金脊鹿角汤联合浮针再灌注活动治疗肾阳亏虚型强直性脊柱炎临床研究

Clinical Study of Jinji Lujiao Decoction Combined with Fu’s Subcutaneous Needling and Reperfusion Exercises in Treatment of Ankylosing Spondylitis of Kidney Yang Deficiency

【目的】观察金脊鹿角汤联合浮针再灌注活动治疗肾阳亏虚型强直性脊柱炎(AS)的临床疗效。【方法】将90例肾阳亏虚型AS患者随机分为治疗组和对照组,每组各45例。治疗组给予金脊鹿角汤联合浮针再灌注治疗,对照组给予双氯芬酸钠缓释片口服治疗,疗程为56 d(其中浮针再灌注治疗隔日1次,共治疗20 d)。观察2组治疗前后中医证候评分、疼痛视觉模拟量表(VAS)评分、巴氏强直性脊柱炎功能指数(BASFI)、关节活动度(胸廓呼吸差和脊柱活动度)和血液炎症指标[血沉(ESR)、C反应蛋白(CRP)、肿瘤坏死因子α(TNF-α)、血小板(PLT)]的变化情况,并评价2组的临床疗效和安全性。【结果】(1)治疗后,治疗组的显效率和总有效率分别为64.4%、95.6%,对照组分别为35.6%、66.7%,治疗组的显效率和总有效率均明显高于对照组(P<0.01)。(2)2组患者治疗后24 h、5 d、10 d、20 d、50 d的VAS评分均较治疗前明显降低(P<0.01),且治疗组治疗后各观察时点的VAS评分均明显低于对照组(P<0.01)。(3)治疗后,2组患者BASFI评分均较治疗前明显提高(P<0.05),且治疗组的BASFI评分明显高于对照组(P<0.05)。(4)治疗后,治疗组的胸廓呼吸差和脊柱活动度(包括Schober试验、指地距、枕墙距、颌柄距)均明显改善(P<0.05),而对照组均无显著性改善(P>0.05),治疗组对各项关节活动度指标的改善作用均优于对照组(P<0.05)。(5)治疗后,2组患者的各项中医证候评分均较治疗前明显改善(P<0.05或P<0.01),停治后2周,治疗组的各项中医证候评分仍较治疗前明显改善(P<0.01),而对照组仅腰骶脊背疼痛、腰膝酸软仍较治疗前有所改善(P<0.05);组间比较,治疗组对各项中医证候评分的改善作用均优于对照组(P<0.05或P<0.01)。(6)治疗后,2组患者的ESR、CRP、TNF-α、PLT水平均较治疗前明显改善(P<0.05或P<0.01),且治疗组的改善作用均明显优于对照组(P<0.05)。(7)治疗组的不良反应发生率为6.67%,明显低于对照组的22.2%,差异有统计学意义(P<0.05)。【结论】金脊鹿角汤联合浮针再灌注治疗肾阳亏虚型AS,能明显缓解疼痛,改善阳虚症状、关节功能和血液炎症指标,疗效确切,安全性高。

Objective To observe the effect of Jinji Lujiao Decoction combined with Fu’s subcutaneous needling(FSN)and reperfusion exercises in the treatment of ankylosing spondylitis(AS)of kidney yang deficiency.Methods Ninety AS patients with kidney yang deficiency were randomized into treatment group and control group,45 cases in each group.Patients in the treatment group were treated with oral use of Jinji Lujiao Decoction combined with FSN and reperfusion exercises,and the control group was given oral use of diclofenac sodium sustained-release tablets for 56 days(FSN and reperfusion exercises were performed once every other day and in a total of 20 days).Before and after treatment,the scores of traditional Chinese medicine(TCM)syndrome manifestations,pain scores evaluated with visual analogue scale(VAS),Bath ankylosing spondylitis function index(BASFI),range of joint motion(including thoracic breathing difference and range of spinal movement),and blood inflammation parametersoferythrocytesedimentationrate(ESR),C-reactive protein(CRP),tumor necrosis factor alpha(TNF-α)and platelet(PLT)in the two groups were observed.After treatment,the clinical efficacy and safety of the two groups were evaluated.Results(1)After treatment,the markedly effective rate and the total effective rate in the treatment group were 64.4%,95.6%respectively,and were higher than those in the control group(35.6%,66.7%respectively),the differences being significant between the two groups(P<0.01).(2)VAS pain scores 24 h,5 d,10 d,20 d,and 50 d after treatment were decreased in the two groups(P<0.01 compared with those before treatment),and the scores in the treatment group were lower than those in the control group at the same time point(P<0.01).(3)After treatment,BASFI scores in the two groups were higher than those before treatment(P<0.05),and the scores in the treatment group were higher than those in the control group(P<0.05).(4)After treatment,the thoracic breathing difference and range of spinal movement(including Schober’s test,fingerto-floor distance,occiput-to-wall distance,mandible-to-sternum distance)in the treatment group were much improved(P<0.05 compared with those before treatment),while showed no significant improvement in the control group(P>0.05),and the improvement of the range of joint motion in the treatment group was superior to that in the control group(P<0.05).(5)After treatment,the scores of TCM syndrome manifestations in the two groups were improved(P<0.05 or P<0.01 compared with those before treatment);2 weeks after suspension of the medication,the scores of all TCM syndrome manifestations in the treatment group were still lower than those before treatment(P<0.01),while in the control group,only the scores of lumbosacral backache and sore-limp loins and knees were still lower than those before treatment(P<0.05).The inter-group comparison showed that the improvement of the scores of all TCM syndrome manifestations in the treatment group was superior to that in the control group(P<0.05 or P<0.01).(6)After treatment,the levels of ESR,CRP,TNF-α,and PLT in the two groups were much improved(P<0.05 or P<0.01 compared with those before treatment),and the improvement in the treatment group was superior to that in the control group(P<0.05).(7)The incidence of adverse reaction in the treatment group was 6.67%,and was lower than that in the control group(22.2%),the difference being significant(P<0.05).Conclusion Jinji Lujiao Decoction combined with FSN and reperfusion exercises is effective and safe in the treatment of AS of kidney yang deficiency through alleviating pain,and improving yang deficiency symptoms,joint function and blood inflammation indicators.