1.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
2.Content determination of seventeen amino acids in Gualoupi Injection and its intermediates and research on their change laws
Xiang TAO ; Jing-Xian ZHANG ; Qing HU ; Jian SUN ; Ying DONG ; Jin-Guo DING ; Hong YU ; Ying-Ying SHEN ; Xiu-Hong MAO ; Shen JI
Chinese Traditional Patent Medicine 2024;46(3):709-717
AIM To determine the contents of aspartic acid,glutamic acid,serine,glycine,threonine,citrulline,arginine,alanine,γ-amino-butyric acid,tyrosine,valine,phenlalanine,isoleucine,ornithine,leucine,lysine and proline in Gualoupi Injection and its intermediates,and to analyze their change laws.METHODS The OPA-FMOC online derivatization analysis was performed on a 45℃ thermostatic Waters XBridge C18 column(4.6 mm×100 mm,3.5 μm),with the mobile phase comprising of phosphate buffer solution-[methanol-acetonitrile-water(45 : 45 : 10)]flowing at 1 mL/min in a gradient elution manner,and the detection wavelengths were set at 262,338 nm.Principal component analysis and heatmap analysis were adopted in chemical pattern recognition for the corresponding intermediates in ten processes of six batches of samples.RESULTS Seventeen amino acids showed good linear relationships within their own ranges(R2>0.998 0),whose average recoveries were 83.4%-119.5%with the RSDs of 0.91%-7.94%.Different batches of samples in the same process were clustered,and the corresponding intermediates in different processed were clustered into three groups.Alcohol precipitation and cation exchange column demonstrated the biggest influences on amino acid composition.CONCLUSION This experiment can provide important references for the critical factors on quality control of Gualoupi Injection,thus ensure the stability and uniformity of final product.
3.Extracellular vesicles(EVs)'journey in recipient cells:from recognition to cargo release
XIANG HUAYUAN ; BAO CHENXUAN ; CHEN QIAOQIAO ; GAO QING ; WANG NAN ; GAO QIANQIAN ; MAO LINGXIANG
Journal of Zhejiang University. Science. B 2024;25(8):633-655
Extracellular vesicles(EVs)are nano-sized bilayer vesicles that are shed or secreted by virtually every cell type.A variety of biomolecules,including proteins,lipids,coding and non-coding RNAs,and mitochondrial DNA,can be selectively encapsulated into EVs and delivered to nearby and distant recipient cells,leading to alterations in the recipient cells,suggesting that EVs play an important role in intercellular communication.EVs play effective roles in physiology and pathology and could be used as diagnostic and therapeutic tools.At present,although the mechanisms of exosome biogenesis and secretion in donor cells are well understood,the molecular mechanism of EV recognition and uptake by recipient cells is still unclear.This review summarizes the current understanding of the molecular mechanisms of EVs'biological journey in recipient cells,from recognition to uptake and cargo release.Furthermore,we highlight how EVs escape endolysosomal degradation after uptake and thus release cargo,which is crucial for studies applying EVs as drug-targeted delivery vehicles.Knowledge of the cellular processes that govern EV uptake is important to shed light on the functions of EVs as well as on related clinical applications.
4.Clinical study on ultrasound-guided cervical vagus nerve block to prevent oculocardiac reflex
Qi-Wei ZHANG ; Hong-Chao LI ; Lin NING ; Qing-Xiang MAO ; Hong YAN
Journal of Regional Anatomy and Operative Surgery 2024;33(9):815-819
Objective To observe the preventive effect of ultrasound-guided cervical vagus nerve block(CVB)in preventing oculocar-diac reflex.Methods A total of 86 patients who underwent posterior scleral reinforcement or ophthalmectomy were recruited and randomly divided into the general anesthesia group and the composite anesthesia group.After admission,patients in the two groups underwent conven-tional general anesthesia induction intubation,and the composite anesthesia group received another 1%lidocaine for right CVB under ultrasound guidance.The heart rate,blood pressure,saturation of peripheral oxygen,atropine usage and surgical procedures of the two groups were recorded.Postoperative comfort degree,hoarseness and complications related to nerve block were compared between the two groups.Results Compared with the general anesthesia group,the proportion of patients using atropine and the proportion of suspending operation in the composite anesthesia group were significantly reduced(P<0.05),and the incidence of oculocardiac reflex and the level of oculocardiac reflex were significantly decreased(P<0.05).The incidence of hoarseness in the composite anesthesia group was higher than that in the general anesthesia group,and the difference was statistically significant(P<0.05).There was no complication related to nerve block occurred in the composite anesthesia group.Conclusion In ophthalmic surgery,ultrasound-guided right CVB can safely and effec-tively inhibit the occurrence of oculocardiac reflex.
5.Association of handgrip strength with aortic stenosis among adults aged 60 years and older: evidence from the 157097 UK Biobank participants.
Cheng-Xiang SONG ; Qing LI ; Cong-Ying XIA ; Lu LONG ; Xiao-Xi ZENG ; Jun-Li LI ; Mao CHEN
Journal of Geriatric Cardiology 2024;21(11):1026-1033
OBJECTIVE:
To examine the association of handgrip strength with aortic stenosis incidence among adults aged 60 years and older.
METHODS:
We conducted a cohort study using the UK Biobank data to assess the relationship between handgrip strength and incident aortic stenosis in individuals aged 60 years and older. Handgrip strength was measured using a Jamar J00105 hydraulic hand dynamometer. Adjusted Cox proportional hazards regression models were conducted to assess the association between handgrip strength and incident aortic stenosis.
RESULTS:
We included 157,097 UK Biobank participants (78,151 women and 78,946 men) in our study, with mean age of 64 ± 2.9 years. During a median follow-up of 8.1 (7.4-8.8) years, 1543 (1.0%) participants developed incident aortic stenosis. Compared with those with the lowest handgrip strength (tertile 1), the adjusted hazard ratios (95% confidence interval) of incident aortic stenosis in the middle (tertile 2) and the highest (tertile 3) were 0.86 (0.77-0.97) and 0.76 (0.67-0.87), respectively.
CONCLUSIONS
Higher handgrip strength was associated with lower risk of developing aortic stenosis in older adults. Future studies warrant preventive strategies for older adults with lower handgrip strength.
6.Simultaneously quantitative analysis of 35 components in gualoupi injection using hydrophilic interaction liquid chromatography tandem mass spectrometry
Xiang TAO ; Jing-xian ZHANG ; Qing HU ; Jian SUN ; Ying DONG ; Jin-guo DING ; Hong YU ; Ying-ying SHEN ; Xiu-hong MAO ; Shen JI
Acta Pharmaceutica Sinica 2023;58(5):1293-1300
A hydrophilic interaction chromatography tandem mass spectrometry method was developed for simultaneous quantification of 35 components in gualoupi injection. The analytes were separated with an ACQUITY XBridge Amide column using 20 mmol·L-1 ammonium formate aqueous solution (pH 3.0) as mobile phase A and 20 mmol·L-1 ammonium formate (pH 3.0)∶acetonitrile (1∶9) as mobile phase B for gradient elution. Mass spectrometry with dynamic multiple reaction monitoring and external standard method were used for quantitative analysis. A total of 35 components were determined in 10 batches of gualoupi injection. The results showed that the 35 compounds had a good linear relationship within their respective concentration ranges with the correlation coefficients (
7.Expert consensus on antiviral therapy of COVID-19
Fujie ZHANG ; Zhuo WANG ; Quanhong WANG ; Qing MAO ; Jinsong BAI ; Hanhui YE ; Jia TIAN ; Tianxin XIANG ; Jihong AN ; Zujiang YU ; Wenjie YANG ; Xingxiang YANG ; Xiaoju ZHANG ; Jie ZHANG ; Lina ZHANG ; Xingwang LI ; Jiabin LI ; Manxiang LI ; Zhiwei LI ; Hourong ZHOU ; Yi SHI ; Xiaoling XU ; Xiaoping TANG ; Hong TANG ; Xixin YAN ; Wenxiang HUANG ; Chaolin HUANG ; Liang DONG ; Baosong XIE ; Jiandong JIANG ; Bin XIONG ; Xuemei WEI ; Jifang SHENG ; Ronghua JIN
Chinese Journal of Clinical Infectious Diseases 2023;16(1):10-20
COVID-19 is caused by a novel coronavirus-severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), which has being spreading around the world, posing a serious threat to human health and lives. Neutralizing antibodies and small molecule inhibitors for virus replication cycle are the main antiviral treatment for novel coronavirus recommended in China. To further promote the rational use of antiviral therapy in clinical practice, the National Center for Infectious Diseases (Beijing Ditan Hospital Capital Medical University and the First Affiliated Hospital, Zhejiang University School of Medicine) invited experts in fields of infectious diseases, respiratory and intensive care to develop an Expert Consensus on Antiviral Therapy of COVID-19 based on the Diagnosis and Treatment Guideline for COVID-19 ( trial version 10) and experiences in the diagnosis and treatment of COVID-19 in China. The consensus is concise, practical and highly operable, hopefully it would improve the understanding of antiviral therapy for clinicians and provide suggestions for standardized medication in treatment of COVID-19.
8.Effects of moxibustion at Yongquan (KI 1) on cognition function and lower limb motor function in patients with post-stroke cognitive impairment of kidney essence deficiency.
Yan-Sheng YE ; Qing-Tang YANG ; Ding-Yu ZHU ; Kai-Xiang DENG ; Hui-Juan LIN ; Xin ZHANG ; Ting JI ; Meng-Zhen ZHUO ; Yu-Mao ZHANG
Chinese Acupuncture & Moxibustion 2023;43(9):1018-1022
OBJECTIVE:
To observe the effects of moxibustion at Yongquan(KI 1) on the cognitive function and lower limb motor function in patients with post-stroke cognitive impairment of kidney essence deficiency.
METHODS:
Eighty-four patients with post-stroke cognitive impairment of kidney essence deficiency were randomly divided into an observation group(42 cases,1 case dropped off)and a control group(42 cases,1 case dropped off).The control group was treated with medication,electroacupuncture,rehabilitation training and repetitive transcranial magnetic stimulation(rTMS);on the basis of the treatment as the control group,moxibustion at bilateral Yongquan(KI 1)was adopted in the observation group.Both groups were treated once a day,5 days a week with 2-day interval,4 weeks were required. The Montreal cognitive assessment (MoCA) score, mini-mental state examination (MMSE) score, Fugl-Meyer assessment-lower extremity (FMA-LE) score, Berg balance scale (BBS) score, functional independence measure (FIM) score, modified fall efficacy scale (MFES) score and scale for the differentiation of syndromes of vascular dementia (SDSVD) score before and after treatment were observed in the two groups.
RESULTS:
After treatment,the MoCA, MMSE, FMA-LE, BBS, FIM and MFES scores were higher than those before treatment in both groups (P<0.05), and the scores in the observation group were higher than those in the control group (P<0.05). After treatment,the SDSVD scores were lower than those before treatment in both groups (P< 0.05), and the SDSVD score in the observation group was lower than that in the control group (P< 0.05).
CONCLUSION
Moxibustion at Yongquan(KI 1) can improve the cognitive function and motor and balance function of lower limbs in patients with post-stroke cognitive impairment of kidney essence deficiency,reduce the risk of fall and improve the quality of life.
Humans
;
Cognition
;
Cognitive Dysfunction/therapy*
;
Dementia, Vascular
;
Kidney
;
Lower Extremity
;
Moxibustion
;
Quality of Life
;
Stroke/complications*
10.A quantitative study of airway ultrasound in predicting difficult laryngoscopy: A prospective study.
Lin NING ; Xing ZHU ; Hong-Chao LI ; Shi-Jie ZHOU ; Qi-Wei ZHANG ; Hong-Yu ZOU ; Qing-Xiang MAO ; Hong YAN
Chinese Journal of Traumatology 2023;26(6):351-356
PURPOSE:
As common clinical screening tests cannot effectively predict a difficult airway, and unanticipated difficult laryngoscopy remains a challenge for physicians. We herein used ultrasound to develop some point-of-care predictors for difficult laryngoscopy.
METHODS:
This prospective observational study included 502 patients who underwent laryngoscopy and a detailed sonographic assessment. Patients under 18 years old, or with maxillofacial deformities or fractures, limited mouth opening, limited neck movement or history of neck surgery were excluded from the study. Laryngoscopic views of all patients were scored and grouping using the modified Cormack-Lehane (CL) scoring system. The measurements acquired comprised tongue width, the longitudinal cross-sectional area of the tongue, tongue volume, the mandible-hyoid bone distance, the hyoid bone-glottis distance, the mandible-hyoid bone-glottis angle, the skin-thyrohyoid membrane distance, the glottis-superior edge of the thyroid cartilage distance (DGTC), the skin-hyoid bone distance, and the epiglottis midway-skin distance. ANOVA and Chi-square were used to compare differences between groups. Logistic regression was used to identify risk factors for difficult laryngoscopy and it was visualized by receiver operating characteristic curves and nomogram. R version 3.6.3 and SPSS version 26.0 were used for statistical analyses.
RESULTS:
Difficult laryngoscopy was indicated in 49 patients (CL grade Ⅲ - Ⅳ) and easy laryngoscopy in 453 patients (CL grade Ⅰ - Ⅱ). The ultrasound-measured mandible-hyoid bone-glottis angle and DGTC significantly differed between the 2 groups (p < 0.001). Difficult laryngoscopy was predicted by an area under the curve (AUC) of 0.930 with a threshold mandible-hyoid bone-glottis angle of 125.5° and by an AUC of 0.722 with a threshold DGTC of 1.22 cm. The longitudinal cross-sectional area of the tongue, tongue width, tongue volume, the mandible-hyoid distance, and the hyoid-glottis distance did not significantly differ between the groups.
CONCLUSION
Difficult laryngoscopy may be anticipated in patients in whom the mandible-hyoid bone-glottis angle is smaller than 125.5° or DGTC is larger than 1.22 cm.
Humans
;
Adolescent
;
Laryngoscopy
;
Prospective Studies
;
Tongue/diagnostic imaging*
;
Respiratory System
;
Ultrasonography

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