针刺配合郑氏舒活酊涂擦治疗经皮内镜下腰椎间盘切除术后感觉异常的临床研究

A clinical study of acupuncture therapy combined with inunction of Zheng’s Shuhuo Ding(舒活酊) for treatment of paresthesia after percutaneous endoscopic lumbar discectomy

目的:观察针刺配合郑氏舒活酊涂擦治疗经皮内镜下腰椎间盘切除术(percutaneous endoscopic lumbar discectomy,PELD)后感觉异常的临床疗效和安全性。方法:选择因腰椎间盘突出症接受PELD治疗后出现感觉异常的42例患者为研究对象。采用随机数字表随机分为基础治疗组和联合治疗组,每组21例。基础治疗组静脉滴注20%甘露醇注射液(每次250 mL,每天1次,连用3 d)、地塞米松注射液(每次10 mg,每天1次,连用3 d),口服甲钴胺片(每次0.5 mg,每天3次,连用30 d),同时进行仰卧位抬腿及踝泵等功能锻炼。联合治疗组在基础治疗组治疗方案的基础上增加针刺治疗和郑氏舒活酊涂擦治疗,针刺治疗每次20 min、郑氏舒活酊涂擦治疗每次15 min,2种治疗方法均每天1次,连续5次为1个疗程,每个疗程结束后休息2 d,共治疗2个疗程。根据患者治疗期间的疼痛程度,必要时给予镇痛药物。分别于治疗前、治疗开始后2周及治疗开始后3个月采用视觉模拟量表(visual analogue scale,VAS)评定患者下肢疼痛和麻木程度,采用 Oswestry功能障碍指数(Oswestry disability index,ODI)问卷表评定感觉异常对患者日常生活的影响,治疗开始后3个月采用改良MacNab标准评价总体疗效,观察记录治疗期间患者镇痛药物的使用情况和不良反应的发生情况。结果:①疼痛VAS评分。时间因素与分组因素存在交互效应( F=6.748,P =0.002);2组疼痛VAS评分总体比较,差异有统计学意义,即存在分组效应( F=6.830,P =0.013);治疗前后不同时点之间疼痛VAS评分的差异有统计学意义,即存在时间效应( F=596.189,P =0.000);2组疼痛VAS评分随时间变化均呈降低趋势,但2组的降低趋势不完全一致[(5.762±0.816)分,(2.905±0.436)分,(1.571±0.598)分, F=339.958,P =0.000;(5.952±1.011)分,(3.881±0.757)分,(1.786± 0.624)分, F=269.273,P =0.000];治疗前及治疗开始后3个月,2组疼痛VAS评分比较,差异均无统计学意义( t=-0.672, P=0.506;t=-1.137,P =0.262);治疗开始后2周,联合治疗组的疼痛VAS评分低于基础治疗组( t=-5.121,P =0.000)。②感觉麻木VAS评分。时间因素与分组因素存在交互效应( F=7.534,P =0.001);2组感觉麻木VAS评分总体比较,差异有统计学意义,即存在分组效应( F=15.104,P =0.000);治疗前后不同时点之间感觉麻木VAS评分的差异有统计学意义,即存在时间效应( F=421.241,P =0.000);2组感觉麻木VAS评分随时间变化均呈降低趋势,但2组的降低趋势不完全一致[(5.238± 0.875)分,(2.738±0.561)分,(1.357±0.854)分, F=339.958,P =0.000;(5.429±0.763)分,(3.905±0.605)分,(1.857± 0.478)分, F=269.273,P =0.000];治疗前2组感觉麻木VAS评分比较,差异无统计学意义( t=-0.752,P =0.457);治疗开始后2周和治疗开始后3个月,联合治疗组的感觉麻木VAS评分均低于基础治疗组( t=-6.479,P=0.000;t=-2.342,P =0.024)。③ODI评分。时间因素与分组因素存在交互效应( F=4.346,P =0.016);2组ODI评分总体比较,差异无统计学意义,即不存在分组效应( F=1.459,P =0.234);治疗前后不同时点之间ODI评分的差异有统计学意义,即存在时间效应( F=261.210, P =0.000 );2组ODI评分随时间变化均呈降低趋势,但2组的降低趋势不完全一致[(39.789±10.930)分,(19.579±8.537)分,(11.325±6.242)分, F=339.958,P =0.000;(40.471±13.929)分,(24.022±9.124)分,(17.462±10.238)分, F=269.273,P =0.000];治疗前和治疗开始后2周,2组ODI评分比较,差异均无统计学意义( t=0.082,P=0.935;t=-1.630,P =0.111);治疗开始后3个月,联合治疗组的ODI评分低于基础治疗组( t=-2.345,P =0.024)。④总体疗效。按照改良MacNab标准评定总体疗效,联合治疗组优15例、良4例、可1例、差1例,基础治疗组优8例、良7例、可4例、差2例。联合治疗组的总体疗效优于基础治疗组( R 联合治疗组=17.81, R 基础治疗组=25.19, Z=-2.158,P =0.031)。疗效评定为差的3例患者,采用针刺配合郑氏舒活酊涂擦治疗(方案同前),继续治疗1个月后症状均缓解。⑤治疗期间镇痛药物使用情况。治疗期间联合治疗组2例口服氨酚曲马多片,基础治疗组8例口服氨酚曲马多片、3例肌肉注射盐酸哌替啶注射液。联合治疗组镇痛药物使用率低于基础治疗组(χ^ 2=9.024,P =0.003)。⑥安全性。2组患者均未发生晕针、针刺后疼痛、针刺后血肿、皮肤过敏、皮肤感染等针刺及中药涂擦相关不良反应。使用镇痛药后,联合治疗组1例出现恶心症状,基础治疗组2例出现恶心症状、2例出现眩晕、1例出现嗜睡、1例出现便秘,停药后不良反应均缓解,未进行特殊处理。结论:在抗炎消肿等常规治疗的基础上给予针刺配合郑氏舒活酊涂擦,可有效改善PELD术后感觉异常患者的疼痛和麻木症状,总体疗效优于单纯的常规治疗,而且具有较高的安全性。

Objective: To observe the clinical curative effects and safety of acupuncture therapy combined with inunction of Zheng’s Shuhuo Ding(舒活酊,SHD)for treatment of paresthesia after percutaneous endoscopic lumbar discectomy(PELD). Methods: Forty-two patients with paresthesia after PELD for treatment of lumbar disc herniation(LDH)were selected as the subjects,and were randomly divided into basic treatment group and combination treatment group by using random digits table,21 cases in each group.All patients in the 2 groups were treated with intravenous drip of 20% mannitol injection(once a day,250 mL at a time for consecutive 3 days)and dexamethasone injection(once a day,10 mg at a time for consecutive 3 days)and oral application of mecobalamin tablets(three times a day,0.5 mg at a time for consecutive 30 days),meanwhile functional exercises such as straight-leg-raise training and ankle pump training were performed in supine position.Moreover,the patients in combination treatment group were treated with acupuncture therapy(20 minutes at a time)and inunction of Zheng’s SHD(15 minutes at a time),once a day for 2 courses of treatment,5 times for each course with a 2-day rest-insertion between courses.The analgesic drugs were used in case of necessity according to the pain degree of patients during the treatment period.The lower limbs pain and numbness and the effect of paresthesia on daily living were evaluated by using visual analogue scale(VAS)and Oswestry disability index(ODI)questionnaires respectively before treatment and at 2 weeks and 3 months after the beginning of the treatment respectively,and the total curative effects were evaluated and compared between the 2 groups by using improved MacNab standard at 3 months after the beginning of the treatment.Moreover,the use of analgesic drugs and the incidence of adverse reactions were observed and recorded during the treatment period. Results: There was interaction between time factor and group factor in pain VAS scores( F=6.748,P = 0.002 ).There was statistical difference in the pain VAS scores between the 2 groups in general,in other words,there was group effect( F=6.830,P =0.013).There was statistical difference in pain VAS scores between different timepoints before and after the treatment,in other words,there was time effect( F=596.189,P =0.000).The pain VAS scores presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(5.762+/-0.816,2.905+/-0.436,1.571+/- 0.598 points, F=339.958,P =0.000;5.952+/-1.011,3.881+/-0.757,1.786+/-0.624 points, F=269.273,P =0.000).There was no statistical difference in pain VAS scores between the 2 groups before treatment and at 3 months after the beginning of the treatment( t=-0.672,P=0.506;t=-1.137,P= 0.262).The pain VAS scores were lower in combination treatment group compared to basic treatment group at 2 weeks after the beginning of the treatment( t=-5.121,P =0.000).There was interaction between time factor and group factor in numbness VAS scores( F=7.534,P= 0.001).There was statistical difference in numbness VAS scores between the 2 groups in general,in other words,there was group effect( F=15.104,P= 0.000).There was statistical difference in numbness VAS scores between different timepoints before and after the treatment,in other words,there was time effect( F=421.241,P =0.000).The numbness VAS scores presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(5.238+/-0.875,2.738+/-0.561,1.357+/-0.854 points, F=339.958,P= 0.000;5.429+/-0.763,3.905+/- 0.605 ,1.857+/-0.478 points, F=269.273,P =0.000).There was no statistical difference in numbness VAS scores between the 2 groups before the treatment( t=-0.752,P =0.457).The numbness VAS scores were lower in combination treatment group compared to basic treatment group at 2 weeks and 3 months after the beginning of the treatment( t=-6.479,P=0.000;t=-2.342,P =0.024).There was interaction between time factor and group factor in ODI scores( F=4.346,P =0.016).There was no statistical difference in ODI scores between the 2 groups in general,in other words,there was no group effect( F=1.459,P =0.234).There was statistical difference in ODI scores between different timepoints before and after the treatment,in other words,there was time effect( F=261.210,P =0.000).The ODI scores presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(39.789+/-10.930,19.579+/-8.537,11.325+/-6.242 points, F=339.958,P =0.000;40.471+/-13.929,24.022+/-9.124,17.462+/-10.238 points, F=269.273,P =0.000).There was no statistical difference in ODI scores between the 2 groups before the treatment and at 2 weeks after the beginning of the treatment( t=0.082,P=0.935;t=-1.630,P =0.111).The ODI scores were lower in combination treatment group compared to basic treatment group at 3 months after the beginning of the treatment ( t=-2.345 ,P =0.024).The total clinical curative effects were evaluated according to improved MacNab standard.Fifteen patients obtained an excellent result,4 good,1 fair and 1 poor in combination treatment group;while 8 patients obtained an excellent result,7 good,4 fair and 2 poor in basic treatment group.The combination treatment group surpassed the basic treatment group in the total clinical curative effects( R combination treatment group =17.81, R basic treatment group =25.19, Z=-2.158,P =0.031).The symptoms of 3 patients with poor clinical curative effects were relieved after treatment with acupuncture therapy and inunction of Zheng’s SHD for another month.During the treatment period,2 patients in combination treatment group and 8 patients in basic treatment group were treated with oral application of tramadol hydrochloride paracetamol tablets and 3 patients in basic treatment group were treated with intramuscular injection of pethidine hydrochloride injection.The usage rate of analgesic drugs was lower in combination treatment group compare to basic treatment group(χ^2=9.024, P =0.003 ).No acupuncture-related and TCM inunction-related adverse reactions such as acupuncture-induced fainting,post-acupuncture pain,post-acupuncture hematoma,skin allergy and skin infection were found in the 2 groups.After analgesic drugs were used,nausea was found in 1 patient in combination tretment group;while nausea(2),dizziness(2),somnolence(1)and constipation(1)were found in patients in basic treatment group.All the adverse reactions were relieved after analgesic drugs were withdrawed and no special treatment were performed. Conclusion: The combination therapy of conventional therapy such as anti-inflammation and detumescence combined with acupuncture and inunction of Zheng’s SHD can effectively improve the pain and numbness symptoms of patients with paresthesia after PELD,and it surpasses the monotherapy of conventional therapy in total clinical curative effects,moreover,it has high safety.