| Objective: To evaluate the clinical efficacy and safety of tonifying kidney and activating blood paste in the treatments of ankylosing spondylitis due to kidney deficiency and blood stagnation for 2 years;to analyze the influence of tonifying kidney and activating blood paste on AS patients' disease activity,quality of life,ESR,CRP and other indicators;and to summarize the medication rules of tonifying kidney and activating blood paste in treating AS.Method: This study was conducted through a prospective multicenter cohort to determine whether tonifying kidney and activating blood TCM or paste was voluntary as exposure factor.Patients were observed and divided into high-exposure group treated with routine treatments of western medicine and tonifying kidney and activating blood TCM and paste,exposure group treated with routine treatments of western medicine and tonifying kidney and activating blood TCM or Chinese patent medicine,and non-exposure group only treated with routine treatments of western medicine.The course of treatments lasted for two years.Referring to the current universal evaluation methods of curative effect,this study observed the relevant indicators of the three groups of patients before and after treatments,ASDAS-CRP as major curative effect index,TCM syndromes scores,BASDAI,BASFI,CRP,ESR and quality of life evaluation as secondary curative effect indexes.Using the platform of TCM inheritance to research the DDDS,four natures and five flavors,channel tropism,prescription regularity and core portfolio of tonifying kidney and activating blood paste.Result:1.Clinical improvements of ASDAS-CRP as major curative effect index was compared after 24 months of treatments.There were 18 significantly improvements,34 clinical improvements,6 no improvements in high-exposure group and total improvement rate was 89.66%,6 significantly improvements,27 clinical improvements,21 no improvements in exposure group and total improvement rate was 61.11%,6 significantly improvements,11 clinical improvements,38 no improvements in non-exposure group and total improvement rate was 30.91%.The comparison among 3 groups of clinical improvement of ASDAS-CRP was statistically significant(P<0.01).All of 3 groups of clinical improvement of ASDAS-CRP had significantly improvements between before treatments and after treatments,high-exposure group and exposure group were significantly better than non-exposure group,also the improvements of high-exposure group were significantly better than exposure group(P<0.01).Comparing the TCM syndromes scores after 24 months of treatments,there were 10 cases were cured,33 cases were markedly effective,12 cases were effective and 3 cases were ineffective in high-exposure group.Total improvement rate was 94.83%.5 cases were cured,17 cases were markedly effective,22 cases were effective and 10 cases were ineffective in exposure group.Total improvement rate was 81.48%.0 case was cured,4 cases were markedly effective,22 cases were effective and 30 cases were ineffective in non-exposure group.Total improvement rate was 45.45%.The comparison among 3 groups of TCM syndromes scores was statistically significant(P<0.01).All of 3 groups of TCM syndromes scores had significantly improvements between before treatments and after treatments(P<0.01).High-exposure group and exposure group were significantly better than nonexposure group,also the improvements of high-exposure group were significantly better than exposure group.2.During 24 months of treatments,there were significant differences in ASDAS-CRP,TCM syndromes scores and BASDAI levels at different time nodes(P<0.01),also there were significant differences in ASDAS-CRP,TCM syndromes score and BASDAI levels in different exposure factors(P<0.01)while there was interaction between time nodes and exposure factors(P<0.01).The effects of high-exposure group and exposure group on ASDAS-CRP,TCM syndromes scores and BASDAI levels changed overtime.3.During 24 months of treatments,there were significant differences in ESR,CRP levels at different time nodes(P<0.01)but was no significant difference in different exposure factors(P>0.05).There was no interaction between exposure factors od ESR and time nodes(P<0.05).There was no significant effect on ESR,CRP levels but there were differences on ESR,CRP levels at 4 different time nodes while the effects of high-exposure group and exposure group on CRP levels changed overtime.4.During 24 months of treatments,there were significant differences in social functions and general health levels at different time nodes(P<0.01),,also there were significant differences in social functions and general health levels in different exposure factors(P<0.01)while there was interaction between time nodes and exposure factors(P<0.01)while the effects of high-exposure group and exposure group on social functions and general health levels changed overtime.5.Top four in DDDS of tonifying kidney and activating blood paste were dendrobium,prepared rehmannia root,lignum millettiae and parasitic loranthus.channel tropism.Top four in channel tropism frequency were liver channel> kidney channel>spleen channel>stomach channel.Calidus natured herbs had the highest frequency of usage in four natures which was 51.39%.Sweet,bitter and pungent had the highest frequency of usage in five flavors which 40.40% was sweet.Conclusion: 1.Treatments of tonifying kidney and activating blood paste can significantly improve ASDAS-CRP clinical improvements rate,TCM syndromes improvements rate of AS patients and reduce the activity of AS,significantly reduce ESR and CRP,and improve BASDAI scores.2.Treatments of tonifying kidney and activating blood paste is safe and reliable and without any obvious untoward effect. |
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