Shengjin Ointment Combined With Hydroxy-chloroquine Sulfate In The Treatment Of Primary Deficiency Of Both Qi And Yin Clinical Observation Of Sjogren’s Syndrome

Objective: The purpose of this study was to observe the clinical efficacy and safety of Shengjin paste combined with hydroxychloroq uine sulfate in the treatment of primary Sjogren’s syndrome with defi ciency of Qi and Yin.Methods:A total of 68 patients with a clinical diagnosis of primary qi and Yin deficiency type Sjogren’s syndrome were selected from January2022 to September 2022 from both the outpatient department and the inpatient department of the rheumatology department of Shijiazhuang Hospital of Traditional Chinese Medicine,and were assigned to a treatment group and a control group using the random number table method in a 1:1ratio with 34 cases in each group.The control group was treated with hydroxychloroquine sulfate orally;the treatment group was treated with Shengjin cream combined with hydroxychloroquine sulfate orally.Patients in both groups received 6 weeks of treatment,which was recorded as the duration of treatment.Changes in the VAS score of dry mouth,dry eye,fatigue,and arthralgia,serum Ig G level,erythrocyte sedimentation rate(ESR),and rheumatoid factor(RF)level were examined in this study,ESSDAI of dry syndrome disease activity index,ESSPRI of dry syndrome patient self-report index,and Chinese medicine symptom score were found pre-and post-treatment in both groups.We compared the relevant safety indices of patients in the two groups before and after treatment and also recorded adverse events and shedding of cases.Statistical analysis of the data was performed using the SPSS26.0 software package,and P<0.05 indicated that the difference was statistically significant.These results were used to assess the clinical effectiveness of Shengjin cream in combination with hydroxychloroquine sulfate in the treatment of primary dry syndrome with both qi and yin deficiency,as well as to assess safety.Results:(1)Before treatment,there was no statistical significance in the general clinical data,VAS independent rating scale(dry mouth,dry eye,arthralgia,fatigue),serum Ig G content,erythrocyte precipitation rate,rheumatoid factor level,ESSDAI score,ESSPRI score and TCM syndrome score of patients(P > 0.05),which could be compared.(2)Before and after treatment,VAS scores of dry mouth,dry eyes,arthralgia and fatigue were statistically different between the two groups(P< 0.05).After treatment,there were statistical differences in VAS scores of dry mouth,dry eyes and fatigue between the two groups(P < 0.05),but no statistical differences in VAS scores of arthralgia between the two groups compared with the control group(P > 0.05).These results indicated that the treatment group was better than the control group in improving dry mouth,dry eyes and fatigue,but had no obvious advantage in improving joint pain.(3)Before and after treatment,there were statistical differences in ESSPRI score,ESSDAI score and binocular Schimmer test score between the two groups after intra-group comparison(P < 0.05).After treatment,there were statistical differences between the two groups in ESSPRI score,ESSDAI score and binocular Schimmer test score(P < 0.05).(4)In terms of laboratory indicators: before and after treatment,the levels of ESR,RF and serum Ig G in two groups were compared within the group,all of which were lower than before treatment,with statistical difference(P < 0.05).After treatment,the contents of ESR and Ig G in the two groups were compared within the group,and the improvement was more obvious in the treatment group,with statistical difference(P < 0.05),but there was no statistical difference in the reduction of RF level between the two groups(P > 0.05).(5)In terms of TCM syndrome scores: before and after treatment,TCM syndrome scores of the two groups were statistically different after intra-group comparison(P < 0.05);After treatment,there was statistical difference in TCM syndrome scores between the two groups(P < 0.05).(6)In terms of efficacy evaluation : the total effective rate of the treatment group was 91.18 %,and the total effective rate of the control group was 76.47 %.After comparison,there was a statistical difference(P< 0.05).(7)Safety analysis: In the course of this clinical observation,the two groups of subjects were generally stable vital signs,blood routine,liver function,kidney function,etc.were generally normal,and no obvious abnormalities were observed in fundus examination.In terms of adverse reaction records,gastrointestinal discomfort occurred in 1 case in the treatment group and 2 cases in the control group,all of which resolved spontaneously after 2-3 days without special treatment.There was no statistical difference in adverse event between the two groups(P > 0.05).Conclusions: Shengjin ointment combined with hydroxychloroquine sulfate in the treatment of primary Sjogren’s syndrome with Qi and Yin deficiency has significant effect on improving clinical symptoms and signs,especially relieving dry mouth and dry eyes,and can reduce related laboratory indicators,which is helpful to control disease activity and relieve clinical discomfort symptoms.Clinical use is convenient and reliable,less adverse reactions,and has good clinical efficacy.