鼻渊舒口服液改善慢性鼻窦炎/鼻息肉鼻内窥镜手术预后的多中心随机对照试验

目的观察鼻渊舒口服液对慢性鼻窦炎/鼻息肉鼻内窥镜手术(FESS)后临床症状和体征的改善情况以及对鼻窦粘膜创伤愈合时间的影响,并对其有效性做出评价.方法将340例临床确诊的慢性鼻窦炎、鼻息肉患者按单纯随机化方法分为试验组170例和对照组170例.试验组手术后除常规抗生素(喹诺酮类抗生素7 d)、局部类固醇激素等治疗外还给予鼻渊舒口服液治疗,每次10ml,每天3次,共20d;对照组手术后仅给予常规抗生紊和局部类固醇激素等治疗20d,而后比较两组疗效.结果试验组综合疗效的总有效率ITT人群为94.1%,即人群为96.4%;对照组综合疗效的总效率中,ITT人群为75.3%,PP人群为79.0%,经秩和检验,试验组和对照组综合疗效的总有效率有显著性差异(ITT:Z=5.635,P=0.018,Z=4.279,P=0.039).结论鼻渊舒口服液不仅可以提高鼻窦手术的疗效,而且可以减少抗生素、激素等药物的疗程,无毒副作用及不良反应.

Multi-Centre Randomized Controlled Trial of Bi Yuan Shu Liquid on Patients with Chronic Nasal Sinusitis or Nasal Polyp after Endosoopic Sinus Surgery

Objective To study the effect of Bi Yuan Shu Liquid on melioration of clinical symptoms and signs of chronic nasal sinusitis or nasal polyp patients after Functional Endosoopic Sinus Surgery (FESS), and discuss the effectiveness of Chinese composite medicine in the overall treatment after FESS. MethodsA total of 340 patients were randomly allocated to treatment group (n=170) and control group (n=170) according to simple randomization procedure. Patients in treatment group were administrated with quinolone, steroid, and Bi Yuan Shu Liquid, which were compared with those in control group who were given quinolone and steroid. ResultsThe apparent effect of treatment group and control group were 30.6% and 42.4% of 42.4% of ITT. Results by Wilcoxon signed rank test indicated that there was a statistically significant difference. ConclusionBi Yuan Shu Liquid may improve the effectiveness of sinus surgery, reduce the time course of antibiotics and hormones, and with out toxicity and side-effect.