滴通鼻炎水喷雾剂治疗变应性鼻炎的临床研究

目的 评价滴通鼻炎水喷雾剂治疗变应性鼻炎（鼻鼽）的临床疗效和安全性。方法 采用随机、盲法、安慰剂平行对照、多中心临床研究，88例变应性鼻炎患者分为试验组66例、对照组22例，分别使用滴通鼻炎水喷雾剂和安慰剂，外用喷鼻，每次2揿（0.13 mL/揿），4 次/d，疗程14 d。用变应性鼻炎临床疗效、鼻塞缓解时间、鼻塞缓解维持时间、喷嚏数评价有效性；一般体格检查、不良反应事件评价安全性。结果 对变应性鼻炎的临床疗效，试验组临床控制率13.64%、显效率46.97%、有效率30.30%、无效率9.09%，对照组临床控制率0.00%、显效率13.64%、有效率27.27%、无效率59.09%，试验组优于对照组（P＜0.05）；鼻塞缓解维持时间和平均喷嚏数，试验组优于对照组（P＜0.01）。两组均无不良反应发生。结论 滴通鼻炎水喷雾剂是治疗变应性鼻炎安全、有效的药物。

Clinical study on Ditong Biyanshui Spray for treatment of allergic rhinitis

Objective To evaluate the clinical efficacy and safety of Ditong Biyanshui Spray for the treatment of allergic rhinitis (Biqiu). Methods A randomized, blinded, placebo controlled, and multicenter trial method was used in this assay. The trial enrolled 88 patients with allergic rhinitis, including 66 cases in experimental group and 22 cases in control group, respectively given Ditong Biyanshui Spray and placebo for external application, pressing 2 once ( 0.13 mL/press ), 4 times/d, using 14 d as a course of treatment. Allergic rhinitis criteria of clinical curative effect, the time for easing stuffy nose and duration, and the number of sneeze were used to assess the efficacy. The general physical examination and adverse events were for assessment in safety. Results The clinical control rate, significant effective rate, effective rate, and ineffective rate were 13.64%, 46.97%, 30.30%, and 9.09% in the experimental group, and 0.00%, 13.64%, 27.27%, and 59.09% in the control group, respectively. Besides nasal congestion relieving duration and the number of sneezes, the overall results showed that the experimental group was superior to the control group with statistical significance (P<0.05). In addition, there were no adverse events in both two groups. Conclusion Ditong Biyanshui Spray is an effective clinical drug for the treatment of allergic rhinitis, as well as a secure drug.