复方色甘酸钠鼻喷雾剂治疗变应性鼻炎的疗效观察

Study on therapeutic effect of complex prescription cromolyn sodium nasal spray in the treatment of allergic rhinitis

目的观察复方色甘酸钠鼻喷剂(色甘酸钠与盐酸赛洛唑啉混合制剂)治疗变应性鼻炎的有效性和安全性。方法采用与已上市的同类有效药物立复汀鼻喷剂作为阳性对照,进行多中心、随机、双盲、平行对照的临床研究。根据病人症状和体征积分变化率进行疗效评估。结果入选病例240例,进入疗效分析229例,安全性分析230例。研究过程中未发生严重不良事件。症状积分变化率的疗效:试验组有效率92.3%,对照组有效率93.8%,经比较无统计学意义。体征积分变化率的疗效为:试验组有效率82.9%,对照组有效率88.4%,经比较无统计学意义。总体疗效:实验组有效率70.9%,对照组有效率78.6%,两组比较无统计学意义。结论复方色甘酸钠鼻喷雾剂,治疗变应性鼻炎安全有效,并与立复汀鼻喷剂等效。

Objective To observe the efficacy and safety of the complex prescription eromolyn sodium nasal spray in the treatment of allergic rhinitis. Methods A randomized, double-blind, multicenter, controlled trial of complex prescription cromolyn sodium and lovocabastine nasal spray was performed in the treatment of allergic rhinitis. Results A total number of 240 patients were encountered in the trial, while 229 and 230 cases were encountered in the pre-protocol analysis and intention-to-treat analysis respectively. Efficacy assessment based on total symptom score reducing index showed that the effective rates of complex prescription cromolyn sodium nasal spray and lovocabastine nasal spray were 92. 3% and 93. 8% respectively. The assessment based on total sign score reducing index showed that the effective rates of both sprays were 82. 9% and 88. 4%. The total effective rates of complex prescription cromolyn sodium nasal spray and lovocabastine nasal spray were 70. 9% and 78. 6% respectively. No serious adverse events were reported in both groups. Conclusion Complex prescription cromolyn sodium nasal spray is effective and safe in the treatment of allergic rhinitis. The efficacy of complex prescription eromolyn sodium nasal spray is similar to that of lovocabastine nasal spray.