Clinical Study On Efficacy And Safety Of Prescription Of Wenshen Juanbi In Treatment Of Ankylosing Spondylitis With Kidney Deficiency And Cold

Objective:This research is about treatment of Ankylosing Spondylitis of kidney deficiency with cold by using Tripterygium Compound.By observing before and after treatment in patients with changes in observation items like lumbosacral spine pain,lumbar vertebral activity limitation,morning stiffness,nocturnal pain and other symptoms and body function index(BASFI),disease activity index(BASDAI),ASDAS-CRP,ASAS20,ASAS40,ESR,C-reactive protein(CRP)and so on,we can objectively evaluate the efficacy and safety of tripterygium compound for AS of kidney deficiency with cold,and provide clinical basis for the extensive use of Tripterygium compound.Methods:Sixty patients who met the criteria were divided into treatment group and control group,32 cases each,according to the principle of parallel open control trial.The observation period is 12 weeks.The observation times were Week 0(before treatment)and Week 12(after treatment).The treatment group took prescription of WenShen JuanBi,and the control group took Celecoxib Capsule(commercial name:Celebrex)produced by company of Pfizer.Patients weighing less than 50kg took 200mg everyday while patients more than 50kg took 200mg twice each day.Patients who did not respond well after 2 weeks switched to meloxicam.Patients weighing less than 50kg took 7.5mg qd,while patients more than 50kg,taking 7.5mg bid.The statistical software SPSS22.0 was used for analysis and comparison to evaluate the efficacy and side effects.When P<0.05,it indicates a statistically significant difference.P>0.05 represented no statistically significant difference.P<0.01 represented significant statistical difference..Results:This study collected 64 patients who were diagnosed with Ankylosing Spondylitis of kidney deficiency with cold in outpatient departments and wards of Jiangsu Provincial Hospital from September 2015 to January 2018.One patient in the experimental group during the course of treatment was dropped out because of treatment interruption treatment and one patient dropped out due to loss of follow-up;In the control group,2 patients dropped out due to loss of visits.Finally,a total of 60 cases of medical records were studied(30 cases in the test group and 30 cases in the control group)to complete the study.1 Comparison of baseline:There were no significant differences in gender,age,course of disease,TCM symptom score,BASFI,BASDAI,ASDAS-CRP,ESR,CRP,blood routine and liver and kidney function between the two groups.2 Comparison of efficacy:The total effective rate of experimental group and control group were 83.33%,60.00%in TCM symptoms and signs,which has statistical differences(P<0.05)?There were significant differences between the TCM symptoms and signs in the experimental group(P<0.01);The control group had statistically significant differences in lumbosacral back pain,lumbar spinal motion limitation,morning stiffness,nocturnal pain,lumbar flexion and weakness(P<0.01).In the peripheral joint swelling,chills and warmth,nocturia,there was no significant difference between the control group before and after treatment(P>0.05);There was significant difference between the two groups before and after treatment(P<0.01)in BASFI,BASDAI and ASDAS-CRP.There was significant difference between the two groups(P<0.01)in ESR and CRP.There was no significant difference in efficacy between the two groups in the lumbosacral spine pain,lumbar spine activity limitation,morning stiffness,nocturnal pain,and peripheral joint swelling(P>0.05).The statistical difference was significant(P<0.01)between these two groups in soreness and weakness of waist and knees,aversion of cold and nocturnal pollakiuria.There was no significant difference in ESR and CRP between these two groups(P>0.05);There was a significant difference between groups(P<0.05)in the BASFI,BASDAI,ASDAS-CRP,ASAS20,ASAS40.3 Safety analysis:Sixty AS patients included in the study had no symptoms of gastrointestinal discomfort,allergies,and there was no significant difference in blood routine,liver and kidney function,and sexual function scores(P>0.05).conclusion:prescription of WenShen JuanBi is effective and safe in improving AS clinical signs and symptoms,ESR,C-reactive protein and BASFI,BASDAI,ASDAS-CRP,but clinical trials still need to increase the sample size for further verify.Studies have shown that prescription of WenShen JuanBi is is effective and safe in treatment of AS of kidney deficiency with cold,and it is worth further clinical study.