| Objective:Based on the theory of traditional Chinese medicine,through the etiology,pathogenesis and clinical features of EORA,we use Erteng Tang to treat dampness-heat blockage type elderly-onset rheumatoid arthritis(EORA).The clinical indexes of TCM symptoms and signs,disease activity index(CADI,DAS28-CRP),health assessment questionnaire disability index(HAQ-DI),rheumatoid arthritis efficacy evaluation(ACR20,ACR50),erythrocyte sedimentation rate(ESR),C-reactive protein(CRP)and the safety indicators are observed before and after treatment.We objectively evaluate the effectiveness and safety of Erteng Decoction for dampness-heat blockage type EORA,giving full play to the advantages of Syndrome Differentiation and Treatment of Traditional Chinese Medicine,to seek suitable clinical treatment for elderly patients.Methods:According to the principle of parallel open controlled trial,60 patients with EORA were divided into the experimental group and the control group with 30 cases each.The observation nodes:Ow and 12w.The experimental group took Erteng Tang once a day,and the control group took methotrexate tablets(specification:2.5mg/tablet;manufacturer:Shanghai Xinyi Pharmaceutical Factory),once a week,10mg each time.A non-steroidal anti-inflammatory drug can be added to the two groups as appropriate.Statistical software SPSS22.0 was used for data statistical analysis.Results:A total of 62 patients with EORA who met the inclusion and exclusion criteria were included in the study from March 2018 to January 2019 in the outpatient department and ward of Jiangsu Provincial Hospital of Traditional Chinese Medicine.During the treatment,one patient in the experimental group could not fall back due to treatment interruption treatment,and one patient in the control group fell off result in lossing of follow-up.Finally,a total of 60 medical records(30 cases in the experimental group and 30 cases in the control group)were studied to complete the study.1.Comparison of baseline:There are no significant differences in general data,clinical symptoms,TCM syndrome and sign scores,CADI,DAS28-CRP,HAQ-DI,ESR and CRP between the two groups(P>0.05)and they are comparable.2.Comparison of efficacy:2.1 Efficacy of Traditional Chinese MedicineIn the total effective rate of TCM syndromes,the total effective rate of the experimental group is 86.66%,and that of the control group is 66.67%.There is a significant difference between the two groups(p<0.05),and the experimental group is superior to the control group.After treatment,the clinical effective rate of the experimental group is higher than that of the control group,and the ineffective rate is lower than that of the control group.There is significant statistical differences between the two groups(p<0.01).In terms of the integral of symptoms and signs of traditional Chinese medicine,compared with the two groups before and after treatment,the experimental group has significant statistical differences in joint pain,joint swelling,morning stiffness,joint tenderness,joint flexion and extension impairment,joint local fever and tongue quality(P<0.01),and has statistical differences in pain night(p<0.05).The control group has significant statistical differences in joint pain,joint swelling,morning stiffness,joint tenderness,joint local fever,and pain night(P<0.01),and statistical differences in joint flexion and extension disability(P<0.05),but has no statistical differences in tongue quality(p>0.05).After treatment,there are significant statistical differences in joint swelling,joint flexion and extension,joint local fever between the two groups(P<0.01).There is statistical difference in tongue quality(P<0.05).Whlie,there was no statistical difference in joint pain,morning stiffness,joint tenderness and night pain(P<0.05).2.2 Efficacy of Western MedicineIn terms of disease curative effect ACR20 and ACR50,the effective rate of ACR20 in the experimental group was 86.67%,that of ACR50 was 30%,and the effective rate of control group was 66.67%,that of ACR50 was 13.33%after treatment.There is a statistical difference between the two groups(p<0.05),and the experimental group is superior to the control group.After treatment,the effective rate of ACR50 in the experimental group was higher than that in the control group,and the ineffective rate was lower than that in the control group.There were significant statistical differences between the two groups(p<0.01).In facts of CDIA,DAS28-CRP and HAQ-DI scores,there are significant statistical differences between the two groups before and after treatment(P<0.01).After treatment,there are significant statistical differences in CDIA,DAS28-CRP and HAQ-DI scores between the two groups(P<0.01).In terms of joint swelling,joint tenderness,pain degree,overall evaluation of patients and overall evaluation of doctors,there are significant statistical differences between the two groups before and after treatment(P<0.01).After treatment,there are significant differences between the two groups in terms of joint tenderness number,pain degree,overall evaluation of patients and overall evaluation of doctors(p<0.05).Especially,in the number of joint swelling,there is significant statistical difference between the two groups(p<0.01).There are statistical differences between the two groups in ESR and CRP before and after treatment(p<0.01).After treatment,there is significant difference in ESR(p<0.01),and statistical difference in CRP between the two groups(p<0.05).3.Comparison of Activity Evaluation Methods for DAS28-CRP and CDAIWhen DAS28-CRP was used to evaluate the disease,there were 0 cases in high activity group,33 cases in moderate activity group,27 cases in low activity group and 0 cases in clinical remission group.When CDAI was used to evaluate the disease condition,there were 0 cases in high activity group,27 cases in moderate activity group,33 cases in low activity group and 0 cases in clinical remission group.After Mann-Whitney U rank sum test,there is no statistical difference in distribution between the two(p>0.05)..Statistics showed that 10 patients had inconsistent disease activity evaluated by the two methods,accounting for 16.7%of the total number of cases.Kappa test showed that Kappa=0.802.The evaluation of EORA disease activity by the two evaluation methods was highly consistent.4.Safety analysisFinally,the control group patients appear the increase of ALT and AST in the study(within 2 times higher than normal).But ALT and AST returned to normal after adding liver-protecting drugs.No other adverse reactions such as gastrointestinal tract and drug allergy were found in both groups.At the same time,there was no statistical difference in blood routine and renal function between the two groups(P>0.05).In the 60 EORA patients finally included in the study,we finds ALT and AST slightly increased in the control group(within 2 times higher than normal).However,ALT and AST returned to normal after adding liver-protecting drugs.In terms of treatment safety,there is no statistical difference between the two groups by chi-square test(P>0.05).There is no statistical difference in blood routine and renal function between the two groups too(P>0.05).Other adverse reactions such as gastrointestinal tract and drug allergy were not found in both groups.conclusion:At present,this study shows that Erteng Tang has achieved initial clinical efficacy in the treatment of dampness-heat blockage type EORA with few adverse reactions.In this study,we demonstrate that Erteng Decoction has obvious curative effect and good safety in improving symptoms and signs,erythrocyte sedimentation rate,C-reactive protein,CDIA,DAS28-CRP,HAQ-DI etc.It has good safety and few adverse reactions,and is worthy of further clinical research. |
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