1.Guidelines for standardized implementation of pharmacist-managed clinics (2026 edition)
Pengxiang ZHOU ; Maobai LIU ; Xiaoli DU ; Xiaoyang LU ; Mei DONG ; Rong DUAN ; Ruigang HOU ; Xiaoyu LI ; Qi CHEN ; Yanxiao XIANG ; Weiyi FENG ; Rong CHEN ; Deshi DONG ; Yong YANG ; Li LI ; Xiaocong ZUO ; Jinfang HU ; Hongliang ZHANG ; Qingchun ZHAO ; Qi LIN ; Yang HU ; Jiaying WU ; Rongsheng ZHAO
China Pharmacy 2026;37(9):1105-1112
OBJECTIVE To formulate Guidelines for the standardized implementation of pharmacist-managed clinics ( 2026 edition ) in response to the challenges faced by such clinics in China, including uneven development, large discrepancies in service specifications, insufficient patient awareness, and limited medical insurance coverage. METHODS Led by the Pharmaceutical Affairs Professional Committee of the Chinese Hospital Association, the Evidence-based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, and the Hospital Pharmacy Professional Committee of the Cross-strait Medical and Health Exchange Association, a total of 19 domestic hospital pharmacy experts were organized. Through a systematic review of national policies and literature research, current practical experience was summarized. Consensus on the contents of the guidelines was reached after in-depth discussions. RESULTS &CONCLUSIONS The guidelines covered five sections: definition and connotation of pharmacist-managed clinics, establishment requirements, implementation and management, post competency, and practical research. Firstly, the definition and connotation included three operational forms of pharmacist-managed clinics (independent mode, physician-pharmacist joint mode, and online pharmacist-managed clinic mode) and classified service modes (specialty-specific, drug-specific, and disease-specific pharmacist-managed clinics). The establishment requirements were further refined, covering system construction (pharmaceutical service management system, quality control and assessment mechanism), personnel qualifications (professional credentials, continuing education and professional training, etc), service recipients, as well as service venues and facilities. Subsequently, the implementation and management of pharmacist-managed clinics were proposed, involving service procedures, intervention measures, documentation and records, patient education and follow-up, humanistic care, as well as risk management and quality control. Finally, post competency encompassed the competency requirements for pharmacists providing services in pharmacist-managed clinics, as well as the suggestions on teaching methods; practical research encouraged the conduct of high-quality pharmaceutical practice in the setting of pharmacist-managed clinics. The guidelines provide valuable guidance for the standardized implementation of pharmacist-managed clinics in China in terms of establishment, management, teaching, and research, fill the guideline gap in this field, and can promote the high-quality development of pharmacist-managed clinics.
2.Prevalence and associated factors of short video addiction among nursing students in higher vocational colleges
YAN Menghua, LU Yixin, WANG Meili, ZHANG Zhenxiang, MEI Yongxia, CHANG Xiaofang, XIANG Xu
Chinese Journal of School Health 2026;47(5):700-703
Objective:
To understand the current status of short video addiction among vocational nursing students in higher vocational colleges (hereinafter referred to as "nursing students") and its related factors, so as to provide a reference for formulating online education programs in colleges.
Methods:
From March to May 2025, a stratified random sample of 2 223 nursing students from four vocational colleges in Henan Province was selected. Short Video Addiction Scale for College Students, Short form Egna Minnen av Barndoms Uppfostran for Chinese, Peer Rejection Scale, and University of California at Los Angels Loneliness Scale were used for investigation. Chi square test and multivariate Logistic regression analysis were used to explore the related factors of short video addiction among nursing students.
Results:
The detection rate of short video addiction of higher vocational nursing students was 26.95%, and the scores for avoidance, loss of control, inefficiency and withdrawal were (8.05±2.97) (10.24±3.09) (4.99±1.88) and (11.97±4.10), respectively. Multivariate Logistic regression analysis showed that sophomore year 2 ( OR=1.83, 95%CI =1.39-2.40), higher maternal education level (secondary school/vocational college: OR =1.34, 95% CI =1.06-1.68; college/undergraduate: OR =1.38, 95% CI =1.05-1.82), paternal overprotection ( OR=1.59, 95%CI =1.27-2.00), high peer rejection ( OR=1.40, 95%CI =1.19-1.66), and strong loneliness ( OR=1.57, 95%CI =1.07-2.28) were associated with a higher risk of short video addiction among nursing students (all P <0.05). Paternal affectionate and warm rearing style ( OR=0.82, 95%CI = 0.71- 0.95) was associated with a lower risk of short video addiction ( P <0.05).
Conclusions
The detection rate of short video addiction among nursing students is relatively high. Short video addiction is related to the nursing students grade, maternal education level, paternal overprotection and affectionate rearing style, peer rejection, and loneliness.
3.Association between triglyceride glucose-body mass index and new-onset metabolic dysfunction-associated fatty liver disease
Xiaohong XIANG ; Yang LI ; Bo LI ; Mei WEI ; Zhongfang ZHOU ; Suqiong HUANG
Journal of Clinical Hepatology 2026;42(4):840-847
ObjectiveTo investigate the association between serum fasting triglyceride glucose-body mass index (TyG-BMI) and new-onset metabolic dysfunction-associated fatty liver disease (MAFLD) within 10 years. MethodsA retrospective analysis was performed for the data of individuals who underwent physical examination in The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University in 2013, 2018, and 2023 and were not diagnosed with MAFLD in 2013, and a total of 1 340 valid subjects were enrolled according to the inclusion and exclusion criteria. The gbmt package in R 4.3.0 was used to construct the dynamic change trajectory model of TyG-BMI, and four different TyG-BMI trajectory groups were determined, i.e., the low-level group (n=352), the medium-level group (n=517), the high-level group (n=314), and the extremely high-level group (n=157). The data on general information and blood biochemical parameters were collected from all subjects and were then compared between groups. The chi-square test was used for comparison of categorical data between groups, and the Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data with heterogeneity of variance between multiple groups. The Cox regression analysis was used to investigate the association between different TyG-BMI trajectories and the risk of MAFLD, and the receiver operating characteristic (ROC) curve was used to assess the value of TyG-BMI in the diagnosis of MAFLD. ResultsThe cumulative incidence rate of MAFLD increased with the increase in the level of TyG-BMI trajectory, with a cumulative incidence rate of 4.83% in the low-level group, 29.98% in the medium-level group, 61.15% in the high-level group, and 83.44% in the extremely high-level group (P<0.001), and the cumulative incidence rate of MAFLD in men was significantly higher than that in women (51.34% vs 20.67%, P<0.001). The multivariate Cox regression analysis showed that increases in the levels of TyG-BMI trajectory, uric acid, diastolic blood pressure, hemoglobin, and alanine aminotransferase were independent risk factors for the onset of MAFLD (all P<0.05), while the increase in high-density lipoprotein cholesterol was an independent protective factor against MAFLD (P<0.001). After adjustment for confounding factors, the medium-, high-, and extremely high-level groups had a hazard ratio of 4.430 (95% confidence interval [CI]: 2.660 — 7.377, P<0.001), 6.937 (95%CI: 4.110 — 11.708, P<0.001), and 7.989 (95%CI: 4.616 — 13.827, P<0.001), respectively. The ROC curve analysis showed that TyG-BMI had the highest diagnostic value, with an area under the ROC curve of 0.859 (95%CI: 0.840 — 0.879), a sensitivity of 79.8%, and a specificity of 76.3%. ConclusionThe risk of MAFLD increases with the increase in the level of TyG-BMI trajectory, and TyG-BMI can be used as a predictive indicator for MAFLD.
4.The SMAD-Pathway Mediates HMGB1-Induced Proliferation and Metastatic Progression in Cutaneous Squamous Cell Carcinoma Cells
De-De LIAN ; Xue Mei LI ; Yu-Xi JIA ; Ming-Wei ZHOU ; Xiang-Ru CHEN ; Yang-Yang TIAN ; Min LI ; Ming-Hui SUN ; Ye ZHAO ; Hong-Jun LI ; Qing-Ling ZHANG
Annals of Dermatology 2026;38(1):51-58
Background:
High-mobility group box protein 1 (HMGB1) is a chromatin-binding protein involved in arthritis, ischemia, sepsis, atherosclerosis, neurodegenerative disorders, meningitis, and cancer. HMGB1 exhibits dual roles in cancer, acting as either a tumor suppressor or oncoprotein depending on context.
Objective:
This research aimed to elucidate HMGB1’s functional significance in cutaneous squamous cell carcinoma (cSCC).
Methods:
We overexpressed HMGB1 in cSCC cell lines using recombinant adenovirus and examined its effects on cell proliferation, colony formation, and cell migration.
Results:
Immunohistochemical analysis revealed elevated HMGB1 expression levels in cSCC tissue relative to normal epidermis. To assess the influence of HMGB1, we employed recombinant adenoviruses expressing HMGB1 to transduce SCC cell lines (SCC12 and SCC13). Enhanced HMGB1 expression significantly promoted cellular proliferation and colony formation capacity.Notably, HMGB1 overexpression elevated the levels of proliferation regulators, including P63, SOX2, CDK4 and CDK6. Furthermore, HMGB1 overexpression substantially enhanced tumor invasiveness, accompanied by upregulation of epithelial-mesenchymal transition (EMT) biomarkers. Mechanistically, overexpression of HMGB1 enhanced transforming growth factor-β signaling by increasing phosphorylation of SMAD2/3, the key mediators of EMT.
Conclusion
These data imply that HMGB1 acts as a tumor-promoting factor in cSCC.
5.Mechanisms of Babaodan in Attenuating Acetaminophen-induced Acute Liver Injury via Metabolic Reprogramming and Inflammatory Pathways
Ying ZHANG ; Yuchang AN ; Xiang ZHU ; Mei ZHONG ; Yanfang ZHENG ; Mingqing HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):122-130
ObjectiveTo investigate the effects and potential mechanisms of Babaodan (BBD) against acetaminophen (APAP)-induced acute liver injury (ALI) based on transcriptomics. MethodsA total of 36 male C57BL/6 mice were randomly divided into 6 groups (n=6 per group): normal group, model group, N-acetylcysteine group (NAC, 120 mg·kg-1), and BBD low-, medium-, and high-dose groups (BBD-L, BBD-M, BBD-H groups, 75, 150, 300 mg·kg-1, respectively). Except for the normal group, all other groups were subjected to APAP-induced ALI. The serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C) were measured in each group. Hepatic levels or activities of malondialdehyde (MDA) and glutathione peroxidase (GSH-Px) were detected using commercial kits. Hematoxylin-eosin (HE) staining was performed to evaluate the degree of liver histopathological damage. Transcriptomic analysis was employed to screen differentially expressed genes (DEGs), and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis was performed to identify differential pathways involved in BBD intervention against ALI. Real-time quantitative polymerase chain reaction (Real-time PCR) and Western blot were applied to validate the expression of differential genes and related pathway proteins. Additionally, glucose (GLU) consumption, as well as lactate (LD) and adenosine triphosphate (ATP) content were assessed across all mouse groups. ResultsPharmacodynamic evaluation showed that, compared with the normal group, the model group exhibited significantly elevated serum levels of ALT, AST, TC, TG, and LDL-C (P<0.01), significantly increased MDA level (P<0.01), and significantly decreased GSH-Px level (P<0.05). Compared with the model group, BBD intervention at different doses significantly reduced the serum levels of ALT, AST, TC, TG, and LDL-C (P<0.05, P<0.01), increased GSH-Px level (P<0.05, P<0.01), significantly decreased MDA level (P<0.01), and ameliorated hepatic histopathological injury. Liver transcriptomic analysis revealed that, following high-dose BBD intervention, the core genes were mainly enriched in pathways related to inflammatory responses and energy metabolic reprogramming, including the interleukin-17 (IL-17) signaling pathway, the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway, fructose and mannose metabolism, and glycolysis. Real-time PCR validation demonstrated that, compared with the normal group, the mRNA expression levels of glycolysis-related genes [hexokinase 1 (HK1), hexokinase 2 (HK2), 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 3 (PFKFB3), 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 4 (PFKFB4), pyruvate kinase M (PKM), and lactate dehydrogenase A (LDHA)], as well as inflammatory cytokines [tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β)] were significantly upregulated in the model group (P<0.05, P<0.01). Compared with the model group, the BBD-H group showed significantly decreased mRNA expression of HK1, HK2, PFKFB3, PFKFB4, PKM, LDHA, TNF-α, IL-6, and IL-1β (P<0.05, P<0.01). Western blot results indicated that, compared with the normal group, the model group had significantly increased expression of glycolysis-related proteins [glucose transporter 1 (GLUT1), HK1, PFKFB3, and PKM], inflammatory proteins [interleukin-18 (IL-18), TNF-α, and IL-1β], and phosphorylated (p)-PI3K and p-Akt proteins (P<0.05, P<0.01). Compared with the model group, the BBD-H group exhibited significantly decreased expression of GLUT1, HK1, PFKFB3, PKM, IL-18, TNF-α, IL-1β, p-PI3K, and p-Akt (P<0.05, P<0.01). Metabolic indicator measurements showed that, compared with the model group, the BBD-H group showed significantly reduced GLU consumption, LD and ATP content (P<0.05, P<0.01). ConclusionBBD may alleviate APAP-induced ALI through dual regulation of metabolic reprogramming and inflammatory responses, potentially via inhibition of the PI3K/Akt signaling pathway.
6.Mechanisms of Babaodan in Attenuating Acetaminophen-induced Acute Liver Injury via Metabolic Reprogramming and Inflammatory Pathways
Ying ZHANG ; Yuchang AN ; Xiang ZHU ; Mei ZHONG ; Yanfang ZHENG ; Mingqing HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):122-130
ObjectiveTo investigate the effects and potential mechanisms of Babaodan (BBD) against acetaminophen (APAP)-induced acute liver injury (ALI) based on transcriptomics. MethodsA total of 36 male C57BL/6 mice were randomly divided into 6 groups (n=6 per group): normal group, model group, N-acetylcysteine group (NAC, 120 mg·kg-1), and BBD low-, medium-, and high-dose groups (BBD-L, BBD-M, BBD-H groups, 75, 150, 300 mg·kg-1, respectively). Except for the normal group, all other groups were subjected to APAP-induced ALI. The serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C) were measured in each group. Hepatic levels or activities of malondialdehyde (MDA) and glutathione peroxidase (GSH-Px) were detected using commercial kits. Hematoxylin-eosin (HE) staining was performed to evaluate the degree of liver histopathological damage. Transcriptomic analysis was employed to screen differentially expressed genes (DEGs), and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis was performed to identify differential pathways involved in BBD intervention against ALI. Real-time quantitative polymerase chain reaction (Real-time PCR) and Western blot were applied to validate the expression of differential genes and related pathway proteins. Additionally, glucose (GLU) consumption, as well as lactate (LD) and adenosine triphosphate (ATP) content were assessed across all mouse groups. ResultsPharmacodynamic evaluation showed that, compared with the normal group, the model group exhibited significantly elevated serum levels of ALT, AST, TC, TG, and LDL-C (P<0.01), significantly increased MDA level (P<0.01), and significantly decreased GSH-Px level (P<0.05). Compared with the model group, BBD intervention at different doses significantly reduced the serum levels of ALT, AST, TC, TG, and LDL-C (P<0.05, P<0.01), increased GSH-Px level (P<0.05, P<0.01), significantly decreased MDA level (P<0.01), and ameliorated hepatic histopathological injury. Liver transcriptomic analysis revealed that, following high-dose BBD intervention, the core genes were mainly enriched in pathways related to inflammatory responses and energy metabolic reprogramming, including the interleukin-17 (IL-17) signaling pathway, the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway, fructose and mannose metabolism, and glycolysis. Real-time PCR validation demonstrated that, compared with the normal group, the mRNA expression levels of glycolysis-related genes [hexokinase 1 (HK1), hexokinase 2 (HK2), 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 3 (PFKFB3), 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 4 (PFKFB4), pyruvate kinase M (PKM), and lactate dehydrogenase A (LDHA)], as well as inflammatory cytokines [tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β)] were significantly upregulated in the model group (P<0.05, P<0.01). Compared with the model group, the BBD-H group showed significantly decreased mRNA expression of HK1, HK2, PFKFB3, PFKFB4, PKM, LDHA, TNF-α, IL-6, and IL-1β (P<0.05, P<0.01). Western blot results indicated that, compared with the normal group, the model group had significantly increased expression of glycolysis-related proteins [glucose transporter 1 (GLUT1), HK1, PFKFB3, and PKM], inflammatory proteins [interleukin-18 (IL-18), TNF-α, and IL-1β], and phosphorylated (p)-PI3K and p-Akt proteins (P<0.05, P<0.01). Compared with the model group, the BBD-H group exhibited significantly decreased expression of GLUT1, HK1, PFKFB3, PKM, IL-18, TNF-α, IL-1β, p-PI3K, and p-Akt (P<0.05, P<0.01). Metabolic indicator measurements showed that, compared with the model group, the BBD-H group showed significantly reduced GLU consumption, LD and ATP content (P<0.05, P<0.01). ConclusionBBD may alleviate APAP-induced ALI through dual regulation of metabolic reprogramming and inflammatory responses, potentially via inhibition of the PI3K/Akt signaling pathway.
7.Usefulness of intraoperative choledochoscopy in laparoscopic subtotal cholecystectomy for severe cholecystitis
Rui-Hui ZHANG ; Xiang-Nan WANG ; Yue-Feng MA ; Xue-Qian TANG ; Mei-Ju LIN ; Li-Jun SHI ; Jing-Yi LI ; Hong-Wei ZHANG
Annals of Hepato-Biliary-Pancreatic Surgery 2025;29(2):192-198
Laparoscopic subtotal cholecystectomy (LSC) has been a safe and viable alternative to conversion to laparotomy in cases of severe cholecystitis. The objective of this study is to determine the utility of intraoperative choledochoscopy in LSC for the exploration of the gallbladder, cyst duct, and subsequent stone clearance of the cystic duct in cases of severe cholecystitis. A total of 72 patients diagnosed with severe cholecystitis received choledochoscopy-assisted laparoscopic subtotal cholecystectomy (CALSC). A choledochoscopy was performed to explore the gallbladder cavity and/or cystic duct, and to extract stones using a range of techniques. The clinical records, including the operative records and outcomes, were subjected to analysis. No LSC was converted to open surgery, and no bile duct or vascular injuries were sustained. All stones within the cystic duct were removed by a combination of techniques, including high-frequency needle knife electrotomy, basket, and electrohydraulic lithotripsy. A follow-up examination revealed the absence of residual bile duct stones, with the exception of one common bile duct stone, which was extracted via endoscopic retrograde cholangiopancreatography. In certain special cases, CALSC may prove to be an efficacious treatment for the management of severe cholecystitis. This technique allows for optimal comprehension of the situation within the gallbladder cavity and cystic duct, facilitating the removal of stones from the cystic duct and reducing the residue of the non-functional gallbladder remnant.
8.Usefulness of intraoperative choledochoscopy in laparoscopic subtotal cholecystectomy for severe cholecystitis
Rui-Hui ZHANG ; Xiang-Nan WANG ; Yue-Feng MA ; Xue-Qian TANG ; Mei-Ju LIN ; Li-Jun SHI ; Jing-Yi LI ; Hong-Wei ZHANG
Annals of Hepato-Biliary-Pancreatic Surgery 2025;29(2):192-198
Laparoscopic subtotal cholecystectomy (LSC) has been a safe and viable alternative to conversion to laparotomy in cases of severe cholecystitis. The objective of this study is to determine the utility of intraoperative choledochoscopy in LSC for the exploration of the gallbladder, cyst duct, and subsequent stone clearance of the cystic duct in cases of severe cholecystitis. A total of 72 patients diagnosed with severe cholecystitis received choledochoscopy-assisted laparoscopic subtotal cholecystectomy (CALSC). A choledochoscopy was performed to explore the gallbladder cavity and/or cystic duct, and to extract stones using a range of techniques. The clinical records, including the operative records and outcomes, were subjected to analysis. No LSC was converted to open surgery, and no bile duct or vascular injuries were sustained. All stones within the cystic duct were removed by a combination of techniques, including high-frequency needle knife electrotomy, basket, and electrohydraulic lithotripsy. A follow-up examination revealed the absence of residual bile duct stones, with the exception of one common bile duct stone, which was extracted via endoscopic retrograde cholangiopancreatography. In certain special cases, CALSC may prove to be an efficacious treatment for the management of severe cholecystitis. This technique allows for optimal comprehension of the situation within the gallbladder cavity and cystic duct, facilitating the removal of stones from the cystic duct and reducing the residue of the non-functional gallbladder remnant.
9.Severity Assessment Parameters and Diagnostic Technologies of Obstructive Sleep Apnea
Zhuo-Zhi FU ; Ya-Cen WU ; Mei-Xi LI ; Ping-Ping YIN ; Hai-Jun LIN ; Fu ZHANG ; Yu-Xiang YANG
Progress in Biochemistry and Biophysics 2025;52(1):147-161
Obstructive sleep apnea (OSA) is an increasingly widespread sleep-breathing disordered disease, and is an independent risk factor for many high-risk chronic diseases such as hypertension, coronary heart disease, stroke, arrhythmias and diabetes, which is potentially fatal. The key to the prevention and treatment of OSA is early diagnosis and treatment, so the assessment and diagnostic technologies of OSA have become a research hotspot. This paper reviews the research progresses of severity assessment parameters and diagnostic technologies of OSA, and discusses their future development trends. In terms of severity assessment parameters of OSA, apnea hypopnea index (AHI), as the gold standard, together with the percentage of duration of apnea hypopnea (AH%), lowest oxygen saturation (LSpO2), heart rate variability (HRV), oxygen desaturation index (ODI) and the emerging biomarkers, constitute a multi-dimensional evaluation system. Specifically, the AHI, which measures the frequency of sleep respiratory events per hour, does not fully reflect the patients’ overall sleep quality or the extent of their daytime functional impairments. To address this limitation, the AH%, which measures the proportion of the entire sleep cycle affected by apneas and hypopneas, deepens our understanding of the impact on sleep quality. The LSpO2 plays a critical role in highlighting the potential severe hypoxic episodes during sleep, while the HRV offers a different perspective by analyzing the fluctuations in heart rate thereby revealing the activity of the autonomic nervous system. The ODI provides a direct and objective measure of patients’ nocturnal oxygenation stability by calculating the number of desaturation events per hour, and the biomarkers offers novel insights into the diagnosis and management of OSA, and fosters the development of more precise and tailored OSA therapeutic strategies. In terms of diagnostic techniques of OSA, the standardized questionnaire and Epworth sleepiness scale (ESS) is a simple and effective method for preliminary screening of OSA, and the polysomnography (PSG) which is based on recording multiple physiological signals stands for gold standard, but it has limitations of complex operations, high costs and inconvenience. As a convenient alternative, the home sleep apnea testing (HSAT) allows patients to monitor their sleep with simplified equipment in the comfort of their own homes, and the cardiopulmonary coupling (CPC) offers a minimal version that simply analyzes the electrocardiogram (ECG) signals. As an emerging diagnostic technology of OSA, machine learning (ML) and artificial intelligence (AI) adeptly pinpoint respiratory incidents and expose delicate physiological changes, thus casting new light on the diagnostic approach to OSA. In addition, imaging examination utilizes detailed visual representations of the airway’s structure and assists in recognizing structural abnormalities that may result in obstructed airways, while sound monitoring technology records and analyzes snoring and breathing sounds to detect the condition subtly, and thus further expands our medical diagnostic toolkit. As for the future development directions, it can be predicted that interdisciplinary integrated researches, the construction of personalized diagnosis and treatment models, and the popularization of high-tech in clinical applications will become the development trends in the field of OSA evaluation and diagnosis.
10.Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial.
Qing-Yun JIA ; Yi-Ru WANG ; Da-Wei SUN ; Jian-Chun MAO ; Luan XUE ; Xiao-Hua GU ; Xiang YU ; Xue-Mei PIAO ; Hao XU ; Qian-Qian LIANG
Chinese journal of integrative medicine 2025;31(2):99-107
OBJECTIVE:
To explore the efficacy and safety of Juan Bi Pill (JBP) in treatment of active rheumatoid arthritis (RA).
METHODS:
From February 2017 to May 2018, 115 participants from 4 centers were randomly divided into JBP group (57 cases) and placebo group (58 cases) in a 1:1 ratio using a random number table method. Participants received a dose of JBP (4 g, twice a day, orally) combined with methotrexate (MTX, 10 mg per week) or placebo (4 g, twice a day, orally) combined with MTX for 12 weeks. Participants were required with follow-up visits at 24 and 48 weeks, attending 7 assessment visits. Participants were undergo disease activity assessment 7 times (at baseline and 2, 4, 8, 12, 24, 48 weeks) and safety assessments 6 times (at baseline and 4, 8, 12, 24, 48 weeks). The primary endpoint was 28-joint Disease Activity Score (DAS28-ESR and DAS28-CRP). The secondary endpoints included American College of Rheumatology (ACR) criteria for 20% and 50% improvement (ACR20/50), Health Assessment Questionnaire Disability Index (HAQ-DI), clinical disease activity index (CDAI), visual analog scale (VAS), Short Form-36 (SF-36) score, Medial Outcomes Study (MOS) sleep scale score, serum erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), tender joint count, swollen joint count, and morning stiffness. The adverse reactions were observed during the treatment.
RESULTS:
After 12 weeks of treatment, DAS28-ESR and DAS28-CRP scores in both groups were lower than before treatment (both P<0.01), while the remission rate of DAS28-ESR and DAS28-CRP and low disease activity of JBP group were higher than those in the placebo group (both P<0.01). JBP demonstrated better efficacy on ACR20 and ACR50 compliance rate at 12 and 48 weeks comparing to placebo (all P<0.05). The CDAI and HAQ-DI score, pain VAS and global VAS change of RA patients and physicians, the serum ESR and CRP levels, and the number of tenderness and swelling joints were lower than before treatment at 4, 8, 12, 24, 48 weeks in both groups (P<0.05 or P<0.01), while the reduction of above indices in the JBP group was more obvious than those in the placebo group at 12 weeks (ESR and CRP, both P<0.05) or at 12 and 48 weeks (all P<0.01). There was no difference in adverse reactions between the 2 groups during treatment (P=0.75).
CONCLUSION
JBP combined with MTX could effectively reduce disease activity in patients with RA in active stage, reduce the symptoms of arthritis, and improve the quality of life, while ensuring safety, reliability, and fewer adverse effects. (Trial Registration: ClinicalTrials.gov, No. NCT02885597).
Humans
;
Arthritis, Rheumatoid/drug therapy*
;
Methotrexate/adverse effects*
;
Female
;
Double-Blind Method
;
Male
;
Middle Aged
;
Treatment Outcome
;
Drugs, Chinese Herbal/adverse effects*
;
Drug Therapy, Combination
;
Adult
;
Antirheumatic Agents/adverse effects*
;
Aged


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