| 维<SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片是由金银花、连翘、荆芥、淡豆豉、牛蒡子、桔梗、薄荷油、芦根、淡竹叶、甘草、维生素</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">、马来酸氯苯那敏、对乙酰氨基酚</SPAN><SPAN style="FONT-FAMILY: ??">13</SPAN><SPAN style="FONT-FAMILY: 宋体">味药制成的中西药复方制剂，具有辛凉解表，清热解毒的作用。用于流行性感冒引起的发热头痛、咳嗽、口干、咽喉疼痛。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> </SPAN><SPAN style="FONT-FAMILY: ??">2004</SPAN><SPAN style="FONT-FAMILY: 宋体">年</SPAN><SPAN style="FONT-FAMILY: ??">1</SPAN><SPAN style="FONT-FAMILY: 宋体">月</SPAN><SPAN style="FONT-FAMILY: ??">1</SPAN><SPAN style="FONT-FAMILY: 宋体">日至</SPAN><SPAN style="FONT-FAMILY: ??">2010</SPAN><SPAN style="FONT-FAMILY: 宋体">年</SPAN><SPAN style="FONT-FAMILY: ??">4</SPAN><SPAN style="FONT-FAMILY: 宋体">月</SPAN><SPAN style="FONT-FAMILY: ??">30</SPAN><SPAN style="FONT-FAMILY: 宋体">日，国家药品不良反应监测中心病例报告数据库中有关维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片的病例报告数共计</SPAN><SPAN style="FONT-FAMILY: ??">1885</SPAN><SPAN style="FONT-FAMILY: 宋体">例，不良反应</SPAN><SPAN style="FONT-FAMILY: ??">/</SPAN><SPAN style="FONT-FAMILY: 宋体">事件主要累及中枢及外周神经系统、消化系统、皮肤及附属器等。其中维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片严重病例报告共计</SPAN><SPAN style="FONT-FAMILY: ??">48</SPAN><SPAN style="FONT-FAMILY: 宋体">例，约占所有报告的</SPAN><SPAN style="FONT-FAMILY: ??">2.55</SPAN><SPAN style="FONT-FAMILY: 宋体">％，无死亡报告。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"> </SPAN><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"> 一、严重病例的临床表现</SPAN></B><SPAN style="FONT-FAMILY: 宋体"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片严重病例的不良反应</SPAN><SPAN style="FONT-FAMILY: ??">/</SPAN><SPAN style="FONT-FAMILY: 宋体">事件表现如下：皮肤及附属器损害占</SPAN><SPAN style="FONT-FAMILY: ??">75</SPAN><SPAN style="FONT-FAMILY: 宋体">﹪，表现为全身发疹型皮疹伴瘙痒、严重荨麻疹、重症多形红斑型药疹、大疱性表皮松解症；消化系统损害占</SPAN><SPAN style="FONT-FAMILY: ??">12.50</SPAN><SPAN style="FONT-FAMILY: 宋体">﹪，表现为肝功能异常；全身性损害占</SPAN><SPAN style="FONT-FAMILY: ??">10.1</SPAN><SPAN style="FONT-FAMILY: 宋体">﹪，表现为过敏性休克、过敏样反应、昏厥；泌尿系统损害占</SPAN><SPAN style="FONT-FAMILY: ??">4.17</SPAN><SPAN style="FONT-FAMILY: 宋体">﹪，表现为间质性肾炎；血液系统损害占</SPAN><SPAN style="FONT-FAMILY: ??">4.16</SPAN><SPAN style="FONT-FAMILY: 宋体">﹪，表现为白细胞减少、溶血性贫血。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 典型病例</SPAN><SPAN style="FONT-FAMILY: ??">1</SPAN><SPAN style="FONT-FAMILY: 宋体">：患者，男性，</SPAN><SPAN style="FONT-FAMILY: ??">42</SPAN><SPAN style="FONT-FAMILY: 宋体">岁，因</SPAN><SPAN style="FONT-FAMILY: ??">“</SPAN><SPAN style="FONT-FAMILY: 宋体">咽痛</SPAN><SPAN style="FONT-FAMILY: ??">1</SPAN><SPAN style="FONT-FAMILY: 宋体">天</SPAN><SPAN style="FONT-FAMILY: ??">”</SPAN><SPAN style="FONT-FAMILY: 宋体">自购维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片，口服</SPAN><SPAN style="FONT-FAMILY: ??">2</SPAN><SPAN style="FONT-FAMILY: 宋体">小时后出现</SPAN><SPAN style="FONT-FAMILY: ??">“</SPAN><SPAN style="FONT-FAMILY: 宋体">皮肤瘙痒，呼吸困难，胸闷</SPAN><SPAN style="FONT-FAMILY: ??">”</SPAN><SPAN style="FONT-FAMILY: 宋体">，立即就诊。查体：血压</SPAN><SPAN style="FONT-FAMILY: ??">90/40 mmHg</SPAN><SPAN style="FONT-FAMILY: 宋体">，脉搏</SPAN><SPAN style="FONT-FAMILY: ??">104</SPAN><SPAN style="FONT-FAMILY: 宋体">次</SPAN><SPAN style="FONT-FAMILY: ??">/</SPAN><SPAN style="FONT-FAMILY: 宋体">分，不齐，二联律，全身皮肤红斑疹，压之退色，两肺呼吸音清，心律不齐，未闻及杂音。立即给予地塞米松注射剂</SPAN><SPAN style="FONT-FAMILY: ??">10</SPAN><SPAN style="FONT-FAMILY: 宋体">毫克静脉推注，异丙嗪注射剂</SPAN><SPAN style="FONT-FAMILY: ??">25</SPAN><SPAN style="FONT-FAMILY: 宋体">毫克肌注，</SPAN><SPAN style="FONT-FAMILY: ??">5%</SPAN><SPAN style="FONT-FAMILY: 宋体">葡萄糖</SPAN><SPAN style="FONT-FAMILY: ??">250</SPAN><SPAN style="FONT-FAMILY: 宋体">毫升</SPAN><SPAN style="FONT-FAMILY: ??">+10%</SPAN><SPAN style="FONT-FAMILY: 宋体">葡萄糖酸钙注射剂</SPAN><SPAN style="FONT-FAMILY: ??">20</SPAN><SPAN style="FONT-FAMILY: 宋体">毫升静脉滴注，</SPAN><SPAN style="FONT-FAMILY: ??">1</SPAN><SPAN style="FONT-FAMILY: 宋体">小时后，症状减轻，测血压</SPAN><SPAN style="FONT-FAMILY: ??">110/60 mmHg</SPAN><SPAN style="FONT-FAMILY: 宋体">。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 典型病例</SPAN><SPAN style="FONT-FAMILY: ??">2</SPAN><SPAN style="FONT-FAMILY: 宋体">：患者，女性，</SPAN><SPAN style="FONT-FAMILY: ??">33</SPAN><SPAN style="FONT-FAMILY: 宋体">岁，因</SPAN><SPAN style="FONT-FAMILY: ??">“</SPAN><SPAN style="FONT-FAMILY: 宋体">发热，咽喉痛</SPAN><SPAN style="FONT-FAMILY: ??">”</SPAN><SPAN style="FONT-FAMILY: 宋体">到药店购买维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片，口服</SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">次</SPAN><SPAN style="FONT-FAMILY: ??">/</SPAN><SPAN style="FONT-FAMILY: 宋体">日，每次</SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">片，服药</SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">天后，体温未降反而上升至</SPAN><SPAN style="FONT-FAMILY: ??">39</SPAN><SPAN style="FONT-FAMILY: 宋体">度以上，伴厌食、上腹部不适。前往医院就诊，实验室检查报告显示：谷丙转氨酶</SPAN><SPAN style="FONT-FAMILY: ??">364U/L</SPAN><SPAN style="FONT-FAMILY: 宋体">，谷草转氨酶</SPAN><SPAN style="FONT-FAMILY: ??">265U/L</SPAN><SPAN style="FONT-FAMILY: 宋体">，</SPAN><SPAN style="FONT-FAMILY: ??">r-</SPAN><SPAN style="FONT-FAMILY: 宋体">谷氨酰转肽酶</SPAN><SPAN style="FONT-FAMILY: ??">189U/L</SPAN><SPAN style="FONT-FAMILY: 宋体">，碱性磷酸酶</SPAN><SPAN style="FONT-FAMILY: ??">259U/L</SPAN><SPAN style="FONT-FAMILY: 宋体">，总胆汁酸</SPAN><SPAN style="FONT-FAMILY: ??">58.8μmol/L</SPAN><SPAN style="FONT-FAMILY: 宋体">，乳酸脱氢酶</SPAN><SPAN style="FONT-FAMILY: ??">407U/L</SPAN><SPAN style="FONT-FAMILY: 宋体">，甲肝抗体、丙肝抗体、戊肝抗体均阴性。患者</SPAN><SPAN style="FONT-FAMILY: ??">1</SPAN><SPAN style="FONT-FAMILY: 宋体">月前体检肝功能正常，乙肝表面抗体阳性。停用所有药品，给予垂盆草颗粒、肌苷口服液、维生素</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">治疗，三个月后复查肝功能正常。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><B><SPAN style="FONT-FAMILY: 宋体"> </SPAN></B><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"> 二、超说明书用药分析</SPAN></B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 国家中心数据库中维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片不良反应</SPAN><SPAN style="FONT-FAMILY: ??">/</SPAN><SPAN style="FONT-FAMILY: 宋体">事件报告分析显示，该产品存在超说明书使用现象，主要表现如下：</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> </SPAN><SPAN style="FONT-FAMILY: ??">1</SPAN><SPAN style="FONT-FAMILY: 宋体">．未按照说明书推荐的用法用量使用</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片说明书提示：用于成人时，每次</SPAN><SPAN style="FONT-FAMILY: ??">2</SPAN><SPAN style="FONT-FAMILY: 宋体">片，每日</SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">次；国家中心接收的病例中约</SPAN><SPAN style="FONT-FAMILY: ??">14</SPAN><SPAN style="FONT-FAMILY: 宋体">％的患者使用维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片每次</SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">－</SPAN><SPAN style="FONT-FAMILY: ??">4</SPAN><SPAN style="FONT-FAMILY: 宋体">片，每日</SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">次。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 典型病例</SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">：患者，男性，</SPAN><SPAN style="FONT-FAMILY: ??">38</SPAN><SPAN style="FONT-FAMILY: 宋体">岁，因</SPAN><SPAN style="FONT-FAMILY: ??">“</SPAN><SPAN style="FONT-FAMILY: 宋体">感冒</SPAN><SPAN style="FONT-FAMILY: ??">”</SPAN><SPAN style="FONT-FAMILY: 宋体">到当地诊所就诊，予维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片口服</SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">次</SPAN><SPAN style="FONT-FAMILY: ??">/</SPAN><SPAN style="FONT-FAMILY: 宋体">日，每次</SPAN><SPAN style="FONT-FAMILY: ??">4</SPAN><SPAN style="FONT-FAMILY: 宋体">片。</SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">天后，患者全身泛发红斑，自觉轻微瘙痒。前往医院就诊，查体：</SPAN><SPAN style="FONT-FAMILY: ??">T 36.8</SPAN><SPAN style="FONT-FAMILY: 宋体">℃</SPAN><SPAN style="FONT-FAMILY: 宋体">，</SPAN><SPAN style="FONT-FAMILY: ??">P 88</SPAN><SPAN style="FONT-FAMILY: 宋体">次</SPAN><SPAN style="FONT-FAMILY: ??">/</SPAN><SPAN style="FONT-FAMILY: 宋体">分，</SPAN><SPAN style="FONT-FAMILY: ??">BP 152/82mmHg</SPAN><SPAN style="FONT-FAMILY: 宋体">，神智清楚；四肢躯干泛发红斑，部分融合，压之褪色，米粒至蚕豆大小，皮温不高。诊断：发疹型药疹。给予甲基强的龙松</SPAN><SPAN style="FONT-FAMILY: ??">20mg </SPAN><SPAN style="FONT-FAMILY: 宋体">静脉滴注，开瑞坦</SPAN><SPAN style="FONT-FAMILY: ??">10mg </SPAN><SPAN style="FONT-FAMILY: 宋体">口服等治疗，患者好转出院。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> </SPAN><SPAN style="FONT-FAMILY: ??">2</SPAN><SPAN style="FONT-FAMILY: 宋体">．同时合并使用与本品成份相似的其他药品</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片说明书提示：本品不能同时服用与本品成份相似的其他抗感冒药。国家中心收到的维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片严重病例报告中有部分病例同时合并使用其他成分相似的抗感冒药。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 典型病例</SPAN><SPAN style="FONT-FAMILY: ??">4</SPAN><SPAN style="FONT-FAMILY: 宋体">：患者，男性，</SPAN><SPAN style="FONT-FAMILY: ??">8</SPAN><SPAN style="FONT-FAMILY: 宋体">岁，因</SPAN><SPAN style="FONT-FAMILY: ??">“</SPAN><SPAN style="FONT-FAMILY: 宋体">发热</SPAN><SPAN style="FONT-FAMILY: ??">,</SPAN><SPAN style="FONT-FAMILY: 宋体">咽痛</SPAN><SPAN style="FONT-FAMILY: ??">”</SPAN><SPAN style="FONT-FAMILY: 宋体">口服维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片和百服宁（通用名为对乙酰氨基酚）</SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">天后</SPAN><SPAN style="FONT-FAMILY: ??">,</SPAN><SPAN style="FONT-FAMILY: 宋体">双唇出现糜烂</SPAN><SPAN style="FONT-FAMILY: ??">,</SPAN><SPAN style="FONT-FAMILY: 宋体">伴疼痛</SPAN><SPAN style="FONT-FAMILY: ??">,</SPAN><SPAN style="FONT-FAMILY: 宋体">躯干</SPAN><SPAN style="FONT-FAMILY: ??">,</SPAN><SPAN style="FONT-FAMILY: 宋体">四肢出现散在红斑伴瘙痒</SPAN><SPAN style="FONT-FAMILY: ??">,</SPAN><SPAN style="FONT-FAMILY: 宋体">体温开始升高至</SPAN><SPAN style="FONT-FAMILY: ??">39</SPAN><SPAN style="FONT-FAMILY: 宋体">℃</SPAN><SPAN>,</SPAN><SPAN style="FONT-FAMILY: 宋体">前往医院就诊。查体：面部、四肢、躯干散在</SPAN><SPAN style="FONT-FAMILY: ??">0.3-1.0cm</SPAN><SPAN style="FONT-FAMILY: 宋体">大小的水肿性暗红色斑</SPAN><SPAN style="FONT-FAMILY: ??">,</SPAN><SPAN style="FONT-FAMILY: 宋体">圆形或椭圆形。予以甲基强的松龙、琥珀酸氢化可的松、强的松治疗</SPAN><SPAN style="FONT-FAMILY: ??">,10</SPAN><SPAN style="FONT-FAMILY: 宋体">天后痊愈。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> </SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">．对本品所含成分过敏者用药。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片说明书中提示：对本品过敏者禁用，过敏体质者慎用。国家中心数据库分析显示，个别对本品所含某些成分过敏的患者，使用后出现严重不良反应。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 典型病例</SPAN><SPAN style="FONT-FAMILY: ??">5</SPAN><SPAN style="FONT-FAMILY: 宋体">：患者，男性，</SPAN><SPAN style="FONT-FAMILY: ??">28</SPAN><SPAN style="FONT-FAMILY: 宋体">岁，因</SPAN><SPAN style="FONT-FAMILY: ??">“</SPAN><SPAN style="FONT-FAMILY: 宋体">上感</SPAN><SPAN style="FONT-FAMILY: ??">”</SPAN><SPAN style="FONT-FAMILY: 宋体">自服维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片及板蓝根冲剂，用药后第二天发现双手臂、双侧下肢、胸背部及阴囊部出现数个圆形紫红色斑片，直径</SPAN><SPAN style="FONT-FAMILY: ??">3-6cm</SPAN><SPAN style="FONT-FAMILY: 宋体">，无痒痛感，未就诊。第三天部分紫红色斑片中心出现水疱，水疱直径最大约</SPAN><SPAN style="FONT-FAMILY: ??">2cm</SPAN><SPAN style="FONT-FAMILY: 宋体">，疱壁薄、易破，阴囊部出现糜烂，遂就诊于急诊科，诊断为</SPAN><SPAN style="FONT-FAMILY: ??">“</SPAN><SPAN style="FONT-FAMILY: 宋体">多形红斑型药疹</SPAN><SPAN style="FONT-FAMILY: ??">”</SPAN><SPAN style="FONT-FAMILY: 宋体">，患者有青霉素、对乙酰氨基酚过敏史，为进一步诊治收入院治疗。入院后给予甲基强地松龙</SPAN><SPAN style="FONT-FAMILY: ??">40mg</SPAN><SPAN style="FONT-FAMILY: 宋体">静脉滴注，氯雷他定</SPAN><SPAN style="FONT-FAMILY: ??">10mg1</SPAN><SPAN style="FONT-FAMILY: 宋体">天</SPAN><SPAN style="FONT-FAMILY: ??">1</SPAN><SPAN style="FONT-FAMILY: 宋体">次，黄连素液、硼酸液外用湿敷等治疗，</SPAN><SPAN style="FONT-FAMILY: ??">10</SPAN><SPAN style="FONT-FAMILY: 宋体">天后病情明显好转，水疱结痂，糜烂面渗液减少，好转出院。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> </SPAN><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"> 三、影响维</SPAN></B><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: ??">C</SPAN></B><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体">银翘片安全性因素分析</SPAN></B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> 维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片是由</SPAN><SPAN style="FONT-FAMILY: ??">13</SPAN><SPAN style="FONT-FAMILY: 宋体">味药制成的中西药复方制剂，其所含成分对乙酰氨基酚（又称</SPAN><SPAN style="FONT-FAMILY: ??">“</SPAN><SPAN style="FONT-FAMILY: 宋体">扑热息痛</SPAN><SPAN style="FONT-FAMILY: ??">”</SPAN><SPAN style="FONT-FAMILY: 宋体">）的不良反应主要表现为皮疹、荨麻疹、药热、肝肾功能损害以及严重过敏反应等；其所含成分马来酸氯苯那敏（又称</SPAN><SPAN style="FONT-FAMILY: ??">“</SPAN><SPAN style="FONT-FAMILY: 宋体">扑尔敏</SPAN><SPAN style="FONT-FAMILY: ??">”</SPAN><SPAN style="FONT-FAMILY: 宋体">）的不良反应主要表现困倦、虚弱感、为嗜睡、口干、咽喉痛、心悸等。目前，国家中心数据库维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片病例分析提示，该产品的安全性问题与其所含的相关成分有一定关联性。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> </SPAN><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: 宋体"> 四、相关建议</SPAN></B><B><SPAN style="FONT-SIZE: 12pt; FONT-FAMILY: ??"><BR></SPAN></B><SPAN style="FONT-FAMILY: 宋体"> </SPAN><SPAN style="FONT-FAMILY: ??">1</SPAN><SPAN style="FONT-FAMILY: 宋体">．建议医生处方或药店售药时，提示维</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">银翘片为中西药复方制剂，本品含马来酸氯苯那敏、对乙酰氨基酚、维生素</SPAN><SPAN style="FONT-FAMILY: ??">C</SPAN><SPAN style="FONT-FAMILY: 宋体">。对本品所含成份过敏者禁用，过敏体质者慎用。服用本品期间不得饮酒或含有酒精的饮料；不得同时服用与本品成份相似的其他抗感冒药；肝、肾功能受损者慎用；膀胱颈梗阻、甲状腺功能亢进、青光眼、高血压和前列腺肥大者慎用；孕妇及哺乳期妇女慎用；服药期间不得驾驶机、车、船，不得从事高空作业、机械作业及操作精密仪器。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> </SPAN><SPAN style="FONT-FAMILY: ??">2</SPAN><SPAN style="FONT-FAMILY: 宋体">．建议严格按说明书用药，避免超剂量、长期连续用药，用药后应密切观察，出现皮肤瘙痒、皮疹、呼吸困难等早期过敏症状应立即停药并及时处理或立即就诊；出现食欲不振、尿黄、皮肤黄染等症状应立即停药，及时就诊，并监测肝功能。</SPAN><SPAN style="FONT-FAMILY: ??"><BR></SPAN><SPAN style="FONT-FAMILY: 宋体"> </SPAN><SPAN style="FONT-FAMILY: ??">3</SPAN><SPAN style="FONT-FAMILY: 宋体">．建议生产企业应完善产品说明书和包装、标签，增加相关安全性信息，并加强上市后安全性研究，确保产品的安全性信息及时传达给患者和医生。</SPAN><SPAN></SPAN><BR> |
