【作者】 晋松；

【导师】 梁繁荣；

【作者基本信息】 成都中医药大学 ， 针灸推拿学， 2012， 博士

【摘要】 目的：通过随机对照临床试验,客观评价电针治疗腰椎间盘突出所致坐骨神经痛的临床疗效,筛选电针为主治疗腰椎间盘突出所致坐骨神经痛的优效方案。方法：2011年4月至2012年2月,在同一人群地区的成都中医药大学附属医院、四川省第四人民医院、成都市第一人民医院、简阳市人民医院4家医院同时进行,将符合纳入标准的腰椎间盘突出所致坐骨神经痛患者198例,由成都明科宏能临床医学研究有限公司采用中央随机方法,将患者随机分成电针组(A组)、电针联合牵引组(B组)、电针联合牵引与西药组(C组),每组66例。A组采用电针主穴(在阿是穴、腰夹脊穴、大肠俞、环跳中接一组电针)与配穴(在经络辨证或八纲脏腑辨证配穴中接一组电针)治疗,B组在A组治疗的基础上联合电动牵引治疗,C组在B组治疗的基础上联合西药(口服扶他林与维生素B1)治疗。每组患者电针治疗或牵引治疗第1、2周每天治疗1次,连续治疗5天,休息2天；第3、4周间隔1天治疗1次,共治疗3次,休息2天；第5、6周间隔2天治疗1次,共治疗2次；每次治疗30mins,若电针联合牵引治疗每次治疗共60minso扶他林、维生素B1第1、2周每周1天口服2次,连续口服5天,停药2天；第3、4周每周1天口服2次,间隔1天口服1天,共口服3天,停药2天；第5、6周每周1天口服2次,间隔2天口服1天,共口服2天；扶他林每次口服50mg,维生素B1每次口服10mg。在6周治疗期,如达到几乎完全康复或者完全康复即可根据患者意愿终止治疗。以基线和治疗6周后作为评价时间点,采用腿痛VAS视觉模拟评分、腰痛VAS视觉模拟评分、改良罗兰功能问卷评分、健康相关生活质量评分(SF-36)、Likert总体恢复自我评分对患者治疗前后的腿痛程度、腰痛程度、腰腿功能以及生活质量进行评估。结果：1、基线分析：(1)三组患者社会人口学基本特征各项指标(性别、年龄、婚否、民族、身高、体重、体重指数、是否吸烟、工作类型、工作时间)在入组时基线一致(P>0.05),可比性良好；(2)三组患者临床特征各项指标(腰椎间盘突出的节段、突出方向、经络辨证、八纲脏腑辨证)在入组时基线一致(P>0.05),可比性良好；(3)三组患者的病情程度各项指标(腿痛VAS视觉模拟评分、腰痛VAS视觉模拟评分、改良罗兰功能问卷评分、健康相关生活质量评分SF-36)在入组时基线均一致(P>0.05),可比性良好。2、疗效评价：(1)治疗6周后三组腿痛VAS视觉模拟评分均明显低于治疗前(P<0.01),三组组间比较差异无统计学意义(P>0.05)。(2)治疗6周后三组腰痛VAS视觉模拟评分均明显低于治疗前(P<0.01),三组组间比较有显著性差异(P<0.05),电针联合牵引组优于其他两组。(3)治疗6周后三组改良罗兰功能问卷评分均明显低于治疗前(P<0.01),三组组间比较差异无统计学意义(P>0.05)。(4)健康相关生活质量评分SF-36,治疗6周后三组的生理功能、生理职能、躯体疼痛、社会功能、情感职能方面评分明显高于治疗前(P<0.01)；电针联合牵引组总体健康状况、活力、精神健康评分明显高于治疗前(P<0.05)；三组组间比较在生理职能方面有显著性差异(P<0.05),电针联合牵引组优于其他两组,在其他方面无统计学差异(P>0.05)。(5)Likert,总体恢复自我评分,治疗6周后三组组间比较差异无统计学意义(P>0.05)。3、安全性评估：电针组发生不良事件2例,均为取针后出血,无其他不良事件,不良事件发生率为1%。电针联合牵引组、电针联合牵引与西药组无不良事件发生。三组不良事件发生率比较差异无统计学意义(P>0.05)。结论：1、电针治疗、电针联合牵引治疗、电针联合牵引与西药治疗在改善腰椎间盘突出所致坐骨神经痛的腿痛、腰腿功能、生活质量的生理功能、躯体疼痛、总体健康状况、活力、社会功能、情感职能、精神健康方面均是安全、有效的治疗方案,且疗效相当。2、在改善腰椎间盘突出所致坐骨神经痛的腰痛、生活质量的生理职能方面,电针联合牵引治疗可能疗效更好。更多还原

【Abstract】 Objective:To select the superior effect scheme of acupuncture in treating sciatica caused by lumbar disc herniation, via randomized controlled clinical trials based on the objective evaluation of its clinical efficacy.Methods:This trial was conducted between April2011and February2012in4different hospitals with the same population coverage, including Sichuan Provincial Traditional Chinese Medicine Hospital, The Fourth People’s Hospital of Sichuan Province, The First People’s Hospital of Chengdu and Jianyang People’s Hospital.198patients with sciatica caused by lumbar disc herniation which meet the diagnostic criteria were selected. Adopting centrally randomized control method, Chengdu Brightech-Magnosoft Data Services divided all the patients into three groups by RCT with66patients in each group:Electro-acupuncture Group (Group A, main Acupoints Ashi, Yaojiaji, Dachangyshu and Huantiao were taken together with supporting acupoints in line with the pattern identification theory of meridian differentiation or eight principle visceral differentiation of lumbar disc herniation), Electro-acupuncture with Traction Group (Group B, traction treatment was given in addition to the treatment of Group A), Electro-acupuncture together with Traction and Western Medicine Group (Group C, western medicine<Votalin and Vitamin B1> was given in addition to the treatment of Group B).Every patient with Electro-acupuncture or Traction treatments received5treatments weekly in succession for the first two weeks, with two days’ rest; every other day on weekly basis in total3treatments each for the third and forth week; and every third day on weekly basis in total2treatments each for the fifth and sixth week. Each single treatment lasted30minutes and60minutes of Electro-acupuncture combined with Traction. Voltalin and Vitamin B1were taken twice a day and five days in consecutive for the first two weeks, every other day during the3rd and4th week and every third day during the5th and6th week.50mg of Votalin and10mg of Vitamin B1were taken for each treatment. During the six-week-long treatment, the patients could choose to stop the treatment if they fully recovered or almost totally recovered. Time evaluation points were taken for Base Line and Week6. Evaluations were assessed on Visual Analogue Scale (VAS) of their leg pains and waist pains, Modified Roland-Morris Disability Questionnaire, Mos Item Short from Health Survery-36(SF-36), as well as the7-point Likert Scale before and after the treatment. Results:1. Baseline Analysis:(1) The compared baseline of Sociodemographic basic characteristics’indicators of all the patients were consistent with good comparability when they entered their groups respectively(P>0.05)(gender, age, marital status, ethnic, height, weight, weight index, smoke or not, job category, working time).(2) The compared baseline of clinical features’indicators of all the patients were consistent with good comparability when they entered their groups respectively(P>0.05)(different segments, direction, meridian differentiation, eight principle visceral differentiation of lumbar disc herniation).(3) The compared baseline of severity’s indicators of all the patients were consistent with good comparability when they entered their groups respectively (P>0.05)(visual analogue scale of leg pain, visual analogue scale of waist pain, modified Roland-Morris disability questionnaire, SF-36).2. Efficacy Evaluation:(1) Visual Analogue Scale of leg pain:significant difference exists that the VAS scores after treatment are obviously lower than that before the treatment (P<0.01), without statistics difference existing among the three groups(P>0.05).(2) Visual Analogue Scale of waist pain:significant difference exists that the VAS scores after treatment are obviously lower than that before the treatment (P<0.01), with statistics difference existing among the three groups(P<0.05).(3) Modified Roland-Morris Disability Questionnaire:significant difference exists that the Roland scores after treatment are obviously lower than that before the treatment (P<0.01), without statistics difference existing among the three groups(P>0.05).(4) Mos item short from health survey-36(SF-36):in terms of PF, RP, BP, SF and RE, significant difference exists that the scores after treatment are obviously higher than that before the treatment (P<0.01); There exist significant differences in Group B (Electro-acupuncture with Traction) in terms of GH, VT and MH before and after the treatment(P<0.05); Obvious difference in RP was also observed among the three groups, and there is no other statistics difference existing among the three groups(P>0.05).(5) The7-point Likert Scale:there is no statistics difference existing among the three groups(P>0.05).3. Safety Assessment:There occurred2cases of adverse events only in Electro-acupuncture Group, both bleeding cases after electro-acupuncture treatment. There is no obvious difference of the incidence of adverse events among the three groups, which indicates that all the three therapeutic schemes are safe(P>0.05). Conclusions:1. Electro-acupuncture Therapy, Electro-acupuncture with Traction, and Electro-acupuncture together with Traction and Western Medicine Therapy are all safe and effective therapeutic schemes to treat sciatica caused by lumbar disc herniation, waist and leg functioning, as well as PF, BP,GH,VT,SF,RE and MH of life quality.2. Electro-acupuncture with traction therapy is likely to achieve a better curative effect in easing sciatica waist pain caused by lumbar disc herniation and RP of life quality.更多还原