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【drug-news】欧洲药品管理局关于吡罗昔康再评价
QUESTIONS AND ANSWERS ON THE REVIEW OF PIROXICAM
London, 21 June 2007
The European Medicines Agency (EMEA) has recently completed a review of the safety of the non-steroidal anti-inflammatory drug (NSAID) piroxicam. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that piroxicam’s benefits still outweigh its risks, but, based on safety grounds, only in certain, limited indications. In addition, the CHMP has concluded that piroxicam-containing medicines should no longer be used for the treatment of acute (short-term) pain and inflammation. The review was carried out under an ‘Article 31’ referral1.
As for all NSAIDs, piroxicam should always be used at the lowest dose for the shortest possible duration to control symptoms.
What is piroxicam?
Piroxicam is a NSAID, a medicine used to treat inflammation. It has been available on the market for many years and has been used in the treatment of many painful conditions. Piroxicam is known as a non-selective NSAID because it acts on all types of the cyclo-oxygenase enzyme, including one type that is involved in the inflammatory process.
Why was piroxicam reviewed?
The EMEA reviewed the safety of non-selective NSAIDs in 2005 and 2006. It looked at the gastro-intestinal (stomach and bowel) and skin safety of the products, and then at their cardiovascular safety. During this process, piroxicam was singled out for special review because piroxicam-containing medicines are associated with more gastro-intestinal side effects and more serious skin reactions than other non-selective NSAIDs. Consequently, the European Commission asked the CHMP to carry out a full assessment of the benefit-risk balance of piroxicam.
Which data has the CHMP reviewed?
In this review the CHMP has assessed information from previous reviews of safety data, as well as new data from clinical trials and epidemiological studies (studies of the causes and distribution of diseases in the population). It also looked at information published in scientific journals.
What are the conclusions of the CHMP?
Based on the information available, the CHMP has concluded that:
• its use in the treatment of acute painful and inflammatory conditions should be abandoned,
• the use of piroxicam should be limited only to the symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis,
• it should not be used as a first-line treatment,
• the dose of piroxicam should be limited to a maximum of 20 mg a day,
• its use should only be initiated by doctors who are experienced in treating chronic (long term) painful and inflammatory conditions.
In addition, the CHMP added some contraindications and strengthened warnings for piroxicam, to ensure that it is not used in patients who are at a higher risk of developing side effects. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 QUESTIONS AND ANSWERS ON THE REVIEW OF PIROXICAM
London, 21 June 2007
欧洲药品管理局关于吡罗昔康审评结果的问答
The European Medicines Agency (EMEA) has recently completed a review of the safety of the non-steroidal anti-inflammatory drug (NSAID) piroxicam. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that piroxicam’s benefits still outweigh its risks, but, based on safety grounds, only in certain, limited indications. In addition, the CHMP has concluded that piroxicam-containing medicines should no longer be used for the treatment of acute (short-term) pain and inflammation. The review was carried out under an ‘Article 31’ referral1.
欧洲药品管理局（EMEA）最近完成了有关非类固醇抗炎药(NSAID)吡罗昔康的安全性评价。该局人用药品委员会（CHMP）的结论认为，吡罗昔康的益处仍大于其风险，但是，基于安全方面的考虑，其应用仅限于某些特定的适应症。此外，CHMP的结论还指出，含有吡罗昔康的药物不应再用于急性（短期）疼痛和炎症的治疗。该评价是按照“条款31”的要求开展的。
As for all NSAIDs, piroxicam should always be used at the lowest dose for the shortest possible duration to control symptoms.
作为NSAIDs，吡罗昔康用于控制症状时，应该始终尽可能使用最低剂量和最短时间。
What is piroxicam? 吡罗昔康是什么药物？
Piroxicam is a NSAID, a medicine used to treat inflammation. It has been available on the market for many years and has been used in the treatment of many painful conditions. Piroxicam is known as a non-selective NSAID because it acts on all types of the cyclo-oxygenase enzyme, including one type that is involved in the inflammatory process.
吡罗昔康是一种用于治疗炎症的非类固醇抗炎药，该药物已上市多年并用于治疗多种疼痛症状。吡罗昔康是一种非选择性非类固醇抗炎药，作用于包括参与炎症过程的一类环氧酶在内的所有类型的环氧酶。
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作者:admin@医学,生命科学 2011-03-10 17:12
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