國家食品藥品監(jiān)督管理局5月20日發(fā)出通知，“尼美舒利” 非甾體抗炎藥禁用于12歲以下兒童，因考慮到該藥品有肝、腎功能損害等潛在的副作用。 The State Food and Drug Administration issued a circular on May 20 banning the use of Nimesulide, a non-steroidal anti-inflammatory drug, for children 12 and under, citing the dangers of potential side effects such as liver and kidney damage.

國家食品藥品監(jiān)督管理局（簡稱國家藥監(jiān)局）5月20日發(fā)出通知，“尼美舒利” 非甾體抗炎藥禁用于12歲以下兒童，因考慮到該藥品有肝、腎功能損害等潛在的副作用。
The State Food and Drug Administration issued a circular on May 20 banning the use of Nimesulide, a non-steroidal anti-inflammatory drug, for children 12 and under, citing the dangers of potential side effects such as liver and kidney damage.

“尼美舒利”最早于1985年在意大利上市，目前它在全世界50多個(gè)國家和地區(qū)使用，該藥品于1997年進(jìn)入中國市場。
Nimesulide first became available in Italy in 1985. It is now used in more than 50 countries and regions all over the world. The drug entered the Chinese market in 1997.

國家藥監(jiān)局稱，與其它非甾體抗炎藥類似，“尼美舒利”最常見的不良反應(yīng)是嘔吐和胃痛。此外，國內(nèi)外監(jiān)測數(shù)據(jù)中還發(fā)現(xiàn)與該藥品相關(guān)的更嚴(yán)重的問題，如過敏反應(yīng)、凝血功能障礙、白細(xì)胞減少及肝、腎功能損害等。
According to the SFDA, while common non-steroidal anti-inflammatory adverse reactions to the drug include vomiting and stomachaches, domestic and overseas statistics indicate that more severe issues are related to the drug, such as allergy, blood coagulation disorders, decreased white blood cells, and damage to the liver and kidney.

此前，國家藥監(jiān)局規(guī)定該藥品只禁用于1歲以下兒童。
Previously, the SFDA only prevented the use of the drug among children 1 and under.

5月20日當(dāng)天，國家藥監(jiān)局還下令停止生產(chǎn)、銷售和使用“都可喜”（通用名為阿米三嗪蘿巴新片，又名復(fù)方阿米三嗪片），因其“療效不確切”。
The SFDA also ordered a suspension of the production, sales and use of Duxil (or almitrine and raubasine compound) for its "unobvious effect."

國家藥監(jiān)局稱，臨床試驗(yàn)結(jié)果不支持服用“都可喜”能夠有效提高血管性認(rèn)知障礙患者的認(rèn)知功能。
Clinical research found little evidence proving that Duxil effectively improves cognitive ability in patients suffering vascular cognitive impairment, the SFDA said.

此前，該藥物被認(rèn)為可以治療認(rèn)知和感覺神經(jīng)受損癥。
The drug was supposed to treat symptoms related to cognition and sensory nerve damage.

這是繼本月初開始的為期兩個(gè)月的全國基本藥物質(zhì)量監(jiān)測活動(dòng)之后的兩項(xiàng)舉措，目的是確保藥品安全。
The two bans come after a two-month nationwide campaign was launched earlier this month to probe the quality of essential drugs and ensure drug safety.

國家藥品不良反應(yīng)監(jiān)測中心2010年共收到692904份藥品不良反應(yīng)報(bào)告，比2009年增長8.4%；其中，新的和嚴(yán)重的不良反應(yīng)報(bào)告為109991件，比上年增長16.2%。
The National Center for Adverse Drug Reaction Monitoring received 692,904 reports of adverse reactions in 2010, up 8.4 percent compared with those in 2009. Among them, 109,991 cases involved new or severe adverse reactions, up 16.2 percent from the year before.

(中國網(wǎng) 李京榮譯 China.org.cn translated by Li Jingrong May 23, 2011)