| 1.Research objectives:Based on the theory of traditional Chinese medicine,this study conducted a randomized controlled trial(RCT)on the clinical efficacy and safety of Qiangjitongluo prescription and celecoxib(celebrex)in the treatment of ankylosing spondylitis in patients with kidney deficiency dukong and phlegm stasis blocking collaterals syndrome.Compare the before and after treatment TCM syndrome scores,laboratory inflammatory indexes,clinical signs,disease evaluation indicators and the relative comparison of the therapeutic effect evaluation criteria for ankylosing spondylitis of the two groups.In order to provide more references and choices for the better use of traditional Chinese medicine in the treatment of ankylosing spondylitis.the systematic and comprehensive clinical efficacy and related laboratory indexes of Qiangjitongluo prescription in the treatment of ankylosing spondylitis were evaluated.2.Research contents and methods:According to the method of random allocation,the 64 patients diagnosed with AS kidney deficiency dukong and phlegm stasis blocking collaterals syndrome were divided into the treatment group(32 cases)and the control group(32 cases).In the treatment group,Qiangjitongluo prescription was used.The control group was given oral administration of Celecoxib Capsules(celebrex)200mg qd.If the effect is not good after 2 weeks,increase the dosage to 200mg bid.Observation time:12W,observation time points:0W,12W(According to the situation,some patients should review the safety indicators about 6 weeks).3.The result:In this study,64 cases of AS patients with kidney deficiency dukong and phlegm and blood stasis were diagnosed in the outpatient and inpatient department of Jiangsu Province Hospital of Chinese Medicine from July,2018 to January,2020.1n the treatment group,2 cases fell off due to the failure of timely follow-up and incomplete data.In the control group,2 patients lost follow-up and fell off.A total of 60 cases(30 cases in the treatment group,30 cases in the control group)were observed and studied.completed the research.3.1 Baseline comparison before treatment between the two groups:There was no significant difference in the general items,TCM syndrome scores,laboratory indexes,clinical signs,disease evaluation indexes and safety indexes between the two groups.The baseline data of the two groups were basically equal and comparable.3.2 Efficacy comparison:A statistical comparison was made between the TCM syndrome score group before and after treatment in the treatment group,and the results indicated that the differences between the two groups were significant(P<0.05).In the control group,there was a statistical comparison between the TCM syndrome score group before and after treatment,among which the difference of chills and warm,waist and knee tenderness and stabbing pain were not statistically significant(all P were>0.05).Comparison of lumbosacral spinal back pain,morning stiffness,limited movement,joint swelling,light day and heavy night,heavy limb before and after treatment,the results suggested that the data differences were statistically significant(all P<0.05).After treatment the scores of TCM syndromes of the two groups were statistically compared.In terms of morning stiffness,joint swelling,light day and heavy night,and stabbing pain,the results suggested that there was no significant difference in the data(all P values were>0.05).Compared with other TCM syndrome scores,the results indicated that the data differences were all significant(P<0.05).In terms of laboratory inflammatory indicators(ESR,CRP),the statistical comparison between the two groups before and after treatment and between the two groups after treatment indicated that the data differences were all significant(P<0.05).In terms of clinical signs(occipital-wall distance,finger-ground distance,number of peripheral joint swelling,number of peripheral joint pain,and degree of lumbago and back pain),there were significant differences between the two groups before and after treatment(all P values<0.01).After treatment,there was a statistical comparison between the two groups among the signs,in which the difference between the data indicated by the finger-ground distance and the degree of lumbago and back pain was significant(P<0.05),while the difference between the other groups(occipital-wall distance,the number of peripheral joint swelling and the number of peripheral joint tenderness)was not significant(all P values were>0.05).BASDAI?BASFI and total VAS scores of patients were compared before and after treatment.The results indicated that the data differences were all significant(P<0.05),and the data differences were all significant(P<0.05)when compared with the groups of BASDAI,BASFI and total VAS scores of patients after treatment.Compared with the number of patients with ASAS20 in the two groups,it was significantly higher than that in the control group,indicating that the difference was significant(P<0.05).Compared with the number of patients with ASAS40 in the two groups,in terms of data alone,the treatment group was higher than the control group,but the difference was not significant(P value>0.05).In terms of clinical control,obvious effect,effective population and total effective rate,the treatment group was higher than the control group.3.3 Safety comparison:In the treatment group,1 patient showed mild abnormal liver function in the treatment process,and returned to normal after re-examination by adjusting the formula.In the control group,2 patients presented with mild gastrointestinal discomfort,which was alleviated by the addition of anti-acid stomach medicine(pantoprazole).There was no anaphylaxis in the two groups,and there was no significant difference in blood routine and liver and kidney function before and after treatment and between the two groups.4.Conclusion:Qiangjitongluo prescription in the treatment of AS of kidney deficiency dukong and phlegm stasis blocking collaterals syndrome has been clinically observed to be effective in relieving symptoms,improving main signs,delaying disease progression,significantly improving TCM syndrome score,reducing inflammatory indicators,with high total effective rate and little side effects.It provides clinical reference for the better use of safe and effective traditional Chinese medicine in the treatment of AS,which has great medical academic value and is worthy of further research. |
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