| Objective1.To evaluate the efficacy with structural damage progression of Bushen Shuji Granule(BSG)in treating ankylosing spondylitis(AS)patients of Du-meridian cold syndrome,and observe it atat different age,disease duration,baseline,etc;2.To observe the he long-term efficacy with Clinical signs、ESR、CRP,and the safety of BSG in treating AS patients of Du-meridian cold syndrome,explore the overall efficacy and provide a scientific evidence to improve the the level of clinical treatment.MethodsAS patients of Du-meridian cold syndrome were collected from February 2011 to October 2015 in Japan Friendship Hospital.31 patients were 1 year observation group,which had the cervical and lumbar lateral X-ray before treatment and after 1 year treatment.33 patients were 2 year observation group,which had the cervical and lumbar lateral X-ray before treatment and after 2 year treatment.It was a retrospective study,the patient’s age,sex,disease duration,family history,blood,urine,liver function,kidney function,ESR and CRP were recorded by medical records and telephone interviews.Cervical and lumbar lateral X-ray were evaluated by two experienced(working more than 5 years)radiologists with mSASSS.Compared the data before and after treatment with paired t-test or Wilcoxon sign-rank test,and analyzed the correlation with age,gender,disease duration,ESR,CRP and other indicators.Results1.In 1 year observation group:After treatment:patients’ clinical measurements were improved;ESR,CRP were significant reduced compared with those before treatment(p<0.01,p<0.05);The overall average mSASSS score progression was 1.16 ± 1.73.when the level of CRP in baseline was normal(n = 13),the average mSASSS score progression was 0.62 ± 1.67,there was no statistically difference before and after treatment(p>0.05);when patients without syndesmophytes in baseline(n = 20),the average mSASSS score progression was 0.30 ± 0.47.Both were lower than the overall average score mSASSS progression.2.In 2 year observation group:After treatment:patients’ clinical measurements were improved;ESR,CRP were significant reduced compared with those before treatment(p<0.05,p<0.01);The overall average mSASSS score progression was 2.00±1.82.15 patients(45.5%)were"slow progression",13 patients(39.4%).wereC"moderate progression",5 patients(15.2%)were"fast progression".When the level of CRP in baseline was normal(n =15),the average mSASSS score progression was 0.93±0.88;when patients without syndesmop hytes in baseline(n = 22),the average mSASSS score progression was 1.18±0.91.Both were lower than the overall average score mSASSS progress.3.In 1 year observation group and 2 year observation group:After treatment:the average mSASSS score progression were significantly increased when the level of CRP was elevated or with syndesmophytes in baseline(p<0.01,p<0.01,p<0.01,p<0.01),not only significan tly higher than the group of normal CRP in baseline and the group without syndesm ophytes in baseline(p<0.05,p<0.01,p<0.01,p<0.01),but slao higher than overall average mSASSS score progression(1.16± 1.73,2.00±1.82).4.1 patients with diarrhea in 1 year observation group relieved itself;2 patients had epigastric discomfort and back to normal by changing medication time or receiving symptom matic treatment.Blood,urine,liver function,kidney function and electrocardiogram in all patients were normal.Conclusions1.Continued treatment with BSG can improve AS patients of Du-meridian cold syndrome’ clinical measurements,reduce the level of inflammation,and proved to be safe.2.15 patients(45.5%)were "slow progression" in 2 year observation group;Continued treatment with BSG may delay the structural damage progression in patients had normal CRP or without syndesmophytes in baseline.3.The average mSASSS score progression were significantly increased when the level of CRP was elevated or with syndesmophytes in baseline.These patients need more care and effective treatment. |
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