1.Risk factors and prediction models for acute kidney injury caused by voriconazole for injection in patients with moderate to severe renal insufficiency
Shubo WANG ; Tingting JIAO ; Hongliang DONG ; Youcai ZHANG ; Bailing WANG
Adverse Drug Reactions Journal 2024;26(3):150-156
Objective:To explore the risk factors of acute kidney injury (AKI) in patients with moderate and severe renal insufficiency after receiving voriconazole for injection and to establish a model for predicting the occurrence risk.Methods:The study was designed as a retrospective study. The subjects were selected from patients with moderate to severe renal insufficiency who were hospitalized in Jiaozuo People′s Hospital of Henan Province from January 1, 2020 to December 31, 2022 and received treatment with voriconazole for injection. Through the hospital information system, clinical data of patients were collected, including basic information, clinical diagnosis, laboratory test indexes, comorbid diseases, and co-medication. Patients were divided into AKI and non-AKI groups according to whether voriconazole-related AKI occurred. AKI risk factors were analyzed using multiple logistic regression, and prediction models were established accordingly. Calibration curves were plotted using R4.2.3 software, and the model was internally validated using the k-fold cross-validation method.Results:A total of 146 patients were enrolled in the study with an age of 72.4±13.8 years, including 84 males and 62 females; 61 patients (41.8%) of which developed voriconazole-related AKI. Compared with the non-AKI group, the white blood cell count, neutrophils percentage, proportion of patients with basic renal diseases, and proportion of patients with cardiovascular diseases were higher in the AKI group; the days of voriconazole injection treatment, proportion of patients with hematological diseases, and proportion of patients receiving glycopeptide drugs were lower in the AKI group. The results of multiple logistic regression showed that albumin [X 1, odds ratio( OR)=0.946, 95% confidence interval( CI): 0.915-0.977, P=0.001], neutrophil percentage (X 2, OR=1.013, 95 %CI: 1.000- 1.026, P=0.001), and complicated with underlying renal diseases (X 3, OR=2.230, 95 %CI: 1.110-4.483, P= 0.046) were independent influencing factors of AKI caused by voriconazole for injection in patients with moderate and severe renal insufficiency. The prediction model was established and the joint prediction factor Y=14.32X 1+0.23X 2-X 3. When the maximum value of Youden index was 0.382, the best tangent point of receiver operating characteristic curve was -11.33. The internal cross-validation results showed that the accuracy of the model was 0.70 and the Kappa coefficient (consistency) was 0.37. Conclusions:The incidence of AKI in patients with moderate and severe renal insufficiency after receiving voriconazole for injection was 41.8%. Albumin, neutrophil percentage and underlying renal diseases were the independent influencing factors. The calculation of joint predictors based on the above indicators was helpful to predict the risk of AKI and had a certain reference value for clinic.
2.Risk factors and prediction models for acute kidney injury caused by voriconazole for injection in patients with moderate to severe renal insufficiency
Shubo WANG ; Tingting JIAO ; Hongliang DONG ; Youcai ZHANG ; Bailing WANG
Adverse Drug Reactions Journal 2024;26(3):150-156
Objective:To explore the risk factors of acute kidney injury (AKI) in patients with moderate and severe renal insufficiency after receiving voriconazole for injection and to establish a model for predicting the occurrence risk.Methods:The study was designed as a retrospective study. The subjects were selected from patients with moderate to severe renal insufficiency who were hospitalized in Jiaozuo People′s Hospital of Henan Province from January 1, 2020 to December 31, 2022 and received treatment with voriconazole for injection. Through the hospital information system, clinical data of patients were collected, including basic information, clinical diagnosis, laboratory test indexes, comorbid diseases, and co-medication. Patients were divided into AKI and non-AKI groups according to whether voriconazole-related AKI occurred. AKI risk factors were analyzed using multiple logistic regression, and prediction models were established accordingly. Calibration curves were plotted using R4.2.3 software, and the model was internally validated using the k-fold cross-validation method.Results:A total of 146 patients were enrolled in the study with an age of 72.4±13.8 years, including 84 males and 62 females; 61 patients (41.8%) of which developed voriconazole-related AKI. Compared with the non-AKI group, the white blood cell count, neutrophils percentage, proportion of patients with basic renal diseases, and proportion of patients with cardiovascular diseases were higher in the AKI group; the days of voriconazole injection treatment, proportion of patients with hematological diseases, and proportion of patients receiving glycopeptide drugs were lower in the AKI group. The results of multiple logistic regression showed that albumin [X 1, odds ratio( OR)=0.946, 95% confidence interval( CI): 0.915-0.977, P=0.001], neutrophil percentage (X 2, OR=1.013, 95 %CI: 1.000- 1.026, P=0.001), and complicated with underlying renal diseases (X 3, OR=2.230, 95 %CI: 1.110-4.483, P= 0.046) were independent influencing factors of AKI caused by voriconazole for injection in patients with moderate and severe renal insufficiency. The prediction model was established and the joint prediction factor Y=14.32X 1+0.23X 2-X 3. When the maximum value of Youden index was 0.382, the best tangent point of receiver operating characteristic curve was -11.33. The internal cross-validation results showed that the accuracy of the model was 0.70 and the Kappa coefficient (consistency) was 0.37. Conclusions:The incidence of AKI in patients with moderate and severe renal insufficiency after receiving voriconazole for injection was 41.8%. Albumin, neutrophil percentage and underlying renal diseases were the independent influencing factors. The calculation of joint predictors based on the above indicators was helpful to predict the risk of AKI and had a certain reference value for clinic.
3.Early and mid-term outcomes of aortic valvuloplasty in children
Weijie LIANG ; Maozheng XUAN ; Jiangzhen LI ; Dong LIANG ; Liyun ZHAO ; Sijie ZHOU ; Shubo SONG ; Bin LI ; Manman HU ; Taibing FAN
Chinese Journal of Applied Clinical Pediatrics 2023;38(9):681-685
Objective:To analyze the short and mid-term efficacy of aortic valvuloplasty with autopericardium on children with aortic valve diseases.Methods:A total of 26 children with aortic valve diseases (stenosis or regurgitation) who underwent aortic valvuloplasty with autopericardium in Fuwai Central China Cardiovascular Hospital from September 2017 to June 2021 were retrospectively analyzed.The short-term and mid-term follow-up data were collected.The maximum aortic valve pressure gradient, subaortic regurgitation area, left ventricular end-diastolic volume (LVEDV) and left ventricular ejection fraction (LVEF) were compared before and after operation.Paired t test was used to analyze the short-term and mid-term efficacy of aortic valvuloplasty with autopericardium on children with aortic valve diseases. Results:All 26 cases were successfully operated, and there were no deaths and serious complications during the follow-up period of (22.96±6.45) months.There was a significant difference between the preoperative and postoperative maximum aortic valve pressure gradient at 1 month ( t=7.85, P<0.05), 6 months ( t=6.43, P<0.05), 1 year ( t=6.16, P<0.05) and 2 years postoperatively ( t=4.22, P<0.05) in children with aortic stenosis or that combined with mild-to-moderate closure.The follow-up data of 9 children with simple aortic stenosis showed that there was a significant difference between the preoperative (8.87±3.57) cm 2 and postoperative aortic regurgitation area at 1 month ( t=6.85, P<0.05), 6 months ( t=5.13, P<0.05), 1 year ( t=6.62, P<0.05) and 2 years postoperatively ( t=5.41, P<0.05). The LVEDV of 26 children was significantly lower at 6 months[(63.54±27.61) mL], 1 year [(53.61±20.20) mL] and 2 years postoperatively [(64.39±17.78) mL] compared with that of preoperative level[(89.42±45.89) mL]( t=3.89, 4.67, 3.58, all P<0.05). The left ventricular pressure and volume decreased, the enlarged heart was narrowed down, and the geometry of the heart was restored.The LVEF of 26 patients also from (61.65±9.67)% before surgery increased to (67.88±4.69)% 6 months after surgery( t=3.68, P<0.05), and increased to (68.62±4.46)% 1 year after surgery( t=4.01, P<0.05), and increased to (67.55±3.09)% 2 years after operation( t=3.01, P<0.05), and the heart function was improved. Conclusions:Aortic valvuloplasty with autopericardium presents an effective short and mid-term efficacy on children with aortic valve diseases, which prevents or delays the aortic valve replacement.
4.Medium-term follow-up of percutaneous pulmonary valve implantation using the Venus-P self-expanding valve
Shubo SONG ; Taibing FAN ; Yu HAN ; Weijie LIANG ; Bin LI ; Kaiyuan WU ; Lin LIU ; Dong LIANG ; Gejun ZHANG ; Xiangbin PAN
Chinese Journal of Applied Clinical Pediatrics 2022;37(2):98-102
Objective:To evaluate the medium-term clinical and hemodynamic outcomes of percutaneous pulmonary valve implantation (PPVI) using a domestic Venus-P self-expanding valve in the treatment of severe pulmonary regurgitation after Tetralogy of Fallot (TOF).Methods:Retrospective study.From December 2017 to December 2020, 13 TOF patients with (17.8±4.7) years old and (50.2±12.3) kg underwent PPVI using the Venus-P self-expanding valve in the Department of Children′s Heart Center, Zhengzhou University People′s Hospital were recruited.The mean valve size was (31.9±3.1) mm.All patients received the transannular patch surgery and developed severe pulmonary regurgitation.After PPVI, 13 patients were followed up for at least 12 months.The operation-related complications, improvement of valve and heart function and the durability and reintervention of the Venus-P self-expanding valve were analyzed.The right ventricular end-diastolic volume index (RVEDVi) before and after operation was compared by the paired t-test, and the New York Heart Association (NYHA) class was compared by the paired Wilcoxon signed rank sum test. Results:PPVI was successfully performed in all 13 patients without death.At 6 months post-PPVI, cardiac magnetic resonance imaging findings showed that RVEDVi was significantly reduced[(145.7±9.6) mL/m 2vs.(100.2±12.2) mL/m 2, P<0.05], and the NYHA class was significantly improved ( P<0.05). One patient presented moderate pulmonary valve regurgitation at 12 months postoperatively.No vegetation was found on echocardiography, and blood culture was negative in this case.Six patients did not have postoperative pulmonary valve regurgitation, and the remaining presented mild or less pulmonary regurgitation.One patient had sudden ventricular tachycardia on the 6 th day postoperatively, which was converted to sinus rhythm after synchronous electrocardiography.Only one case underwent appendectomy 7 months after operation due to acute appendicitis, and the remaining did not require valve-related reintervention after implantation.During the follow-up for (22.8±8.0) months, no patients had perivalve leakage, stent migration and rupture.Complications like embolization and coronary artery compression were not reported. Conclusions:PPVI using the Venus-P self-expanding valve is safe and effective in patients with severe pulmonary valve regurgitation after TOF surgery, showing an acceptable medium-term follow-up outcome.Studies with a large sample size and long follow-up period are still needed to validate our findings.
5.Open hepatectomy versus laparoscopic in the treatment of primary left-sided hepatolithiasis: a propensity, long-term follow-up analysis at a single center
Shubo PAN ; Chunli WU ; Hui HOU ; Dachen ZHOU ; Xiao CUI ; Liang HE ; Jiong GU ; Lei WANG ; Zongfan YU ; Guiyin DONG ; Shengxue XIE ; Qiru XIONG ; Xiaoping GENG
Chinese Journal of Surgery 2020;58(7):530-538
Methods:Clinical data of 187 patients with left-sided hepatolithiasis and underwent laparoscopically or open left-sided hepatectomy from October 2014 to October 2019 at the Second Affiliated Hospital of Anhui Medical University were retrospectively analyzed in this propensity score matching (PSM) study and were matched in terms of age, sex, body mass index, liver function, ASA score, comorbidities, history of biliary surgery, and smoking history on the ratio of 1∶1.There were 47 cases in each group and the mean age were (54.7±12.3)years old(range:34 to 75 years old) and (53.2±12.6) years old (range: 34 to 75 years old) in open and laparoscopically group respectively. The data of operation time, intraoperative blood loss, postoperative hospital-stay, complication rate, biliary fistula rate, stone clearance rate, and stone recurrence rate were compared. The quantitative data were compared using t-test or rank-sum test. Count data were analyzed with χ 2 test or Fisher test. Results:No significant difference was observed in the clinical characteristics of included 94 patients in this study(all P>0.05).The length of the postoperative hospital-stay after OLH was significantly higher than that in the LLH group((10.8±3.1) days vs.(8.5±2.2)days, t=4.085, P=0.000). LLR significantly decreased the incidence of postoperative biliary fistula compared with the OLH (6.3% vs.21.2%, χ 2=4.374, P=0.036) and the rates of postoperative complications in the OLH group was significantly higher than that in the LLH group (48.9% vs.27.6%, χ 2=4.502, P=0.034). Moreover, the stone recurrence rates in the LLH group was significantly lower than that after OLR (4.2% vs. 17.0%, χ 2=4.029, P=0.045). OLH (95 % CI: 1.55 to 10.75, P=0.004) and postoperative complications (95 % CI: 1.29 to 9.52, P=0.013) were independent risk factors for prolonged hospital stay. OLH (95 % CI: 1.428 to 44.080, P=0.018) and residual stones (95 % CI: 1.580 to 62.379, P=0.014) were independent risk factors for the occurrence of postoperative biliary fistula. Biliary fistula (95 % CI: 1.078 to 24.517, P=0.040) was an independent risk factor for the recurrence of stones. Conclusion:Compared with OLH, LLH is safe and effective for the treatment of the primary left-sided hepatolithiasis with the clinical benefits of shorter hospital stay, fewer morbidity and biliary fistula occurrence, and lower stone recurrence rates.
6.Isolation and identification of unknown impurities of alogliptin benzoate
Yilun ZHANG ; Xinyi ZHAO ; Shubo DONG ; Chao DONG ; Wenbin SHEN ; Haijuan DONG
Journal of China Pharmaceutical University 2020;51(4):490-495
By silica gel column chromatography, solvent extraction and preparative high performance liquid chromatography (HPLC), four new related substance were isolated and purified from the mass production and preparation process of alogliptin benzoate. Then it was analyzed and confirmed by various spectrum identification methods such as nuclear magnetic resonance (NMR) spectroscopy, high-resolution mass spectrometry (HR-MS) and Fourier-transform infrared spectroscopy (FTIR) according to its physical and chemical properties. The chemical structures of the four related substances produced in each step of the synthesis process of alogliptin benzoate were determined, and they were named as impurities L, M, T, and V. These four related substances were new impurities which were found for the first time. The isolation and identification of these impurities are of great importance to the quality control of alogliptin benzoate, and the optimization of manufacturing process.
7.Open hepatectomy versus laparoscopic in the treatment of primary left-sided hepatolithiasis: a propensity, long-term follow-up analysis at a single center
Shubo PAN ; Chunli WU ; Hui HOU ; Dachen ZHOU ; Xiao CUI ; Liang HE ; Jiong GU ; Lei WANG ; Zongfan YU ; Guiyin DONG ; Shengxue XIE ; Qiru XIONG ; Xiaoping GENG
Chinese Journal of Surgery 2020;58(7):530-538
Methods:Clinical data of 187 patients with left-sided hepatolithiasis and underwent laparoscopically or open left-sided hepatectomy from October 2014 to October 2019 at the Second Affiliated Hospital of Anhui Medical University were retrospectively analyzed in this propensity score matching (PSM) study and were matched in terms of age, sex, body mass index, liver function, ASA score, comorbidities, history of biliary surgery, and smoking history on the ratio of 1∶1.There were 47 cases in each group and the mean age were (54.7±12.3)years old(range:34 to 75 years old) and (53.2±12.6) years old (range: 34 to 75 years old) in open and laparoscopically group respectively. The data of operation time, intraoperative blood loss, postoperative hospital-stay, complication rate, biliary fistula rate, stone clearance rate, and stone recurrence rate were compared. The quantitative data were compared using t-test or rank-sum test. Count data were analyzed with χ 2 test or Fisher test. Results:No significant difference was observed in the clinical characteristics of included 94 patients in this study(all P>0.05).The length of the postoperative hospital-stay after OLH was significantly higher than that in the LLH group((10.8±3.1) days vs.(8.5±2.2)days, t=4.085, P=0.000). LLR significantly decreased the incidence of postoperative biliary fistula compared with the OLH (6.3% vs.21.2%, χ 2=4.374, P=0.036) and the rates of postoperative complications in the OLH group was significantly higher than that in the LLH group (48.9% vs.27.6%, χ 2=4.502, P=0.034). Moreover, the stone recurrence rates in the LLH group was significantly lower than that after OLR (4.2% vs. 17.0%, χ 2=4.029, P=0.045). OLH (95 % CI: 1.55 to 10.75, P=0.004) and postoperative complications (95 % CI: 1.29 to 9.52, P=0.013) were independent risk factors for prolonged hospital stay. OLH (95 % CI: 1.428 to 44.080, P=0.018) and residual stones (95 % CI: 1.580 to 62.379, P=0.014) were independent risk factors for the occurrence of postoperative biliary fistula. Biliary fistula (95 % CI: 1.078 to 24.517, P=0.040) was an independent risk factor for the recurrence of stones. Conclusion:Compared with OLH, LLH is safe and effective for the treatment of the primary left-sided hepatolithiasis with the clinical benefits of shorter hospital stay, fewer morbidity and biliary fistula occurrence, and lower stone recurrence rates.
8.Effect of stage 1 repair of coarctation of aorta combined with cardiac anomalies and analysis of median follow-up finding
Weijie LIANG ; Taibing FAN ; Liyun ZHAO ; Bin LI ; Shubo SONG ; Haoju DONG ; Sijie ZHOU
Chinese Journal of Applied Clinical Pediatrics 2018;33(23):1785-1787
Objective To summarize the outcomes and the median follow -up finding of stage 1 surgical approaches of coarctation of aorta(CoA)combined with cardiac anomalies.Methods A retrospective study was per-formed for summarizing the operative and follow-up finding of 82 patients(40 males and 42 females)of CoA combined with cardiac anomalies,who underwent stage 1 repair from February 2013 to December 2016 at the Department of Cardio-vascular Surgery,Henan Provincial People's Hospital.The operative age was ranged from 1 month to 8 years old[mean (11.92 ± 22. 51)months]and the weight was (7.31 ± 6.79)kg. Forty -five cases had ventricular septal defect (VSD)or atrial septal defect (ASD).Septal defect and patent ductus arteriosus were found in 31 patients.CoA was associated with aortic arch hypoplasia in 5 patients.Complex cardiovascular deformity was found in 7 cases.The surgical methods included end-to-end anastomosis,end-to-side anastomosis and patch augmentation of the coarctation seg-ment.Results Seven patients died after operation,3 cases of them died of low cardiac output syndrome amd circulatory failure,1 case died of circulatory failure and respiratory failure,1 patient died of malignant arrhythmia,and 2 cases died of respiratory failure.Postoperative echocardiogram suggested that anastomosis maintained patency in all the patients. The follow-up time was 8 months to 4 years,63 patients were followed up,and follow-up rate was 77%.No death or aneurysm occurred during follow-up period.Recoarctation was found in 5 cases.Conclusions Stage 1 repair for CoA combined with cardiac anomalies is effective,and has low complications during postoperative and median follow-up period.Long-term results need further study.
9.The follow-up outcome for minimally surgical device closure of doubly committed sub-arterial ventricular septal defect via left sub-axillary route
Sijie ZHOU ; Taibing FAN ; Shubo SONG ; Weijie LIANG ; Haoju DONG ; Bin LI ; Manman HU ; Liyun ZHAO ; Lin LIU ; Bangtian PENG
Chinese Journal of Applied Clinical Pediatrics 2017;32(13):993-995
Objective To investigate the feasibility and safety of surgical device closure of doubly committed sub-arterial ventricular septal defect via left sub-axillary.Methods A total of 45 patients diagnosed as doubly committed sub-arterial ventricular septal defect (dcVSD) with transthoracic echocardiography (TTE) and transesophageal echocardiography(TEE) were enrolled from June 2014 to August 2016 in Henan Children Heart Center,Henan Provincial People's Hospital.There were 39 males and 6 females,with the mean age of (2.2 ±2.1) years old(0.5-8.0 years),the body weight (13.8 ± 7.1) kg(7.0-34.1 kg),the defect size (4.5 ± 1.0) mm (3.0-8.0 mm).After general anesthesia,the patients were in supine and evaluated by TEE which indicated whether they were fit to closure.Then,they were turned to the right lateral position while this technique was determined.A vertical incision of 2-3 cm was made between the third and the fifth intercostal space and invasion in thoracic space via fourth intercostal space.Puncture was done at the anterior surface of right ventricular outlet tract to build a delivery tract.The occluder was released and the VSD was occluded under transesophageal echocardiography guidance.Results Forty-one patients had a successful surgical dcVSD closure with asymmetric occluders sized (6.0 ± 1.5) mm(4-10 mm).Among 4 failure cases,2 cases (4.4%) were switched to open-heart surgical repair,1 case (2.2%) due to device related aortic regurgitation,the rest 1 case (2.2%) experienced a dislocation of occluder into pulmonary artery and was converted to surgical repair after retrieve of occluder.Trivial residual shunt was detected in 2 cases (4.4%) postoperatively,a spontaneous closure was observed by 1 month follow-up and 3 months follow-ups,respectively.All the patients were discharged 5 to 8 days after the operation.With a follow-up of (10.4 ±5.0) months [3-24 months],there were no complications such as pericardial effusion,displacement of device,atrioventricular block or new valvular dysfunction.Conclusions Minimally invasive device closure of doubly committed sub-arterial ventricular septal defect via left sub-axillary is a feasible and safe treatment for closure of dcVSD.This technique has advantages of minor wound,less exudation,covert incision,however,long term follow-up is necessary.
10.Clinical Experience and Short-term Outcome for Minimally Invasive Occlusion in Patients With Peri-membranous Ventricular Septal Defect via Right Subaxillary Route
Shubo SONG ; Taibing FAN ; Bin LI ; Weijie LIANG ; Haoju DONG ; Kaiyuan WU
Chinese Circulation Journal 2016;31(3):272-275
Objective: To summarize the clinical experience and short-term outcome of minimally invasive occlusion in patients with peri-membranous ventricular septal defect (PmVSD) via right subaxillary route under trans-esophageal echocardiography (TEE) guidance.
Methods: A total of 122 PmVSD patients treated in our hospital from 2014-01 to 2015-07 were summarized. There were 54 male and 68 female with the mean age of (2.7±2.2, 0.5-9.7) years, mean body weight of (13.9±6.0, 6.1-38.0) kg and mean PmVSD diameter of (3.8±0.8, 2.5-7.0) mm. The patients were taken left lateral position, a (2-3) cm incision was performed along right mid-axillary line between the 3rd rib and 4th rib, the thoracic entrance was at 4th inter-costal space. A purse-string suture was conducted on right atrial surface, a special hollow probe was inserted into right atrium and crossed tricuspid into right ventricle under TEE guidance; the probe was adjusted to the point or crossed VSD into left ventricle followed by guide wire insertion to establish a deliver pathway, and ifnally, occlusion device was regularly deployed to close the defect. Post-operative ECG, TEE and chest X-ray were conducted for followed-up study.
Results: There were 119/122 (98.4%) patients occluded successfully and 3 failed patients were converted to cardiopulmonary bypass surgery at the original incision. The average size of occluder was (4.9±1.1, 4-10) mm and all devices were concentric. The patients were followed up at the mean of (8.3±5.0, 1.0-19.8) months, during that period, 12/119 (10.1%) had new mild tricuspid regurgitation, 16 (13.4%) suffered from incomplete right bundle branch block, 4 (3.4%) had small residual shunt and 2 of them were self-closed at 1 and 3 months after operation respectively. There were no complete atrio-ventricular block, no new aortic valve regurgitation and no device dislocation.
Conclusion: Minimally invasive occlusion of PmVSD via right subaxillary route under TEE guidance was a safe, effective, feasible and better cosmetic method for treating relevant patients; while its long-term outcome should be further observed.

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