首页|期刊导航|中国针灸|经皮耳穴迷走神经刺激治疗原发性帕金森病:随机对照单盲试验

经皮耳穴迷走神经刺激治疗原发性帕金森病:随机对照单盲试验OA

Transcutaneous auricular vagus nerve stimulation in treatment of primary Parkinson's disease:a randomized,controlled,single-blind trial

中文摘要英文摘要

目的:观察经皮耳穴迷走神经刺激(taVNS)对原发性帕金森病(PD)自主神经症状和运动症状的治疗效果.方法:将60例原发性PD患者随机分为观察组30例(剔除1例、脱落1例)和对照组30例(剔除 4例、脱落1例).两组患者予口服复方左旋多巴治疗,若入组时已服用复方左旋多巴类以外的抗PD药物,维持入组前用药方案,连续治疗 8 周.观察组使用SDZ-ⅡB型电子针疗仪对耳甲区(每次取单侧,两耳交替进行)进行taVNS治疗,选择脉冲频率4 Hz/20 Hz疏密波,电流5~10 mA,每次30 min,每周治疗3次,至少隔天进行,共治疗8周.对照组对耳舟区进行脉冲刺激治疗,操作、疗程均同观察组.于治疗前和治疗后,观察两组原发性帕金森病自主神经症状量表(SCOPA-AUT)评分、世界运动障碍协会修订版帕金森病综合评价量表(MDS-UPDRS)-Ⅲ/Ⅱ评分、中医老年颤证功能障碍评分、改良H-Y分级、帕金森患者生活质量调查量表(PDQ-39)评分,并于治疗后进行安全性评价.结果:治疗后,观察组患者 SCOPA-AUT、MDS-UPDRS-Ⅲ/Ⅱ、中医老年颤证功能障碍评分和 PDQ-39评分均较治疗前降低(P<0.001,P<0.05);对照组PDQ-39 评分较治疗前升高(P<0.05),其余指标治疗前后比较差异无统计学意义(P>0.05);两组患者 H-Y 分级治疗后比较差异无统计学意义(P>0.05).观察组患者SCOPA-AUT、MDS-UPDRS-Ⅱ、中医老年颤证功能障碍评分和 PDQ-39 评分降低幅度均大于对照组(P<0.001).两组未见明显不良反应.结论:taVNS辅助复方左旋多巴治疗可以改善原发性PD患者的自主神经症状和运动症状,提高其日常生活质量,且无不良反应.

Objective To explore the therapeutic effect of transcutaneous auricular vagus nerve stimulation(taVNS)on autonomic and motor symptoms in primary Parkinson's disease(PD).Methods A total of 60 patients with primary PD were randomly divided into an observation group(30 cases,1 case excluded and 1 case dropped out)and a control group(30 cases,4 cases excluded and 1 case dropped out).The patients of the two groups received the oral administration of compound levodopa.If the patients had taken the other anti-PD drugs except compound levodopa preparations before enrolled,the original medication regimen was remained.The treatment lasted 8 weeks.In the observation group,the taVNS was delivered with SDZ-ⅡB type electric acupuncture instrument attached to the concha unilaterally and alternatively,at the frequency of 4 Hz/20 Hz and disperse-dense wave,and at the electric current of 5 mA to 10 mA,for 30 min each time.The taVNS was given 3 times a week,at least once every two days and for 8 weeks.In the control group,the pulse stimulation was given at the scapha,the operation and duration of treatment were the same as the observation group.The scores were observed for the scale for outcomes in Parkinson's disease-autonomic symptoms(SCOPA-AUT),part Ⅲ/Ⅱof Movement Disorder Society-unified Parkinson's disease rating scale(MDS-UPDRS-Ⅲ,MDS-UPDRS-Ⅱ),the geriatric tremor syndrome in TCM,the modified Hoehn-Yahr(H-Y)rate,and Parkinson's disease quality of life questionnaire(PDQ-39)before and after treatment;and the safety of treatment was evaluated after treatment in the two groups.Results After treatment,the scores of SCOPA-AUT,MDS-UPDRS-Ⅲ,MDS-UPDRS-Ⅱ,geriatric tremor syndrome of TCM and PDQ-39 were all lower than those before treatment in the observation group(P<0.001,P<0.05);PDQ-39 score was higher in the control group compared with that before treatment(P<0.05),and the other indexes did not show the statistical differences(P>0.05).There was no difference in H-Y rate after treatment between the two groups(P>0.05).In the observation group,the reduction ranges of SCOPA-AUT,MDS-UPDRS-Ⅱ,geriatric tremor syndrome of TCM and PDQ-39 scores were larger when compared with the control group(P<0.001).The obvious adverse reactions were not presented in the two groups.Conclusion The taVNS,as an adjunctive therapy to medication with compound levodopa,can attenuate the autonomic and motor symptoms of the patients with primary PD and improve the daily quality of life without adverse reactions.

余泽程;李哲;周志成;郑春叶;苏巧珍;侯小燕;雒晓东;刘梓言;蓝晓艳;王利军

广州中医药大学深圳医院(福田)脑病科,广东 深圳 518034广州中医药大学第二附属医院,广东 广州 510120深圳市中西医结合医院广州中医药大学第二附属医院,广东 广州 510120广州中医药大学第二附属医院,广东 广州 510120广州中医药大学第二附属医院,广东 广州 510120广州中医药大学第二附属医院,广东 广州 510120佛山市中医院河源市人民医院广州中医药大学深圳医院(福田)脑病科,广东 深圳 518034

原发性帕金森病经皮耳穴迷走神经刺激自主神经症状运动症状耳穴随机对照试验

primary Parkinson's diseasetranscutaneous auricular vagus nerve stimulationautonomic symptomsmotor symptomsauricular pointsrandomized controlled trial(RCT)

《中国针灸》 2026 (2)

168-175,8

国家自然科学基金青年项目:82004459国家中医药管理局高水平中医药重点学科建设项目:zyyzdxk-2023154广东省中医药局中医药科研项目:20221160、20241130广东省中医院朝阳人才科研专项资助项目:ZY2022KY09广东省中医院名中医药专家学术经验传承工作室建设项目

10.13703/j.0255-2930.20241116-0002

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