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.Risk factors analysis and risk prediction model of anxiety and depression in patients with prostate cancer after castration
Xuelian LI ; Weiping DONG ; Song XUE ; Ruiping SU ; Bo LI ; Guojun WU ; Ruixiao LI
Journal of Chinese Physician 2025;27(7):989-993
Objective:To analyze the risk factors of anxiety and depression in prostate cancer patients after castration, and establish a risk prediction model.Methods:A retrospective analysis was conducted on the data of 60 prostate cancer patients treated in Xi′an People′s Hospital from January 2019 to January 2022. The patients were divided into a training group ( n=42) and a validation group ( n=18) at a ratio of 7∶3. The patients received surgical castration and medical castration. One month after castration, the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) were used to evaluate the anxiety symptoms and depression levels of the patients, respectively. Univariate and multivariate logistic regression analyses were used to identify the risk factors for negative emotions in prostate cancer patients after castration, and a risk prediction model was established. Results:In the training group, 19 patients had a SAS score ≥50, and 21 patients had an SDS score ≥50. Based on these scores, the training group was divided into a negative emotion group ( n=19) and an emotional stability group ( n=23). Multivariate logistic regression analysis showed that marital status, castration scheme, and postoperative Visual Analogue Scale (VAS) score were independent influencing factors for negative emotions in prostate cancer patients after castration ( OR=3.589, 3.364, 5.912, all P<0.05). In both the training group and the validation group, the risk scores of patients with negative emotions were significantly higher than those with emotional stability. In the training group, the area under the curve (AUC) of the risk prediction model for predicting negative emotions was 0.747, with a specificity of 71.02% and a sensitivity of 66.11%; in the validation group, the AUC, specificity, and sensitivity were 0.761, 66.59%, and 76.21%, respectively. The Hosmer-Lemeshow test showed that χ 2 was 4.285 6, P value was 0.830, and the c-index was 0.773(0.692-0.854). The calibration curve showed that the predicted curve was basically consistent with the actual curve, indicating that the prediction model had good discriminative ability and accuracy. Decision curve analysis showed that the model had high clinical significance. Conclusions:Marital status, castration scheme, and postoperative VAS score are important factors affecting anxiety and depression in prostate cancer patients after castration, and the regression model can successfully predict the risk of negative emotions.
3.Risk factors analysis and risk prediction model of anxiety and depression in patients with prostate cancer after castration
Xuelian LI ; Weiping DONG ; Song XUE ; Ruiping SU ; Bo LI ; Guojun WU ; Ruixiao LI
Journal of Chinese Physician 2025;27(7):989-993
Objective:To analyze the risk factors of anxiety and depression in prostate cancer patients after castration, and establish a risk prediction model.Methods:A retrospective analysis was conducted on the data of 60 prostate cancer patients treated in Xi′an People′s Hospital from January 2019 to January 2022. The patients were divided into a training group ( n=42) and a validation group ( n=18) at a ratio of 7∶3. The patients received surgical castration and medical castration. One month after castration, the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) were used to evaluate the anxiety symptoms and depression levels of the patients, respectively. Univariate and multivariate logistic regression analyses were used to identify the risk factors for negative emotions in prostate cancer patients after castration, and a risk prediction model was established. Results:In the training group, 19 patients had a SAS score ≥50, and 21 patients had an SDS score ≥50. Based on these scores, the training group was divided into a negative emotion group ( n=19) and an emotional stability group ( n=23). Multivariate logistic regression analysis showed that marital status, castration scheme, and postoperative Visual Analogue Scale (VAS) score were independent influencing factors for negative emotions in prostate cancer patients after castration ( OR=3.589, 3.364, 5.912, all P<0.05). In both the training group and the validation group, the risk scores of patients with negative emotions were significantly higher than those with emotional stability. In the training group, the area under the curve (AUC) of the risk prediction model for predicting negative emotions was 0.747, with a specificity of 71.02% and a sensitivity of 66.11%; in the validation group, the AUC, specificity, and sensitivity were 0.761, 66.59%, and 76.21%, respectively. The Hosmer-Lemeshow test showed that χ 2 was 4.285 6, P value was 0.830, and the c-index was 0.773(0.692-0.854). The calibration curve showed that the predicted curve was basically consistent with the actual curve, indicating that the prediction model had good discriminative ability and accuracy. Decision curve analysis showed that the model had high clinical significance. Conclusions:Marital status, castration scheme, and postoperative VAS score are important factors affecting anxiety and depression in prostate cancer patients after castration, and the regression model can successfully predict the risk of negative emotions.
4.Personalized surgical treatment for portal hypertension based on portal venous hemodynamics
Yang BO ; Mingguo TIAN ; Feng LIU ; Yong YANG ; Baoding LI ; Dong JIA ; Guangming WU ; Guojun XIN
Chinese Journal of Hepatobiliary Surgery 2022;28(4):284-288
Objective:To study the clinical results of personalized surgical treatment for portal hypertension based on portal venous hemodynamics.Methods:A retrospective study was performed on patients with portal hypertension who underwent surgical treatment from January 2016 to December 2020 at the People’s Hospital of Ningxia Hui Autonomous Region and Wuhai People’s Hospital. Of 229 patients included into this study, there were 156 males and 73 females, with age of (4±11) years old. Portal vein CT and ultrasound doppler examination were performed preoperatively and portal vein manometry and ultrasound doppler examination were performed intraoperatively to evaluate portal venous hemodynamics. Based on the evaluation results, different surgical treatments were adopted. Postoperative complications and results of the operations were recorded. Long-term outcomes were evaluated by the rate of recurrence of gastroesophageal varices which was classified as disappearance, mild, moderate and severe according to endoscopic findings.Results:All the 229 patients completed the operations successfully. All together 13 operative treatments were used: (1) simple splenectomy ( n=11); (2) devascularization ( n=176), including 86 patients with splenectomy combined with extensive devascularization, 44 patients with splenectomy combined with selective devascularization and with preservation of paraesophageal veins, 39 patients with splenectomy combined with selective devascularization and reconstruction of spontaneous portosystemic shunt (34 patients with selective devascularization and reconstruction of spontaneous gastrorenal shunt and 5 patients with selective devascularization and reconstruction of spontaneous splenorenal shunt), 4 patients with secondary devascularization for variceal recurrence and 3 patients with devascularization and preservation of spleen; (3) shunt procedures were performed in 42 patients including 21 patients with splenectomy combined with coronary renal shunt, 11 patients with splenectomy combined with coronary-caval shunt, 6 patients with distal splenorenal shunt, 2 patients with proximal splenorenal shunt combined with devascularization, 1 patient with right gastroepiploic vein-inferior vena cava shunt and 1 patient with trans-inferior mesenteric vein coronary renal shunt. There were no operative deaths. The Clavien-Dindo grade 3 and above postoperative complication rate was 6.6% (15/229). Two hundred and eight patients were followed up for 6-60 months, with a median follow-up of 38 months. Severe recurrent varices were found in 21 patients (10.1%, 21/208), with 5 patients (2.4%, 5/208) presented with variceal bleeding. The rate of severe varices after selective shunting and selective devascularization by reconstructing the spontaneous portosystemic shunt (4.2%, 3/72) was significantly lower than that of the other devascularization procedures (13.7%, 17/124)(χ 2=4.53, P=0.033). Conclusion:Better clinical results were achieved by selecting the appropriate surgical procedures based on portal venous hemodynamic characteristics of patients. Selective shunting and selective devascularization by reconstructing the spontaneous portosystemic shunts significantly reduced the recurrence rate of severe varies.
5.Investigation of Intestinal Absorption Characteristics of Multi-index Components of Danggui Buxuetang Based on Drug Absorption Simulating System
Jia ZHANG ; Yuan GAO ; Xiangjie ZHOU ; Wufeng GAO ; Yue ZHOU ; Lixia MA ; Xinya ZHUANG ; Jie DONG ; Wei GU ; Guojun YAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(16):188-195
ObjectiveTo investigate the intestinal absorption characteristics of multi-index components in Danggui Buxuetang with drug absorption simulating system (DASS) established by everted intestinal sac model. MethodThe intestinal absorption solution at different time points after administration of Danggui Buxuetang was collected and detected by high performance liquid chromatography (HPLC), acetonitrile (A)-0.2% glacial acetic acid solution (B) was used as the mobile phase for gradient elution (0-16 min, 15%-23%A; 16-20 min, 23%-28%A; 20-25 min, 28%-30%A; 25-30 min, 30%A; 30-35 min, 30%-65%A; 35-45 min, 65%-95%A), the detection wavelength was 302 nm. HPLC fingerprint of intestinal absorption solution was established and the common peak was calibrated, and the relative cumulative absorption rate of each index component was calculated. The relative cumulative absorption curves of components were fitted with various mathematical models by DDSolver 1.0 to explore the absorption law of different components. ResultThe absorption process of C2 (calycosin-7-glucoside) and C6 in Danggui Buxuetang was in line with zero-order equation, C9 was best fitted by Weibull equation, and the remaining 7 components were in line with Makoid-Banakar equation. C1 with C2, C3, C5, C7 and C10, C2 with C5 and C7, C3 with C4, C5, C7 and C10, C4 with C6 and C10, C5 with C7, C6 with C10, C7 with C10, C8 with C9 were absorbed simultaneously during the absorption process. With the prolongation of time, the overall cumulative absorption rate of Danggui Buxuetang increased. At 120 min, the overall cumulative absorption rate of Danggui Buxuetang exceeded 38%, and reached 49.14% at 180 min. ConclusionTen ingredients in Danggui Buxuetang are absorbed in the jejunum, but absorption law of various components is different, which shows that the intestinal absorption of compound preparations of traditional Chinese medicine (TCM) has multiple characteristics. Intestinal absorption study of TCM compound preparations with chemical composition as the index can reveal some of its absorption law, but it is not complete.
6.Effect of proximal splenic vein ligation on prevention of portal vein thrombosis after splenectomy for portal hypertension
Mingguo TIAN ; Baoding LI ; Guojun XIN ; Dong JIA ; Yafei WANG
Chinese Journal of General Surgery 2021;36(1):39-42
Objective:To evaluate the preventive effect of proximal splenic vein ligation after splenectomy on the splenic vein originated portal vein thrombosis (PVT) in portal hypertension.Methods:The clinical data of 94 patients of portal hypertension who had received splenectomy were retrospectively analysed. The proximal splenic vein was ligated in 36 cases during pericardial devascularization and coronary renal shunt with splenectomy. The other 58 cases who had received pericardial devascularization without proximal splenic vein ligation served as control. All of the patients in both groups were given heparin infusion postoperatively through the catheter which was placed in the right gastroepiploic vein during operation. CT portal veinography was performed at the 7th-14th postoperative day for detection of PVT.Results:None of the PVT occurred in the splenic vein ligation group. In the control group, PVT occurred in 22 cases(38%) and splenic vein thrombosis occurred in all the 58 cases (100%). PVT incidence between the two groups is significantly different (0 vs. 38%, χ 2=17.828, P<0.05). Conclusions:Ligation of the proximal splenic vein during splenectomy can effectively prevent the postoperative splenic vein originated PVT in portal hypertension.
7.An analysis of global research on SARS-CoV-2.
Longhao ZHANG ; Baihong LI ; Peng JIA ; Jian PU ; Bei BAI ; Yin LI ; Peijia ZHU ; Lei LI ; Guojun ZENG ; Xin ZHAO ; Shanshan DONG ; Menghan LIU ; Nan ZHANG
Journal of Biomedical Engineering 2020;37(2):236-245
The SARS-CoV-2 has been spread to 26 countries around the world since its outbreak. By February 16, 2020, more than 68 000 people had been diagnosed with COVID-19. Researchers from all over the world have carried out timely studies on this public health emergency and produced a number of scientific publications. This review aims to re-analyze and summarize the current research findings in a timely manner to guide scholars in relevant fields to further SARS-CoV-2 research and assist healthcare professionals in their work and decision-making. The SARS-CoV-2 related terms were selected in both English and Chinese and were searched in several major databases, including Pubmed, Web of Science, CNKI, Wanfang, and VIP databases. The reference list of each search result was screened for relevance, which was further supplemented to the search results. The included studies were categorized by topics with key characteristics extracted, re-analyzed, and summarized. A total of 301 articles were finally included with 136 in Chinese and 165 in English. The number of publications has rapidly increased since mid-January, 2020, and a peak day was 6th February on which 50 articles were published. The top three countries publishing articles were China, the United States and the United Kingdom. The and its specialty journals have published the most articles, with contribution also from journals such as ( ), ( ), and . All articles were categorized into epidemiology, clinical diagnosis and treatment, basic research, pregnant women and children, mental health, epidemic prevention & control, and others. The literatures related to SARS-CoV-2 are emerging rapidly. It is necessary to sort out and summarize the research topic in time, which has a good reference value for staff in different positions. At the same time, it is necessary to strengthen the judgment of the quality of literatures.
Betacoronavirus
;
Bibliometrics
;
Biomedical Research
;
trends
;
China
;
Coronavirus Infections
;
Humans
;
Pandemics
;
Periodicals as Topic
;
Pneumonia, Viral
;
United Kingdom
;
United States
8.Changing rules of free portal pressure and influencing factors after splenectomy combined with pericardial devascularization
Fudong JIANG ; Mingguo TIAN ; Yong YANG ; Dong JIA ; Mingqi LIU ; Guojun XIN
Chinese Journal of Digestive Surgery 2019;18(4):375-379
Objective To summarize the changing rules of free portal pressure (FPP) after splenectomy combined with pericardial devascularization and investigate its influencing factors.Methods The retrospective cross-sectional study was conducted.The clinicopathological data of 55 patients with portal hypertension who were admitted to the People's Hospital of Ningxia Hui Autonomous Region from January 2016 to September 2018 were collected.There were 39 males and 16 females,aged from 17 to 67 years,with a median age of 46 years.FPP was measured using CT portal vein angiography before splenectomy and intraoperative manometry after cantheterization to the right gastroepiploic veins.Observation indicators:(1) comparison between intraoperative and postoperative FPP;(2) dynamic changes of FPP at the seventh postoperative day;(3) comparison of FPP before and after Valsalva manoeuvre;(4) relationship of FPP with mean arterial pressure and heart rate.Measurement data with normal distribution were represented as Mean ±SD.Repeated measurement data were analyzed using repeated ANOVA.Paired data were analyzed by the paired t test.The linear correlation analysis was done for relevance.Results (1) Comparison between intraoperative and postoperative FPP:55 patients underwent open splenectomy combined with pericardial devascularization.The FPP before splenectomy,after splenectomy combined with pericardial devascularization intraoperatively,at the first and the seventh day postoperatively was (34±6)cmH2O (1 cmH2O=0.098 kPa),(28±6)cmH2O,(34±5)cmH2O and (30±5)cmH2O,respectively,showing a statistically significant difference (F=43.23,P<0.05).The FPP before splenectomy was statistically significant different from the FPP after splenectomy combined with pericardial devascularization intraoperatively,at the first and the seventh day postoperatively,respectively (P < 0.05).The FPP after splenectomy combined with pericardial devascularization intraoperatively was statistically significant different from the FPP at the first and the seventh day postoperatively,respectively (P<0.05).There was a statistically significant difference between FPP at the first and the seventh day postoperatively (P < 0.05).(2) Dynamic changes of FPP at the seventh postoperative day:the FPP was (30 ± 5) cmH2 O,(29 ± 5) cmH2 O,(29 ± 5) cmH2 O,(29 ± 5) cmH2 O,(28 ± 5) cmH2 O,(28± 5) cmH2 O,(28 ± 5) cmH2 O,(29 ± 5) cmH2 O,(29 ± 5) cmH2 O,(30 ± 5) cmH2 O,(30± 5)cmH2O,(30±5)cmH2O,(31±5)cmH2O,(31±5)cmH2O,(31±5)cmH2O,(31±5)cmH2O,(31±5)cmH2O,(32±5)cmH2O,(31±5)cmH2O,(31±5)cmH2O,(31±5)cmH2O,(31±5)cmH2O,(30± 5) cmH2O,(30±5) cmH2O from 00:00 to 24:00 at the seventh day postoperatively.Level of FPP was higher from 12:00 to 21:00 and lower from 01:00 to 08:00,with a peak value at 17:00 and valley value from 04:00 to 06:00.(3) Comparison of FPP before and after Valsalva maneuvre:the FPP was (30± 5) cmH2O and (32± 5) cmH20 before and after Valsalva manoeuvre,respectively,showing a statistically significant difference (t =82.72,P< 0.05).(4) Relationship of FPP with mean arterial pressure and heart rate.Linear correlation analysis showed positive correlations of FPP with mean arterial pressure and heart rate respectively,but the correlation was not significant (r =0.10,0.16,P< 0.05).Conclusions FPP can be reduced significantly after splenectomy combined with pericardial devascularization intraoperatively and it rises briefly again after operation.FPP has regularly circadian fluctuations and is significantly increased by Valsalva Manoeuvre.There is a positive correlation of FPP with mean arterial pressure and heart rate respectively,but the correlation is not significant.
9. Detection of colorectal polyps and adenomas in asymptomatic health examination population and analysis of relevant clinical factors
Lingling LIU ; Guojun WANG ; Dong XU ; Tingting WANG ; Li FU ; Li LI
International Journal of Surgery 2019;46(10):686-691
Objective:
To analysis the incidence and relevant clinical factors of colorectal polyps and adenomas in population of health examination.
Methods:
Colonoscopy results and clinical data of 615 cases undergoing health examination from January 2018 to March 2019 were analyzed retrospectively in International Medical Center, Beijing Friendship Hospital, Capital Medical University.There were 436 males and 179 females, average age 47.38 years, aged 18-81 years. The clinical data contained sex, age, smoking history, drinking history, body mass index.Chi-square test and trend chi-square test were used to compare the differences of polyp detection rate and adenoma detection rate in different populations. Multivariate Logistic regression analysis were applied to explore the potential factors associated with the polyp detection rate and adenoma detection rate.
Results:
Two hundred and forty cases(39.02%) with colorectal disease were checked out, include 206 cases(33.50%) with colorectal polyps and 138 cases(22.44%) with colorectal adenomas. In the detection rate of colorectal polyps, male were higher than female[36.70%(160/436)
10.Research development of post-traumatic growth in patients with spinal cord injury
Xueying GAO ; Guojun DONG ; Haichen SUN ; Yanhui WAN ; Huilin CHENG
Chinese Journal of Practical Nursing 2018;34(17):1344-1347
The article describes the epidemiology of spinal cord injury (SCI), the measurement methods and affecting factors of post-traumatic growth of SCI patients and treatment strategy of promoting post-traumatic growth of SCI patients. The purposes of the article are to provide help of promote positive psychological changes and improve the quality of life of SCI patients.

Result Analysis
Print
Save
E-mail