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【medical-news】鼻内使用去氨加压素不再是加拿大
OTTAWA, Ontario -- July 18, 2008 -- Health Canada is informing healthcare professionals that all intranasal formulations of desmopressin (DDAVP), including DDAVP Spray and DDAVP Rhinyle Nasal Solution, are no longer indicated for the treatment of primary nocturnal enuresis (PNE) due to an increased risk of hyponatremia with the intranasal formulations.
· All intranasal formulations of desmopressin are now contraindicated for the treatment of PNE.
· All patients using intranasal formulations of desmopressin for treatment of PNE should be reassessed to determine their need for continued treatment and to discuss other options.
· If ongoing treatment is considered necessary, patients should be switched to the lowest starting dose of an oral formulation, with the dose increased only if necessary to control symptoms.
· New patients treated for PNE with desmopressin should only be prescribed an oral formulation.
· Fluid intake and desmopressin dosage should be adjusted carefully in order to reduce the possibility of water retention and hyponatremia, especially in very young and elderly patients or when significant daily variables occur such as hot climate conditions, intense exercise, or other situations where increased water intake can be expected.
· Prodromal symptoms such as headache, nausea, or vomiting may herald impending hyponatremia. A patient treated with desmopressin for PNE and/or their guardian should be advised that if such symptoms occur, desmopressin should be discontinued and medical attention sought immediately.
Worldwide postmarketing data indicate a higher incidence of hyponatremia in patients being treated with the desmopressin intranasal formulations compared with the oral formulations.
Hyponatremia has been reported at a rate of approximately 5 cases per 10 million doses for nasal formulations and about 1 case per 10 million doses for oral formulations.
When desmopressin treatment is needed, physicians should discuss with the patient and/or guardian the importance of limiting the amount of fluid intake 1 hour before taking the medication and during the 8 hours postdose. Intranasal Desmopressin Loses Indication for Primary Nocturnal Enuresis in Canada
OTTAWA, Ontario -- July 18, 2008 –
加拿大——鼻腔用去氨加压素不再用于原发性夜间遗尿症
Health Canada is informing healthcare professionals that all intranasal formulations of desmopressin (DDAVP), including DDAVP Spray and DDAVP Rhinyle Nasal Solution, are no longer indicated for the treatment of primary nocturnal enuresis (PNE) due to an increased risk of hyponatremia with the intranasal formulations.
加拿大卫生部对医务人员发出通知：鉴于鼻腔用去氨加压素(DDAVP)的低血钠风险会增高，其所有鼻腔用剂型包括喷鼻剂和滴鼻液不再用于原发性夜间遗尿症(PNE)的治疗。
• All intranasal formulations of desmopressin are now contraindicated for the treatment of PNE.
从现在开始去氨加压素所有鼻腔用剂型都禁忌用于PNE。
• All patients using intranasal formulations of desmopressin for treatment of PNE should be reassessed to determine their need for continued treatment and to discuss other options.
要对所有正在使用鼻腔用去氨加压素的患者进行重新评估，来决定是继续用药还是选择别的治疗方案。
• If ongoing treatment is considered necessary, patients should be switched to the lowest starting dose of an oral formulation, with the dose increased only if necessary to control symptoms.
如果患者需要要继续用药，应选择口服去氨加压素，并且从最低剂量开始增量，直到控制住症状。
• New patients treated for PNE with desmopressin should only be prescribed an oral formulation.
PNE新患者仅限用去氨加压素的口服剂型。
• Fluid intake and desmopressin dosage should be adjusted carefully in order to reduce the possibility of water retention and hyponatremia, especially in very young and elderly patients or when significant daily variables occur such as hot climate conditions, intense exercise, or other situations where increased water intake can be expected.
为减少水潴留和低血钠，特别是针对儿童和老年患者在气候炎热、剧烈运动、或者水分摄入增多的情况下，必须调整好液体摄入量和去氨加压素的剂量。
• Prodromal symptoms such as headache, nausea, or vomiting may herald impending hyponatremia. A patient treated with desmopressin for PNE and/or their guardian should be advised that if such symptoms occur, desmopressin should be discontinued and medical attention sought immediately.
低血钠的先兆症状有：头痛、恶心、呕吐。当这些先兆出现时，PNE患者应停用去氨加压素，并立即就诊。
Worldwide postmarketing data indicate a higher incidence of hyponatremia in patients being treated with the desmopressin intranasal formulations compared with the oral formulations.
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作者:admin@医学,生命科学 2011-08-14 05:14
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