天奇平衡颗粒治疗帕金森病左旋多巴诱导运动障碍的疗效和安全性：一项随机、双盲、安慰剂对照试验。

Efficacy and safety of Tianqi Pingchan Granule, a compound Chinese herbal medicine, for levodopa-induced dyskinesia in Parkinson's disease: A randomized double-blind placebo-controlled trial.

机构信息

Department of Neurology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China.

Department of Neurology, Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing 210022, Jiangsu Province, China.

出版信息

J Integr Med. 2024 Sep;22(5):545-551. doi: 10.1016/j.joim.2024.07.002. Epub 2024 Jul 9.

DOI:10.1016/j.joim.2024.07.002

PMID:39060125

Abstract

BACKGROUND

Patients with Parkinson's disease (PD) undergoing long-term levodopa therapy are prone to develop levodopa-induced dyskinesia (LID). Amantadine is the main drug recommended for the treatment of LID by current guidelines, but it is far from meeting clinical needs. Tianqi Pingchan Granule (TPG), a compound Chinese herbal medicine, has been developed to relieve symptom of LID.

OBJECTIVE

This randomized controlled trial evaluated the efficacy and safety of the combination of TPG and amantadine for LID.

DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This is a randomized double-blind placebo-controlled trial, conducted from January 2020 to August 2021 at 6 sites in Jiangsu, Zhejiang and Shanghai, China. One hundred PD patients with ≥ 0.5 h of LID were randomly assigned to either the TPG plus amantadine group (TPG group) or the placebo plus amantadine group (placebo group), and treated for a period of 12 weeks. To ensure unbiased results, all study participants, investigators and sponsors were unaware of group allocations. Additionally, the data analysts remained blinded until the analysis was finalized.

MAIN OUTCOME MEASURES

The primary outcome was assessed using the Unified Dyskinesia Rating Scale (UDysRS) (Range 0-104). The key secondary end point was improvement of motor and non-motor symptoms. Safety analyses included all enrolled patients.

RESULTS

One hundred patients were enrolled and randomized into the two treatment groups. The changes in UDysRS at week 12 were -11.02 for the TPG group and -4.19 for the placebo group (treatment difference -6.83 [-10.53 to -3.12]; P = 0.0004). Adverse events were reported for 2 of 50 patients (4.0%) in each of the groups.

CONCLUSION

This study indicated that a 12-week treatment of amantadine plus TPG effectively reduced UDysRS scores and was well tolerated, demonstrating the efficacy and safety of TPG for the treatment of LID in PD.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT04173832.

PLEASE CITE THIS ARTICLE AS

Zhang Y, Zhu XB, Zhao Y, Cui GY, Li WT, Yuan CX, Huang JP, Wan Y, Wu N, Song L, Zhao JH, Liang Y, Xu CY, Liu MJ, Gao C, Chen XX, Liu ZG. Efficacy and safety of Tianqi Pingchan Granule, a compound Chinese herbal medicine, for levodopa-induced dyskinesia in Parkinson's disease: A randomized double-blind placebo-controlled trial. J Integr Med. 2024; 22(5): 545-551.

摘要

背景

帕金森病（PD）患者长期接受左旋多巴治疗后易发生左旋多巴诱导的运动障碍（LID）。目前的指南推荐金刚烷胺作为治疗 LID 的主要药物，但远不能满足临床需求。天奇平颤颗粒（TPG）是一种复方中药，已被开发用于缓解 LID 症状。

目的

本随机对照试验评估了 TPG 联合金刚烷胺治疗 LID 的疗效和安全性。

设计、地点、参与者和干预措施：这是一项随机、双盲、安慰剂对照试验，于 2020 年 1 月至 2021 年 8 月在江苏、浙江和上海的 6 个地点进行。100 例 LID 时间≥0.5 h 的 PD 患者被随机分配至 TPG 联合金刚烷胺组（TPG 组）或安慰剂联合金刚烷胺组（安慰剂组），并接受为期 12 周的治疗。为了确保结果无偏，所有研究参与者、研究者和赞助商均不了解分组情况。此外，数据分析人员在分析完成之前保持盲态。