Hayden G F, Randall J E, Randall J C, Hendley J O
Arch Otolaryngol. 1984 Aug;110(8):512-4. doi: 10.1001/archotol.1984.00800340024005.
One hundred fifty-two children were enrolled in a randomized, controlled clinical trial of the efficacy of phenylephrine hydrochloride nose drops or nasal spray in hastening the resolution of middle ear effusion. Children with persistent effusion were recruited for the study during a return visit two weeks after an episode of acute otitis media. Forty-six patients (30%) dropped out of the study, many because they failed to tolerate the medication, especially the nose drops. Another 27 (18%) had to be excluded because of intercurrent illness or systemic drug therapy. Among those children completing the study, rates of clinical and tympanometric cure during the following four weeks were similar in the drug and placebo groups. In view of the absence of documented clinical efficacy and the practical difficulties inherent in their administration, topical decongestants appear to have a limited role, if any, in treating children with persistent effusion.
152名儿童参与了一项关于盐酸去氧肾上腺素滴鼻剂或鼻喷雾剂在加速中耳积液消退方面疗效的随机对照临床试验。持续性中耳积液患儿在急性中耳炎发作两周后的复诊时被纳入该研究。46名患者(30%)退出了研究,许多是因为他们无法耐受药物,尤其是滴鼻剂。另外27名(18%)因并发疾病或全身药物治疗而不得不被排除。在完成研究的儿童中,药物组和安慰剂组在接下来四周的临床治愈和鼓室图治愈的比例相似。鉴于缺乏已证实的临床疗效以及给药过程中固有的实际困难,局部减充血剂在治疗持续性中耳积液儿童方面似乎作用有限,即便有作用也不大。