【摘要】 目的 评价清咽滴丸治疗风热喉痹及痰火郁结喉痹的临床疗效及安全性。方法 采用病例注册登记研究的方法进行临床多中心研究，共观察4375例喉痹患者，由中医辩证为风热证及痰火郁结证，按医嘱服用清咽滴丸，分别于治疗第1天和第7天就主要症状咽痛进行VAS评分，对各症状消失率及疾病痊愈率等疗效指标进行评价，并观察该药的不良反应。结果 清咽滴丸治疗7天后，风热喉痹及痰火郁结喉痹患者VAS评分变化率分别为（96.45±11.26）%、（94.63±13.70）%，与治疗前相比均有显著降低（P<0.01）。风热证以及痰火郁结证治疗后各临床症状均有显著缓解，差异具有统计学意义。喉痹痊愈率风热证77.01%，痰火郁结证57.78%，清咽滴丸治疗风热证疗效更佳。结论 清咽滴丸治疗风热及痰火郁结喉痹均有较好疗效及安全性，治疗风热证总体疗效优于痰火郁结证。更多还原

【Abstract】 Objective To evaluate the clinical efficacy and safety of Qingyan Dropping Pills in sore throat of wind-heat syndrome and of phlegm-fire stagnation. Methods a multiccntcr clinical study was conducted using the method of case registration study,observing a total of 4375 patients with laryngeal paralysis. They were dialectized as wind-heat syndrome and sputum-fire stagnation syndrome by Chinese medicine practitioners, and were given Qingyan Dropping Pills as prescribed by the doctor. Patients were treated with Qingyan dropping pills, followed up on the first and seventh day. VAS scores were performed for the main symptoms of pharyngialgia, and therapeutic indexes such as the disappearance rate of symptoms additionally, adverse reactions to the drug were observed. And the adverse reactions of the drug were observed. Results After 7 days of treatment, the change rates of VAS scores were(96.45± 11.26)% and(94.63±13.70)%, respectively, and the VAS scores were significantly reduced(P<0.01). For patients with wind-heat syndrome after treatment related symptoms were significantly relieved, the differences were statistically significant, as well as for pharyngeal fire stagnation syndrome patients. The cure rate of wind-heat syndrome was 77.01%, and that of phlegm-fire stagnation syndrome was 57.78%. Qingyan dripping pills had better therapeutic effect on wind-heat syndrome. Conclusion Qingyan Dropping Pills demonstrate has good efficacy and safety in the treatment of wind-heat paralysis of the throat and phlegm-fire paralysis of the throat, and the overall efficacy in the treatment of wind-heat paralysis of the throat is better than that of phlegm-fire paralysis of the throat.更多还原