药罐疗法结合推拿治疗腰椎间盘突出症的随机对照试验

Herbal cupping therapy combined with massage for lumbar disc herniation：a randomized controlled study

关键词:  药罐  腰椎间盘突出症  拔罐  推拿  疼痛  日常功能活动

Key words:  herbal cupping  lumbar disc herniation（LDH）  cupping  massage  pain  daily functional activity

摘要:

[目的] 评估药罐疗法结合推拿与竹罐疗法结合推拿在治疗血瘀证型腰椎间盘突出症患者中的临床疗效和安全性。[方法] 本研究为随机对照试验，将76名患者以1∶1的比例随机分配到两组。两组患者均需接受推拿治疗。试验组在委中（双）、肾俞（双）、大肠俞（双）接受药罐疗法，对照组患者在相应腧穴接受竹罐拔罐。主要结果是治疗前后2周的JOA总分的变化。视觉模拟标尺法、血小板计数（PLT）、纤维蛋白原（Fb）含量、全血黏度（高剪切率）和总有效率为次要结果。不良事件将在每次就诊时进行评估。[结果] 在本试验中，有63人完成了研究，人口统计学和临床基线特征没有统计学差异（P>0.05）。经过2周治疗，两组的干预方案均可以提高主观症状和日常生活限制两个维度的得分以及JOA总分（P<0.05），并降低视觉模拟标尺法得分（P<0.001），且试验组表现较对照组更有优势（P=0.02）。从临床疗效出发，试验组较对照组的总有效率更高（P=0.007）。两组的高剪切率，纤维蛋白原含量以及血小板计数均较治疗前未产生明显的统计学差异（P>0.05）。所有受试者均未发生与干预措施相关的不良事件。[结论] 本研究确定了竹罐（或药罐）疗法结合推拿用于改善血瘀证型的腰椎间盘突出症患者的疼痛和日常功能活动方面安全有效，而且在改善临床体征和提升临床总有效率方面药罐疗法结合推拿显示出更为显著的优势，但临床结局的改善未能与血小板、纤维蛋白原及高剪切率的变化呈现明显的相关性，其机制仍有待进一步的探索。

Abstract:

[Objective] To evaluate the clinical efficacy and safety of herbal cupping therapy combined with massage and bamboo cupping therapy combined with massage in the treatment of patients with lumbar disc herniation of blood stasis type. [Methods] This study is a randomized controlled trial，and 76 patients were randomly divided into two groups in a 1∶1 ratio. All patients received massage therapy. The treatment group received medicated jar therapy at Weizhong（bilateral），Shenshu（bilateral），and Dachangshu（bilateral），while the control group received bamboo cupping at the corresponding acupoints. The primary outcome was the change in the JOA score before and after two weeks of treatment. Secondary outcomes included the Visual Analogue Scale（VAS），platelet count，fibrinogen content，whole blood viscosity（high shear rate），and the overall effectiveness of the treatment. Adverse events were assessed at each visit. [Results] In this trial，63 participants completed the study，with no statistical difference in demographic and clinical baseline characteristics（P>0.05）. After two weeks of treatment，both intervention schemes improved scores in subjective symptoms（P<0.05），daily life limitations（P<0.05），and JOA total scores（P<0.05） while reducing VAS scores（P<0.001），with the treatment group showing more advantages over the control group（P=0.02）. Clinically，the overall effectiveness rate was higher in the treatment group than in the control group（P=0.007）. No significant statistical differences were observed in high shear rate，fibrinogen content，and platelet count between the groups before and after treatment（P>0.05）. No adverse events related to the interventions occurred in any of the subjects. [Conclusion] This study confirmed that both medicated cupping combined with massage and cupping therapy combined with massage improve the pain level and daily functional activities in patients with blood stasis syndrome type LDH. However，no significant correlation was found with changes in platelet count，fibrinogen，and high shear rate，and the mechanisms still require further exploration.