Ovesen T, Felding J U, Tommerup B, Schousboe L P, Petersen C G
ENT Department, Aarhus University Hospital, Denmark.
Acta Otolaryngol Suppl. 2000;543:79-81. doi: 10.1080/000164800454044.
Previous studies have demonstrated the anti-inflammatory, anti-oxidant, and mucolytic nature of N-acetylcysteine (NAC). Theoretically, these properties make the substance ideal for therapeutic use against otitis media with effusion (OME). The disease is characterized as a sustained non-specific inflammation of the middle ear mucosa with secretory transformation of the epithelium resulting in accumulation of fluid in the middle ear space. To investigate the effects of instillation of NAC in the middle ear, a double-blind, placebo-controlled, randomized trial was carried out. A total of 75 children who were undergoing their first bilateral insertion of ventilation tubes (VT) due to OME were randomized to Mucomyst (NAC) or placebo (the vehicle) on one ear in relation to the VT insertion. The contralateral ear underwent VT insertion exclusively. Instillation of Mucomyst or placebo was repeated 3 and 7 days afterwards. The children were followed regularly for 11-39 months. Episodes of otorrhea, recurrence of OME after VT extrusion and re-insertion of VTs were registered as primary outcome parameters. The results demonstrated that Mucomyst significantly reduced the recurrence of OME and re-insertion of VTs (p < 0.025) and significantly increased the time until VT extrusion (p < 0.0167). In addition, the number of episodes of ear problems and visits at the ENT clinic were reduced significantly by NAC (p < 0.0383).
先前的研究已经证实了N-乙酰半胱氨酸（NAC）具有抗炎、抗氧化和黏液溶解的特性。从理论上讲，这些特性使该物质成为治疗分泌性中耳炎（OME）的理想药物。该疾病的特征是中耳黏膜持续发生非特异性炎症，上皮细胞发生分泌性转化，导致中耳腔积液。为了研究中耳滴注NAC的效果，进行了一项双盲、安慰剂对照的随机试验。共有75名因OME首次接受双侧鼓膜置管（VT）的儿童，在VT置入时，其一只耳朵被随机分配接受沐舒坦（NAC）或安慰剂（赋形剂）治疗。对侧耳朵仅接受VT置入。在之后的第3天和第7天重复滴注沐舒坦或安慰剂。对这些儿童进行了11至39个月的定期随访。耳漏发作、VT拔除后OME复发以及再次置入VT的情况被记录为主要结局参数。结果表明，沐舒坦显著降低了OME的复发率和VT的再次置入率（p<0.025），并显著延长了VT拔除的时间（p<0.0167）。此外，NAC显著减少了耳部问题发作的次数以及在耳鼻喉科诊所的就诊次数（p<0.0383）。
