Woitalla Dirk, Kassubek Jan, Timmermann Lars, Lauterbach Thomas, Berkels Reinhard, Grieger Frank, Müller Thomas
St Josef-Hospital Universitätsklinik, Bochum, Germany.
Department of Neurology, University of Ulm, Ulm, Germany.
Parkinsonism Relat Disord. 2015 Mar;21(3):199-204. doi: 10.1016/j.parkreldis.2014.11.024. Epub 2014 Dec 4.
Gastrointestinal (GI) symptoms are common among patients with Parkinson's disease (PD), due to both the disease itself and anti-PD drugs. We hypothesized that transdermal drug administration may result in fewer GI problems. This prospective observational study (ClinicalTrials.gov: NCT01159691) investigated effect of switching to rotigotine transdermal patch from oral anti-PD medications in patients with PD and existing GI symptoms.
Patients were enrolled if their physician was planning to switch them to rotigotine because of GI symptoms experienced while receiving oral anti-PD medications. Effectiveness assessments included a visual analog scale (VAS) measuring intensity of GI symptoms from 0 (no disorder) to 100 mm (extremely severe disorder), a questionnaire on the frequency and intensity of six individual GI complaints (heartburn, bloating, nausea, vomiting, abdominal pain, diarrhea), each rated 0-12 for a sum score of 0-72, and patient satisfaction regarding GI symptoms over approximately 6 weeks after switching.
Of 75 patients who received rotigotine, 58 had follow-up data available for final analysis. Intensity of GI complaints improved numerically on both the VAS (47.5 ± 24.4 mm [n = 65] at baseline, 19.7 ± 23.3 mm [n = 58] after around 6 weeks) and the sum score of GI complaints (11.2 ± 9.0 at baseline, 2.1 ± 4.4 [n = 58] after around 6 weeks). Fifty of 58 patients were "satisfied" or "very satisfied" regarding GI symptoms over around 6 weeks following switch to the patch.
This study suggests that a switch from oral anti-PD medications to rotigotine transdermal patch may improve existing GI symptoms among patients with PD. Additional controlled studies are needed to confirm this finding.
帕金森病(PD)患者常出现胃肠道(GI)症状,这是由疾病本身和抗帕金森病药物共同导致的。我们推测经皮给药可能会减少胃肠道问题。这项前瞻性观察性研究(ClinicalTrials.gov:NCT01159691)调查了帕金森病且已有胃肠道症状的患者从口服抗帕金森病药物转换为罗替戈汀透皮贴剂的效果。
如果患者的医生计划因在接受口服抗帕金森病药物时出现胃肠道症状而将他们转换为罗替戈汀,则将其纳入研究。有效性评估包括一个视觉模拟量表(VAS),用于测量胃肠道症状的强度,范围从0(无不适)到100毫米(极其严重的不适);一份关于六种个体胃肠道不适(烧心、腹胀、恶心、呕吐、腹痛、腹泻)的频率和强度的问卷,每种不适的评分为0 - 12分,总分0 - 72分;以及转换后约6周内患者对胃肠道症状的满意度。
在75名接受罗替戈汀治疗的患者中,58名有可供最终分析的随访数据。胃肠道不适的强度在VAS上(基线时为47.5±24.4毫米[n = 65],约6周后为19.7±23.3毫米[n = 58])以及胃肠道不适的总分(基线时为11.2±9.0,约6周后为2.1±4.4[n = 58])在数值上均有所改善。在转换为贴剂后约6周内,58名患者中有50名对胃肠道症状“满意”或“非常满意”。
本研究表明,从口服抗帕金森病药物转换为罗替戈汀透皮贴剂可能会改善帕金森病患者现有的胃肠道症状。需要更多对照研究来证实这一发现。