| Objective:To explore the clinical efficacy of the modified Shenzhu decoction on non-radiological axial spondyloarthritis(nr-ax Sp A),in order to provide a reference treatment for such patients.Methods:Patients diagnosed with nr-ax Sp A in the Orthopedic clinic or inpatient ward,People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine(TCM)from March2022 to December 2022 were randomly divided into experimental group and control group.The control group was treated with Loxoprofen Sodiun Tablets,60 mg each time and twice a day for 2 weeks,and Magnesium Aluminum Carbonate Chewable Tablets were given to protect gastric mucosa,the experimental group was treated with the modified Shenzhu decoction,2 packet of the decoction each day,warm-taken decoction in the morning and evening,for 2 weeks.The lumbosacral pain score(NRS)was recorded and analyzed before treatment,1 week and 2 weeks after treatment.And the changes of lumbar range of motion,TCM syndrome efficacy and CRP before and after treatment.Results:A total of 68 patients were enrolled in this study,34 patients in the experimental group and 34 patients in the control group finally completed the whole process.1.Comparison of baseline data: There were no statistically significant differences in general demographic sociological data,clinical data,and evaluation index levels(NRS,lumbar range of motion,TCM syndrome score,and CRP level)between the two groups before intervention(all P > 0.05),indicating that the baseline data of the two groups were balanced and comparable.2.Lumbosacral pain: The results of repeated measures variance showed that there were statistically significant differences in NRS between the two groups in time effect,group effect,and time and group interaction(all P < 0.05).Comparison within groups: NRS of the two groups after 1 week and 2 weeks of treatment were lower than those before treatment,and NRS after 2 weeks of treatment was lower than that after 1 week of treatment,and the differences were statistically significant(all P < 0.05).Comparison between groups: there was no significant difference in NRS between the two groups before and after 1 week of treatment(P > 0.05).However after 2 weeks of treatment,NRS in the experimental group was lower than that in the control group,and the difference was statistically significant(P < 0.05).3.Lumbar range of motion: Comparison within groups: the results of paired sample t-test showed that the lumbar range of motion in the four directions of left rotation,right rotation,forward flexion and backward extension of the two groups after the treatment were greater than those before the treatment,and the differences were statistically significant(all P<0.05).Comparison between groups: the results of two independent samples t/t’ test showed that after 2 weeks of treatment,the lumbar range of motion in the four directions of left rotation,right rotation,flexion and extension in the experimental group were greater than those in the control group,and the differences were statistically significant(all P < 0.05).4.Efficacy of TCM syndromes: Non-parametric independent sample Mann-Whitney U test results showed that after 2 weeks of treatment,the TCM syndromes efficacy of the experimental group was higher than that of the control group,and the difference was statistically significant(P < 0.05).5.CRP levels: comparison within groups: The results of non-parametric Wilcoxon paired signed rank test showed that the CRP levels of the two groups after the trial were lower than those before the treatment,and the differences were statistically significant(all P < 0.05).Comparison between groups: non-parametric Mann-Whitney U test showed that after 2 weeks of treatment,there was no significant difference in CRP levels between the two groups(P >0.05).6.Safety evaluation: During the whole process of this study,all patients had no adverse reactions such as rash,allergy,nausea,vomiting related to traditional Chinese medicine decoction,and there was no obvious abnormal change in liver and kidney function before and after the study.Conclusions:The modified Shenzhu decoction can improved the curative effect of nr-ax Sp A,including range from reducing the pain score,improving the lumbar range of motion and enhancing curative effect of TCM syndromes. |