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高度警惕:头孢曲松钠七种用法危及患者!

2017-06-22 佚名 基层医生论坛

国家药品不良反应监测中心病例报告数据库统计显示,抗感染药不良事件报告比例接近总体报告的50%;头孢曲松钠不良事件报告总数、严重报告数量在抗感染药中均占较高比例,死亡病例报告数量位居抗感染药首位。为此,国家食品药品监督管理局曾召开新闻发布会,专门对头孢曲松钠的临床不合理使用提出警示。

头孢曲松钠警示

国家药品不良反应监测中心病例报告数据库统计显示,抗感染药不良事件报告比例接近总体报告的50%;头孢曲松钠不良事件报告总数、严重报告数量在抗感染药中均占较高比例,死亡病例报告数量位居抗感染药首位。为此,国家食品药品监督管理局曾召开新闻发布会,专门对头孢曲松钠的临床不合理使用提出警示。

头孢曲松钠的不合理使用在临床上主要体现于哪些方面呢?从2007年下半年,国家药品不良反应监测中心开始对此品种进行全面评价,整个评价工作历时半年之久,经过全面系统的评价,头孢曲松钠合理使用下,利益明显大于风险;在药品不良反应/事件报告中不合理用药现象广泛存在,不合理用药使得用药的风险明显扩大,不良事件数量明显增加。记者约请国家药品不良反应监测中心有关专家对头孢曲松钠的临床不合理使用主要问题进行了总结,并提出相应建议。

1、用药不对症  不合理使用问题一:超出适应症用药(用药不对症)

【典型病例】患者,女性,17岁,因胃肠型感冒来院就诊,使用头孢曲松钠后意识模糊。立即停用头孢曲松钠,10分钟后自觉症状好转。

【专家分析】头孢曲松钠并不适用于胃肠型感冒,一般适用于严重感染,如呼吸道感染、败血症、腹腔感染、肾盂肾炎、盆腔炎性疾病、骨关节感染、皮肤软组织感染、中枢神经系统感染等。国家中心病例报告数据库显示,严重病例中超适应症用药约占严重病例报告总数的10%。

2、超剂量用药 不合理使用问题二:儿童超剂量用药

【典型病例】患儿,男性,4岁,体重11kg,因支气管炎给予头孢曲松钠2g。1分钟后,患儿出现流涕、口吐白痰,立即关闭输液,进行抢救,30分钟后,抢救无效死亡。

【专家分析】头孢曲松钠药品说明书中明确提示,儿童静脉给药每日剂量为体重20-80mg/kg。国家中心病例报告数据库显示,部分儿童患者存在超剂量使用的情况。

3、药物混合使用 不合理使用问题三:配伍禁忌用药(与其他药物混合使用)

【典型病例】患者,女性,60岁,因上呼吸道感染,去当地村卫生所就诊,给予头孢曲松钠、地塞米松、利巴韦林混合用药。约20分钟后突感呼吸困难,继而心跳停止,抢救八小时无效死亡。

【专家分析】头孢曲松钠药品说明书中明确提示,由于可能会产生药物间的不相容性,不能将该品与其他药物混合使用,需联合用药时应分开使用。国家中心病例报告数据库显示,严重病例中存在头孢曲松钠与其他药品混合静脉使用的问题。其中以头孢曲松钠与地塞米松混合静脉使用占大多数,其次是与利巴韦林等抗病毒药物和/或中药注射剂混合静脉使用。少数病例一次混合使用药品多达4种。药物过敏者用药

4、不合理使用问题四:禁忌症用药(药物过敏者用药)

【典型病例】患者,女性,35岁,既往青霉素过敏史。因“蚊虫叮伤继发感染”给予头孢曲松钠治疗。大约2分钟后,病人全身不适,立即停止输液,15分钟后患者突然心跳停止,继续抢救无效死亡。

【专家分析】头孢曲松钠说明书【禁忌】和【注意事项】项中,已明确注明“该品禁用于对头孢菌素过敏的病人。”“使用该品前应详细询问患者过敏史,对于任何过敏体质患者均应慎用该品。对青霉素过敏者可能会对该品产生交叉过敏反应,应慎用。”国家中心病例报告数据库分析显示,存在过敏体质或对头孢曲松钠、青霉素过敏者的用药情况,并导致患者死亡的严重后果。

5、用药期间饮酒 不合理使用问题五:用药期间饮酒

【典型病例】患者,男性,60岁,因上呼吸道感染给予头孢曲松钠治疗,每天一次。第三天上午患者饮酒后,突然出现呼吸困难,立即给予抢救,症状逐渐减轻。

【专家分析】头孢曲松钠可影响乙醇代谢,使血中乙酰醛浓度上升,表现为面部潮红、头痛、眩晕、腹痛、恶心、呕吐、气促、心率加快、血压降低、嗜睡、幻觉等。故用药期间及停药后1周内应避免饮酒,也应避免口服含乙醇类的药物、饮料或静脉输入含乙醇的药物。

6、手术期不合理用药 不合理使用问题六:手术期不合理用药,

【典型病例】患者,男性,34岁,肾结石手术后,给予头孢曲松钠治疗。滴注至10ml时,患者恶心、呕吐,立即停止输液。10分钟后,患者出现呼吸困难、牙关紧闭,转送重症监护室。

【专家分析】围手术期用药应遵守《抗菌药物临床应用指导原则》 、《围手术期预防应用抗菌药物指南》 等相关要求。国家中心病例报告数据库显示,头孢曲松钠严重病例报告中围手术期用药的有46例,主要存在用药时机选择不当、高起点用药或无适应症用药、长疗程用药等问题,并由此可能造成严重不良事件的发生。

新生儿高胆红素血症用药

7、不合理使用问题七:新生儿高胆红素血症用药

【典型病例】患儿,男性,9天,因新生儿高胆红素血症给予头孢曲松钠等药治疗,每天一次。第三天上午8∶30,患儿出现发热、呼吸急促,12∶55患儿呼吸停止,抢救无效,于14∶10分宣告临床死亡。

【专家分析】头孢曲松钠说明书中明确提示,头孢曲松钠可将胆红素从血清白蛋白上置换下来,患有高胆红素血症的新生儿(尤其是早产儿)可能发展成核黄疸,应慎用或避免使用该品。但国家中心病例报告数据库资料显示,临床上存在新生儿高胆红素血症使用头孢曲松钠的情况。

临床使用提醒:不超量,单独配伍,选择适应症用药,注意与青霉素的交叉过敏反应,用药前询问是否有饮酒史,用药后交待患者不能饮酒,小儿,新生儿最好不用。

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    2018-10-07 xyfg98

    这么多不良事件,真是长知识了

    0

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    2017-06-24 天涯183

    非常好的文章,学习了,很受益

    0

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  5. [GetPortalCommentsPageByObjectIdResponse(id=348386, encodeId=01ad34838649, content=这么多不良事件,真是长知识了, beContent=null, objectType=article, channel=null, level=null, likeNumber=150, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sun Oct 07 17:45:16 CST 2018, time=2018-10-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1984681, encodeId=6957198468108, content=<a href='/topic/show?id=000e44349df' target=_blank style='color:#2F92EE;'>#头孢曲松钠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44349, encryptionId=000e44349df, topicName=头孢曲松钠)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e452500029, createdName=12498568m50暂无昵称, createdTime=Fri Apr 20 09:55:00 CST 2018, time=2018-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=214841, encodeId=fe40214841d4, content=非常好的文章,学习了,很受益, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Sat Jun 24 15:23:29 CST 2017, time=2017-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379563, encodeId=e67b13e956384, content=<a href='/topic/show?id=d9694434815' target=_blank style='color:#2F92EE;'>#头孢曲松#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44348, encryptionId=d9694434815, topicName=头孢曲松)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Sat Jun 24 03:55:00 CST 2017, time=2017-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1459530, encodeId=d41d145953060, content=<a href='/topic/show?id=82a24434020' target=_blank style='color:#2F92EE;'>#头孢#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44340, encryptionId=82a24434020, topicName=头孢)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=acae6165124, createdName=jj000003, createdTime=Sat Jun 24 03:55:00 CST 2017, time=2017-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=214001, encodeId=69a421400127, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Thu Jun 22 16:23:12 CST 2017, time=2017-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=213961, encodeId=b32421396194, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=123, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Thu Jun 22 16:05:04 CST 2017, time=2017-06-22, status=1, ipAttribution=)]
    2017-06-24 jj000003
  6. [GetPortalCommentsPageByObjectIdResponse(id=348386, encodeId=01ad34838649, content=这么多不良事件,真是长知识了, beContent=null, objectType=article, channel=null, level=null, likeNumber=150, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fe261399236, createdName=xyfg98, createdTime=Sun Oct 07 17:45:16 CST 2018, time=2018-10-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1984681, encodeId=6957198468108, content=<a href='/topic/show?id=000e44349df' target=_blank style='color:#2F92EE;'>#头孢曲松钠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44349, encryptionId=000e44349df, topicName=头孢曲松钠)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e452500029, createdName=12498568m50暂无昵称, createdTime=Fri Apr 20 09:55:00 CST 2018, time=2018-04-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=214841, encodeId=fe40214841d4, content=非常好的文章,学习了,很受益, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7LIiaRZTzJ3SEfiauCzTMPW7YvPPYLNJBXG9oh6Al1icq2VQQkIHWxqXehcicTS62YKJVBhxeth3wggw/0, createdBy=7ce01621306, createdName=天涯183, createdTime=Sat Jun 24 15:23:29 CST 2017, time=2017-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379563, encodeId=e67b13e956384, content=<a href='/topic/show?id=d9694434815' target=_blank style='color:#2F92EE;'>#头孢曲松#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44348, encryptionId=d9694434815, topicName=头孢曲松)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Sat Jun 24 03:55:00 CST 2017, time=2017-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1459530, encodeId=d41d145953060, content=<a href='/topic/show?id=82a24434020' target=_blank style='color:#2F92EE;'>#头孢#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44340, encryptionId=82a24434020, topicName=头孢)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=acae6165124, createdName=jj000003, createdTime=Sat Jun 24 03:55:00 CST 2017, time=2017-06-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=214001, encodeId=69a421400127, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Thu Jun 22 16:23:12 CST 2017, time=2017-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=213961, encodeId=b32421396194, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=123, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Thu Jun 22 16:05:04 CST 2017, time=2017-06-22, status=1, ipAttribution=)]
    2017-06-22 Y—xianghai

    学习了新知识

    0

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    2017-06-22 Y—xianghai

    学习了新知识

    0

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头孢曲松钠是半合成的第3 代头孢菌素,被列入国家基本药物。头孢曲松通过抑制细菌细胞壁的合成发挥抗菌作用,主要用于敏感的革兰阴性杆菌和部分敏感的革兰阳性球菌所致的严重感染,因其抗菌作用强, 半衰期长,疗效肯定,临床广泛用于治疗呼吸道感染、败血症、腹腔感染、肾盂肾炎、盆腔炎性疾病、骨关节感染、皮肤软组织感染、中枢神经系统感染等。近年来, 随着头孢曲松钠临床应用日益广泛, 其不良反应报告也随之增加,

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