Newson-Smith G, Powell M, Baehre M, Garnham S P, MacMahon M T
ASTA Medica AG, Frankfurt, Germany.
Eur Arch Otorhinolaryngol. 1997;254(5):236-41. doi: 10.1007/BF00874095.
This study compared a new intranasal anti-allergic drug, azelastine (0.56 mg bid) with intranasal beclomethasone (0.2 mg bid) and placebo in the treatment of symptoms associated with seasonal rhinitis. After administering placebo for 3-5 days as a "run-in" period, eligible patients were randomized to treatment for 2 weeks: 83 patients received azelastine, 83 beclomethasone and 77 placebo. Each of six symptoms was assessed daily using a four-point scale. Total symptom scores showed that azelastine-treated patients experienced a more rapid onset of overall symptom relief than beclomethasone-treated patients. This was significant on day 1 (P < 0.003) and continued until day 5. By the end of the 2-week study period, the beclomethasone-treated group showed greater improvement than both the azelastine and placebo groups (P = 0.002 and P = 0.0001, respectively). In contrast, visual analogue scales at this time showed no significant differences between the azelastine and beclomethasone treatment groups, with both groups demonstrating significant reductions in total symptom scores compared to placebo (P = 0.0004 and P = 0.0001, respectively). Differing sensitivities were found in the four-point scales reported by the patients and the investigators and the patients' visual analogue scales in the measurement of symptom severity. However, all three techniques confirmed that both azelastine nasal spray and beclomethasone nasal spray were effective treatments for seasonal rhinitis. While a greater improvement in overall symptoms was found for the beclamethasone-treated patients compared to azelastine-treated patients, diary card data confirmed the more immediate onset of symptom relief provided by azelastine. No serious adverse events were found in the present study and included no complaints of drowsiness.
本研究比较了一种新型鼻内用抗组胺药氮卓斯汀（0.56毫克，每日两次）与鼻内用倍氯米松（0.2毫克，每日两次）及安慰剂治疗季节性鼻炎相关症状的效果。在作为“导入期”给予安慰剂3 - 5天之后，符合条件的患者被随机分组接受为期2周的治疗：83例患者接受氮卓斯汀治疗，83例接受倍氯米松治疗，77例接受安慰剂治疗。每天使用四分制量表对六种症状中的每一种进行评估。总症状评分显示，与接受倍氯米松治疗的患者相比，接受氮卓斯汀治疗的患者总体症状缓解起效更快。在第1天这一差异具有显著性（P < 0.003），并持续至第5天。到为期2周的研究期结束时，接受倍氯米松治疗的组比接受氮卓斯汀和安慰剂治疗的组改善更明显（分别为P = 0.002和P = 0.0001）。相比之下，此时的视觉模拟量表显示氮卓斯汀和倍氯米松治疗组之间无显著差异，与安慰剂相比，两组的总症状评分均显著降低（分别为P = 0.0004和P = 0.0001）。在患者和研究者报告的四分制量表以及患者的视觉模拟量表对症状严重程度的测量中发现了不同的敏感性。然而，所有这三种技术均证实氮卓斯汀鼻喷雾剂和倍氯米松鼻喷雾剂都是治疗季节性鼻炎的有效疗法。虽然与接受氮卓斯汀治疗的患者相比，接受倍氯米松治疗的患者总体症状改善更明显，但日记卡数据证实氮卓斯汀能更快缓解症状。本研究未发现严重不良事件，也没有嗜睡的主诉。
