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

扫码查看

原文链接

万方数据

外文摘要：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 treat-ment 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 symp-toms.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.

外文关键词：

Parkinson's diseaseTianqi Pingchan GranuleLevodopa-induced dyskinesia

作者：

Yu Zhang、Xiao-bo Zhu、Yang Zhao、Gui-yun Cui、Wen-tao Li、Can-xing Yuan、Jian-ping Huang、Ying Wan、Na Wu、Lu Song、Jia-hao Zhao、Yan Liang、Chuan-ying Xu、Mei-juan Liu、Chen Gao、Xin-xin Chen、Zhen-guo Liu

展开 >

作者单位：

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

Parkinson's Disease Center,the Affiliated Hospital of Xuzhou Medical University,Xuzhou 221004,Jiangsu Province,China

Department of Neurology,Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China

Department of Neurology,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China

Department of Neurology,Wenzhou Central Hospital,Wenzhou 325000,Zhejiang Province,China

展开 >

出版年：

2024

DOI：

10.1016/j.joim.2024.07.002

结合医学学报(英文版)

上海市中西医结合学会,上海长海医院

结合医学学报(英文版)

CSTPCD

影响因子：0.711

ISSN：2095-4964

年,卷(期)：2024.22(5)