Background Acupotomy,a more invasive procedure than acupuncture,involves the use of a thicker needle with an integrated knife at the tip,necessitating safety research.We aimed to define relevant adverse events(AEs)and...Background Acupotomy,a more invasive procedure than acupuncture,involves the use of a thicker needle with an integrated knife at the tip,necessitating safety research.We aimed to define relevant adverse events(AEs)and create a standardized form of the ACUPOtomy-related AEs CHECKlist(ACUPOCHECK).Methods Before conducting the Delphi process,a systematic review and pilot prospective study were conducted to gather information on previously reported AEs.Using these data,pilot versions of the ACUPOCHECK and Delphi questionnaires were developed.The Delphi questionnaire involved selecting types of AE for inclusion,establishing separate criteria for acupotomy-related AEs,and achieving a consensus on AE assessment.Thirteen Korean doctors with experience in acupotomy or AE research were recruited to participate in each Delphi round.Consensus was considered to have been reached if the critical value for the content validity ratio met or exceeded 0.538.Results The final ACUPOCHECK was developed using four rounds of the Delphi method and one face-to-face consensus meeting.It included 12 local AEs(pain,hemorrhage,bruise,hematoma,edema,pruritus,rash,infection,nerve damage,dysesthesia,movement impairment,and pneumothorax)and 14 systemic AEs(disease aggravation,needle fatigue,sleepiness,procedural nausea,procedural vomiting,procedural headache,procedural dizziness,sweating,procedural shock,syncope,dyspnea,procedural pain,sleep disorder,and postprocedural infection).Separate criteria were established for pain,hemorrhage and bruising:pain was defined as pain that occurrs during daily activities and persists for longer than 72 h,hemorrhage as bleeding that continues for≥3 min despite pressure application,and bruising as having a bruise with a diameter of≥3 cm.Open-ended descriptions were allowed for AEs not covered by the checklist,and severity and causality were assessed using the Common Terminology Criteria for Adverse Events and modified World Health Organization-Uppsala Monitoring Center criteria.Conclusion ACUPOCHECK provides a standardization framework that can help research on traditional practices as well as new tools and techniques that are more invasive and may cause more severe AEs.Subsequent studies will use ACUPOCHECK to develop rational safety guidelines for acupotomy techniques.展开更多
Objective:To investigate the changes in radial pulse induced by thermal stresses(TSs).Methods:Sixty subjects were enrolled.Using an open-label,2x2 crossover randomization design,both feet of each subject were immersed...Objective:To investigate the changes in radial pulse induced by thermal stresses(TSs).Methods:Sixty subjects were enrolled.Using an open-label,2x2 crossover randomization design,both feet of each subject were immersed in 15%:water for cold stress(CS)and in 40 X:water for heat stress(HS)for 5 min each.Radial pulse,respiration and electrocardiogram(ECG)signals were recorded before,during and immediately after the TSs.Results:The an alysis of heart rate variability revealed that CS in creased the low-freque ncy(LF)and high-frequency(HF)components(P<0.05)and that HS reduced the LF and HF components(P<0.01).Both TSs reduced the normalized LF,increased the normalized HF,and reduced the LF/HF ratio.The differences in the ECG signals were more dominant during the TS sessions,but those in the radial pulse signals became more domi nant immediately after the TS sessi ons.CS decreased the pulse depth(P<0.01)and in creased the radial augme ntation in dex(P<0.1),and HS in creased the pulse pressure(P<0.1)and sube ndocardial viability ratio(P<0.01).There were no significant differences in pulse rate during the three time sequences of each TS.The respiration rate was increased(P<0.1),and the pulse rate per respiration(P/R ratio)was significantly decreased(P<0.05)with CS.The HF region(10-30 Hz)of the pulse spectral density was suppressed during both TSs.Conclusions:CS induced vasoconstriction and sympathetic reactions,and HS induced vasodilation and parasympathetic reacti ons.Based on defi nitions used in pulse diag no sis,we made the novel discoveries that the pulse became slower(decreased P/R ratio),more floating and tenser under CS and that the HF region of the spectral power decreased significantly under both TSs.展开更多
基金funded by the Establishment of Real World Data-based Clinical Evidence of Korean Medicine Health Technology(No.KSN1823211)Additionally,it received support from a National Research Foundation of Korea grant funded by the Korean government(No.NRF-2022R1C1C2008738).
文摘Background Acupotomy,a more invasive procedure than acupuncture,involves the use of a thicker needle with an integrated knife at the tip,necessitating safety research.We aimed to define relevant adverse events(AEs)and create a standardized form of the ACUPOtomy-related AEs CHECKlist(ACUPOCHECK).Methods Before conducting the Delphi process,a systematic review and pilot prospective study were conducted to gather information on previously reported AEs.Using these data,pilot versions of the ACUPOCHECK and Delphi questionnaires were developed.The Delphi questionnaire involved selecting types of AE for inclusion,establishing separate criteria for acupotomy-related AEs,and achieving a consensus on AE assessment.Thirteen Korean doctors with experience in acupotomy or AE research were recruited to participate in each Delphi round.Consensus was considered to have been reached if the critical value for the content validity ratio met or exceeded 0.538.Results The final ACUPOCHECK was developed using four rounds of the Delphi method and one face-to-face consensus meeting.It included 12 local AEs(pain,hemorrhage,bruise,hematoma,edema,pruritus,rash,infection,nerve damage,dysesthesia,movement impairment,and pneumothorax)and 14 systemic AEs(disease aggravation,needle fatigue,sleepiness,procedural nausea,procedural vomiting,procedural headache,procedural dizziness,sweating,procedural shock,syncope,dyspnea,procedural pain,sleep disorder,and postprocedural infection).Separate criteria were established for pain,hemorrhage and bruising:pain was defined as pain that occurrs during daily activities and persists for longer than 72 h,hemorrhage as bleeding that continues for≥3 min despite pressure application,and bruising as having a bruise with a diameter of≥3 cm.Open-ended descriptions were allowed for AEs not covered by the checklist,and severity and causality were assessed using the Common Terminology Criteria for Adverse Events and modified World Health Organization-Uppsala Monitoring Center criteria.Conclusion ACUPOCHECK provides a standardization framework that can help research on traditional practices as well as new tools and techniques that are more invasive and may cause more severe AEs.Subsequent studies will use ACUPOCHECK to develop rational safety guidelines for acupotomy techniques.
基金Supported by the Korea Institute of Oriental Medicine funded by the Korean government(No.K17021)。
文摘Objective:To investigate the changes in radial pulse induced by thermal stresses(TSs).Methods:Sixty subjects were enrolled.Using an open-label,2x2 crossover randomization design,both feet of each subject were immersed in 15%:water for cold stress(CS)and in 40 X:water for heat stress(HS)for 5 min each.Radial pulse,respiration and electrocardiogram(ECG)signals were recorded before,during and immediately after the TSs.Results:The an alysis of heart rate variability revealed that CS in creased the low-freque ncy(LF)and high-frequency(HF)components(P<0.05)and that HS reduced the LF and HF components(P<0.01).Both TSs reduced the normalized LF,increased the normalized HF,and reduced the LF/HF ratio.The differences in the ECG signals were more dominant during the TS sessions,but those in the radial pulse signals became more domi nant immediately after the TS sessi ons.CS decreased the pulse depth(P<0.01)and in creased the radial augme ntation in dex(P<0.1),and HS in creased the pulse pressure(P<0.1)and sube ndocardial viability ratio(P<0.01).There were no significant differences in pulse rate during the three time sequences of each TS.The respiration rate was increased(P<0.1),and the pulse rate per respiration(P/R ratio)was significantly decreased(P<0.05)with CS.The HF region(10-30 Hz)of the pulse spectral density was suppressed during both TSs.Conclusions:CS induced vasoconstriction and sympathetic reactions,and HS induced vasodilation and parasympathetic reacti ons.Based on defi nitions used in pulse diag no sis,we made the novel discoveries that the pulse became slower(decreased P/R ratio),more floating and tenser under CS and that the HF region of the spectral power decreased significantly under both TSs.
