國家食品藥品監督管理局5月20日發出通知，“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.

國家食品藥品監督管理局（簡稱國家藥監局）5月20日發出通知，“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多個國家和地區使用，該藥品于1997年進入中國市場。
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”最常見的不良反應是嘔吐和胃痛。此外，國內外監測數據中還發現與該藥品相關的更嚴重的問題，如過敏反應、凝血功能障礙、白細胞減少及肝、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，國家藥監局規定該藥品只禁用于1歲以下兒童。
Previously, the SFDA only prevented the use of the drug among children 1 and under.

5月20日當天，國家藥監局還下令停止生產、銷售和使用“都可喜”（通用名為阿米三嗪蘿巴新片，又名復方阿米三嗪片），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."

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

此前，該藥物被認為可以治療認知和感覺神經受損癥。
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月的全國基本藥物質量監測活動之后的兩項舉措，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.

國家藥品不良反應監測中心2010年共收到692904份藥品不良反應報告，比2009年增長8.4%；其中，新的和嚴重的不良反應報告為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 李京榮譯 China.org.cn translated by Li Jingrong May 23, 2011)