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针刺对缺血性脑卒中恢复的疗效:中国多中心随机对照试验

Acupuncture efficacy on ischemic stroke recovery: multicenter randomized controlled trial in China.

作者信息

Zhang Shihong, Wu Bo, Liu Ming, Li Ning, Zeng Xianrong, Liu Hua, Yang Qingcheng, Han Zhao, Rao Ping, Wang Dong

机构信息

From the Department of Neurology (S.Z., B.W., M.L.) and Department of Acupuncture and Moxibustion (N.L.), West China Hospital, State Key Laboratory of Biotherapy and Cancer Center, Sichuan University, Chengdu, Sichuan Province, China; Department of Neurology (X.Z.), the People's Hospital of Sichuan province, Chengdu, Sichuan Province, China; Department of Neurology (H.L.), the Second Clinical Medical College of North Sichuan Medical College and Nanchong Central Hospital, Nanchong, China; Department of Neurology (Q.Y.), the People's Hospital of Anyang City, Anyang, Henan Province, China; Department of Neurology (Z.H.), the first Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang Province, China; Department of Neurology (P.R.), the First People's Hospital of Chengdu City, Chengdu, Sichuan Province, China; and the Department of Neurology (D.W.), the Third Affiliated Hospital of Neimenggu Medical College, Baotou, Neimenggu Autonomous Region, China.

出版信息

Stroke. 2015 May;46(5):1301-6. doi: 10.1161/STROKEAHA.114.007659. Epub 2015 Apr 14.

DOI:10.1161/STROKEAHA.114.007659
PMID:25873601
Abstract

BACKGROUND AND PURPOSE

Acupuncture is a frequently used complementary treatment for ischemic stroke in China but the evidence available from previous randomized trials is inconclusive. The objective of this study was to assess the efficacy and safety of acupuncture in a more robustly designed larger scale trial.

METHODS

This is a multicenter, single-blinded, randomized controlled trial. Eight hundred sixty-two hospitalized patients with limb paralysis between 3 to 10 days after ischemic stroke onset were allocated acupuncture plus standard care or standard care alone. The acupuncture was applied 5 times per week for 3 to 4 weeks. The primary outcomes were defined as follows: (1) death/disability according to Barthel index and (2) death/institutional care at 6 months.

RESULTS

There was a tendency of fewer patients being dead or dependent in acupuncture group (80/385, 20.7%) than in control group (102/396, 25.8%) at 6 months (odds ratio, 0.75; 95% confidence interval, 0.54-1.05). The benefit was noted in subgroup receiving ≥10 sessions of acupuncture (odds ratio, 0.68; 95% confidence interval, 0.47-0.98). There was no statistical difference in death or institutional care between the 2 groups (odds ratio, 1.06; 95% confidence interval, 0.63-1.79). Severe adverse events occurred in 7.6% and 8.3% of patients in the 2 groups, respectively.

CONCLUSIONS

Acupuncture seemed to be safe in the subacute phase of ischemic stroke. If the potential benefits observed are confirmed in future larger study, the health gain from wider use of the treatment could be substantial.

CLINICAL TRIAL REGISTRATION

URL: http://www.chictr.org/en/. Unique identifier: ChiCTR-TRC-11001353.

摘要

背景与目的

在中国,针灸是缺血性脑卒中常用的辅助治疗方法,但既往随机试验提供的证据尚无定论。本研究的目的是在一项设计更完善、规模更大的试验中评估针灸的疗效和安全性。

方法

这是一项多中心、单盲、随机对照试验。862例缺血性脑卒中发病后3至10天住院的肢体瘫痪患者被随机分为针灸联合标准治疗组或单纯标准治疗组。针灸每周进行5次,共3至4周。主要结局定义如下:(1)根据Barthel指数评定的死亡/残疾情况;(2)6个月时的死亡/机构照料情况。

结果

6个月时,针灸组死亡或依赖的患者人数(80/385,20.7%)有少于对照组(102/396,25.8%)的趋势(优势比,0.75;95%置信区间,0.54 - 1.05)。在接受≥10次针灸治疗的亚组中观察到了这种益处(优势比,0.68;95%置信区间,0.47 - 0.98)。两组在死亡或机构照料方面无统计学差异(优势比,1.06;95%置信区间,0.63 - 1.79)。两组分别有7.6%和8.3%的患者发生严重不良事件。

结论

在缺血性脑卒中的亚急性期,针灸似乎是安全的。如果未来更大规模的研究证实了所观察到的潜在益处,那么更广泛地使用该治疗方法可能会带来显著的健康收益。

临床试验注册

网址:http://www.chictr.org/en/。唯一标识符:ChiCTR - TRC - 11001353。

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