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亚甲蓝治疗腰椎小关节综合征的临床效果及安全性。

Clinical Effects and Safety of the Use of Methylene Blue for the Treatment of Lumbar Facet Joint Syndrome.

机构信息

Department of Pain, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.

出版信息

Pain Physician. 2022 Jan;25(1):E15-E26.

PMID:35051142
Abstract

BACKGROUND

Lumbar facet joint syndrome (LFJS) has been suggested to be a main source of low back pain. Methylene blue (MB), an inhibitor of nitric oxide synthesis with potential analgesic and anti-inflammatory properties, has been widely applied for a variety of pain-related diseases. However, no studies have been conducted on the treatment of LFJS patients using MB.

OBJECTIVES

The purpose of this study was to evaluate the therapeutic effects of intra-articular injection of MB on LFJS patients.

STUDY DESIGN

A prospective, randomized, controlled clinical trial.

SETTING

Department of pain, Shanghai East Hospital.

METHODS

A total of 120 eligible patients with LFJS were randomly divided into an MB group and a control group. Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), Pittsburgh Sleep Quality Index (PSQI), Patient Health Questionnaire-9 (PHQ-9) were used to evaluate the pre-operation and post-operation states of the patients, and adverse events were recorded. The patients participating in this study were followed up for a period of 6 months.

RESULTS

A total of 104 patients were followed up for the entire 6 months period. The control group included 51 patients, and the MB group included 53 patients. In both groups, the NRS scores, ODI scores, PHQ-9 scores, and PSQI scores decreased at different time points after treatment, compared to baseline. Moreover, the NRS scores were significantly lower than that of the control group at 3 months and 6 months after operation (P < 0.05). The ODI, PSQI, and PHQ-9 scores of the MB group were also respective significantly lower than that of the control group at 3 months and 6 months after operation (P < 0.05). As for the clinical efficacy, the total effective treatment rate of the MB group was significantly higher than that of the control group at 6 months after the procedure (P < 0.05). On the first day after operation, the incidence of hyperglycemia in patients with diabetes in the MB group was significantly lower than that of the control group (P < 0.05).

LIMITATIONS

Firstly, the patients enrolled were recruited from a single center, and the sample size was small. Secondly, the patients were only followed-up for a period of 6 months after treatment. Thirdly, double blinding was not used in the design of this research study.

CONCLUSION

Ultrasound-guided intra-articular MB injection is a safe and effective therapy for patients with LFJS. Intra-articular injection with MB can significantly reduce pain intensity, improve patient lumbar function, pain-related depression and sleep quality, increase total effective rate with no severe adverse side effects.

摘要

背景

腰椎小关节综合征(LFJS)被认为是腰痛的主要来源。亚甲蓝(MB)是一种一氧化氮合成抑制剂,具有潜在的镇痛和抗炎作用,已广泛应用于各种与疼痛相关的疾病。然而,目前尚无研究应用 MB 治疗 LFJS 患者。

目的

本研究旨在评估关节内注射 MB 治疗 LFJS 患者的疗效。

研究设计

前瞻性、随机、对照临床试验。

设置

上海东方医院疼痛科。

方法

共纳入 120 例符合条件的 LFJS 患者,随机分为 MB 组和对照组。采用数字评分量表(NRS)、Oswestry 功能障碍指数(ODI)、匹兹堡睡眠质量指数(PSQI)、患者健康问卷-9(PHQ-9)评估患者术前和术后状态,并记录不良事件。所有患者均随访 6 个月。

结果

共有 104 例患者完成了整个 6 个月的随访。对照组 51 例,MB 组 53 例。两组患者治疗后不同时间点 NRS 评分、ODI 评分、PHQ-9 评分和 PSQI 评分均较基线下降,且术后 3 个月和 6 个月时 MB 组 NRS 评分明显低于对照组(P < 0.05)。术后 3 个月和 6 个月时,MB 组 ODI、PSQI 和 PHQ-9 评分也明显低于对照组(P < 0.05)。临床疗效方面,术后 6 个月 MB 组总有效治疗率明显高于对照组(P < 0.05)。术后第 1 天,MB 组糖尿病患者高血糖发生率明显低于对照组(P < 0.05)。

局限性

首先,纳入的患者均来自单一中心,样本量较小。其次,患者仅在治疗后随访 6 个月。第三,本研究设计未采用双盲法。

结论

超声引导下关节内 MB 注射治疗 LFJS 患者安全有效。关节内注射 MB 可显著减轻疼痛强度,改善患者腰椎功能,减轻与疼痛相关的抑郁和睡眠质量,提高总有效率,无严重不良反应。

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