目的:探讨活血方定向透药联合常规康复疗法治疗斜外侧入路腰椎椎间融合术(oblique lumbar interbody fusion,OLIF)后残留腰腿痛的临床疗效。方法:将62例OLIF术后残留腰腿痛的患者随机分为联合康复疗法组和常规康复疗法组,每组31例。常规康复疗法组采用口服塞来昔布胶囊和乙哌立松片及常规康复锻炼治疗,联合康复疗法组在常规康复疗法的基础上联合活血方定向透药治疗;2组均治疗14 d。记录并比较2组患者治疗前和治疗结束时的腰腿疼痛视觉模拟量表(visual analogue scale,VAS)评分、Oswestry功能障碍指数(Oswestry disability index,ODI)、左侧腰大肌横截面积(cross-sectional area,CSA),简明健康状况调查表(short form 36 health survey questionnaire,SF-36)中的生理功能、社会功能、精神健康、生理职能评分,以及血清肌酸激酶(creatine kinase,CK)、白细胞介素(interleukin,IL)-1、IL-6含量。结果:试验过程中,2组均无脱落病例。①腰腿疼痛VAS评分。治疗结束时,2组患者腰腿疼痛VAS评分均低于治疗前[(6。84±0。86)分,(0。90±0。54)分,t=32。561,P=0。000;(6。97± 0。95)分,(1。35±0。61)分,t=27。744,P=0。000],联合康复疗法组患者腰腿疼痛VAS评分低于常规康复疗法组(t=3。095,P=0。004)。②ODI。治疗结束时,2 组患者 ODI 均低于治疗前[(18。65±2。56)%,(8。16±2。27)%,t=17。058,P=0。000;(18。29± 2。52)%,(9。97±1。83)%,t=14。869,P=0。000],联合康复疗法组患者ODI低于常规康复疗法组(t=3。450,P=0。002)。③左侧腰大肌CSA。治疗结束时,2组患者左侧腰大肌CSA均小于治疗前[(922。15±18。21)mm2,(784。89±19。02)mm2,t=29。024,P=0。000;(917。93±17。41)mm2,(801。38±13。26)mm2,t=29。652,P=0。000],联合康复疗法组患者左侧腰大肌 CSA 小于常规康复疗法组(t=3。959,P=0。000)。④SF-36中的生理功能、社会功能、精神健康及生理职能评分。治疗结束时,2组患者生理功能、社会功能、精神健康及生理职能评分均高于治疗前[生理功能评分:(51。42±3。02)分,(72。32±3。34)分,t=25。846,P=0。000;(50。68±2。56)分,(63。42±3。89)分,t=15。237,P=0。000;社会功能评分:(58。03±3。24)分,(81。39±4。10)分,t=24。898,P=0。000;(58。19±3。82)分,(74。13±2。79)分,t=18。770,P=0。000;精神健康评分:(61。32±4。44)分,(83。97±3。45)分,t=22。432,P=0。000;(61。26±4。73)分,(73。68±3。44)分,t=11。832,P=0。000;生理职能评分:(60。71±3。39)分,(83。03± 3。33)分,t=26。352,P=0。000;(61。29±3。05)分,(73。77±3。95)分,t=1。940,P=0。000],联合康复疗法组患者生理功能、社会功能、精神健康及生理职能评分均高于常规康复疗法组(t=9。670,P=0。000;t=8。154,P=0。000;t=11。763,P=0。000;t=9。980,P=0。000)。⑤血清CK、IL-1和IL-6含量。治疗结束时,2组患者血清CK、IL-1、IL-6含量均低于治疗前[血清CK含量:(303。29±14。61)U·L-1,(186。26±10。26)U·L-1,t=36。502,P=0。000;(301。06±10。85)U·L-1,(204。65±15。25)U·L-1,t=28。680,P=0。000;血清 IL-1 含量:(3。89±0。15)pg·mL-1,(1。01±0。16)pg·mL-1,t=72。516,P=0。000;(3。87±0。18)pg·mL-1,(1。49±0。18)pg·mL-1,t=52。425,P=0。000;血清 IL-6 含量:(13。73±0。84)pg·mL-1,(4。83±0。22)pg·mL-1,t=57。210,P=0。000;(13。45±1。12)pg·mL-1,(5。98±0。18)pg·mL-1,t=36。697,P=0。000],联合康复疗法组患者血清 CK、IL-1、IL-6 含量均低于常规康复疗法组(t=5。569,P=0。000;t=11。059,P=0。000;t=22。258,P=0。000)。结论:对于OLIF术后残留腰腿痛的患者,活血方定向透药联合常规康复疗法较单纯常规康复疗法能更好地降低炎症反应、减轻腰大肌水肿、缓解腰腿疼痛症状、改善腰椎功能和提高患者生活质量。
Directional transdermal iontophoresis of Huoxue Fang(活血方)combined with conventional rehabilitation therapy for treatment of residual lumbocrural pain following oblique lumbar interbody fusion:a clinical study
Objective:To explore the clinical outcomes of directional transdermal iontophoresis of Huoxue Fang(活血方,HXF)com-bined with conventional rehabilitation therapy for treatment of residual lumbocrural pain emerged after oblique lumbar interbody fusion(OLIF).Methods:Sixty-two patients with residual lumbocrural pain after OLIF were randomized into combined rehabilitation therapy group and conventional rehabilitation therapy group,31 cases in each group.All patients in the 2 groups were treated with oral application of cele-coxib capsules and eperisone tablets,followed by conventional rehabilitation exercises;while the ones in combined rehabilitation therapy group were further treated with directional transdermal iontophoresis of HXF.All patients were treated for consecutive 14 days.The lumbo-crural pain visual analogue scale(VAS)score,Oswestry disability index(ODI),cross-sectional area(CSA)of the left psoas major muscle,the scores for physical functioning(PF),social functioning(SF),mental health(MH),and role-physical(RP)in the short form 36 health survey questionnaire(SF-36)as well as the serum levels of creatine kinase(CK),interleukin(IL)-1,and IL-6 were recorded and compared between the 2 groups before the treatment and at the end of treatment,respectively.Results:During the trial,no patients dropped out of the study.①The lumbocrural pain VAS score decreased at the end of treatment compared to pretreatment in the 2 groups(6.84±0.86 vs 0.90±0.54 points,t=32.561,P=0.000;6.97±0.95 vs 1.35±0.61 points,t=27.744,P=0.000),and it was lower in combined re-habilitation therapy group compared to conventional rehabilitation therapy group(t=3.095,P=0.004).②The ODI decreased at the end of treatment compared to pretreatment in the 2 groups(18.65±2.56 vs 8.16±2.27%,t=17.058,P=0.000;18.29±2.52 vs 9.97± 1.83%,t=14.869,P=0.000),and it was lower in combined rehabilitation therapy group compared to conventional rehabilitation therapy group(t=3.450,P=0.002).③The CSA of the left psoas major muscle decreased at the end of treatment compared to pretreatment in the 2 groups(922.15±18.21 vs 784.89±19.02 mm(2),t=29.024,P=0.000;917.93±17.41 vs 801.38±13.26 mm(2),t=29.652,P=0.000),and it was smaller in combined rehabilitation therapy group compared to conventional rehabilitation therapy group(t=3.959,P=0.000).④The scores for PF,SF,MH and RP increased at the end of treatment compared to pretreatment in the 2 groups(score for PF:51.42±3.02 vs 72.32±3.34 points,t=25.846,P=0.000;50.68±2.56 vs 63.42±3.89 points,t=15.237,P=0.000;score for SF:58.03±3.24 vs 81.39±4.10 points,t=24.898,P=0.000;58.19±3.82 vs 74.13±2.79 points,t=18.770,P=0.000;score for MH:61.32±4.44 vs 83.97±3.45 points,t=22.432,P=0.000;61.26±4.73 vs 73.68±3.44 points,t=11.832,P=0.000;score for RP:60.71±3.39 vs 83.03±3.33 points,t=26.352,P=0.000;61.29±3.05 vs 73.77±3.95 points,t=1.940,P=0.000),and they were higher in combined rehabilitation therapy group compared to conventional rehabilitation therapy group(t=9.670,P=0.000;t=8.154,P=0.000;t=11.763,P=0.000;t=9.980,P=0.000).⑤The serum levels of CK,IL-1 and IL-6 decreased at the end of treatment compared to pretreatment in the 2 groups(serum level of CK:303.29±14.61 vs 186.26±10.26 U/L,t=36.502,P=0.000;301.06±10.85 vs 204.65±15.25 U/L,t=28.680,P=0.000;serum level of IL-1:3.89±0.15 vs 1.01±0.16 pg/mL,t=72.516,P=0.000;3.87±0.18 vs 1.49±0.18 pg/mL,t=52.425,P=0.000;serum level of IL-6:13.73±0.84 vs 4.83±0.22 pg/mL,t=57.210,P=0.000;13.45± 1.12 vs 5.98±0.18 pg/mL,t=36.697,P=0.000),and they were lower in combined rehabilitation therapy group compared to conven-tional rehabilitation therapy group(t=5.569,P=0.000;t=11.059,P=0.000;t=22.258,P=0.000).Conclusion:Directional transder-mal iontophoresis of HXF combined with conventional rehabilitation therapy can better reduce inflammatory response,alleviate psoas major muscle edema,relieve lumbocrural pain symptoms,improve lumbar function and the quality of life compared to conventional rehabilitation therapy alone in patients with residual lumbocrural pain after OLIF.
postoperative complicationslumbago leg painspinal fusionrehabilitationexternal treatmenttraditional chinese medicine tar-geted transdermal medicineclinical trial