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  

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 

机构地区：[1]Department of Neurology,Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200092,China [2]Department of Neurology,Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine,Nanjing 210022,Jiangsu Province,China [3]Parkinson’s Disease Center,the Affiliated Hospital of Xuzhou Medical University,Xuzhou 221004,Jiangsu Province,China [4]Department of Neurology,Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China [5]Department of Neurology,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China [6]Department of Neurology,Wenzhou Central Hospital,Wenzhou 325000,Zhejiang Province,China

出　　处：《Journal of Integrative Medicine》2024年第5期545-551,共7页结合医学学报（英文版）

基　　金：supported by the National Key R&D Program of China(No.2017YFC1310300);National Natural Science Foundation of China(No.81974173,82171242);Pilot Project of Clinical Cooperation Between Chinese and Western Medicine in Shanghai(No.ZXYXZ-201907).

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 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.

关 键 词：Parkinson’s disease Tianqi Pingchan Granule Levodopa-induced dyskinesia 

分 类 号：R277.7[医药卫生—中医学]