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.Sex-specific effects of Semen Cuscutae aqueous extract on behavior, proteomics, and gut microbiota in rats
Zihan ZHAO ; Yaling YANG ; Junhui ZHOU ; Jie REN ; Zhiqiang LUO ; Ruibin BAI ; Jian YANG
Science of Traditional Chinese Medicine 2026;4(1):50-61
Background: Sex-based differences often influence the therapeutic efficacy and safety of medications. Semen Cuscutae is a traditional tonic botanical drug with sex-specific characteristics, traditionally indicated for conditions such as impotence (exclusive to males) and restless fetus (exclusive to pregnant females). However, most existing studies have focused on a single sex. Objective: To evaluate the sex-specific biological effects of Semen Cuscutae in rats and explore its molecular mechanisms, with the aim of uncovering its pharmacological characteristics through a multiomics approach. Methods: A traditional aqueous extract of Semen Cuscutae (SCA) was used as the experimental material. Forty adult Sprague-Dawley rats (equal numbers of males and females) were randomly divided into 4 groups: male control, male SCA treatment (240 mg/kg), female control, and female SCA treatment (240 mg/kg), with 10 rats in each group. The biological effects were comprehensively evaluated using a combination of open field test, biochemical analyses, proteomics, and gut microbiota profiling. Results: As a tonic botanical drug, SCA appeared to directly affect the mental and behavioral state of rats. It significantly altered the time spent by rats in the center area during the open field test, showing a sex-dependent reversal of behaviors. Proteomic analysis of brain tissue identified 624 differentially expressed proteins across the groups, with 10 key differentially expressed proteins related to sex differences, including fibroblast growth factor receptor 3, transcription elongation factor A protein-like 1, 40S ribosomal protein S25, neural cell adhesion molecule, and anion exchange protein 2 (SLC4A2). Enrichment analysis revealed that in male rats, SCA upregulated proteins involved in biological processes such as ribosome function and energy derivation, supporting protein synthesis and enhancing energy supply, showing an overall gain effect. In contrast, in female rats, SCA downregulated proteins associated with processes such as positive regulation of target of rapamycin (TOR) signaling and vesicle transport, suggesting suppression of neuronal signaling and material transport, indicative of a shift toward a more restrained physiological state. Furthermore, SCA reduced gut microbiota diversity in female rats but increased it in males, including the abundance of Akkermansia, which may serve as a crucial mediator. Conclusion: Overall, the biological effects of SCA differ significantly between male and female rats, with evidence suggesting greater health benefits in males. These findings help elucidate the scientific basis of its traditional applications and provide guidance for the precise application of SCA as a functional health food.
3.Annual review of clinical research on lung transplantation worldwide in 2025
Linxi LIU ; Jingchen XU ; Rui YANG ; Xinchen JIANG ; Ting DENG ; Ling ZHOU ; Kaiyue YANG ; Xiaohan JIN ; Zhiqiang DENG ; Xiangyun ZHENG ; Dong TIAN
Organ Transplantation 2026;17(4):574-581
Lung transplantation is currently the only effective treatment for end-stage lung disease. However, the field of lung transplantation still faces numerous challenges, including donor shortage, primary graft dysfunction, rejection, infection and others. In 2025, scholars worldwide have made remarkable progress in clinical research on lung transplantation. This article systematically reviews the cutting-edge developments in clinical research on lung transplantation in 2025, focusing on the application of novel evaluation tools in donor lung screening, optimization of lung perfusion techniques, exploration of extracorporeal membrane oxygenation and robot-assisted minimally invasive surgery, as well as mechanistic research and intervention strategies for primary graft dysfunction, acute kidney injury and chronic lung allograft dysfunction. Meanwhile, hot topics such as the management of special populations, prevention and control of postoperative infections, and improvement of quality of life are summarized. This review aims to conclude the important annual research findings and provide references for the clinical practice and research development of lung transplantation in China.
4.Vonoprazan-based quadruple therapy is non-inferior to esomeprazole-based quadruple therapy for Helicobacter pylori eradication: A multicenter, double-blind, randomized, phase 3 study.
Zhiqiang SONG ; Qin DU ; Guoxin ZHANG ; Zhenyu ZHANG ; Fei LIU ; Nonghua LU ; Liqun GU ; Shingo KURODA ; Liya ZHOU
Chinese Medical Journal 2025;138(22):2938-2946
BACKGROUND:
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.
METHODS:
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 13 C urea breath test at 4 weeks after treatment. The non-inferiority margin was at 10%.
RESULTS:
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.
CONCLUSION:
Vonoprazan was found to be well-tolerated and non-inferior to esomeprazole for eradicating H. pylori in patients from China.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT04198363.
Humans
;
Esomeprazole/therapeutic use*
;
Double-Blind Method
;
Helicobacter Infections/drug therapy*
;
Male
;
Female
;
Middle Aged
;
Helicobacter pylori/pathogenicity*
;
Pyrroles/therapeutic use*
;
Sulfonamides/therapeutic use*
;
Adult
;
Clarithromycin/therapeutic use*
;
Amoxicillin/therapeutic use*
;
Aged
;
Anti-Bacterial Agents/therapeutic use*
;
Pyrrolidines/therapeutic use*
;
Drug Therapy, Combination
;
Proton Pump Inhibitors/therapeutic use*
5.A critical role for Phocaeicola vulgatus in negatively impacting metformin response in diabetes.
Manyun CHEN ; Yilei PENG ; Yuhui HU ; Zhiqiang KANG ; Ting CHEN ; Yulong ZHANG ; Xiaoping CHEN ; Qing LI ; Zuyi YUAN ; Yue WU ; Heng XU ; Gan ZHOU ; Tao LIU ; Honghao ZHOU ; Chunsu YUAN ; Weihua HUANG ; Wei ZHANG
Acta Pharmaceutica Sinica B 2025;15(5):2511-2528
Metformin has been demonstrated to attenuate hyperglycaemia by modulating the gut microbiota. However, the mechanisms through which the microbiome mediates metformin monotherapy failure (MMF) are unclear. Herein, in a prospective clinical cohort study of newly diagnosed type 2 diabetes mellitus (T2DM) patients treated with metformin monotherapy, metagenomic sequencing of faecal samples revealed that Phocaeicola vulgatus abundance was approximately 12 times higher in nonresponders than in responders. P. vulgatus rapidly hydrolysed taurine-conjugated bile acids, leading to ceramide accumulation and reversing the improvements in glucose intolerance conferred by metformin in high-fat diet-fed mice. Interestingly, C22:0 ceramide bound to mitochondrial fission factor to induce mitochondrial fragmentation and impair hepatic oxidative phosphorylation in P. vulgatus-colonized hyperglycaemic mice, which could be exacerbated by metformin. This work suggests that metformin may be unsuitable for P. vulgatus-rich T2DM patients and that clinicians should be aware of metformin toxicity to mitochondria. Suppressing P. vulgatus growth with cefaclor or improving mitochondrial function using adenosylcobalamin may represent simple, safe, effective therapeutic strategies for addressing MMF.
6.Investigation of 90Sr radioactivity levels in drinking water and food around the Qinshan Nuclear Power Plant from 2012 to 2022
Lei ZHOU ; Yiyao CAO ; Hua ZOU ; Rui WANG ; Hong REN ; Peng WANG ; Shunfei YU ; Zhiqiang XUAN ; Zhongjun LAI
Chinese Journal of Radiological Medicine and Protection 2025;45(5):449-453
Objective:To investigate the radioactivity levels and variation trends of 90Sr in drinking water and food around the Qinshan Nuclear Power Plant in operation. Methods:From 2012 to 2022, the source, factory, and tap water was collected within 30 km around the Qinshan Nuclear Power Plant during the wet and dry seasons (i.e., May and October, respectively) each year to determine the 90Sr concentration in water. According to the dietary habits of local residents, four kinds of food, including rice, cabbage, mullet, and crucian carp, were collected to determine and analyze the 90Sr radioactivity concentration in food using the bis-(2-ethylhexyl) phosphoric acid extraction chromatographic method. Results:From 2012 to 2022, the 90Sr radioactivity concentrations in the source, factory, and tap water around the Qinshan Nuclear Power Plant ranged from 3.73 to 11.89 mBq/L, 2.95 to 9.83 mBq/L, and 3.12 to 8.70 mBq/L, respectively, showing nonsignificant fluctuations over the years. The 90Sr radioactivity concentrations in rice, cabbage, mullet, and crucian carp ranged from 0.02 to 0.46 Bq/kg (dry weight), 0.26 to 1.07 Bq/kg (fresh weight), 0.38 to 1.05 Bq/kg (fresh weight), and 0.08 to 1.32 Bq/kg (fresh weight), respectively, all below the national standard limits. Conclusions:From 2012 to 2022, the 90Sr radioactivity levels in drinking water and food around the Qinshan Nuclear Power Plant were at the background level and remained stable.
7.Metabolic engineering of Escherichia coli for the biosynthesis of O-acetyl-L-homoserine.
Lianggang HUANG ; Feng GAO ; Nuoran XU ; Junping ZHOU ; Kun NIU ; Bo ZHANG ; Zhiqiang LIU ; Yuguo ZHENG
Chinese Journal of Biotechnology 2025;41(1):256-270
O-acetyl-L-homoserine (OAH) is a promising platform compound for the production of L-methionine and other valuable compounds, while its low yield and low conversion rate limit the industrial application. To solve these problems, we constructed a strain for high OAH production with the previously constructed L-homoserine producer Escherichia coli HS33 as the chassis by systematic metabolic engineering. Firstly, PEP accumulation, pyruvate utilization, and OAH synthesis pathway (overexpressing aspB, aspA, and thrAC1034T) were enhanced to obtain an initial strain accumulating 13.37 g/L OAH. Subsequently, the co-factor synthesis genes were integrated to supply reducing power and energy, which increased the yield to 15.79 g/L. The OAH yield of the engineered strain OAH28 was further increased to 17.49 g/L by strengthening the acetic acid reuse pathway, improving the supply of acetyl-CoA, and regulating the expression of MetX from different sources. Finally, in a 5 L fermenter, OAH28 achieved an OAH titer of 47.12 g/L, with a glucose conversion rate of 32% and productivity of 0.59 g/(L·h). The results lay a foundation for increasing the OAH production by metabolic engineering and give insights into the industrial production of OAH.
Metabolic Engineering/methods*
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Escherichia coli/genetics*
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Homoserine/biosynthesis*
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Fermentation
8.Preparation of multi-layer compound microcapsules and their application in self-healing of concrete cracks.
Jianmiao XU ; Yuanyuan ZHOU ; Feng CHENG ; Zhiqiang LIU
Chinese Journal of Biotechnology 2025;41(1):448-460
Concrete is widely used in building construction, civil engineering, roads, bridges, etc., but concrete cracking remains a major issue in the engineering industry. To develop an effective and feasible concrete repair technology, this study combined microbial and microencapsulation technologies to prepare a multi-layer compound microcapsule using the piercing method. The formulation and drying method of microcapsules were optimized by taking their embedding rate and mechanical properties as evaluation criteria. The calcium transcrystallization process of microcapsules and the crystal form of products were characterized and compared with the calcium transcrystallization process in free cells. Finally, the effects of microcapsule incorporation on mechanical properties, impermeability, and self-healing performance of concrete specimens were then tested. The results showed that the air-dried multi-layer compound microcapsules, formulated with 1.0% wet cells of Bacillus cereus, 1.5% calcium chloride, 3.0% sodium alginate, 5.0% nutrients, 6.0% glycerol, 0.6% chitosan, and 2.0% urea, achieved an embedding rate of 95.3%, a rupture force of 60.0 N and a hardness of 150.8 N. These microcapsules can transform from a solid state to a flowing colloidal state when the microorganisms inside undergo a calcium formation reaction. Both the microcapsules and free cells produced stable calcite crystal forms of calcium carbonate through the calcium conversion reaction, with the microcapsules producing more uniform-sized particles, which are more conducive to accumulation in cracks, thereby enhancing the stability of repair. When microcapsules were incorporated into the concrete specimen at a content of 0.45%, the flexural strength of the specimen increased by 17.3%, and the compressive strength increased by 12.3%. In the water impermeability test, specimens with microcapsules demonstrated better impermeability compensation for the cement concrete than those with free cells. The self-healing effect of cracks proved that multi-layer compound microcapsules could completely repair cracks up to 0.7 mm wide, and a repair rate of 95% for 0.8 mm wide cracks. In this study, a multi-layer compound microcapsule was developed to protect microorganisms in concrete and provide nutrients required for their growth, which provided a new idea for microbial induced calcium carbonate precipitation in concrete crack repair.
Construction Materials
;
Capsules/chemistry*
;
Bacillus cereus/metabolism*
;
Alginates/chemistry*
9.Exploration and practice of teaching reform in Synthetic Biology.
Bo ZHANG ; Lianggang HUANG ; Aiping PANG ; Zheyan WU ; Junping ZHOU ; Xue CAI ; Lijuan WANG ; Kun NIU ; Liqun JIN ; Zhiqiang LIU ; Yuguo ZHENG
Chinese Journal of Biotechnology 2025;41(8):3311-3317
Synthetic biology is a crucial tool for the development of the bio-industry and bio-economy, representing a significant aspect of new quality productive forces. As a core course for graduate students in bioengineering, Synthetic Biology plays a vital role in ensuring the supply of essential talents for the development of the bio-industry in the new era. To better serve regional economic development and provide high-level talents for China's progress in the bio-industry, we analyzed typical issues encountered in the past teaching activities, set up a multi-disciplinary teaching team, optimized the course contents, adjusted the teaching mode, and mobilized students' learning interest. With the application of scientific research project as the starting point, we guided students to think and discuss deeply through the simulation of application writing and project defense, which improved students' critical thinking and innovative thinking. With industrialization as a focus, we explored a new training model combining production, education, and research through the joint practice base of the university and enterprises introduced typical cases of biomanufacturing to encourage students to engage in scientific research. The teaching reform significantly enhances the comprehensive abilities and national sentiments of graduate students. This paper hopes to serve as a reference for colleagues engaged in teaching in this field.
Synthetic Biology/education*
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Teaching
;
China
;
Humans
10.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.

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