柔性纳米电极型小针刀在颈型颈椎病诊治中的应用
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摘要
[目的]评估柔性纳米电极型小针刀的稳定性、信度、效度、最小临床意义变化值,评价柔性纳米电极小针刀在颈型颈椎病应用中的可行性,并为其在临床应用中提供理论基础。[方法]招募健康志愿者和颈型颈椎病患者各30名,分别使用柔性纳米电极小针刀在颈椎棘突旁共6个进针点进行采集,分别在10k、30k、50k频率下,记录5分钟内的阻抗变化。各研究对象在不同频率下,各时间点的阻抗值取6个进针点的平均值进行统计学分析,评估各自的稳定性、信度、效度,分析患者组治疗前后阻抗变化,获得最小临床意义变化值。[结果]当频率为30k时,标准差及变异系数最小,时间稳定性、个体稳定性最好,信度评价和效度评价也是最好的。因此柔性纳米电极型小针刀的最佳频率为30k。患者组阻抗与MPQ评分之间的相关系数r为0.927,为正相关,有显著的统计学意义(P<0.001)。应用校标法,显示有效的最小意义变化值为9.9,应用线性回归分析,显示有效的最小意义变化值为6.35。[结论]在频率为30k时,柔性纳米电极型小针刀具有良好的稳定性及信度和效度,且可反映颈型颈椎病患者的疾病程度与针刀治疗的效果,在颈型颈椎病的诊治中具有良好的可行性。
[Objective] To evaluate the stability, reliability, validity and minimum clinical important index of flexible nano-electrode small needle knife,evaluate the feasibility of flexible nano-electrode small needle knife in the application of cervical type cervical spondylosis, and provide theory basis for its clinical application. [Methods] Recruited 30 healthy volunteers and 30 patients with cervical spondylosis, using a flexible nano-electrode small needle knife to collect impedance at 6 points of cervical spine under a frequency of 10 k, 30 k, 50 k, recorded within 5 minutes. The impedance values of each point were taken at different frequencies, and the average value of the 6 points was statistically analyzed to evaluate the stability, reliability and validity of the patients. The impedance changes before and after treatment were analyzed in the patient group to obtain the minimum clinical important index.[Results] When the frequency was 30 k, the standard deviation and coefficient of variation were the smallest, the time stability and individual stability were the best, and the reliability evaluation and validity evaluation were also the best. Therefore, the optimum frequency of the flexible nano-electrode type small needle knife was 30 k. The correlation coefficient r between the impedance and the MPQ score in patient group was 0.927, which was positively correlated and statistically significant(P <0.001). Applying the calibration method, the effective minimum clinical important index was 9.9, and linear regression analysis was applied to show that the effective minimum clinical important index was 6.35. [Conclusions] At a frequency of 30 k, the flexible nano-electrode type small needle knife has good stability, reliability and validity, and can reflect the disease degree of patients with cervical type cervical spondylosis and the effect of needle-knife treatment. It has good feasibility of diagnosis and treatment in cervical type cervical spondylosis.
[Objective] To evaluate the stability, reliability, validity and minimum clinical important index of flexible nano-electrode small needle knife,evaluate the feasibility of flexible nano-electrode small needle knife in the application of cervical type cervical spondylosis, and provide theory basis for its clinical application. [Methods] Recruited 30 healthy volunteers and 30 patients with cervical spondylosis, using a flexible nano-electrode small needle knife to collect impedance at 6 points of cervical spine under a frequency of 10 k, 30 k, 50 k, recorded within 5 minutes. The impedance values of each point were taken at different frequencies, and the average value of the 6 points was statistically analyzed to evaluate the stability, reliability and validity of the patients. The impedance changes before and after treatment were analyzed in the patient group to obtain the minimum clinical important index.[Results] When the frequency was 30 k, the standard deviation and coefficient of variation were the smallest, the time stability and individual stability were the best, and the reliability evaluation and validity evaluation were also the best. Therefore, the optimum frequency of the flexible nano-electrode type small needle knife was 30 k. The correlation coefficient r between the impedance and the MPQ score in patient group was 0.927, which was positively correlated and statistically significant(P <0.001). Applying the calibration method, the effective minimum clinical important index was 9.9, and linear regression analysis was applied to show that the effective minimum clinical important index was 6.35. [Conclusions] At a frequency of 30 k, the flexible nano-electrode type small needle knife has good stability, reliability and validity, and can reflect the disease degree of patients with cervical type cervical spondylosis and the effect of needle-knife treatment. It has good feasibility of diagnosis and treatment in cervical type cervical spondylosis.
引文
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[10]张义,权伍成,尹萍,等.针刀疗法的适应证和优势病种分析[J].中国针灸,2010,30(6):525-528.ZHANG Yi, QUAN Wucheng, YIN Ping, et al. Analysis on indications and dominant diseases of acupotomology[J].Chinese Acupuncture&Moxibustion, 2010,30(6):525-528.
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[12] Tarsi GM, Gould RA, Chung JA, et al. Method for nonoptical quantification of in situ local soft tissue biomechanics[J]. Journal of Biomechanics, 2013, 46(11):1938-1942.
[13] Jeong JW, Shin G, Park SI, et al. Soft materials in neuroengineering for hard problems in neuroscience[J]. Neuron, 2015, 86(1):175-186.
[14] Duan X, Fu TM, Liu J, et al. Nanoelectronics-biology frontier:From nanoscopic probes for action potential recording in live cells to three-dimensional cyborg tissues[J]. Nano Today, 2013, 8(4):351-373.
[15] Peng P, Rajamani R, Erdman AG. Flexible tactile sensor for tissue elasticity measurements[J].Journal of Microelectromechanical Systems, 2009, 18(6):1226-1233.
[16] Dagdeviren C, Shi Y, Joe P, et al. Conformal piezoelectric systems for clinical and experimental characterization of soft tissue biomechanics[J]. Nature Materials, 2015, 14(7):728-736.
[17] Liu Y, Gao L, Sun J, et al. Stable Nafion-functionalized graphene dispersions for transparent conducting films[J].Nanotechnology, 2009, 20(46):465605.
[18] Gong S, Schwalb W, Wang Y, et al. A wearable and highly sensitive pressure sensor with ultrathin gold nanowires[J]. Nature Communications, 2014, 5(2):3132.
[19] Yokota T, Inoue Y, Terakawa Y, et al. Ultraflexible,large-area, physiological temperature sensors for multipoint measurements[J]. Proceedings of the National Academy of Sciences of the United States of America, 2015,112(47):14533-8.
[20] Apollo NV, Maturana MI, Tong W, et al. Soft, flexible freestanding neural stimulation and recording electrodes fabricated from reduced graphene oxide[J]. Advanced Functional Materials, 2015, 25(23):3551-3559.
[21] Park DW, Schendel AA, Mikael S, et al. Graphenebased carbon-layered electrode array technology for neural imaging and optogenetic applications[J]. Nature Communications, 2011, 5:5258.
[22] Fang Y, Hou J, Fang Y. Flexible bio-interfaced nanoelectronics[J]. Journal of Materials Chemistry C,2014,2(7):1178-1183.
[23] Yoo JM, Kang JH, Hong BH. Graphene-based nanomaterials for versatile imaging studies[J].Chemical Society Reviews, 2015, 44(14):4835-52.
[24] Allen MJ, Tung VC, Kaner RB. Honeycomb carbon:A review of graphene[J].Chemical Reviews,2009,110(1):132.
[25] Magliulo M, Mulla MY, Singh M, et al. Printable and flexible electronics:from TFTs to bioelectronic devices[J].Journal of Materials Chemistry C,2015,3(48):12347-12363.
[2] Vahedi M, Mazdeh M, Hajilooi M, et al. The relationship between salivary alpha amylase activity and score of McGill pain questionnaire in patients with tension type headache[J].Basic and clinical neuroscience,2018,9(1):59-64.
[3]刘颖,林锐,胡幼平.量表在颈椎病临床疗效评价中的应用[J].针灸临床杂志,2011,27(8):63-65.LIU Ying, LIN Rui, HU Youping. Applications of scales in the therapeutic evaluation of cervical spondylosis[J].Journal of Clinical Acupuncture and Moxibustion, 2011,27(8):63-65.
[4]艾金伟,李德胜,刘羽,等.中医辩证治疗膝骨性关节炎的网状Meta分析[J].中国循证医学杂志,2016,16(5):532-542.AI Jinwei,LI Desheng,LIU Yu,et al.Effectiveness of traditional Chinese medicine therapy for knee osteoarthritis:A network Meta-analysis[J].Chinese Journal of EvidenceBased Medicine, 2016(5):532-542.
[5]张建强,荣姗姗.针刺规律性阿是穴治疗颈型颈椎病临床研究[J].中国针灸,2013(s1):31-34.ZHANG Jianqiang, RONG Shanshan. Clinical observation on cervical spondylopathy treated with acupuncture at Ashi points[J]. Chinese Acupuncture&Moxibustion, 2013(s1):31-34.
[6]杨瑜,潘路平,林咸明.基于“颈腰同治”理论温针灸治疗颈型颈椎病临床疗效观察[J].中国针灸,2016,36(11):1147-1151.YANG Yu, PAN Luping, LIN Xianming. Clinical efficacy of warm needling therapy on cervical spondylosis of neck type based on the theory of “treatment both for the neck and lumbus”[J]. Chinese Acupuncture&Moxibustion,2016, 36(11):1147-1151.
[7]王雪,苏少杰,沈特立.针刺“手四针”治疗风寒湿型颈型颈椎病临床观察[J].中国针灸,2016,36(11):1152-1154.WANG Xue, SU Shaojie, SHEN Teli. Clinical observation of cervical spondylosis of neck type with wind-colddamp treated with fourhand-needling therapy[J]. Chinese Acupuncture&Moxibustion, 2016, 36(11):1152-1154.
[8]王峻良,顾非.近10年颈型颈椎病研究综述[J].颈腰痛杂志,2014,35(3):211-213.WANG Junliang, GU Fei. Review of the past decade neck cervical spondylosis[J]. The Journal of Cervicodynia and Lumbodynia, 2014,35(3):211-213.
[9]罗巨利,周长征,唐成剑.中药离子导入结合小针刀治疗颈型颈椎病的临床观察[J].中国医药指南, 2015(10):21-22.LUO Juli, ZHOU Changzheng, TANG Chengjian. Clinical medicine iontophoresis combined with a small knife treatment of cervical cervical spondylosis[J]. Guide of China Medicine, 2015(10):21-22.
[10]张义,权伍成,尹萍,等.针刀疗法的适应证和优势病种分析[J].中国针灸,2010,30(6):525-528.ZHANG Yi, QUAN Wucheng, YIN Ping, et al. Analysis on indications and dominant diseases of acupotomology[J].Chinese Acupuncture&Moxibustion, 2010,30(6):525-528.
[11] Kim DH, Ghaffari R, Lu N, et al. Flexible and stretchable electronics for biointegrated devices[J]. Annual Review of Biomedical Engineering, 2015, 14(1):113-128.
[12] Tarsi GM, Gould RA, Chung JA, et al. Method for nonoptical quantification of in situ local soft tissue biomechanics[J]. Journal of Biomechanics, 2013, 46(11):1938-1942.
[13] Jeong JW, Shin G, Park SI, et al. Soft materials in neuroengineering for hard problems in neuroscience[J]. Neuron, 2015, 86(1):175-186.
[14] Duan X, Fu TM, Liu J, et al. Nanoelectronics-biology frontier:From nanoscopic probes for action potential recording in live cells to three-dimensional cyborg tissues[J]. Nano Today, 2013, 8(4):351-373.
[15] Peng P, Rajamani R, Erdman AG. Flexible tactile sensor for tissue elasticity measurements[J].Journal of Microelectromechanical Systems, 2009, 18(6):1226-1233.
[16] Dagdeviren C, Shi Y, Joe P, et al. Conformal piezoelectric systems for clinical and experimental characterization of soft tissue biomechanics[J]. Nature Materials, 2015, 14(7):728-736.
[17] Liu Y, Gao L, Sun J, et al. Stable Nafion-functionalized graphene dispersions for transparent conducting films[J].Nanotechnology, 2009, 20(46):465605.
[18] Gong S, Schwalb W, Wang Y, et al. A wearable and highly sensitive pressure sensor with ultrathin gold nanowires[J]. Nature Communications, 2014, 5(2):3132.
[19] Yokota T, Inoue Y, Terakawa Y, et al. Ultraflexible,large-area, physiological temperature sensors for multipoint measurements[J]. Proceedings of the National Academy of Sciences of the United States of America, 2015,112(47):14533-8.
[20] Apollo NV, Maturana MI, Tong W, et al. Soft, flexible freestanding neural stimulation and recording electrodes fabricated from reduced graphene oxide[J]. Advanced Functional Materials, 2015, 25(23):3551-3559.
[21] Park DW, Schendel AA, Mikael S, et al. Graphenebased carbon-layered electrode array technology for neural imaging and optogenetic applications[J]. Nature Communications, 2011, 5:5258.
[22] Fang Y, Hou J, Fang Y. Flexible bio-interfaced nanoelectronics[J]. Journal of Materials Chemistry C,2014,2(7):1178-1183.
[23] Yoo JM, Kang JH, Hong BH. Graphene-based nanomaterials for versatile imaging studies[J].Chemical Society Reviews, 2015, 44(14):4835-52.
[24] Allen MJ, Tung VC, Kaner RB. Honeycomb carbon:A review of graphene[J].Chemical Reviews,2009,110(1):132.
[25] Magliulo M, Mulla MY, Singh M, et al. Printable and flexible electronics:from TFTs to bioelectronic devices[J].Journal of Materials Chemistry C,2015,3(48):12347-12363.