Kim Me-Riong, Shin Joon-Shik, Lee Jinho, Lee Yoon Jae, Ahn Yong-Jun, Park Ki Byung, Lee Hwa Dong, Lee Yoonmi, Kim Sung Geun, Ha In-Hyuk
From the Jaseng Spine and Joint Research Institute (M-RK, J-SS, JL, YJL, Y-JA, KBP, I-HH), Jaseng Medical Foundation, Seoul; and Korea Promotion Institute for Traditional Medicine Industry (HDL, YL, SGK), Gyeongsan-si, Gyeongbuk, Republic of Korea.
Medicine (Baltimore). 2016 May;95(18):e3635. doi: 10.1097/MD.0000000000003635.
We investigated the range and frequency of significant adverse events (AEs) in use of pharmacopuncture and acupuncture using large-scale, single-center safety data as evidence supporting safety of acupuncture with pharmacopuncture, used extensively in Asia, is scarce. Status reports (nurse records in ambulatory and inpatient care units, and administrative event records) as a part of an internal audit at a Korean Medicine hospital specializing in the treatment of musculoskeletal disorders, patient complaints filed through the hospital website, and medical records of patients visiting from December, 2010 (inception of internal audit) to October, 2014 were retrospectively reviewed. A total 80,523 patients (5966 inpatients and 74,557 outpatients) visited during this period. Inpatients received an average 31.9 ± 20.7 acupuncture, 23.0 ± 15.6 pharmacopuncture, and 15.4 ± 11.3 bee venom pharmacopuncture sessions, and outpatients were administered 8.2 ± 12.2 acupuncture, 7.8 ± 11.5 pharmacopuncture, and 10.0 ± 12.3 bee venom sessions, respectively. AEs associated with acupuncture/pharmacopuncture were forgotten needle (n = 47), hypersensitivity to bee venom (n = 37), presyncopic episode (n = 4), pneumothorax (n = 4), and infection (n = 2). Most cases were mild requiring little or no additional intervention and leaving no sequelae. Although serious AEs including infection (n = 2) and anaphylaxis associated with bee venom treatment (n = 3) were also reported, incidence was rare at 0.002% in infection and 0.019% in anaphylaxis. Incidence of AEs associated with acupuncture/pharmacopuncture treatment was low, and most cases were not serious. Still, however rare, avoidable AEs can and should be prevented through education and corrective action. Further prospective studies on the effect of error reduction strategies on incidence of adverse effects are warranted.
我们利用大规模单中心安全数据，对药针疗法和针灸过程中严重不良事件（AE）的范围及发生频率展开调查，因为在亚洲广泛应用的药针疗法安全性的相关证据十分匮乏。我们回顾性分析了一家专门治疗肌肉骨骼疾病的韩医医院内部审计的状态报告（门诊和住院护理单元的护士记录以及行政事件记录）、通过医院网站提交的患者投诉，以及2010年12月（内部审计开始）至2014年10月期间就诊患者的病历。在此期间，共有80523名患者前来就诊（5966名住院患者和74557名门诊患者）。住院患者平均接受31.9±20.7次针灸、23.0±15.6次药针疗法，以及15.4±11.3次蜂毒药针疗法，门诊患者分别接受8.2±12.2次针灸、7.8±11.5次药针疗法，以及10.0±12.3次蜂毒疗法。与针灸/药针疗法相关的不良事件有滞针（n = 47）、蜂毒过敏（n = 37）、晕厥前发作（n = 4）、气胸（n = 4）以及感染（n = 2）。大多数病例症状轻微，几乎无需或无需额外干预，且无后遗症。虽然也报告了包括感染（n = 2）和蜂毒治疗相关过敏反应（n = 3）在内的严重不良事件，但感染发生率为0.002%，过敏反应发生率为0.019%，均很罕见。与针灸/药针疗法治疗相关的不良事件发生率较低，且大多数病例并不严重。然而，即便罕见，可通过教育和纠正措施预防可避免的不良事件。有必要进一步开展前瞻性研究，探讨减少误差策略对不良反应发生率的影响。
