Suckfüll M
Klinikum Grosshadern, 81377, München, Germany.
Lancet. 2002 Dec 7;360(9348):1811-7. doi: 10.1016/S0140-6736(02)11768-5.
Sudden sensorineural hearing loss (SSHL) is thought to have many different origins, including disturbances of microcirculation, autoimmune pathology, and viral infection. We aimed to determine whether acute reduction of plasma fibrinogen and serum LDL is effective for treatment of SSHL of suspected vascular origin.
Between January, 2000, and June, 2001, we recruited 201 patients with sudden hearing loss from four otorhinolaryngology clinics in Germany. Patients were randomly allocated to single fibrinogen/LDL apheresis or standard treatment (250 mg prednisolone reduced by 25 mg per day, 500 mL 6% hydroxyethyl starch, 400 mg pentoxifylline per day). The primary outcome was recovery of hearing as measured by pure-tone audiometry 48 h after the start of treatment. Secondary outcomes were recovery of hearing 6 weeks after treatment, improvement of speech audiometry, tinnitus, and frequency of side-effects. Analysis was done per protocol.
Overall improvement of pure-tone thresholds was slightly but not significantly better in patients given apheresis than in those given standard treatment (difference 7.7, 95% CI -8.2 to 23.6). However, the mean sound level at which 50% of recorded digits were recognised was significantly lower after 48 h in the apheresis group (21.6 dB, SD 20.8) than in the standard group (29.3 dB, 29.4; p=0.034). After 6 weeks, the mean 50% speech perception was at 13.6 dB (SD 14.3) in the apheresis group and at 20.8 dB (25.4) in those on standard treatment (p=0.059). At 48 h, in patients with plasma fibrinogen concentrations of more than 295 mg/dL, speech perception was improved much more in those on apheresis (15.3 dB, 17.3) than in those on standard treatment (6.1 dB, 10.4; p=0.005).
A single fibrinogen/LDL apheresis lasting for 2 h could be used as an alternative to conventional infusion treatment and prednisolone for 10 days. Patients with a plasma fibrinogen of more than 8.68 micromol/L improve much better when treated with apheresis, especially if serum LDL concentrations are also raised.
突发性感音神经性听力损失（SSHL）被认为有许多不同的病因，包括微循环障碍、自身免疫性病变和病毒感染。我们旨在确定急性降低血浆纤维蛋白原和血清低密度脂蛋白（LDL）是否对疑似血管源性SSHL的治疗有效。
在2000年1月至2001年6月期间，我们从德国的四家耳鼻喉科诊所招募了201例突发性听力损失患者。患者被随机分配接受单次纤维蛋白原/LDL血液成分分离术或标准治疗（250mg泼尼松龙，每天减少25mg，500mL 6%羟乙基淀粉，每天400mg己酮可可碱）。主要结局是治疗开始后48小时通过纯音听力测定法测量的听力恢复情况。次要结局是治疗6周后的听力恢复情况、言语测听改善情况、耳鸣以及副作用发生频率。分析按照方案进行。
接受血液成分分离术的患者纯音阈值的总体改善略好于接受标准治疗的患者，但差异无统计学意义（差值7.7，95%置信区间-8.2至23.6）。然而，血液成分分离术组在48小时后的半数记录数字可被识别的平均声级（21.6dB，标准差20.8）显著低于标准治疗组（29.3dB，29.4；p=0.034）。6周后，血液成分分离术组的半数言语感知平均声级为13.6dB（标准差14.3），标准治疗组为20.8dB（25.4）（p=0.059）。在48小时时，血浆纤维蛋白原浓度超过295mg/dL的患者中，接受血液成分分离术的患者言语感知改善程度（15.3dB，17.3）远高于接受标准治疗的患者（6.1dB，10.4；p=0.005）。
持续2小时的单次纤维蛋白原/LDL血液成分分离术可作为传统输注治疗和10天泼尼松龙治疗的替代方法。血浆纤维蛋白原超过8.68微摩尔/升的患者在接受血液成分分离术治疗时改善更好，尤其是血清LDL浓度也升高时。
