Incaudo G, Schatz M, Yamamoto F, Mellon M, Crepea S, Johnson J D
J Allergy Clin Immunol. 1980 Jan;65(1):41-9. doi: 10.1016/0091-6749(80)90175-x.
The effectiveness and safety of 200 micrograms/day of intranasal flunisolide in the treatment of perennial rhinitis was studied in 56 patients in a 6 wk double-blind parallel vehicle controlled clinical trial. In addition, patients failing to respond to placebo were entered into a 6 wk open trial with the active drug. Forty-six percent of the flunisolide-treated patients achieved total or substantial control of their nasal symptoms compared to 11% of the placebo-treated group in the double-blind study (p = 0.031). Eighty percent of patients achieved total or substantial control of their nasal symptoms in the 6 wk open study. No adverse effects attributable to flunisolide were observed. Parameters of IgE-mediated reactivity, including immediate-type skin test reactivity, total serum and nasal secretion IgE, specific serum and nasal secretion IgE, and nasal eosinophilia, were also assessed in these patients. Although benefit from flunisolide significantly correlated with all of these parameters except specific serum IgE, the absence of these findings did not preclude significant benefit from the drug. This study demonstrates the efficacy and safety of intranasal flunisolide in the treatment of perennial rhinitis, especially but not exclusively in those patients with evidence of IgE-mediated reactivity.
在一项为期6周的双盲平行安慰剂对照临床试验中，对56例常年性鼻炎患者研究了每日200微克鼻内氟尼缩松治疗的有效性和安全性。此外，对未对安慰剂产生反应的患者进行了为期6周的活性药物开放试验。在双盲研究中，46%接受氟尼缩松治疗的患者实现了鼻症状的完全或显著控制，而安慰剂治疗组为11%（p = 0.031）。在6周的开放研究中，80%的患者实现了鼻症状的完全或显著控制。未观察到与氟尼缩松相关的不良反应。还对这些患者的IgE介导反应性参数进行了评估，包括速发型皮肤试验反应性、血清和鼻分泌物总IgE、血清和鼻分泌物特异性IgE以及鼻嗜酸性粒细胞增多。虽然除血清特异性IgE外，氟尼缩松的益处与所有这些参数显著相关，但这些指标的缺乏并不排除药物带来显著益处。本研究证明了鼻内氟尼缩松治疗常年性鼻炎的有效性和安全性，尤其是但不限于有IgE介导反应性证据的患者。
