| 陈诗雅;李茜羽;张楚天;陈文洁;陈 茜;尹鹭峰;孙林娟;蔡 晶.苁蓉舒痉颗粒对帕金森病患者黑质代谢物影响随机对照研究[J].中国中西医结合杂志,2024,44(3):296-302 |
| 苁蓉舒痉颗粒对帕金森病患者黑质代谢物影响随机对照研究 |
| Effectiveness of Congrong Shujing Granules on Expression of Substantia Nigra Metabolites in Parkinson's Disease Patients：A Randomized Controlled Trial |
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| DOI： |
| 中文关键词: 帕金森病 补肾益髓 苁蓉舒痉颗粒 随机对照试验 黑质 中药复方 中西医结合 |
| 英文关键词:Parkinson's disease Bushen Yisui Formula CongrongShujing Granules randomized controlled trial Substantia Nigra Chinese herbal compound Integrative medicine |
| 基金项目:2023年中医医院老年病科建设项目（No.闽卫中医函〔2023〕810 号-7）;福建省2022年省级临床重点专科建设项目（No.闽卫医政函〔2022〕884 号）;重大新药创制科技重大专项（No.2019ZX09301154） |
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| 中文摘要: |
| 目的 评估苁蓉舒痉颗粒对帕金森病（PD）患者黑质代谢物影响的临床疗效及安全性。方法 采用双中心分层随机化的方法，两中心分别将符合入组标准的PD患者30例，随机分2组，观察组15例予苁蓉舒痉颗粒加基础西药治疗，对照组15例予中药安慰剂加基础西药治疗，疗程12周。治疗前后进行国际运动障碍学会帕金森病综合评定量表（MDS-UPDRS）评分、磁共振波谱检测、肌电图检查、39项帕金森病生活质量问卷（PDQ-39）、非运动症状评定量表（NMSS）评分，并检测血尿常规、肝肾功能、心电图，记录不良反应事件。结果 两中心意向性分析人群60例，安全性分析人群60例，磁共振波谱符合方案人群53例，肌电图符合方案人群45例。与本组治疗前比较，对照组治疗后MDS-UPDRSⅠ、PDQ-39及NMSS评分均降低（P＜0.05）；观察组治疗后MDS-UPDRS量表各部分评分及总分、PDQ-39与NMSS评分均降低，病轻侧黑质N-乙酰天冬氨酸/肌酸（NAA/Cr）值升高（P＜0.05）。与对照组同期比较，观察组治疗后MDS-UPDRSⅠ、MDS-UPDRS Ⅲ、PDQ-39及NMSS评分均降低，病轻侧黑质NAA/Cr值升高（P＜0.05）。治疗期间，对照组出现不良反应1例，观察后症状减轻至消失。与治疗前比较，所有患者的安全性指标无显著改变（P>0.05）。结论 苁蓉舒痉颗粒可改善PD患者的运动症状及非运动症状，提高生活质量，提高黑质神经元活性，其治疗PD具有较好的安全性。（中国临床试验注册中心No.ChiCTR2000034107） |
| 英文摘要: |
| Objective To evaluate the clinical efficacy and safety of Congrong Shujing Granules on substantia nigra metabolites in the treatment of Parkinson's disease（PD）. Methods According to the double-center stratified randomization，30 PD patients meeting the enrollment criteria were randomly divided into 2 groups，15 patients in the observation group were treated with Congrong Shujing Granules plus basic Western medicine，and 15 patients in the control group were treated with placebo plus basic Western medicine. The course of treatment lasted for 12 weeks.The scores of Movement Disorder Society- Unified Parkinson Disease Rating Scale（MDS-UPDRS），magnetic resonance spectroscopy（MRS），electromyography（EMG），39-item Parkinson's Disease Quality of Life Questionnaire（PDQ-39）and non-Motor Symptom Rating Scale（NMSS）were determined before and after treatment. Blood and urine routine，liver and kidney function，electrocardiogram were detected，and adverse events were recorded. Results There were 60 cases in ITT group，60 cases in safety group，53 cases of MRS Per-Protocol（PP）and 45 cases of EMG PP in the two centers. Compared with the same group before treatment，the MDS-UPDRSⅠ，PDQ-39 and NMSS scores were all reduced in the control group（P<0.05）. And in the observation group，the scores of each domain and total score of MDS-UPDRS scale，PDQ-39 and NMSS scores were all reduced，and the N-acetylaspartate/creatine（NAA/Cr）value in substantia nigra of mild side was increased（P<0.05）. Compared with the control group at the same time，MDS-UPDRSⅠ，MDS-UPDRSⅢ，PDQ-39 and NMSS scores were decreased，and the NAA/Cr value in substantia nigra of mild side was increased in the observation group（P<0.05）. During the treatment period，there was 1 case of adverse reaction in the control group，and the symptoms were reduced to disappear after observation. Compared with baseline，there was no significant change in the safety index of all patients（P>0.05）. Conclusions Congrong Shujing Granules can improve the motor symptoms and non-motor symptoms of PD patients，improve the quality of life，promote the proliferation of glial cells. It has good safety in the treatment of PD.（Chinese Clinical Trial Registry，No.ChiCTR2000034107） |
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