1.Research progress on prevention and treatment of hepatocellular carcinoma with traditional Chinese medicine based on gut microbiota.
Rui REN ; Xing YANG ; Ping-Ping REN ; Qian BI ; Bing-Zhao DU ; Qing-Yan ZHANG ; Xue-Han WANG ; Zhong-Qi JIANG ; Jin-Xiao LIANG ; Ming-Yi SHAO
China Journal of Chinese Materia Medica 2025;50(15):4190-4200
Hepatocellular carcinoma(HCC), the third leading cause of cancer-related death worldwide, is characterized by high mortality and recurrence rates. Common treatments include hepatectomy, liver transplantation, ablation therapy, interventional therapy, radiotherapy, systemic therapy, and traditional Chinese medicine(TCM). While exhibiting specific advantages, these approaches are associated with varying degrees of adverse effects. To alleviate patients' suffering and burdens, it is crucial to explore additional treatments and elucidate the pathogenesis of HCC, laying a foundation for the development of new TCM-based drugs. With emerging research on gut microbiota, it has been revealed that microbiota plays a vital role in the development of HCC by influencing intestinal barrier function, microbial metabolites, and immune regulation. TCM, with its multi-component, multi-target, and multi-pathway characteristics, has been increasingly recognized as a vital therapeutic treatment for HCC, particularly in patients at intermediate or advanced stages, by prolonging survival and improving quality of life. Recent global studies demonstrate that TCM exerts anti-HCC effects by modulating gut microbiota, restoring intestinal barrier function, regulating microbial composition and its metabolites, suppressing inflammation, and enhancing immune responses, thereby inhibiting the malignant phenotype of HCC. This review aims to elucidate the mechanisms by which gut microbiota contributes to the development and progression of HCC and highlight the regulatory effects of TCM, addressing the current gap in systematic understanding of the "TCM-gut microbiota-HCC" axis. The findings provide theoretical support for integrating TCM with western medicine in HCC treatment and promote the transition from basic research to precision clinical therapy through microbiota-targeted drug development and TCM-based interventions.
Humans
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Gastrointestinal Microbiome/drug effects*
;
Carcinoma, Hepatocellular/microbiology*
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Liver Neoplasms/microbiology*
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Drugs, Chinese Herbal/administration & dosage*
;
Animals
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Medicine, Chinese Traditional
2.Orthopedic manipulation combined with percutaneous reduction and Kirschner wire internal fixation for Sanders typeⅡand Ⅲ calcaneal fractures.
Feng DAI ; Jin-Tao LIU ; Zhi-Gang ZHANG ; Xue-Qiang SHEN ; Li-Ming WU ; Peng-Fei YU ; Hong JIANG
China Journal of Orthopaedics and Traumatology 2025;38(3):306-310
OBJECTIVE:
To explore clinical effects of bone setting manipulation combined with pry reduction and Kirschner needle internal fixation in treating SandersⅡ-Ⅲ calcaneal fracture.
METHODS:
Clinical data of 52 patients with types Sanders Ⅱand Ⅲ calcaneal fracture (foot) treated with bone-setting manipulation combined with pry reduction and Kirscher needle internal fixation from July 2017 to July 2019 were retrospectively analyzed, including 43 males and 9 females, aged from 31 to 72 years old with an average of (50.83±10.48) years old; 15 patients with Sanders typeⅡ and 37 patients with Sanders type Ⅲ. The changes of Bühler angle, Gissane angle, calcaneus width and calcaneus height before operation and 24 months after operation were compared, and Maryland foot function score was performed to evaluate clinical effects.
RESULTS:
All patients were followed up from 24 to 60 months with an average of (41.50±9.86)months. The fracture healed normally and the healing time was (11.00±0.95) weeks. Bühler angle, Gissane angle, calcaneal bone width and calcaneal bone height were increased from (16.37±8.36)°, (96.27±9.62)°, (46.82±4.67) mm, (38.41±3.58) mm before operation to (31.48±8.24)°, (111.62±8.69)°, (42.06±4.83) mm, (44.21±3.82) mm at 24 months after operation, and the difference were statistically significant (P<0.01). Postoperative Maryland score at 24 months was (93.04±8.83), 40 patients got excellent result, 7 good and 5 fair.
CONCLUSION
Orthopedic manipulation combined with percutaneous reduction and Kirschner wire internal fixation could significantly improve Bühler angle, Gissane angle, width, and height of Sanders typeⅡ and Ⅲ calcaneal fractures, and the curative effect is satisfactory.
Humans
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Male
;
Female
;
Calcaneus/surgery*
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Middle Aged
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Fracture Fixation, Internal/methods*
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Adult
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Aged
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Fractures, Bone/therapy*
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Retrospective Studies
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Bone Wires
;
Manipulation, Orthopedic/methods*
3.Experimental study on autologous osteochondral transplantation in the treatment of recurrent anterior dislocation of the shoulder joint with articular cartilage defect in rabbits.
Tao LIU ; Sen FANG ; Fang-Xiang LIU ; Ming-Tao ZHANG ; Zhi-Tao YANG ; Bo-Rong ZHANG ; Jun-Wen LIANG ; Xi-Hao WANG ; Jin JIANG ; Xiang-Dong YUN
China Journal of Orthopaedics and Traumatology 2025;38(6):619-625
OBJECTIVE:
To explore clinical effect of autologous osteochondral transplantation (AOT) in the treatment of recurrent anterior dislocation of the shoulder joint with glenoid cartilage defect in rabbits by establishing a model of recurrent anterior dislocation of the shoulder joint with < 20% glenoid cartilage defect in rabbits.
METHODS:
Twenty-four male New Zealand white rabbits, aged 6-month-old, weighed (2.69±0.17) kg were selected. The labrum of shoulder joint of rabbits was artificially destroyed to establish a model of recurrent anterior dislocation of shoulder joint with cartilage defect. They were divided into AOT surgery group and simple suture group, with 12 rabbits in each group. AOT group were underwent AOT surgery, while simple suture group was treated with simple Bankart suture for recurrent shoulder joint dislocation. At 6 and 12 weeks after operation, 6 rabbits between two groups were sacrificed for sampling. The dietary conditions, activity conditions, mental states of rabbits and healing conditions of grafts in the specimens were observed and compared between two groups. HE staining was used to observe cell creep, cell morphology, inflammatory cell infiltration, fibrochondrocytes and their arrangement. Masson staining was used to observe the formation and arrangement of collagen fibers; Safrane-green staining was used to observe the regeneration of articular cartilage, subchondral bone and bone tissue. Bone mineral density (BMD), bone volume (BV) and trabecular thickness (Tb.Th) between two groups were measured by Micro-CT to evaluate the remodeling of shoulder glenoid bone defects by autologous osteochondral cartilage.
RESULTS:
After different surgical interventions were carried out in both groups of rabbits, at 6 weeks after the operation, the abduction, extension, internal rotation and external rotation of the shoulder joint on the operated side showed limited range of motion compared with the contralateral side, while adduction and forward flexion showed no obvious abnormalities compared with the contralateral side. At 12 weeks after operation, the range motion of tshoulder joints in both groups of rabbits had returned to the state before modeling. The effects of HE staining, Masson staining and safrane-green staining at 12 weeks after operation in both groups were stronger than the staining results at 6 weeks after operation. Moreover, the results of HE staining, Masson staining and safranin fixation green staining in AOT group at 6 and 12 weeks after operation were all higher than those in simple suture group. Micro-CT scan results at 6 and 12 weeks after operation showed that BMD (0.427±0.014), (0.466±0.032) g·cm-3, BV(116.171±3.527), (159.327±3.500) mm3, and Tb.Th (0.230±0.006), (0.285±0.009) mm in AOT group, which were higher than those of simple suture group in BMD(0.358±0.011), (0.384±0.096) g·cm-3, BV(72.657±3.903), (118.713±3.860) mm3, and Tb.Th(0.204±0.009), (0.243±0.007) mm;and the differences were statistically significant (P<0.05).
CONCLUSION
AOT procedure could effectively promote osteogenesis and fibrocartilage regeneration in the cartilage defect area of the shoulder glenoid <20%, which is conducive to reshaping the structure of the shoulder glenoid.
Animals
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Rabbits
;
Male
;
Transplantation, Autologous
;
Cartilage, Articular/injuries*
;
Shoulder Dislocation/physiopathology*
;
Bone Transplantation
;
Shoulder Joint/surgery*
4.Comparative study on lengthened proximal femoral nail antirotation and InterTan in the treatment of subtrochanteric femur fractures in the elderly.
Zhen-Shan WANG ; Ming-Cong DING ; Jin JIANG ; Jing-Sheng LIU ; Tong-Qun YANG
China Journal of Orthopaedics and Traumatology 2025;38(7):662-667
OBJECTIVE:
To investigate the clinical efficacy of lengthened proximal femoral nail antirotation (PFNA) and InterTan in the treatment of subtrochanteric femur fractures in the elderly.
METHODS:
A retrospective analysis was performed on the data of 65 elderly patients diagnosed with subtrochanteric femoral fractures who met the inclusion criteria between October 2016 and January 2022. The enrolled patients were categorized into two groups according to the type of internal fixation used: the lengthened proximal femoral nail antirotation(PFNA) group and the InterTan group. There were 32 patients in the PFNA group, comprising 20 males and 12 females, with ages ranging from 60 to 85 years old with an average of (69.3±6.7 ) years old. Among these patients, 15 patients resulted from traffic accidents and 17 patients were caused by falls. According to the Seinsheimer classification system, there were 11 patients as type Ⅱ, 14 patients as type Ⅲ, 6 patients as type Ⅳ, and 1 patient as type Ⅴ. The InterTan group comprised 33 patients, including 20 males and 13 females, aged from 60 to 85 years old with an average of (69.8±7.8 ) years old. Of these, 15 patients resulted from traffic accidents, while 18 patients were caused by falls. According to the Seinsheimer classification system, 10 patients as type Ⅱ, 15 patients as type Ⅲ, 7 patients as type Ⅳ, and 1 patient as type Ⅴ. The intraoperative blood loss, operative duration, and fracture healing time were recorded and compared between two groups. The quality of fracture reduction was assessed using Chang's criteria. Additionally, the Harris hip score was utilized to evaluate hip function in both groups at 3 months postoperatively and at the final follow-up.
RESULTS:
All patients were followed up for a period ranging from 10 to 20 months with an average of (14.6±4.5) months. No statistically significant differences were observed between two groups in terms of operation time, intraoperative blood loss, quality of fracture reduction, or reduction methods (P>0.05). Three months after the surgery, the Harris hip score in the InterTan group was 80.0(78.0, 83.5) points, which was significantly higher than that in the PFNA group, which recorded a score of 77.5(75.0, 81.8) points. This difference was statistically significant (P<0.05). At the final follow-up, the Harris hip score in the InterTan group was 80.0(76.5, 87.0), while that in the PFNA group was 78.0(74.3, 82.8). No statistically significant difference was observed between two groups (P>0.05).
CONCLUSION
The use of lengthened PFNA and InterTan in the treatment of elderly subtrochanteric femur fractures can both achieve good treatment results, with the advantages of simple operation, firm fixation, and low failure rate of internal fixation. The lengthened InterTan can achieve better hip function than PFNA.
Humans
;
Male
;
Female
;
Aged
;
Aged, 80 and over
;
Bone Nails
;
Retrospective Studies
;
Hip Fractures/surgery*
;
Middle Aged
;
Fracture Fixation, Intramedullary/instrumentation*
;
Fracture Fixation, Internal/methods*
;
Femoral Fractures/surgery*
5.Comparative efficacy of two hemopurification filters for treating intra-abdominal sepsis: A retrospective study.
Ye ZHOU ; Ming-Jun LIU ; Xiao LIN ; Jin-Hua JIANG ; Hui-Chang ZHUO
Chinese Journal of Traumatology 2025;28(5):352-360
PURPOSE:
To compare the efficacy of continuous renal replacement therapy (CRRT) using either oXiris or conventional hemopurification filters in the treatment of intra-abdominal sepsis.
METHODS:
We conducted a retrospective analysis of septic patients with severe intra-abdominal infections admitted to our hospital from October 2019 to August 2023. Patients who meet the criteria for intra-abdominal sepsis based on medical history, symptoms, physical examination, and laboratory/imaging findings were included.
EXCLUSION CRITERIA:
pregnancy, terminal malignancy, prior CRRT before intensive care unit admission, pre-existing liver or renal failure. Heart rate (HR), mean arterial pressure, oxygenation index, lactic acid level (Lac), platelet count (PLT), neutrophil percentage, serum levels of procalcitonin, C-reactive protein, interleukin (IL)-6, norepinephrine dosage, acute physiology and chronic health evaluation II (APACHE II), and sequential organ failure assessment (SOFA) scores before and after 24 h and 72 h of treatment, as well as ventilator use time, hemopurification treatment time, intensive care unit and hospital lengths of stay, and 14-day and 28-day mortality were compared between patients receiving CRRT using either oXiris or conventional hemofiltration. Statistical analysis was performed using SPSS Statistics 26.0 software, including the construction of predictive models via logistic regression equations and repeated measures ANOVA.
RESULTS:
Baseline values including time to antibiotic administration, time to source control, and time to initiation of CRRT were similar between the 2 groups (all p>0.05). Patients receiving conventional CRRT exhibited significant changes in HR but of none of the other indexes at the 24 h and 72 h time points (p=0.041, p=0.026, respectively). The oXiris group showed significant improvements in HR, Lac, IL-6, and APACHE II score 24 h after treatment (p<0.05); after 72 h, all indexes were improved except PLT (all p<0.05). Intergroup comparison disclosed significant differences in HR, Lac, norepinephrine dose, APACHE II, SOFA, neutrophil percentage, and IL-6 after 24 h of treatment (p<0.05). Mean arterial pressure, serum levels of procalcitonin, C-reactive protein, SOFA score, and norepinephrine dosage were similar between the 2 groups at 24 h (p>0.05). Except for HR, oxygenation index, and PLT, post-treatment change rates of △ (%) were significantly greater in the oXiris group (p < 0.05). Duration of ventilator use, CRRT time, and intensive care unit and hospital lengths of stay were similar between the 2 groups (p>0.05). The 14-day mortality rates of the 2 groups were similar (p=0.091). After excluding patients whose CRRT was interrupted, 28-day mortality was significantly lower in the oXiris than in the conventional group (25.0% vs. 54.2%; p=0.050). The 28-day mortality rate increased by 9.6% for each additional hour required for source control and by 21.3% for each 1-point increase in APACHE II score.
CONCLUSIONS
In severe abdominal infections, the oXiris filter may have advantages over conventional CRRT, which may provide an alternative to clinical treatment. Meanwhile, early active infection source control may reduce the case mortality rate of patients with severe abdominal infections.
Humans
;
Retrospective Studies
;
Female
;
Male
;
Middle Aged
;
Sepsis/mortality*
;
Aged
;
Adult
;
Continuous Renal Replacement Therapy/methods*
;
Intraabdominal Infections/mortality*
;
APACHE
;
Organ Dysfunction Scores
;
Intensive Care Units
;
Treatment Outcome
6.Impact of physical activity on semen quality: a review of current evidence.
Jing CHEN ; Jin-Ming GUO ; Bang-Jian JIANG ; Fan-Yuan SUN ; Yong-Cun QU
Asian Journal of Andrology 2025;27(5):574-580
A growing global trend indicates a decline in semen quality, with a lack of physical activity identified as one of the contributing factors. Exercise is medication, and numerous studies have explored its effects on semen quality. However, there is no consensus on the most effective type and intensity of exercise for improving semen quality, owing to inconsistent findings across studies. These discrepancies may be attributable to variations in study populations ( e.g. , healthy versus infertile individuals) and research methodologies ( e.g., observational versus interventional studies). This paper reviews the existing literature from the databases PubMed, Web of Science, and Google Scholar, reclassifying articles on their subject and research designs to delineate the relationship between exercise and semen quality. It also summarizes the mechanisms through which exercise influences semen quality, including hormonal regulation, oxidative stress, and inflammatory factors.
Humans
;
Semen Analysis
;
Male
;
Exercise/physiology*
;
Oxidative Stress/physiology*
;
Infertility, Male/physiopathology*
;
Sperm Motility/physiology*
7.Zedoarondiol Inhibits Neovascularization in Atherosclerotic Plaques of ApoE-/- Mice by Reducing Platelet Exosomes-Derived MiR-let-7a.
Bei-Li XIE ; Bo-Ce SONG ; Ming-Wang LIU ; Wei WEN ; Yu-Xin YAN ; Meng-Jie GAO ; Lu-Lian JIANG ; Zhi-Die JIN ; Lin YANG ; Jian-Gang LIU ; Da-Zhuo SHI ; Fu-Hai ZHAO
Chinese journal of integrative medicine 2025;31(3):228-239
OBJECTIVE:
To investigate the effect of zedoarondiol on neovascularization of atherosclerotic (AS) plaque by exosomes experiment.
METHODS:
ApoE-/- mice were fed with high-fat diet to establish AS model and treated with high- and low-dose (10, 5 mg/kg daily) of zedoarondiol, respectively. After 14 weeks, the expressions of anti-angiogenic protein thrombospondin 1 (THBS-1) and its receptor CD36 in plaques, as well as platelet activation rate and exosome-derived miR-let-7a were detected. Then, zedoarondiol was used to intervene in platelets in vitro, and miR-let-7a was detected in platelet-derived exosomes (Pexo). Finally, human umbilical vein endothelial cells (HUVECs) were transfected with miR-let-7a mimics and treated with Pexo to observe the effect of miR-let-7a in Pexo on tube formation.
RESULTS:
Animal experiments showed that after treating with zedoarondiol, the neovascularization density in plaques of AS mice was significantly reduced, THBS-1 and CD36 increased, the platelet activation rate was markedly reduced, and the miR-let-7a level in Pexo was reduced (P<0.01). In vitro experiments, the platelet activation rate and miR-let-7a levels in Pexo were significantly reduced after zedoarondiol's intervention. Cell experiments showed that after Pexo's intervention, the tube length increased, and the transfection of miR-let-7a minics further increased the tube length of cells, while reducing the expressions of THBS-1 and CD36.
CONCLUSION
Zedoarondiol has the effect of inhibiting neovascularization within plaque in AS mice, and its mechanism may be potentially related to inhibiting platelet activation and reducing the Pexo-derived miRNA-let-7a level.
Animals
;
MicroRNAs/genetics*
;
Exosomes/drug effects*
;
Plaque, Atherosclerotic/genetics*
;
Neovascularization, Pathologic/genetics*
;
Human Umbilical Vein Endothelial Cells/metabolism*
;
Humans
;
Blood Platelets/drug effects*
;
Apolipoproteins E/deficiency*
;
Thrombospondin 1/metabolism*
;
CD36 Antigens/metabolism*
;
Platelet Activation/drug effects*
;
Male
;
Mice
;
Mice, Inbred C57BL
8.Enhanced radiotheranostic targeting of integrin α5β1 with PEGylation-enabled peptide multidisplay platform (PEGibody): A strategy for prolonged tumor retention with fast blood clearance.
Siqi ZHANG ; Xiaohui MA ; Jiang WU ; Jieting SHEN ; Yuntao SHI ; Xingkai WANG ; Lin XIE ; Xiaona SUN ; Yuxuan WU ; Hao TIAN ; Xin GAO ; Xueyao CHEN ; Hongyi HUANG ; Lu CHEN ; Xuekai SONG ; Qichen HU ; Hailong ZHANG ; Feng WANG ; Zhao-Hui JIN ; Ming-Rong ZHANG ; Rui WANG ; Kuan HU
Acta Pharmaceutica Sinica B 2025;15(2):692-706
Peptide-based radiopharmaceuticals targeting integrin α5β1 show promise for precise tumor diagnosis and treatment. However, current peptide-based radioligands that target α5β1 demonstrate inadequate in vivo performance owing to limited tumor retention. The use of PEGylation to enhance the tumor retention of radiopharmaceuticals by prolonging blood circulation time poses a risk of increased blood toxicity. Therefore, a PEGylation strategy that boosts tumor retention while minimizing blood circulation time is urgently needed. Here, we developed a PEGylation-enabled peptide multidisplay platform (PEGibody) for PR_b, an α5β1 targeting peptide. PEGibody generation involved PEGylation and self-assembly. [64Cu]QM-2303 PEGibodies displayed spherical nanoparticles ranging from 100 to 200 nm in diameter. Compared with non-PEGylated radioligands, [64Cu]QM-2303 demonstrated enhanced tumor retention time due to increased binding affinity and stability. Importantly, the biodistribution analysis confirmed rapid clearance of [64Cu]QM-2303 from the bloodstream. Administration of a single dose of [177Lu]QM-2303 led to robust antitumor efficacy. Furthermore, [64Cu]/[177Lu]QM-2303 exhibited low hematological and organ toxicity in both healthy and tumor-bearing mice. Therefore, this study presents a PEGibody-based radiotheranostic approach that enhances tumor retention time and provides long-lasting antitumor effects without prolonging blood circulation lifetime. The PEGibody-based radiopharmaceutical [64Cu]/[177Lu]QM-2303 shows great potential for positron emission tomography imaging-guided targeted radionuclide therapy for α5β1-overexpressing tumors.
9.Association between the non-treatment threshold or upper limit of normal of alanine aminotransferase and liver pathological injury in patients with chronic hepatitis B virus infection and a persistently low level of alanine aminotransferase
Ming SHU ; Suwen JIANG ; Airong HU ; Qin CHEN ; Jialan WANG ; Menghan JIN ; Haojin ZHANG ; Shiqi YANG ; Shiyang FAN
Journal of Clinical Hepatology 2025;41(10):2044-2053
ObjectiveTo investigate the significance of different non-treatment thresholds or upper limits of normal (ULN) of alanine aminotransferase (ALT) in evaluating significant liver pathological injury in patients with chronic hepatitis B virus (HBV) infection, and to provide guidance for clinical diagnosis and treatment. MethodsThis study was conducted among 733 patients with chronic HBV infection who were hospitalized in Ningbo No. 2 Hospital from January 2015 to December 2023 and underwent liver biopsy and histopathological examination, and all patients had a persistent ALT level of ≤40 U/L and positive HBV DNA (>30 IU/mL). According to the treatment threshold or ULN of ALT, the patients were divided into group 1 with 575 patients (≤35 U/L for male patients, ≤25 U/L for female patients), group 2 with 430 patients (≤30 U/L for male patients, ≤19 U/L for female patients), group 3 with 443 patients (≤27 U/L for male patients, ≤24 U/L for female patients), group 4 with 446 patients (≤25 U/L), group 5 with 158 patients (>35 U/L for male patients, >25 U/L for female patients), and group 6 with 145 patients (>30 — ≤35 U/L for male patients, >19 — ≤25 U/L for female patients). Groups 2, 5, and 6 were compared to analyze the severity of liver pathological injury in patients with different ALT levels and the constituent ratio of patients with significant liver pathological injury, and groups 1, 2, 3, and 4 were compared to investigate the value of different ULN or non-treatment thresholds of ALT in determining liver inflammation grade (G), liver fibrosis stage (S), and the treatment indication based on liver pathology. The independent-samples t test was used for comparison of normally distributed continuous data between two groups; a one-way analysis of variance was used for comparison between multiple groups, and the least significant difference t-test or the Tambane’s test was used for further comparison between two groups; the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, and the Kruskal-Wallis H test was used for comparison between multiple groups and further comparison between two groups; the chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups; a Ridit analysis was used for comparison of ranked data. A multivariate Logistic regression analysis (forward stepwise) was performed with whether liver pathology met the treatment indication (≥G2 and/or ≥S2) as the dependent variable and related factors with a significant impact on the dependent variable (P <0.05) as the independent variable. The receiver operating characteristic (ROC) curve was plotted, and the area under the ROC curve (AUC), as well as sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio, was used to assess the diagnostic value of different non-treatment thresholds of ALT. ResultsAmong the 733 patients, 259 (35.33%) had ≥G2 liver inflammation, 211 (28.79%) had ≥S2 liver fibrosis, and 306 (41.75%) had treatment indication (≥G2 and/or ≥S2). There was a significant difference in liver inflammation grade (G0 — G4) between groups 2, 5, and 6 (χ2=22.869, P <0.001), and there were also significant differences in the constituent ratios of patients with ≥G2 or ≥G3 liver inflammation between the three groups (χ2=21.742 and 14.921, P<0.001 and P=0.001). There was a significant difference in liver fibrosis stage (S0 — S4) between groups 2, 5, and 6 (χ2=16.565, P<0.001), and there were also significant differences in the constituent ratios of patients with ≥S2, ≥S3 or S4 liver fibrosis between the three groups (χ2=13.264, 13.050, and 6.260, P=0.001, 0.001, and 0.044). There were significant differences between groups 2, 5, and 6 in the constituent ratios of patients with or without treatment indication based on liver pathology (χ2=20.728, P<0.001). There were significant differences between groups 2, 5, and 6 in the constituent ratio of male patients (χ2=24.836, P<0.05), age (F=5.710, P<0.05), ALT (F=473.193, P<0.05), aspartate aminotransferase (AST) (F=107.774, P<0.05), ALT/AST ratio (F=40.167, P<0.05), γ-glutamyl transpeptidase (GGT) (H=15.463, P<0.05), aspartate aminotransferase-to-platelet ratio index (APRI) (H=63.024, P<0.05), and LIF-5 (5 indicators for liver inflammation and fibrosis) (H=46.397, P<0.05). In groups 1 — 4, compared with the patients without treatment indication, the patients with treatment indication had a significantly lower constituent ratio of patients with positive HBeAg, significantly lower levels of platelet count (PLT) and HBV DNA, and significantly higher age, ALT, AST, GGT, APRI, FIB-4, and LIF-5 (all P<0.05). The Logistic regression analysis showed that age (odds ratio [OR]=1.044, 95% confidence interval [CI]: 1.025 — 1.063, P<0.001), GGT (OR=1.022, 95%CI: 1.007 — 1.038, P=0.003), and HBV DNA (OR=0.839, 95%CI: 0.765 — 0.919, P<0.001) were influencing factors for treatment indication based on liver pathology in group 1; HBeAg (OR=1.978, 95%CI: 1.269 — 3.082, P=0.003), age (OR=1.048, 95%CI: 1.025 — 1.071, P<0.001), GGT (OR=1.016, 95%CI: 1.001 — 1.031, P=0.041), and PLT (OR=0.995, 95%CI: 0.991 — 1.000, P=0.049) were influencing factors in group 2; age (OR=1.040, 95%CI: 1.014 — 1.066, P=0.002), ALT (OR=1.047, 95%CI: 1.005 — 1.092, P=0.029), HBV DNA (OR=0.817, 95%CI: 0.736 — 0.907, P<0.001), and LIF-5 (OR=7.382, 95%CI: 1.151 — 47.330, P=0.035) were influencing factors in group 3; age (OR=1.054, 95%CI: 1.031 — 1.077, P<0.001), ALT (OR=1.061, 95%CI: 1.016 — 1.107, P=0.008), and HBV DNA (OR=0.825, 95%CI: 0.743 — 0.917, P<0.001) were influencing factors in group 4. The diagnostic performance for identifying ≥G2 liver inflammation, ≥S2 liver fibrosis, and treatment indication in groups 1 — 4 had an AUC of >0.7; group 1 showed the lowest sensitivity (28.76%) and the highest specificity, positive predictive value, positive likelihood ratio, and negative likelihood ratio in judging treatment indication; group 2 had the highest sensitivity and negative predictive value and the lowest negative likelihood ratio; groups 3 and 4 had similar diagnostic indicators. ConclusionIn patients with chronic HBV infection and a persistently low ALT level, the severity of liver histopathological injury and the constituent ratio of significant liver histopathological injury decrease with the reduction in ALT level. A higher non-treatment threshold or ULN of ALT can help to identify the patients requiring treatment (with a higher specificity), while a lower non-treatment threshold or ULN of ALT can help to identify the patients who do not require treatment (with a higher sensitivity).
10.Clinical trial of brexpiprazole in the treatment of adults with acute schizophrenia
Shu-Zhe ZHOU ; Liang LI ; Dong YANG ; Jin-Guo ZHAI ; Tao JIANG ; Yu-Zhong SHI ; Bin WU ; Xiang-Ping WU ; Ke-Qing LI ; Tie-Bang LIU ; Jie LI ; Shi-You TANG ; Li-Li WANG ; Xue-Yi WANG ; Yun-Long TAN ; Qi LIU ; Uki MOTOMICHI ; Ming-Ji XIAN ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(5):654-658
Objective To evaluate the efficacy and safety of brexpiprazole in treating acute schizophrenia.Methods Patients with schizophrenia were randomly divided into treatment group and control group.The treatment group was given brexpiprozole 2-4 mg·d-1 orally and the control group was given aripiprazole 10-20 mg·d-1orally,both were treated for 6 weeks.Clinical efficacy of the two groups,the response rate at endpoint,the changes from baseline to endpoint of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Improvement(CGI-S),Personal and Social Performance scale(PSP),PANSS Positive syndrome subscale,PANSS negative syndrome subscale were compared.The incidence of treatment-related adverse events in two groups were compared.Results There were 184 patients in treatment group and 186 patients in control group.After treatment,the response rates of treatment group and control group were 79.50%(140 cases/184 cases)and 82.40%(150 cases/186 cases),the scores of CGI-I of treatment group and control group were(2.00±1.20)and(1.90±1.01),with no significant difference(all P>0.05).From baseline to Week 6,the mean change of PANSS total score wese(-30.70±16.96)points in treatment group and(-32.20±17.00)points in control group,with no significant difference(P>0.05).The changes of CGI-S scores in treatment group and control group were(-2.00±1.27)and(-1.90±1.22)points,PSP scores were(18.80±14.77)and(19.20±14.55)points,PANSS positive syndrome scores were(-10.30±5.93)and(-10.80±5.81)points,PANSS negative syndrome scores were(-6.80±5.98)and(-7.30±5.15)points,with no significant difference(P>0.05).There was no significant difference in the incidence of treatment-related adverse events between the two group(69.00%vs.64.50%,P>0.05).Conclusion The non-inferiority of Brexpiprazole to aripiprazole was established,with comparable efficacy and acceptability.

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