Gu Si-Chun, Ye Qing, Wang Chang-De, Zhao Shao-Rong, Zhou Jie, Gao Chen, Zhang Yu, Liu Zhen-Guo, Yuan Can-Xing
Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Department of Neurology, Shanghai TCM-integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Front Pharmacol. 2022 Feb 25;13:739194. doi: 10.3389/fphar.2022.739194. eCollection 2022.
Pingchan granule (PCG) is a traditional Chinese medicine for treating Parkinson's disease (PD). This study aimed at evaluating the efficacy and safety of PCG for motor and non-motor symptoms of PD. In this multicenter, randomized, double-blind, placebo-controlled trial, 292 participants with mild-to-moderate PD were included and followed for 36 weeks (24 week treatment, 12-week follow-up after intervention), randomly assigned at a 1:1 ratio to receive PCG or placebo. The primary outcomes included the severity of motor symptoms assessed by the Unified Parkinson's disease Rating Scale (UPDRS) part 3 (UPDRS-III) score and the rate of disease progression assessed by the total UPDRS score. Secondary outcomes included non-motor symptoms assessed using the Scale for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT), Parkinson's disease Sleep Scale (PDSS), 24-item Hamilton Rating Scale for Depression (HAM-D), Hamilton Rating Scale for Anxiety (HAM-A), UPDRS part 2 (UPDRS-II), and 39-item Parkinson's Disease Questionnaire (PDQ-39) scores. Assessments were done at baseline (T0), 12 weeks (T1), 24 weeks (T2), and 36 weeks (T3). Generalized estimating equation analyses revealed that the PCG group had significantly better improvement in UPDRS-III score at T1, T2, and T3 [time-by-group interaction, T1: β, -0.92 (95% CI, -1.59--0.25; = 0.01); T2: β, -2.08 (95% CI, -2.90--1.27; < 0.001); T3: β, -4.54 (95% CI, -5.37--3.71; < 0.001))]. The PCG group showed a greater decrease (rate of disease change) in the total UPDRS score between T0 and T2 [-2.23 (95% CI, -2.72--1.73; < 0.001) points per week vs -0.21 (95% CI, -0.80-0.39; = 0.50) points per week in the placebo group, < 0.001]. Ameliorations of SCOPA-AUT, PDSS, HAM-D, HAM-A, UPDRS-II, and PDQ-39 scores were also observed. PCG had a long-lasting and extensive symptomatic efficacy for both motor and non-motor symptoms of PD with good tolerance. Chinese Clinical Trial Register, ChiCTR-INR-17011949.
平颤颗粒（PCG）是一种用于治疗帕金森病（PD）的中药。本研究旨在评估平颤颗粒对帕金森病运动和非运动症状的疗效及安全性。在这项多中心、随机、双盲、安慰剂对照试验中，纳入了292例轻度至中度帕金森病患者，并随访36周（24周治疗期，干预后12周随访期），按1:1比例随机分配接受平颤颗粒或安慰剂。主要结局包括通过统一帕金森病评定量表（UPDRS）第3部分（UPDRS-III）评分评估的运动症状严重程度以及通过UPDRS总分评估的疾病进展率。次要结局包括使用帕金森病自主神经功能结局量表（SCOPA-AUT）、帕金森病睡眠量表（PDSS）、24项汉密尔顿抑郁量表（HAM-D）、汉密尔顿焦虑量表（HAM-A）、UPDRS第2部分（UPDRS-II）和39项帕金森病问卷（PDQ-39）评分评估的非运动症状。在基线（T0）、12周（T1）、24周（T2）和36周（T3）进行评估。广义估计方程分析显示，平颤颗粒组在T1、T2和T3时UPDRS-III评分有显著更好的改善[时间-组交互作用，T1：β，-0.92（95%CI，-1.59--0.25；P = 0.01）；T2：β，-2.08（95%CI，-2.90--1.27；P < 0.001）；T3：β，-4.54（95%CI，-5.37--3.71；P < 0.001）]。平颤颗粒组在T0至T2期间UPDRS总分的下降幅度更大（疾病变化率）[-2.23（95%CI，-2.72--1.73；P < 0.001）分/周，而安慰剂组为-0.21（95%CI，-0.80 - 0.39；P = 0.50）分/周，P < 0.001]。还观察到SCOPA-AUT、PDSS、HAM-D、HAM-A、UPDRS-II和PDQ-39评分的改善。平颤颗粒对帕金森病的运动和非运动症状均具有持久且广泛的症状疗效，耐受性良好。中国临床试验注册中心，ChiCTR-INR-17011949。
