Kim Suna, Kim Gook-Beom, Kim Hyo-Jun, Park Joon, Lee Ji-Won, Jeong Wu-Jin, Kim Hye-Gyeong, Kim Min-Young, Park Kyoung-Sun, Lee Jinho, Lee Jun-Hwan, Shin Joon-Shik, Shin Byung-Cheul, Ha In-Hyuk
Daejeon Jaseng Hospital of Korean Medicine, Daejeon 35263, Korea.
Jaseng Spine and Joint Research Institute, Jaseng Medical Foundations, Seoul 06110, Korea.
Healthcare (Basel). 2022 Feb 2;10(2):294. doi: 10.3390/healthcare10020294.
Studies have reported that mild adverse events (AEs) are common after manual therapy and that there is a risk of serious injury. We aimed to assess the safety of Chuna manipulation therapy (CMT), a traditional manual Korean therapy, by analysing AEs in patients who underwent this treatment. Patients who received at least one session of CMT between December 2009 and March 2019 at 14 Korean medicine hospitals were included. Electronic patient charts and internal audit data obtained from situation report logs were retrospectively analysed. All data were reviewed by two researchers. The inter-rater agreement was assessed using the Cohen's kappa coefficient, and reliability analysis among hospitals was assessed using Cronbach's Alpha coefficient. In total, 2,682,258 CMT procedures were performed in 289,953 patients during the study period. There were 50 AEs, including worsened pain ( = 29), rib fracture ( = 11), falls during treatment ( = 6), chest pain ( = 2), dizziness ( = 1), and unpleasant feeling ( = 1). The incidence of mild to moderate AEs was 1.83 (95% confidence interval [CI] 1.36-2.39) per 100,000 treatment sessions, and that of severe AEs was 0.04 (95% CI 0.00-0.16) per 100,000 treatment sessions. Thus, AEs of any level of severity were very rare after CMT. Moreover, there were no instances of carotid artery dissection or spinal cord injury, which are the most severe AEs associated with manual therapy in other countries.
研究报告称,手法治疗后轻度不良事件(AE)很常见,且存在严重受伤的风险。我们旨在通过分析接受这种治疗的患者的不良事件,评估传统韩国手法治疗——推拿整复疗法(CMT)的安全性。纳入了2009年12月至2019年3月期间在14家韩医医院接受至少一次CMT治疗的患者。对从情况报告日志中获取的电子病历和内部审计数据进行了回顾性分析。所有数据由两名研究人员进行审查。使用科恩kappa系数评估评分者间的一致性,并使用克朗巴赫α系数评估医院间的可靠性分析。在研究期间,共对289,953名患者进行了2,682,258次CMT治疗。发生了50起不良事件,包括疼痛加重(n = 29)、肋骨骨折(n = 11)、治疗期间跌倒(n = 6)、胸痛(n = 2)、头晕(n = 1)和不适感(n = 1)。轻度至中度不良事件的发生率为每100,000次治疗1.83例(95%置信区间[CI] 1.36 - 2.39),重度不良事件的发生率为每100,000次治疗0.04例(95%CI 0.00 - 0.16)。因此,CMT后任何严重程度的不良事件都非常罕见。此外,没有发生颈动脉夹层或脊髓损伤的情况,而在其他国家,这些是与手法治疗相关的最严重不良事件。