| <DIV>(网络翻译稿）</DIV>
<DIV><FONT size=4> 醋酸曲安奈德是一种合成皮质激素类药物，最初被用于抗炎治疗。加拿大1966年批准了10mg/ml的混悬液，1973年批准了40mg/ml的混悬液，近来不断有类似产品被使用。在加拿大，40mg/ml混悬液被允许肌内、关节内给药，或者腱鞘和神经节注射，适用于全身性的皮质激素治疗，如皮肤病、类风湿性关节炎、结缔组织病等。</FONT></DIV>
<DIV><FONT size=4> 加拿大不允许玻璃体内或眼球内注射曲安奈德，有报道称曲安奈德可用于糖尿病的黄斑水肿，囊性黄斑水肿，脉络膜新生血管的治疗。2007年，法国曾有过玻璃体内注射40mg/ml的曲安奈德混悬液而致严重不良反应的警告。</FONT></DIV>
<DIV><FONT size=4> 眼表面、口服或静脉使用皮质激素能引起眼部不良反应，局部注射，即使注射部位远离眼睛，同样也能引起眼睛并发症，如进行性白内障、青光眼，甚至还有视网膜或脉络膜闭塞。</FONT></DIV>
<DIV><FONT size=4> 玻璃体内注射曲安奈德已有几例并发症报道，直接的并发症包括视网膜玻璃，玻璃体出血，随后还有进行性白内障，类固醇诱导的青光眼以及眼内炎。</FONT></DIV>
<DIV><FONT size=4> 曲安奈德能存在很长时间，玻璃体内注射后1.5年仍能在房水中测到很低的浓度。有报道称6例患者玻璃体内注射后导致眼内压升高，有原发性开角型青光眼的患者具有更高的风险。</FONT></DIV>
<DIV><FONT size=4> 在加拿大，一些科学文献中报道了玻璃体内注射曲安奈德导致的不良反应，包括眼内压升高后需要青光眼药物治疗（60例），进行性白内障需要手术摘除的（12例），眼内炎（1例），暂时性视网膜中央动脉闭塞（1例）。</FONT></DIV>
<DIV><FONT size=4> 1973年1月1日至2009年6月31日，加拿大卫生署收到1例有关玻璃体内注射曲安奈德联合光敏治疗而致的可疑严重不良反应，一个13岁女孩在3个月内2次使用曲安奈德后导致眼内压升高，视网膜出血，视力敏锐度减退。</FONT></DIV>
<P><FONT size=4> 虽然不良反应报告较少，但自愿报告仍是用来监测药物安全和有效性的最普遍方法，如果有使用曲安奈德后出现可疑不良反应，请大家积极报告</FONT></P>
<P>原文：</P>
<DIV><B>Intravitreal injection of triamcinolone acetonide and serious ocular adverse reactions</B></DIV>
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<DIV>Triamcinolone acetonide is a synthetic corticosteroid primarily used for its marked anti-inflammatory action.1 It was authorized for use in Canada as a 10-mg/mL suspension (Kenalog 10) in 1966, and as a 40-mg/mL suspension (Kenalog 40) in 1973. Currently, generic products are also available. In Canada, the 40-mg/mL suspension has been authorized for intramuscular and intraarticular administration or for injection into tendon sheaths or ganglia. It is indicated for systemic corticosteroid therapy in conditions such as dermatoses, or rheumatoid arthritis and other connective tissue disorders.1</DIV>
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<DIV>Intravitreal or intraocular injection of this product is not an authorized route of administration in Canada. Diabetic macular edema, cystoid macular edema and choroidal neovascularization secondary to agerelated macular degeneration are among the conditions for which the use of intravitreal injection of triamcinolone has been reported.2,3 In 2007, a safety notice was published in France regarding the occurrence of serious ocular adverse reactions (ARs) following intravitreal injections of the 40-mg/mL suspension.4</DIV>
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<DIV>Topical ophthalmic, oral and intravenous corticosteroids have long been associated with ocular ARs. Local injections of steroids, even at sites far from the eye, have been associated with eye complications such as the development of cataract, glaucoma, and even retinal and choroidal emboli.5</DIV>
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<DIV>Intravitreal injection of triamcinolone has several reported complications. Immediate complications include retinal detachment and vitreous hemorrhage. Complications developing later include cataract progression, steroid-induced glaucoma and endophthalmitis.2 </DIV>
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<DIV>Triamcinolone persists for long periods. Low concentrations were found in samples of aqueous humor up to 1.5 years after intravitreal injection.6 Cases of increased intraocular pressure requiring medical intervention following intravitreal injection have also been reported. Patients with a history of primary open-angle glaucoma are at a higher risk of increased intraocular pressure.2</DIV>
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<DIV>A number of ocular ARs following intravitreal injection of triamcinolone in Canada have been reported in scientific literature.2 They included increased intraocular pressure requiring glaucoma medication (60 cases), cataract progression requiring extraction (12), endophthalmitis (1) and temporary occlusion of the central retinal artery (1).</DIV>
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<DIV>From Jan. 1, 1973, to Jan. 31, 2009, Health Canada received 1 report of serious ocular ARs suspected of being associated with combined photodynamic therapy and intravitreal injection of triamcinolone. The case involved a 13- year-old girl in whom increased intraocular pressure, retinal hemorrhage and reduced visual acuity developed following two injections of triamcinolone given about 3 months apart.</DIV>
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<DIV>Although underreporting of ARs is well documented, voluntary reporting is one of the most common ways to monitor the safety and effectiveness of marketed health products. Health care professionals are encouraged to report to Health Canada any ocular Ars suspected of being associated with triamcinolone.</DIV>
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<DIV>Nadiya Jirova, MSc, Health Canada</DIV>
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<DIV><I>References</I></DIV>
<DIV>1. Kenalog-40 Injection (sterile triamcinolone acetonide suspension) [product monograph]. Montreal (QC): Westwood Squibb; 1992.</DIV>
<DIV>2. Baath J, Ells AL, et al. Safety profile of intravitreal triamcinolone acetonide. J Ocul Pharmacol Ther 2007;23(3):304-10.</DIV>
<DIV>3. Chaudhary V, Mao A, et al. Triamcinolone acetonide as adjunctive treatment to verteporfin in neovascular age-related macular degeneration.A prospective randomized trial. Ophthalmology 2007;114(12):2183-9.</DIV>
<DIV>4. Information importante de pharmacovigilance. Rueil-Malmaison (France): Bristol-Myers Squibb; 2007 Aug 6. Available: www.afssaps.fr/Infos-de -securite/Lettres-aux-professionnels-de-sante /Cas-d-endophtalmie-d-inflammation-oculaire-d-augmentation-de-la-pression-intraoculaire-et-de-troubles-visuels-incluant-des-cas-de-cecite-observes-chez-des-patients-a-la-suite-d-administration-intraoculaire-de-KENACORT-RETARD-au-cours-d-utilisations-hors-AMM/(language)/fre-FR (accessed 2009 Apr 29).</DIV>
<DIV>5. Carnahan MC, Goldstein DA. Ocular complications of topical, peri-ocular, and systemic corticosteroids. Curr Opin Ophthalmol 2000;11(6):478-83.</DIV>
<DIV>6. Jermak CM, Dellacroce JT, et al. Triamcinolone acetonide in ocular therapeutics. Surv Ophthalmol 2007;52(5):503-22.</DIV> |
