本文關(guān)鍵詞：針刺手法操作差異的臨床研究及其方法學(xué)探討　出處：《北京中醫(yī)藥大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 方法學(xué)探討 交叉試驗(yàn) 療效評(píng)價(jià) 手法操作 針刺 Acusensor

【摘要】：目的基于隨機(jī)交叉試驗(yàn)及量化記錄針刺手法操作,在針刺處方水平一致的前提下,評(píng)價(jià)不同針灸醫(yī)生治療相同患者手法操作的差異性、穩(wěn)定性,及自身手法操作的穩(wěn)定性,探索針刺手法操作與臨床療效的相關(guān)性。進(jìn)而為針刺臨床研究提供一種定量、定性采集針刺手法操作信息的模式,并對(duì)今后的針刺臨床研究中干預(yù)措施設(shè)置提供方法學(xué)參考。方法本研究采用隨機(jī)交叉對(duì)照試驗(yàn),招募來自于中國中醫(yī)科學(xué)院西苑醫(yī)院腫瘤科,單用或聯(lián)用順鉑作為化療藥物的癌癥住院患者,并且可以完成連續(xù)2周期的化療方法。排除化療期間因其他原因接受針刺治療,或伴有非化療引起的惡心嘔吐情況,如腸梗阻,患有感染性疾病或嚴(yán)重心、腦、腎疾病,嚴(yán)重精神疾病,合并放療或激素治療的患者。將合格的患者隨機(jī)分到A、B兩組,在常規(guī)化療及鎮(zhèn)吐治療的基礎(chǔ)上,A組患者第一階段先接受甲醫(yī)生針刺,經(jīng)洗脫期,在第二階段換為接受乙醫(yī)生針刺。B組患者第一階段先接受乙醫(yī)生針刺,經(jīng)洗脫期,在第二階段換為接受甲醫(yī)生針刺。洗脫期為兩相鄰化療周期的間歇期,約為21天。甲醫(yī)生為高資歷針灸醫(yī)生,針灸臨床經(jīng)驗(yàn)15年,乙醫(yī)生為低資歷針灸醫(yī)生,針灸臨床經(jīng)驗(yàn)5年。每一階段,兩組患者均從化療給藥前開始接受針刺治療,每天1次,連續(xù)5天。針刺治療之前,甲、乙同時(shí)進(jìn)行床旁問診,并獨(dú)立制定針刺方案,但針刺時(shí),兩名醫(yī)生均按照甲醫(yī)生制定的針刺方案(包括辨證、腧穴選擇、取穴、針刺強(qiáng)度、深度、留針時(shí)間、補(bǔ)瀉手法)執(zhí)行手針操作。借助Acusensor測量儀客觀、定量記錄手針操作的全過程,監(jiān)測提插頻率、位移,捻轉(zhuǎn)頻率、位移隨時(shí)間變化的波形圖,通過快速傅里葉變換法擬合為提插最大位移、主導(dǎo)頻率、捻轉(zhuǎn)最大位移、主導(dǎo)頻率4個(gè)參數(shù)。療效評(píng)價(jià)和手法操作參數(shù)的分析是針對(duì)甲醫(yī)生組與乙醫(yī)生組之間的比較來實(shí)現(xiàn)。這兩組的患者是相同的。完成統(tǒng)計(jì)分析后,對(duì)兩名醫(yī)生進(jìn)行一對(duì)一深度訪談。通過醫(yī)評(píng)NCI量表及患者自評(píng)Rhodes量表,比較治療相同患者時(shí),兩名醫(yī)生的療效差異。分析4個(gè)手法參數(shù),評(píng)價(jià)不同針灸醫(yī)生治療相同患者手法操作的差異性、穩(wěn)定性,及自身手法操作的穩(wěn)定性。探索針刺手法操作與臨床療效的相關(guān)性。比較兩階段內(nèi),甲醫(yī)生辨證處方穩(wěn)定性,患者對(duì)不同醫(yī)生針刺治療的信心、滿意度、針刺期望、醫(yī)患交流滿意度等評(píng)估可能影響療效的相關(guān)因素對(duì)試驗(yàn)結(jié)果造成的偏倚。連續(xù)變量采用配對(duì)t檢驗(yàn)(非正態(tài)時(shí)采用配對(duì)秩和檢驗(yàn)),二分類、等級(jí)變量采用卡方檢驗(yàn)(或Fisher精確概率法)。結(jié)果本研究共納入合格患者39例,第一輪針刺治療由甲醫(yī)生完成,第二輪治療由乙醫(yī)生完成者(A組)20例,順序相反者(B組)19例;甲醫(yī)生共計(jì)治療39例,乙醫(yī)生共計(jì)治療39例�；�采用全數(shù)據(jù)集分析,手法操作差異結(jié)果評(píng)價(jià)采用符合方案數(shù)據(jù)集分析(符合配對(duì)條件者,每組各25例)。干預(yù)開始前,A、B兩組患者在性別、年齡、身體質(zhì)量指數(shù)、卡氏評(píng)分、焦慮抑郁評(píng)分、針刺期望、針刺信心、化療藥給藥天數(shù)、鎮(zhèn)吐藥給藥天數(shù)、治療前NCI評(píng)分及Rhodes量表評(píng)分等基線均無明顯差異。經(jīng)非參數(shù)檢驗(yàn),隨機(jī)交叉試驗(yàn)順序效應(yīng)(Z=-0.225,P=0.822)及針刺治療的殘余效應(yīng)(Z=-0.422,P=0.673)均無統(tǒng)計(jì)學(xué)意義。前期療效評(píng)價(jià)結(jié)果發(fā)現(xiàn)針刺治療同一患者時(shí),第3次針刺治療時(shí)患者癥狀最為明顯,高資歷醫(yī)生的療效與低資歷醫(yī)生療效有顯著性差異,高資歷醫(yī)生更好(NCI量表、Rhode量表)。本研究手法操作差異研究部分的試驗(yàn)結(jié)果表明:1)兩名醫(yī)生針刺相同患者時(shí),在4個(gè)主穴的手法操作中,提插頻率均沒有統(tǒng)計(jì)學(xué)差異,但是提插位移、捻轉(zhuǎn)位移參數(shù)的差異具有統(tǒng)計(jì)學(xué)意義。高資歷醫(yī)生針刺中脘(P0.001)、內(nèi)關(guān)(P0.001)、足三里(P0.001)的提插位移深于低資歷針灸醫(yī)生,針刺天樞(P0.001)的提插位移淺于低資歷針灸醫(yī)生。高資歷針灸醫(yī)生針刺天樞(P0.001)、內(nèi)關(guān)(P=0.046)、足三里(P0.001)的捻轉(zhuǎn)位移大于低資歷針灸醫(yī)生,針刺中脘(P=0.004)的捻轉(zhuǎn)位移小于低資歷針灸醫(yī)生。在腹部腧穴,中脘(P=0.004)、天樞(P=0.004)實(shí)施手法操作時(shí),低資歷醫(yī)生捻轉(zhuǎn)頻率快于高資歷醫(yī)生;在四肢穴位,內(nèi)關(guān)、足三里上,捻轉(zhuǎn)頻率無統(tǒng)計(jì)學(xué)差異。2)針刺同一批患者時(shí),兩名醫(yī)生在4個(gè)主穴提插位移的穩(wěn)定性都存在差異(P0.001),低資歷針灸醫(yī)生的穩(wěn)定性優(yōu)于高資歷醫(yī)生。兩名醫(yī)生在針刺內(nèi)關(guān)穴時(shí),4個(gè)手法參數(shù)的穩(wěn)定性均具有統(tǒng)計(jì)學(xué)差異(P0.05),低資歷針灸醫(yī)生的穩(wěn)定性優(yōu)于高資歷醫(yī)生。3)不同時(shí)間點(diǎn)針刺同一患者時(shí),高資歷醫(yī)生在62.5%(10/16)的手法參數(shù)上體現(xiàn)出手法操作的穩(wěn)定性;低資歷醫(yī)生在50.0%(8/16)的手法參數(shù)上體現(xiàn)出手法操作穩(wěn)定性,高資歷醫(yī)生的手法操作較低資歷醫(yī)生穩(wěn)定,特別是在內(nèi)關(guān)穴的操作上。4)兩階段針刺治療結(jié)束后,患者分別對(duì)兩名醫(yī)生的針刺治療信心、滿意度、針刺期望、醫(yī)患交流滿意度等評(píng)分無統(tǒng)計(jì)學(xué)差異(P0.10)。本研究針刺方案部分對(duì)比性研究結(jié)果發(fā)現(xiàn):1)第一階段,高、低資歷醫(yī)生同時(shí)問診相同患者后,辨證一致率為38.5%(15/39),Kappa=0.220。選取的穴位無統(tǒng)計(jì)學(xué)差異(χ2=8.746,P=0.724),主穴為中脘,雙側(cè):天樞、內(nèi)關(guān)、足三里。為4個(gè)主穴擬定的針刺強(qiáng)度、針刺深度、留針時(shí)間、補(bǔ)瀉手法存在統(tǒng)計(jì)學(xué)差異(P0.05)。2)兩階段內(nèi),高資歷醫(yī)生問診相同患者后,選取的穴位無統(tǒng)計(jì)學(xué)差異(F=4.99,P=0.986),主穴為中脘,雙側(cè):天樞、內(nèi)關(guān)、足三里。為4個(gè)主穴擬定的針刺強(qiáng)度、針刺深度、留針時(shí)間、補(bǔ)瀉手法穩(wěn)定(P0.10),無統(tǒng)計(jì)學(xué)差異。本研究通過定性訪談對(duì)于上述結(jié)果進(jìn)行補(bǔ)充說明,發(fā)現(xiàn):醫(yī)生在問診時(shí)切入點(diǎn)及側(cè)重角度不同,辨證的結(jié)果會(huì)存在較大的差異;雖然選穴的思路及原則不盡相同,但是由于病機(jī)相對(duì)簡單明了,且穴位具有的雙向調(diào)節(jié)作用,兩名醫(yī)生的選穴基本一致。低資歷醫(yī)生為了達(dá)到補(bǔ)虛瀉實(shí)的目的,在制定針刺處方考慮重度手法、增加留針時(shí)間,補(bǔ)法瀉法相結(jié)合的方式增強(qiáng)針刺治療的刺激量。與定量研究中方案結(jié)果相一致。然而,在與定量手法參數(shù)分析結(jié)果相比較時(shí),發(fā)現(xiàn)低資歷醫(yī)生由于缺乏信心,及手法操作并不嫻熟,其真實(shí)的手針操作明顯弱于高資歷醫(yī)生,產(chǎn)生的刺激量未能達(dá)到高資歷醫(yī)生平補(bǔ)平瀉所期望的中等強(qiáng)度。結(jié)論:在相同患者、病情相似、針刺處方水平一致,且可能影響療效的其他因素被盡量控制的前提下,高資歷醫(yī)生在手針操作時(shí)提插捻轉(zhuǎn)的位移大于低資歷醫(yī)生,其對(duì)患者帶來的刺激量相對(duì)較大。高資歷醫(yī)生在針刺同一患者時(shí),手法操作的穩(wěn)定性較高,針刺不同患者時(shí),會(huì)依據(jù)患者體型胖瘦、嚴(yán)重程度小范圍調(diào)整手法的提插、捻轉(zhuǎn)。低資歷醫(yī)生在針刺同一患者時(shí),手法操作的穩(wěn)定性較差,針刺不同患者時(shí),提插、捻轉(zhuǎn)調(diào)整的幅度不明顯。對(duì)兩位醫(yī)生針刺方案的分析,以及定性訪談所獲得的信息支持上述手法參數(shù)數(shù)據(jù)分析的結(jié)果。將上述結(jié)果與本項(xiàng)目前期分析的療效比較結(jié)果相聯(lián)系,發(fā)現(xiàn)手法操作的差異會(huì)影響療效。但由于參與試驗(yàn)的高、低資歷醫(yī)生各只有1名,完成配對(duì)手法操作參數(shù)采集的患者有限,未能做到盲法,本試驗(yàn)結(jié)果的解釋需要謹(jǐn)慎。但本研究可以為針刺臨床試驗(yàn)的開展提供方法學(xué)建議。即評(píng)價(jià)或探索針刺療法的效果時(shí),應(yīng)充分考慮針灸醫(yī)生資歷及手法操作對(duì)研究結(jié)果的影響,提示未來開展精確的針刺療效評(píng)價(jià)研究時(shí),可借助定量檢測儀器,對(duì)參與試驗(yàn)的針灸醫(yī)生的手法操作進(jìn)行預(yù)先的培訓(xùn)及考核,使其操作處于同一水平。
[Abstract]:Objective a randomized crossover trial and the quantification of acupuncture manipulation based on the record, in the premise of acupuncture prescription under the same level, differences, evaluation of different acupuncture doctor in the same patients manipulation stability, stability and its manipulation, to explore the relationship between the efficacy of acupuncture manipulation and clinical. So as to provide a quantitative clinical study of acupuncture. The qualitative collection of acupuncture manipulation of information model, and the intervention of acupuncture clinical research in the future is to provide methodological reference. Methods this study used a randomized crossover controlled trial, recruited from Xiyuan Hospital oncology China Academy of traditional Chinese medicine, alone or in combination with cisplatin as chemotherapy of cancer patients, and can complete the chemotherapy method 2 consecutive cycles. Excluded for other reasons during chemotherapy received acupuncture treatment, or with non chemotherapy induced nausea and vomiting situation, such as Intestinal obstruction, infectious disease or serious heart, brain, kidney disease, severe mental illness, combined with radiotherapy or hormone therapy. The qualified patients were randomly divided into A, B two groups, in the conventional chemotherapy and antemetic treatment, patients in group A first stage to accept a doctor by acupuncture a washout period in the second stage to accept the doctor B acupuncture group.B patients with first stage B doctors accept acupuncture, after the washout period, in the second stage for receiving a doctor of acupuncture. The intermittent period of washout period for two adjacent cycles of chemotherapy, about 21 days. A doctor for highly qualified acupuncturist, 15 years of acupuncture clinical experience, doctor B low qualifications acupuncture, acupuncture clinical experience of 5 years. Each stage, two groups of patients from chemotherapy before administration began to receive acupuncture treatment, 1 times a day for 5 days. Before acupuncture treatment, a, B and bedside inquiry, and formulate the acupuncture program, But acupuncture, two doctors are in accordance with a physician's acupuncture programs (including syndrome differentiation, selection of acupoints, acupoints, acupuncture intensity, depth of needle retention time, reinforcing and reducing) operation. With the help of Acusensor implementation of hand needle measuring instrument objective, the whole process of quantitative records of hand acupuncture operation, monitoring the inserted frequency, displacement. Twisting frequency, waveform displacement change over time, through the fast Fourier transform method to fit for lifting and thrusting, maximum displacement, dominant frequency, twisting the maximum displacement, the 4 parameters of the dominant frequency. Analysis of operating parameters and efficacy evaluation techniques is for a comparison between group and group B the doctor doctor. In order to achieve the two groups the patient is the same. After statistical analysis, the two doctors of medicine through in-depth interviews. The evaluation of Rhodes scale and NCI scale were compared with the same treatment, the curative effect difference of two doctors. The analysis of 4 technique parameters, evaluation The price difference, different acupuncture manipulation in patients with the same medical treatment stability, stability and its manipulation. To explore the relationship between acupuncture manipulation and clinical curative effect. Compared with two phase, a doctor dialectical prescription for patients with different stability, doctor of acupuncture in the treatment of confidence, satisfaction, acupuncture expectation, satisfaction evaluation of doctor-patient communication may be related factors affecting the efficacy of the test results caused by bias. Continuous variables using the paired t test (non normal when using paired Wilcoxon test), two grade classification variables using chi square test (or Fisher exact test). The results of this study included 39 cases of eligible patients, the first round is completed by a doctor of acupuncture treatment the second round of treatment, the doctor who performed by B (A group) 20 cases, the order of the contrary (B group) 19 cases; a total of 39 cases of doctor treatment, doctor B total treatment of 39 cases with full set of data analysis baseline, The operation results were evaluated using the analysis with the difference in data (matched condition, 25 cases in each group). The intervention before the start of A, B of the two groups in gender, age, body mass index, Karnofsky score, anxiety depression score, Acupuncture Acupuncture Treatment of expectations and confidence, drug delivery days, Zhen the drug delivery days before treatment NCI score and Rhodes score at baseline were not significantly different. The non parametric test, randomized crossover trial order effect (Z=-0.225, P=0.822) and the residual effect of acupuncture treatment (Z=-0.422, P=0.673) were not statistically significant. Results early curative effect evaluation of acupuncture in the treatment of patients with the same third, the acupuncture treatment in patients with the most obvious symptoms, there was significant difference between low and high qualified doctors qualifications curative effect, high qualified doctors better (NCI scale, Rhode scale). This experimental manipulation differences of partial results table Ming: 1) two doctors in the same acupuncture patients, 4 main points of manipulation, lifting and thrusting frequency were not statistically different, but the lifting and thrusting displacement, turn twist displacement parameters difference was statistically significant. The high qualified doctor of acupuncture Zhongwan (P0.001), Neiguan (P0.001), three (in P0.001) the lifting and thrusting displacement of deep in junior doctor of acupuncture and moxibustion, acupuncture at Tianshu (P0.001) lifting thrusting displacement shallow in low seniority acupuncture doctor. Senior doctor of acupuncture and moxibustion acupuncture at Tianshu (P0.001), Neiguan (P=0.046), Zusanli (P0.001) twist displacement is greater than the low qualifications acupuncture doctor, acupuncture Zhongwan (P=0.004) the twist displacement is less than the junior doctor. In the abdominal acupuncture acupoints, Zhongwan, Tianshu (P=0.004) (P=0.004) the implementation of manipulation, junior doctors twirling frequency faster than highly qualified doctors; in the limbs acupoint, Neiguan, Zusanli, twirling frequency have no significant difference.2) with a group of patients with acupuncture when two The doctor provided stability in 4 inserted displacement of the main points are different (P0.001), low qualified acupuncturist is more stable than the high qualifications. Doctor two doctors in acupuncture, manipulation stability of 4 parameters were statistically significant (P0.05), low qualified acupuncturist is more stable than the high qualifications doctor.3) at different time points of acupuncture the same patient, senior doctor in 62.5% (10/16) technique parameters reflects the stability of manipulation; junior doctors in 50% (8/16) technique parameters reflect the manipulation stability, high seniority doctors manipulation low seniority doctors stable, especially in Neiguan the operation point.4) the end of the two stage after acupuncture treatment, acupuncture treatment were the confidence of two doctors satisfaction, acupuncture expectations, there was no significant difference in doctor-patient communication satisfaction score (P0.10). The research department of acupuncture treatment The comparison results showed: 1) the first stage, high, junior doctors also interrogation same patients, consistent rate of differentiation for the 38.5% (15/39), no significant difference between the Kappa=0.220. acupoints (x 2=8.746, P=0.724), the main points: Tianshu, Zhongwan, bilateral Neiguan, Zusanli for 4 main. The acupuncture point strength, needling depth, needle retention time, reinforcing and reducing statistical differences (P0.05).2) in the two stage, highly qualified doctor the same patients, no significant difference between the selected points (F=4.99, P=0.986), the main points: Tianshu, Zhongwan, bilateral Neiguan, Zusanli for 4. The main points of the acupuncture intensity, depth of acupuncture, needle retention time, reinforcing and reducing methods of stability (P0.10), the difference was not statistically significant. This study through qualitative interviews for the above results were found: the doctor added that the starting point and focus on different angles during interrogation, the results of differentiation have large difference Although different; ideas and principles of acupoints are not the same, but the pathogenesis is relatively simple and clear, two-way regulation and the acupoint has the acupoints of two doctors are basically the same. Junior doctors in order to achieve the purpose of real tonic diarrhea, in the formulation of the prescription into severe way, increase the retaining time of acupuncture treatment. The amount of stimulation strengthening method by way of combining with quantitative research. In the scheme results. However, in comparison with quantitative analysis technique parameters results, we found that low seniority doctors due to lack of confidence, and the manipulation is not skilled, the real hand needle was weaker than that of highly qualified doctors, failed to stimulate the doctor qualification reached the middle high strength reinforcing reducing desired. Conclusion: in the same patient, similar condition, acupuncture prescription level consistent, and other factors affecting the effect of the premise is to control the, Senior doctor twirling lifting and thrusting displacement is greater than the junior doctors in hand acupuncture operation, the amount of stimulation on the patients with relatively high qualifications. In the same patient doctor of acupuncture manipulation, high stability, acupuncture in different patients, patients will be based on the size and severity of the small range adjustment technique lifting and thrusting, twirling. Junior doctors in the same patient acupuncture, acupuncture manipulation stability, different patients, lifting and thrusting, twisting adjustment is not obvious. The analysis of the two doctor acupuncture treatment, and the qualitative information obtained by the above analysis supported the results of the data. The technique parameters effect of the results and the previous analysis results linked to differences that manipulation will affect the efficacy. But due to participate in the test of high, junior doctors each only 1, to complete the matching manipulation parameter acquisition Patients with limited, failed blind method, the results of the experiment. But the need for caution in the interpretation of this study can be used for acupuncture clinical trials provide methodological advice. The evaluation or explore the acupuncture effect, should fully consider the influence of acupuncture and manipulation of the doctor qualification results, suggesting that research on Acupuncture effect evaluation precision the future, by means of quantitative testing instrument, doctors involved in the trial of acupuncture manipulation of the training and examination in advance, so that the operation is at the same level.

【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R246

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