1.The SMILE study: Study of long-term methotrexate and iguratimod combination therapy in early rheumatoid arthritis.
Fang DU ; Qing DAI ; Jialin TENG ; Liangjing LU ; Shuang YE ; Ping YE ; Zhiqian LIN ; Hong DING ; Min DAI ; Chunde BAO
Chinese Medical Journal 2025;138(14):1705-1713
BACKGROUND:
Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation and joint destruction. Iguratimod (IGU) is a novel conventional synthetic disease-modifying antirheumatic drugs (csDMARD) with good efficacy and safety for the treatment of active RA in China and Japan. However, the long-term effects of IGU on the progression of bone destruction or radiographic progression in patients with active RA remain unknown. We aimed to investigate the efficacy and safety of iguratimod (IGU), a combination of methotrexate (MTX) and IGU, and IGU in patients with active rheumatoid arthritis (RA) who were naïve to MTX.
METHODS:
This multicenter, double-blind, randomized, non-inferiority clinical trial was conducted at 28 centers for over 52 weeks in China. In total, 911 patients were randomized (1:1:1) to receive MTX monotherapy (10-15 mg weekly, n = 293), IGU monotherapy (25 mg twice daily, n = 297), or IGU + MTX (10-15 mg weekly for MTX and 25 mg twice daily for IGU, n = 305) for 52 weeks. The patients' clinical characteristics, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), disease activity score in 28 joints-C-reactive protein (DAS28-CRP) level, and disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR) were assessed at baseline. The primary endpoints were the proportion of patients with ≥20% improvement according to the American College of Rheumatology (ACR20) response and changes in the van der Heijde-modified total Sharp score (vdH-mTSS) at week 52.
RESULTS:
The proportions of patients achieving an ACR20 response at week 52 were 77.44%, 77.05 %, and 65.87% for IGU monotherapy, IGU + MTX, and MTX monotherapy, respectively. The non-inferiority of IGU monotherapy to MTX monotherapy was established with the ACR20 (11.57%; 95% confidence interval [CI], 4.35-18.79%; P <0.001) and vdH-mTSS (-0.37; 95% CI, -1.22-0.47; P = 0.022). IGU monotherapy was also superior to MTX monotherapy in terms of ACR20 ( P = 0.002) but not the vdH-mTSS. The superiority of IGU + MTX over MTX monotherapy was confirmed in terms of the ACR20 (11.18%; 95% CI, 3.99-18.37%; P = 0.003), but not in the vdH-mTSS (-0.68; 95% CI, -1.46-0.11; P = 0.091). However, the difference in the incidence rates of adverse events was not statistically significant.
CONCLUSIONS:
IGU monotherapy/IGU + MTX showed a more favorable clinical response than did MTX monotherapy. IGU may have some clinical benefits over MTX in terms of radiographic progression, implying that IGU may be considered as an initial therapeutic option for patients with active RA.
TRIAL REGISTRATION
https://classic.clinicaltrials.gov/ , NCT01548001.
Adult
;
Aged
;
Female
;
Humans
;
Male
;
Middle Aged
;
Antirheumatic Agents/therapeutic use*
;
Arthritis, Rheumatoid/drug therapy*
;
Chromones/adverse effects*
;
Double-Blind Method
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Drug Therapy, Combination
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Methotrexate/adverse effects*
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Treatment Outcome
;
Sulfonamides
2.Development and Initial Validation of the Multi-Dimensional Attention Rating Scale in Highly Educated Adults.
Xin-Yang ZHANG ; Karen SPRUYT ; Jia-Yue SI ; Lin-Lin ZHANG ; Ting-Ting WU ; Yan-Nan LIU ; Di-Ga GAN ; Yu-Xin HU ; Si-Yu LIU ; Teng GAO ; Yi ZHONG ; Yao GE ; Zhe LI ; Zi-Yan LIN ; Yan-Ping BAO ; Xue-Qin WANG ; Yu-Feng WANG ; Lin LU
Chinese Medical Sciences Journal 2025;40(2):100-110
OBJECTIVES:
To report the development, validation, and findings of the Multi-dimensional Attention Rating Scale (MARS), a self-report tool crafted to evaluate six-dimension attention levels.
METHODS:
The MARS was developed based on Classical Test Theory (CTT). Totally 202 highly educated healthy adult participants were recruited for reliability and validity tests. Reliability was measured using Cronbach's alpha and test-retest reliability. Structural validity was explored using principal component analysis. Criterion validity was analyzed by correlating MARS scores with the Toronto Hospital Alertness Test (THAT), the Attentional Control Scale (ACS), and the Attention Network Test (ANT).
RESULTS:
The MARS comprises 12 items spanning six distinct dimensions of attention: focused attention, sustained attention, shifting attention, selective attention, divided attention, and response inhibition.As assessed by six experts, the content validation index (CVI) was 0.95, the Cronbach's alpha for the MARS was 0.78, and the test-retest reliability was 0.81. Four factors were identified (cumulative variance contribution rate 68.79%). The total score of MARS was correlated positively with THAT (r = 0.60, P < 0.01) and ACS (r = 0.78, P < 0.01) and negatively with ANT's reaction time for alerting (r = -0.31, P = 0.049).
CONCLUSIONS
The MARS can reliably and validly assess six-dimension attention levels in real-world settings and is expected to be a new tool for assessing multi-dimensional attention impairments in different mental disorders.
Humans
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Adult
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Male
;
Attention/physiology*
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Female
;
Middle Aged
;
Reproducibility of Results
;
Young Adult
;
Psychometrics
3.Research on the health performance of basic medical insurance for flexible employees
Fang-Teng FU ; Bao-Zhen DAI ; Peng MIAO
Chinese Journal of Health Policy 2024;17(7):25-34
This paper evaluates the impact of basic medical insurance on the health status of flexible employees based on the CFPS three-period balanced panel data from 2016 to 2020,using Ordered Probit Model and Two-way Fixed Effects Model.It is found that basic medical insurance significantly promotes the physical and mental health of flexible employees.Further heterogeneity analysis reveals that the health performance of basic medical insurance was particularly significant for middle-aged and old-aged,rural,east-central and better-educated flexible employees.In addition,the mediation effect analysis indicates that basic medical insurance promots the health of flexible employees through the mediation channels of improving the utilization of medical services and reducing the burden of disease costs.This paper suggests promoting the comprehensive participation of flexible employees;improving the medical insurance system for middle-aged and elderly flexible employees;accelerating the sinking of high-quality medical resources to rural and western areas;and actively exploring a new mode of participation in medical check-ups by flexible employees,with a view to lowering the incidence of serious illnesses and major illnesses among flexible employees and improving health performance.
4.Quality evaluation of Yanyangke Mixture
Xiao-Lian LIANG ; Xiong-Bin GUI ; Yong CHEN ; Zheng-Teng YANG ; Jia-Bao MA ; Feng-Xian ZHAO ; Hai-Mei SONG ; Jia-Ru FENG
Chinese Traditional Patent Medicine 2024;46(6):1781-1787
AIM To evaluate the quality of Yanyangke Mixture.METHODS The HPLC fingerprints were established,after which cluster analysis,principal component analysis and partial least squares discriminant analysis were performed.The contents of liquiritin,rosmarinic acid,sheganoside,irisgenin,honokiol,monoammonium glycyrrhizinate,irisflorentin,isoliquiritin and magnolol were determined,the analysis was performed on a 35 ℃ thermostatic Agilent ZORBAX SB-C18 column(5 μm,250 mmx4.6 mm),with the mobile phase comprising of 0.1%phosphoric acid-acetonitrile flowing at 1 mL/min in a gradient elution manner,and multi-wavelength detection was adopted.RESULTS There were ten common peaks in the fingerprints for twelve batches of samples with the similarities of more than 0.9.Various batches of samples were clustered into three types,three principal components displayed the acumulative variance contribution rate of 87.448%,peaks 5、14(honokiol),3(liquiritin),11(monoammonium glycyrrhizinate)and 15(asarinin)were quality markers.Nine constituents showed good linear relationships within their own ranges(r>0.999 0),whose average recoveries were 98.5%-103.6%with the RSDs of 0.92%-1.7%.CONCLUSION This stable and reliable method can provide a basis for the quality control of Yanyangke Mixture.
6.Utility of combining PIVKA-II and AFP in the surveillance and monitoring of hepatocellular carcinoma in the Asia-Pacific region
Do Young KIM ; Bao Nguyen TOAN ; Chee-Kiat TAN ; Irsan HASAN ; Lyana SETIAWAN ; Ming-Lung YU ; Namiki IZUMI ; Nguyen Nguyen HUYEN ; Pierce Kah-Hoe CHOW ; Rosmawati MOHAMED ; Stephen Lam CHAN ; Tawesak TANWANDEE ; Teng-Yu LEE ; Thi Thanh Nguyen HAI ; Tian YANG ; Woo-Chang LEE ; Henry Lik Yuen CHAN
Clinical and Molecular Hepatology 2023;29(2):277-292
Even though the combined use of ultrasound (US) and alpha-fetoprotein (AFP) is recommended for the surveillance of hepatocellular carcinoma (HCC), the utilization of AFP has its challenges, including accuracy dependent on its cut-off levels, degree of liver necroinflammation, and etiology of liver disease. Though various studies have demonstrated the utility of protein induced by vitamin K absence II (PIVKA-II) in surveillance, treatment monitoring, and predicting recurrence, it is still not recommended as a routine biomarker test. A panel of 17 experts from Asia-Pacific, gathered to discuss and reach a consensus on the clinical usefulness and value of PIVKA-II for the surveillance and treatment monitoring of HCC, based on six predetermined statements. The experts agreed that PIVKA-II was valuable in the detection of HCC in AFP-negative patients, and could potentially benefit detection of early HCC in combination with AFP. PIVKA-II is clinically useful for monitoring curative and intra-arterial locoregional treatments, outcomes, and recurrence, and could potentially predict microvascular invasion risk and facilitate patient selection for liver transplant. However, combining PIVKA-II with US and AFP for HCC surveillance, including small HCC, still requires more evidence, whilst its role in detecting AFP-negative HCC will potentially increase as more patients are treated for hepatitis-related HCC. PIVKA-II in combination with AFP and US has a clinical role in the Asia-Pacific region for surveillance. However, implementation of PIVKA-II in the region will have some challenges, such as requiring standardization of cut-off values, its cost-effectiveness and improving awareness among healthcare providers.
8. Treatment advice of small molecule antiviral drugs for elderly COVID-19
Min PAN ; Shuang CHANG ; Xiao-Xia FENG ; Guang-He FEI ; Jia-Bin LI ; Hua WANG ; Du-Juan XU ; Chang-Hui WANG ; Yan SUN ; Xiao-Yun FAN ; Tian-Jing ZHANG ; Wei WEI ; Ling-Ling ZHANG ; Jim LI ; Fei-Hu CHEN ; Xiao-Ming MENG ; Hong-Mei ZHAO ; Min DAI ; Yi XIANG ; Meng-Shu CAO ; Xiao-Yang CHEN ; Xian-Wei YE ; Xiao-Wen HU ; Ling JIANG ; Yong-Zhong WANG ; Hao LIU ; Hai-Tang XIE ; Ping FANG ; Zhen-Dong QIAN ; Chao TANG ; Gang YANG ; Xiao-Bao TENG ; Chao-Xia QIAN ; Guo-Zheng DING
Chinese Pharmacological Bulletin 2023;39(3):425-430
COVID-19 has been prevalent for three years. The virulence of SARS-CoV-2 is weaken as it mutates continuously. However, elderly patients, especially those with underlying diseases, are still at high risk of developing severe infections. With the continuous study of the molecular structure and pathogenic mechanism of SARS-CoV-2, antiviral drugs for COVID-19 have been successively marketed, and these anti-SARS-CoV-2 drugs can effectively reduce the severe rate and mortality of elderly patients. This article reviews the mechanism, clinical medication regimens, drug interactions and adverse reactions of five small molecule antiviral drugs currently approved for marketing in China, so as to provide advice for the clinical rational use of anti-SARS-CoV-2 in the elderly.
9.Effects of predictive nursing based on group management model in elderly patients with anesthesia
Chunmei LIU ; Ying TENG ; Jie BAO
Chinese Journal of Modern Nursing 2023;29(1):89-92
Objective:To explore the effect of predictive nursing based on group management model on the recovery of elderly anesthesia patients, the quality of postoperative recovery and the complications during the recovery period.Methods:From May 2020 to May 2021, 190 elderly surgical patients admitted to the Postanesthesia Care Unit (PACU) of the First Affiliated Hospital with Nanjing Medical University in the Department of Anesthesia and Perioperative Medicine were selected by the convenient sampling. The patients were randomly divided into observation group and control group with 95 cases each. The control group received routine nursing, while the observation group received predictive nursing based on group management model. Before entering the PACU (before intervention) and before leaving the PACU (after intervention) , the Aldrete Score and the Quality of Recovery 40 Questionnaire (QoR-40) were used to evaluate the patients' recovery and postoperative recovery quality, and the complications of the two groups in the recovery period were recorded and compared.Results:After intervention, the Aldrete score and postoperative recovery quality score of the observation group were higher than those of the control group, and the differences were statistically significant ( P<0.05) . The total incidence of complications in the observation group was 4.21% (4/95) , which was lower than 11.58% (11/95) in the control group with a statistical difference ( P<0.05) . Conclusions:Predictive nursing based on group management model can effectively improve the recovery of elderly anesthesia patients and the quality of postoperative recovery, and reduce the occurrence of complications during the recovery of patients.
10.Diagnostic value of ultrasonography in Poland′s syndrome
Liyuan CUI ; Lishan ZHANG ; Hengtao QI ; Tiezheng WANG ; Lihua LIU ; Shougang BAO ; Xiaofei MU ; Jianbo TENG
Chinese Journal of Ultrasonography 2022;31(2):157-160
Objective:To investigate the diagnostic value of ultrasonography in Poland′s syndrome.Methods:From February 2016 to December 2020, the ultrasonographic images of 15 patients with Poland′s syndrome diagnosed by Provincial Hospital Affiliated to Shandong First Medical University were retrospectively analyzed, and the ultrasonographic features were summarized.Results:High-frequency ultrasound could clearly show the anatomical structures of each layer of the chest wall of the patients with Poland′s syndrome. The sonogram of Poland′s syndrome mainly showed the absence of all or part of the pectoralis major on the affected side, some of which were combined with the absence of pectoralis minor. The difference between the thickness of the affected chest wall and the healthy side was statistically significant ( P<0.01). Among the 15 cases of Poland′s syndrome, 11 cases had brachydactyly or syndactyly. Ultrasound showed that the bifurcation position of the common palmar digital artery of the middle finger was lower than that of the healthy side. Conclusions:The ultrasonography is an effective imaging method for diagnosis of Poland′s syndrome.

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