卡比多巴/左旋多巴肠内悬浮液与脑深部电刺激对医疗保险按服务收费的晚期帕金森病患者减轻服药负担的比较效果
Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson's Disease.
作者信息
Soileau Michael J, Pagan Fernando L, Fasano Alfonso, Rodriguez-Cruz Ramon, Yan Connie H, Gupta Niodita R, Teigland Christie L, Pulungan Zulkarnain, Schinkel Jill K, Kandukuri Prasanna L, Ladhani Omar A, Siddiqui Mustafa S
机构信息
Texas Movement Disorder Specialists, 204 S. Interstate 35, Suite 103, Georgetown, TX, 78628, USA.
Georgetown University Hospital, 3800 Reservoir Rd, NW 7 PHC, Washington, DC, 20007, USA.
出版信息
Neurol Ther. 2023 Apr;12(2):459-478. doi: 10.1007/s40120-022-00433-w. Epub 2023 Jan 18.
INTRODUCTION
Complex polypharmacy regimens to manage persistent motor fluctuations result in significant pill burden for patients with advanced Parkinson's disease (APD). This study evaluated the effectiveness of carbidopa/levodopa enteral suspension (CLES) and deep brain stimulation (DBS) on reducing pill burden in APD patients.
METHODS
We utilized 100% Medicare fee-for-service claims from 2014 to 2018 linked to CLES Patient Support Program (PSP) data. CLES initiators (CLES-I) were propensity matched 1:1 with patients enrolled in PSP who did not initiate treatment (CLES-NI) (N = 188) or undergo DBS, and 1:3 with patients who received DBS (N = 204, N = 612). Average daily pill burden and levodopa equivalent daily dosage (LEDD) were measured at baseline, 0-6 months and 7-12 months follow-up.
RESULTS
CLES-I and CLES-NI had higher pill burden than DBS patients at baseline. However, at 6 months post-treatment, CLES-I had significantly fewer pills/day than CLES-NI (4.7 versus 11.4, p < 0.05) and DBS (4.8 versus 7.4, p < 0.05). A significant reduction in pill burden was observed at 0-6 months (46.3%) and 7-12 months (68.3%) follow-up for CLES-I (p < 0.001) versus increased burden for CLES-NI (+10.5%, p < 0.05 and +8.2%, p > 0.05) and insignificant reductions for DBS (-3.9% and -6.1%, p > 0.05). Mean adjusted pill burden showed 57.3% fewer pills at 0-6 months and 74.1% at 7-12 months among CLES-I compared with CLES-NI, and 49.6% and 70.1% reduction compared with DBS. CLES-I showed a decrease in LEDD at 7-12 months compared with baseline (935 to 237 mg) and to CLES-NI (237 mg versus 1112 mg) and DBS patients (236 mg versus 594 mg).
CONCLUSION
CLES led to a significant reduction in pill burden and oral LEDD compared with CLES-NI and DBS patients. Pill burden reduction could be considered a treatment goal for patients with APD challenged by complex polypharmacy regimens that interfere with activities of daily living and quality of life.
引言
用于管理持续性运动波动的复杂联合药物治疗方案给晚期帕金森病（APD）患者带来了沉重的服药负担。本研究评估了卡比多巴/左旋多巴肠内悬浮液（CLES）和深部脑刺激（DBS）对减轻APD患者服药负担的有效性。
方法
我们利用了2014年至2018年与CLES患者支持计划（PSP）数据相关联的100%医疗保险按服务收费索赔。CLES启动者（CLES-I）与未启动治疗（CLES-NI）（N = 188）或未接受DBS的PSP登记患者进行1:1倾向匹配，与接受DBS的患者进行1:3倾向匹配（N = 204，N = 612）。在基线、0 - 6个月和7 - 12个月随访时测量平均每日服药负担和左旋多巴等效日剂量（LEDD）。
结果
在基线时，CLES-I和CLES-NI的服药负担高于DBS患者。然而，在治疗后6个月，CLES-I的每日服药片数明显少于CLES-NI（4.7片对11.4片，p < 0.05）和DBS（4.8片对7.4片，p < 0.05）。在0 - 6个月（46.3%）和7 - 12个月（68.3%）随访时，CLES-I的服药负担显著降低（p < 0.001），而CLES-NI的负担增加（+10.5%，p < 0.05和 +8.2%，p > 0.05），DBS的负担降低不显著（-3.9%和 -6.1%，p > 0.05）。与CLES-NI相比，CLES-I在0 - 6个月和7 - 12个月时的平均调整后服药负担分别减少了57.3%和74.1%，与DBS相比分别减少了49.6%和70.1%。与基线相比，CLES-I在7 - 12个月时的LEDD有所下降（从935毫克降至237毫克），与CLES-NI（237毫克对1112毫克）和DBS患者（236毫克对594毫克）相比也是如此。
结论
与CLES-NI和DBS患者相比，CLES导致服药负担和口服LEDD显著降低。对于因干扰日常生活活动和生活质量的复杂联合药物治疗方案而面临挑战的APD患者，减轻服药负担可被视为一个治疗目标。
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