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Lancet:鼓室内注射甲基强的松龙治疗梅尼埃尔氏病,疗效如何?

2016-11-17 MedSci MedSci原创

梅尼埃尔氏病以严重的眩晕发作和听力损失为特点。对于难治性梅尼埃尔氏病的标准治疗方法鼓室内注射庆大霉素,可以改善眩晕,但是会损害前庭功能,以及导致听力恶化。 研究目的是,比较鼓室内注射糖皮质激素甲基强的松龙与庆大霉素,对梅尼埃尔氏病的疗效。 研究纳入18-70岁难治性梅尼埃尔氏病患者,共计60名,按1:1随机分为鼓室内注射糖皮质激素甲基强的松龙(62·5 mg/mL,n=30)或庆大霉素

梅尼埃尔氏病以严重的眩晕发作和听力损失为特点。对于难治性梅尼埃尔氏病的标准治疗方法鼓室内注射庆大霉素,可以改善眩晕,但是会损害前庭功能,以及导致听力恶化。

研究目的是,比较鼓室内注射糖皮质激素甲基强的松龙与庆大霉素,对梅尼埃尔氏病的疗效。

研究纳入18-70岁难治性梅尼埃尔氏病患者,共计60名,按1:1随机分为鼓室内注射糖皮质激素甲基强的松龙(62·5 mg/mL,n=30)或庆大霉素(40 mg/mL,n=30),每隔两周注射一次,并随访2年。主要结果是,最后6个月(随访18-24个月)与第一次注射前6个月比较眩晕发作情况。

数据显示,最后6个月与第一次注射前6个月比较,庆大霉素组患者的眩晕发作次数从19.9 (SD 16.7)下降到2.5 (5.8)(87%),基强的松龙组患者的眩晕发作次数从16.4 (12.5)下降到1.6 (3.4)(90%;平均差 −0.9, 95% CI −3.4 to 1.6)。

庆大霉素组和甲基强的松龙组分别有8名和15名患者经戴面具的临床医生给予治疗后,再由非盲法的临床医生进行评估,注射后患者的眩晕情况并没有改善,成为无反应者。其中两名无反应者从甲基强的松龙组转到庆大霉素组。这两种药物的耐受性良好,没有安全问题。

六例患者报告了不良事件,两组各三例。最常见的不良事件是轻微的耳朵感染,庆大霉素组和甲基强的松龙组各有1例患者和两例患者。

原始出处:


Mitesh Patel,et al.Intratympanic methylprednisolone versus gentamicin in patients with unilateral Ménière's disease: a randomised, double-blind, comparative effectiveness trial.Lancet.Published: 16 November 2016

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    2017-08-24 howi
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    2016-12-20 往日如昨

    受益匪浅

    0

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    2016-12-02 墨尔

    统计学特点很明显。

    0

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    2016-12-01 suepisode

    分组这件事儿是个学问

    0

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