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
;
Drug Therapy, Combination
;
Methotrexate/adverse effects*
;
Treatment Outcome
;
Sulfonamides
2.COVID-19 vaccination status and its impact on psoriatic lesions in patients with psoriasis treated with biologics: a single-center cross-sectional study
Ying YANG ; Qing GUO ; Suchun HOU ; Xue MIN ; Jiabin TIAN ; Zhuhui QIAO ; Jialin LIN ; Xiaofei WANG ; Lantuya WU ; Zhenying ZHANG ; Zhengfeng LI ; Bin WANG ; Xiaoming LIU
Chinese Journal of Dermatology 2023;56(1):59-63
Objective:To investigate COVID-19 vaccination status and relevant adverse reactions in patients with psoriasis treated with biological agents, and to explore the effect of COVID-19 vaccination on psoriatic lesions.Methods:Clinical data were collected from 572 psoriasis patients aged 18 - 60 years, who were registered in the management system of psoriasis patients treated with biological agents in the University of Hong Kong-Shenzhen Hospital from May 2019 to June 2021. The COVID-19 vaccination status was investigated by telephone interviews, and the vaccination-related information was obtained by fixed healthcare workers during a fixed time period according to a predesigned questionnaire. Measurement data were compared between two groups by using t test, and enumeration data were compared by using chi-square test or Fisher′s exact test. Results:The COVID-19 vaccination coverage rate was 43.13% (226 cases) among the 524 patients who completed the telephone interview, and was significantly lower in the biological agent treatment group (30.79%, 105/341) than in the traditional drug treatment group (66.12%, 121/183; χ2 = 60.60, P < 0.001) . The main reason for not being vaccinated was patients′ fear of vaccine safety (49.66%, 148/298) , followed by doctors′ not recommending (26.51%, 79/298) . In the biological agent treatment group after vaccination, the exacerbation of psoriatic lesions was more common in patients receiving prolonged-interval treatment (42.86%, 6/14) compared with those receiving regular treatment (4.40%, 4/91; Fisher′s exact test, P < 0.001) . Skin lesions were severely aggravated in two patients after COVID-19 vaccination, who ever experienced allergic reactions and whose skin lesions did not completely subside after the treatment with biological agents. Conclusions:The COVID-19 vaccination coverage rate was relatively low in the psoriasis patients treated with biological agents, and no serious adverse reaction was observed after vaccination. Prolonged-interval treatment due to COVID-19 vaccination ran the risk of exacerbation of skin lesions.
3.Totally endoscopic vs open thyroidectomy for differentiated thyroid cancer
Yiming CAO ; Yaqiang ZHUANG ; Jiapeng HUANG ; Tao ZHOU ; Jialin QING ; Danying WANG
Chinese Journal of General Surgery 2021;36(6):421-425
Objective:To compare toally endoscopic thyroidectomy(TET) with open thyroidectomy(OT) in the treatment of differentiated thyroid cancer.Methods:Data of 190 patients at Liuzhou People's Hospital from Jul 2017 to Dec 2019 were analyzed. Patients were divided into endoscopic surgery group ( n=95) and open surgery group ( n=95). Results:The operation time and the hospital stay in endoscopic group were longer than that in open surgery group[(153±25) min vs. (116±17) min, (5.56±1.08) d vs.(5.08±1.04) d, t=11.827,3.083, both P<0.05)]. There was no significant difference in intraoperative blood loss [(33±14) ml vs. (37±16) ml, t=-1.851 P>0.05], recurrent laryngeal nerve paralysis, hypoparathyroidism and wound complications (4% vs. 9%, 9% vs. 15%,1% vs. 3%, all P>0.05). There was no significant difference in the number of central lymph node dissection between the two groups (6.12±3.54 vs. 6.35±4.75, t=-0.404, P<0.05). The length of scar in endoscopic group was shorter [(3.03±0.27) cm vs. (6.47±0.53) cm, t=-56.138, P<0.05), and the postoperative cosmetic score evaluated by the patients was higher (8.76±0.75 vs. 7.39±0.76, P<0.05), than those in open group. There were no tumor recurrence nor metastasis in neither group by short term follow-up. Conclusions:TET is similar to OT on clinical curative effectiveness for differentiated thyroid carcinoma while carries a better cosmetic result .
4.Exploring on Source of Fu-Zheng Therapy as Major Traditional Chinese Medicine Cancer Treatment
Jialin YAO ; Qing WANG ; Ling XU
World Science and Technology-Modernization of Traditional Chinese Medicine 2013;(5):1089-1095
Fu-Zheng Pei-Ben therapy, as a major therapeutic principle, has become the main guiding thought of cancer therapy currently. Through the traditional Chinese medicine (TCM) history, Fu-Zheng Pei-Ben thera-py is one of the most important therapies . As early as the Spring and Autumn Period , the importance of vital qi has been recorded in the Huang-Di Nei-Jing. After that, TCM doctors have enriched the connotation and extension of the Fu-Zhe ng therapy . Until modern times , Professor Liu Jiaxiang applied Fu-Zhe ng therapy to the treatment of cancer . This paper explained the sources of Fu-Zhe ng cancer therapy through the analy-sis of its history in order to provide a reference to deepen the theoretical studies in the diagnosis and treat-ment of cancer in the future .
5.Study on intervention and comparison of rational use of antibiotics on perioperative period of clean incision and clean-defiled incision.
Yuqin WANG ; Lihong WANG ; Yanxia XU ; Shujie WANG ; Jialin WANG ; Ping JIANG ; Fei LI ; Haiou SHI ; Hailian WANG ; Jingli ZHANG ; Lianzhen CHEN ; Jiang LIU ; Qing WANG
Chinese Journal of Epidemiology 2002;23(4):301-303
OBJECTIVETo explore a set of scientific evaluation and intervention methods on perioperatur period which fits for China's situation, and to promote the development of rational drug use.
METHODSTwo would tertiary general hospitals were selected and separated in to intervention group and control group. Intervention was carried out and compared at the same period on inpatient surgical cases of thryroidectomy, mastectomy, cholescystectomy, and hysteromyomectomy plus appendix.
RESULTSThe average drug costs was decreased from 1 601.27 yuan to 1 489.59 yuan and the average antibiotics use from 740.20 yuan to 352.03 yuan (P < 0.01) in the intervention group pre and post intervention. There was a remarkable improvement on the rationality of antibiotics use in intervention group, from 31.35% to 91.81% (P < 0.01) pre and post intervention, implemented in the hospital.
CONCLUSIONIt is practicable and effective to implement rational drug use where intervention was carried out, since it plays an active role on promoting safely, effectively and economic antibiotic use in China.
Anti-Bacterial Agents ; economics ; therapeutic use ; Drug Costs ; Drug Utilization ; economics ; General Surgery ; Humans ; Perioperative Care

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