Seppey M, Schweri T, Häusler R
Rhinology Unit, Inselspital Bern, Switzerland.
ORL J Otorhinolaryngol Relat Spec. 1996 Mar-Apr;58(2):87-92. doi: 10.1159/000276805.
Twenty-eight patients undergoing rhinologic surgery were enrolled in a clinical study to compare two post-operative cleansing preparations. Patients were asked to wash their nasal fossae for 1 month, either with Rhinomer, a cleansing preparation of isotonic, sterile, undiluted sea water, presented in slightly pressurised bottle with neither CFC nor preservative, or with Prorhinel, a marketed solution containing an antiseptic agent. Patients were randomly allocated to treatment beginning 2 days after surgery. Nasal status was assessed by symptoms (blocking nose, rhinorrhoea, sneezing, itching and impaired smell) and rhinologic endoscopy (colour of the nasal mucosa, swelling of the mucosa, secretions, presence of crusts or pus). Patients attended control visits on days 9, 15 and 30 following surgery. They were asked to record symptom intensity and use of a rescue medication (Vibrocil, dimetindene 0.25 mg and phenylephrine 2.5 mg/ml) on a diary card. Twenty-six of 28 patients were eligible for efficacy analysis, 14 in the Rhinomer group and 12 in the Prorhinel group, In both groups, intensity of complaints decreased markedly over the study period. No severe adverse drug reactions were reported in either treatment. Evoked complaint frequency was comparable between groups, but patient's and physician's opinion on tolerability was significantly different between treatments, in favour of Rhinomer. In addition, the test preparation was found to be easier to use than Prorhinel. The weekly average frequency of use of the rescue medication was not significantly different between treatments. When both patients and physicians were asked about treatment efficacy, they expressed an opinion significantly more favourable to Rhinomer than to the reference drug. In this study, Rhinomer has shown efficacious results that justify its use in washing of the nasal cavities following endonasal surgery.
28例接受鼻科手术的患者被纳入一项临床研究，以比较两种术后清洁制剂。患者被要求用Rhinomer（一种等渗、无菌、未稀释的海水清洁制剂，装在无氟氯化碳和防腐剂的微压瓶中）或Prorinel（一种含有防腐剂的市售溶液）冲洗鼻腔1个月。患者在术后2天开始随机分配接受治疗。通过症状（鼻塞、流涕、打喷嚏、瘙痒和嗅觉减退）和鼻科内窥镜检查（鼻黏膜颜色、黏膜肿胀、分泌物、结痂或脓液的存在）评估鼻腔状况。患者在术后第9、15和30天进行对照访视。他们被要求在日记卡上记录症状强度和急救药物（Vibrocil，0.25毫克二甲茚定和2.5毫克/毫升去氧肾上腺素）的使用情况。28例患者中有26例符合疗效分析条件，Rhinomer组14例，Prorinel组12例。在两组中，研究期间投诉强度均显著下降。两种治疗均未报告严重药物不良反应。两组诱发投诉频率相当，但患者和医生对耐受性的看法在两种治疗之间存在显著差异，支持Rhinomer。此外，发现试验制剂比Prorinel更易于使用。两种治疗之间急救药物的每周平均使用频率无显著差异。当询问患者和医生关于治疗疗效时，他们对Rhinomer的评价明显比对参比药物更有利。在这项研究中，Rhinomer已显示出有效的结果，证明其可用于鼻内手术后鼻腔冲洗。
