| Objective:To systematically evaluate the clinical efficacy and safety of Chinese herbal compound in the treatment of rheumatoid arthritis with interstitial lung disease(RA-ILD);to evaluate the effectiveness of clearing away heat,detoxifying,and removing phlegm and collaterals in the treatment of RA-ILD And safety.Methods:Study 1:Search CNKI,Wan Fang,VIP,CBM,Pub Med,Cochrane Library,EMbase database of Chinese medicine compound treatment of RA-ILD clinical randomized controlled trials(RCT),search time from the establishment of the database to August 1,2019.The search terms are:"rheumatoid arthritis","pulmonary interstitial disease","interstitial lung disease","Chinese medicine","Rheumatoid Arthritis","Interstitial Lung Diseases,"Integrated traditional Chinese and western medicine",etc.Study 2:A total of 60 patients with RA-ILD who meet the criteria were included,30 in the experimental group and 30 in the control group.The control group was treated with western medicines such as glucocorticoids and immunosuppressants(the hormones and immunosuppressants in the treatment drugs can be selected according to the patient's condition and the doctor's judgment).On the basis of the control group,the experimental group was combined with a traditional Chinese medicine compound for clearing away heat,detoxifying,and eliminating phlegm and collaterals:Hedyotis diffusa 30g,scutellaria 20g,fritillaria 10g,fennel 20g,orange red 10g,salvia 20g,turmeric 10g,Siegesbeckiae 15g Anemarrhena 10g,Platycodon grandiflorum 10g,Windbreak 10g,Raw licorice 6g.The course of treatment is 24 weeks.Observe the clinical efficacy,imaging evaluation,TCM syndrome scores,improvement of TCM syndrome elements,DAS28 score,HAQ score,RF,CCP,ESR,Ig G,Ig A,Ig M,safety indicators and The occurrence of adverse reactions.Result:Study 1:Include 12 RCT studies with a total of 762 patients,including 402 in theexperimental group and 360 in the control group.One study in the experimental group was a simple Chinese medicine compound treatment,the rest were Chinese medicine compoundcombined with western medicine treatment,and the control group was treated with conventional western medicine.The results of the Meta analysis are as follows:(1)Total clinical effective rate:RR=1.43,95%CI(1.28,1.60),P<0.00001,the difference is statistically significant(P<0.05).(2)Chest HRCT score:The combination found that the heterogeneity was large,and the combination was not carried out.The results of 6 studies all showed that the experimental group was better than the control group(P<0.05).(3)Laboratory indicators:In terms of ESR:MD=-8.36,95%CI(-13.45,-3.26),P=0.001,the difference is statistically significant(P<0.05);in terms of CRP:MD=-0.76,95%CI(-1.99,0.48),P=0.23,the difference was not statistically significant(P>0.05);in terms of RF:the combined found that the heterogeneity was large,and the combined analysis was notperformed.The results of the three studies all showed the test The group is better than the control group(P<0.05).A total of 1 study showed that there was no significant difference between the two groups(P>0.05).(4)Lung function:in terms of FVC%:MD=7.40,95%CI(1.24,13.57),P=0.02,the difference is statistically significant(P<0.05);in terms of VC%:MD=5.98,95%CI(1.94,10.03),P=0.004,the difference is statistically significant(P<0.05);in terms of TLC%:MD=6.56,95%CI(3.24,9.87),P=0.0001,the difference is statistically significant(P<0.05);in terms of FEV1%:due to different interventions,no combined analysis was performed,and the results showed that the treatment group was better than the control group(P<0.05);in terms ofDLCO%:MD=8.03,95%CI(2.25,13.81)),P=0.006,the difference is statistically significant(P<0.05);in terms of Pa O2:the combined discovery of greater heterogeneity,no combined analysis,the results of the two studies show that the treatment group is better than the control group(P<0.05).(5)Adverse reactions:RR=0.48,95%CI(0.21,1.12),P=0.09,the difference was not statistically significant(P>0.05).Study 2:1 case fell off in each of the two groups,which was not included in the statistical analysis.The results of each study are as follows:(1)Disease efficacy:9 cases were markedly effective in the experimental group,18 cases were effective,and 2 cases were ineffective,with a total effective rate of 93.10%;in the control group,6 cases were markedly effective,17 cases were effective,and 6 cases were ineffective,with a total effective rate of 79.31%.There was a statistically significantdifference in the efficacy of the two groups of diseases(P<0.05).(2)Improvement of chest HRCT score:After treatment,the difference in the test group was statistically significant(P<0.001);while the control group had no significant difference after treatment compared to before treatment(P>0.05).After treatment,the difference between the groups was not statistically significant(P>0.05).(3)Improvement of TCM syndrome scores:The differences between the two groups aftertreatment were statistically significant(P<0.001).After treatment,the differences between the groups were statistically significant(P<0.001).The total effective rate of TCM syndromes in the experimental group was 86.66%,and the total effective rate of TCM syndromes in thecontrol group was 65.52%.(4)Improvement of TCM syndrome elements:in the test group,cough,sputum,chesttightness,shortness of breath,fatigue,dyspnea,joint pain,joint swelling,joint tenderness,poor joint flexion and extension,morning stiffness,thirst,sweating Compared with before treatment,the difference was statistically significant(P<0.05),and compared with before treatment in terms of fever,the difference was not statistically significant(P>0.05).Thecontrol group had statistically significant differences in cough,shortness of breath,joint pain,joint swelling,poor joint flexion and extension,morning stiffness,thirst,and sweatingcompared with before treatment(P<0.05).There was no significant difference in chest tightness,fatigue,dyspnea,joint tenderness,and fever compared with before treatment(P>0.05).After treatment,the comparison between the groups showed that the experimental group had statistically significant differences in improving fatigue,dyspnea,and jointtenderness(P<0.05),while it improved cough,sputum,chest tightness,shortness of breath,joint pain,joint swelling,and joint tenderness.There were no significant differences in flexion and extension,morning stiffness,fever,thirst,and sweating(P>0.05).(5)Improvement of DAS28 score:The difference between the two groups after treatment was statistically significant(P<0.001).After treatment,the difference between the groups was not statistically significant(P>0.05).After treatment,the total effective rate of DAS28 score in the experimental group was 86.21%,and the total effective rate of DAS28 score in the control group was 72.41%.(6)Improvement of laboratory indicators:Improvement of RF and Ig M:The difference in the experimental group after treatment was statistically significant(P<0.05),and the difference in the control group was not statistically significant after treatment compared with beforetreatment Significance(P>0.05);ESR,Ig A improvement:after treatment compared withbefore treatment,the difference between the two groups was statistically significant(P<0.05);anti-CCP antibody,Ig G improvement:two groups after treatment compared with beforetreatment In comparison,the differences were not statistically significant(P>0.05).Aftertreatment,there was no significant difference between the groups in the improvement of RF,anti-CCP antibody,ESR,ESR,Ig A,and Ig M(P>0.05).(7)Improvement of HAQ score in the evaluation of quality of life:After treatment,compared with before treatment,the difference between the two groups was statistically significant(P<0.001).After treatment,the difference was statistically significant(P<0.05).(8)Safety indicators:The overall adverse reactions between the two groups were compared by?~2test,and the difference was not statistically significant(P=0.286?~2=1.137).Conclusion:Study 1:This study confirms that pure traditional Chinese medicine or combined with western medicine has certain advantages in the treatment of RA-ILD.It is excellent in total effective rate,HRCT score,ESR,lung function indicators FVC%,VC%,TLC%,FEV1%,DLCO%Yu pure western medicine.Study 2:The traditional Chinese medicine compound of clearing heat,detoxifying,resolving phlegm and dredging collaterals has certain advantages in the treatment of RA-ILD.It can significantly improve the clinical efficacy,reduce chest HRCT score and DAS28 score,improve fatigue,dyspnea,joint tenderness,and reduce RF and ESR,Ig A,Ig M and HAQ scores have significant advantages. |
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