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
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Crotonates/adverse effects*
;
Toluidines/adverse effects*
;
Nitriles
;
Hydroxybutyrates
;
Female
;
Male
;
Adult
;
ATP Binding Cassette Transporter, Subfamily G, Member 2/genetics*
;
Middle Aged
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Multiple Sclerosis, Relapsing-Remitting/genetics*
;
Prospective Studies
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Young Adult
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Neoplasm Proteins/genetics*
;
East Asian People
2.Comparison of the therapeutic efficacy of different methods of anesthesia in microscopic varicocelectomy for the treatment of varicocele.
Qun-Sheng LI ; Ning-Hua LI ; Lei ZHOU ; Dong-Run LI ; Jie LU ; Chun-Yan HE ; Yu-Nu ZHOU ; Jian-Mo CHEN ; Wen-Tao YANG
National Journal of Andrology 2025;31(8):692-697
OBJECTIVE:
To compare the therapeutic efficacy and safety of local anesthesia and spinal anesthesia for the patients with varicocele (VC) who underwent microsurgical varicocelectomy (MV).
METHODS:
We retrospectively analyzed the data of VC patients who underwent MV treatment at the Andrology Department of the Affiliated Ruikang Hospital of Guangxi University of Chinese Medicine from May 2020 to March 2023. Cases with complete clinical data and follow-up evaluation were selected and divided into a control group (spinal anesthesia) and an observation group (local anesthesia) according to different anesthesia methods. The surgical time (including anesthesia time), visual analogue scale (VAS) score for pain, hospital stay, treatment cost, sperm concentration, forward motile sperm rate, and normal sperm morphology rate after three months of surgery, as well as postoperative complications and recurrence rate were compared between the two groups.
RESULTS:
A total of 107 eligible cases were included, with 56 cases in the control group and 51 cases in the observation group. There was no significant difference in the VAS score for pain during and after four hours of surgery, as well as postoperative complications, and recurrence rate between the two groups (P> 0.05). There was an significant increase in sperm concentration, forward motile sperm rate, and normal sperm morphology rate in both of two groups after three months of surgery (P<0.05). However, there was no significant difference between the two groups three months after surgery (P>0.05). The surgical time and hospital stay were shorter than those of the control group (P<0.05). And the treatment cost in observation group was lower than that of the control group (P<0.05).
CONCLUSION
Both local anesthesia and lumbar anesthesia for MV treatment of VC have good efficacy and safety. However, patients treated with MV under local anesthesia for VC have obvious advantages in terms of operation time (including anesthesia time), hospital stay, and treatment cost, which is worthy of clinical promotion and application.
Humans
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Male
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Varicocele/surgery*
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Retrospective Studies
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Microsurgery
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Anesthesia, Spinal
;
Adult
;
Treatment Outcome
;
Anesthesia, Local
3.Expert consensus on the application of nasal cavity filling substances in nasal surgery patients(2025, Shanghai).
Keqing ZHAO ; Shaoqing YU ; Hongquan WEI ; Chenjie YU ; Guangke WANG ; Shijie QIU ; Yanjun WANG ; Hongtao ZHEN ; Yucheng YANG ; Yurong GU ; Tao GUO ; Feng LIU ; Meiping LU ; Bin SUN ; Yanli YANG ; Yuzhu WAN ; Cuida MENG ; Yanan SUN ; Yi ZHAO ; Qun LI ; An LI ; Luo BA ; Linli TIAN ; Guodong YU ; Xin FENG ; Wen LIU ; Yongtuan LI ; Jian WU ; De HUAI ; Dongsheng GU ; Hanqiang LU ; Xinyi SHI ; Huiping YE ; Yan JIANG ; Weitian ZHANG ; Yu XU ; Zhenxiao HUANG ; Huabin LI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(4):285-291
This consensus will introduce the characteristics of fillers used in the surgical cavities of domestic nasal surgery patients based on relevant literature and expert opinions. It will also provide recommendations for the selection of cavity fillers for different nasal diseases, with chronic sinusitis as a representative example.
Humans
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Nasal Cavity/surgery*
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Nasal Surgical Procedures
;
China
;
Consensus
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Sinusitis/surgery*
;
Dermal Fillers
4.Effect of laparoscopic salpingectomy on ovarian reserve function and serum neuropeptide Y and cortisol in patients with ectopic pregnancy
Rong SHI ; Xianfang ZHENG ; Qun TAO ; Junmo CHEN ; Xiaohua GE
The Journal of Practical Medicine 2024;40(6):801-806
Objective To explore the effect of laparoscopic salpingectomy on ovarian reserve function and serum neuropeptide Y(NPY)and cortisol(Cor)in patients with ectopic pregnancy.Methods 82 patients with ectopic pregnancy who had visited Chaohu Hospital Affiliated to Anhui Medical University from June 2018 to June 2021 were randomly divided into two groups,with 41 in each group.The control group underwent laparoscopic salpingostomy and suturing for embryo retrieval,while the study group underwent laparoscopic salpingectomy.Surgical duration,intraoperative blood loss,time to postsurgical mobilization,length of hospital stay,serum NPY and Cor levels,antral follicle count(AFC),indexes for peak flow velocity and resistance of ovarian artery were compared between the two groups.Follow-up was conducted for two years after surgery,and the success rate of pregnancy and the ectopic pregnancy rate were recorded.Results The surgical duration in the study group was shorter than that in the control group(P<0.05).The differences in serum NPY and Cor values between the two groups immediately after surgery and at postoperative week one were not statistically significant(P>0.05).At postoperative months1 and 6,the peak flow velocity of the affected ovary was lower in the study group than in the control group,whereas the resistance index was higher(P<0.05).At postoperative month 6,both groups showed an increase in peak flow velocity and a decrease in resistance index(P<0.05).There were no statistically signifi-cant differences in AFC and the success rate of pregnancy between the two groups postoperatively(P>0.05).The ectopic pregnancy rate in the study group was lower than that in the control group(P<0.05).Conclusion As compared with laparoscopic salpingostomy,laparoscopic salpingectomy for ectopic pregnancy can also preserve postoperative ovarian antral follicle count(AFC),and it has greater advantage in reducing the risk of recurrent ectopic pregnancy after surgery.
5.Surgical strategy for treatment of complex aortic coarctation
Xiaohan XU ; Miti WU ; Faliang ZHAN ; Tao YE ; Yizhou GAO ; Weidong GU ; Qun GU ; Yongfeng SHAO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(05):776-781
Objective To summarize the clinical experience of the treatment for complex aortic coarctation with extra anatomic bypass and anatomic correction techniques. Methods The clinical data of patients with complex aortic coarctation treated in the First Affiliated Hospital of Nanjing Medical University and Friendship Hospital of Ili Kazakh Autonomous Prefecture between April 2012 and November 2020 were retrospectively reviewed. Results A total of 12 patients were enrolled, including 5 males and 7 females aged 11-54 (34.3±16.2) years. Extra anatomic bypass grafting was performed in 8 patients and anatomic correction was performed in 4 patients. The operations were successful in all patients. There was no perioperative death. The average cardiopulmonary bypass time was 203.0±46.0 min (7 median incision patients), and the average intraoperative blood loss was 665.0±102.0 mL. The average postoperative ventilator support time was 32.3±7.5 h, and the average postoperative hospital stay time was 10.2±4.3 d. The mean drainage volume of median incision was 1 580.0±360.0 mL, and the mean drainage time was 9.3±2.7 d. The mean drainage volume of left thoracotomy was 890.0±235.0 mL, and the mean drainage time was 4.8±2.5 d. One patient had a transient hoarse after operation and recovered 6 months later. The follow-up period ranged from 2 to 10 years with an average time of 81.0±27.0 months. All patients had a recovery of hypertension, cardiac afterload after 2 years postoperatively. One patient who received an artificial blood vessel replacement in situ was examined stenosis recurrence at the third year after discharge. Others were asymptomatic during the follow-up period. There were no death or other complications. Conclusion The treatment strategy for complex aortic coarctation should be individualized according to the anatomical features and concomitant heart diseases. Extra anatomic bypass technique is a safe and feasible choice.
6.Research progress of thermal ablation in the treatment of thyroid micropapillary carcinoma
Jin LIU ; Xiaoping WANG ; Lindi QU ; Qun WANG ; Ying GAO ; Yuan GU ; Yifei GONG ; Tao LI ; Xiaodan TANG ; Kunhe SHI
Journal of Xi'an Jiaotong University(Medical Sciences) 2024;45(6):1041-1046
Thyroid cancer is the most common malignant tumor of the head and neck, among which papillary thyroid carcinoma is the most common. Papillary thyroid carcinoma with a diameter of ≤ 1.0 cm is called thyroid micropapillary carcinoma. In recent years, thermal ablation technology for the treatment of thyroid micropapillary carcinoma has developed rapidly at home and abroad. At present, many guidelines, consensus and clinical studies related to thermal ablation treatment of thyroid micropapillary carcinoma have been published at home and abroad. Based on the existing literature, guidelines and clinical studies, this article summarizes, discusses and analyzes the advantages, indications, efficacy, safety, and existing problems of thermal ablation therapy for thyroid cancer.
7.Association between prenatal exposure to PM 2.5 and fetal growth: a prospective cohort study
Lei HUANG ; Hong LYU ; Xin XU ; Tianyu SUN ; Yiyuan CHEN ; Yanjie ZHANG ; Bo YANG ; Qun LU ; Yangqian JIANG ; Tao JIANG ; Jiangbo DU ; Xiaoyan WANG ; Hongxia MA ; Zhibin HU ; Yuan LIN
Chinese Journal of Epidemiology 2024;45(6):794-801
Objective:To investigate the association of exposure to PM 2.5 and its constituents during pregnancy and fetal growth and to further identify critical windows of exposure for fetal growth. Methods:We included 4 089 mother-child pairs from the Jiangsu Birth Cohort Study between January 2016 and October 2019. Data of general characteristics, clinical information, daily average PM 2.5 exposure, and its constituents during pregnancy were collected. Fetal growth parameters, including head circumference (HC), abdominal circumference (AC), and femur length (FL), were measured by ultrasound after 20 weeks of gestation, and then estimated fetal weight (EFW) was calculated. Generalized linear mixed models were adopted to examine the associations of prenatal exposure to PM 2.5 and its constituents with fetal growth. Distributed lag nonlinear models were used to identify critical exposure windows for each outcome. Results:A 10 μg/m 3 increase in PM 2.5 exposure during pregnancy was associated with a decrease of 0.025 ( β=-0.025, 95% CI: -0.048- -0.001) in HC Z-score, 0.026 ( β=-0.026, 95% CI: -0.049- -0.003) in AC Z-score, and 0.028 ( β=-0.028, 95% CI:-0.052--0.004) in EFW Z-score, along with an increased risk of 8.5% ( RR=1.085, 95% CI: 1.010-1.165) and 13.5% ( RR=1.135, 95% CI: 1.016-1.268) for undergrowth of HC and EFW, respectively. Regarding PM 2.5 constituents, prenatal exposure to black carbon, organic matter, nitrate, sulfate (SO 42-) and ammonium consistently correlated with decreased HC Z-score. SO 42- exposure was also associated with decreased FL Z-scores. In addition, we found that gestational weeks 2-5 were critical windows for HC, weeks 4-13 and 19-40 for AC, weeks 4-13 and 23-37 for FL, and weeks 4-12 and 20-40 for EFW. Conclusions:Our findings demonstrated that exposure to PM 2.5 and its constituents during pregnancy could adversely affect fetal growth and the critical windows for different fetal growth parameters are not completely consistent.
8.Coronary artery perforation after using shockwave balloon during percutaneous coronary intervention treatment:a case report
Chen-Ji XU ; Fei LI ; Fa ZHENG ; Bin ZHANG ; Feng-Xia QU ; Jian-Meng WANG ; Ya-Qun ZHOU ; Xian-Liang LI ; Song-Tao WANG ; Yan SHAO ; Chang-Hong LU
Chinese Journal of Interventional Cardiology 2024;32(7):405-408
Coronary perforation is when a contrast agent or blood flows outside a blood vessel through a tear in a coronary artery.In this case,we reported a case of percutaneous coronary intervention for coronary calcified lesions,which led to iatrogenic coronary perforation and cardiac tamponade after the use of Shockwave balloon to treat intracoronary calcified nodules,and the management of PCI-related CAP was systematically reviewed through the literature.
9.A case of hyperdivergent and bimaxillary protrusion treated with Clear alingers
Piao XIE ; Tao SHEN ; Mengying GUO ; Qun SHI ; Jian LIU
Journal of Practical Stomatology 2024;40(3):439-442
In this paper,a case of a hyperdivergent and bimaxillary protrusion with individual teeth cross bite in the anterior region treated by invisible orthodontic appliances was reported.At the end of the treatment,the teeth were aligned,the face profile of the patient was im-proved and the overbite and overjet were normal.
10.Clinical Observation of Xiaoying Sanjie Granules in the Treatment of Benign Thyroid Nodules with Qi Stagnation and Phlegm Obstruction Type
Yu-Xi ZHOU ; Tao-Qing YIN ; Shuai XU ; Jun-Wei WU ; Ren-Qun YE
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(7):1750-1756
Objective To observe the efficacy and safety of Xiaoying Sanjie Granules(derived from the modified Sini San and Banxia Houpo Decoction)in the treatment of patients with benign thyroid nodules of qi stagnation and phlegm obstruction type.Methods A retrospective study was conducted.According to the treatment methods,60 patients with benign thyroid nodules of qi stagnation and phlegm obstruction type were divided into observation group and control group,30 cases in each group.The control group was given health training alone,and the observation group was given oral use of Xiaoying Sanjie Granules on the basis of treatment for the control group.The course of treatment covered 12 weeks.The changes of traditional Chinese medicine(TCM)syndrome scores,maximum cross-section diameter of the thyroid nodule and thyroid function indexes of thyroid stimulating hormone(TSH),free triiodothyronine(FT3)and free thyroxine(FT4)in the two groups before and after treatment were observed.After treatment,the clinical efficacy and adverse reactions were compared between the two groups.Results(1)After 12 weeks of treatment,the total effective rate of the observation group was 73.33%(22/30),and that of the control group was 10.00%(3/30).The intergroup comparison(tested by chi-square test)showed that the efficacy of the observation group was significantly superior to that of the control group(P<0.01).(2)After treatment,the TCM syndrome scores of the observation group were significantly lower than those before treatment(P<0.01),and the maximum cross-section diameter of the thyroid nodule was significantly smaller than that before treatment(P<0.01).However,no obvious improvement of TCM syndromes and the maximum cross-section diameter of the thyroid nodule was presented in the control group(P>0.05).The intergroup comparison showed that the decrease of TCM syndrome scores and the reduction of the maximum cross-section diameter of the thyroid nodule in the observation group were significantly superior to those in the control group(P>0.05).(4)During the treatment,no obvious adverse reactions occurred in the two groups,indicating high safety.Conclusion Xiaoying Sanjie Granules exerts certain effects on patients with benign thyroid nodules of qi stagnation and phlegm obstruction type.The granuels are effective on significantly reduce the maximum cross-section diameter of the thyroid nodule,improve the clinical symptoms of patients,and has fewer adverse reactions,with high safety.

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