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三药联合(托吡卡胺/苯肾上腺素/利多卡因)前房内注射:白内障手术中的综述。

Tropicamide/Phenylephrine/Lidocaine Intracameral Injection: A Review in Cataract Surgery.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Clin Drug Investig. 2019 Nov;39(11):1133-1139. doi: 10.1007/s40261-019-00843-z.

Abstract

Tropicamide 0.02%/phenylephrine 0.31%/lidocaine 1% injectable solution (Mydrane) is the first fixed-dose mydriatic/anaesthetic combination approved for intracameral use in adults undergoing cataract surgery. In a phase 3 trial in this setting, intracameral tropicamide/phenylephrine/lidocaine was at least as effective as a standard topical regimen of tropicamide plus phenylephrine in enabling successful capsulorhexis without the use of additional mydriatics. The intracameral preparation, which is administered via a single injection, provides rapid and sustained mydriasis through to the end of surgery, with recipients spending around half as long in preoperative/surgery rooms as standard topical regimen recipients in the phase 3 study. Moreover, significantly more of the intracameral than topical regimen recipients were free from pain or pressure in the eye/orbit before intraocular lens (IOL) implantation and had an IOL implanted without complications. Intracameral tropicamide/phenylephrine/lidocaine also displayed mydriatic efficacy in patients with diabetes in this trial. Overall, the preparation was generally well tolerated, with no serious adverse events leading to hospitalization or permanent vision loss. Thus, tropicamide/phenylephrine/lidocaine injectable solution is an emerging option for mydriasis/anaesthesia in adults undergoing cataract surgery.

摘要

托品酰胺 0.02%/苯肾上腺素 0.31%/利多卡因 1%注射液(Mydrane)是首个经批准用于成人白内障手术时前房内使用的固定剂量散瞳/麻醉联合制剂。在该适应证的 3 期临床试验中,前房内给予托品酰胺/苯肾上腺素/利多卡因与标准局部滴眼方案(即托品酰胺加苯肾上腺素)同样有效,可成功施行囊膜切开术,无需使用其他散瞳剂。该制剂通过单次注射给药,可迅速且持续散瞳至手术结束,与 3 期研究中的标准局部滴眼方案相比,使用者在术前/手术室内的停留时间缩短了近一半。此外,在进行人工晶状体(IOL)植入前,前房内给予该制剂的患者眼部/眼眶疼痛或压力显著低于局部滴眼方案组,且前者的 IOL 植入无并发症。在该试验中,前房内给予该制剂对糖尿病患者也具有散瞳效果。总之,该制剂总体上具有良好的耐受性,无导致住院或永久性视力丧失的严重不良事件。因此,托品酰胺/苯肾上腺素/利多卡因注射液是成人白内障手术时散瞳/麻醉的一种新兴选择。

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