荷普欣(注射用更昔洛韦钠)
2024年更昔洛韦注射液市场分析报告
2024年更昔洛韦注射液市场分析报告一、市场概况作为一种抗病毒药物，更昔洛韦注射液在抗击病毒方面发挥着重要作用。
本文将对更昔洛韦注射液市场进行详细分析，包括市场规模、市场发展趋势以及市场竞争等方面。
二、市场规模据市场调研统计数据显示，更昔洛韦注射液市场的规模逐年增长。
目前，该市场的年销售额已达到X亿元，预计未来几年仍将保持较高的增长率。
这可以归因于更昔洛韦注射液在抗病毒领域的广泛应用以及其独特的药效。
三、市场发展趋势1. 技术升级推动市场增长随着医疗技术的不断发展，更昔洛韦注射液的制造技术也在不断升级。
新技术的引入不仅提高了产品的质量和安全性，还缩短了制造周期和降低了成本。
这使得更昔洛韦注射液更易于普及和推广，进一步推动了市场的增长。
2. 市场竞争加剧随着市场规模的扩大，更昔洛韦注射液市场的竞争也日益激烈。
目前，市场上已出现了多家生产更昔洛韦注射液的制药企业，它们之间在产品质量、价格和销售渠道等方面展开了激烈的竞争。
这种市场竞争既促进了产品的不断改进，也为消费者带来了更多选择，但同时也对企业带来了一定的压力。
3. 人口老龄化趋势随着人口老龄化趋势的加剧，慢性病和传染病的发病率也呈上升趋势。
更昔洛韦注射液作为一种重要的抗病毒药物，对于老年人及易感人群来说具有重要意义。
因此，随着老龄人口的不断增加，更昔洛韦注射液市场将迎来更多的机会和潜力。
四、市场竞争格局当前，更昔洛韦注射液市场的主要竞争者包括国内外多家制药企业。
这些企业在产品质量、价格、品牌影响力以及销售渠道等方面展开竞争。
其中一些知名企业通过不断创新和技术升级，提高了产品的附加值和竞争力。
然而，由于产品相似度较高，企业之间的竞争主要体现在价格和服务上。
五、市场前景展望更昔洛韦注射液市场具有较高的发展潜力。
随着技术的不断进步和医疗水平的提高，更昔洛韦注射液的市场需求将进一步增加。
同时，人口老龄化加剧和疾病防控意识的提升也将带来更多的市场机遇。
然而，市场竞争也将加剧，企业需加强研发创新、提高产品质量和服务水平，以保持竞争优势。
2024年更昔洛韦注射液市场前景分析
2024年更昔洛韦注射液市场前景分析引言近年来，随着人民生活水平的提高和医疗技术的不断进步，人们对药物的需求也在不断增长。
更昔洛韦注射液作为一种常用的抗病毒药物，在治疗病毒感染方面发挥着重要作用。
本文旨在分析更昔洛韦注射液在市场中的前景，为相关企业以及投资者提供参考。
目前市场现状1. 销售额增长迅速根据市场调研数据显示，近年来，更昔洛韦注射液的销售额呈现快速增长的趋势。
这主要得益于病毒感染疾病的增多，以及人们对健康的日益关注。
预计未来几年，更昔洛韦注射液的市场需求将继续保持增长。
2. 临床应用广泛更昔洛韦注射液是一种广谱的抗病毒药物，主要用于治疗疱疹病毒感染、巨细胞病毒感染等。
其在临床上的应用非常广泛，效果显著，因此备受医生和患者的青睐。
3. 市场竞争激烈尽管更昔洛韦注射液市场需求不断增长，但市场上同类产品也不断增多，竞争变得激烈。
目前市场上有多个制药公司生产更昔洛韦注射液，这些公司之间的竞争主要表现在品质、价格和品牌知名度等方面。
市场前景分析1. 市场需求持续增长随着病毒感染疾病的增多以及人们对健康的关注度提高，更昔洛韦注射液的市场需求将持续增长。
尤其是在发展中国家，由于卫生条件的改善和疾病防控水平的提高，更昔洛韦注射液的市场潜力将更为巨大。
2. 技术创新驱动市场发展随着科技的不断进步，更昔洛韦注射液的制造技术也在不断创新。
新的制造工艺和设备的应用，将进一步提高产品质量和生产效率，从而推动市场的发展。
3. 市场竞争格局变化在竞争激烈的市场环境下，企业需要不断提升产品质量和服务水平，同时加大市场推广力度，提升品牌知名度。
市场竞争格局可能会发生变化，领先企业有机会在竞争中脱颖而出。
4. 政策环境影响市场发展政策环境对于药物市场的发展具有重要影响。
随着国家医疗体制改革的推进，药品市场将面临更多的监管和政策变化。
企业需要时刻关注政策动态，合规运营，以避免不必要的风险。
5. 国际市场拓展机会更昔洛韦注射液作为一种常用的抗病毒药物，在国际市场上也具有广阔的发展前景。
更昔洛韦钠与普通更昔洛韦治疗小儿病毒性脑炎疗效观察
更昔洛韦钠与普通更昔洛韦治疗小儿病毒性脑炎疗效观察罗强;田培超;岳珍珍;陈国洪
【期刊名称】《中国实用神经疾病杂志》
【年(卷),期】2008(11)10
【摘要】目的观察更昔洛韦钠(荷普欣)及普通更昔洛韦治疗小儿病毒性脑炎的临床疗效.方法将40例病毒性脑炎患儿随机分成更昔洛韦钠组(治疗组)和普通更昔洛韦组(对照组),每组20例,所有病人都采用静脉给药,对2组患儿治疗效果进行观察.结果更昔洛韦钠治疗小儿病毒性脑炎头痛、呕吐、抽搐、意识恢复的时间较普通更昔洛韦对照组明显缩短,两者比较有显著差异(P＜0.05,更昔洛韦钠组比普通更昔洛韦组不良反应少且程度轻(P＜0.05.结论更昔洛韦钠治疗小儿病毒性脑炎疗效显著,作用迅速,安全性好,不良反应小,值得临床推广.
【总页数】2页(P31-32)
【作者】罗强;田培超;岳珍珍;陈国洪
【作者单位】郑州大学第一附属医院,郑州,450052;郑州大学第一附属医院,郑州,450052;郑州大学第一附属医院,郑州,450052;郑州市儿童医院神经内科,郑州,450053
【正文语种】中文
【中图分类】R512.3
【相关文献】
1.更昔洛韦联合干扰素治疗小儿病毒性脑炎患儿的临床疗效观察 [J], 常伟
2.更昔洛韦与丙种球蛋白治疗小儿病毒性脑炎疗效观察分析 [J], 王哲
3.更昔洛韦钠联合锌剂治疗小儿秋冬季腹泻的疗效观察 [J], 邢利嫦
4.更昔洛韦联合丙种球蛋白及干扰素治疗小儿病毒性脑炎疗效观察 [J], 张艳萍
5.更昔洛韦钠治疗小儿病毒性脑炎疗效观察 [J], 张永平
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注射用更昔洛韦钠与注射用丹参多酚酸盐存在配伍禁忌
患者满意度 ，促进医患关 系的和谐发展 ，不但 可提升护理质量 ，同 时可提升护理人员综合素质 ，在临床护理中值得应用推广 。
参 考 文 献 ［１］ 徐小雅 ，王永生，王效惠，等．护理风险管理在心血 管、呼吸 内
科护理 中的应用及效果评价［Ｊ］．四川 医学，２０１２，３３：９０６－９０８． ［２］ 李利花 ，陈登高．护理风 险管理 在心血 管 患者 临床 护理 中
『８］ 刘玲 玲．护理风险 管理在心血 管呼吸 内科 护理 中的应 用及 效果评价 ［Ｊ］．世界 最新 医学信息文摘 ，２０１６，１６：２３１－２３２．
［９］ 姚 红娜．中西 医护理风 险管理在 心血管呼吸 内科护理 中的 应用及效果评价 ［Ｊ］．中外健 康文摘 ，２０１４，２５：２５６—２５７．
［５］ 李亚 洁，张立颖 ，李瑛 ，等．风 险管理在 护理 管理 中的应 用 ［Ｊ］．中华现代护理 杂志 ，２００４，３９（１２）：９１８．
『６１ 何 丽霞．护理 风险管理在心血 管呼吸 内科 护理 中的应 用及 效果分析 ［Ｊ］．中国伤残 医学 ，２０１４，１７：２６０－２６１．
『７１ 关玉芳．护理风险 管理在 心血 管、呼吸 内科护 理 中的 临床 应 用 ［Ｊ＿．饮 食 保 健 ，２０１５，２：１１—１２．
的实施效果 『Ｊ１．世界 临床 医学 ，２０１６，１０：１７２—１７３． ［３］ 石琳 ．心血管 内科老年 患者风 险护理探 讨［Ｊ］．中国现代 药
物 应 用 ．２０１３．７：２５０－２５１． ［４］ 马在 萍．心血管 内科病房的护理风 险管理 ［Ｊ］．山西 医药杂
志 ，２０１４，４３：２２５－２２７．
2024年更昔洛韦注射液市场调研报告
2024年更昔洛韦注射液市场调研报告1. 介绍更昔洛韦注射液是一种抗病毒药物，主要用于治疗疱疹病毒感染引起的皮肤和粘膜病变。
它被广泛应用于临床，具有良好的疗效和安全性。
本报告旨在通过市场调研，对更昔洛韦注射液的市场销售情况、竞争格局、潜在机会等进行分析和总结。
2. 市场规模根据市场调研数据显示，更昔洛韦注射液市场在过去几年一直保持稳定增长的态势。
截至目前，该市场的年销售额已达到xx亿美元。
预计在未来几年，随着病毒感染疾病的不断增多和人们对药物治疗需求的增加，更昔洛韦注射液市场的规模还将进一步扩大。
3. 市场竞争格局更昔洛韦注射液市场上存在着多家主要的竞争企业，包括公司A、公司B和公司C等。
这些企业在产品研发、生产能力和市场营销方面具有较高的竞争力。
公司A在市场份额方面占据主导地位，其产品具有良好的口碑和广泛的应用领域。
公司B和公司C虽然市场份额较小，但它们在产品质量和价格方面具有一定优势。
4. 市场增长驱动因素市场调研数据显示，更昔洛韦注射液市场的增长主要由以下几个因素驱动：•疱疹病毒感染疾病的高发率：随着人们生活水平的提高和免疫力的下降，疱疹病毒感染疾病（如单纯疱疹、带状疱疹等）的发病率也在不断增加。
•医疗保健服务的普及：随着医疗保健服务的普及和医疗技术的进步，患者对更昔洛韦注射液等药物的需求量不断增加。
•新产品的研发和上市：随着科技的不断进步，新的更昔洛韦注射液产品不断研发和推出，满足了不同患者的治疗需求。
5. 市场前景基于对市场调研数据的分析，预计未来几年更昔洛韦注射液市场将保持稳定增长。
这主要得益于疾病发病率的增加、医疗保健服务的改善以及新产品的不断研发和上市。
同时，尽管市场竞争激烈，但市场份额占据主导地位的公司A有望通过持续的创新和市场推广，保持其领先地位。
6. 结论通过市场调研报告可以看出，更昔洛韦注射液市场具有较大的市场潜力和增长空间。
企业应该加强产品研发和市场营销，提高产品质量和竞争力，以赢得更多市场份额。
静脉输注更昔洛韦引起外渗的原因和预防
静脉输注更昔洛韦引起外渗的原因和预防
郝粉英;梁新
【期刊名称】《全科护理》
【年(卷),期】2006(004)035
【摘要】@@ 近年来,临床上巨细胞病毒感染患儿越来越多,治疗常采用静脉输注更昔洛韦.该药为白色疏松块状物或粉末;有引湿性;属核苷类抗病毒药,鸟嘌呤核苷衍生物.该药静脉输注过程中易渗于血管周围组织,引起局部组织肿胀疼痛、静脉炎、组织坏死、甚至功能障碍,既增加患儿痛苦,又造成住院时间延长.本文分析和总结了该药物外渗的原因和防治措施.
【总页数】2页(P45-46)
【作者】郝粉英;梁新
【作者单位】030013,山西省儿童医院;030013,山西省儿童医院
【正文语种】中文
【中图分类】R471
【相关文献】
1.静脉输注化疗药物外渗引起组织严重损伤的措施 [J], 赵君妍
2.新生儿静脉输液外渗引起水泡原因分析与预防 [J], 谭启明;窦月玲
3.静脉输注更昔洛韦引起外渗的原因和预防 [J], 郝粉英;梁新
4.静脉输注化疗药物外渗的原因分析及预防措施 [J], 刘丽丽
5.1例经输液港静脉输注化疗药物严重外渗引起的反思及全院持续质量改进 [J], 郝楠;李娜;康小云;夏鹏;张昊;辛霞
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更昔洛韦注射液治疗婴儿巨细胞病毒感染36例的不良反应观察及护理
更昔洛韦注射液治疗婴儿巨细胞病毒感染36例的不良反应观
察及护理
赖香菊
【期刊名称】《中国药业》
【年(卷),期】2013(022)009
【摘要】目的探讨更昔洛韦注射液治疗婴儿巨细胞病毒感染的不良反应及护理方法.方法对婴儿巨细胞感染患儿36例应用更昔洛韦注射液静脉滴注治疗,观察和记录不良反应情况.结果患儿使用更昔洛韦注射液后病情好转,但同时出现了呕吐(27.78％)、皮疹(25.00％)、贫血(13.89％)、中性粒细胞减少(38.89％)和血小板减少(8.33％)等不良反应.结论更昔洛韦注射液在对婴儿巨细胞病毒感染起到良好疗效的同时,也会引起多种不良反应.医务人员要及时采取相关护理措施,严重时应及时停药.
【总页数】2页(P79-80)
【作者】赖香菊
【作者单位】浙江省金华市人民医院儿科,浙江金华321000
【正文语种】中文
【中图分类】R969.4;R978.5;R473.72
【相关文献】
1.更昔洛韦、酪酸梭菌联合使用对巨细胞病毒感染引起婴儿淤胆型肝炎综合征的治疗效果观察 [J], 王晓玲;王江涛
2.更昔洛韦治疗111例婴儿巨细胞病毒感染不良反应分析 [J], 郝世莉;许红梅
3.更昔洛韦治疗婴儿巨细胞病毒感染所致高胆红素血症疗效观察 [J], 高美哲;李瑞峰;吴起
4.更昔洛韦加金双歧治疗巨细胞病毒感染引起婴儿淤胆型肝炎综合征临床观察 [J], 王英姿;汪祝萍;程海英
5.更昔洛韦治疗婴儿巨细胞病毒感染的观察和护理体会 [J], 邵荷芳
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更昔洛韦钠的功能主治
更昔洛韦钠的功能主治功能主治更昔洛韦钠是一种抗病毒药物，主要用于治疗疱疹病毒感染导致的疾病。
其主要功能和主治包括：1.治疗疱疹病毒感染：更昔洛韦钠可用于治疗多种疱疹病毒感染，包括单纯疱疹病毒感染（如唇疱疹、生殖器疱疹）和带状疱疹等。
2.抑制病毒复制：该药物能够抑制疱疹病毒的复制过程，从而减轻病毒感染带来的不适症状，并加速疾病的康复过程。
3.缓解病毒感染症状：更昔洛韦钠能够缓解病毒感染导致的疼痛、瘙痒、灼热等症状，改善患者的生活质量。
4.预防疱疹病毒复发：经过治疗后，更昔洛韦钠还能有效预防疱疹病毒的复发，减少疾病的再次发作概率。
用法用量使用更昔洛韦钠时，需要按照医生的指导和药物说明书的建议进行正确的用法用量。
一般来说：•剂型：更昔洛韦钠常见的剂型有片剂、注射剂等。
•口服用法：根据具体病情和医生建议，一般成人口服的剂量为每次500mg，每日2次，连续7-10天；对于疱疹带状疱疹，推荐口服剂量为每次1g，每日3次，连续7天。
•静脉注射用法：通常使用更昔洛韦钠注射剂，剂量一般为每次5mg/kg，每8小时静脉注射，连续5-7天。
•儿童用法：儿童用法用量需根据年龄和体重来确定，需遵循医生的建议和具体的说明。
注意事项使用更昔洛韦钠时，还需要注意以下事项：1.遵医嘱使用：根据医生的指导和药物说明书上的用法用量进行使用，不得自行调整剂量或停药，以免影响治疗效果。
2.避免过量使用：应严格按照医生的指导和药物说明使用更昔洛韦钠，避免使用过量导致不良反应的发生。
3.注意药物过敏：对更昔洛韦钠成分过敏的患者禁用该药物，使用过程中如出现过敏反应，应立即停用并就医处理。
4.注意肾功能：更昔洛韦钠在体内通过肾脏排泄，因此对于肾功能异常的患者，使用该药物时需注意剂量的调整和监测肾功能。
5.孕妇和哺乳期妇女慎用：目前对于孕妇和哺乳期妇女使用更昔洛韦钠的数据有限，应在医生指导下使用。
不良反应尽管更昔洛韦钠是一种常用的抗病毒药物，但在使用过程中仍可能发生一些不良反应。
更昔洛韦针的用法与用途
更昔洛韦针的用法与用途更昔洛韦针是一种治疗疱疹病毒感染的药物，其主要成分是更昔洛韦，可以通过皮下注射的方式给药。
以下是更昔洛韦针的用法与用途的详细介绍。
一、更昔洛韦针的用法：1. 具体剂量和给药频率应根据患者的年龄、体重、病情以及肾功能来确定，应遵循医生的建议和处方。
2. 使用前应仔细观察药物的外观，如药物出现明显的悬浊物或颜色变化，应禁止使用。
3. 更昔洛韦针是注射用药物，应在专业医生或者护士的指导下进行皮下注射。
4. 给药前应先用酒精消毒皮肤，然后将10-12.5毫克更昔洛韦缓慢地注射到腹壁皮下组织中。
5. 给药后应观察患者是否出现过敏反应和不适症状，如出现不适应立即停药并咨询医生。
二、更昔洛韦针的用途：1. 治疗水痘和带状疱疹：水痘和带状疱疹都是由人类单纯疱疹病毒（HSV）引起的疾病。
更昔洛韦可以抑制病毒的复制和传播，减轻症状、缩短病程，并减少并发症的发生。
水痘主要发生在儿童和青少年中，而带状疱疹多发生在中老年人身上。
2. 预防水痘和带状疱疹：更昔洛韦还可以用于预防水痘和带状疱疹的发生。
接触到病毒的患者，尤其是免疫系统功能较弱的人群，如免疫缺陷或接受器官移植的患者，可以使用更昔洛韦针来预防疾病的发生。
3. 治疗严重疱疹病毒感染：更昔洛韦针也可以用于治疗疱疹病毒引起的其他感染，如口腔疱疹、眼部疱疹和生殖器疱疹等。
这些感染在免疫系统较弱的患者中，如HIV感染者，可能会出现严重的症状和并发症。
4. 治疗新生儿疱疹感染：对于新生儿出生后感染疱疹病毒的情况，更昔洛韦针是一种常用的治疗方法。
早期治疗可以减轻症状，降低并发症风险，并有助于保护婴儿的生命。
5. 预防巨细胞病毒（CMV）感染：对于免疫抑制的器官移植患者，CMV感染是一种常见的并发症。
更昔洛韦针可以用于预防器官移植后CMV感染的发生。
更昔洛韦针作为一种抗病毒药物，在临床上广泛应用于各种病毒感染的治疗和预防。
但是，使用更昔洛韦针也存在一些注意事项和可能的副作用。
注射用更昔洛韦注意事项
注射用更昔洛韦注意事项
注射用更昔洛韦活性成分为更昔洛韦钠盐，用于预防和治疗危及生命或视觉的受巨细胞病毒感染的免疫缺陷病人，以及预防与巨细胞病毒感染有关的器官移植病人。
静脉注射本品过量可致不可逆转的各类血小板减少，持续骨髓抑制，可逆性中性粒细胞减少或粒细胞减少，肝肾功能损害和癫痫。
而且对阿昔洛韦以及本药品过敏的患者必须严禁使用本药物。
那么，在使用注射用更昔洛韦时还有哪些注意事项呢？注射用更昔洛韦注意事项！
本品可引起致突变、致畸及致癌，因此，临床应用于人体时应考虑潜在的致畸和致癌性；肾功能不全患者应根据肌酐清除率调整剂量；病人接受本品后可出现癫痫发作，嗜睡，头晕，共济失调，精神混乱和/或昏迷。
假如出现这些症状，会影响病人驾驶和操作机器的能力；如超过包装上标明的使用期限即不可再使用。
注射用更昔洛韦治疗儿童
注射用更昔洛韦治疗儿童手足口病临床应用及疗效分析肠道病毒EV7１，姆(亦称手足口病)多发生于学龄前儿童，尤以3岁以下年龄组成病率最高，可引起手、足、口腔等部位的斑丘疹、疮疹、个别患儿可引起脑炎、脑脊髓炎、肺水肿、循环衰竭等，我院主要针对留观以及轻型手足口病患儿采用注射用更昔洛韦治疗，临床疗效满意，治疗效果好。
1 对象和方法1.1 病例选择按以下标准入选：①根据临床表现及实验室检查诊断为手足口病的住院患儿，年龄在8个月—5岁，无重型病例表现(即无脑炎、脑膜炎、肺水肿、循环衰竭等表现的)②未应用其他抗病毒药物，伴有发热、咽痛、扁桃体肿大、口流涎、流涕、咳嗽，食欲不振，精神差。
2 方法①药物配制：将本品钠盐(武汉长联来福生化药业有限公司生产粉剂)，加入10ml用水后振荡溶解，液体应澄明无色，可在室温下稳定12小时，切勿冷藏。
进一步用0．9％氯化钠注射液或5％葡萄糖注射液稀释，含药量低于10mg／ml静脉滴注1小时，每日一次，每次5mg／kg，较重者可每日二次，疗程为5—7天。
②记录患儿治疗前症状及体征，逐日观察并记录治疗后疗状和体征变化，于治疗前及治疗后测患儿外周血象，肝功能，肾功能，胸片。
③联用碳青霉烯类或第2、3代头孢菌素预防和控制细菌感染。
④保持口腔清洁，多饮水，禁用刺激性药物。
淡盐水漱口，疼痛严重者可在餐前用2％利多卡因涂抹局部。
食物以微温或凉的流质或半流质为宜，发热后(体温太子38．5℃)用退热剂。
3 临床资料共85例，年龄分组：8个月—2岁14例，2—3岁50例，4—5岁21例。
85例中发热占57例，体温在38．5℃以下，多为低热(37.4℃—38℃)之间，55例出现咽痛，65例扁桃体红肿，25例白细胞计数>10×10９/L。
4 疗效体征痊愈：症状体征，实验室检查恢复正常。
显效：病情明显好转，体征尚未完全恢复。
好转：病情有所好转!但不明显。
无效：治疗72小时后病情无好转或有所加重。
更昔洛韦注射液的功能主治
更昔洛韦注射液的功能主治1. 简介更昔洛韦注射液是一种抗病毒药物，主要成分是更昔洛韦。
该药物通过抑制病毒复制和扩散，从而起到抗病毒的作用。
更昔洛韦注射液广泛用于临床治疗多种病毒感染，具有多种功能和主治。
2. 功能主治2.1 高效抗病毒作用更昔洛韦注射液具有高效的抗病毒作用。
它主要用于治疗以下病毒感染：•冠状病毒感染：更昔洛韦注射液在冠状病毒感染的治疗中发挥重要作用。
它可以抑制病毒的复制和扩散，帮助患者恢复健康。
•乙肝病毒感染：更昔洛韦注射液也被广泛应用于乙肝病毒感染的治疗中。
它可以抑制乙肝病毒的复制，减轻乙肝病毒引起的炎症反应，改善肝功能。
•副流感病毒感染：更昔洛韦注射液也可以用于副流感病毒感染的治疗。
它可以抑制副流感病毒的复制，减轻疾病症状，提高患者的康复率。
2.2 具有抗炎作用除了抗病毒作用外，更昔洛韦注射液还具有一定的抗炎作用。
它可以抑制病毒感染引起的炎症反应，减轻炎症症状，缓解患者的疼痛和不适。
2.3 促进免疫系统功能恢复更昔洛韦注射液还可以促进免疫系统的功能恢复。
它可以调节免疫系统的免疫应答，提高机体的抗病能力，从而帮助患者更快地康复。
2.4 预防病毒感染复发更昔洛韦注射液还可以预防病毒感染的复发。
它可以抑制病毒的复制和扩散，减少病毒在体内的存活时间，降低感染再次发作的风险。
3. 使用方法更昔洛韦注射液是一种静脉注射剂，只能由医务人员在医疗机构内使用。
具体使用方法如下：1.在使用前，应仔细读取药物说明书，了解使用方法和注意事项。
2.注射前，应先准备好注射器、注射针等医疗器械，并确保其无损坏。
3.取出一瓶更昔洛韦注射液，检查药液是否清澈，如有浑浊或颗粒状，应丢弃该瓶药物。
4.用无菌酒精棉球擦拭药瓶盖的橡胶塞，将注射针插入瓶盖，抽取适量的药液。
5.注射液的剂量应根据患者的具体情况和医生的建议进行确定。
6.将抽取的药液注入注射器中，并排除气泡。
7.选择注射部位，将注射针插入皮肤和组织，并将药液缓慢注射入体内。
临床更昔洛韦药物儿童应用、用法用量及注意事项
临床更昔洛韦药物儿童应用、用法用量及注
意事项
儿童用药
更昔洛韦应用于儿童的适应证包括先天或围产期巨细胞病毒(CMB)感染，是治疗症状性先天性CMV感染的首选药物。
因为有潜在的长期致癌性和生殖系统毒性，儿童应用本品时应非常小心，需评估接受治疗的益处是否超过其风险。
应严格掌握更昔洛韦的应用指征：
①有中枢神经系统累及的先天性CMV感染；
②有明显活动期症状的CMV感染，如肺炎、肝炎或脑炎等。
无症状性CMV感染或轻症，尤其是生后感染，可暂不用该药。
用法用量
治疗剂量为每日12mg∕kg,分2次给药，静脉滴注，疗程6周。
注意事项
该药仅能抑制病毒的复制，不能杀灭病毒，长期应用可引起耐药性及远期毒、副作用，主要有粒细胞和血小板减少，肝、肾功能损害、胃肠道及神经系统并发症等。
FDA黑框警告：血液毒性、生育力受损、胎儿毒性、诱变和致癌作用
1、血液学毒性：在使用注射用更昔洛韦治疗的患者中报告了粒细胞减少、贫血、血小板减少和全血细胞减少的情况。
2、生育力受损：根据动物数据和有限的人类数据，注射用更昔洛韦可能导致男性精子发生暂时或永久抑制以及抑制女性的生育力。
3、胎儿毒性：根据动物数据，使用注射用更昔洛韦有可能导致
人类胎儿出生缺陷。
4、诱变和致癌作用：根据动物数据，用注射用更昔洛韦有可能导致癌症的发生。
注射用更昔洛韦说明书
注射用更昔洛韦以下内容仅供参考，请以药品包装盒中的说明书为准。
注射用更昔洛韦说明书【说明书修订日期】核准日期：2007年04月29日修改日期：2010年10月01日修改日期：2010年12月08日【药品名称】注射用更昔洛韦【英文名】Ganciclovir for Injection【汉语拼音】zhusheyong Gengxiluowei【成份】本品的活性成份为更昔洛韦。
辅料名称:氢氧化钠【性状】本品为白色疏松块状物或粉末；有引湿性。
【适应症】1．适用于免疫缺陷患者（包括艾滋病患者）并发巨细胞病毒视网膜炎的诱导期和维持期治疗。
2．亦可用于接受器官移植的患者预防巨细胞病毒感染及用于巨细胞病毒血清试验阳性的艾滋病患者预防发生巨细胞病毒疾病。
【规格】(1)50mg(2)0.15g(3)0.25g(4)0.5g【用法用量】1．诱导期：静脉滴注按体重一次5mg/kg，每12小时1次，每次静滴1小时以上，疗程14～21日，肾功能减退者剂量应酌减。
肌酐清除率为50～69ml/分钟时，每12小时静脉滴注2.5mg/kg；肌酐消除率为25～49ml/分钟时，每24小时静脉滴注2.5mg/kg：肌酐清除率为10～24ml/分钟时，每24小时静脉滴注1.25mg/kg；肌酐清除率＜10ml/分钟时，每周给药3次，每次1.25mg/kg于血液透析后给予。
2．维持期：静脉滴注按体重一次5mg/kg，一日1次，静滴1小时以上。
肾功能减退者按肌酐清除率调整剂量：肌酐清除率为50～69ml/分钟时，每24小时静脉滴注2.5mg/kg；肌酐清除率为25～49ml/分钟时，每24小时静脉滴注1.25mg/kg；肌酐清除率为10～24ml/分钟时，每24小时静脉滴注0.625mg/kg；肌酐消除率＜10ml/分钟时，每周给药3次，每次0.625mg/kg于血液透析后给予。
3．预防用药：静脉滴注按体重一次5mg/kg，滴注时间至少1小时以上，每12小时1次，连续7～14日：继以5mg/Kg,一日1次，共7日。
丽科伟（注射用更昔洛韦）
丽科伟(注射用更昔洛韦)【药品名称】商品名称：丽科伟通用名称：注射用更昔洛韦英文名称：Gancicl ovir for Injecti on【成份】主要成分：更昔洛韦化学名：9-(1,3-二羟基-2-丙氧甲基)-鸟嘌呤分子式：C9H12N5O4分子量：255.23。
【适应症】1. 适用于免疫缺陷患者（包括艾滋病患者）并发巨细胞病毒视网膜炎的诱导期和维持期治疗。
2. 亦可用于接受器官移植的患者预防巨细胞病毒感染及用于巨细胞病毒血清试验阳性的艾滋病患者预防发生巨细胞病毒疾病。
【用法用量】1 诱导期：静脉滴注按体重一次5m g/kg，每12小时1次，每次静滴1小时以上，疗程14～21日，肾功能减退者剂量应酌减。
肌酐清除率为50～69ml/分钟时，每12小时静脉滴注2.5mg/kg；肌酐清除率为25～49ml/分钟时，每24小时静脉滴注2.5mg/kg；肌酐清除率为10～24ml/分钟时，每24小时静脉滴注1.25mg/kg；肌酐清除率【不良反应】1 常见的不良反应为骨髓抑制，用药后约40%的患者中性粒细胞数减低至1000/mm3以下，约20%的患者血小板计数减低至50000/mm3以下，此外可有贫血。
2 中枢神经系统症状如精神异常、紧张、震颤等，发生率约5%，偶有昏迷、抽搐等。
3 可出现皮疹、瘙痒、药物热、头痛、头昏、呼吸困难、恶心、呕吐、腹痛、食欲减退、肝功能异常、消化道出血、心律失常、血压升高或降低、血尿、血尿素氮增加、脱发、血糖降低、水肿、周身不适、肌酐增加、嗜酸性细胞增多症、注射局部疼痛、静脉炎等；有巨细胞病毒感染性视网膜炎的艾滋病患者可出现视网膜剥离。
【禁忌】对本品或阿昔洛韦过敏者禁用。
【注意事项】1 本品化学结构与阿昔洛韦相似，对后者过敏的患者也可能对本品过敏。
2 本品并不能治愈巨细胞病毒感染，因此用于艾滋病患者合并巨细胞病毒感染时往往需长期维持用药，防止复发。
注射用更昔洛韦说明书
注射用更昔洛韦说明书注射用更昔洛韦治疗巨细胞病毒，人类孢疹病毒感染的首选药物，高效低耐药性，广谱抗病毒。
下面是店铺整理的注射用更昔洛韦说明书，欢迎阅读。
注射用更昔洛韦商品介绍通用名：注射用更昔洛韦生产厂家: 广东阳江制药厂有限公司批准文号：国药准字H20033717药品规格：0.125g*1支药品价格：￥49.84元注射用更昔洛韦说明书【商品名】德洛好【通用名】注射用更昔洛韦【英文名】Ganciclovir for Injection【汉语拼音】ZhuSheYongGengXiLuoWei【主要成份】更昔洛韦。
【性状】德洛好为白色粉末或疏松块状物。
【适应症】治疗巨细胞病毒，人类孢疹病毒感染的首选药物，高效低耐药性，广谱抗病毒。
1、适用于免疫缺陷患者(包括艾滋病患者)并发巨细胞病毒视网膜炎的诱导期和维持期治疗。
2、亦可用于接受器官移植的患者预防巨细胞病毒感染及用于巨细胞病毒血清试验阳性的艾滋病患者预防发生巨细胞病毒疾病。
【用法用量】1、诱导期静脉滴注按体重一次5mg/kg，每12小时1次，每次静滴1小时以上，疗程14～21日，肾功能减退者剂量应酌减。
肌酐清除率为50～69ml/分钟时，每12小时静脉滴注2.5mg/kg;肌酐清除率为25～49ml/分钟时，每24小时静脉滴注2.5mg/kg;肌酐清除率为10～24ml/分钟时，每24小时静脉滴注1.25mg/kg;肌酐清除率〈10ml/分钟时，每周给药3次，每次1.25mg/kg于血液透析后给予。
2、维持期静脉滴注按体重一次5mg/kg，一日1次。
【药理毒理】更昔洛韦是合成的核苷类抗病毒药物，在体内可抑制疱疹病毒的复制，包括单纯疱疹病毒、水痘-带状疱疹病毒、EB病毒和巨细胞病毒等，尤以对缺乏胸苷激酶的耐药毒株及巨细胞病毒的作用显著;此外，德洛好对乙肝病毒，腺病毒及疱疹Ⅵ病毒亦有较强作用。
在作用机理上，德洛好进入宿主细胞后主要由敏感病毒诱导的一种或多种细胞激酶磷酸化为更昔洛韦三磷酸，其在病毒感染细胞内的浓度可以高于非感染细胞100倍，并通过两种方式抑制病毒复制。
更昔洛韦注射说明书
1CYTOVENE -IV2(ganciclovir sodium for injection)3FOR INTRAVENOUS INFUSION ONLY45Rx only6WARNING7THE CLINICAL TOXICITY OF CYTOVENE-IV INCLUDES 8GRANULOCYTOPENIA, ANEMIA AND THROMBOCYTOPENIA. IN ANIMAL 9STUDIES GANCICLOVIR WAS CARCINOGENIC, TERATOGENIC AND 10CAUSED ASPERMATOGENESIS.CYTOVENE-IV IS INDICATED FOR USE ONLY IN THE TREATMENT OF 1112CYTOMEGALOVIRUS (CMV) RETINITIS IN IMMUNOCOMPROMISED 13PATIENTS AND FOR THE PREVENTION OF CMV DISEASE IN TRANSPLANT 14PATIENTS AT RISK FOR CMV DISEASE (see INDICATIONS AND USAGE).15DESCRIPTION16Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). 17CYTOVENE-IV is the brand name for ganciclovir sodium for injection.18CYTOVENE-IV is available as sterile lyophilized powder in strength of 500 mg per vial 19for intravenous administration only. Each vial of CYTOVENE-IV contains the equivalent 20of 500 mg ganciclovir as the sodium salt (46 mg sodium). Reconstitution with 10 mL of 21Sterile Water for Injection, USP, yields a solution with pH 11 and a ganciclovir 22concentration of approximately 50 mg/mL. Further dilution in an appropriate intravenous 23solution must be performed before infusion (see DOSAGE AND ADMINISTRATION).24Ganciclovir is a white to off-white crystalline powder with a molecular formula of 25C9H13N504 and a molecular weight of 255.23. The chemical name for ganciclovir is 9-[[2-26hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine. Ganciclovir is a polar hydrophilic 27compound with a solubility of 2.6 mg/mL in water at 25°C and an n-octanol/water partition 28coefficient of 0.022. The pK a s for ganciclovir are 2.2 and 9.4.29Ganciclovir, when formulated as monosodium salt in the IV dosage form, is a white to off-30white lyophilized powder with the molecular formula of C9H12N5Na04, and a molecular 31weight of 277.22. The chemical name for ganciclovir sodium is 9-[[2-hydroxy-1-32(hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt. The lyophilized powder has an 33aqueous solubility of greater than 50 mg/mL at 25°C. At physiological pH, ganciclovir sodium exists as the un-ionized form with a solubility of approximately 6 mg/mL at 37°C. 3435The chemical structures of ganciclovir sodium and ganciclovir are:3637ganciclovir sodium ganciclovir38All doses in this insert are specified in terms of ganciclovir.39VIROLOGY40Mechanism of Action41Ganciclovir is an acyclic nucleoside analogue of 2'-deoxyguanosine that inhibits replication of herpes viruses. Ganciclovir has been shown to be active against cytomegalovirus (CMV) 4243and herpes simplex virus (HSV) in human clinical studies.44To achieve anti-CMV activity, ganciclovir is phosphorylated first to the monophosphate 45form by a CMV-encoded (UL97 gene) protein kinase homologue, then to the di- and 46triphosphate forms by cellular kinases. Ganciclovir triphosphate concentrations may be47100-fold greater in CMV-infected than in uninfected cells, indicating preferential phosphorylation in infected cells. Ganciclovir triphosphate, once formed, persists for days 4849in the CMV-infected cell. Ganciclovir triphosphate is believed to inhibit viral DNA50synthesis by (1) competitive inhibition of viral DNA polymerases; and (2) incorporation51into viral DNA, resulting in eventual termination of viral DNA elongation.52Antiviral Activity53The median concentration of ganciclovir that inhibits CMV replication (IC50) in vitro (laboratory strains or clinical isolates) has ranged from 0.02 to 3.48 g/mL. Ganciclovir 5455inhibits mammalian cell proliferation (CIC50) in vitro at higher concentrations ranging from 5630 to 725 g/mL. Bone marrow-derived colony-forming cells are more sensitive (CIC50 570.028 to 0.7 g/mL). The relationship of in vitro sensitivity of CMV to ganciclovir and58clinical response has not been established.59Clinical Antiviral Effect of CYTOVENE-IV and Ganciclovir CapsulesCYTOVENE-IV6061In a study of CYTOVENE-IV treatment of life- or sight-threatening CMV disease in62immunocompromised patients, 121 of 314 patients had CMV cultured within 7 days prior63to treatment and sequential posttreatment viral cultures of urine, blood, throat and/or64semen. As judged by conversion to culture negativity, or a greater than 100-fold decrease in65in vitro CMV titer, at least 83% of patients had a virologic response with a median responsetime of 7 to 15 days.6667Antiviral activity of CYTOVENE-IV was demonstrated in two randomized studies for the68prevention of CMV disease in transplant recipients (see Table 1).Table 1 Patients With Positive CMV Cultures69Heart Allograft* (n = 147) Bone Marrow Allograft (n = 72) Time CYTOVENE-IV†Placebo CYTOVENE-IV‡ PlaceboPretreatment 1/67 (2%) 5/64 (8%) 37/37 (100%) 35/35 (100%) Week 2 2/75 (3%) 11/67 (16%) 2/31 (6%) 19/28 (68%) Week 4 3/66 (5%) 28/66 (43%) 0/24 (0%) 16/20 (80%) 70* CMV seropositive or receiving graft from seropositive donor71† 5 mg/kg bid for 14 days followed by 6 mg/kg qd for 5 days/week for 14 days72‡ 5 mg/kg bid for 7 days followed by 5 mg/kg qd until day 100 posttransplant73Ganciclovir Capsules74In trials comparing CYTOVENE-IV with Ganciclovir capsules for the maintenance 75treatment of CMV retinitis in patients with AIDS, serial urine cultures and other available cultures (semen, biopsy specimens, blood and others) showed that a small proportion of 7677patients remained culture-positive during maintenance therapy with no statistically 78significant differences in CMV isolation rates between treatment groups.79Viral Resistance80The current working definition of CMV resistance to ganciclovir in in vitro assays is IC50 81>3.0 g/mL (12.0 M). CMV resistance to ganciclovir has been observed in individuals 82with AIDS and CMV retinitis who have never received ganciclovir therapy. Viral resistance 83has also been observed in patients receiving prolonged treatment for CMV retinitis with 84CYTOVENE-IV. In a controlled study of oral ganciclovir for prevention of AIDS-85associated CMV disease, 364 individuals had one or more cultures performed after at least 8690 days of ganciclovir treatment. Of these, 113 had at least one positive culture. The last 87available isolate from each subject was tested for reduced sensitivity, and 2 of 40 were 88found to be resistant to ganciclovir. These resistant isolates were associated with 89subsequent treatment failure for retinitis.90The possibility of viral resistance should be considered in patients who show poor clinical 91response or experience persistent viral excretion during therapy. The principal mechanism 92of resistance to ganciclovir in CMV is the decreased ability to form the active triphosphate 93moiety; resistant viruses have been described that contain mutations in the UL97 gene of 94CMV that controls phosphorylation of ganciclovir. Mutations in the viral DNA polymerase 95have also been reported to confer viral resistance to ganciclovir.96CLINICAL PHARMACOLOGY97Pharmacokinetics98BECAUSE THE MAJOR ELIMINATION PATHWAY FOR GANCICLOVIR IS 99RENAL, DOSAGE REDUCTIONS ACCORDING TO CREATININE CLEARANCE 100ARE REQUIRED FOR CYTOVENE-IV. FOR DOSING INSTRUCTIONS IN 101PATIENTS WITH RENAL IMPAIRMENT, REFER TO DOSAGE AND 102ADMINISTRATION.Absorption103At the end of a 1-hour intravenous infusion of 5 mg/kg ganciclovir, total AUC ranged 104between 22.1 3.2 (n=16) and 26.8 6.1 g·hr/mL (n=16) and C max ranged between 1058.27 1.02 (n=16) and 9.0 1.4 g/mL (n=16).106Distribution107The steady-state volume of distribution of ganciclovir after intravenous administration was 1080.74 0.15 L/kg (n=98). Cerebrospinal fluid concentrations obtained 0.25 to 5.67 hours 109postdose in 3 patients who received 2.5 mg/kg ganciclovir intravenously q8h or q12h 110ranged from 0.31 to 0.68 g/mL representing 24% to 70% of the respective plasma 111concentrations. Binding to plasma proteins was 1% to 2% over ganciclovir concentrations 112of 0.5 and 51 g/mL.113Elimination114When administered intravenously, ganciclovir exhibits linear pharmacokinetics over the 115range of 1.6 to 5.0 mg/kg and when administered orally, it exhibits linear kinetics up to a 116total daily dose of 4 g/day. Renal excretion of unchanged drug by glomerular filtration and 117active tubular secretion is the major route of elimination of ganciclovir. In patients with 118normal renal function, 91.3 5.0% (n=4) of intravenously administered ganciclovir was 119recovered unmetabolized in the urine. Systemic clearance of intravenously administered 120ganciclovir was 3.52 0.80 mL/min/kg (n=98) while renal clearance was 3.20 0.80 121mL/min/kg (n=47), accounting for 91 11% of the systemic clearance (n=47). Half-life 122was 3.5 0.9 hours (n=98) following IV administration and 4.8 0.9 hours (n=39) 123following oral administration.124Special Populations125Renal Impairment126The pharmacokinetics following intravenous administration of CYTOVENE-IV solution 127were evaluated in 10 immunocompromised patients with renal impairment who received 128doses ranging from 1.25 to 5.0 mg/kg.129Table 2 Pharmacokinetics of Patients with Renal Impairment130Estimated Creatinine Clearance (mL/min) n Dose Clearance(mL/min)Mean SDHalf-life(hours)Mean SD50-79 4 3.2-5 mg/kg 128 + 63 4.6 1.425-49 3 3-5 mg/kg 57 + 8 4.4 + 0.4<25 3 1.25-5 mg/kg 30 + 13 10.7 + 5.7Based on these observations, it is necessary to modify the dosage of ganciclovir in patients 131with renal impairment (see DOSAGE AND ADMINISTRATION).132Hemodialysis reduces plasma concentrations of ganciclovir by about 50% after intravenous 133administration.134Race/Ethnicity and Gender135136The effects of race/ethnicity and gender were studied in subjects receiving a dose regimen 137of 1000 mg every 8 hours. Although the numbers of blacks (16%) and Hispanics (20%)138were small, there appeared to be a trend towards a lower steady-state C max and AUC0-8 in 139these subpopulations as compared to Caucasians. No definitive conclusions regarding 140gender differences could be made because of the small number of females (12%); however,141no differences between males and females were observed.142Pediatrics143Ganciclovir pharmacokinetics were studied in 27 neonates, aged 2 to 49 days. At an 144intravenous dose of 4 mg/kg (n=14) or 6 mg/kg (n=13), the pharmacokinetic parameters 145were, respectively, C max of 5.5 1.6 and 7.0 1.6 g/mL, systemic clearance of 1463.14 1.75 and 3.56 1.27 mL/min/kg, and t½ of 2.4 hours (harmonic mean) for both. 147Ganciclovir pharmacokinetics were also studied in 10 pediatric patients, aged 9 months to 14812 years. The pharmacokinetic characteristics of ganciclovir were the same after single and 149multiple (q12h) intravenous doses (5 mg/kg). The steady-state volume of distribution was 1500.64 0.22 L/kg, C max was 7.9 3.9 g/mL, systemic clearance was 4.7 2.2 mL/min/kg, 151and t½ was 2.4 0.7 hours. The pharmacokinetics of intravenous ganciclovir in pediatric152patients are similar to those observed in adults.153Elderly154No studies have been conducted in adults older than 65 years of age.155INDICATIONS AND USAGE156CYTOVENE-IV is indicated for the treatment of CMV retinitis in immunocompromised 157patients, including patients with acquired immunodeficiency syndrome (AIDS). 158CYTOVENE-IV is also indicated for the prevention of CMV disease in transplantrecipients at risk for CMV disease (see CLINICAL TRIALS).159160SAFETY AND EFFICACY OF CYTOVENE-IV HA VE NOT BEEN ESTABLISHED 161FOR CONGENITAL OR NEONATAL CMV DISEASE; NOR FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS; NOR FOR USE IN 162163NON-IMMUNOCOMPROMISED INDIVIDUALS.CLINICAL TRIALS1641651. Treatment of CMV Retinitis166The diagnosis of CMV retinitis should be made by indirect ophthalmoscopy. Other conditions in the differential diagnosis of CMV retinitis include candidiasis, toxoplasmosis, 167168histoplasmosis, retinal scars and cotton wool spots, any of which may produce a retinal 169appearance similar to CMV. For this reason it is essential that the diagnosis of CMV be 170established by an ophthalmologist familiar with the retinal presentation of these conditions.171The diagnosis of CMV retinitis may be supported by culture of CMV from urine, blood, 172throat or other sites, but a negative CMV culture does not rule out CMV retinitis.Studies With CYTOVENE-IV173In a retrospective, non-randomized, single-center analysis of 41 patients with AIDS and 174CMV retinitis diagnosed by ophthalmologic examination between August 1983 and April 1751988, treatment with CYTOVENE-IV solution resulted in a significant delay in mean 176(median) time to first retinitis progression compared to untreated controls [105 (71) days 177from diagnosis vs 35 (29) days from diagnosis]. Patients in this series received induction 178treatment of CYTOVENE-IV 5 mg/kg bid for 14 to 21 days followed by maintenance 179treatment with either 5 mg/kg once daily, 7 days per week or 6 mg/kg once daily, 5 days per 180week (see DOSAGE AND ADMINISTRATION).181In a controlled, randomized study conducted between February 1989 and December 1990,1 182immediate treatment with CYTOVENE-IV was compared to delayed treatment in 42 183patients with AIDS and peripheral CMV retinitis; 35 of 42 patients (13 in the immediate-184treatment group and 22 in the delayed-treatment group) were included in the analysis of 185time to retinitis progression. Based on masked assessment of fundus photographs, the mean 186[95% CI] and median [95% CI] times to progression of retinitis were 66 days [39, 94] and 18750 days [40, 84], respectively, in the immediate-treatment group compared to 19 days [11, 18827] and 13.5 days [8, 18], respectively, in the delayed-treatment group.189Studies Comparing Ganciclovir Capsules to CYTOVENE-IV190Table 3 Population Characteristics in Studies ICM 1653, ICM 1774 191and AVI 034192ICM 1653 (n=121) ICM 1774(n=225)A VI 034(n=159)Median age (years) Range3824-623722-563923-62Sex Males 116 (96%) 222 (99%) 148 (93%) Females 5 (4%) 3 (1%) 10 (6%)Asian 3 (3%) 5 (2%) 7 (4%) Ethnicity Black 11 (9%) 9 (4%) 3 (2%) Caucasian 98 (81%) 186 (83%) 140 (88%)Other 9 (7%) 25 (11%) 8 (5%)Median CD4 Count Range9.50-1417.00-8010.00-320Mean (SD)Observation Time (days) 107.9 (43.0) 97.6 (42.5) 80.9 (47.0) 193ICM 1653: In this randomized, open-label, parallel group trial, conducted between March 1941991 and November 1992, patients with AIDS and newly diagnosed CMV retinitis 195received a 3-week induction course of CYTOVENE-IV solution, 5 mg/kg bid for 14 days 196followed by 5 mg/kg once daily for 1 additional week.2 Following the 21-day intravenous 197induction course, patients with stable CMV retinitis were randomized to receive 20 weeks 198of maintenance treatment with either CYTOVENE-IV solution, 5 mg/kg once daily, or 199ganciclovir capsules, 500 mg 6 times daily (3000 mg/day). The study showed that the 200mean [95% CI] and median [95% CI] times to progression of CMV retinitis, as assessed 201by masked reading of fundus photographs, were 57 days [44, 70] and 29 days [28, 43], 202203respectively, for patients on oral therapy compared to 62 days [50, 73] and 49 days [29,20461], respectively, for patients on intravenous therapy. The difference [95% CI] in the 205mean time to progression between the oral and intravenous therapies (oral - IV) was -5 206days [-22, 12]. See Figure 1 for comparison of the proportion of patients remaining free207of progression over time.208ICM 1774: In this three-arm, randomized, open-label, parallel group trial, conducted 209between June 1991 and August 1993, patients with AIDS and stable CMV retinitis 210following from 4 weeks to 4 months of treatment with CYTOVENE-IV solution were211randomized to receive maintenance treatment with CYTOVENE-IV solution, 5 mg/kg 212once daily, ganciclovir capsules, 500 mg 6 times daily, or ganciclovir capsules, 1000 mg 213tid for 20 weeks. The study showed that the mean [95% CI] and median [95% CI] times214to progression of CMV retinitis, as assessed by masked reading of fundus photographs, 215were 54 days [48, 60] and 42 days [31, 54], respectively, for patients on oral therapy 216compared to 66 days [56, 76] and 54 days [41, 69], respectively, for patients on217intravenous therapy. The difference [95% CI] in the mean time to progression between 218the oral and intravenous therapies (oral - IV) was -12 days [-24, 0]. See Figure 2for 219comparison of the proportion of patients remaining free of progression over time.AVI 034: In this randomized, open-label, parallel group trial, conducted between June 2202211991 and February 1993, patients with AIDS and newly diagnosed (81%) or previously 222treated (19%) CMV retinitis who had tolerated 10 to 21 days of induction treatment with CYTOVENE-IV, 5 mg/kg twice daily, were randomized to receive 20 weeks of 223224maintenance treatment with either ganciclovir capsules, 500 mg 6 times daily or 225CYTOVENE-IV solution, 5 mg/kg/day.3 The mean [95% CI] and median [95% CI] times 226to progression of CMV retinitis, as assessed by masked reading of fundus photographs,227were 51 days [44, 57] and 41 days [31, 45], respectively, for patients on oral therapy 228compared to 62 days [52, 72] and 60 days [42, 83], respectively, for patients on intravenous therapy. The difference [95% CI] in the mean time to progression between 229230the oral and intravenous therapies (oral - IV) was -11 days [-24, 1]. See Figure 3for 231comparison of the proportion of patients remaining free of progression over time.232Comparison of other CMV retinitis outcomes between oral and IV formulations 233(development of bilateral retinitis, progression into Zone 1, and deterioration of visual234acuity), while not definitive, showed no marked differences between treatment groups in 235these studies. Because of low event rates among these endpoints, these studies are 236underpowered to rule out significant differences in these endpoints.237Figure 1 ICM 1653238239Figure 2 ICM 1774240241Figure 3 AVI 0342422432. Prevention of CMV Disease in Transplant Recipients244245CYTOVENE-IV was evaluated in three randomized, controlled trials of prevention of246CMV disease in organ transplant recipients.247ICM 1496: In a randomized, double-blind, placebo-controlled study of 149 heart transplant 248recipients4 at risk for CMV infection (CMV seropositive or a seronegative recipient of an 249organ from a CMV seropositive donor), there was a statistically significant reduction in theoverall incidence of CMV disease in patients treated with CYTOVENE-IV. Immediately 250251posttransplant, patients received CYTOVENE-IV solution 5 mg/kg bid for 14 days 252followed by 6 mg/kg qd for 5 days/week for an additional 14 days. Twelve of the 76 (16%)patients treated with CYTOVENE-IV vs 31 of the 73 (43%) placebo-treated patients 253254developed CMV disease during the 120-day posttransplant observation period. No 255significant differences in hematologic toxicities were seen between the two treatment256groups (refer to Table 6 in ADVERSE EVENTS).257ICM 1689: In a randomized, double-blind, placebo-controlled study of 72 bone marrow 258transplant recipients5 with asymptomatic CMV infection (CMV positive culture of urine, 259throat or blood) there was a statistically significant reduction in the incidence of CMV260disease in patients treated with CYTOVENE-IV following successful hematopoietic 261engraftment. Patients with virologic evidence of CMV infection received CYTOVENE-262IV solution 5 mg/kg bid for 7 days followed by 5 mg/kg qd through day 100263posttransplant. One of the 37 (3%) patients treated with CYTOVENE-IV vs 15 of the 35 264(43%) placebo-treated patients developed CMV disease during the study. At 6 months posttransplant, there continued to be a statistically significant reduction in the incidence 265266of CMV disease in patients treated with CYTOVENE-IV. Six of 37 (16%) patients treated 267with CYTOVENE-IV vs 15 of the 35 (43%) placebo-treated patients developed disease through 6 months posttransplant. The overall rate of survival was statistically 268269significantly higher in the group treated with CYTOVENE-IV, both at day 100 and day 270180 posttransplant. Although the differences in hematologic toxicities were not 271statistically significant, the incidence of neutropenia was higher in the group treated with272CYTOVENE-IV (refer to Table 6 in ADVERSE EVENTS).273ICM 1570: A second, randomized, unblinded study evaluated 40 allogeneic bone marrow 274transplant recipients at risk for CMV disease.6Patients underwent bronchoscopy and 275bronchoalveolar lavage (BAL) on day 35 posttransplant. Patients with histologic,276immunologic or virologic evidence of CMV infection in the lung were then randomized to 277observation or treatment with CYTOVENE-IV solution (5 mg/kg bid for 14 days followed 278by 5 mg/kg qd 5 days/week until day 120). Four of 20 (20%) patients treated with279CYTOVENE-IV and 14 of 20 (70%) control patients developed interstitial pneumonia. The 280incidence of CMV disease was significantly lower in the group treated with CYTOVENE-281IV, consistent with the results observed in ICM 1689.282CONTRAINDICATIONSCYTOVENE-IV is contraindicated in patients with hypersensitivity to ganciclovir or 283284acyclovir.WARNINGS285286Hematologic287CYTOVENE-IV should not be administered if the absolute neutrophil count is less than 500 cells/ L or the platelet count is less than 25,000 cells/ L.Granulocytopenia 288289(neutropenia), anemia and thrombocytopenia have been observed in patients treated with290CYTOVENE-IV. The frequency and severity of these events vary widely in different291patient populations (see ADVERSE EVENTS).292CYTOVENE-IV should, therefore, be used with caution in patients with pre-existing293cytopenias or with a history of cytopenic reactions to other drugs, chemicals or irradiation.294Granulocytopenia usually occurs during the first or second week of treatment but may295occur at any time during treatment. Cell counts usually begin to recover within 3 to 7 days296of discontinuing drug. Colony-stimulating factors have been shown to increase neutrophil297and white blood cell counts in patients receiving CYTOVENE-IV solution for treatment of298CMV retinitis.299Impairment of FertilityAnimal data indicate that administration of ganciclovir causes inhibition of 300301spermatogenesis and subsequent infertility. These effects were reversible at lower doses302and irreversible at higher doses (see PRECAUTIONS: Carcinogenesis, Mutagenesis‡and Impairment of Fertility‡). Although data in humans have not been obtained 303304regarding this effect, it is considered probable that ganciclovir at the recommended doses305causes temporary or permanent inhibition of spermatogenesis. Animal data also indicate306that suppression of fertility in females may occur.307Teratogenesis308Because of the mutagenic and teratogenic potential of ganciclovir, women of childbearing309potential should be advised to use effective contraception during treatment. Similarly, men310should be advised to practice barrier contraception during and for at least 90 days following311treatment with CYTOVENE-IV (see PRECAUTIONS: Pregnancy‡: Category C).312PRECAUTIONS313General314In clinical studies with CYTOVENE-IV, the maximum single dose administered was 6mg/kg by intravenous infusion over 1 hour. Larger doses have resulted in increased 315316toxicity. It is likely that more rapid infusions would also result in increased toxicity (see317OVERDOSAGE). Administration of CYTOVENE-IV solution should be accompanied byadequate hydration.318319Initially reconstituted solutions of CYTOVENE-IV have a high pH (pH 11). Despite further320dilution in intravenous fluids, phlebitis and/or pain may occur at the site of intravenous321infusion. Care must be taken to infuse solutions containing CYTOVENE-IV only into veins322with adequate blood flow to permit rapid dilution and distribution (see DOSAGE AND323ADMINISTRATION).Since ganciclovir is excreted by the kidneys, normal clearance depends on adequate renal 324325function. IF RENAL FUNCTION IS IMPAIRED, DOSAGE ADJUSTMENTS ARE 326REQUIRED FOR CYTOVENE-IV. Such adjustments should be based on measured or estimated creatinine clearance values (see DOSAGE AND ADMINISTRATION).327328Information for Patients329All patients should be informed that the major toxicities of ganciclovir are 330granulocytopenia (neutropenia), anemia and thrombocytopenia and that dose modifications 331may be required, including discontinuation. The importance of close monitoring of blood 332counts while on therapy should be emphasized. Patients should be informed that 333ganciclovir has been associated with elevations in serum creatinine.334Patients should be advised that ganciclovir has caused decreased sperm production in 335animals and may cause infertility in humans. Women of childbearing potential should be 336advised that ganciclovir causes birth defects in animals and should not be used during 337pregnancy. Women of childbearing potential should be advised to use effective 338contraception during treatment with CYTOVENE-IV. Similarly, men should be advised to practice barrier contraception during and for at least 90 days following treatment with 339340CYTOVENE-IV.341Patients should be advised that ganciclovir causes tumors in animals. Although there is no information from human studies, ganciclovir should be considered a potential carcinogen. 342343All HIV+ Patients344These patients may be receiving zidovudine. Patients should be counseled that treatment 345with both ganciclovir and zidovudine simultaneously may not be tolerated by some patients 346and may result in severe granulocytopenia (neutropenia). Patients with AIDS may be 347receiving didanosine. Patients should be counseled that concomitant treatment with both 348ganciclovir and didanosine can cause didanosine serum concentrations to be significantly 349increased.350HIV+ Patients With CMV Retinitis351Ganciclovir is not a cure for CMV retinitis, and immunocompromised patients may 352continue to experience progression of retinitis during or following treatment. Patients 353should be advised to have ophthalmologic follow-up examinations at a minimum of every4 to 6 weeks while being treated with CYTOVENE-IV. Some patients will require more 354355frequent follow-up.356Transplant RecipientsTransplant recipients should be counseled regarding the high frequency of impaired renal 357358function in transplant recipients who received CYTOVENE-IV solution in controlled 359clinical trials, particularly in patients receiving concomitant administration of nephrotoxic 360agents such as cyclosporine and amphotericin B. Although the specific mechanism of this 361toxicity, which in most cases was reversible, has not been determined, the higher rate of 362renal impairment in patients receiving CYTOVENE-IV solution compared with those who。
注射用更昔洛韦与2种输液配伍的稳定性
注射用更昔洛韦与2种输液配伍的稳定性
赵文霞;刘丽仙
【期刊名称】《浙江医学教育》
【年(卷),期】2010(009)002
【摘要】目的:考察25℃下6小时内注射用更昔洛韦与乳酸钠林格注射液、果糖注射液的配伍稳定性.方法:采用HPLC法测定0-6小时内注射用更昔洛韦与2种输液配伍后的含量变化,同时观察其含量、外观、pH等变化.结果:25℃下6小时内,注射用更昔洛韦分别与2种输液配伍后含量、紫外吸收光谱、外观、pH基本不变.结论:注射用更昔洛韦在6小时内可与上述2种输液配伍使用.
【总页数】3页(P40-41,44)
【作者】赵文霞;刘丽仙
【作者单位】浙江医学高等专科学校,浙江,杭州,310053;丽水市人民医院,浙江,丽水,323000
【正文语种】中文
【中图分类】R969.2
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