Background:Despite the efficacy of absolute ethanol(EtOH),its radiolucency introduces several risks in interventional therapy for treating vascular malformations.This study aims to develop a novel radiopaque ethanol i...Background:Despite the efficacy of absolute ethanol(EtOH),its radiolucency introduces several risks in interventional therapy for treating vascular malformations.This study aims to develop a novel radiopaque ethanol injection(REI)to address this issue.Methods:Iopromide is mixed with ethanol to achieve radiopacity and improve the physicochemical properties of the solution.Overall,82 male New Zealand white rabbits are selected for in vivo radiopacity testing,peripheral vein sclerosis[animals were divided into the following 5 groups(n=6):negative control(NC,saline,0.250 ml/kg),positive control(EtOH,0.250 ml/kg),low-dose REI(L-D REI,0.125 ml/kg),moderate-dose REI(M-D REI,0.250 ml/kg),and highdose REI(H-D REI 0.375 ml/kg)],pharmacokinetic analyses(the blood sample was harvested before injection,5 min,10 min,20 min,40 min,1 h,2 h,4 h,and 8 h after injection in peripheral vein sclerosis experiment),peripheral artery embolization[animals were divided into the following 5 groups(n=3):NC(saline,0.250 ml/kg),positive control(EtOH,0.250 ml/kg),L-D REI(0.125 ml/kg),M-D REI(0.250 ml/kg),and H-D REI(0.375 ml/kg)],kidney transcatheter arterial embolization[animals were divided into the following 4 groups(n=3):positive control(EtOH,0.250 ml/kg),L-D REI(0.125 ml/kg),M-D REI(0.250 ml/kg),and H-D REI(0.375 ml/kg);each healthy kidney was injected with saline as negative control],and biosafety evaluations[animals were divided into the following 5 groups(n=3):NC(0.250 ml/kg),high-dose EtOH(0.375 ml/kg),L-D REI(0.125 ml/kg),M-D REI(0.250 ml/kg),and H-D REI(0.375 ml/kg)].Then,a prospective cohort study involving 6 patients with peripheral venous malformations(VMs)is performed to explore the clinical safety and effectiveness of REI.From Jun 1,2023 to August 31,2023,6 patients[age:(33.3±17.2)years]with lingual VMs received sclerotherapy of REI and 2-month follow-up.Adverse events and serious adverse events were evaluated,whereas the efficacy of REI was determined by both the traceability of the REI under DSA throughout the entire injection and the therapeutic effect 2 months after a single injection.Results:The REI contains 81.4%ethanol(v/v)and 111.3 mg/ml iodine,which can be traced throughout the injection in the animals and patients.The REI also exerts a similar effect as EtOH on peripheral venous sclerosis,peripheral arterial embolization,and renal embolization.Furthermore,the REI can be metabolized at a similar rate compared to EtOH and Ultravist^(®)and did not cause injury to the animals’heart,liver,spleen,lungs,kidneys and brain.No REIrelated adverse effects have occurred during sclerotherapy of VMs,and 4/6 patients(66.7%)have achieved complete response at follow-up.Conclusion:In conclusion,REI is safe,exerts therapeutic effects,and compensates for the radiolucency of EtOH in treating VMs.Trial registration:The clinical trial was registered as No.ChiCTR2300071751 on May 242023.展开更多
This case highlights a patient with Gilbert syndrome who underwent endoscopic retrograde cholangiopancreatography(ERCP) with removal of bile duct stones, who then experienced an unexplained increase in bilirubin, with...This case highlights a patient with Gilbert syndrome who underwent endoscopic retrograde cholangiopancreatography(ERCP) with removal of bile duct stones, who then experienced an unexplained increase in bilirubin, with total bilirubin(TBIL) levels increasing from 159.5 μmol/L to 396.2 μmol/L and to a maximum of 502.8 μmol/L after 9 d. Following the decrease in the TBIL level, enhanced magnetic resonance cholangiopancreatography(MRCP) was performed to exclude any possible remaining choledocholithiasis. Nevertheless, the serum bilirubin level increased again, with TBIL levels rising from 455.7 μmol/L to 594.8 μmol/L and a maximum level of 660.3 μmol/L with no remaining bile duct stones. A liver biopsy showed severe bile duct cholestasis with no inflammation. Based on the exclusion of other potential causes of hyperbilirubinemia and the fact that both instances of increased bilirubin occurred after ERCP and MRCP, the contrast agents iopromide and gadoterate meglumine were suspected to be the causes of the hyperbilirubinemia. As of the writing of this report, the patient's bilirubin levels have spontaneously returned to baseline levels. In summary,ERCP and MRCP utilizing the contrast agents iopromide and gadoterate meglumine may possibly induce prolonged hyperbilirubinemia.展开更多
Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the s...Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolerability and diagnostic image quality of Iopromide in an unselected sub-set of the Chinese population. Methods: we analysed data for Chinese ambulatory and in-patients who received Iopromide for an imaging procedure (in accordance with the local package insert and routine clinical practice), as part of an international post-marketing surveillance study. Use of premedication was at the discretion of the attending physician. Patient demographics, clinical history, type of examination, contrast quality and tolerability, including pre-specified adverse drug reactions, were recorded. All statistical analyses were descriptive. Results: case report forms for 20,000 Chinese patients (61.3% men) were analysed, of whom 153 patients (0.77%) had risk factors for idiosyncratic contrast media reactions (at-risk group). Use of premedication, most commonly corticosteroids, was recorded for 5658 patients (28.3%) and 86 at-risk patients (56.2% of the at-risk group), respectively. The mean (±standard deviation) dose of iodine administered was 29 ± 5.5 g. During the physician’s evaluation of image parameters, contrast quality was considered to be “good” (64.7%) or “excellent” (29.3%) in the majority of patients. 571 patients (2.9%) experienced at least one adverse drug reaction [most frequently nausea (0.70%) and dysgeusia (0.62%)], which were typically transient and of mild intensity. Two serious adverse drug reactions were reported [edema (n = 1), decreased blood pressure and dyspnea (n = 1)]. The incidence of adverse drug reactions was increased in the at-risk group versus the overall patient population, and tended to reduce with premedication (mainly corticosteroids). Conclusions: Iopromide was well tolerated and proved to be an efficient contrast agent in a large, non-selected sub-set of Chinese patients undergoing different types of diagnostic imaging procedures.展开更多
基金supported by the Transverse Research Project of Shanghai Ninth People’s Hospital(JYHX2022007)the Clinical Research Program of Ninth People’s Hospital,Shanghai Jiao Tong University School of Medicine(JYLJ202111).
文摘Background:Despite the efficacy of absolute ethanol(EtOH),its radiolucency introduces several risks in interventional therapy for treating vascular malformations.This study aims to develop a novel radiopaque ethanol injection(REI)to address this issue.Methods:Iopromide is mixed with ethanol to achieve radiopacity and improve the physicochemical properties of the solution.Overall,82 male New Zealand white rabbits are selected for in vivo radiopacity testing,peripheral vein sclerosis[animals were divided into the following 5 groups(n=6):negative control(NC,saline,0.250 ml/kg),positive control(EtOH,0.250 ml/kg),low-dose REI(L-D REI,0.125 ml/kg),moderate-dose REI(M-D REI,0.250 ml/kg),and highdose REI(H-D REI 0.375 ml/kg)],pharmacokinetic analyses(the blood sample was harvested before injection,5 min,10 min,20 min,40 min,1 h,2 h,4 h,and 8 h after injection in peripheral vein sclerosis experiment),peripheral artery embolization[animals were divided into the following 5 groups(n=3):NC(saline,0.250 ml/kg),positive control(EtOH,0.250 ml/kg),L-D REI(0.125 ml/kg),M-D REI(0.250 ml/kg),and H-D REI(0.375 ml/kg)],kidney transcatheter arterial embolization[animals were divided into the following 4 groups(n=3):positive control(EtOH,0.250 ml/kg),L-D REI(0.125 ml/kg),M-D REI(0.250 ml/kg),and H-D REI(0.375 ml/kg);each healthy kidney was injected with saline as negative control],and biosafety evaluations[animals were divided into the following 5 groups(n=3):NC(0.250 ml/kg),high-dose EtOH(0.375 ml/kg),L-D REI(0.125 ml/kg),M-D REI(0.250 ml/kg),and H-D REI(0.375 ml/kg)].Then,a prospective cohort study involving 6 patients with peripheral venous malformations(VMs)is performed to explore the clinical safety and effectiveness of REI.From Jun 1,2023 to August 31,2023,6 patients[age:(33.3±17.2)years]with lingual VMs received sclerotherapy of REI and 2-month follow-up.Adverse events and serious adverse events were evaluated,whereas the efficacy of REI was determined by both the traceability of the REI under DSA throughout the entire injection and the therapeutic effect 2 months after a single injection.Results:The REI contains 81.4%ethanol(v/v)and 111.3 mg/ml iodine,which can be traced throughout the injection in the animals and patients.The REI also exerts a similar effect as EtOH on peripheral venous sclerosis,peripheral arterial embolization,and renal embolization.Furthermore,the REI can be metabolized at a similar rate compared to EtOH and Ultravist^(®)and did not cause injury to the animals’heart,liver,spleen,lungs,kidneys and brain.No REIrelated adverse effects have occurred during sclerotherapy of VMs,and 4/6 patients(66.7%)have achieved complete response at follow-up.Conclusion:In conclusion,REI is safe,exerts therapeutic effects,and compensates for the radiolucency of EtOH in treating VMs.Trial registration:The clinical trial was registered as No.ChiCTR2300071751 on May 242023.
基金Supported by National Natural Science Foundation of China,No.81470849
文摘This case highlights a patient with Gilbert syndrome who underwent endoscopic retrograde cholangiopancreatography(ERCP) with removal of bile duct stones, who then experienced an unexplained increase in bilirubin, with total bilirubin(TBIL) levels increasing from 159.5 μmol/L to 396.2 μmol/L and to a maximum of 502.8 μmol/L after 9 d. Following the decrease in the TBIL level, enhanced magnetic resonance cholangiopancreatography(MRCP) was performed to exclude any possible remaining choledocholithiasis. Nevertheless, the serum bilirubin level increased again, with TBIL levels rising from 455.7 μmol/L to 594.8 μmol/L and a maximum level of 660.3 μmol/L with no remaining bile duct stones. A liver biopsy showed severe bile duct cholestasis with no inflammation. Based on the exclusion of other potential causes of hyperbilirubinemia and the fact that both instances of increased bilirubin occurred after ERCP and MRCP, the contrast agents iopromide and gadoterate meglumine were suspected to be the causes of the hyperbilirubinemia. As of the writing of this report, the patient's bilirubin levels have spontaneously returned to baseline levels. In summary,ERCP and MRCP utilizing the contrast agents iopromide and gadoterate meglumine may possibly induce prolonged hyperbilirubinemia.
文摘Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolerability and diagnostic image quality of Iopromide in an unselected sub-set of the Chinese population. Methods: we analysed data for Chinese ambulatory and in-patients who received Iopromide for an imaging procedure (in accordance with the local package insert and routine clinical practice), as part of an international post-marketing surveillance study. Use of premedication was at the discretion of the attending physician. Patient demographics, clinical history, type of examination, contrast quality and tolerability, including pre-specified adverse drug reactions, were recorded. All statistical analyses were descriptive. Results: case report forms for 20,000 Chinese patients (61.3% men) were analysed, of whom 153 patients (0.77%) had risk factors for idiosyncratic contrast media reactions (at-risk group). Use of premedication, most commonly corticosteroids, was recorded for 5658 patients (28.3%) and 86 at-risk patients (56.2% of the at-risk group), respectively. The mean (±standard deviation) dose of iodine administered was 29 ± 5.5 g. During the physician’s evaluation of image parameters, contrast quality was considered to be “good” (64.7%) or “excellent” (29.3%) in the majority of patients. 571 patients (2.9%) experienced at least one adverse drug reaction [most frequently nausea (0.70%) and dysgeusia (0.62%)], which were typically transient and of mild intensity. Two serious adverse drug reactions were reported [edema (n = 1), decreased blood pressure and dyspnea (n = 1)]. The incidence of adverse drug reactions was increased in the at-risk group versus the overall patient population, and tended to reduce with premedication (mainly corticosteroids). Conclusions: Iopromide was well tolerated and proved to be an efficient contrast agent in a large, non-selected sub-set of Chinese patients undergoing different types of diagnostic imaging procedures.
