正交设计法优化夹脊穴脉冲电场脊髓损伤康复处方的临床研究

Orthogonal design method to optimize rehabilitation prescription of pulsed electric field at Jiaji (EX-B 2) points for spinal cord injury

目的：通过正交设计选择夹脊穴脉冲电场治疗脊髓损伤（SCI）最优处方,为临床治疗本病提供参考。方法：选取56例SCI患者,36例患者进行正交试验,20例患者进行临床验证。36例进行正交设计患者,以Frankel分级变化为观察指标,筛选脉冲电场最优处方,研究包括脉冲频率（A因素：AⅠ：低频（10^2 Hz）,AⅡ：中频（10^4 Hz）,AⅢ：高频（10^5 Hz））、脉冲幅度（B因素：BⅠ：0~30V,BⅡ：0~60V,BⅢ：0~90V）、脉冲宽度（C因素：CⅠ：0.4ms,CⅡ：0.6ms,CⅢ：0.9ms））、针刺时间（D因素：DⅠ：1个月,DⅡ：3个月,DⅢ：5个月）;对20例患者进行临床效果观察,观察筛选的脉冲夹脊电场最优处方结合常规康复方法对患者痉挛程度、感觉与运动功能评分、Barthel指数、脊髓损伤严重程度（Frankel分级）的影响。结果：1正交试验表明,最优处方为AⅢBⅢCⅠDⅢ,即脉冲频率为高频（10^5 Hz）、脉冲幅度为0~90V、脉冲宽度为0.4ms、针刺时间为5个月;220例患者临床验证表明,治疗后Ashworth评分、腱反射及阵挛均明显改善（P〈0.001,P〈0.01）,运动功能评分、感觉功能评分明显提高（P〈0.001,P〈0.05）,Barthel指数、Frankel分级亦明显改善（P〈0.001,P〈0.05）。结论：夹脊穴脉冲电场治疗SCI的最优处方：脉冲频率为高频（105 Hz）、脉冲幅度为0~90V、脉冲宽度为0.4ms、针刺时间为5个月,采用夹脊穴脉冲电场配合常规康复可明显改善SCI患者痉挛程度、提高运动及感觉功能、改善日常生活活动能力及Frankel分级。

Objective By using orthogonal design method to optimize prescription of pulsed electric field at Jiaji （EX- B 2） points for spinal cord injury （SCI）. Methods Fifty-six patients of SCI were selected, in which 36 cases were divided into orthogonal design trial and 20 cases were into clinical verification. With 36 patients who received orthogonal design trial, Frankel grading scale was used as observation index to screen optimal prescription of pulsed electric field. Pulse frequency （factor A） included low frequency （factor AⅠ, 10^2 Hz）, moderate frequency （factor AⅡ, 10^4 Hz） and high frequency （factor AⅢ , 10^5 Hz） ; pulse amplitude （factor B） included 0-30 V （factor BⅠ ）, 0-60 V （factor BⅡ ） and 0-90 V （factor BⅢ ） ; pulse width （factor C） included 0.4 ms （factor CⅠ ）, 0.6 ms （factor CⅡ ） and 0.9 ms （factor CⅢ ）; acupuncture time （factor D） included one month （DⅠ）, three months （DⅡ） and five months （DⅢ）. Twenty patients were used for clinical efficacy observation, and the effects of screened optimal pre- scription of pulsed electric field at Jiaji （EX-B 2） points combined with regular rehabilitation training on spasm se- verity, score of sensory and motor functions, Barthel index and Frankel score were observed. Results ① As results of orthogonal design trial, the optimal prescription was AⅢ BⅢ CⅠ DⅢ, which were high frequency （10s Hz）, 0-90 V of pulse amplitude, 0.4 ms of pulse width and 5 months of treatment time. ② As results of 20-patient clinical verification, Ashworth score, tendon reflex and clonus were all significantly improved （P〈0. 001, P〈 0.01）, the scores of sensory and motor functions were evidently improved （P〈0. 001, P〈0.05）, and Barthel in-dex and Frankel score were also enhanced （P〈0. 001, P〈0.05）. Conclusion The optimal prescription of pulsed electric field at Jiaji （EX-B 2） points for spinal cord injury is high frequency （10^5 Hz）, 0-90 V of pulse amplitude, 0.4 ms of pulse width and 5 months of treatment time. The optimal prescription of pulsed electric field at jiaji （EX-B 2） points combined with regular rehabilitation could obviously improve spasm severity, enhance senso- ry and motor functions, and ameliorate activity of daily life and Frankel score.