| Ankylosing spondylitis (AS) is a refractory immune system disease.lt encompasses a group of rheumatic disorders that often cause high disability rate and have a serious impact on patients’ quality of life.Objective:This study basics on the confirm of the safety and effectiveness of the treatment of AS by taking TCM Decoction previously.And we still use Qingre qiangji and Bushen qiangji decoction differentiationly for internal treatment.Under the guidance of "internal and external treatment", we propose that acupoint application has a synergistic effective.We establish the treatment of AS by taking TCM internal and external treatment that combine TCM decoction with Acupoint Application. Aimming to promote the development of AS therapeutics and the study of TCM characteristic clinical application.Methods:It’s a randomized, controlled, prospective study,with60active AS patients randomly assigned to the experimental group(group1) of30cases and the control group(group2) of30cases.Group1was given Qingre qiangji or Bushen Qiangji decoction combined with external treatment of acupoint application, group2was given Qingre qiangji or Bushen Qiangji decoction.Both them are treatmented for24weeks.We take the0,4,8,12,24weeks as the evaluation point. Use the ASAS20standard, BASDAI50standard, combined with TCM syndrome curative effect evaluation, assessment of the quality of life as the multidimensional effect evaluation system.Through statistical analysis and comparison of two groups before and after treatment in VAS score, BASDAI, BASFI, BASMI and some of the major clinical measuring signs and single symptomatic efficacy of Chinese Medicine, and observation patient safety indicators such as blood and urine routine, hepatic and renal function, ECG and other adverse reactions during the experiment, we evaluation the synergistic effect and safety of Acupoint Application in the treatment of AS.Results:1.West medical effectiveness index:ASAS20:after treatment of4weeks,8weeks,12weeks,24weeks, compliance rate in AS patients of group2with ASAS20were36.7%,80%,86.7%,86.7%; in group1the compliance rate of ASAS20were46.7%,86.7%,93.3%,90%, both in the two groups the ASAS20compliance rate increased after treatment and group1was higher than that of group2. BASDAI50:after treatment of4,8,12,24weeks the patients compliance rate of BASDAI50in group2were10%,36.7%,70%,80%; that rate in group1were10%,43.3%,73.3%,86.7%, both in the two groups the BASDAI50compliance rate were increased steadily and group1was higher than the group2when the evaluation point is8weeks,12 weeks,24weeks.VAS score:the spinal pain VAS score, VAS score of spinal inflammation and night pain VAS score in both two groups after treatment were decreased.The improvement means comparison between two groups in above three VAS score, the difference was not statistically significant (P>0.05). After treatment the hip joint pain VAS score decreased both in two groups, mean improvement of hip pain VAS score in two groups shows statistically significant differences in the evaluation point of4weeks,8weeks (P<0.05),and shows no statistically significant in the evaluation point of12weeks,24weeks (P>0.05).The BASMI score:after treatment, BASMI scores of the two groups were decreased, the differences were statistically significant (P<0.01or P<0.05); BASMI scores between the two groups about the improve mean comparison, shows no statistical significance in the evaluation point of4weeks,8weeks (P>0.05), there is statistical significance in the evaluation point of12weeks,24weeks (P<0.05).The measurement of main clinical signs:Before and after the treatmen cervical rotational degree in group2, the difference does not have statistical significance(P>0.05),except for8weeks. Before and after the treatment in group1, the differences were statistically significant (P＜0.05). Comparison of cervical rotation degree mean between two groups, the difference was not statistically significant (P>0.05). The average compared of Tragus-wall distance, lumbar scoliosis in two groups before and after treatment, the differences were statistically significant (P<0.05). The mean comparison between groups, the difference was not statistically significant (P>0.05). The mean lumbar flexion in group2when the evaluated point is8,12,24weeks after the treatment, the differences were not statistically significant (P>0.05). The differences were statistically significant (P<0.05) group1. The comparison between two groups in lumbar flexion improved mean scores, the difference was not statistically significant (P>0.05). The ankle spacing increased after treatment both in two groups, compared with before treatment, the differences were statistically significant (P<0.05) The difference was statistically significant (P<0.05)in the evaluation point of24weeks about the improvement mean score comparison of ankle distance between two groups. The BASFI score:after treatment, BASFI scores of the two groups were decreased,the differences were statistically significant (P<0.01or P<0.05)after and before treatment; the improve mean comparison of BASFI scores between the two groups shows statistical significance in the evaluation point of4weeks,8weeks (P<0.05), there is not statistically significant in the evaluation point of12weeks,24weeks (P>0.05). The patient global assessmen (PGA) score:after treatment, PGA scores of the two groups were decreased,the differences were statistically significant (P＜0.01) after and before treatment; the improve mean comparison in PGA scores between the two groups shows no statistical significance (P>0.05) in the evaluation point of4weeks,8weeks,12weeks,24weeks.The HAQ score:both two groups before and after treatment the differences were statistically significant (P＜0.05), the treatment is effective; the improvement means of HAQ score between two groups shows statistically significant (P＜0.01or P<0.05), and curative effect in group1is better than that of group2.2.Evaluation of TCM syndromes curative effect:in the treatment of4weeks,8weeks,12weeks,24weeks, the total effective TCM syndrome integral evaluation of curative effect of two groups are:group2was73.3%,73.3%,93.3%,93.3%; group1was60%,93.3%,96.7%,100%, the effect performance in group1was significantly better than the in group2in the aging. Two groups of TCM syndrome integral decreased, before and after treatment, P values were less than0.05, the difference was statistically significant, the effect of the two groups was significant.3.Safety index:In the whole clinical study, blood routine, urine routine, liver and kidney function, electrocardiogram and other safety indicators showed no obvious abnormalities both in group1and group2. The two groups showed no nausea, vomiting and other gastrointestinal adverse reaction and local skin irritation. We can confirm the safety of the TCM internal and external treatment.Conclusion:There is synergistic effects by Acupoint Application in treating ankylosing spondylitis, especially in improving functional activities, patients hip lumbosacral, chest and back pain, cervical pain, night pain.In the orther hand it shows obvious advantages in group1compared with group2in patients with cervical rotation, ankle spacing and morning stiffness symptoms.There is no toxic side effect,but can be used conveniently and is worthy of clinical application. |
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