| <DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px" face=Calibri>澳大利亚网站<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">TGA</SPAN>提醒医务人员，坎地沙坦和其他血管紧张素<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">II</SPAN>受体拮抗剂以及<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">ACE</SPAN>抑制剂禁用于妊娠期。妊娠期暴露于上述药物可能导致胎儿毒性。已发生妊娠或计划妊娠的患者应改用其他抗高血压药治疗。</FONT></SPAN></DIV>
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><FONT face=Calibri><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">TGA</SPAN><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">已接到<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">4</SPAN>份关于妊娠期使用坎地沙坦后发生胎儿畸形的报告，其中<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">3</SPAN>份报告是在<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">2011</SPAN>年收到的。一病例中，在受孕前开始使用坎地沙坦，并持续使用至妊娠<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">30</SPAN>周。胎儿被诊断为肾功能衰竭、肾钙质沉着症和先天性泌尿生殖系统异常。另一病例中，诊断为无羊水和可能的肾脏发育不良。妊娠<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">34</SPAN>周时胎儿死亡，此时已停用坎地沙坦<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">7</SPAN>周。第三个病例中报告为肾功能衰竭和肾脏畸形。</SPAN></FONT></FONT></FONT></DIV>
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12px; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; PADDING-TOP: 0px"><FONT face=Calibri><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">TGA</SPAN><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">也收到了关于妊娠期使用厄贝沙坦、依那普利、赖诺普利、培哚普利和卡托普利后发生胎儿畸形的报告。</SPAN></FONT></FONT></FONT></DIV>
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px" face=Calibri>血管紧张素<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">II</SPAN>受体拮抗剂和<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">ACE</SPAN>抑制剂被归为澳大利亚妊娠期用药的<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">D</SPAN>类。此类药物禁用于妊娠期。</FONT></SPAN></DIV>
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px" face=Calibri>作用于肾素<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">-</SPAN>血管紧张素系统的抗高血压药与胎儿肾功能降低、羊水过少和颅骨骨化延迟相关。此类药物用于妊娠期与新生儿肾功能衰竭、低血压和低钾血症等疾病相关<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">1</SPAN>。认为在中孕期和晚孕期暴露发生胎儿畸形的风险最高<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">2</SPAN>。</FONT></SPAN></DIV>
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px" face=Calibri>对医务人员的建议：</FONT></SPAN></DIV>
<DIV style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; WORD-SPACING: 0px; FONT: 10.5pt/18px Calibri, sans-serif; TEXT-TRANSFORM: none; COLOR: rgb(0,0,0); TEXT-INDENT: 28pt; PADDING-TOP: 0px; WHITE-SPACE: normal; LETTER-SPACING: normal; BACKGROUND-COLOR: rgb(243,244,244); TEXT-ALIGN: justify; webkit-text-size-adjust: auto; WIDOWS: 2; ORPHANS: 2; webkit-text-stroke-width: 0px"><SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 12pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 21px; PADDING-TOP: 0px"><FONT style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px" face=Calibri>对于生育年龄女性，医务人员应考察血管紧张素<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">II</SPAN>受体拮抗剂和<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">ACE</SPAN>抑制剂的使用。对于上述女性，应告知对胎儿的风险，并建议使用适当的避孕措施，以避免意外的胎儿暴露。正在接受血管紧张素<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">II</SPAN>受体拮抗剂或<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">ACE</SPAN>抑制剂治疗的患者如发生妊娠或计划妊娠，应建议其与医生进行讨论。已发生妊娠或计划妊娠的女性应改用其他抗高血压药治疗。关于妊娠期使用抗高血压药的信息，见<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">2012</SPAN>年<SPAN style="PADDING-RIGHT: 0px; PADDING-LEFT: 0px; FONT-SIZE: 10.5pt; PADDING-BOTTOM: 0px; MARGIN: 0px auto; LINE-HEIGHT: 24px; PADDING-TOP: 0px">4</SPAN>月的《澳大利亚处方者》。</FONT></SPAN></DIV> |
