Furuse Nobutatsu, Shinbara Hisashi, Uehara Akihito, Sugawara Masaaki, Yamazaki Toshiya, Hosaka Masayoshi, Yamashita Hitoshi
Committee for Safe Acupuncture, Academic & Research Department, Japan Society of Acupuncture and Moxibustion, Tokyo, Japan.
Osaka Minami Prefectural Special Needs Education School for the Visually Impaired, Osaka, Japan.
Med Acupunct. 2017 Jun 1;29(3):155-162. doi: 10.1089/acu.2017.1230.
There have been only a few prospective surveys on adverse events (AEs) in Japanese-style acupuncture practice, and these surveys were conducted only in a single college acupuncture clinic. The goal of this research was to assess the safety of acupuncture and moxibustion performed in educational facilities in Japan. This was a multicenter prospective survey, using paper reporting forms. It was conducted in eight acupuncture clinics affiliated with educational institutions. The subjects were outpatients attending the clinics. The main outcome measure was the number of reported adverse events. The study was conducted for 5-7 months at each facility between October 2014 and June 2015. Participating acupuncture practitioners were instructed to self-report AEs observed during and after treatment; patients were interviewed upon treatment completion. For returning patients, treatment was preceded by an interview survey regarding the AEs identified after the previous treatment session. A specialized 4-sheet questionnaire was used. Two hundred and thirty-two acupuncture practitioners participated, 2180 patients received treatment, and there were 14,039 sessions, overall. In total, 847 (6.03%) AEs were reported. The most common AEs included subcutaneous bleeding and hematomas (370, 2.64%), followed by discomfort (109, 0.78%) and residual pain at insertion points (94, 0.67%). No infections or serious AEs were reported. Acupuncture and moxibustion performed in educational facilities in Japan were safe because most of the AEs reported were mild and transient. However, the risk cannot be defined definitely because the survey sample size was too small.
关于日式针灸治疗中不良事件（AE）的前瞻性调查仅有少数几项，且这些调查仅在一所大学的针灸诊所进行。本研究的目的是评估在日本教育机构中实施的针灸和艾灸的安全性。这是一项使用纸质报告表的多中心前瞻性调查。研究在八所与教育机构相关的针灸诊所进行。研究对象为诊所的门诊患者。主要观察指标是报告的不良事件数量。在2014年10月至2015年6月期间，每个机构进行了5 - 7个月的研究。参与研究的针灸从业者被要求自行报告治疗期间及之后观察到的不良事件；患者在治疗结束时接受访谈。对于复诊患者，在治疗前会就上一次治疗后发现的不良事件进行访谈调查。使用了一份专门的四页问卷。共有232名针灸从业者参与，2180名患者接受了治疗，总共进行了14039次治疗。总共报告了847例（6.03%）不良事件。最常见的不良事件包括皮下出血和血肿（370例，2.64%），其次是不适（109例，0.78%）和针刺点残留疼痛（94例，0.67%）。未报告感染或严重不良事件。在日本教育机构中实施的针灸和艾灸是安全的，因为报告的大多数不良事件是轻微且短暂的。然而，由于调查样本量过小，风险无法明确界定。
