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互动式头皮电针对脑卒中后认知功能、抑郁和焦虑的影响:一项多中心、随机、对照试验。

Effect of Interactive Dynamic Scalp Acupuncture on Post-Stroke Cognitive Function, Depression, and Anxiety: A Multicenter, Randomized, Controlled Trial.

机构信息

Department of Rehabilitation Medicine, Dapeng New District Nan'ao People's Hospital, Shenzhen, Guangdong Province, 518121, China.

Department of Rehabilitation Medicine, Shenzhen Second People's Hospital, Shenzhen, Guangdong Province, 518037, China.

出版信息

Chin J Integr Med. 2022 Feb;28(2):106-115. doi: 10.1007/s11655-021-3338-1. Epub 2021 Dec 7.

Abstract

OBJECTIVE

To compare the clinical effects of interactive dynamic scalp acupuncture (IDSA), simple combination therapy (SCT), and traditional scalp acupuncture (TSA) on cognitive function, depression and anxiety in patients with post-stroke cognitive impairment.

METHODS

A total of 660 patients with post-stroke cognitive impairment who were admitted to 3 hospitals in Shenzhen City between May 2017 and May 2020 were recruited and randomly assigned to the IDSA (218 cases), SCT (222 cases) and TSA groups (220 cases) according to a random number table. All the patients received conventional drug therapy for cerebral stroke and exercise rehabilitation training. Scalp acupuncture and computer-based cognitive training (CBCT) were performed simultaneously in the IDSA group, but separately in the morning and in the afternoon in the SCT group. The patients in the TSA group underwent scalp acupuncture only. The course of treatment was 8 weeks. Before treatment (M0), 1 (M1) and 2 months (M2) after treatment, as well as follow-up at 1 (M3) and 2 months (M4), the cognitive function of patients was assessed using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment Scale (MoCA) Scales; depression, anxiety, sleep quality, and self-care ability of patients were assessed using Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), Pittsburgh Sleep Quality Index (PSQI), and Modified Barthel Index (MBI), respectively. During this trial, all adverse events (AEs) were accurately recorded.

RESULTS

There were no significant differences in the MMSE, MoCA, HAMD, HAMA, PSQI, and MBI scores among the 3 groups at M0 (all P>0.05). In the IDSA group, the MMSE, MoCA and MBI scores from M2 to M4 were significantly higher than those in the SCT and TSA groups, while the HAMD, HAMA and PSQI scores were significantly reduced (all P<0.01). The changes of all above scores (M2-M0, M4-M0) were significantly superior to those in the SCT and TSA groups (all P<0.01, except M4-M0 of HAMD). At M2, the severity of MMSE, HAMD, HAMA, PSQI and MBI in the IDSA group was significantly lower than that in the SCT and TSA groups (all P<0.01). There was no serious AE during this trial.

CONCLUSIONS

IDSA can not only significantly improve cognitive function, but also reduce depression, anxiety, which finally improves the patient's self-care ability. The effect of IDSA was significantly better than SCT and TSA. (Trial registration No. ChiCTR1900027206).

摘要

目的

比较互动式动态头皮针刺(IDSA)、单纯联合治疗(SCT)和传统头皮针刺(TSA)对脑卒中后认知障碍患者认知功能、抑郁和焦虑的临床疗效。

方法

2017 年 5 月至 2020 年 5 月,深圳市 3 家医院共纳入 660 例脑卒中后认知障碍患者,按随机数字表法分为 IDSA 组(218 例)、SCT 组(222 例)和 TSA 组(220 例)。所有患者均接受常规脑卒中药物治疗和运动康复训练。IDSA 组同时进行头皮针刺和基于计算机的认知训练(CBCT),SCT 组上午和下午分别进行头皮针刺和 CBCT,TSA 组仅进行头皮针刺。疗程 8 周。治疗前(M0)、治疗后 1 个月(M1)、2 个月(M2)、随访 1 个月(M3)、2 个月(M4)时,采用简易精神状态检查量表(MMSE)和蒙特利尔认知评估量表(MoCA)评估患者认知功能;采用汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)、匹兹堡睡眠质量指数(PSQI)和改良巴氏指数(MBI)评估患者抑郁、焦虑、睡眠质量和自我护理能力。试验期间,准确记录所有不良事件(AE)。

结果

3 组患者 M0 时 MMSE、MoCA、HAMD、HAMA、PSQI、MBI 评分比较,差异均无统计学意义(均 P>0.05)。IDSA 组 M2 至 M4 时 MMSE、MoCA、MBI 评分均高于 SCT 组和 TSA 组,HAMD、HAMA、PSQI 评分均低于 SCT 组和 TSA 组(均 P<0.01)。与 SCT 组和 TSA 组比较,IDSA 组各时间点 MMSE、MoCA、MBI 评分差值[(M2-M0)、(M4-M0)]及 HAMD、HAMA、PSQI 评分差值[(M2-M0)、(M4-M0)]均显著增大(均 P<0.01,除 HAMD 时 M4-M0 评分外)。M2 时,IDSA 组 MMSE、HAMD、HAMA、PSQI、MBI 评分严重程度均低于 SCT 组和 TSA 组(均 P<0.01)。试验期间未发生严重 AE。

结论

IDSA 不仅能显著改善认知功能,还能减轻抑郁、焦虑,最终提高患者自我护理能力,其疗效优于 SCT 和 TSA。(临床试验注册号:ChiCTR1900027206)

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