ABSTRACT
Resumo Fundamento Em 2007, a Food and Drug Administration (FDA) determinou revisões sobre segurança dos agentes de contraste ecocardiográfico (ACE) disponíveis no mercado após relatos de mortes. Ao longo desses anos, diversos estudos comprovaram a segurança dos ACE, porém com poucos estudos relacionados ao SonoVue®. Objetivos Avaliar a segurança do SonoVue® durante o ecocardiograma sob estresse farmacológico (EEF) por meio da análise da incidência de reações alérgicas e da comparação entre os grupos quanto ao surgimento de arritmia, efeitos colaterais menores e eventos adversos. Métodos Estudo observacional, prospectivo, no qual 2.346 pacientes foram submetidos ao EEF e divididos em dois grupos: grupo 1 com ACE (n=1.099) e grupo 2 sem ACE (n=1.247). Os pacientes foram avaliados durante o EEF - 24 horas e 30 dias. Foi definido p significativo quando <0,05. Resultados O grupo 1 apresentou efeitos colaterais mais leves, como cefaleia (5/0,5% vs. 19/1,5%, p=0,012) e hipertensão reativa (3/0,3% vs . 19/1,5%, p=0,002), menos arritmias como extrassístoles ventriculares (180/16,4% vs . 247/19,8%, p=0,032) e taquicardia paroxística supraventricular (2/0,2% vs . 15/1,2%, p=0,003), assim como nenhum evento adverso como infarto agudo do miocárdio (IAM) e óbito. No grupo 2, um paciente apresentou IAM <24h (1/01%) e dois óbitos <30 dias (2/0,1%). Urticária relacionada ao SonoVue® foi observada em 3 (0,3%) pacientes sem reação anafilática. Conclusão SonoVue® demonstrou segurança durante o EEF, não sendo observados morte, IAM ou reação anafilática. Observou-se menor incidência de efeitos colaterais mais leves e arritmias no grupo que utilizou o ACE, assim como baixa incidência de reações alérgicas leves.
Abstract Background In 2007, the United States Food and Drug Administration mandated safety reviews of commercially available echocardiographic contrast agents (ECA), following reports of death. During the past years, different studies have proven the safety of ECA, but there have been few studies on SonoVue®. Objectives To evaluate the safety of SonoVue® during pharmacological stress echocardiography (PSE), by analyzing the incidence of allergic reactions and comparing groups regarding the appearance of arrhythmia, minor side effects and adverse events. Methods In this observational, prospective study, 2346 patients underwent PSE, and they were divided into the following 2 groups: group 1 with ECA (n = 1099) and group 2 without ECA (n = 1247). Patients were evaluated during PSE, at 24 hours, and at 30 days. Statistical significance was defined as p < 0.05. Results Group 1 had fewer minor side effects, such as headache (5/0.5% versus 19/1.5%, p = 0.012) and less reactive hypertension (3/0.3% versus 19/1.5%, p = 0.002); fewer arrhythmias, such as ventricular extrasystoles (180/16.4% versus 247/19.8%, p = 0.032) and paroxysmal supraventricular tachycardia (2/0.2% versus 15/1.2%, p = 0.003); and no adverse events, such as acute myocardial infarction (AMI) or death. In group 2, 1 patient had AMI in < 24 hours (1/01%), and there were 2 deaths in < 30 days (2/0.1%). SonoVue®-related urticaria was seen in 3 (0.3%) patients, without anaphylactic reaction. Conclusion SonoVue® demonstrated safety during PSE. No cases of death, AMI, or anaphylactic reaction were observed. There was a lower incidence of minor side effects and arrhythmias in the group that received ECA, as well as a low incidence of mild allergic reactions.
Subject(s)
Humans , Contrast Media/adverse effects , Echocardiography, Stress , Phospholipids , Sulfur Hexafluoride , United States , Echocardiography , Prospective StudiesABSTRACT
Objective To explore the conditions of transfecting bone morphogenetic protein 2 (BMP2) gene into human periodontal ligament fibroblasts (HPDLFs) by SonoVue and its effects on osteogenesis differentiation of HPDLFs. Methods The HPDLFs were primary cultured and transfected under different conditions (concentrations of SonoVue, different ultrasound exposure intensity and time) to screening for the optimum parameters. Cells were randomly divided into four groups- SonoVue + plasmid+ultrasound group, liposome + plasmid group, ultrasound group, and blank control group. After transfection with the corresponding strategies, the alkaline phosphatase activity was detected on day 3,5,7 and 9 d, and alizarin red staining was applied to check the calciumnodus on day 21 d, respectively. The mRNA expression of osteopontin (OPN), bone sialoprotein (BSP), type I collagen (Col I), osteocalcin (OCN), and runt-related transcription factor-2 (Runx2) was detected by RT-PCR on day 7, 10 and 14 d of transfection. Results The transfection rate and the cell survival rate were relatively high under the following condition- 0. 8 W/cm2, 90 s and 20% SonoVue solution, and they were selected as the final transfection parameters. Both alkaline phosphatase activity and matrix mineralization content in SonoVue+plasmid+ultrasound group were significantly higher than those in blank control group and ultrasound group (P0. 05). Conclusion The BMP2 gene can be successfully transfected into HPDLFs by SonoVue and can induce osteogenesis differentiation of HPDLFs, which lays a foundation for its application in periodontal tissue engineering.
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OBJECTIVE: To determine whether pretreatment evaluation with contrast-enhanced ultrasonography (CEUS) is effective for percutaneous radiofrequency ablation (RFA) of hepatocellular carcinoma (HCC) with poor conspicuity on conventional ultrasonography (US). MATERIALS AND METHODS: This retrospective study was approved by the institutional review board and informed consent was waived. From June 2008 to July 2011, 82 patients having HCCs (1.2 +/- 0.4 cm) with poor conspicuity on planning US for RFA were evaluated with CEUS prior to percutaneous RFA. We analyzed our database, radiologic reports, and US images in order to determine whether the location of HCC candidates on planning US coincide with that on CEUS. To avoid incomplete ablation, percutaneous RFA was performed only when HCC nodules were identified on CEUS. The rate of technical success was assessed. The cumulative rate of local tumor progression was estimated with the use of the Kaplan-Meier method (mean follow-up: 24.0 +/- 13.0 months). RESULTS: Among 82 patients, 73 (89%) HCCs were identified on CEUS, whereas 9 (11%) were not. Of 73 identifiable HCCs on CEUS, the location of HCC on planning US corresponded with that on CEUS in 64 (87.7%), whereas the location did not correspond in 9 (12.3%) HCCs. Technical success was achieved for all 73 identifiable HCCs on CEUS in a single (n = 72) or two (n = 1) RFA sessions. Cumulative rates of local tumor progression were estimated as 1.9% and 15.4% at 1 and 3 years, respectively. CONCLUSION: Pretreatment evaluation with CEUS is effective for percutaneous RFA of HCCs with poor conspicuity on conventional US.
Subject(s)
Female , Humans , Male , Middle Aged , Carcinoma, Hepatocellular/surgery , Catheter Ablation/methods , Contrast Media , Follow-Up Studies , Liver Neoplasms/surgery , Neoplasm Staging , Preoperative Period , Retrospective StudiesABSTRACT
Objective: To assess the diagnostic value of oral SonoVue in contrast-enhanced ultrasound examination of stomach, so as to pave a way for future clinical research and application. Methods: Four patients with pathologically-confirmed advanced gastric cancer underwent contrast-enhanced ultrasound examination of stomach using the following 3 contrast strategies: oral intake of Chinese herb solution, oral intake of SonoVue solution and intravenous injection of SonoVue. The 3 sonograms of each patient were reviewed, in a blind manner, by 9 ultrasound specialists taking into consideration of the following 6 indications: the clearness of tumor on the gastric internal surface, the appearance of tumor ulceration, the appearance of tumor intrusion, width of tumor infiltration, depth of tumor infiltration, and gastric obstruction severity. The findings were statistically analyzed and the diagnostic value of oral SonoVue for gastric diseases was assessed. Results: Oral intake of SonoVue solution obtained the best sonogram among the 3 contrast strategies. The inter-observers variability was minimal for sonograms of patients in oral SonoVue group considering the first 3 and the last indications mentioned above; the variability was minimal for sonograms of patients who received intravenous injection of SonoVue considering metastasis degree and infiltration depth. Conclusion: Oral gastric contrast-enhanced ultrasound examination using oral SonoVue is stable in demonstrating gastric cancer. The quality of sonograms using oral SonoVue is better than that using oral Chinese herbs.
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Objective: To evaluate the perfusion defect of superficial lesions by high-frequency contrast-enhanced ultrasound through comparing the results of low-frequency and high-frequency contrast-enhanced ultrasound, and to put forward the preliminary countermeasures. Methods: Twenty-three patients (9 male and 14 female, aged 45.87 ± 9.32 years, ranging 34-73 years) with 6 sorts of superficial lesions, including 1 parotid pleomorphic adenoma, 3 thyroid adenomas, 5 thyroid adenocarcinomas, 5 cervical metastases, 7 breast carcinomas and 2 of testicular seminomas, were examined by both low-frequency and high-frequency contrast-enhanced ultrasounds. CEUS with SonoVue under CPS-Cadence mode was performed for each lesion using abdominal probe (low-frequency probe) 5 min before small parts probe (high-frequency probe). ACQ software was used to determine the peak intensity (PI) and the results were analyzed by Student's t test in pairs. Results: The PI values of all the 6 types of lesions were significantly lower in high-frequency contrast-enhanced ultrasound images than those in the low-frequency contrast-enhanced ultrasound images (P<0.001). Conclusion: The micro-vascular enhancement of superficial lesions by high-frequency CEUS might be lower than the real enhancement intensity. Abdominal low-frequency probe should be recommended for revealing the perfusion status of superficial lesions after high-frequency probe, which is used for observing the morphology and internal structures of superficial lesions.
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Objective:To investigate the feasibility and efficacy of focused ultrasound surgical clamp(FUSC)for partial hepatectomy,and find out the enhancement effect of SonoVue to FUSC.Methods:Twelve healthy goats were randomly divided into a FUSC group(n=6)in which FUSC was only used for the liver ablation,and a SonoVue + FUSC group(n=6)in which FUSC was performed immediately after iv injection of ultrasound contrast agent SonoVue.A FUSC was comprised of two ultrasound transducers fixed on a forceps-like handle.The directions of focused ultrasound beams produced by both transducers were opposite,with the same central axes.Ultrasound energy was continuously delivered by two transducers to ablate liver tissue located between both transducers.The frequency was 1.6 MHz,and the acoustic power was 150 W.All goats in both groups underwent laparotomy,and then the liver was totally exposed for an ablative procedure.Blood loss,FUSC exposure time,operation time required for the hepatectomy and the cross-section area of the resected liver were recorded.Histological changes were observed in the removed liver,and 10ml blood samples were collected in each goat to measure blood cells and hepatic functions after surgical procedure.All goats were followed up for complications and survival.Results:After surgical procedure,all animals survived well,and no complications were observed during follow-up period.Mean blood loss and mean exposure time were(16.9?4.2)ml and(174?9)s in the FUSC group,and(16.3?3.5)ml and(122?9)s in the SonoVue+FUSC group respectively.A statistical difference of average FUSC exposure time per unit area(P0.05)in both groups.Pathological examination showed coagulation necrosis of the targeted liver tissue,and small blood vessels were severely destroyed,with the occlusion of the ablated vessels.There was a transient increase of serum ALT,AST,TB and DB levels postoperatively in all goats,and they reduced to a normal level 7 days after surgical procedure.Conclusion:FUSC is feasible and effective for partial hepatectomy,which has advantage of convenience,less time and blood loss.FUSC combined with microbubble contrast agen(tSonoVue)can enhance the biological effects of FUSC and improve the efficiency of FUSC.
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Objective:To evaluate the perfusion defect of superficial lesions by high-frequency contrast-enhanced ultrasound through comparing the results of low-frequency and high-frequency contrast-enhanced ultrasound,and to put forward the preliminary countermeasures.Methods:Twenty-three patients(9 male and 14 female,aged 45.87?9.32 years,ranging 34-73 years)with 6 sorts of superficial lesions,including 1 parotid pleomorphic adenoma,3 thyroid adenomas,5 thyroid adenocarcinomas,5 cervical metastases,7 breast carcinomas and 2 of testicular seminomas,were examined by both low-frequency and high-frequency contrast-enhanced ultrasounds.CEUS with SonoVue under CPS-Cadence mode was performed for each lesion using abdominal probe(low-frequency probe)5 min before small parts probe(high-frequency probe).ACQ software was used to determine the peak intensity(PI)and the results were analyzed by Student's t test in pairs.Results:The PI values of all the 6 types of lesions were significantly lower in high-frequency contrast-enhanced ultrasound images than those in the low-frequency contrast-enhanced ultrasound images(P
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Objective:To study the formation of lesions,caused byHIFU with SonoVue,in liver tissues containing blood vessels with the diameter of about 3mm.Methods:The livers of ten goats were insonicated linearly by Model-JC focused ultrasound tumour therapeutic system.The target regions contained blood vessels with the diameter of about 3mm,with or without SonoVue.24 hours after the insonication,the goats were executed with overdosage anesthetics.The length,width and thickness of the lesions were measured,then the necrosies volumes with and without SonoVue were compared.Results:When the depth was 30mm,and the target regions caotained large blood vessels,HIFU with SonoVue could form lesions effectively.There was difference of necrosis volumes between lesions with and without SonoVue,and the difference was significan(tP