Chang Hee Jin, Park Jongkyu, Oh Sohee, Shin Chaewon, Kim Ji Won, Cho Jin Whan, Lee Jee-Young
Department of Neurology, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea.
Department of Neurology, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
J Mov Disord. 2025 Jul;18(3):244-252. doi: 10.14802/jmd.25031. Epub 2025 May 7.
Delayed ON is a condition in which Parkinson's disease (PD) patients do not experience the effect of levodopa in time after taking the dosage. The ability of various oral levodopa regimens to overcome this problem has been poorly investigated. To evaluate the efficacy of levodopa/benserazide dispersible tablets in PD patients with delayed ON to the first morning dose.
This multicenter, randomized, crossover trial involved 40 eligible PD patients with delayed ON. The participants were randomized to receive either levodopa/benserazide 100 mg dispersible or regular tablets for 4 weeks, followed by a one-week wash-out interval and an alternate drug for another 4 weeks. Participants took the investigational drug with the first morning dose of their antiparkinsonian medications. Other medications were not changed during the trial. The primary outcome was changes in time-to-ON after the first-morning dose recorded in a special diary before and after each therapy. We also evaluated changes in parkinsonism, motor fluctuations, and dyskinesia using the Unified PD Rating Scale and the Unified Dyskinesia Rating Scale. Finally, we investigated whether efficacy was affected by Helicobacter pylori status via baseline serum samples from every participant.
Nine patients dropped out during the trial. The time-to-ON was significantly reduced by the dispersible tablet compared with the regular tablet (-34.72 vs. -23.81 minutes, p=0.014). There were no significant changes in parkinsonian severity or dyskinesia with either drug. The dispersible formulation was beneficial for both Helicobacter pylori-positive and -negative groups.
Levodopa/benserazide dispersible formulations can improve time-to-ON without exacerbating dyskinesia in PD patients suffering from delayed ON.
延迟起效是帕金森病（PD）患者服用左旋多巴剂量后不能及时体验到药物效果的一种情况。各种口服左旋多巴治疗方案克服这一问题的能力尚未得到充分研究。本研究旨在评估左旋多巴/苄丝肼分散片对延迟起效的PD患者首次晨服剂量的疗效。
这项多中心、随机、交叉试验纳入了40例符合条件的延迟起效的PD患者。参与者被随机分为接受左旋多巴/苄丝肼100mg分散片或普通片治疗4周，随后有1周的洗脱期，再接受另一种药物治疗4周。参与者在服用抗帕金森病药物的首次晨服剂量时同时服用研究药物。试验期间其他药物不变。主要结局是每次治疗前后在特殊日记中记录的首次晨服剂量后起效时间的变化。我们还使用统一帕金森病评定量表和统一运动障碍评定量表评估帕金森症状、运动波动和运动障碍的变化。最后，我们通过每位参与者的基线血清样本研究疗效是否受幽门螺杆菌状态的影响。
9例患者在试验期间退出。与普通片相比，分散片显著缩短了起效时间（-34.72分钟对-23.81分钟，p=0.014）。两种药物治疗后帕金森严重程度或运动障碍均无显著变化。分散片制剂对幽门螺杆菌阳性和阴性组均有益。
左旋多巴/苄丝肼分散片制剂可改善延迟起效的PD患者的起效时间，且不会加重运动障碍。
