1.Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study.
Chao QUAN ; Hongyu ZHOU ; Huan YANG ; Zheng JIAO ; Meini ZHANG ; Baorong ZHANG ; Guojun TAN ; Bitao BU ; Tao JIN ; Chunyang LI ; Qun XUE ; Huiqing DONG ; Fudong SHI ; Xinyue QIN ; Xinghu ZHANG ; Feng GAO ; Hua ZHANG ; Jiawei WANG ; Xueqiang HU ; Yueting CHEN ; Jue LIU ; Wei QIU
Chinese Medical Journal 2025;138(4):452-458
BACKGROUND:
Disease-modifying therapies have been approved for the treatment of relapsing multiple sclerosis (RMS). The present study aims to examine the safety of teriflunomide in Chinese patients with RMS.
METHODS:
This non-randomized, multi-center, 24-week, prospective study enrolled RMS patients with variant (c.421C>A) or wild type ABCG2 who received once-daily oral teriflunomide 14 mg. The primary endpoint was the relationship between ABCG2 polymorphisms and teriflunomide exposure over 24 weeks. Safety was assessed over the 24-week treatment with teriflunomide.
RESULTS:
Eighty-two patients were assigned to variant ( n = 42) and wild type groups ( n = 40), respectively. Geometric mean and geometric standard deviation (SD) of pre-dose concentration (variant, 54.9 [38.0] μg/mL; wild type, 49.1 [32.0] μg/mL) and area under plasma concentration-time curve over a dosing interval (AUC tau ) (variant, 1731.3 [769.0] μg∙h/mL; wild type, 1564.5 [1053.0] μg∙h/mL) values at steady state were approximately similar between the two groups. Safety profile was similar and well tolerated across variant and wild type groups in terms of rates of treatment emergent adverse events (TEAE), treatment-related TEAE, grade ≥3 TEAE, and serious adverse events (AEs). No new specific safety concerns or deaths were reported in the study.
CONCLUSION:
ABCG2 polymorphisms did not affect the steady-state exposure of teriflunomide, suggesting a similar efficacy and safety profile between variant and wild type RMS patients.
REGISTRATION
NCT04410965, https://clinicaltrials.gov .
Humans
;
Crotonates/adverse effects*
;
Toluidines/adverse effects*
;
Nitriles
;
Hydroxybutyrates
;
Female
;
Male
;
Adult
;
ATP Binding Cassette Transporter, Subfamily G, Member 2/genetics*
;
Middle Aged
;
Multiple Sclerosis, Relapsing-Remitting/genetics*
;
Prospective Studies
;
Young Adult
;
Neoplasm Proteins/genetics*
;
East Asian People
2.Application of tNGS in patients with influenza A
Qing SUN ; Ying FENG ; Yali QIU ; Guojun ZHENG
Chongqing Medicine 2025;54(11):2612-2615,2620
Objective To explore the application value of targeted next-generation sequencing(tNGS)in the detection of influenza A virus.Methods A retrospective analysis was conducted on the clinical data of 116 patients suspected of having influenza A at our hospital from October 2024 to February 2025.All patients underwent sputum tNGS and throat swab influenza nucleic acid tests due to fever and pulmonary infection,and the diagnostic efficacy of the two methods was compared.Results Among 116 patients,93 were diagnosed with influenza A.Among these 93 influenza A patients,the detection rate of tNGS was higher than that of in-fluenza nucleic acid testing(P<0.05).The results of tNGS and influenza nucleic acid testing for influenza A showed significant consistency with the confirmed diagnosis(P<0.05).There was a statistically significant difference in tNGS sequence counts between the influenza nucleic acid-positive and negative groups(P<0.05).Twenty-three patients excluded from influenza A diagnosis served as the control group.Comparisons of white blood cell(WBC)counts among the influenza nucleic acid-positive group,negative group,and control group showed statistically significant differences(P<0.05),whereas comparisons of C-reactive protein(CRP)and serum amyloid A(SAA)showed no statistically significant differences(P>0.05).Conclusion tNGS demonstrates significant advantages in detecting influenza A virus.Combined with peripheral blood infection-related in-dicators for comprehensive diagnosis,it may provide a more effective approach for early diagnosis and treatment of influenza virus infectious diseases.
3.Correlation between serum lncRNA ANRIL and CNOT2 and clinicopathological characteristics and prognosis in elderly patients with breast cancer
Weigang MOU ; Li GAO ; Guojun QIU
International Journal of Laboratory Medicine 2025;46(19):2391-2396
Objective To analyze serum levels of long chain non coding RNA(lncRNA)ANRIL,CCR4-NOT transcription complex subunit 2(CNOT2)in breast cancer patients and their relationship with clinico-pathological characteristics and prognosis.Methods From February 2018 to February 2021,a total of 126 eld-erly patients with breast cancer in the hospital were selected as the breast cancer group.According to whether tumor progression occurred during follow-up,the patients were divided into poor prognosis group(n=26)and good prognosis group(n=100).60 old healthy female people who underwent physical examination during the same time were taken as control group.Statistical analysis was used to study the differences of serum lncRNA ANRIL and CNOT2 levels in patients with different clinical and pathological characteristics.The prognostic factors of elderly patients with breast cancer were conducted by Kaplan-Meier curve and Cox regression analy-sis.Receiver operating characteristic curve was drawn to assess the prognostic value of serum lncRNA ANRIL and CNOT2 in elderly patients with breast cancer.Results The levels of serum lncRNA ANRIL and CNOT2 in the breast cancer group were higher than those in the control group(P<0.05).The serum lncRNA AN-RIL and CNOT2 levels in patients with TNM stage Ⅲ and histological grade Ⅲ were higher than those in pa-tients with TNM stage Ⅰ-Ⅱ and histological grade Ⅰ—Ⅱ(P<0.05).The level of serum lncRNA ANRIL and CONT2 in poor prognosis group were higher than that in the good prognosis group(P<0.05).The 3-year progression free survival rates of lncRNA ANRIL high and low expression group,CNOT2 high and low expression group were 66.67%(40/60),90.91%(60/66)and 66.13%(41/62),92.19%(59/64),respective-ly,with statistically significant differences(P<0.05).TNM stage Ⅲ,histological grade Ⅲ,serum lncRNA ANRIL and CNOT2 were risk factors affecting the prognosis of elderly patients with breast cancer(P<0.05).The area under the curve of serum lncRNA ANRIL and CNOT2 combined in assessment of prognosis in elderly patients with breast cancer was higher than that of lncRNA ANRIL and CNOT2 alone(P<0.05).Conclusion The expression of serum lncRNA ANRIL and CNOT2 in elderly breast cancer are up-regulated,which are related to TNM stage and histological grading,and are markers to evaluate the prognosis of elderly patients with breast cancer.
4. Clinical Characteristics and Survival of Primary Duodenal Lymphoma: Analysis Based on SEER Database
Qiu QIU ; Hong PENG ; Wensheng WANG ; Guojun LI
Chinese Journal of Gastroenterology 2021;26(1):9-16
Background: Primary duodenal lymphoma (PDL) is a rare extranodal malignant lymphoma. Till now, there are insufficient data regarding its clinical characteristics and prognosis. Aims: To analyze the clinical characteristics and prognostic factors of PDL based on SEER database. Methods: Patients diagnosed as PDL between 1975 and 2015 were evaluated via data collected from the SEER database. The demographic, clinical, pathological features and survival time were reviewed. Survival analysis was conducted by using Kaplan-Meier method. Univariate and multivariate Cox regression analyses were applied to identify the survival predictors. Results: A total of 1 659 patients with PDL were enrolled in the study. The median age was 64 years, and the median survival time was 40 months. The overwhelming majority of PDLs were B-cell non-Hodgkin lymphomas (B-NHL), of which, follicular lymphoma (36.0%) and diffuse large B-cell lymphoma (DLBCL; 30.5%) accounting for approximately two thirds of the PDL patients. The 1-, 3-, 5-, and 10-year overall survival rates were 49.2%, 39.0%, 31.4%, and 13.8%, respectively. The prognosis of T-cell non-Hodgkin lymphoma (T-NHL) had a worse survival than B-NHL, and the prognosis of DLBCL was the worst in B-NHL. In multivariate Cox regression analysis, male gender, old age (>65 years), divorced/widowed or unmarried, T-NHL, and advanced clinical stage were identified as the independent risk factors for poor overall and tumor-specific survival in PDL patients, while diagnosed after 1997 (rituximab launch date) was an independent protective factor (all P<0.05). Conclusions: The prognosis of PDL patients is independently correlated with the gender, age, marital status, time of diagnosis, as well as the tumor pathological type and clinical stage. Early diagnosis of DLBCL and T-NHL may prolong the survival time. Immunotherapy such as rituximab may also improve the survival.
5.Change of plasma Apelin level in patients with acute pancreatitis and its clinical significance
Qiu QIU ; Guojun LI ; Hong PENG ; Lianyun YANG
Chongqing Medicine 2018;47(1):40-42
Objective To explore the change of plasma Apelin level in the patients with acute pancreatitis(AP) and its clinical significance.Methods Fifty cases of AP in the hospital from July 2015 to June 2016 were collected as the AP group and divided into the mild AP group(MAP) and severe AP group(SAP).Other contemporaneous 30 healthy volunteers undergoing physical examination were selected as the control group.The differences in Apelin-13,Apelin-36 and C reactive protein(CRP) levels on admission and were APACHE Ⅱ score were compared between the two groups.The correlation between Apelin-13 and Apelin-36 with APACHE Ⅱ score was analyzed.The differences of plasma CRP,Apelin-13 and Apelin-36 levels on 4 d after admission were compared between the MAP group and SAP group.Results Plasma Apelin-36,Apelin-36 and CRP levels and APACHE Ⅱ score on admission in the AP group were significantly higher than that in the control group(P<0.05),plasma Apelin-13,Apelin-36 and CRP levels and APACHE Ⅱ score in the SAP group were significantly higher than those in the MAP group(P<0.05),the plasma Apelin-13 and Apelin-36 levels were positively correlated with the APACHE Ⅱ score(P<0.05);the plasma Apelin-36,Apelin-36 and CRP levelson 4 d after admission in the SAP group were higher than those in the MAP group(P<0.05).Conclusion Early stage of AP has the changes of plasma Apelin-13 and Apelin-36 levels,which are closely correlated with the severity of disease.
6.Prediction on the axillary lymph node metastasis for breast cancer patients
Huancheng ZENG ; Siqi QIU ; Wenhe HUANG ; Guojun ZHANG
Journal of International Oncology 2015;42(11):852-855
Axillary lymph node status isone of the most important prognostic factors for the patients with breast cancer.Physical examination combining with ultrasound, mammography, CT, MRI and PET-CT can improve the predictive efficiency, but there is still high false negative rate.Ultrasound-guided fine-needle aspiration for axillary lymph node can improve preoperative diagnostic rate effectively.Using mathematical and statistical methods, building models for predicting sentinel lymph node or non-sentinel lymph node status with clinicopathological features helps to calculate the risk of lymph node involvement.Whether screening out patients with low risk of lymph node involvement avoiding axillary surgery is safe or not is still to be evaluated by relevant clinical trials.
7.Value of color Doppler flow imaging and Doppler power imaging in diagnosis of choroidal detachment
Guojun LIU ; Weiqiang KANG ; Yijie QIU
Chinese Journal of Ultrasonography 2003;0(08):-
Objective To investigate value of color Doppler flow imaging(CDFI) and Doppler power imaging(CDPI) in the diagnosis of choroidal detachment(CD). Methods Color Doppler ultrasound was performed in 30 cases with choroidal detachment. At the base of eyeball shape, lens, vitreous and retina examined by ultrasound, intraocular band-shaped echo was examined by CDFI and CDPI, to understand its blood flow. The observation was compared with that of surgical results. Results Of 30 cases with choroidal detachment, the diagnostic positive correspondonce of ultrasound was 80.0%, while ultrasound combined with CDFI and CDPI, the correspondence increased up to 96.7%. The sonographic features of CDFI and CDPI in choroidal detachment patients were abundant blood flow in band-shape or short stick-like. In 3 cases out of 4 cases with retinal detachment, blood flow was not abundant,their blood flow showed a sparked pattern. In addition, 14 cases combined with vitreous hemorrhage, 8 cases had vitreous opacity and 4 cases vitreous proliferation. Ultrasound diagnosis corresponded with that of clinical surgery in 27 choroidal detachment cases. Conclusions Ultrasound combined with CDFI and CDPI provide valuable references for diagnosis and treatment of choroidal detachment.
9.Value of ultrasound on diagnosis of posterior dislocation of the lens
Guojun LIU ; Weiqiang KANG ; Yijie QIU ; Al ET
Chinese Journal of Ultrasonography 1993;0(04):-
ObjectiveTo investigate the value of ultrasound on the diagnosis of posterior dislocation of the lens. MethodsThe eyes of 38 patients with different kinds of posterior dislocation of the lens were examined by color Doppler ultrasound to understand location, forms, and echogram of the lens and relation with their environmental tissues. ResultsOf 38 cases, 13 cases with complete posterior dislocation of the lens, 3 cases with posterior dislocation of intraocular lens, and 22 cases with incomplete posterior dislocation of the lens were proved. Also, 4 cases with vitreous hemorrhage, 13 cases with vitreous opacity and fibrous membrane, 15 cases with posterior detachment of the vitreous, 3 cases with retinal detachment were found. In addition, 33 cases underwent vitrectomy combining lensectomy or removal of the lens, among them, diagnostic ratio of ultrasound was 100%. ConclusionsHigh practical value is shown in posterior dislocation of the lens by ultrasound as one of the important methods on the diagnosis. At the same time, it provides valuable references for choosing surgical methods of posterior dislocation of the lens.
10.Discussion on the Barriers to Entry Into International Pharmaceutical Industry
China Pharmacy 1991;0(05):-
OBJECTIVE:To discuss the barriers to entry of pharmaceutical industry of our country into international market.METHODS:Directed by the theory of the barriers to entry of the industry organization theory,the barriers to entry into the international pharmaceutical industry was ordered by using the methods of the excess profit,the enterprise numbers,and the proportion of enterprise scale.RESULTS:The barriers to entry into the international chemical pharmaceutical industry and the medical instrument industry are the highest in the sequence of pharmaceutical industry.CONCLUSION:At the time that the industry of our country is reforming,we should regulate and direct the pharmaceutical industry right by using the theory of the industry organization.

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