1.Analysis of adverse events signaling of lurasidone by Open Vigil FDA2.1
Yu-Qing CHEN ; Zhan-Zhang WANG ; Xiu-Qing ZHU ; Ye YANG ; Li-Jing DAI ; Hao-Yang LU ; E-Mei SONG ; Yu-Guan WEN
The Chinese Journal of Clinical Pharmacology 2024;40(17):2567-2571
Objective To investigate the occurrence of adverse events of lurasidone in the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database by using Open Vigil FDA2.1,to enrich the experience and provide the basis for the clinical use of the drug in China.Methods Using Open Vigil FDA2.1,adverse event data were extracted from the FAERS database for a total of 51 quarters from the 4th quarter of 2010 to the 3rd quarter of 2023,and the ratio of reporting ratio(ROR)method and the proportional reporting ratio(PRR)method were used for data mining and analysis.Results A total of 32 728 adverse event reports with lurasidone as the first suspected drug was obtained,with a larger proportion of females(54.26%)and occurring mostly in adults(18 to 59 years).After the screening,326 preferred term(PT)signals were obtained,involving 20 system-organ classifications(injury,poisoning and procedural complications,general disorders and administration site conditions,psychiatric disorders,etc.).Among them,PTs with the higher frequency of occurrence included off label use,feeling abnormal,crying,anxiety,depression,insomnia,etc.PTs with stronger signal strength included activation syndrome,mania,tongue movement disturbance,hypoprolactinaemia,akathisia,etc.Multiple new suspected adverse drug reactions were unearthed,including hypoprolactinaemia,emotional poverty,stiff tongue,etc.Conclusion Lurasidone has a favorable safety profile,and women need to closely monitor prolactin levels when taking this medication.The drug is relatively safe for use in pregnant,puerperal and perinatal women and patients with poor metabolic function.Hypoprolactinaemia and restless leg syndrome are new rare suspected adverse events with lurasidone.
2.Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults (version 2024)
Qingde WANG ; Yuan HE ; Bohua CHEN ; Tongwei CHU ; Jinpeng DU ; Jian DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Hua GUO ; Yong HAI ; Lijun HE ; Dianming JIANG ; Jianyuan JIANG ; Bin LIN ; Bin LIU ; Baoge LIU ; Chunde LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Hongjian LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Hong XIA ; Guoyong YIN ; Jinglong YAN ; Wen YUAN ; Zhaoming YE ; Jie ZHAO ; Jianguo ZHANG ; Yue ZHU ; Yingjie ZHOU ; Zhongmin ZHANG ; Wei MEI ; Dingjun HAO ; Baorong HE
Chinese Journal of Trauma 2024;40(2):97-106
Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.
3.Clinical characteristics and nutritional status of children with Crohn's disease and risk factors for malnutrition
Dong-Dan LI ; Xiao-Lin YE ; Mei-Chen WANG ; Hong-Mei HUANG ; Jie YAN ; Tian-Zhuo ZHANG ; Fei-Hong YU ; De-Xiu GUAN ; Wen-Li YANG ; Lu-Lu XIA ; Jie WU
Chinese Journal of Contemporary Pediatrics 2024;26(11):1194-1201
Objective To investigate the nutritional status of children with Crohn's Disease (CD) at diagnosis and its association with clinical characteristics. Methods A retrospective analysis was performed for the clinical data and nutritional status of 118 children with CD who were admitted to Beijing Children's Hospital,Capital Medical University,from January 2016 to January 2024. A multivariate logistic regression analysis was used to investigate the risk factors for malnutrition. Results A total of 118 children with CD were included,among whom there were 68 boys (57.6%) and 50 girls (42.4%),with a mean age of (11±4) years. Clinical symptoms mainly included recurrent abdominal pain (73.7%,87/118),diarrhea (37.3%,44/118),and hematochezia (32.2%,38/118),and 63.6% (75/118) of the children had weight loss at diagnosis. The incidence rate of malnutrition was 63.6% (75/118),and the children with moderate or severe malnutrition accounted for 67% (50/75). There were 50 children (42.4%) with emaciation,8 (6.8%) with growth retardation,and 9 (7.6%) with overweight or obesity. Measurement of nutritional indices showed a reduction in serum albumin in 83 children (70.3%),anemia in 74 children (62.7%),and a reduction in 25 hydroxyvitamin D in 15 children (60%,15/25). The children with malnutrition had significantly higher disease activity,proportion of children with intestinal stenosis,and erythrocyte sedimentation rate and a significant reduction in serum albumin (P<0.05). The multivariate logistic regression analysis showed that intestinal stenosis was an independent risk factor for malnutrition in children with CD (OR=4.416,P<0.05). Conclusions There is a high incidence rate of malnutrition in children with CD at diagnosis,which is associated with disease activity and disease behavior. The nutritional status of children with CD should be closely monitored.
4.Positive Association of TEAD1 With Schizophrenia in a Northeast Chinese Han Population
Yang SUN ; Lin WEN ; Yi-Yang LUO ; Wen-Juan HU ; Hui-Wen REN ; Ye LV ; Cong ZHANG ; Ping GAO ; Li-Na XUAN ; Guan-Yu WANG ; Cheng-Jie LI ; Zhi-Xin XIANG ; Zhi-Lin LUAN
Psychiatry Investigation 2023;20(12):1168-1176
Objective:
Schizophrenia is a complex and devastating psychiatric disorder with a strong genetic background. However, much uncertainty still exists about the role of genetic susceptibility in the pathophysiology of schizophrenia. TEA domain transcription factor 1 (TEAD1) is a transcription factor associated with neurodevelopment and has modulating effects on various nervous system diseases. In the current study, we performed a case–control association study in a Northeast Chinese Han population to explore the characteristics of pathogenic TEAD1 polymorphisms and potential association with schizophrenia.
Methods:
We recruited a total of 721 schizophrenia patients and 1,195 healthy controls in this study. The 9 single nucleotide polymorphisms (SNPs) in the gene region of TEAD1 were selected and genotyped.
Results:
The genetic association analyses showed that five SNPs (rs12289262, rs6485989, rs4415740, rs7113256, and rs1866709) were significantly different between schizophrenia patients and healthy controls in allele or/and genotype frequencies. After Bonferroni correction, the association of three SNPs (rs4415740, rs7113256, and rs1866709) with schizophrenia were still evident. Haplotype analysis revealed that two strong linkage disequilibrium blocks (rs6485989-rs4415740-rs7113256 and rs16911710-rs12364619-rs1866709) were globally associated with schizophrenia. Four haplotypes (C-C-C and T-T-T, rs6485989-rs4415740-rs7113256; G-T-A and G-T-G, rs16911710-rs12364619-rs1866709) were significantly different between schizophrenia patients and healthy controls.
Conclusion
The current findings indicated that the human TEAD1 gene has a genetic association with schizophrenia in the Chinese Han population and may act as a susceptibility gene for schizophrenia.
5.Yixin Ningshen Tablet Alleviates Comorbidity of Myocardial Infarction and Depression by Enhancing Myocardial Energy Metabolism and Increasing Availability of Monoamine Neurotransmitter.
Bing JIANG ; Ruo-Ming WU ; Hai-Dong LI ; Kun LI ; Hui LI ; Wen-Zhen DANG ; Gui-Ze FENG ; Wei-Lian BAO ; Guan YE ; Xiao-Yan SHEN
Chinese journal of integrative medicine 2022;28(7):586-593
OBJECTIVE:
To investigate the therapeutic effect of Yixin Ningshen Tablet (YXNS) on comorbidity of myocardial infarction (MI) and depression in rats and explore the underlying mechanism.
METHODS:
The Sprague-Dawley rats were randomly divided into 5 groups with 7 rats in each group according to their weights, including control, model, fluoxetine (FLXT, 10 mg/kg), low-dose YXNS (LYXNS, 100 mg/kg), and high-dose YXNS (HYXNS, 300 mg/kg) groups. All rats were pretreated with corresponding drugs for 12 weeks. The rat model of MI and depression was constructed by ligation of left anterior descending coronary artery and chronic mild stress stimulation. The echocardiography, sucrose preference test, open field test, and forced swim test were performed. Myocardial infarction (MI) area and myocardial apoptosis was also detected. Serum levels of interleukin (IL)-6, IL-1β, tumor necrosis factor-α (TNF-α), 5-hydroxytryptamine (5-HT), adrenocorticotrophic hormone (ACTH), corticosterone (CORT), and norepinephrine (NE) were determined by enzyme linked immunosorbent assay. The proteins of adenosine 5'-monophosphate -activated protein kinase (AMPK), p-AMPK, peroxisome proliferator-activated receptor gamma coactivator-1α (PGC-1α), and nuclear respiratory factor 1 (NRF1) in heart were detected by Western blot analysis. The expression levels of TNF-α, IL-6, indoleamine 2,3-dioxygenase (IDO1), kynurenine 3-monooxygenase (KMO), and kynureninase (KYNU) in hippocampus were detected by real-time quantitative polymerase chain reaction.
RESULTS:
Compared with the model group, the cardiac function of rats treated with YXNS improved significantly (P<0.01). Meanwhile, YXNS effectively reduced MI size and cardiomyocytes apoptosis of rats (P<0.01 or P<0.05), promoted AMPK phosphorylation, and increased PGC-1α protein expression (P<0.01 or P<0.05). HYXNS significantly increased locomotor activity of rats, decreased the levels of TNF-α, IL-6 and IL-1β, and increased the serum levels of 5-HT, NE, ACTH, and CORT (all P<0.05). Moreover, HYXNS decreased the mRNA expressions of IDO1, KMO and KYNU (P<0.05).
CONCLUSIONS
YXNS can relieve MI by enhancing myocardial energy metabolism. Meanwhile, YXNS can alleviate depression by resisting inflammation and increasing availability of monoamine neurotransmitters. It may be used as a potential drug to treat comorbidity of MI and depression.
AMP-Activated Protein Kinases/metabolism*
;
Adrenocorticotropic Hormone
;
Animals
;
Comorbidity
;
Depression/drug therapy*
;
Energy Metabolism
;
Interleukin-6/metabolism*
;
Myocardial Infarction/pathology*
;
Neurotransmitter Agents
;
Rats
;
Rats, Sprague-Dawley
;
Serotonin/metabolism*
;
Tablets
;
Tumor Necrosis Factor-alpha/metabolism*
6.Preliminary analysis of the promotion effect of laparoscopic standardized surgical treatment for gastric cancer in regional medical centers in Shanghai.
Xiao Dong SHEN ; Ming XU ; Chang SU ; Min YE ; Wei LI ; Zhen Xi YANG ; Jiang HAN ; Zhi Qi ZHANG ; Hong Gang XIANG ; Lin Hai YU ; Peng SUN ; Wen Hai HUANG ; Bo Wen XIE ; Ying Xin GUAN ; Zeng Hao CAI ; Wenpeng ZHANG ; Lu ZANG
Chinese Journal of Gastrointestinal Surgery 2022;25(8):708-715
Objective: To explore the promotion effect of laparoscopic standardized surgery for gastric cancer observational in some regional medical centers in Shanghai. Methods: A retrospective cohort study was carried out. Eleven regional medical centers in Shanghai received the promotion program of laparoscopic standardized surgery for gastric cancer, which was led by Ruijin Hospital, Shanghai Jiaotong University School of Medicine (Shanghai Minimally Invasive Surgery Center) from January to December 2020. Clinicopathological data of gastric cancer patients treated at these 11 regional medical centers before and after the promotion program were collected. Inclusion criteria were as follows: patients undergoing laparoscopic distal gastrectomy or total gastrectomy; gastric cancer confirmed by pathology; without distant metastasis or peritoneal metastasis. Patients who did not undergo laparoscopic D2 radical resection, or received neoadjuvant chemotherapy before surgery, or without complete clinical data were excluded. Patients undergoing laparoscopic surgery from January to December 2019 were included in the pre-promotion group (46 cases). Patients undergoing laparoscopic surgery from January to December 2021 were included in the post-promotion group (102 cases). In addition, patients undergoing laparoscopic surgery at Ruijin Hospital from January 2021 to December were included in the control group (138 cases). The baseline data, perioperative measurements postoperative complications, and pathological results of the three groups were analyzed and compared. Results: There were no significant differences in baseline characteristics among the three groups (all P>0.05). Compared with the pre-promotion group, the operation time in post-promotion group was significantly shorter [(207.3±36.0) minutes vs. (254.2±47.1) minutes, t=7.038,P<0.001], and the number of harvested lymph node was significantly more (24.4±12.2 vs. 18.9±5.5, t=2.900, P=0.004). However, there were no significant differences in the extent of resection, time to fluid intake, and postoperative hospital stay between the two groups (all P>0.05). Compared with the control group, the operation time [(207.3±36.0) minutes vs (172.6±26.0) minutes, t=8.281, P<0.001], time to fluid intake [(6.3±3.2) days than (5.5±3.0) days, t=2.029, P=0.044], and the postoperative hospital stay [(14.3±5.6) days vs. (10.1±4.8) days, t=6.036, P<0.001] in the post- promotion group were still longer. Total gastrectomy was less common in the post-promotion group compared with the control group [18 cases (17.6%) vs. 41 cases (29.7%), χ2=7.380, P=0.007]. However, there was no significant difference in the number of harvested lymph node between the two groups (P>0.05). The morbidity of postoperative complication in the post-promotion group (9.8%, 10/102) was significantly lower than that in the pre-promotion group (23.9%, 11/46) (χ2=5.183, P=0.023), while above morbidity was not significantly different between the post-promotion group and the control group [9.8% vs. 6.5% (9/138), χ2=0.867, P=0.352]. Conclusion: After the promotion of laparoscopic standardized surgery for gastric cancer in regional medical centers, the standardization degree of surgery has been improved, and the morbidity of postoperative complication decreases. Laparoscopic standardized surgery for gastric cancer can be promoted to more regional medical centers.
China
;
Gastrectomy/methods*
;
Hospitals
;
Humans
;
Laparoscopy
;
Lymph Node Excision/methods*
;
Postoperative Complications/etiology*
;
Retrospective Studies
;
Stomach Neoplasms/pathology*
;
Treatment Outcome
7.3- to 24-month Follow-up on COVID-19 with Pulmonary Tuberculosis Survivors after Discharge: Results from a Prospective, Multicenter Study
Ya Jing WANG ; Yu Xing ZONG ; Hui Gui WU ; Lin Yuan QI ; Zhen Hui LI ; Yu Xin JI ; Lin TONG ; Lei ZHANG ; Bo Ming YANG ; Ye Pu YANG ; Ke Ji LI ; Rong Fu XIAO ; Song Lin ZHANG ; Hong Yun HU ; De Hong LIU ; Fang Shou XU ; Sheng SUN ; Wei WU ; Ya MAO ; Qing Min LI ; Hua Hao HOU ; Yuan Zhao GONG ; Yang GUO ; Wen Li JIAO ; Jin QIN ; Yi Ding WANG ; Fang WANG ; Li GUAN ; Gang LIN ; Yan MA ; Ping Yan WANG ; Nan Nan SHI
Biomedical and Environmental Sciences 2022;35(12):1091-1099
Objective Coronavirus disease 2019 (COVID-19) and tuberculosis (TB) are major public health and social issues worldwide. The long-term follow-up of COVID-19 with pulmonary TB (PTB) survivors after discharge is unclear. This study aimed to comprehensively describe clinical outcomes, including sequela and recurrence at 3, 12, and 24 months after discharge, among COVID-19 with PTB survivors. Methods From January 22, 2020 to May 6, 2022, with a follow-up by August 26, 2022, a prospective, multicenter follow-up study was conducted on COVID-19 with PTB survivors after discharge in 13hospitals from four provinces in China. Clinical outcomes, including sequela, recurrence of COVID-19, and PTB survivors, were collected via telephone and face-to-face interviews at 3, 12, and 24 months after discharge. Results Thirty-two COVID-19 with PTB survivors were included. The median age was 52 (45, 59) years, and 23 (71.9%) were men. Among them, nearly two-thirds (62.5%) of the survivors were moderate, three (9.4%) were severe, and more than half (59.4%) had at least one comorbidity (PTB excluded). The proportion of COVID-19 survivors with at least one sequela symptom decreased from 40.6% at 3 months to 15.8% at 24 months, with anxiety having a higher proportion over a follow-up. Cough and amnesia recovered at the 12-month follow-up, while anxiety, fatigue, and trouble sleeping remained after 24 months. Additionally, one (3.1%) case presented two recurrences of PTB and no re-positive COVID-19 during the follow-up period. Conclusion The proportion of long symptoms in COVID-19 with PTB survivors decreased over time, while nearly one in six still experience persistent symptoms with a higher proportion of anxiety. The recurrence of PTB and the psychological support of COVID-19 with PTB after discharge require more attention.
8.Minimally invasive osteotomy and manual reduction for hallux valgus.
Guan-Nan WEN ; Yun TONG ; Jie ZHANG ; Ye LI ; Hai-Qun ZHANG ; Li-Kun JIN ; Jian-Min WEN ; Yuan-Yuan LIU
China Journal of Orthopaedics and Traumatology 2021;34(5):467-471
OBJECTIVE:
To explore clinical effects of minimally invasive osteotomy and manual reduction in treating hallux valgus.
METHODS:
From January 2018 to May 2019, 31 patients (42 feet) with hallux valgus were treated with minimally invasive osteotomy and manual reduction, including 3 males and 28 females aged from 18 to 76 years old with an average of (50.1± 4.9) years old. Preoperative and postoperative hallux valgus (HVA), intermetatarsal angles(IMA), length difference between 1 and 2 metatarsals were recorded and compared, and American Orthopedic Foot and Ankle Society (AOFAS)score were observed and measured.
RESULTS:
Thirty-one patients (42 feet) were followed up from 14 to 18 months with an average of (15.1± 1.2) months. HVA, IM before operation were (38.5±5.4)°, (13.0± 1.1)°, and improved to (14.3±4.7)°and (9.1±1.5)°after operation respectively(
CONCLUSION
Minimally invasive osteotomy and manual reduction in treating hallux valgus have advantages of shorter operation time, less length of incision, and could correct hallux valgus deformity, improve front feet and receive good clinical effect in further.
Adolescent
;
Adult
;
Aged
;
Female
;
Hallux Valgus/surgery*
;
Humans
;
Male
;
Metatarsal Bones/surgery*
;
Middle Aged
;
Osteotomy
;
Radiography
;
Treatment Outcome
;
Young Adult
9.Preliminary clinical application of a double-tube flexible ureteral access sheath
Fanhua MENG ; Xiangxin JIANG ; Liping WEN ; Liyin YE ; Yingjun QIAN ; Wansong CAI ; Wanjiang XU ; Sheng GUAN ; Jingfeng WEI ; Suo SHEN ; Shangjun JIANG
Chinese Journal of Urology 2021;42(7):540-541
The placement of the flexible ureteroscopic sheath during lithotripsy may injure the ureter. We have developed a double-tube flexible ureteral access sheath. Thirteen patients with renal calculi were treated with double-tube and flexible sheath in one stage. CT examination of 13 cases showed that the ureter was normal. The double-tube flexible ureteral access sheath makes the operation of sheathing easy, safe and effective.
10.Rolling needle pricking-cupping therapy and traditional pricking-cupping therapy for cervical spondylosis of neck type: a randomized controlled trial.
Yi-Jun YE ; Yu-Xiu XIE ; Tian-Wei YAN ; Shan-Shan LIU ; Bo WANG ; Xi-Ru LIU ; Guan-Tao WANG ; Zheng-Dong TANG ; Wen MA ; Wei-Dong SHEN
Chinese Acupuncture & Moxibustion 2020;40(12):1299-1303
OBJECTIVE:
To compare the clinical efficacy between rolling needle pricking-cupping (RNP-C) and traditional pricking-cupping (TP-C) for cervical spondylosis of neck type.
METHODS:
A total of 96 patients with cervical spondylosis of neck type were randomly divided into an RNP-C group, a TP-C group and an electroacupuncture (EA) group, 32 cases in each group. Each group was treated with EA at Jingbailao (EX-HN 15), Fengchi (GB 20), Dazhui (GV 14), Jianjing (GB 21) and
RESULTS:
Compared before treatment, the scores of NPQ and VAS in each group were all reduced at 2 and 4 weeks into treatment and follow-up (
CONCLUSION
TP-C and RNP-C could both improve the cervical pain symptoms in patients with cervical spondylosis of neck type, and improve the overall function of the cervical spine, and the curative effect is similar.
Acupuncture Points
;
Acupuncture Therapy
;
Cervical Vertebrae
;
Cupping Therapy
;
Humans
;
Spondylosis/therapy*
;
Treatment Outcome

Result Analysis
Print
Save
E-mail