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熱敏灸治療腫脹型膝關(guān)節(jié)骨性關(guān)節(jié)炎大樣本、多中心、中央隨機(jī)對(duì)照試驗(yàn)研究Alargesamplemulticenterrandomizedcontrolledtrialonheatsensitivemoxibustioninpatientswithkneeosteoarthritisofswelling-type國家重點(diǎn)基礎(chǔ)研究發(fā)展計(jì)劃(973計(jì)劃)資助FundedbyNationaldevelopmentprogrammeofkeybasicresearch(973programme)膝關(guān)節(jié)骨性關(guān)節(jié)炎-----中老年人腿部的“頭號(hào)殺手”,致殘率53%。采用艾灸療法治療102例被建議做膝關(guān)節(jié)置換術(shù)患者,86例免除膝關(guān)節(jié)置換術(shù)。然而這根小小的艾條為什么有這樣的神奇功效?醫(yī)生又是通過哪種艾灸技術(shù)來治療膝關(guān)節(jié)骨性關(guān)節(jié)炎的?Kneeosteoarthritisistheleadingkillerofthelegofelderly,whichdisabilityratecanreach53%.Wehavetreated102casessuggestedkneereplacementbeforebyHeatsensitivemoxibustionand85of102casesavoidedsurgeryeventually.However,whythemoxastickhasamagiceffect?Furthermore,whichmoxibustiontechnologydidthephysicianstaketotreatkneeosteoarthritis?前言Introduction熱敏灸病例一:何某,男,56歲。Case1:MrHe,male,56yearsold主訴:右膝關(guān)節(jié)酸痛、腫脹3年,行走不便,下蹲困難,已被建議做膝關(guān)節(jié)置換術(shù)。Maincomplaints:Thepatienthadsufferedsorenessandswellingofhisrightkneejointfor3yearsthatmadeitdifficultforhimtowalkandsquat.Thepatienthadbeensuggestedtokneereplacement.診斷:膝關(guān)節(jié)骨性關(guān)節(jié)炎。Diagnose:kneeosteoarthritis熱敏灸是怎樣治療膝關(guān)節(jié)骨性關(guān)節(jié)炎的?HowtotreatkneeosteoarthritisbyHeatsensitivemoxibustion?艾灸探查:當(dāng)艾條在患者右膝關(guān)節(jié)內(nèi)側(cè)緩慢移動(dòng)至內(nèi)膝眼穴上1厘米處時(shí),患者感一股熱流向深部慢慢灌注,感到舒適,而在膝關(guān)節(jié)其它位置施灸,僅感皮膚表面熱。ExaminationwithMoxastick:Whenthemoxastickwasmovingfrominsideofthepatient’srightkneejointto1cmawayfromNeiqiyanpoint,hecouldfeelaheatcurrentdeeplyandfeltcomfortable.Butwhenperformedmoxibustionontheotherplaceofthekneejoint,thepatientonlyfelthotinskinsurface.熱敏灸是怎樣治療膝關(guān)節(jié)骨性關(guān)節(jié)炎的?HowtotreatkneeosteoarthritisbyHeatsensitivemoxibustion?艾灸治療:于是選擇右內(nèi)膝眼穴上1厘米處施灸,約5分鐘后患者熱感進(jìn)入整個(gè)膝關(guān)節(jié)腔,非常溫暖舒適。90分鐘后關(guān)節(jié)腔熱感消失,并感皮膚灼熱,于是結(jié)束一次熱敏灸治療。Moxibustiontherapy:

Thephysicianperformedmoxibustiononthe1cmawayfromrightNeiqiyanpoint.After5minutes,thepatientfelthotintothewholekneejointcavity,whichwaswarmandcomfortable.After90minutes,thehotsensationofkneejointcavitydisappearedandthepatientfeltscorchinghotinhisskin.SothisHeatsensitivemoxibustiontherapywasfinished.療效:灸后右膝關(guān)節(jié)疼痛明顯減輕。按以上方案治療20次,

右膝關(guān)節(jié)腫脹、酸痛消失,行走時(shí)已無不適,一年后隨訪無復(fù)發(fā)。Effect:Thepainofthepatient’srightkneejointwasrelievedsignificantlyafterthemoxibustiontherapy.Accordingtoabovetherapyfor20times,theswellingandsorenessoftherightkneejointdisappeared.Thepatientcouldwalknormally.Oneyearlater,thepatientdidn’thavearecurrencethroughafollowing-upvisit.熱敏灸是怎樣治療膝關(guān)節(jié)骨性關(guān)節(jié)炎的?HowtotreatkneeosteoarthritisbyHeatsensitivemoxibustion?當(dāng)艾條在患者右膝關(guān)節(jié)內(nèi)側(cè)緩慢移動(dòng)至內(nèi)膝眼穴上1厘米處時(shí),患者感一股熱流向深部慢慢灌注,感到舒適,而在膝關(guān)節(jié)其它位置施灸,僅感皮膚表面熱。ExaminationwithMoxastick:Whenthemoxastickwasmovingfrominsideofthepatient’srightkneejointto1cmawayfromNeiqiyanpoint,hecouldfeelaheatcurrentdeeplyandfeltcomfortable.Butwhenperformedmoxibustionontheotherplaceofthekneejoint,thepatientonlyfelthotinskinsurface.熱敏灸是怎樣治療膝關(guān)節(jié)骨性關(guān)節(jié)炎的?HowtotreatkneeosteoarthritisbyHeatsensitivemoxibustion?本病例艾灸操作Heatsensitivemoxibustion目前臨床艾灸操作Regularmoxibustiontherapy不同?different?選穴方法不同!Pointsselectingmethodsaredifferent!經(jīng)穴Meridianpoints特殊灸感出現(xiàn)部位LocationofspecialmoxibustionsensationHappens艾灸探查選穴:

出現(xiàn)上述特殊灸感的部位,被稱為熱敏穴位。

這個(gè)病例表明,達(dá)到上述滿意的療效,并不僅僅是這根艾條的功勞,更重要的是找到熱敏穴位。熱敏穴位找到了,就能夠事半功倍。

Abovesitesthathavespecialmoxibustionsensationarecalled“heatsensitivepoint”.

Thiscaseshowedthesatisfiedclinicaleffectnotonlydependedonthemoxastick,butalsothethermalacupoints.Iftheheatsensitivepointsarefound,thecurativeeffectwillbesignificant.特殊灸感---熱敏穴位

Specialmoxibustionsensation:heatsensitivepoint8

熱敏穴位是江西中醫(yī)藥大學(xué)科研團(tuán)隊(duì)20余年灸療研究的一項(xiàng)重要科學(xué)發(fā)現(xiàn)!

---在疾病過程中,人體體表會(huì)出現(xiàn)對(duì)熱特別敏感的穴位,產(chǎn)生“小刺激大反應(yīng)”,是灸療的特異性穴位!

Theheatsensitivepointisagreatscientificdiscoveryinover-twenty-yearsresearchbythescientificresearchteamofJiangxiUniversityofTraditionalChineseMedicine.

Therearesomespecialpointssensitivetoheatonthesurfaceofdiseasepeople.Thesepointshavegreatreactiontolittlestimulation.一項(xiàng)重要科學(xué)發(fā)現(xiàn)----熱敏穴位?Animportantscientificdiscovery:

heatsensitivepoint9

在健康人,熱敏穴位出現(xiàn)率約10%左右;在疾病狀態(tài)下出現(xiàn)率上升為70%左右;疾病好轉(zhuǎn)后熱敏穴位出現(xiàn)率又下降至15%左右。

Theoccurrencerateoftheheatsensitivepointisabout10%toahealthyhuman;theoccurrenceratewillincreasetoabout70%inthediseasestate;anditwilldecreasetoabout15%whenthediseasebecured.

(1)熱敏穴位在人群中有普遍性,與疾病狀態(tài)高度相關(guān)Theheatsensitivepointisuniversalinthepopulation,whichisrelatedtothestateofdisease.健康人疾病好轉(zhuǎn)患者10%15%70%9熱敏穴位的臨床特征

Clinicalfeaturesoftheheatsensitivepoint10(2)艾灸熱敏穴位激發(fā)得氣具有高效性、氣至病所率高達(dá)86.73%。

Moxibustiontheheatsensitivepointcanbringaboutthedesiredsensationof“Qi”,andtherateof“Qireachingaffectedarea”willreach86.73%.氣至病所率(%)86.7322.41熱敏穴位的臨床特征

Clinicalfeaturesoftheheatsensitivepoint采用紅外成像技術(shù)客觀顯示灸療熱敏現(xiàn)象Heat-sensivtivephenomenonshowedbyinfraredimagingtechnology12采用高密度腦電技術(shù)客觀顯示灸療熱敏現(xiàn)象Heat-sensitivephenomenonshowedbyHDEGGnon-sensitizedsensitizedgroups采用高密度腦電技術(shù)客觀顯示灸療熱敏現(xiàn)象HeatsensitivephenomenonshowedbyHDEGGPhasecoherencechangesatthe

betaandthetafrequencyrange采用高密度腦電技術(shù)客觀顯示灸療熱敏現(xiàn)象HeatsensitivephenomenonshowedbyHDEGG選擇熱敏穴位施灸的一種懸灸療法Itisakindofmoxibustiontherapythroughchoosingtheheatsensitivepoint.什么是熱敏灸?Whatisheatsensitivemoxibustion?熱敏灸核心技術(shù)Thecoretechnologyofheatsensitivemoxibustion

探敏定位exploringandlocatingtheheat-sensitiveacupoint消敏定量quantifyingmoxibustiondosagebyheatsensitivepointvanishing17艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎探敏定位的隨機(jī)對(duì)照試驗(yàn)RCTonexploringtheheatsensitivepointsofheatsensitivemoxibustioninpatientswithKOA患者來源

患者來源于2010年5月至2012年6月江西、江蘇、陜西、安徽四個(gè)中心的4家醫(yī)院,包括江西中醫(yī)學(xué)院附屬醫(yī)院、江蘇省中醫(yī)院、陜西省中醫(yī)醫(yī)院、安徽中醫(yī)學(xué)院第一附屬醫(yī)院?;颊邅碜葬樉目频拈T診和住院部。

Wecollectedthepatientsdocumentsfrom4hospitalsinjiangxi,Jiangshu,ShanxiandAnhuiprovinces,whichweretheaffiliatedhospitalofJiangxiuniversityofTCM,JiangshuprovincehospitalofTCM,ShanxiprovincehospitalofTCMandthefirstaffiliatedhospitalofAnhuiuniversityofTCMfromMay2010toJune2012.Allthepatientswerefromoutpatientandinpatientdepartmentsindepartmentofacupunctureandmoxibustion.

本試驗(yàn)圍繞熱敏穴位施灸是否優(yōu)于固定經(jīng)穴施灸這一關(guān)鍵問題,以腫脹型膝關(guān)節(jié)骨性關(guān)節(jié)炎為研究對(duì)象,采用多中心隨機(jī)對(duì)照試驗(yàn)設(shè)計(jì)方法,對(duì)比其療效差異。

Thestudyfocusedonwhetheritisbettertoperformmoxibustiononheat-sensitiveacupointthanmeridianacupoints.WiththeSwellingTypeKneeOsteoarthritisastheresearchobject,itadoptedthemulticenterrandomizedcontrolledtrialtodesignthemethodsandcomparedthecurativeeffects.Patients

18研究方法分為三組,共計(jì)432例患者試驗(yàn)組:熱敏穴位灸組(每次45分鐘)對(duì)照A組:固定經(jīng)穴灸組(每次45分鐘)對(duì)照B組:西藥對(duì)照組(注射玻璃酸鈉)治療30天,隨訪觀察6個(gè)月。觀察時(shí)點(diǎn)分別為治療前、治療結(jié)束后即刻、治療結(jié)束后6個(gè)月。以膝關(guān)節(jié)GPCRND-KOA評(píng)分量表為依據(jù)擬定療效標(biāo)準(zhǔn)。艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎探敏定位的隨機(jī)對(duì)照試驗(yàn)RCTonexploringtheheatsensitivepointsofheatsensitivemoxibustioninpatientswithKOAMethods

Total432casesaredividedinto3groups:Trialgroup:Heatsensitivepointgroup(45minutespertime)ControlAgroup:Fixedmeridianacupointgroup(45minutespertime)ControlBgroup:Westernmedicinegroup(sodiumhyaluronate

injection

)Treatmentperiodis30days,follow-uptimeis6months.Observationtimepointsarebeforetreatment,immediatelyaftertreatment,6monthsaftertreatment.AccordingtoGPCRND-KOAscales,wehaveconfirmedtheclinicaleffectcriterion.19研究結(jié)果膝關(guān)節(jié)GPCRND-KOA評(píng)分量表總分GPCRND-KOAgradingscale觀測時(shí)點(diǎn)Observationtime組別Groups試驗(yàn)組Trialgroup對(duì)照A組ControlAgroup對(duì)照B組ControlBgroup治療前Beforetreatment11.2±3.311.3±3.212.1±2.9治療30天30daysoftreatment2.8±1.8★◆4.9±2.8★5.6±2.1★隨訪6個(gè)月Follow-upvisitafter6months3.6±1.6★●6.4±1.5★8.2±1.9★艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎探敏定位的隨機(jī)對(duì)照試驗(yàn)RCTonexploringtheheatsensitivepointsofheatsensitivemoxibustioninpatientswithKOAResults

20研究結(jié)果膝關(guān)節(jié)周徑比較Comparisonofcircumferenceofkneejoint觀測時(shí)點(diǎn)Observationtime組別Groups試驗(yàn)組Trialgroup對(duì)照A組ControlAgroup對(duì)照B組ControlBgroup治療前Beforetreatment40.2±3.539.3±3.239.1±2.8治療30天30daysoftreatment36.8±2.7○◆38.3±2.638.6±2.2隨訪6個(gè)月Follow-upvisitafter6months35.7±1.8○◆37.4±1.6○37.2±1.4○Results

艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎探敏定位的隨機(jī)對(duì)照試驗(yàn)RCTonexploringtheheatsensitivepointsofheatsensitivemoxibustioninpatientswithKOA21研究結(jié)果治療結(jié)束后三組間臨床整體療效比較Overallclinicaleffectcomparisonof3groupsaftertreatment組別Groups治愈Cured顯效Significanteffect有效Effective無效Invalid愈顯率obviouscurativerate試驗(yàn)組Trialgroup31(21.52)69(47.92)40(27.78)4(2.78)100(69.44)對(duì)照A組ControlA

group16(11.11)50(34.72)62(43.05)16(11.12)66(45.83)對(duì)照B組ControlBgroup14(9.72)63(43.75)52(36.11)15(10.42)77(53.47)Results

艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎探敏定位的隨機(jī)對(duì)照試驗(yàn)RCTonexploringtheheatsensitivepointsofheatsensitivemoxibustioninpatientswithKOA22

研究結(jié)果表明,試驗(yàn)組的GPCRND-KOA評(píng)分、關(guān)節(jié)周徑、臨床整體療效明顯優(yōu)于對(duì)照組。因此,熱敏穴位施灸的療效明顯優(yōu)于固定經(jīng)穴施灸的療效。ThestudyresultsdemonstratedthatGPCRND-KOAgrade,circumferenceofkneejoint,overallclinicaleffectintrialgrouparesuperiortothoseincontrolgroup.Therefore,theclinicaleffectofheatsensitivemoxibustionissuperiortothatofmoxibustiononthefixedmeridianacupoints.

辨敏選穴施灸優(yōu)于辨證選穴施灸辨敏選穴施灸=辨證選穴(+擇敏)施灸

Theefficacyofmoxibustiononheatsensitivepointissuperiortothatofmoxibustionbasedonsyndrome

differentiation.

Moxibustionbyexploringtheheatsensitivepoint=moxibustionbyselectingheatsensitivepoint

onthebasisofsyndrome

differentiation艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎探敏定位的隨機(jī)對(duì)照試驗(yàn)RCTonexploringtheheatsensitivepointsofheatsensitivemoxibustioninpatientswithKOA23患者來源患者來源于2009年7月至2011年3月江西、江蘇、陜西、安徽四個(gè)中心的4家醫(yī)院,包括江西中醫(yī)學(xué)院附屬醫(yī)院、江蘇省中醫(yī)院、陜西省中醫(yī)醫(yī)院、安徽中醫(yī)學(xué)院第一附屬醫(yī)院?;颊邅碜葬樉目频拈T診和住院部。Wecollectedthepatientsdocumentsfrom4hospitalsinjiangxi,Jiangshu,ShanxiandAnhuiprovinces,whichweretheaffiliatedhospitalofJiangxiuniversityofTCM,JiangshuprovincehospitalofTCM,ShanxiprovincehospitalofTCMandthefirstaffiliatedhospitalofAnhuiuniversityofTCMfromJuly2009toMarch2011.Allthepatientswerefromoutpatientandinpatientdepartmentsindepartmentofacupunctureandmoxibustion.

本試驗(yàn)圍繞個(gè)體化消敏灸量是否優(yōu)于常規(guī)固定灸量這一關(guān)鍵問題,以腫脹型膝關(guān)節(jié)骨性關(guān)節(jié)炎為研究對(duì)象,采用多中心隨機(jī)對(duì)照試驗(yàn)設(shè)計(jì)方法,對(duì)比其療效差異。

Thisstudymainlydiscussedthekeyquestionwhethertheeffectofindividualizedmoxibustiondosageissuperiortoregularfixedmoxibustiondosage.WiththeSwellingTypeKneeOsteoarthritisastheresearchobject,itadoptedthemulticenterrandomizedcontrolledtrialtodesignthemethodsandcomparedthecurativeeffects.艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎消敏定量的隨機(jī)對(duì)照試驗(yàn)RCTonquantifyingmoxibustiondosagebyheatsensitivepointsvanishingofmoxibustiontherapyforKOAPatients

24研究方法所有患者均為患者膝部熱敏穴位陽性。分為兩組:試驗(yàn)組:消敏灸量組(以熱敏灸感消失為度)對(duì)照組:常規(guī)固定灸量組(每穴15分鐘)觀察周期為30天,隨訪觀察6個(gè)月。觀察時(shí)點(diǎn)分別為治療前、治療結(jié)束后即刻、治療結(jié)束后6個(gè)月。以膝關(guān)節(jié)GPCRND-KOA評(píng)分量表為依據(jù)擬定療效標(biāo)準(zhǔn)。Allpaitentshaveheatsensitivepointinkneepart.Theyaredividedintotwogroups:Testgroup:individualizedmoxibustiondosage(endingmoxibustionbyheat-sensitivepointsvanishing)Controlledgroup:regularfixedmoxibustiondosage(15minutesforeachpoint)Treatmentperiodis30days,follow-uptimeis6months.Observationtimepointsarebeforetreatment,immediatelyaftertreatment,6monthsaftertreatment.AccordingtoGPCRND-KOAscales,wehaveconfirmedtheclinicaleffectcriterion.艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎消敏定量的隨機(jī)對(duì)照試驗(yàn)RCTonquantifyingmoxibustiondosagebyheatsensitivepointsvanishingofmoxibustiontherapyforKOAMethods

25研究結(jié)果膝關(guān)節(jié)GPCRND-KOA評(píng)分量表總分GPCRND-KOAgradingscale觀測時(shí)點(diǎn)Observationtime組別Groups試驗(yàn)組Trialgroup對(duì)照組Controlgroup治療前Beforetreatment11.22±3.110.14±3.0治療30天30daysoftreatment5.6±1.9★●8.3±2.0★隨訪6個(gè)月Follow-upvisitafter6months3.5±1.3★●5.1±1.4★艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎消敏定量的隨機(jī)對(duì)照試驗(yàn)RCTonquantifyingmoxibustiondosagebyheatsensitivepointsvanishingofmoxibustiontherapyforKOAResults

26研究結(jié)果觀測時(shí)點(diǎn)Observationtime組別Groups試驗(yàn)組Trialgroup對(duì)照組Controlgroup治療前Beforetreatment39.32±3.439.01±2.4治療30天30daysoftreatment36.21±3.4○◆38.02±2.7隨訪6個(gè)月Follow-upvisitafter6months35.81±3.6○◆37.92±2.7○Results

膝關(guān)節(jié)周徑比較Comparisonofcircumferenceofkneejoint艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎消敏定量的隨機(jī)對(duì)照試驗(yàn)RCTonquantifyingmoxibustiondosagebyheatsensitivepointsvanishingofmoxibustiontherapyforKOA27研究結(jié)果艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎消敏定量的隨機(jī)對(duì)照試驗(yàn)RCTonquantifyingmoxibustiondosagebyheatsensitivepointsvanishingofmoxibustiontherapyforKOAResults

治療結(jié)束后兩組間臨床整體療效比較Overallclinicaleffectcomparisonof2groupsaftertreatment組別Groups治愈Cured顯效Significanteffect有效Effective無效Invalid愈顯率obviouscurativerate試驗(yàn)組Trialgroup18(25.00)20(27.78)30(41.67)3(5.55)50(52.78)對(duì)照組Controlgroup9(12.50)12(16.44)46(63.89)5(7.17)21(29.16)28二、創(chuàng)新點(diǎn)(三)-----

傳統(tǒng)艾灸每穴治療時(shí)間為10-15分鐘(經(jīng)氣激發(fā)潛伏期),灸療療效潛力未充分發(fā)揮;

Thetimeoftraditionalmoxibustionis10-15minutes(incubationperiodofstimulatingmeridianqi)

,thepotentialcurativeeffectisnotachieved.從艾灸開始至經(jīng)氣傳導(dǎo)期結(jié)束,這段施灸時(shí)間約為40-45分鐘,稱為腧穴消敏時(shí)間,這主要是經(jīng)氣的傳導(dǎo)與氣至病所期,是灸療療效的充分發(fā)揮期;

Formthebeginningoftreatmenttotheendofthetransmissionperiodofmeridianqi,itis40-45minutes,whichiscalledsensitizationfadingperiod.Inthisperiod,itismainlyfortransmittingsensationalongmerdiansandsensationgoingwherethediseaseislocated,andthisstageismakingfullplayofthemoxibustioneffect.

因此,消敏時(shí)間是最佳的充足灸量的施灸時(shí)間。Thussensitizationfadingperiodisthebesttimeandquantityofmoxibustion.T(時(shí)間)51015

20

25

30

35404550灸感P經(jīng)氣激發(fā)潛伏期經(jīng)氣傳導(dǎo)期消退期灸療經(jīng)氣激發(fā)的時(shí)-效曲線Thetime-activity-curveofstimulatingmerdianqi

艾灸艾灸治療膝關(guān)節(jié)骨性關(guān)節(jié)炎消敏定量的隨機(jī)對(duì)照試驗(yàn)RCTonquantifyingmoxibustiondosagebyheatsensitivepointsvanishingofmoxibustiontherapyforKOA29

經(jīng)隨機(jī)對(duì)照臨床試驗(yàn)研究表明:Theindicationsoftherandomizedcontrolledclinictrail:灸療時(shí)間未達(dá)到消敏時(shí)間(如15分鐘),療效潛力沒有充分發(fā)揮;

Ifthetreatmenttimeislessthanthesensitizationfadingperiod(suchas15minutes),thepotentialcurativeeffectisnotachieved.達(dá)到消敏時(shí)間(平均40分鐘),療效明顯提高(如右圖所示,癥狀積分值明顯下降);

Ifthetreatmenttimeisthesensitizationfadingperiod(40minutesaverage),thecurativeeffectissignificantlyimproved(asshowninthefigure,thegr

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