药物穴位注射疗法作为腰椎管狭窄症患者的辅助治疗：一项实用随机对照试验性研究
Pharmacopuncture Therapy as an Adjunctive Treatment for Patients with Lumbar Spinal Stenosis: A Pragmatic Randomized Controlled Pilot Trial.
作者信息
Oh Yoona, Han Chang-Hyun, Kim Yeonhak, Kim Jihun, Yang Changsop, Choi Young Eun, Kang Byoung-Kab, Kim Kun Hyung, Yang Gi Young, Lee Byung Ryul, Kim Eunseok
机构信息
Department of Acupuncture and Moxibustion Medicine, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea.
Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea.
出版信息
J Pain Res. 2024 Mar 6;17:837-849. doi: 10.2147/JPR.S438219. eCollection 2024.
PURPOSE
Pharmacopuncture therapy (PPT) combines medicinal extracts with acupuncture and is widely used as an adjunct in clinical practice. This study assessed the safety and feasibility of PPT in addition to conventional Korean Medicine treatment (CKMT), including electroacupuncture, cupping and infra-red, for lumbar spinal stenosis (LSS).
PATIENTS AND METHODS
Forty patients diagnosed with LSS were randomly assigned to undergo PPT with CKMT (experimental group) or CKMT alone (control group) at a 1:1 ratio, receiving 10 sessions of each intervention over five weeks. The primary clinical outcome was measured using the 100-mm Visual Analog Scale (VAS) for buttock and leg pain five weeks post-treatment. Secondary outcomes included clinically important difference (CID), Zurich Claudication Questionnaire, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and the patient's global impression of change. The adverse events were assessed at each visit. The analysis of covariance was conducted to compare between two groups.
RESULTS
Intervention completion rates were 95% and 100% in the experimental and control groups, respectively. No statistically significant differences were found between groups regarding the primary outcome (adjusted mean difference: 8.0; 95% confidence interval: -1.4-17.4). The mean difference in the 100-mm VAS for low back pain at week 5 (adjusted mean difference: 12.9; 95% confidence interval: 2.4-23.4) and the proportion of patients who reached the minimum CID was higher in the experimental group than in the control group. However, no significant differences were observed with other secondary outcomes. One patient in the experimental group experienced a systemic skin rash that resolved the same day, whereas the adverse events in the other group were mild and transient.
CONCLUSION
This trial demonstrated the feasibility of add-on effects and the safety of pharmacopuncture in patients with LSS. Further studies are warranted to evaluate the add-on effects of PPT in treating LSS.
TRIAL REGISTRATION
Clinical Research Information Service (CRIS), KCT0007229; registered on April 26, 2022.
目的
药物针灸疗法（PPT）将药用提取物与针灸相结合，在临床实践中被广泛用作辅助治疗方法。本研究评估了在包括电针、拔罐和红外线在内的传统韩医治疗（CKMT）基础上，PPT治疗腰椎管狭窄症（LSS）的安全性和可行性。
患者与方法
40例被诊断为LSS的患者按1:1比例随机分为接受PPT联合CKMT治疗的实验组和仅接受CKMT治疗的对照组，在五周内各接受10次干预治疗。主要临床结局指标采用100毫米视觉模拟量表（VAS）在治疗后五周测量臀部和腿部疼痛程度。次要结局指标包括临床重要差异（CID）、苏黎世跛行问卷、自我报告的步行能力、改良-改良肖伯试验、欧洲五维健康量表（EuroQol 5-dimension 5-level questionnaire）以及患者对治疗变化的总体印象。每次就诊时评估不良事件。采用协方差分析比较两组之间的差异。
结果
实验组和对照组的干预完成率分别为95%和100%。两组在主要结局指标方面未发现统计学显著差异（调整后平均差异：8.0；95%置信区间：-1.4至17.4）。实验组在第5周时腰痛100毫米VAS的平均差异（调整后平均差异：12.9；95%置信区间：2.4至23.4）以及达到最小临床重要差异的患者比例高于对照组。然而，在其他次要结局指标方面未观察到显著差异。实验组有1例患者出现全身性皮疹，当天消退，而另一组的不良事件轻微且短暂。
结论
本试验证明了在LSS患者中药物针灸附加效应的可行性和安全性。有必要进一步开展研究以评估PPT治疗LSS的附加效应。
试验注册
韩国临床研究信息服务中心（CRIS），KCT0007229；于2022年4月26日注册。
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