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臭氧与甲泼尼龙治疗系统性硬化症腕管综合征患者腕管内注射的随机单盲临床试验

Intra-Carpal Injection of Ozone versus Methylprednisolone in Carpal Tunnel Syndrome of Systemic Sclerosis Patients: A Randomized Single-Blind Clinical Trial.

机构信息

Department of Anesthesia and Intensive Care, Faculty of Medicine, Assuit University, Assiut, Egypt.

Department Rheumatology and Rehabilitation, Assiut University, Assiut, Egypt.

出版信息

Pain Physician. 2021 Jul;24(4):E453-E458.

Abstract

BACKGROUND

Carpal tunnel syndrome (CTS) is the most entrapment syndrome in general and is the most frequent peripheral nervous system involvement in systemic sclerosis (SSc). Local injection of steroid hydrodissection or ozone-oxygen showed favourable outcome in CTS in general.

OBJECTIVES

To compare the clinical efficacy of ozone versus methylprednisolone intracarpal injection upon pain, functional status, and nerve conduction in patients with CTS due to SSc.

STUDY DESIGN

A randomized single-blinded trial.

SETTING

Anesthesia, pain, and rheumatology clinics in a university hospital.

METHODS

Fifty CTS patients with > 3 months duration of SSc were equally randomized into either group O (injection of ozone/oxygen 25 mu-g/mL in 20 mL) or group M (methylprednisolone acetate 40mg, and 40 mg lidocaine in 20 mL). Visual analog scale (VAS) was measured pre-injection, then re-evaluated post-injection at 4 time points (1 week, 1 month, 3 months , and 6 months); Cochin Hand Function Scale (CHFS); and a median nerve electrophysiologic study was done before injection, then by the end of 3 months and 6 months.

RESULTS

VAS was significantly lower in group M after 1 week (P = 0.01). Group O showed significantly lower VAS after 3 and 6 month (P < 0.001). Additionally, there was a significant decrease in the VAS during the whole study period within each group, in comparison to its baseline value. CHFS was significantly lower in the ozone group after 6 months (P < 0.001). The sixth month's sensory conduction was significantly higher in group O (P = 0.002). The motor distal latency was significantly lower in the ozone group after 3 and 6 months (P < 0.001).

LIMITATIONS

Follow-up period could be furtherly extended.

CONCLUSION

Both intracarpal ozone or methylprednisolone afford favorable effects upon CTS in patients with SSc. However, ozone alleviates pain much more, enhances the hand functional status, and improves median nerve conduction in study with over six months duration.

摘要

背景

腕管综合征(CTS)是最常见的一般性嵌压综合征,也是系统性硬化症(SSc)中最常见的周围神经系统受累。局部注射类固醇水分离或臭氧-氧气在 CTS 中显示出良好的效果。

目的

比较臭氧与甲泼尼龙腕管内注射治疗系统性硬化症相关 CTS 患者疼痛、功能状态和神经传导的临床疗效。

研究设计

随机单盲试验。

设置

大学医院的麻醉、疼痛和风湿病科。

方法

50 例 CTS 患者,SSc 病程>3 个月,随机分为 O 组(注射臭氧/氧气 25 μ g/mL,共 20 mL)或 M 组(甲泼尼龙醋酸酯 40mg,共 20 mL 利多卡因)。视觉模拟评分(VAS)在注射前测量,然后在 4 个时间点(1 周、1 个月、3 个月和 6 个月)进行重新评估;科钦手功能量表(CHFS);并在注射前、3 个月和 6 个月进行正中神经电生理研究。

结果

M 组在 1 周时 VAS 明显较低(P = 0.01)。O 组在 3 个月和 6 个月时 VAS 明显较低(P < 0.001)。此外,与基线值相比,每组在整个研究期间 VAS 均显著下降。O 组在 6 个月时 CHFS 明显较低(P < 0.001)。O 组在 6 个月时感觉传导明显较高(P = 0.002)。O 组在 3 个月和 6 个月时运动远端潜伏期明显较低(P < 0.001)。

局限性

随访时间可以进一步延长。

结论

腕管内臭氧或甲泼尼龙均可对系统性硬化症相关 CTS 患者产生有利影响。然而,臭氧在超过 6 个月的研究中缓解疼痛的效果更明显,改善手部功能状态,改善正中神经传导。

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