Efficacy of single or combined midodrine and pyridostigmine in orthostatic hypotension
Efficacy of single or combined midodrine and pyridostigmine in orthostatic hypotension
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DOI：
10.1212/wnl.0000000000004340
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发表时间：
2017-09-05
期刊：
影响因子：
9.9
通讯作者：
Chu, Kon
中科院分区：
文献类型：
--
作者：
Byun, Jung-Ick;Moon, Jangsup;Chu, Kon
目的：评价米多君与吡斯的明单独或联合治疗神经源性直立性低血压的远期(最长3个月)疗效和安全性。总共有87名有症状的神经源性OH患者入选并随机接受3种治疗中的一种：单用米多君、单用吡斯的明或米多君1吡斯的明。在治疗后1个月和3个月进行随访。主要的结果指标是3个月后立位血压(BP)下降的改善。次要终点是治疗1个月时立位血压下降的改善情况，以及评估OH相关症状的问卷评分的改善。结果：治疗3个月后，所有治疗组的立位收缩压和舒张压下降均有明显改善。治疗3个月后立位症状明显改善，症状严重程度分别为：单用米多君组、单用米多君1组、单用吡斯的明组。有11.5%的患者报告了轻中度不良事件。结论：米多君和吡斯的明单独或联合治疗OH患者3个月是有效和安全的。米多君在改善OH相关症状方面优于吡斯的明。临床试验。GOV识别符：NCT02308124.证据分类：这项研究提供了IV类证据，证明对于神经源性OH患者，单独使用米多君、单独使用吡斯的明或同时使用米多君和吡斯的明是安全的，在改善直立性血压下降方面具有类似的效果，最长可达3个月。
Objective: To evaluate the long-term (for up to 3 months) efficacy and safety of single or combined therapy with midodrine and pyridostigmine for neurogenic orthostatic hypotension (OH).Methods: This was a randomized, open-label clinical trial. In total, 87 patients with symptomatic neurogenic OH were enrolled and randomized to receive 1 of 3 treatments: midodrine only, pyridostigmine only, or midodrine 1 pyridostigmine. The patients were followed up at 1 and 3 months after treatment. The primary outcome measures were improvement in orthostatic blood pressure (BP) drop at 3 months. Secondary endpoints were improvement of the orthostatic BP drop at 1 month and amelioration of the questionnaire score evaluating OH-associated symptoms.Results: Orthostatic systolic and diastolic BP drops improved significantly at 3 months after treatment in all treatment groups. Orthostatic symptoms were significantly ameliorated during the 3-month treatment, and the symptom severity was as follows: midodrine only, midodrine 1 pyridostigmine, pyridostigmine only group. Mild to moderate adverse events were reported by 11.5% of the patients.Conclusions: Single or combination treatment with midodrine and pyridostigmine was effective and safe in patients with OH for up to 3 months. Midodrine was better than pyridostigmine at improving OH-related symptoms.Clinicaltrials. gov identifier: NCT02308124.Classification of evidence: This study provides Class IV evidence that for patients with neurogenic OH, long-term treatment with midodrine alone, pyridostigmine alone, or both midodrine and pyridostigmine is safe and has similar effects in improving orthostatic BP drop up to 3 months.