高剂量与低剂量吸入左旋多巴（CVT-301）治疗帕金森病患者的OFF 期：随机对照试验的荟萃分析。
High-dose versus low-dose inhaled levodopa (CVT-301) in patients with Parkinson disease for the treatment of OFF episodes: a meta-analysis of randomized controlled trials.
机构信息
Department of Neurosurgery & Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, 188 Shizi Street, Suzhou, 215006, Jiangsu Province, China.
Department of Neurosurgery, The First People's Hospital of Taicang City, Taicang Affiliated Hospital of Soochow University, Suzhou, 215400, Jiangsu Province, China.
出版信息
Neurol Sci. 2022 Nov;43(11):6233-6241. doi: 10.1007/s10072-022-06298-z. Epub 2022 Jul 30.
BACKGROUND
Levodopa is the most commonly used first-line drug for Parkinson's disease. However, during the period of medication, the generation of motor fluctuations affects the life quality of patients. CVT-301, as an inhaled levodopa for the treatment of OFF episodes, rose in response to this condition.
METHODS
We systematically searched Medline, EMBASE, Cochrane Library, and Clinicaltrials.gov for relevant randomized controlled trials, from the earliest available date to February 12, 2022, to evaluate the efficacy of high and low dose of inhaled levodopa in patients with Parkinson's disease.
RESULTS
A total of six multicenter, randomized controlled trials with 1166 patients were included. Compared with placebo, CVT-301 has a statistically significant effect on the treatment of Parkinson's patients with OFF episodes of medication interval. The UPDRS Part III score decreased more significantly in the high-dose group 30 minutes after administration than the low-dose group (WMD = - 4.51; 95% CI, - 7.34 to - 1.68; p = 0.002). More patients in the high-dose group achieved and maintained an on state up to 60 min after receiving study medication (RR = 1.17; 95% CI, 1.08 to 1.27; p < 0.001). And more patients were proved with improved PGIC scores in the high-dose group (RR = 1.13; 95% CI, 1.05 to 1.21; p = 0.001).
CONCLUSIONS
High doses CVT-301 can improve the motor function of the patient to some extent. There seems no risk of increasing adverse reactions.
背景
左旋多巴是治疗帕金森病最常用的一线药物。然而，在用药期间，运动波动的产生会影响患者的生活质量。CVT-301 作为一种治疗“OFF 期”的吸入性左旋多巴应运而生。
方法
我们系统地检索了 Medline、EMBASE、Cochrane 图书馆和 Clinicaltrials.gov 中相关的随机对照试验，检索时间从最早可获得日期到 2022 年 2 月 12 日，以评估高、低剂量吸入性左旋多巴治疗帕金森病患者的疗效。
结果
共纳入 6 项多中心、随机对照试验，共 1166 例患者。与安慰剂相比，CVT-301 对治疗帕金森病患者的药物间隔“OFF 期”具有统计学意义。高剂量组给药后 30 分钟 UPDRS 第 III 部分评分较低剂量组下降更为明显（WMD= −4.51；95%CI，−7.34 至−1.68；p=0.002）。更多高剂量组患者在接受研究药物治疗后 60 分钟内达到并维持“ON”状态（RR=1.17；95%CI，1.08 至 1.27；p<0.001）。更多高剂量组患者的 PGIC 评分改善（RR=1.13；95%CI，1.05 至 1.21；p=0.001）。
结论
高剂量 CVT-301 可在一定程度上改善患者的运动功能，且似乎不会增加不良反应的风险。
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