Hussain I F, Brady C M, Swinn M J, Mathias C J, Fowler C J
Uro-Neurology, National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG, UK.
J Neurol Neurosurg Psychiatry. 2001 Sep;71(3):371-4. doi: 10.1136/jnnp.71.3.371.
To assess the efficacy and safety of sildenafil citrate (Viagra) in men with erectile dysfunction and parkinsonism due either to Parkinson's disease or multiple system atrophy.
Twenty four patients with erectile disease were recruited, 12 with Parkinson's disease and 12 with multiple system atrophy, into a randomised, double blind, placebo controlled, crossover study of sildenafil citrate. The starting dose was 50 mg active or placebo medication with the opportunity for dose adjustment depending on efficacy and tolerability. The international index of erectile function questionnaire (IIEF) was used to assess treatment efficacy and a quality of life questionnaire to assess the effect of treatment on sex life and whole life. Criteria for entry included a definite neurological diagnosis and a standing systolic blood pressure of 90-180 mm Hg and diastolic blood pressure of 50-110 mm Hg, on treatment if necessary. Blood pressure was taken at randomisation (visit 2) and crossover (visit 5) lying, sitting, and standing, before and 1 hour after taking the study medication in hospital.
Sidenafil citrate was efficacious in men with parkinsonism with a significant improvement, as demonstrated in questionnaire responses, in ability to achieve and maintain an erection and improvement in quality of sex life. In Parkinson's disease there was minimal change in blood pressure between active and placebo medication. In multiple system atrophy, six patients were studied before recruitment was stopped because three men showed a severe drop in blood pressure 1 hour after taking the active medication. Two were already known to have orthostatic hypotension and were receiving treatment with ephedrine and midodrine but the third had asymptomatic hypotension. However, the blood pressures in all three had been within the inclusion criterion for the study protocol. Despite a significant postural fall in blood pressure after sildenafil, all patients with multiple system atrophy reported a good erectile response and were reluctant to discontinue the medication.
Sidenafil citrate (50 mg) is efficacious in the treatment of erectile dysfunction in parkinsonism due to Parkinson's disease or multiple system atrophy; however, it may unmask or exacerbate hypotension in multiple system atrophy. As Parkinson's disease may be diagnostically difficult to distinguish from multiple system atrophy, especially in the early stages, we recommend measurement of lying and standing blood pressure before prescribing sildenafil to men with parkinsonism. Furthermore, such patients should be made aware of seeking medical advice if they develop symptoms on treatment suggestive of orthostatic hypotension.
评估枸橼酸西地那非(万艾可)对帕金森病或多系统萎缩所致勃起功能障碍男性患者的疗效和安全性。
招募24例勃起功能障碍患者,其中12例为帕金森病患者,12例为多系统萎缩患者,进行枸橼酸西地那非的随机、双盲、安慰剂对照、交叉研究。起始剂量为50mg活性药物或安慰剂,可根据疗效和耐受性进行剂量调整。采用国际勃起功能指数问卷(IIEF)评估治疗效果,并用生活质量问卷评估治疗对性生活和整体生活的影响。入选标准包括明确的神经学诊断,必要时治疗期间站立收缩压为90 - 180mmHg,舒张压为50 - 110mmHg。在医院服用研究药物前及服药后1小时,于随机分组时(访视2)和交叉时(访视5)测量卧位、坐位和立位血压。
枸橼酸西地那非对帕金森综合征男性患者有效,问卷结果显示勃起功能及性生活质量显著改善。在帕金森病患者中,活性药物与安慰剂用药期间血压变化极小。在多系统萎缩患者中,招募停止前研究了6例患者,因为3例男性在服用活性药物1小时后血压严重下降。其中2例已知患有体位性低血压,正在接受麻黄碱和米多君治疗,但第3例有无症状性低血压。然而,这3例患者的血压均在研究方案的纳入标准范围内。尽管服用西地那非后血压有显著的体位性下降,但所有多系统萎缩患者均报告勃起反应良好,且不愿停药。
枸橼酸西地那非(50mg)对帕金森病或多系统萎缩所致帕金森综合征的勃起功能障碍有效;然而,它可能会暴露或加重多系统萎缩患者的低血压症状。由于帕金森病在诊断上可能难以与多系统萎缩区分,尤其是在早期阶段,我们建议在给帕金森综合征男性患者开西地那非之前测量卧位和立位血压。此外,此类患者在治疗过程中出现提示体位性低血压的症状时应告知寻求医疗建议。