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口服减充血剂在高血压患者中是否安全?证据评估及临床试验评估框架。

Are oral decongestants safe in hypertension? An evaluation of the evidence and a framework for assessing clinical trials.

作者信息

Radack K, Deck C C

出版信息

Ann Allergy. 1986 May;56(5):396-401.

PMID:3706827
Abstract

The safety of sympathomimetic decongestants (SMDs) in patients with hypertension remains controversial. Little experimental evidence exists for making proper recommendations regarding their use in hypertensive subjects. In order to determine the correct role of SMDs in such patients, physicians will need criteria with which to assess new data and reevaluate the existing literature. Using standardized methodologic criteria to judge clinical trials, we critically appraised the published evidence of the effects of SMDs on blood pressure control in hypertensive patients. A search of the English literature from 1966 to 1984 revealed 12 prospective clinical studies out of 37 articles that specifically addressed the potential adverse pressor effect of SMDs. Of these, only one study evaluated hypertensive patients in a double-blind randomized fashion. Despite few threats to generalizability, the results of that investigation suggest that intranasal phenylephrine is safe in patients with controlled hypertension. The effects of phenylpropanolamine and pseudoephedrine in hypertensive patients are unclear since only small numbers of unrepresentative normotensive subjects have been studied; thus, the evidence to support the widespread belief that SMDs are unsafe in hypertensive patients is weak and circumstantial. Recommendations for treatment and methods to improve future study designs are suggested.

摘要

拟交感神经减充血剂(SMDs)在高血压患者中的安全性仍存在争议。几乎没有实验证据可用于就其在高血压患者中的使用做出恰当建议。为了确定SMDs在此类患者中的正确作用,医生将需要用于评估新数据和重新评估现有文献的标准。我们使用标准化的方法学标准来评判临床试验,对已发表的关于SMDs对高血压患者血压控制影响的证据进行了严格评估。检索1966年至1984年的英文文献发现,37篇文章中有12项前瞻性临床研究专门探讨了SMDs潜在的升压不良反应。其中,只有一项研究以双盲随机方式评估了高血压患者。尽管对普遍性的威胁较小,但该研究结果表明,鼻腔用去氧肾上腺素在血压得到控制的高血压患者中是安全的。由于仅对少量不具代表性的血压正常受试者进行了研究,所以苯丙醇胺和伪麻黄碱在高血压患者中的作用尚不清楚;因此,支持普遍认为SMDs在高血压患者中不安全这一观点的证据薄弱且间接。文中还提出了治疗建议以及改进未来研究设计的方法。

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引用本文的文献

1
Pharmacology of nasal medications: an update.鼻腔药物的药理学:更新。
Can Fam Physician. 1988 Dec;34:2706-9.
2
Substitution of phenylephrine for pseudoephedrine as a nasal decongeststant. An illogical way to control methamphetamine abuse.用去氧肾上腺素替代伪麻黄碱作为鼻减充血剂。一种控制甲基苯丙胺滥用的不合理方法。
Br J Clin Pharmacol. 2007 Jan;63(1):10-4. doi: 10.1111/j.1365-2125.2006.02833.x. Epub 2006 Nov 20.
3
Non-prescription sympathomimetic agents and hypertension.
Med Toxicol Adverse Drug Exp. 1988 Sep-Oct;3(5):387-417. doi: 10.1007/BF03259892.
4
Drug interactions in hypertensive patients. Pharmacokinetic, pharmacodynamic and genetic considerations.高血压患者的药物相互作用。药代动力学、药效学及遗传学考量
Clin Pharmacokinet. 1990 Apr;18(4):295-317. doi: 10.2165/00003088-199018040-00003.