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随机对照试验:超声与运动对强直性脊柱炎患者的疗效

Randomized, Controlled Trial: Efficacy of Ultrasound and Exercise in Patients With Ankylosing Spondylitis.

作者信息

Sun Ying-Yan, Cui Hu-Jun, Dong Jia-Nan, Sun Ping, Meng Qing-Xin

出版信息

Altern Ther Health Med. 2018 Jul;24(4):30-34.

PMID:29477133
Abstract

CONTEXT

The aim in treating ankylosing spondylitis (AS) is to reduce patients' symptoms, including pain, stiffness, and fatigue; to correct their posture; and to improve their quality of life. Currently, no definitive therapy is available for treating AS. Previous studies have reported positive results regarding the efficacy of exercise.

OBJECTIVE

This study aimed to assess the efficacy of ultrasound, combined with exercise, in patients with AS.

DESIGN

The research team designed a randomized, double-blind, 2-arm parallel-group, placebo-controlled trial.

SETTING

The study took place at the Affiliated Hongqi Hospital of Mudanjiang Medical University (Mudanjiang, China).

PARTICIPANTS

Participants were 62 individuals with AS who were patients at the hospital.

INTERVENTION

Participants were randomly assigned to one of 2 groups: (1) the intervention group, who received exercise and ultrasound therapy; or (2) the control group, who received exercise and placebo ultrasound therapy, without an active probe, both for 8 wk.

OUTCOME MEASURES

The outcome measures included (1) the numerical rating scale (NRS), (2) the Bath ankylosing spondylitis metrology index (BASMI), (3) the Bath ankylosing spondylitis disease activity index (BASDAI), (4) the Bath ankylosing spondylitis functional index (BASFI), and (5) the ankylosing spondylitis quality of life (ASQoL) questionnaire. All outcomes were measured at baseline and at the end of 4 and 8 wk of treatment.

RESULT

Fifty-seven patients fulfilled the requirements of the study. Ultrasound and exercise therapy showed greater efficacy than the placebo ultrasound and exercise in decreasing the scores for the NRS, daily and at night; the BASMI; the BASDAI; the BASFI; and the ASQoL, at the end of both 4 and 8 wk of treatment. No adverse events were noted in either group.

CONCLUSIONS

The study demonstrated that 8 wk of ultrasound and exercise therapy was efficacious in patients with AS.

摘要

背景

治疗强直性脊柱炎(AS)的目的是减轻患者症状,包括疼痛、僵硬和疲劳;纠正姿势;提高生活质量。目前,尚无明确的AS治疗方法。既往研究报道了运动疗法的积极效果。

目的

本研究旨在评估超声联合运动对AS患者的疗效。

设计

研究团队设计了一项随机、双盲、双臂平行组、安慰剂对照试验。

地点

研究在牡丹江医学院附属红旗医院(中国牡丹江)进行。

参与者

参与者为62例在该医院就诊的AS患者。

干预措施

参与者被随机分为两组:(1)干预组,接受运动和超声治疗;(2)对照组,接受运动和无活性探头的安慰剂超声治疗,均为期8周。

观察指标

观察指标包括:(1)数字评分量表(NRS);(2)巴斯强直性脊柱炎测量指数(BASMI);(3)巴斯强直性脊柱炎疾病活动指数(BASDAI);(4)巴斯强直性脊柱炎功能指数(BASFI);(5)强直性脊柱炎生活质量(ASQoL)问卷。所有指标在基线、治疗4周和8周结束时进行测量。

结果

57例患者符合研究要求。在治疗4周和8周结束时,超声联合运动疗法在降低NRS日间和夜间评分、BASMI、BASDAI、BASFI及ASQoL方面,比安慰剂超声联合运动疗法更有效。两组均未观察到不良事件。

结论

该研究表明,8周的超声联合运动疗法对AS患者有效。

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It is time for an organised, scientific approach to the application of patient-reported outcome measures in clinical studies and trials.
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