Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study

The purpose of this study was to evaluate and compare the radiographic efficacy and safety of iodixanol (Visipaque; 270 and 320 mg I/ml) and iohexol (Omnipaque; 300 mg I/ml) in myelography. The study was randomized, double-blind and comparative including 398 patients from five European university clinics. The radiographic visualisation was evaluated as poor, good or excellent. Adverse events were recorded by interviewing the patients after the myelography, and each patient was given a questionnaire to be returned after 1 week. In cervical myelography with cervical puncture more films with excellent quality was obtained after iodixanol 320 mgI/ml compared with iohexol 300 mgI/ml (p = 0.009). Also in lumbar myelography iodixanol 320 mgI/ml compared favourably with iohexol 300 mgI/ml (p = 0.006). The most frequent adverse event was headache, which occurred in 5–35 % of patients during the first 24 h and in 19–61 % within the first 7 days, depending on the centre. There was no difference in frequency and severity of the adverse effects between the contrast media. Received 13 March 1997; Revision received 29 December 1997; Accepted 5 January 1997     

低剂量等渗造影剂碘克沙醇脑部CTA分支血管强化差异分析

目的:探讨低剂量脑部CTA各级分支血管强化程度差异.方法:对16例应用碘克沙醇的患者行脑部CTA检查,在CT窗宽、窗位和容积再现阈值均固定的条件下,由2名医师分别对各级血管CT值进行测量,并对比2组测量结果间的一致性;对同一医师所测不同血管的CT值进行比较.结果:2名医师所测量的颈内动脉、基底动脉和大脑中动脉CT值分别为:(436.12±82.47)、(354.67±61.56)、(353.63±65.79)HU及(429.18±81.04)、(361.46±72.91)、(357.88±64.20)HU,两两比较Kappa值分别为0.756、0.654和0.718,表明2名医师所测2组结果间一致性较好;同一医师所测颈内动脉与基底动脉之间和颈内动脉与大脑中动脉之间强化程度的差异均有统计学意义(P＜0.05);而基底动脉与大脑中动脉之间差异无统计学意义(P＞0.05).结论:2名医师脑部CTA的CT值测量的一致性较好;不同分级血管之间(颈内动脉与基底动脉之间和颈内动脉与大脑中动脉之间)强化程度有差异性,同级别的血管(基底动脉与大脑中动脉)之间强化程度无差异.     

碘克沙醇及Ficoll-400分离纯化大鼠胰岛细胞的效果对比

目的:分别使用碘克沙醇和Ficoll-400密度梯度液纯化大鼠胰岛细胞,比较两者分离纯化大鼠胰岛细胞的收获量、纯度、活性和功能.方法:将20只SD大鼠随机分为碘克沙醇纯化组和Ficoll-400纯化组,以胶原酶P消化分离SD大鼠胰腺,分别采用碘克沙醇及Ficoll-400密度梯度液来纯化胰岛细胞.通过DTZ染色,计数胰岛细胞的数量和纯度,用胰岛素释放试验和胰岛移植评估胰岛细胞的功能.结果:碘克沙醇-HCA液纯化组的胰岛细胞收获量及纯度与Ficoll-HCA无明显差别,碘克沙醇-HCA组纯化的胰岛细胞活率则显著高于Ficoll-HCA组(93.3%±3.5% vs 84.8%±3.8%,P<0.01),同时胰岛细胞逆转糖尿病大鼠高血糖状态的时间显著延长(11.4±2.1 vs 7.0±1.6 d,P<0.05).结论:与Ficoll-400相比,使用碘克沙醇纯化大鼠胰岛可提高胰岛细胞的活率及功能.     

Renal effects of contrast media in diabetic patients undergoing diagnostic or interventional coronary angiography

BACKGROUND: The use of safe iodinated contrast media (CM) to prevent contrast-induced nephropathy (CIN) is an important consideration among renally impaired diabetic patients during coronary angiography. HYPOTHESIS: Diabetic patients with normal or mild renal dysfunction are less likely to receive renal protective measures during angiography, yet they may also be at risk for CIN. We compared the renal effects of iopamidol and iodixanol in diabetic patients who were referred for angiography. METHODS: Diabetic patients (N=122) with a serum creatinine (SCr) level of < or = 2 mg/dl were double-blind randomized to receive nonionic CM: iopamidol-370 (low osmolar, monomeric) or iodixanol-320 (iso-osmolar, dimeric). Renal stability was evaluated at baseline and at Days 1, 3, and 7 post-angiography. The primary endpoint was a > or = 25% increase in SCr. RESULTS: Seventeen (10 iopamidol, 7 iodixanol; P=NS) patients had an increase in SCr > or = 25% over baseline. Over all days, analysis revealed nonsignificant differences in the incidence of CIN between the two study groups regardless of how CIN was defined. CONCLUSIONS: Diabetic patients with normal or mild renal dysfunction are at risk for CIN. No significant difference in renal response was observed for these CM in this at-risk population.     

等渗造影剂(碘克沙醇)在介入微创治疗中对患者肾功能的影响(附59例分析)

目的研究等渗造影剂（碘克沙醇）在介入微创治疗中对患者肾功能的影响.方法2003年2月至2004年10月实施的介入微创手术中应用等渗造影剂59例.所有患者按术前的肾功能分为两组：术前肾功能正常组[血肌酐（Scr）＜178 μmol/L和肾小球滤过率（GFR）＞50 ml/min]和术前肾功能不全组（Scr≥178μmol/L且＜445 μmol/L或GFR＞25 ml/min且≤50 ml/min）.比较两组患者手术前、后即刻及术后第1、2、3、7天时Scr、血尿素氮（BUN）、β2-微球蛋白（β2-M）、尿比重（SG）的变化情况.结果术前肾功能正常组患者术后Scr、BUN、β2-M、SG 4项指标与术前的差异无显著性（P＞0.05）.术前肾功能不全组患者术后4项指标也未较术前升高,但术后第7天Scr水平较第2、3天明显下降（P＜0.05）.结论等渗造影剂对接受介入手术治疗的患者的肾功能无明显影响.     

Sodium-calcium balance in coronary angiography and experimental experience with iodixanol

The present short review describes the physiological effects of rapid transient changes in cardiac extracellular ions (electrolytes) caused by the bolus of x-ray contrast medium (CM) during coronary angiography. The underlying hypothesis is that as the molecular and osmolal toxicities of modern CM is low, cardiac side-effects result mainly from secondary and biphasic ionic changes which occur during the initial washout phase and during the later re-introduction of blood. In particular the washout pattern for sodium (Na) and calcium (Ca) has great influence on cardiac function. Thus the Na-Ca exchange system of the cardiac cell membrane plays a pivotal role in controlling intracellular Ca and contractility during very brief coronary bolus injections of both nonionic and ionic CM. The nonionic dimer iodixanol is hyposmolal without an additive. Animal experiments demonstrate the value of taking myocarcardial Na-Ca relationships into careful consideration when adding ions to iodixanol and formulating an isotonic CM like Visipaque     

低渗对比剂碘克酸和等渗对比剂碘克沙醇对血小板和白细胞活化的影响

目的 探讨低渗对比剂碘克酸和等渗对比剂碘克沙醇对血小板和白细胞活化的影响.方法 将水蛭素抗凝的全血分别与0%、2%、5%、10% 不同浓度的等渗对比剂碘克沙醇和低渗对比剂碘克酸在37℃温度下抚育5 min,用全血流式细胞技术测定血小板活化指标P选择素、白细胞活化指标CD11b,以及血小板-白细胞聚集体.结果 2%、5%、10% 3种不同浓度的碘克酸对自发的血小板P选择素的表达没有影响 (P=0.237),而碘克沙醇轻度增加其表达(P<0.01);两者均显著降低1 μmol/L二磷酸腺苷诱导的P选择素表达(P<0.001),同时也降低二磷酸腺苷刺激的血小板-白细胞聚集(P<0.001),这一作用不受对比剂浓度的影响.无论是自发状态下,还是在0.1 μmol/L N-甲酰-甲硫氨酰-亮氨酰-苯丙氨酸刺激下,碘克酸对白细胞活化指标CD11b的表达没有影响,而碘克沙醇在两种状态下均轻度增加CD11b的表达(P<0.05).碘克酸对胶原刺激血小板后诱导的CD11b的表达有抑制作用(P<0.05),而碘克沙醇对此无影响;但两者对胶原刺激的血小板-白细胞聚集体形成均有明显抑制作用(P<0.05).结论 对比剂碘克沙醇和碘克酸均能降低二磷酸腺苷刺激的血小板活化和血小板-白细胞聚集.碘克酸不影响自发的P选择素表达和白细胞活化,而碘克沙醇轻度增加自发的血小板和白细胞活化.就对血小板和白细胞影响方面而言,低渗对比剂碘克酸比等渗对比剂碘克沙醇应用更为安全.     

Optimal contrast agents for vascular imaging on computed tomography: iodixanol versus iohexol

RATIONALE AND OBJECTIVES: Dimeric nonionic iodinated contrast has a lower osmolality than monomeric nonionic iodinated contrast but is available at lower iodine concentrations. Less dilution of intravascular fluid by influx from the extravascular space is proposed to occur with decreasing osmolality. The purpose of this study was to determine if a dimeric nonionic iso-osmolar contrast agent (iodixanol) gives equal vascular enhancement compared with a monomeric nonionic hyperosmolar contrast agent (iohexol). MATERIALS AND METHODS: A dynamic single-level computed tomography (CT) scan was performed of the abdominal aorta of 12 sedated rabbits using a four-row multidetector CT scanner following injection of 1.5 mL contrast/kg body weight at 2 mL/sec. The rabbits were injected with the dimeric contrast agent iodixanol (Visipaque 320; Amersham Health) or the monomeric contrast agent iohexol (Omnipaque 350; Amersham Health). The order of the type of contrast media injected was randomized for each rabbit, and the interval between injections was 2 weeks. Using the 2.5-mm detectors, four contiguous 3-mm contrast-enhanced scans were obtained at a single level every 5 seconds for 120 seconds (total of 24 scans) with a kVp of 120, mA.s of 110, field of view of 106 mm, and soft tissue reconstruction algorithm. A single level was chosen to measure the attenuation of the abdominal aorta at 5-second intervals. The mean attenuation and standard deviation values were recorded for the whole aorta, for the central half of the vessel, and for the peripheral half of the vessel. A log-log transformation of the data was performed and regression analysis was done on the outcomes of interest (e.g., mean, standard deviation) on time for each region. RESULTS: There was no statistically significant difference in mean attenuation for the whole aorta for iodixanol and iohexol (P = .918) even though the iodine content was 9.3% less with the dimeric iodixanol. The time-attenuation curve of iodixanol paralleled that of iohexol for all time points. The mean attenuation values of the central half of the aorta (P = .354) and peripheral half of the aorta (P = .758) were also not statistically different for the two contrast agents. CONCLUSION: The vascular attenuation provided by a 9.3% lower iodine concentration of iso-osmolar iodixanol is equal to that given by hyperosmolar iohexol. This suggests that there is less intravascular dilution of iso-osmolar contrast. The enhancement across the cross section of the vessel is also similar for both contrast agents. This suggests the vascular studies with iodixanol and iohexol are of equal quality even when a lower dose of iodine is given with iodixanol. It is relevant for patients with borderline or diminished renal function in whom less volume of contrast may be administered.     

Comparison in myelography between iodixanol 270 and 320 mgI/ml and iotrolan 300 mgI/ml: a multicentre, randomised, parallel-group, double-blind, phase III trial

The objective of the trial was to compare the safety and efficacy of the non-ionic, dimeric, isotonic contrast medium iodixanol (Visipaque 270 and 320 mgI/ml) with those of iotrolan (Isovist 300 mgI/ml) in myelography. After lumbar or cervical puncture, 315 patients were examined in a multicentre, double-blind, randomised, comparative myelography study. Image quality, changes in vital signs, immediate and delayed adverse events were registered. There was a tendency for better images with iodixanol 320 than with iodixanol 270 and iotrolan 300, but the overall quality was good or excellent with all products. The frequency of patients reporting adverse events and headache varied much across centres, but there was no statistically significant difference between the contrast media. The incidence of events was higher after lumbar puncture than after cervical puncture, in women rather than in men, and after puncture with a 22-gauge (G) bevel-tipped needle compared with a 24 G Sprotte needle. The frequency of headache did not correlate with the absence of pathology. The higher iodine concentration in iodixanol 320 could be an advantage for film quality. When compared with iotrolan 300, iodixanol 320 and 270 give similar incidences of adverse events, including headache.     

冠状动脉介入诊疗术对肾功能影响的532例分析

目的探讨对比剂肾病（contrast-induced nephropathy,CIN）在非选择性患者中的发病率及其危险因素,以及等渗对比剂碘克沙醇的肾安全性。方法共入选532例接受冠状动脉介入诊疗术的患者,测定患者术前1周内任一天及术后48h的肾功能。以术后48h血肌酐（serum creatinine,SCr）较术前升高25%或升高44.2μmol/L（0.5mg/dL）为CIN的诊断标准,分析对比剂对肾功能的影响。用Logistic多因素回归分析CIN发生的危险因素。结果（1）532例患者中29例发生CIN,发病率为5.5%;（2）术前估计肾小球滤过率（estimate glomerular filtration rate,eGFR）〈45mL/min的患者CIN发病率显著高于eGFR≥45mL/min的患者（17.5%比4.5%,P=0.002）;（3）532例患者中,427例使用低渗对比剂,105例使用等渗对比剂碘克沙醇,低渗对比剂组术前平均eGFR显著高于等渗对比剂组（81.4±27.6mL/min比62.5±22.8mL/min,P=0.000）,两者CIN发病率差异无统计学意义（5.6%比4.8%,P=0.797）;（4）Logistic多因素分析显示,术前使用利尿剂、术前eGFR〈45mL/min、对比剂用量≥500mL是CIN的独立危险因素。结论冠状动脉介入诊疗术后CIN在非选择性患者中的发病率为5.5%。在术前eGFR〈45mL/min的患者中CIN的发病率显著升高。等渗对比剂碘克沙醇对肾的安全性可能略优于低渗对比剂。术前使用利尿剂、术前eGFR〈45mL/min、对比剂用量≥500mL是CIN的独立危险因素。