1.Signal mining and analysis for adverse events of avatrombopag based on FAERS
Rui XIONG ; Jin WANG ; Zhen YANG ; Yanmei LUO ; Hong ZHANG ; Yongtao TONG ; Xiaodan LAI
Journal of Army Medical University 2024;46(4):369-376
Objective To mine the adverse drug events(ADE)signal of avatrombopag,an effective drug for thrombocytopenia treatment,based on real world data in order to provide reference for its clinical safety application.Methods The OpenVigil2.1 pharmacovigilance platform was used to obtain the ADE report data of avatrombopag from May 2018 to March 2023 in the database of FDA adverse event reporting system(FAERS).The ADE signals were classified and described by the system organ class(SOC)and preferred term(PT)of the ADE terminology set in the Medical Dictionary for Regulatory Activities(MedDRA),and reporting odds ratio(ROR)and UK Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive standard were used to detect the positive ADE signals.Results A total of 1 879 ADE reports related to avatrombopag were obtained,24 SOCs were involved,and 28 positive ADE signals were detected at PT level.Among these signals,the strongest ones were renal vein thrombosis,portal vein thrombosis and graft versus host disease,while the reports accounting for the largest numbers were headache,fatigue and asthenia.There were 8 ADE signals discovered newly,that is,seasonal allergy,back disorder,musculoskeletal discomfort,flatulence,hypersomnia,rash macular,emotional disorder,and rhinorrhoea.Conclusion For clinical use of avatrombopag,clinicians should not only concern the risk of thrombosis,but also pay close attention to ADE signals such as seasonal allergy,back disorder,musculoskeletal discomfort,flatulence,hypersomnia,rash macular,emotional disorder,and rhinorrhoea that are not documented in the instructions.
2.Application of highly selective arterial indocyanine green angiography in the design of anterolateral thigh free flap
Shi WANG ; Shuai DONG ; Yang CAO ; Guiyang WANG ; Chengpeng YANG ; Fengwen SUN ; Yongtao HUANG ; Liping GUO ; Liang YANG ; Rong ZHOU ; Jihui JU
Chinese Journal of Burns 2024;40(10):948-954
Objective:To introduce the application of highly selective arterial indocyanine green angiography (hereinafter referred to as highly selective arterial angiography) in the design of anterolateral thigh free flap.Methods:This study was a retrospective observational study. From November 2023 to April 2024, 29 patients with wounds in extremities which were repaired by anterolateral thigh free flaps designed under the assistance of highly selective arterial angiography and met the inclusion criteria were admitted to the Department of Hand Surgery and Department of Wound Repair Surgery of Suzhou Ruihua Orthopedic Hospital, including 26 males and 3 females, aged 16 to 71 years. The wound area after debridement ranged from 8.0 cm×4.5 cm to 27.0 cm×16.0 cm. During the surgery, highly selective arterial angiography was used to assist in flap design. The fluorescence development range of the source arteries or perforators of flaps was observed. The blood supply range of the source arteries or perforators of flaps was determined based on the fluorescence development of the skin, and the excision position of the flap was adjusted. The flap incision area ranged from 9.0 cm×6.0 cm to 29.0 cm×16.0 cm. During the surgery, the number of highly selective arterial angiography, the type of source artery of perforators for puncture, and changes in the excision position of flaps were observed and recorded. After surgery, the blood supply and survival of flaps, the healing of wounds and the survival of skin grafts in the flap donor sites, and the angiography-related complications were observed.Results:All the 32 flaps of 29 patients were successfully excised. The highly selective arterial angiography was performed 37 times, including 13 cases of puncture of the oblique branch of the lateral circumflex femoral artery, 6 cases of puncture of the descending branch, 8 cases of double puncture of the oblique and descending branches, and 2 cases of puncture of arteries from other branches. During the surgery, the excision position of 28 flaps did not change, the excision position of 3 flaps moved towards proximal extremity of the thigh, and the excision position of 1 flap moved towards distal extremity of the thigh. All the flaps survived successfully after the surgery, and there was no partial necrosis of the flaps at the proximal or distal ends. The wounds in the flap donor sites healed, and all skin grafts survived. No angiography-related complications occurred.Conclusions:Highly selective arterial angiography can be used to determine the blood supply range of the source artery and perforators of the anterolateral thigh free flaps during the surgery. It can evaluate the blood supply of flaps more intuitively and objectively. Its application in assisting flap design can avoid partial flap necrosis caused by unreasonable preoperative design to a certain extent, and it is safe and reliable.
3.Establish of the risk predictive model for varicella outbreaks in primary and middle schools
ZHENG Yongtao, YE Chunmei, NI Zuowei, ZHANG Jiani, LAI Fenhua, GAO Yanmin, YANG Dongbo, WANG Yanmei
Chinese Journal of School Health 2024;45(6):873-877
Objective:
To investigate the epidemiological characteristics of varicella outbreaks in primary and middle schools, and to establish a risk predictive model, so as to provide scientific guidance for the prevention of varicella outbreaks in schools.
Methods:
Based on a nested case-control study, primary and middle schools in 4 districts of Shanghai (Yangpu District and Jingan District) and Hangzhou (Xiaoshan District and Linping District) from January to December 2023 were selected to observe the status of varicella outbreaks. Associated factors of varicella outbreaks were investigated and used for establishing the predictive model, which was evaluated by the Hosmer-Lemeshow(H-L) goodness of fit test, receiver operating characteristic (ROC) curve, Calibration curve, decision curve analysis (DCA).
Results:
A total of 98 varicella outbreaks were included, with 195 schools without varicella outbreaks during the same period as controls. Eight factors, including the availability of warm water in restroom, availability of hand soap in restroom, average class size, duration of student attendance at school per day, presence of a fulltime school doctor, hesitancy of the school principal towards varicella vaccination, and rates of first and second doses of varicella vaccination, were identified as potential factors for school varicella outbreaks, with statistically significant differences (χ2/Z=10.01, 20.49, 17.43, 9.74, 32.17, 6.60, 2.20, 3.39, P<0.05). The 8 variables above were employed to construct a risk predictive model, and Hosmer-Lemeshow goodness of fit test yielded a χ2 value of 5.863 (P>0.05); the area under the ROC curve (AUC) was 0.846 (95%CI=0.799-0.893); Calibration curve analysis indicated good consistency between predicted and actual values of the model. DCA demonstrated favorable predictive performance of the model over a wide range.
Conclusions
The predictive model for school varicella outbreaks demonstrates satisfactory accuracy and efficacy. It suggested to make good use of this prediction model and take relevant measures to reduce the risk of varicella transmission in schools.
4.Echocardiographic evaluation on infants with pulmonary atresia and intact ventricular septum:Surgical decision and post operation right ventricle development
Jing YANG ; Wenhong DING ; Qiang WANG ; Bin LI ; Yongtao WU ; Yuekun SUN ; Zhenbo HU
Chinese Journal of Medical Imaging Technology 2024;40(11):1672-1676
Objective To observe value of echocardiographic evaluation on infants with pulmonary atresia and intact ventricular septum(PA/IVS)for surgical decision and post operation right ventricle(RV)development.Methods Forty-six PA/IVS infants who underwent pulmonary valve(PV)annuloplasty(group A,n=25),PV annuloplasty and RV outflow tract reconstruction with/without additional systemic-to-pulmonary artery shunt(group B,n=15),and systemic-to-pulmonary artery shunt and atrial septal enlargement(group C,n=6)were retrospectively enrolled.Status of RV developments were compared among groups before operation as well as 1 and 6 months after operation.Results The presentation age in group B was younger than,while in group C was older than that in group A(both P<0.05).Before operation,tricuspid valve(TV)annulus diameter,TV annulus Z-score and TV/mitral valve(MV)annulus ratio in groups B and C were both smaller than those in group A(all P<0.05),whereas RV/left ventricle(LV)longitudinal diameter ratio in group B was larger and PV annulus Z-score in group C was smaller than those in group A(both P<0.05).Meanwhile,preoperative PV annulus Z-score and RV/LV longitudinal diameter ratio in group B were both larger than those in group C(both P<0.05).One month after operations,TV annulus diameter,TV annulus Z-score and TV/MV annulus ratio in group B and C,as well as PV annulus diameter,PV annulus Z-score and RV/LV longitudinal diameter ratio in group C were all smaller than those in group A(all P<0.05),while PV annulus diameter,PV annulus Z-score and RV/LV longitudinal diameter ratio in group C were all smaller than those in group B(all P<0.05).Six months after operations,no significant difference of TV annulus diameter,PV annulus diameter,PV annulus Z-score,TV/MV annulus ratio nor RV/LV longitudinal diameter ratio was found between group A and B(all P>0.05),but the above indexes in group C were all lower than those in group A and B(all P<0.05).Besides,no significant difference of TV annulus Z-score was found between group A and B(P>0.05),which were lower in group C than in group A(P<0.05).Conclusion Echocardiographic evaluation on PA/IVS infants was helpful to establishment of forward blood flow from RV to pulmonary arteries in time,hence promoting RV development.
5.The clinical effect of flow-diverting stent for treatment of unruptured internal carotid artery small- and medium-sized wide-neck aneurysms
Juan BAO ; Yi CAO ; Xian ZHANG ; Rui JING ; Yongtao YANG ; Feixiong CHEN ; Jiayi HU ; Yunfei LI
Chinese Journal of Surgery 2024;62(12):1104-1112
Objective:To study the feasibility of domestic flow diverter(TFD) for the treatment of unruptured internal carotid artery small- and medium-sized wide-neck aneurysms.Methods:This is a retrospective case series study.The study retrospectively evaluated consecutive 54 patients with unruptured intracranial small- and medium-sized wide-neck aneurysms treated with TFD in the Department of Cerebrovascular Disease,the Second Affiliated Hospital of Kunming Medical University between October 2019 and January 2024. There were 11 males and 43 females, and the age of patients was (54.9±9.6) years (range:36 to 74 years). There were 63 aneurysms in 54 patients,6 of which were tandem multiple small aneurysms. One case had saccular aneurysms of bilateral internal carotid artery. The maximum diameter of aneurysm was (4.1±0.8) mm (range: 1.5 to 10.0 mm).The ratio of the maximum diameter of the aneurysm to the neck width diameter was 1.3±0.4 (range:0.4 to 2.4). The surgical and follow-up data were collected. The aneurysm embolization rate at the immediate operation and follow-up,and the complications were analyzed. The degree of aneurysm embolization was evaluated using the O′Kelly-Marotta (OKM) grading system,with OKM grade D as complete occlusion and grade C and above (C1,C2,C3 and D) as successful occlusion. Clinical outcomes of all patients were evaluated by modified Rankin scale(mRS).Results:For 63 aneurysms, 48 aneurysms were treated with TFD alone,and 15 aneurysms were treated with a combination of TFD and coiling. The immediate postoperative successful occlusion rate was 14.3% (9/63) and the complete occlusion rate was 3.2% (2/63). Follow-up results were obtained for all of the patients. The follow-up time ( M(IQR)) was 124 (182) days (range: 85 to 754 days). The time to aneurysm successful occlusion was 140.5 (151.5) days (range: 85 to 308 days). At final follow-up,the successful aneurysm occlusion rate was 68.3% (43/63) and the complete occlusion rate was 58.7% (37/63). The complete occlusion rate of the TFD group was 50.0% (24/48) and the TFD+coiling group was 13/15. All patients had no aneurysm rupture,ischemic complications and no recurrence of the aneurysm needed to retreatment during the intraoperative and follow-up period. A total of 3 mild haemorrhagic complications which were related to dual-antiplatelet agents. Twelve patients had asymptomatic mild-moderate stent stenosis. TFD covered 66 branch vessels totally. Only 6 branches were affected by the time of the last follow-up and none of the patients had relevant ischaemic symptoms. All of 54 patients were evaluated as mRS score<2 points at the last follow-up. Conclusion:Using TFD to treat internal carotid artery unruptured small and medium-sized wide-neck aneurysms can simplify the surgical procedure with low complication rate, which is a clinically optional treatment approach.
6.Auxiliary role of Fisher discriminant function based on inflammatory cytokines in diagnosis of depressive disorder
Hailing JIA ; Yongtao YANG ; Lijun CUI ; Yanmei GUO ; Baoping YAN ; Wei CUI ; Xiuli SUN
Sichuan Mental Health 2024;37(4):312-316
Background Currently,the diagnosis of depressive disorder relies on symptomatology,which is greatly influenced by subjective factors such as clinicians' experience.Finding more accurate and reliable quantitative diagnostic methods is currently an urgent problem.Objective To explore the value of Fisher discriminant function based on inflammatory cytokines in the diagnosis of depressive disorder,so as to provide references for clinical diagnosis.Methods A total of 136 patients diagnosed with depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders,fifth edition(DSM-5)criteria,who underwent inpatient treatment at Hebei Mental Health Center from April 2020 to November 2020,were enrolled as study group.67 healthy participants matched for age and gender,was recruited during the same period.Serum levels of inflammatory cytokine were measured using enzyme-linked immunosorbent assay(ELISA).Fisher discriminant model was employed to establish a discriminant function for inflammatory cytokines exhibiting significant statistical differences between study group and control group,which was then validated.Results The levels of pro-inflammatory cytokines interleukin-1β(IL-1β),interleukin-6(IL-6),interferon-γ(INF-γ)and tumor necrosis factor-α(TNF-α)were higher in the study group compared with control group,with statistically significant differences(U=9.115,5.239,4.431,5.428,P<0.01).Conversely,the levels of anti-inflammatory cytokines interleukin-4(IL-4),interleukin-10(IL-10)and interleukin-13(IL-13)were lower in the study group compared with control group,with statistically significant differences(U=7.398,7.331,7.614,P<0.01).The retrospective test in Fisher discriminant function achieved a correct discrimination rate of 89.66%,and the cross validation achieved a correct discrimination rate of 88.67%.Conclusion The Fisher discriminant function developed in this study may serve as a valuable auxiliary method in the diagnosis of depressive disorder.
7.The clinical effect of flow-diverting stent for treatment of unruptured internal carotid artery small- and medium-sized wide-neck aneurysms
Juan BAO ; Yi CAO ; Xian ZHANG ; Rui JING ; Yongtao YANG ; Feixiong CHEN ; Jiayi HU ; Yunfei LI
Chinese Journal of Surgery 2024;62(12):1104-1112
Objective:To study the feasibility of domestic flow diverter(TFD) for the treatment of unruptured internal carotid artery small- and medium-sized wide-neck aneurysms.Methods:This is a retrospective case series study.The study retrospectively evaluated consecutive 54 patients with unruptured intracranial small- and medium-sized wide-neck aneurysms treated with TFD in the Department of Cerebrovascular Disease,the Second Affiliated Hospital of Kunming Medical University between October 2019 and January 2024. There were 11 males and 43 females, and the age of patients was (54.9±9.6) years (range:36 to 74 years). There were 63 aneurysms in 54 patients,6 of which were tandem multiple small aneurysms. One case had saccular aneurysms of bilateral internal carotid artery. The maximum diameter of aneurysm was (4.1±0.8) mm (range: 1.5 to 10.0 mm).The ratio of the maximum diameter of the aneurysm to the neck width diameter was 1.3±0.4 (range:0.4 to 2.4). The surgical and follow-up data were collected. The aneurysm embolization rate at the immediate operation and follow-up,and the complications were analyzed. The degree of aneurysm embolization was evaluated using the O′Kelly-Marotta (OKM) grading system,with OKM grade D as complete occlusion and grade C and above (C1,C2,C3 and D) as successful occlusion. Clinical outcomes of all patients were evaluated by modified Rankin scale(mRS).Results:For 63 aneurysms, 48 aneurysms were treated with TFD alone,and 15 aneurysms were treated with a combination of TFD and coiling. The immediate postoperative successful occlusion rate was 14.3% (9/63) and the complete occlusion rate was 3.2% (2/63). Follow-up results were obtained for all of the patients. The follow-up time ( M(IQR)) was 124 (182) days (range: 85 to 754 days). The time to aneurysm successful occlusion was 140.5 (151.5) days (range: 85 to 308 days). At final follow-up,the successful aneurysm occlusion rate was 68.3% (43/63) and the complete occlusion rate was 58.7% (37/63). The complete occlusion rate of the TFD group was 50.0% (24/48) and the TFD+coiling group was 13/15. All patients had no aneurysm rupture,ischemic complications and no recurrence of the aneurysm needed to retreatment during the intraoperative and follow-up period. A total of 3 mild haemorrhagic complications which were related to dual-antiplatelet agents. Twelve patients had asymptomatic mild-moderate stent stenosis. TFD covered 66 branch vessels totally. Only 6 branches were affected by the time of the last follow-up and none of the patients had relevant ischaemic symptoms. All of 54 patients were evaluated as mRS score<2 points at the last follow-up. Conclusion:Using TFD to treat internal carotid artery unruptured small and medium-sized wide-neck aneurysms can simplify the surgical procedure with low complication rate, which is a clinically optional treatment approach.
8.Application of "ABC" three line perforator locating method for free anterolateral perforator flap of calf
Tao ZHANG ; Lin YANG ; Junnan CHENG ; Shengzhe LIU ; Zhijin LIU ; Yongtao HUANG ; Qinfeng GAO ; Fengwen SUN ; Chengpeng YANG ; Jihui JU
Chinese Journal of Microsurgery 2023;46(1):70-75
Objective:To explore the feasibility of an "ABC" three line perforator locating method in design and harvest of free anterolateral perforator flap of calf.Methods:Between March 2021 and November 2021, 42 patients with 62 wounds on hand and foot were treated in the Department of Hand Surgery, Suzhou Ruihua Orthopaedic Hospital. The "ABC" three line perforator locating method was applied to determine the location and source of perforating branch before operation and to guide the design and harvest of flap during operation in wound reconstruction. Among the 42 patients, 24 had the injury of single digit, 7 had the injuries with 2 digits, 4 with 3 digits, 1 with 4 digits, 1 of the first web, 1 in the wrist, 2 of the great toe, 1 of second toe and 1 in dorsal foot. The sizes of soft tissue defect were 1.5 cm×2.0 cm-3.0 cm×14.0 cm. The sizes of the flaps were 2.0 cm×2.5 cm-3.5 cm×15.0 cm. All donor sites were sutured directly. In the follow-up, sensations of flaps were evaluated following the sensory function evaluation standard of British Medical Research Council(BMRC), and the recovery of the donor and recipient sites was evaluated by the flap comprehensive evaluation scale. Regular follow-up were scheduled at outpatient clinic.Results:A total of 162 perforators were located before operation. There were 95 perforating branches being explored in the operation, of which 5 patients had 1 extra perforating branch than that located before surgery. Seventy-six perforating branches were found consistent with preoperative localisation, with a coincidence rate of 84.4%(76/90). Sixty-four perforating branches were found consistent with the preoperative source with an accuracy rate of 84.2%(64/76). All the 62 flaps survived without a vascular compromise. Follow-up lasted for 6-10(mean 7.1) months. The colour and texture of the flaps were excellent. The flaps were thin and wear-resistant. The sensory function of the flaps was evaluated at S 1-S 3 by BMRC. Comprehensive evaluation scale of flap was excellent in 38 patients and good in 4 patients. Conclusion:"ABC" three line perforator locating method in design of free anterolateral calf flap is a feasible and an ideal auxiliary method in surgical practice. It combines anatomical knowledge, clinical experience and Doppler ultrasound localisation as well as accurately guides the location and source prediction of perforator before surgery.
9.Preliminary exploration on operation process for autologous ozonized blood transfusion
Jianjun WU ; Yan BAI ; Yanli BAI ; Zhanshan ZHA ; Jing CHEN ; Yahan FAN ; Jiwu GONG ; Shouyong HUN ; Hongbing LI ; Zhongjun LI ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Jiubo LIU ; Jingling LUO ; Xianjun MA ; Deying MENG ; Shijie MU ; Mei QIN ; Hui WANG ; Haiyan WANG ; Qiushi WANG ; Quanli WANG ; Xiaoning WANG ; Yongjun WANG ; Changsong WU ; Lin WU ; Jue XIE ; Pu XU ; Liying XU ; Mingchia YANG ; Yongtao YANG ; Yang YU ; Zebo YU ; Juan ZHANG ; Xiaoyu ZHOU ; Xuelian ZHOU ; Shuming ZHAO
Chinese Journal of Blood Transfusion 2023;36(2):95-100
Autologous ozonized blood transfusion(AOBT) is a therapy of re-transfusion of 100-200 mL of autologous blood after shaking and agitation with appropriate amount of oxygen-ozone in vitro. The oxidation of blood through the strong oxidation of ozone can enhance the non-specific immune response of the body, regulate the internal environment and promote health. This therapy has been increasingly applied in clinical practice, while no unified standard for the operation process in terms of ozone concentration, treatment frequency and treatment course had been established. This operation process of AOBT is primarily explored in order to standardize the operation process and ensure its safety and efficacy.
10.The effect of high dose hyperbaric ozone autologous blood therapy(HOT) on oxygenation index and inflammatory factor level in ARDS dogs
Yongtao YANG ; Xusheng CHEN ; Zhongrui WANG ; Peng LI ; Jianjun HAN
Chinese Journal of Blood Transfusion 2023;36(2):101-104
【Objective】 To investigate the effects of high-dose hyperbaric trioxygen autologous blood therapy (HOT) on oxygenation index (PaO


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