针刺手法操作差异的临床研究及其方法学探讨

发布时间：2017-12-31 04:04

本文关键词：针刺手法操作差异的临床研究及其方法学探讨　出处：《北京中医药大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的基于随机交叉试验及量化记录针刺手法操作,在针刺处方水平一致的前提下,评价不同针灸医生治疗相同患者手法操作的差异性、稳定性,及自身手法操作的稳定性,探索针刺手法操作与临床疗效的相关性。进而为针刺临床研究提供一种定量、定性采集针刺手法操作信息的模式,并对今后的针刺临床研究中干预措施设置提供方法学参考。方法本研究采用随机交叉对照试验,招募来自于中国中医科学院西苑医院肿瘤科,单用或联用顺铂作为化疗药物的癌症住院患者,并且可以完成连续2周期的化疗方法。排除化疗期间因其他原因接受针刺治疗,或伴有非化疗引起的恶心呕吐情况,如肠梗阻,患有感染性疾病或严重心、脑、肾疾病,严重精神疾病,合并放疗或激素治疗的患者。将合格的患者随机分到A、B两组,在常规化疗及镇吐治疗的基础上,A组患者第一阶段先接受甲医生针刺,经洗脱期,在第二阶段换为接受乙医生针刺。B组患者第一阶段先接受乙医生针刺,经洗脱期,在第二阶段换为接受甲医生针刺。洗脱期为两相邻化疗周期的间歇期,约为21天。甲医生为高资历针灸医生,针灸临床经验15年,乙医生为低资历针灸医生,针灸临床经验5年。每一阶段,两组患者均从化疗给药前开始接受针刺治疗,每天1次,连续5天。针刺治疗之前,甲、乙同时进行床旁问诊,并独立制定针刺方案,但针刺时,两名医生均按照甲医生制定的针刺方案(包括辨证、腧穴选择、取穴、针刺强度、深度、留针时间、补泻手法)执行手针操作。借助Acusensor测量仪客观、定量记录手针操作的全过程,监测提插频率、位移,捻转频率、位移随时间变化的波形图,通过快速傅里叶变换法拟合为提插最大位移、主导频率、捻转最大位移、主导频率4个参数。疗效评价和手法操作参数的分析是针对甲医生组与乙医生组之间的比较来实现。这两组的患者是相同的。完成统计分析后,对两名医生进行一对一深度访谈。通过医评NCI量表及患者自评Rhodes量表,比较治疗相同患者时,两名医生的疗效差异。分析4个手法参数,评价不同针灸医生治疗相同患者手法操作的差异性、稳定性,及自身手法操作的稳定性。探索针刺手法操作与临床疗效的相关性。比较两阶段内,甲医生辨证处方稳定性,患者对不同医生针刺治疗的信心、满意度、针刺期望、医患交流满意度等评估可能影响疗效的相关因素对试验结果造成的偏倚。连续变量采用配对t检验(非正态时采用配对秩和检验),二分类、等级变量采用卡方检验(或Fisher精确概率法)。结果本研究共纳入合格患者39例,第一轮针刺治疗由甲医生完成,第二轮治疗由乙医生完成者(A组)20例,顺序相反者(B组)19例;甲医生共计治疗39例,乙医生共计治疗39例。基线采用全数据集分析,手法操作差异结果评价采用符合方案数据集分析(符合配对条件者,每组各25例)。干预开始前,A、B两组患者在性别、年龄、身体质量指数、卡氏评分、焦虑抑郁评分、针刺期望、针刺信心、化疗药给药天数、镇吐药给药天数、治疗前NCI评分及Rhodes量表评分等基线均无明显差异。经非参数检验,随机交叉试验顺序效应(Z=-0.225,P=0.822)及针刺治疗的残余效应(Z=-0.422,P=0.673)均无统计学意义。前期疗效评价结果发现针刺治疗同一患者时,第3次针刺治疗时患者症状最为明显,高资历医生的疗效与低资历医生疗效有显著性差异,高资历医生更好(NCI量表、Rhode量表)。本研究手法操作差异研究部分的试验结果表明:1)两名医生针刺相同患者时,在4个主穴的手法操作中,提插频率均没有统计学差异,但是提插位移、捻转位移参数的差异具有统计学意义。高资历医生针刺中脘(P0.001)、内关(P0.001)、足三里(P0.001)的提插位移深于低资历针灸医生,针刺天枢(P0.001)的提插位移浅于低资历针灸医生。高资历针灸医生针刺天枢(P0.001)、内关(P=0.046)、足三里(P0.001)的捻转位移大于低资历针灸医生,针刺中脘(P=0.004)的捻转位移小于低资历针灸医生。在腹部腧穴,中脘(P=0.004)、天枢(P=0.004)实施手法操作时,低资历医生捻转频率快于高资历医生;在四肢穴位,内关、足三里上,捻转频率无统计学差异。2)针刺同一批患者时,两名医生在4个主穴提插位移的稳定性都存在差异(P0.001),低资历针灸医生的稳定性优于高资历医生。两名医生在针刺内关穴时,4个手法参数的稳定性均具有统计学差异(P0.05),低资历针灸医生的稳定性优于高资历医生。3)不同时间点针刺同一患者时,高资历医生在62.5%(10/16)的手法参数上体现出手法操作的稳定性;低资历医生在50.0%(8/16)的手法参数上体现出手法操作稳定性,高资历医生的手法操作较低资历医生稳定,特别是在内关穴的操作上。4)两阶段针刺治疗结束后,患者分别对两名医生的针刺治疗信心、满意度、针刺期望、医患交流满意度等评分无统计学差异(P0.10)。本研究针刺方案部分对比性研究结果发现:1)第一阶段,高、低资历医生同时问诊相同患者后,辨证一致率为38.5%(15/39),Kappa=0.220。选取的穴位无统计学差异(χ2=8.746,P=0.724),主穴为中脘,双侧:天枢、内关、足三里。为4个主穴拟定的针刺强度、针刺深度、留针时间、补泻手法存在统计学差异(P0.05)。2)两阶段内,高资历医生问诊相同患者后,选取的穴位无统计学差异(F=4.99,P=0.986),主穴为中脘,双侧:天枢、内关、足三里。为4个主穴拟定的针刺强度、针刺深度、留针时间、补泻手法稳定(P0.10),无统计学差异。本研究通过定性访谈对于上述结果进行补充说明,发现:医生在问诊时切入点及侧重角度不同,辨证的结果会存在较大的差异;虽然选穴的思路及原则不尽相同,但是由于病机相对简单明了,且穴位具有的双向调节作用,两名医生的选穴基本一致。低资历医生为了达到补虚泻实的目的,在制定针刺处方考虑重度手法、增加留针时间,补法泻法相结合的方式增强针刺治疗的刺激量。与定量研究中方案结果相一致。然而,在与定量手法参数分析结果相比较时,发现低资历医生由于缺乏信心,及手法操作并不娴熟,其真实的手针操作明显弱于高资历医生,产生的刺激量未能达到高资历医生平补平泻所期望的中等强度。结论:在相同患者、病情相似、针刺处方水平一致,且可能影响疗效的其他因素被尽量控制的前提下,高资历医生在手针操作时提插捻转的位移大于低资历医生,其对患者带来的刺激量相对较大。高资历医生在针刺同一患者时,手法操作的稳定性较高,针刺不同患者时,会依据患者体型胖瘦、严重程度小范围调整手法的提插、捻转。低资历医生在针刺同一患者时,手法操作的稳定性较差,针刺不同患者时,提插、捻转调整的幅度不明显。对两位医生针刺方案的分析,以及定性访谈所获得的信息支持上述手法参数数据分析的结果。将上述结果与本项目前期分析的疗效比较结果相联系,发现手法操作的差异会影响疗效。但由于参与试验的高、低资历医生各只有1名,完成配对手法操作参数采集的患者有限,未能做到盲法,本试验结果的解释需要谨慎。但本研究可以为针刺临床试验的开展提供方法学建议。即评价或探索针刺疗法的效果时,应充分考虑针灸医生资历及手法操作对研究结果的影响,提示未来开展精确的针刺疗效评价研究时,可借助定量检测仪器,对参与试验的针灸医生的手法操作进行预先的培训及考核,使其操作处于同一水平。
[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.

【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R246

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