康瑞

康莱说明

Conray是一种无菌水溶液，旨在用作诊断不透射线的介质。 Conray含有60％w / v的碘丙酸酯葡甲胺，它是1-脱氧-1-（甲基氨基）-D-葡萄糖醇5-乙酰氨基-2,4,6三碘代-N-甲基间苯二甲酸酯（盐），并具有以下结构式：

每毫升包含600毫克的碘草酸酯葡甲胺，0.09毫克的乙二胺四乙酸钙二钠作为稳定剂和0.125毫克的磷酸二氢钠作为缓冲剂。该溶液提供28.2％（282 mg / mL）有机结合的碘。 Conray的渗透压为每升约1000 mOsmol，渗透压为每千克约1400 mOsmol，因此在使用条件下具有高渗性。粘度（cps）在25°C下约为6，在37°C下约为4。 pH为6.5至7.7。

康莱是一种不含任何不溶固体的透明溶液。在正常的室温下不会发生结晶。将其装在已被氮气置换掉的空气中的容器中。

Conray-临床药理学

血管内注射后，Conray迅速通过循环系统转运至肾脏，并通过肾小球滤过而在尿液中原样排泄。血管内注射不透射线造影剂的药代动力学通常最好用两室模型来描述，该模型具有用于药物分配的快速α相和用于药物消除的慢β相。在肾功能正常的患者中，Conray的α和β半衰期分别约为10分钟和90分钟。

血管内注射后可进行血管造影，这将使血管造影可视化，直到发生明显的血液稀释为止。

肾脏蓄积足够快，以至于在大多数情况下，注射后约3至8分钟，在肾盏和骨盆中会出现最大的射线照相密度。在肾功能不全的患者中，只有经过较长时间才能实现诊断性混浊。

可注射的碘化造影剂通过肾脏或肝脏排出。这两个排泄途径并不互斥，但主要排泄途径似乎与造影剂对血清白蛋白的亲和力有关。乙草酸盐与血清白蛋白结合不良，主要通过肾脏排泄。

肝脏和小肠是排泄的主要替代途径。在严重肾功能不全的患者中，该造影剂通过胆囊排入小肠的排泄量急剧增加。

乙草酸盐穿过人类的胎盘屏障，并在母乳中原样排泄。

胆道系统，胰管或关节间隙可通过将造影剂直接注射到要研究的区域中来观察。

头部的CT扫描

当用于计算机断层扫描大脑扫描中的对比增强时，增强的程度与碘的施用量直接相关。快速注射全部剂量会在注射后立即产生峰值血碘浓度，此峰值在接下来的五到十分钟内迅速下降。这可以通过在血管和细胞外液区室中的稀释来解释，这导致血浆浓度最初急剧下降。与细胞外区室的平衡大约需要十分钟。此后，下降变为指数。在达到峰值血碘水平后，经常会出现最大程度的对比度增强。最大对比度增强的延迟范围可能从五分钟到四十分钟不等，具体取决于达到的碘峰值水平和病变的细胞类型。这种滞后表明图像的对比度增强至少部分取决于病变内和血池外碘的积累。

在脑部扫描中，由于存在“血脑屏障”，造影剂（Conray）不会在正常的脑组织中积聚。正常大脑中X射线吸收的增加是由于血池中存在造影剂。血脑屏障的破坏（例如发生在脑部恶性肿瘤中）允许造影剂在间质肿瘤组织内积累；邻近的正常脑组织不含造影剂。

非肿瘤性病变（例如动静脉畸形和动脉瘤）的图像增强取决于循环血池中的碘含量。

当用于颅脑计算机血管造影术时，快速推注和/或输注结合快速CT扫描将清楚地描绘出脑血管。

身体的CT扫描1

在非神经组织中（机体CT期间），Conray从血管迅速扩散到血管外空间。由于不存在屏障，X射线吸收的增加与血流量，造影剂浓度和间质组织对造影剂的提取有关。因此，对比增强是由于正常和异常组织之间的血管外扩散的相对差异，这种情况与大脑中的情况完全不同。

Conray在正常和异常组织中的药代动力学已显示出可变性。

与未增强CT相比，用Conray增强CT对确定某些部位的某些病变的诊断可能具有更大的益处，并且可以提供病变的其他特征。在其他情况下，造影剂可以使仅使用CT看不见的病变可视化，或者可以帮助确定未经增强CT所见的可疑病变。

推注造影剂后30到90秒内以及动脉内而非静脉内给药后，对比度增强最大。因此，使用连续扫描技术（从注射开始的一系列2到3秒钟扫描-动态CT扫描）可以改善对肿瘤和其他病变（如脓肿）的增强和诊断评估，偶尔会发现更广泛的疾病。通过比较增强扫描和未增强扫描，可以将囊肿或类似的非血管化病变与血管化实体病变区分开。非血管病变显示CT数无变化，而血管病变显示增加。后者可能是良性，恶性或正常，但不太可能是囊肿，血肿或其他非血管化病变。

由于未增强的扫描可能会为每个患者提供足够的信息，因此应根据对临床，其他放射学和未增强的CT检查结果的仔细评估来决定是否使用对比增强剂，这会增加风险并增加暴露。

康莱的适应症和用法

Conray可用于排尿泌尿造影，脑血管造影，外周动脉造影，静脉造影，关节造影，直接胆管造影，内镜逆行胰胆管造影，计算机断层扫描脑图像造影增强，颅内计算机血管造影，静脉数字减影血管造影和动脉数字减影血管造影。

Conray还可以用于增强计算机断层扫描，以检测和评估肝脏，胰腺，肾脏，腹主动脉，纵隔，腹腔和腹膜后间隙中的病变。在注射造影剂后的前30到90秒钟内以1-3秒钟的间隔进行的连续或多次扫描（动态CT扫描）可能会增强诊断意义，并且可能有助于确定某些病变的诊断。这些部位比单独使用CT可以提供更大的保证，并且可以提供病变的其他特征。在其他情况下，造影剂可以使仅使用CT看不见的病变可视化，或者可以帮助定义未经增强CT所见的可疑病变（请参阅临床药理学）。尚未发现延迟身体CT扫描可能有帮助的患者亚型。已经报道了不一致的结果，并且在用于延迟CT扫描的时间范围内，异常和正常组织可能是等密度的。这种不加区别地使用造影剂的风险是众所周知的，因此不建议使用。目前，仅使用动态CT技术记录了一致的结果。

禁忌症

有关超敏反应，请参阅“一般注意事项”。 Conray不应用于脊髓造影。如果关节内或附近存在感染，则不应进行关节造影。凝血功能缺陷和凝血酶原时间延长的患者禁用经皮肝穿刺胆道造影。内镜逆行胰胆管造影术在胰腺炎的急性发作期间或严重的临床上明显的胆管炎期间以及禁止内镜检查的患者中是禁忌的。

警告

严重不良事件-鞘内给药不良：由于鞘内注射碘化造影剂而未进行鞘内给药，未进行鞘内使用，因此已报告了严重的不良反应。这些严重的不良反应包括：死亡，惊厥，脑出血，昏迷，麻痹，蛛网膜炎，急性肾功能衰竭，心脏骤停，癫痫发作，横纹肌溶解症，体温过高和脑水肿。必须特别注意以确保不在鞘内施用该药物。

含碘碘化造影剂在体外比非离子型造影剂更能抑制血液凝结。尽管如此，还是要谨慎避免血液与含有离子造影剂的注射器长时间接触。

在使用离子和非离子造影剂的血管造影过程中，已经报道了导致心肌梗塞和中风的严重，很少致命的血栓栓塞事件。因此，特别是在血管造影过程中，细致的血管内给药技术是必要的，以最大程度地减少血栓栓塞事件。许多因素，包括手术时间，导管和注射器的材料，潜在的疾病状态以及伴随的药物治疗，都可能导致血栓栓塞事件的发展。由于这些原因，建议采用细致的血管造影技术，包括密切注意导丝和导管的操作，使用歧管系统和/或三通旋塞阀，频繁用肝素盐溶液冲洗导管并最大程度地缩短手术时间。据报道，使用塑料注射器代替玻璃注射器可减少但不能消除体外凝结的可能性。

含碘不透射线介质的给药已引起严重或致命的反应。完全准备好处理任何造影剂反应至关重要。

在脑动脉造影，选择性脊柱动脉造影和供应脊髓血管的动脉造影之后，已经报道了严重的神经系统后遗症，包括永久性麻痹。给予血管加压药后切勿进行造影剂的血管内注射，因为它们会强烈增强神经系统作用。

在蛛网膜下腔出血的患者中，已经报道了对比剂给药与临床恶化（包括惊厥和死亡）之间的罕见关联。因此，在这些患者中应谨慎使用血管内碘化造影剂。

在已知患有多发性骨髓瘤的患者中使用血管内造影剂存在一定风险。在这种情况下，无尿症已发展，导致进行性尿毒症，肾衰竭并最终导致死亡。尽管造影剂和脱水均未单独证明是骨髓瘤无尿的原因，但据推测两者的组合可能是病因。骨髓瘤患者的风险并非该手术的禁忌证；但是，不建议在准备这些患者进行检查时进行局部脱水，因为这可能会导致骨髓瘤蛋白在肾小管中沉淀。包括透析在内的任何形式的治疗都无法成功地逆转这种影响。在血管内给予造影剂之前，应考虑多发于40岁以上人群的骨髓瘤。

应谨慎对待已知或怀疑患有嗜铬细胞瘤的患者使用不透射线的材料。如果医生认为此类程序可能带来的好处大于考虑的风险，则可以执行该程序；但是，不透射线介质的注入量应保持在绝对最低水平。在整个手术过程中应评估血压，并应有治疗高血压危象的措施。

当将材料静脉内或动脉内注射时，造影剂已经显示出对镰状细胞病纯合子个体的镰状化现象。

服用含碘不透射线介质以增强CT脑图像的对比度后，惊厥发生于原发性或转移性脑病变患者。

在患有晚期肾脏疾病的患者中，应谨慎使用碘化造影剂，并且仅在需要检查的情况下才应使用碘化造影剂，因为该介质的排泄可能会受到损害。合并肾脏和肝脏疾病的患者，患有严重高血压或充血性心力衰竭的患者以及最近接受肾脏移植的患者可能会带来额外的风险。

有肝功能不全患者口服胆囊造影剂，再加血管内不透射线碘剂，也有隐性肾脏疾病，尤其是糖尿病和高血压患者，有肾功能衰竭的报道。在这些类型的患者中，在服用造影剂之前，不应有液体限制，并且应尽一切努力保持正常的水合作用，因为脱水是影响进一步肾功能损害的最重要因素。

据报道，在服用碘化造影剂后，患有糖尿病肾病的糖尿病患者和易感的非糖尿病患者（通常是患有肾脏疾病的老年人）发生了急性肾衰竭。因此，在这些患者中进行射线照相之前，应仔细考虑潜在的风险。

对内毒素血症和/或体温升高的患者进行造影剂研究时应谨慎。

甲亢或自发性甲状腺结节患者在血管内使用碘化不透射线药物后发生甲状腺风暴的报道表明，在此类患者中使用这种药物之前应评估这种额外的风险。含碘的造影剂可能会改变甲状腺功能测试的结果，这取决于碘的估算，例如PBI和放射性碘摄取研究。如有指示，应在给药前进行此类测试。

严重的皮肤不良反应：给予血管内造影剂后1小时至几周可能出现严重的皮肤不良反应（SCAR）。这些反应包括史蒂文斯-约翰逊综合征和中毒性表皮坏死溶解（SJS / TEN），急性全身性皮疹性脓疱病（AGEP）以及具有嗜酸性粒细胞增多和全身症状的药物反应（DRESS）。重复使用造影剂，可能会增加反应的严重性，缩短发作时间；预防性药物可能无法预防或减轻严重的皮肤不良反应。避免对有严重皮肤不良反应史的患者服用Conray。

预防措施

一般

涉及使用碘化血管内造影剂的诊断程序应在要执行的特定程序的技术人员和经验丰富的人员的指导下进行。所有使用造影剂的程序都有一定的产生不良反应的风险。尽管大多数反应可能是次要的，但可能会在没有警告的情况下发生威胁生命和致命的反应。在进行此类程序之前，应始终仔细评估风险收益因子。应始终随时配备设备齐全的应急推车或同等的物资和设备，以及有能力识别和治疗各种严重不良反应或由于该程序而引起的情况的人员。如果发生严重反应，请立即停止给药。由于已知会发生严重的延迟反应，因此在给药后至少30至60分钟应有急救设施和合格人员（请参阅“不良反应” ）。

预备性脱水是危险的，可能导致婴儿，幼儿，老年人，既往有肾功能不全的患者，晚期血管疾病的患者和糖尿病患者的急性肾衰竭。

对造影剂的严重反应通常类似于过敏反应。这促使人们使用了一些挑衅性的预测试方法，这些方法都不可用来预测严重的反应。在严重反应与抗原-抗体反应或其他变态反应之间尚无结论性关系。应始终考虑先前接受过造影剂而没有不良影响的患者发生特异反应的可能性。在注射任何造影剂之前，应询问患者以获得病史，重点是过敏和超敏反应。支气管哮喘或变态反应（包括食物）的阳性史，变态反应的家族史或对造影剂的先前反应或超敏反应可能意味着比平常更大的风险。通过暗示组胺敏感性并因此倾向于反应，这样的病史在预测反应潜力方面可能比预测试更准确，尽管在个别情况下不一定是反应的严重性或类型。当认为诊断程序必不可少时，这种类型的阳性病史不会任意禁忌使用造影剂，但一定要小心（请参阅“不良反应” ）。

表现出强烈过敏史，先前对造影剂有反应或预测试呈阳性的患者应考虑包括皮质类固醇和抗组胺药在内的预防性治疗，因为这些患者的反应发生率是普通人群的两到三倍。足够剂量的皮质类固醇应在造影剂注射之前足够早地开始以使其有效，并应持续至注射期间和注射后24小时。抗组胺药应在造影剂注射后30分钟内给药。最近的报道表明，这种预处理不能预防严重的威胁生命的反应，但可以降低其发生率和严重性。这些注射应使用单独的注射器。

在年幼或不合作的儿童以及某些成年患者中，某些手术的进行可能会指示全身麻醉。但是，这些患者的不良反应发生率更高。这可能归因于患者无法识别不良症状，或归因于麻醉的降压作用，这可能延长循环时间并增加造影剂的接触时间。

同型半胱氨酸尿症患者应尽可能避免进行血管造影检查，因为有引起血栓形成和栓塞的风险。

给患者的信息

应指导接受碘化血管内造影剂的患者：

1. 如果您怀孕，请告知医生。
2. 如果您患有糖尿病或患有多发性骨髓瘤，嗜铬细胞瘤，纯合镰状细胞病或已知的甲状腺疾病，请告知医生（请参阅警告）。
3. 如果您对任何药物，食物过敏或对先前用于X射线检查的染料注射有任何反应，请通知医生（请参阅“注意事项”，“一般” ）。
4. 告知医生您目前正在服用的其他药物，包括非处方药。
5. 如果计划将来进行甲状腺检查，请咨询您的医生。该药物中的碘可能会干扰以后的甲状腺检查。
6. 劝告患者在接受Conray治疗后如果出现皮疹，请告知医生。

致癌，诱变，生育力受损

尚未进行长期动物研究来评估致癌潜力。但是，动物研究表明，这种药物不会诱变，也不会影响男性或女性的生育能力。

怀孕类别B

已经在小鼠，大鼠和兔子中进行了高达人类剂量6.6倍的剂量的生殖研究，并且没有发现因Conray而导致生育力受损或对胎儿造成伤害的证据。但是，尚无对孕妇的适当且对照良好的研究。由于动物繁殖研究并不总是能够预测人类的反应，因此只有在明确需要的情况下，才应在怀孕期间使用这种药物。

护理母亲

乳草酸盐在母乳中原样排泄。由于可能会对哺乳婴儿产生不良影响，因此，在使用这种药物后的24小时内，应以奶瓶喂养代替母乳喂养。

（针对特定程序的注意事项将在该程序下发表评论。）

不良反应

对可注射造影剂的不良反应分为两类：化学毒性反应和特异反应。

化学毒性反应是由造影剂的理化性质，注射剂量和注射速度引起的。造影剂灌注的所有血液动力学紊乱和对器官或血管的伤害都包括在此类别中。

特异反应包括所有其他反应。它们在20至40岁的患者中更常见。特异反应可能取决于也可能不取决于注射剂量，注射速度，注射方式和射线照相程序。特异反应可分为轻度，中度和重度。次要反应是自限性的，持续时间短。严重的反应危及生命，治疗是紧急和强制性的。

已经报道了在施用含碘造影剂后的死亡人数。根据临床文献，死亡的发生率据报道为10,000分之一（0.01％）至少于100,000分之一（0.001％）。

结合使用含碘造影剂已观察到以下不良反应。

最常见的不良反应是恶心，呕吐，面部潮红和体温感。这些通常是短暂的。其他反应包括：

过敏反应：荨麻疹的皮肤表现，有或没有瘙痒，红斑和斑丘疹。口干。出汗。结膜症状。面部，周围和血管神经性水肿。与呼吸系统有关的症状包括打喷嚏，鼻塞，咳嗽，窒息，呼吸困难，胸闷和喘息，这可能是更严重和不常见的反应的初步表现，包括哮喘发作，喉痉挛和支气管痉挛伴或不伴水肿，肺水肿，呼吸暂停和发。这些过敏型反应很少会发展为过敏反应，并失去意识和昏迷以及严重的心血管疾病。

心血管反应：全身血管舒张，潮红和静脉痉挛。偶有血栓形成或很少发生血栓性静脉炎。红细胞结块和凝集，起皱并干扰血块形成。据报道，极少见的弥散性血管内凝血导致死亡。严重的心血管反应包括罕见的低血压休克，冠状动脉供血不足，心律不齐，纤颤和停搏。这些严重的反应通常可以通过及时适当的管理来逆转。但是，已经发生了死亡事故。

内分泌反应：在成人和儿童患者（包括婴儿）中加碘造影剂后，很少有人报告甲状腺功能低下或甲状腺短暂抑制的甲状腺功能检查。一些患者因甲状腺功能减退而接受治疗。

皮肤和皮下组织疾病：反应范围从轻度（例如皮疹，红斑，瘙痒，荨麻疹和皮肤变色）到严重：[例如史蒂文斯-约翰逊综合症和中毒性表皮坏死症（SJS / TEN），急性全身性皮炎性脓疱病（AGEP）和嗜酸性粒细胞增多和全身症状的药物反应]

技术反应：灼痛，血肿，瘀斑和组织坏死，感觉异常或麻木，由于注射率引起的血管收缩，血栓形成和血栓性静脉炎而引起的外渗。

神经系统反应：脊髓损伤引起的痉挛，抽搐，失语，晕厥，轻瘫，麻痹，麻痹以及与横断性脊髓炎综合征相关的病理，视野丧失通常是短暂的，但可能是永久性的，昏迷和死亡。

其他反应：头痛，发抖，发抖，发冷，无发烧和头昏眼花。暂时性肾关闭或其他肾病。

（对特定程序的不良反应会受到该程序的评论。）

过量

可能发生过量。过量使用会危害生命，并主要影响肺和心血管系统。症状可能包括发osis，心动过缓，酸中毒，肺出血，抽搐，昏迷和心脏骤停。药物过量的治疗旨在支持所有重要功能并迅速采取对症治疗。

氨基磺酸盐是可透析的。

各种浓度的碘草酸盐葡甲胺的静脉内LD 50值（以碘克/千克体重计）在小鼠中为5.7至8.9 g / kg，在大鼠中为9.8至11.2 g / kg。 LD 50值随着注入速率的增加而降低。

康莱剂量和管理

注射时建议Conray达到或接近体温。

应该指示患者在检查之前省略餐食。可以在检查前进行适当的处​​方药，包括巴比妥类，镇静剂或止痛药。

建议使用初步胶片检查患者的位置和X射线暴露因素。

如果在给药过程中发生轻微反应，则应减慢或停止注射直至反应消退。如果发生重大反应，应立即中止注射。

在任何情况下，都不得在同一注射器中将皮质类固醇或抗组胺药与造影剂混合，因为存在化学不相容的可能性。

给药前应目视检查肠胃外药品是否有颗粒物和变色。

专家制图

静脉注射后，Conray被肾脏迅速排泄。推注后30秒，可以在肾实质中看到Conray。在大多数情况下，在注射后3至8分钟内，肾盏和骨盆的最大射线照相密度就会发生。在患有严重肾功能不全的患者中，对比显像可能会大大延迟。

患者准备

对患者进行适当的准备对于最佳可视化非常重要。除非禁忌，否则建议在检查前一天低残留饮食，在检查前一天晚上服用泻药。

预防措施

婴儿和幼儿在排泄性尿路造影前不应有任何液体限制。康莱注射液代表一种渗透负荷，如果由于部分脱水而使血清渗透压增加，则可能会加剧高渗性脱水（请参阅“警告和注意事项，有关准备性脱水的一般信息”）。

不良反应

参见“一般不良反应”部分。

常用剂量

成人-通常剂量为30至60毫升。平均体重在14岁以上的儿童可以接受成人剂量。通常在30至90秒内注射总剂量。在预期可视性差的情况下（例如，老年患者或肾功能受损的患者），可能需要使用更高的剂量以获得最佳效果。当需要肾图和/或顺序尿路图时，通常应在15至30秒内迅速注射总剂量。

儿童的剂量与年龄和体重成比例地减少。建议以大约0.5 mL / kg体重的剂量为婴儿和儿童提供以下大致时间表：

脑血管造影

通过任何公认的技术，Conray可用于可视化脑血管。

患者准备

脑血管造影通常在局部或全身麻醉下进行（请参阅“注意事项”，“一般” ）。可以按照指示使用预防用药。

通常在注射造影剂之前进行初步的射线照相。

预防措施

除先前描述的一般预防措施外，对于患有晚期动脉硬化，严重高血压，心脏代偿失调，衰老，近期脑血栓形成或栓塞和偏头痛的患者，应特别注意进行脑血管造影。

不良反应

脑动脉造影不良反应的主要来源似乎与重复注射造影剂，给予高于推荐剂量的剂量，存在闭塞性动脉粥样硬化性血管疾病以及注射的方法和技术有关。

不良反应通常是轻度和短暂的。经常会感到面部和颈部有温暖的感觉。很少会观察到更严重的烧灼不适。

与脑血管造影有关的严重神经系统反应未包括在一般不良反应中，包括中风，健忘症和呼吸困难。

可能以某种频率发生的心血管反应是心动过缓和全身血压降低。血压变化是短暂的，通常不需要治疗。

常用剂量

所用的通常剂量随注射部位和方法以及患者的年龄，状况和体重而变化。在成人中，通常通过单次快速注射6至10 mL，通过经皮针头或导管方法进行颈动脉和椎骨血管造影。如所示进行另外的注射。在成年人中，逆行肱脑血管造影通常是通过一次向右肱动脉快速注射35至50 mL进行的。取决于注入的血管和所遵循的程序，可以采用其他剂量。儿童剂量与年龄和体重成比例减少。

周边动脉造影和静脉造影

可以注射Conray以观察动脉和静脉的外周循环。上肢和下肢的动脉造影可以通过任何已建立的技术获得。最常见的是，对手臂的肱动脉或腿部的股动脉进行经皮注射。通过注入上，下肢的适当静脉获得静脉图。

患者准备

该过程通常在局部或全身麻醉下进行（请参阅“注意事项”，“一般” ）。 Premedication may be employed as indicated.

A preliminary radiograph is usually made prior to the injection of the contrast agent.

预防措施

In addition to the general precautions previously described, moderate decreases in blood pressure occur frequently with intra-arterial (brachial) injections. This change is usually transient and requires no treatment; however, the blood pressure should be monitored for approximately ten minutes following injection. Special care is required when venography is performed in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection or a totally obstructed venous system. In the presence of venous stasis, vein irrigation with normal saline should be considered following the procedure. Venography is optimally performed with a more dilute solution such as Conray 43 (Iothalamate Meglumine Injection USP 43%).

Extreme caution during injection of the contrast agent is necessary to avoid extravasation and fluoroscopy is recommended. This is especially important in patients with severe arterial or venous disease.

不良反应

In addition to the general adverse reactions previously described, hemorrhage and thrombosis have occurred at the puncture site of the percutaneous injection. Brachial plexus injury has been reported following axillary artery injection. Thrombophlebitis, syncope and very rare cases of gangrene have been reported following venography.

Usual Dosage

Peripheral Arteriography: In adults a single rapid injection of 20 to 40 mL is normally sufficient to visualize the entire extremity. The dose for children is reduced in proportion to body weight. Venography: The usual dose for adults is a single rapid injection of 20 to 40 mL. The dose for children is reduced in proportion to body weight. Following the procedure, the venous system should be flushed with either 5% dextrose in water (D5W) or normal saline (Sodium Chloride Injection USP) or the contrast medium should be removed by leg massage and/or leg elevation.

ARTHROGRAPHY

预防措施

In addition to the general precautions previously described, strict aseptic technique is required to prevent the introduction of infection. Fluoroscopic control should be used to ensure proper introduction of the needle into the synovial space and prevent extracapsular injection. Aspiration of excessive synovial fluid will reduce the pain on injection and prevent the rapid dilution of the contrast agent. It is important that undue pressure not be exerted during the injection.

不良反应

In addition to the general adverse reactions previously described arthrography may induce joint pain or discomfort which is usually mild and transient but occasionally may be severe and persist for 24 to 48 hours following the procedure. Effusion requiring aspiration may occur in patients with rheumatoid arthritis.

Usual Dosage

Arthrography is usually performed under local anesthesia. The amount of contrast agent required is solely dependent on the size of the joint to be injected and the technique employed.

The following dosage schedule for normal adult joints should serve only as a guide since joints may require more or less contrast medium for optimal visualization. Dosage should be reduced for children in proportion to body weight.

Passive or active manipulation is used to disperse the medium throughout the joint space.

The lower volumes of contrast medium are usually employed for double contrast examinations. Following the injection of the contrast medium 50 to 100 cc of either filtered room air or carbon dioxide is introduced for examination of the knee and lesser volumes for other joints. The concomitant use of epinephrine 1:1000 will reduce the rate of contrast medium absorption as well as the production of synovial fluids and consequent dilution of the medium.

DIRECT CHOLANGIOGRAPHY

预防措施

In addition to the general precautions previously described, in the presence of acute pancreatitis, direct cholangiography, if necessary, should be employed with caution, injecting no more than 5 to 10 mL without undue pressure. Percutaneous transhepatic cholangiography should only be attempted when compatible blood for potential transfusions is in readiness and emergency surgical facilities are available. The patient should be carefully monitored for at least 24 hours to ensure prompt detection of bile leakage and hemorrhage. Appropriate premedication of the patient is recommended and drugs which are cholespastic, such as morphine, should be avoided. Respiratory movements should be controlled during introduction of the needle.

不良反应

Adverse reactions may often be attributed to injection pressure or excessive volume of the medium resulting in overdistention of the ducts and producing local pain.

Some of the medium may enter the pancreatic duct which may result in pancreatic irritation. Occasionally, nausea, vomiting, fever, and tachycardia have been observed. Pancholangitis resulting in liver abscess or septicemia has been reported.

In percutaneous transhepatic cholangiography, some discomfort is common, but severe pain is unusual. Complications of the procedure are often serious and have been reported in 4 to 6 percent of patients. These reactions have included bile leakage and biliary peritonitis, gall bladder perforation, internal bleeding (sometimes massive), blood-bile fistula resulting in septicemia involving gram-negative organisms, and tension pneumothorax from inadvertent puncture of the diaphragm or lung. Bile leakage is more likely to occur in patients with obstructions that cause unrelieved high biliary pressure.

剂量和给药

It is advisable that Conray be at or close to body temperature when injected. The injection is made slowly without undue pressure, taking the necessary precautions to avoid the introduction of bubbles.

Operative – The usual dose is 10 mL but as much as 25 mL may be needed depending upon the caliber of the ducts. If desired, the contrast agent may be diluted 1:1 with Sodium Chloride Injection USP using strict aseptic procedures. Following surgical exploration of the ductal system, repeat studies may be performed before closure of the abdomen, using the same dose as before.

Postoperative – Postoperatively, the ductal system may be examined by injection of the contrast agent through an in-place T-tube. These delayed cholangiograms are usually made from the fifth to the tenth postoperative day prior to removal of the T-tube. The usual dose is the same as for operative cholangiography.

Percutaneous Transhepatic Cholangiography – This procedure is recommended for carefully selected patients for the differential diagnosis of jaundice due to extrahepatic biliary obstruction or parenchymal disease. The procedure is only employed where oral or intravenous cholangiography and other procedures have failed to provide the necessary information. In obstructed cases, percutaneous transhepatic cholangiography is used to determine the cause and site of obstruction to help plan surgery. The technique may also be of value in avoiding laparotomy in poor risk jaundice patients since failure to enter a duct suggests hepatocellular disease. Careful attention to technique is essential for the success and safety of the procedure. The procedure is usually performed under local anesthesia following analgesic premedication.

Depending upon the caliber of the biliary tree, a dose of 20 to 40 mL is generally sufficient to opacify the entire ductal system. If desired, the contrast agent may be diluted 1:1 with Sodium Chloride injection USP using strict aseptic procedures.

As the needle is advanced or withdrawn, a bile duct may be located by frequent aspiration for bile or mucus. Before the dose is administered, as much bile as possible is aspirated. The injection may be repeated for exposures in different planes and repositioning of the patient, if necessary, should be done with care. If a duct is not readily located by aspiration, successive small doses of 1 to 2 mL of the medium are injected into the liver as the needle is gradually withdrawn, until a duct is visualized by x-ray.

If no duct can be located after 3 or 4 attempts, the procedure should be terminated. Inability to enter a duct by a person experienced in the technique is generally considered to be strongly suggestive of hepatocellular disease.

ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY

Endoscopic retrograde cholangiopancreatography (ERCP) is indicated in carefully selected patients with known or suspected pancreatic or biliary tract disease when other diagnostic procedures have failed to provide the necessary diagnostic information. Prior to the development of ERCP, x-ray examination of the pancreatic ducts could only be obtained at laparotomy.

预防措施

Endoscopic retrograde cholangiopancreatography should only be performed by personnel skilled and experienced with the procedure, and careful attention to technique is essential for the success and safety of the procedure. Fluoroscopy is mandatory during injection to prevent over distention of the duct systems.

不良反应

Adverse reactions that have occurred which are attributable to either the procedure or to Conray, include nausea, vomiting, fever, severe abdominal pain, duodenal wall intravasation, septicemia, pancreatitis and perforation of the common bile duct associated with pathology.

剂量和给药

The procedure is usually performed following pharyngeal anesthesia and analgesic or sedative premedication. Duodenal motility may be controlled in patients with active duodenal peristalsis with an appropriate antiperistaltic agent.

The contrast medium should be injected slowly under fluoroscopic control employing the minimal dose that is adequate to visualize the common bile duct, the pancreatic duct, or both duct systems. The dosage will vary greatly depending on the pathological findings and can range from 10 to 100 mL for visualization of the common bile duct; and from 2 to 10 mL for visualization of the pancreatic duct.

Following the procedure, the patient should be kept under close observation for 24 hours.

CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC (CT) BRAIN IMAGING

Tumors

Conray may be useful to enhance the demonstration of the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas; ependymomas; medulloblastomas; meningiomas; neuromas; pinealomas; pituitary adenomas; craniopharyngiomas; germinomas; and metastatic lesions.

The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated.

In cases where lesions have calcified, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement.

Non-Neoplastic Conditions

The use of Conray may be beneficial in the image enhancement of non-neoplastic lesions. General infarctions of recent onset may be better visualized with the contrast enhancement, while some infarctions are obscured if contrast media are used. The use of iodinated contrast media results in contrast enhancement in about 60% of cerebral infarctions studied from one to four weeks from the onset of symptoms.

Sites of active infection may also be enhanced following contrast medium administration.

Arteriovenous malformations and aneurysms will show contrast enhancement. In the case of these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool.

The opacification of the inferior vermis following contrast medium administration has resulted in false positive diagnoses in a number of normal studies.

患者准备

No special patient preparation is required for contrast enhancement of CT brain scanning. However, it is advisable to ensure that patients are well hydrated prior to examination.

Usual Dosage

The usual dosage in adults and children is 2 mL/kg (1 mL/lb) by intravenous administration, not to exceed a total dose of 150 mL. In most cases, scanning may be performed immediately after completion of administration; however, when fast scanning equipment (less than 1 minute) is used, consideration should be given to waiting approximately 5 minutes to allow for maximum contrast enhancement.

CRANIAL COMPUTERIZED ANGIOTOMOGRAPHY

Conray may be administered for cranial computerized angiotomography when necessary to visualize the cerebral vessels to detect cerebrovascular lesions and to evaluate the anatomical relationship between the cerebral blood vessels and other parenchymal or space occupying lesions.

Usual Dosage

Conray may be administered by intravenous bolus injection, or by bolus injection followed by rapid infusion.

For bolus injection, the usual dose in adults and children is 0.5 to 1.0 mL/kg at an injection rate of 2 mL/second with scanning begun immediately after administration. This dose may be repeated as necessary. The total dose per procedure should not exceed 200 mL, and in children the total dose is reduced in approximate proportion to age and body weight.

In adults, when the combination bolus and infusion technique is used, a 50 mL bolus injection followed by a rapid infusion of 150 mL may be given or a 100 mL bolus injection followed by a rapid infusion of 100 mL may be used. Scanning is begun immediately after the bolus administration. In children, the dose is reduced in approximate proportion to age and body weight.

CONTRAST ENHANCEMENT IN BODY COMPUTED TOMOGRAPHY1

Conray may be administered when necessary to visualize vessels and organs in patients undergoing CT of the chest, abdomen and pelvis.

患者准备

No special patient preparation is required for contrast enhancement in body CT. In patients undergoing abdominal or pelvic examination, opacification of the bowel may be valuable in scan interpretation.

预防措施

In addition to the general precautions previously described, it is advisable to ensure that patients are adequately hydrated prior to examination. Patient motion, including respiration, can markedly affect image quality, therefore, patient cooperation is essential. The use of an intravascular contrast medium can obscure tumors in patients undergoing CT evaluation of the liver resulting in a false negative diagnosis. Dynamic CT scanning is the procedure of choice for malignant tumor enhancement (see CLINICAL PHARMACOLOGY ).

Usual Dosage

Conray may be administered by bolus injection, by rapid infusion or by a combination of both.

For vascular opacification, a bolus injection of 25 to 50 mL may be used, repeated as necessary. When prolonged arterial or venous phase enhancement is required and for the enhancement of specific lesions, a rapid infusion of 150 mL may be used. In some instances, a 100 to 150 mL infusion may be employed to define the area of interest followed by bolus injections of 20 to 50 mL to clarify selected scans.

INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY

Intravenous digital subtraction angiography (IV DSA) is a radiographic modality which allows dynamic imaging of the arterial system following intravenous injection of iodinated x-ray contrast media through the use of image intensification, enhancement of the iodine signal and digital processing of the image data. Temporal subtraction of the images obtained during the “first arterial pass” of the injected contrast medium injection yield images which are devoid of bone and soft tissue.

Areas that have been most frequently examined by intravenous DSA are the heart, including coronary by-pass grafts; the pulmonary arteries; the arteries of the brachiocephalic circulation; the aortic arch; the abdominal aorta and its major branches including the celiac, mesenterics and renal arteries; the iliac arteries; and the arteries of the extremities.

患者准备

No special patient preparation is required for intravenous digital subtraction angiography. However, it is advisable to ensure that patients are well hydrated prior to examination.

预防措施

In addition to the general precautions previously described, the risks associated with IV DSA are those usually attendant with catheter procedures and include intramural injections, vessel dissection and tissue extravasation. Small test injections of contrast medium made under fluoroscopic observation to ensure the catheter tip is properly positioned, and in the case of peripheral placement that the vein is of adequate size, will reduce this potential.

Patient motion, including respiration and swallowing, can result in marked image degradation yielding non-diagnostic studies. Therefore, patient cooperation is essential.

不良反应

See section on general Adverse Reactions .

Usual Dosage

Conray may be injected either centrally, into the superior or inferior vena cava, or peripherally into an appropriate arm vein. For central injections, catheters may be introduced at the antecubital fossa into either the basilic or cephalic vein or at the leg into the femoral vein and advanced to the distal segment of the corresponding vena cava. For peripheral injections, the catheter is introduced at the antecubital fossa into the appropriate size arm vein. In order to reduce the potential for extravasation during peripheral injection, a catheter of approximately 20 cm in length should be employed.

Depending on the area to be imaged, the usual dose range is 20 to 40 mL. Injections may be repeated as necessary.

Central catheter injections are usually made with a power injector with an injection rate of between 10 and 30 mL/second. When making peripheral injections, rates of 12 to 20 mL/second should be used, depending on the size of the vein. Also, since contrast medium may remain in the arm vein for an extended period following injection, it may be advisable to flush the vein, immediately following injection with an appropriate volume (20 to 25 mL) of 5% Dextrose in water or normal saline.

ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY

Arterial digital subtraction angiography provides images similar in quality to conventional film-screen systems. The advantages of arterial DSA when compared to standard film angiography include: the use of less contrast medium; the use of lower concentrations for some procedures; a decreased need for selective arterial catheterization reducing the possibility of dislodging atheromatous plaques or significantly reducing the blood flow in the artery; and a shortened examination time. The limitations of arterial DSA include: reduced spatial resolution; limited field size; and the inability to conduct simultaneous biplane examinations.

患者准备

No special patient preparation is required for arterial DSA. However, it is advisable to ensure that patients are well hydrated prior to examination.

预防措施

In addition to the general precautions described, the risks associated with arterial DSA are those usually attendant with catheter procedures. Following the procedure, gentle pressure hemostasis is required, followed by observation and immobilization of the limb for several hours to prevent hemorrhage from the site of arterial puncture.

Usual Dosage

The following dosage schedule for adults should serve only as a guide since the volume administered, the concentration selected and the flow rate will be determined by the resolution of the equipment being used. As a general rule, the volume used and the flow rates for arterial DSA are 50% or less than that used for conventional film arteriography. Diagnostic studies have been obtained using Conray undiluted (28.2% iodine), diluted 1:1 (14.1% iodine), and diluted 1:2 (9.4% iodine). Sodium Chloride Injection USP or Water for Injection USP may be used for dilution.

The following doses, equivalent in iodine content to undiluted Conray, have been used.

How is Conray Supplied

存储

Store below 30°C (86°F). Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the container should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved, and that the container and closure have not been damaged.

This preparation is sensitive to light and must be protected from strong daylight or direct exposure to the sun.

As with all contrast media, glass containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closu