1.郑州大学第二附属医院,河南省郑州市金水区经八路2号,450014
2.河南中医药大学
3.首都医科大学附属北京中医医院
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收稿:2024-08-26,
修回:2025-04-16,
纸质出版:2025-07-17
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朱敬云,高希言,王琳琳等.针刺联合左旋多巴治疗帕金森病临床疗效和安全性的随机对照试验[J].中医杂志,2025,66(14):1456-1462.
ZHU Jingyun,GAO Xiyan,WANG Linlin,et al.Efficacy and Safety of Acupuncture Combined with Levodopa in the Treatment of Parkinson's Disease: A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2025,66(14):1456-1462.
朱敬云,高希言,王琳琳等.针刺联合左旋多巴治疗帕金森病临床疗效和安全性的随机对照试验[J].中医杂志,2025,66(14):1456-1462. DOI: 10.13288/j.11-2166/r.2025.14.009.
ZHU Jingyun,GAO Xiyan,WANG Linlin,et al.Efficacy and Safety of Acupuncture Combined with Levodopa in the Treatment of Parkinson's Disease: A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2025,66(14):1456-1462. DOI: 10.13288/j.11-2166/r.2025.14.009.
目的
2
评价针刺联合左旋多巴治疗帕金森病(PD)的临床疗效和安全性。
方法
2
纳入60例PD患者,随机分为试验组和对照组,每组30例。对照组接受左旋多巴治疗,初始剂量为每次100 mg,每日3次,逐渐增加至每日最大剂量不超过800 mg;试验组在左旋多巴治疗基础上,接受每周3次的针刺治疗,取穴百会、头部舞蹈震颤区及双侧合谷、太冲。两组均治疗12周。分别在治疗前及治疗6周、12周对患者进行统一帕金森病评分量表(UPDRS)、剂末现象-9项问卷(WOQ-9)、蒙特利尔认知评估量表(MoCA)、简易智力状态检查量表(MMSE)、抑郁评定量表(DRS)、汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)、帕金森病生活质量问卷(PDQ-39)和匹兹堡睡眠质量指数(PSQI)评价。采用重复测量方差分析评估各指标的时间、组别及交互作用方面的影响,同时采用相关分析方法评估各评分与联合治疗的相关性。研究期间记录两组不良事件发生情况。
结果
2
与本组治疗前比较,两组在治疗6周和12周的UPDRS总分、WOQ-9总分、DRS评分、HAMD评分、HAMA评分、PDQ-39评分及PSQI评分均降低,而MoCA和MMSE评分升高(
P
<0.05)。与对照组比较,试验组在治疗6周和12周后UPDRS总分、WOQ-9总分、DRS评分、HAMD评分、HAMA评分、PDQ-39评分及PSQI评分均降低,MoCA和MMSE评分升高(
P
<0.05)。重复测量方差分析表明,所有评估指标在时间主效应、组别主效应以及时间与组别的交互作用上均具有统计学意义(
P
<0.01)。Spearman相关分析显示,联合治疗与治疗12周的UPDRS、WOQ-9、DRS、HAMD、HAMA、PDQ-39和PSQI评分呈负相关,而与MoCA和MMSE评分呈正相关(
P
<0.05)。两组均未发生严重不良事件,未影响治疗。
结论
2
在改善运动功能、非运动症状、认知功能、抑郁和焦虑、生活质量及睡眠质量方面,针刺联合左旋多巴的治疗效果优于单纯口服左旋多巴,且安全性较好。
Objective
2
To evaluate the clinical efficacy and safety of acupuncture combined with levodopa in the treatment of Parkinson's disease(PD).
Methods
2
A total of 60 patients with PD were enrolled and randomly assigned to test group or control group, with 30 patients in each group. The control group received levodopa only, starting at 100 mg per dose, three times daily, with gradual increases not exceeding a maximum daily dose of 800 mg. The test group received acupuncture three times per week in addition to levodopa. Both groups were treated for 12 weeks. Assessments were conducted before treatment, after 6 and 12 weeks treatment, using the Unified Parkinson's Disease Rating Scale(UPDRS), Wearing-Off Questionnaire-9(WOQ-9), Montreal Cognitive Assessment(MoCA), Mini-Mental State Examination(MMSE), Depression Rating Scale(DRS), Hamilton Depression Scale(HAMD), Hamilton Anxiety Scale(HAMA), PD Questionnaire-39(PDQ-39), and Pittsburgh Sleep Quality Index(PSQI). Repeated measures ANOVA was utilized to evaluate the effects of time, group, and their interaction on each index. Spearman correlation analysis was conducted to examine the relationships between combined treatment and outcome scores. Adverse events in both groups were recorded throughout the study.
Results
2
Both groups showed significant improvemen
ts after 6 and 12 weeks treatment, with decreases in UPDRS total score, WOQ-9 total score, DRS score, HAMD score, HAMA score, PDQ-39 score, and PSQI score, and increases in MoCA and MMSE scores(
P
<0.05). Compared with the control group, the test group demonstrated significantly greater improvements in all the above indicators after 6 and 12 weeks (
P
<0.05). Repeated measures ANOVA showed significant time main effects, group main effects, and their interaction across all outcome measures(
P
<0.01). Spearman correlation analysis revealed that combined therapy was significantly negatively correlated with UPDRS, WOQ-9, DRS, HAMD, HAMA, PDQ-39, and PSQI scores, while positively correlated with MoCA and MMSE scores after 12 weeks of treatment(
P
<0.05). Both groups did not experience any serious adverse events and did not affect treatment.
Conclusion
2
Acupuncture combined with levodopa is more effective than levodopa alone in improving motor function, non-motor symptoms, cognitive function, depression and anxiety, quality of life, and sleep quality in patients with PD, with good safety.
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