风痛膏穴位敷贴治疗肾虚督寒型强直性脊柱炎患者的临床研究

Clinical research of acupoint application of Fengtong Plaster in treatment of ankylosing spondylitis of kidney deficiency and governor vessel cold

关键词:  风痛膏  穴位敷贴  肾虚督寒  强直性脊柱炎

Key words:  Fengtong Plaster  acupoint application  kidney deficiency and governor vessel cold  ankylosing spondylitis

摘要:

[目的] 通过观察风痛膏穴位敷贴治疗肾虚督寒型强直性脊柱炎患者临床疗效、炎症指标及安全性，探索中医外治法治疗强直性脊柱炎新途径。[方法] 采用随机对照临床试验的方法进行研究，将82例肾虚督寒型强直性脊柱炎患者随机分为治疗组和对照组，两组均给予基础药物美洛昔康片，治疗组除基础药物外，加予风痛膏穴位敷贴，两组疗程共4周。观察患者治疗前与治疗4周后国际强直性脊柱炎评价工作组（ASAS）制定的ASAS20、ASAS40改善情况、中医证候疗效、患者总体评价、脊柱疼痛评分、关节活动度、强直性脊柱炎疾病活动性指数（BASDAI）评分、强直性脊柱炎功能指数（BASFI）评分、C反应蛋白（CRP）、红细胞沉降率（ESR），观察患者的药物不良反应。[结果] 1）总体疗效比较：治疗组和对照组经4周治疗后，ASAS20达标率分别为51.35%和62.16%，ASAS40达标率分别为29.73%和5.40%，总有效率分别为81.08%和67.56%，治疗组ASAS40达标率较对照组更优（P<0.05）。2）中医证候疗效：治疗4周后治疗组的有效率为94.59%，对照组的有效率为32.43%，治疗组较对照组疗效更优（P<0.05），且在具体症状腰背僵硬、腰背发冷、腰膝酸软、畏寒喜暖方面改善更显著（P<0.05）。3）观察性指标比较：①患者总体评价、脊柱疼痛评分：两组治疗前后均提示明显改善（P<0.05），组间比较治疗组较对照组改善更优（P<0.05）；②关节活动度：两组治疗前后枕墙距、指地距、胸廓活动度、Schober试验均明显改善（P<0.05），组间比较治疗组Schober试验改善较对照组更优（P<0.05），其余无统计学差异（P>0.05）；③BASDAI评分、BASFI评分：两组治疗前后均显著改善（P<0.05），组间比较BASDAI评分改善未出现统计学差异（P>0.05），BASFI评分改善治疗组较对照组更优（P<0.05）；④CRP、ESR：治疗前后两组均显著改善（P<0.05），组间比较差异无统计学意义（P>0.05）。4）安全性评价：经过4周治疗后，两组患者均未出现严重不良反应。[结论] 风痛膏穴位敷贴治疗肾虚督寒型强直性脊柱炎能明显改善患者临床症状、中医证候疗效和关节功能，疗效可靠，且使用方便安全。

Abstract:

[Objective] To observe the clinical efficacy and the influence of the inflammatory markers, safety of acupoint application of Fengtong Plaster in the treatment of ankylosing spondylitis (AS) with syndrome of kidney deficiency and governor vessel cold, to explore a new approach to treating ankylosing spondylitis with external treatment of traditional Chinese medicine (TCM).[Methods] A completely randomized, controlled trial was used to divide 82 cases of AS with patterns of kidney deficiency and governor vessel cold into the treatment group and control group. Both groups were treated with the conventional Western medicine Meloxicam and the treatment group was given acupoint application of Fengtong Plaster additionally, with a course of 4 weeks. The data of the ASAS20 and ASAS40 assessment, TCM symptom scores, patient's global assessment, spinal pain score, joint mobility, BASFI, BASDAI, CRP and ESR before and after 4 weeks of treatment were compared, and the adverse drug reactions in patients were observed.[Results] 1) Clinical efficacy:After 4 weeks of treatment, the ASAS20 compliance rates of the treatment group and the control group were 51.35% and 62.16%, the ASAS40 compliance rates were 29.73% and 5.40%, and the total effective rates were 81.08% and 67.56%. Respectively the treatment group was better than the control group with theASAS40 compliance rate (P<0.05). 2) TCM efficacy:After 4 weeks of treatment, the therapeutic effect of the treatment group was better than that therapeutic effect of the control group with the total effective rate 94.59% and 32.43% (P<0.05), and has obvious advantage in improving the TCM symptoms(stiffness of the back and waist, coldness of the back and waist, soreness and weakness of the lower back and knees, aversion to cold and desire for warmth) (P<0.05). 3) Comparing of therapeutic effect assessment indexes:①Patient's global assessment and spinal pain score:Both groups showed significant improvement after treatment (P<0.05), and the treatment groups was better than the control group (P<0.05). ②Joint mobility:the occipital wall distance, finger-ground distance, thoracic mobility, and Schober distance were significantly improved after treatment in the two groups (P<0.05). Compared with the treatment group, the improvement in the Schober test was better than the control group (P<0.05), and there was no significant difference in the rest (P>0.05). ③BASDAI and BASFI:Both groups showed significant improvement after treatment (P<0.05). There was no significant difference in BASDAI improvement between two groups and the BASFI improvement in the treatment groups was better than the control group (P<0.05). ④CRP and ESR:Both groups showed significant improvement before and after treatment (P<0.05), but there was no significant difference between two groups (P>0.05). 4) Safety:After 4 weeks of treatment, there was no significant abnormalities in the safety indices of the two groups, and there was no serious adverse reactions.[Conclusion] The application of acupoint application of Fengtong Plaster in the treatment of ankylosing spondylitis due to kidney deficiency and governor cold can significantly improve the clinical symptoms, TCM symptoms and joint function.The therapeutic effect is reliable, convenient and safe.