目的 評(píng)價(jià)滴通鼻炎水噴霧劑治療變應(yīng)性鼻炎（鼻鼽）的臨床療效和安全性。方法 采用隨機(jī)、盲法、安慰劑平行對(duì)照、多中心臨床研究，88例變應(yīng)性鼻炎患者分為試驗(yàn)組66例、對(duì)照組22例，分別使用滴通鼻炎水噴霧劑和安慰劑，外用噴鼻，每次2撳（0.13 mL/撳），4 次/d，療程14 d。用變應(yīng)性鼻炎臨床療效、鼻塞緩解時(shí)間、鼻塞緩解維持時(shí)間、噴嚏數(shù)評(píng)價(jià)有效性；一般體格檢查、不良反應(yīng)事件評(píng)價(jià)安全性。結(jié)果 對(duì)變應(yīng)性鼻炎的臨床療效，試驗(yàn)組臨床控制率13.64%、顯效率46.97%、有效率30.30%、無(wú)效率9.09%，對(duì)照組臨床控制率0.00%、顯效率13.64%、有效率27.27%、無(wú)效率59.09%，試驗(yàn)組優(yōu)于對(duì)照組（P＜0.05）；鼻塞緩解維持時(shí)間和平均噴嚏數(shù)，試驗(yàn)組優(yōu)于對(duì)照組（P＜0.01）。兩組均無(wú)不良反應(yīng)發(fā)生。結(jié)論 滴通鼻炎水噴霧劑是治療變應(yīng)性鼻炎安全、有效的藥物。

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.