“尼美舒利”禁用于12岁以下儿童

国家食品药品监督管理局（简称国家药监局）5月20日发出通知，“尼美舒利” 非甾体抗炎药禁用于12岁以下儿童，因考虑到该药品有肝、肾功能损害等潜在的副作用。
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多个国家和地区使用，该药品于1997年进入中国市场。
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.

国家药监局称，与其它非甾体抗炎药类似，“尼美舒利”最常见的不良反应是呕吐和胃痛。此外，国内外监测数据中还发现与该药品相关的更严重的问题，如过敏反应、凝血功能障碍、白细胞减少及肝、肾功能损害等。
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，国家药监局规定该药品只禁用于1岁以下儿童。
Previously, the SFDA only prevented the use of the drug among children 1 and under.

5月20日当天，国家药监局还下令停止生产、销售和使用“都可喜”（通用名为阿米三嗪萝巴新片，又名复方阿米三嗪片），因其“疗效不确切”。
The SFDA also ordered a suspension of the production, sales and use of Duxil (or almitrine and raubasine compound) for its "unobvious effect."

国家药监局称，临床试验结果不支持服用“都可喜”能够有效提高血管性认知障碍患者的认知功能。
Clinical research found little evidence proving that Duxil effectively improves cognitive ability in patients suffering vascular cognitive impairment, the SFDA said.

此前，该药物被认为可以治疗认知和感觉神经受损症。
The drug was supposed to treat symptoms related to cognition and sensory nerve damage.

这是继本月初开始的为期两个月的全国基本药物质量监测活动之后的两项举措，目的是确保药品安全。
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.

国家药品不良反应监测中心2010年共收到692904份药品不良反应报告，比2009年增长8.4%；其中，新的和严重的不良反应报告为109991件，比上年增长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.

(中国网 李京荣译 China.org.cn translated by Li Jingrong May 23, 2011)