Safety of acupotomy in a real-world setting:A prospective pilot and feasibility study  

作　　者：Sang-Hoon Yoon Chan-Young Kwon Hee-Geun Jo Jae-Uk Sul Hyangsook Lee Jiyoon Won Su Jin Jeong Jun-Hwan Lee Jungtae Leem 

机构地区：[1]Chung-Yeon Korean Medicine Clinic,Gangnam-gu,Seoul 06224,Republic of Korea [2]Department of Oriental Neuropsychiatry,Dong-eui University College of Korean Medicine,Busanjin-gu,Busan 47340,Republic of Korea [3]Department of Herbal Pharmacology,College of Korean Medicine,Gachon University,1342 Seongnamdae-ro,Sujeong-gu,Seongnam 13120,Republic of Korea [4]Department of Korean Rehabilitation Medicine,Dongshin University Korean Medicine Hospital,Gwangju 61619,Republic of Korea [5]Acupuncture and Meridian Science Research Center,Kyung Hee University,Dongdaemun-gu,Seoul 02447,Republic of Korea [6]Department of Science in Korean Medicine,Graduate School,Kyung Hee University,Dongdaemun-gu,Seoul 02447,Republic of Korea [7]KM Science Research Division,Korea Institute of Oriental Medicine,Daejeon 34054,Republic of Korea [8]Department of Statistics Support,Medical Science Research Institute,Kyung Hee University Medical Center,Dongdaemun-gu,Seoul 02447,Republic of Korea [9]Clinical Medicine Division,Korea Institute of Oriental Medicine,Yuseong-gu,Daejeon 34054,Republic of Korea [10]Korean Medicine Life Science,University of Science&Technology(UST),Campus of Korea Institute of Oriental Medicine,Yuseong-gu,Daejeon 34054,Republic of Korea [11]College of Korean Medicine,Wonkwang University,Iksan,Jeollabuk-do,54538,Republic of Korea

出　　处：《Journal of Integrative Medicine》2022年第6期514-523,共10页结合医学学报（英文版）

基　　金：funded by the Korea Institute of Oriental Medicine(No.K18121);supported by the National Research Foundation of Korea grant funded by the Korea Government(Ministry of Science and ICT)(No.NRF-2022R1C1C2008738)。

摘　　要：Objective:Acupotomy is a modern acupuncture method that includes modern surgical methods.Since acupotomy is relatively more invasive than filiform acupuncture treatment,it is important to establish the safety profile of this practice.To justify further large-scale prospective observational studies,this preliminary study was performed to assess the feasibility of the approach and investigate the safety profile and factors potentially associated with adverse events(AEs).Methods:This was a prospective pilot study that assessed the feasibility of a large-scale forthcoming safety study on acupotomy treatment in a real-world setting.The feasibility(call response rate,dropout rate,response rate for each variable and recruitment per month)and safety profile(incidence,type,severity and causality of AEs,and factors potentially associated with AEs)were measured.Results:A total of 28 participants joined the study from January to May 2018.A follow-up assessment was achieved in 258(1185 treatment points)out of 261 sessions(1214 treatment points).The response rate via telephone on the day after treatment was 87.3%.There were 8 systemic AEs in all the sessions(8/258;3.11%)and 27 local AEs on the total points treated(27/1185;2.28%).Severe AEs did not occur.Total AE and local AE occurrence were associated with blade width and the number of needle stimulations per treatment point.Conclusion:The findings suggest that it could be feasible to analyze the safety of acupotomy in a realworld setting.Moreover,the primary data on some relevant AEs could be determined.We are planning large-scale prospective studies based on these findings.Trial registration:Clinical Research Information Service(CRIS)KCT0002849(https://cris.nih.go.kr/cris/search/detailSearch.do/11487).

关 键 词：ACUPOTOMY Acupuncture SAFETY Adverse effects Observational study Traditional Chinese medicine 

分 类 号：R245[医药卫生—针灸推拿学]