Kehrl Wolfgang, Sonnemann Uwe, Dethlefsen Uwe
Marienkrankenhaus, Klink and Ambulatorium für HNO-Frankeiten, Clinical Research, Aachen, Germany.
Laryngoscope. 2004 Apr;114(4):738-42. doi: 10.1097/00005537-200404000-00027.
OBJECTIVES/HYPOTHESIS: Nonpurulent rhinosinusitis can be treated successfully with cineole.
Prospective, randomized, double-blinded, placebo-controlled study.
We compared efficacy and safety of cineole capsules with placebo capsules in 152 patients with acute rhinosinusitis (76 patients in each treatment group). The dosage of the active ingredient was two 100-mg capsules of cineole three times daily. The primary end point was the reduction of a defined symptoms-sum-score based on symptoms and signs comparing baseline therapy difference from the beginning to the end of the 7-day treatment.
All randomly selected patients were assigned to the intention-to-treat-population. At the beginning, the mean symptoms-sum-score was 15.6 in both treatment groups. The mean values for the symptoms-sum-scores in the cineole group were 6.9 +/- 2.9 after 4 days and 3.0 +/- 2.8 after 7 days, and in the placebo group, 12.2 +/- 2.5 after 4 days and 9.2 +/- 3.0 after 7 days. The differences between both groups were clinically relevant and statistically significant after 4 and 7 days. The result for the primary end point was validated by the amelioration of the following secondary end points: headache on bending, frontal headache, sensitivity of pressure points of trigeminal nerve, impairment of general condition, nasal obstruction, and rhinological secretion. Mild side effects, possibly associated with medication, were observed in two patients as heartburn and exanthema after treatment with cineole.
In patients with acute nonpurulent rhinosinusitis, timely treatment with cineole is effective and safe before antibiotics are indicated.
目的/假设：桉叶油可成功治疗非化脓性鼻窦炎。
前瞻性、随机、双盲、安慰剂对照研究。
我们比较了桉叶油胶囊与安慰剂胶囊对152例急性鼻窦炎患者（每个治疗组76例）的疗效和安全性。活性成分的剂量为每日3次，每次2粒100毫克的桉叶油胶囊。主要终点是根据症状和体征，比较7天治疗开始至结束时基线治疗差异，以确定症状总和评分的降低情况。
所有随机选择的患者均纳入意向性治疗人群。开始时，两个治疗组的平均症状总和评分均为15.6。桉叶油组4天后症状总和评分的平均值为6.9±2.9，7天后为3.0±2.8；安慰剂组4天后为12.2±2.5，7天后为9.2±3.0。两组之间的差异在4天和7天后具有临床相关性且具有统计学意义。主要终点的结果通过以下次要终点的改善得到验证：弯腰时头痛、额头痛、三叉神经压痛点敏感性、一般状况受损、鼻塞和鼻分泌物。在两名患者中观察到可能与药物相关的轻微副作用，为服用桉叶油治疗后的烧心和皮疹。
对于急性非化脓性鼻窦炎患者，在需要使用抗生素之前，及时使用桉叶油治疗是有效且安全的。
