, with follow-up continued until December 31, 2023. According to the sequence of CRT and immune checkpoint inhibitors (ICIs) therapy, patients were divided into 3 groups: ICIs simultaneous with CRT (sICR, n=20), chemotherapy combined with ICIs followed by CRT (CI-CR, n=53), and CRT followed by consolidative ICIs (CR-I, n=39). Analyses were performed before and after propensity score matching (PSM). Survival outcomes were assessed using the Kaplan-Meier method and compared by log-rank tests, and prognostic factors were identified through multivariate Cox regression analysis. Results:The median overall survival (OS) and progression-free survival (PFS) for the entire cohort were 30.1 months (95% CI: 21.4-38.9) and 12.8 months (95% CI: 9.14-16.1), respectively. Before PSM: No significant differences were observed in OS and PFS among the 3 groups ( χ2=0.18, 1.05; P=0.669, 0.305). However, OS in the sICR and CR-I groups was significantly better than that in the CI-CR group ( χ2=4.43, 6.11; P=0.035, 0.013). After PSM: Each group included 17 patients. There were no significant differences in OS or PFS among the 3 groups ( χ2=2.50, 2.74; P=0.287, 0.254), and pairwise comparisons also showed no significant differences. Multivariate Cox regression analysis revealed that clinical stage ( HR=3.392, 95% CI: 1.215-9.470, P=0.020), number of immunotherapy cycles ( HR=0.312, 95% CI: 0.100-0.972, P=0.044), and treatment response ( HR=6.566, 95% CI: 1.705-25.284, P=0.006) were independent prognostic factors for OS. After PSM, the numbers of patients with grade ≥2 treatment-related adverse events were 13 in the sICR group, 10 in the CI-CR group, and 9 in the CR-I group, with no significant differences among them ( χ2=2.181, P=0.336). Conclusions:First-line immunotherapy combined with chemoradiotherapy showed favorable clinical efficacy in locally advanced NSCLC compared to other studies, but the treatment sequence did not significantly affect prognosis. It is recommended that immunotherapy be administered for at least four cycles.
10.Analysis of the efficacy of lamb′s tripe extract and vitamin B 12 capsule on chronic atrophic gastritis at different sites
Dongdong XIA ; Huahong XIE ; Bo JIANG ; Hong XU ; Zhanguo NIE ; Chengwei TANG ; Qiang GUO ; Xiaoping ZOU ; Shuisheng SHI ; Tao SUN ; Shourong SHEN ; Guoqing LI ; Xiaozhong GUO ; Xiaoyan ZHAO ; Jiaming QIAN ; Weixing CHEN ; Guiying ZHANG ; Aijun LIAO ; Jingyuan FANG ; Daiming FAN ; Kaichun WU
Chinese Journal of Digestion 2025;45(3):162-168
Objective:To evaluate the efficacy of lamb′s tripe extract and vitamin B 12 capsule (LTEVB 12C) on chronic atrophic gastritis (CAG) at different locations (antrum lesser curvature, antrum greater curvature, gastric angle, corpus lesser curvature, and corpus greater curvature). Methods:From August 2011 to January 2013, 715 patients with CAG in a multicenter, randomized, double-blind, placebo-controlled trial were enrolled from 16 tertiary first-class hospitals across the country, including the First Affiliated Hospital of Air Force Medical University, Nanfang Hospital of Southern Medical University, the First Hospital of Jilin University, West China Hospital of Sichuan University, etc., there were 476 cases in the LTEVB 12C group and 239 cases in the placebo group. The patients of the LTEVB 12C group received LTEVB 12C, and the patients of placebo group received LTEVB 12C mimetic, all the medications were taken 3 capsules each time and 3 times a day after meals, and the treatment course of 2 groups were both 6 months. The efficacy evaluation criteria included the effective rate (a decrease of ≥1 in histopathological score compared with baseline after 6 months of treatment) and the reversal rate (a decrease of ≥ 2 in histopathological score compared with baseline after 6 months of treatment in the patients with moderate to severe CAG). The impact of lesion sites on the therapeutic effects of LTEVB 12C was analyzed by logistic regression analysis. The two-way unordered Cochran-Mantel-Haenszel chi-square test considering the center effect and Pearson chi-square test were used for statistical analysis. Results:The effective rates of chronic inflammation at the antrum greater curvature and corpus greater curvature (23.3%, 110/473 vs. 13.0%, 31/239; 20.3%, 96/472 vs. 12.6%, 30/239), the effective rates of atrophy at the antrum lesser curvature, antrum greater curvature, gastric angle, corpus lesser curvature, and the corpus greater curvature (27.0%, 118/437 vs. 15.7%, 34/216; 29.2%, 126/432 vs. 18.5%, 38/205; 27.8%, 121/435 vs. 16.7%, 36/216; 32.5%, 127/391 vs. 19.8%, 37/187; 33.0%, 119/361 vs. 21.8%, 39/179), and the effective rates of intestinal metaplasia at the antrum lesser curvature, antrum greater curvature, gastric angle, and the corpus lesser curvature (45.0%, 112/249 vs. 29.8%, 31/104; 53.8%, 86/160 vs. 33.9%, 21/62; 45.8%, 103/225 vs. 24.0%, 25/104; 51.9%, 83/160 vs. 28.3%, 17/60) of the LTEVB 12C group were all higher than those of the placebo group, and the differences were statistically significant ( χ2=10.76, 6.39, 9.69, 7.91, 11.05, 9.62, 8.57, 5.20, 7.11, 12.45, and 6.73; all P<0.05). The reversal rates of chronic inflammation at the corpus lesser curvature and corpus greater curvature (5.2%, 12/231 vs. 0, 0/123; 4.7%, 8/170 vs. 0, 0/88), the reversal rates of atrophy at the antrum lesser curvature, antrum greater curvature, corpus lesser curvature, and the corpus greater curvature (6.8%, 22/323 vs. 1.3%, 2/151; 9.2%, 29/315 vs. 1.4%, 2/144; 14.2%, 38/267 vs. 2.5%, 3/121; 20.8%, 35/168 vs. 5.8%, 4/69), and the reversal rates of intestinal metaplasia at the antrum lesser curvature, antrum greater curvature, gastric angle, and the corpus lesser curvature (29.8%, 39/131 vs. 9.1%, 4/44; 41.0%, 32/78 vs. 12.5%, 3/24; 33.3%, 44/132 vs. 4.8%, 3/63; 50.0%, 37/74 vs. 8.7%, 2/23) of the LTEVB 12C group were all higher than those of the placebo group, and the differences were statistically significant ( χ2=6.58, 5.12, 5.60, 8.61, 11.43, 6.59, 7.30, 4.95, 15.92, 7.62; all P<0.05). There were no statistically significant differences in the effective rates and reversal rates of active inflammation at different locations between the LTEVB 12C group and the placebo group (all P>0.05). The results of logistic regression analysis (taking the antrum lesser curvature as the reference) further confirmed that the reversal rates of chronic inflammation ( OR=0.22, 95% confidence interval (95% CI): 0.07 to 0.67; OR=0.24, 95% CI: 0.07 to 0.80), atrophy ( OR=0.28, 95% CI: 0.16 to 0.49; OR=0.28, 95% CI: 0.16 to 0.49), and intestinal metaplasia ( OR=0.42, 95% CI: 0.24 to 0.77; OR=0.20, 95% CI: 0.08 to 0.52) at the corpus lesser curvature and corpus greater curvature were all higher than those at the antrum lesser curvature, and the differences were statistically significant (all P<0.05). There were no statistically siginificant differences in the reversal rates of the aforementioned pathological features between the antrum greater curvature, gastric angle, and the antrum lesser curvature (all P>0.05). Conclusion:LTEVB 12C can achieve good efficacy in the treatment of CAG, and the chronic inflammation, atrophy, and intestinal metaplasia at multiple locations are improved, especially at the corpus lesser curvature and the corpus greater curvature.

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