Objective:To observe and analyze the clinical efficacy of the method of warming yang and Dredging Meridians、Regulating and harmonizing the Ying-nutrients and Wei-defence in the treatment of systemic sclerosis,and to objectively evaluate its efficacy and safety.Methods:44 patients with SSc(Yang deficiency pattern and disharmony between Ying-nutrients and Wei-defence pattern)treated at Rheumatology&Immunology,Linyi Hospital of Traditional Chinese Medicine,between October 2020 and December 2022 were selected.The grouping was randomized and controlled,and 44 patients were divided into a control group and a test group,with 22 patients in each group.Pure Western medicine treatment as a control,and the self-designed "Wenyang Tongluo Tiao Ying" formula plus basic Western medical treatment as the test group.Observation of patients’symptoms and laboratory physicochemical indices before and after 12 weeks of treatment.SPSS26.0 was applied to compare the TCM evidence score,laboratory physical and chemical indexes,mRSS,RCS,and to analyze and discuss.Results:Forty-one cases were finally included in the analysis of the study results;among them,22 cases were enrolled in the experimental group,21 cases completed observation,and 1 case was shed;22 cases were enrolled in the test group,20 cases completed observation,and 2 cases were shed.1.Comparison of TCM evidence scores:In the test group,the total TCM symptom score improved better than that of the experimental group,and the difference was statistically significant(P<0.05);after comparing and analyzing the eight individual symptom scores of skin sclerosis,Raynaud’ s phenomenon,end of toe ulcer,arthralgia,fatigue,cold form and limbs,evil wind and cold,and sweating in the two groups,the differences were statistically significant(P<0.05).The differences were statistically significant(P<0.05),and the efficacy of the test group was more significant than that of the experimental group;the differences were not statistically significant(P>0.05)for the four symptoms of skin sclerosis,ulcers at the ends of fingers and toes,coldness in the extremities,and sweating at times,and the efficacy of the two groups was comparable.2.Comparison of laboratory indicators:Comparing the decrease levels of ANA,CRP,RF and ESR in the two groups after treatment,the decrease level of CRP in the test group was better than that in the control group,and the difference was statistically significant(P<0.05);the level of RF and ESR in the two groups decreased significantly after treatment compared with that before treatment,and the difference within the group was statistically significant(P<0.01),and the difference between the groups was not statistically significant(P>0.05);ANA titers decreased after treatment in the test group compared with before,with statistically significant differences within the group(P<0.05),and no statistically significant differences between the groups(P>0.05).3.Comparison of RCS score and mRSS score:the difference in RCS score between patient groups after treatment was statistically significant(P<0.05),and the improvement in Reynolds condition was more obvious in the test group than in the control group;the difference in mRSS score between the two groups after treatment was not statistically significant(P>0.05).4.Evaluation of TCM Syndrome Efficacy:The total effective rate of Chinese medicine was 93.2%in the test group and 70.0%in the control group,and the difference was statistically significant(P<0.05),and the Chinese medicine efficacy of the test group was better than that of the control group.5.Safety evaluation:No adverse reactions occurred in the test group,one adverse reaction occurred in the control group,the patient had gastrointestinal discomfort,which may be related to the application of hydroxychloroquine,and was treated with omeprazole enteric capsules,and the symptoms disappeared after treatment.Both groups completed the observation.Conclusion:"Wen Yang Tongluo Tiao Ying Formula" can significantly improve the TCM symptoms of SSc,effectively relieve the symptoms of Raynaud’ s phenomenon,joint involvement,fatigue and wind chill associated with SSc,significantly reduce the Raynaud’ s condition(RCS)score,and effectively improve the ANA titer level with good safety. |