| Objectives1.By using Meta-analysis method,the literature of randomized controlled trial about Tripterygium hypoglaucum treatment of RA are reviewed systematically,which provides evidence of evidence-based medicine for the validity of the treatment on RA with the Tripterygium hypoglaucum.2.Selecting the eligible RA patients as the investigated subject,and choosing the Tripterygium hypoglaucum decoction as the drug treatment,the method of randomized controlled trial are employed to investigate the curative effect and the quality of life represented with the clinical symptoms and laboratory index,and then to evaluate the effectiveness of the Tripterygium hypoglaucum decoction on curing RA.Method1.Systematic ReviewThrough the literature retrieval in the Chinese and English date-base,as well as the manual retrieval in library,the literature of randomized controlled trial on the Tripterygium hypoglaucum treatment of RA are collected and sorted.Meta-analysis is adopted to analyze the date with Revman 5.2:Weighted Mean Difference(MD)or Standard Mean Difference(SMD)are used for continuous measurement-variables while Effect Ratio Value Ratio(OR)is used for binary classification count-variables,and Estimation interval of both overall parameters is 95%;Chi-square is carry out for the heterogeneous test with the test level a=0.1 and I2=50%,then the Fixed Effects Model is adopted to merge the total effects when P>0.1,I2<50%,indicating the homogeneity,while the Random Effects Model is adopted to merge the total effects when P<0.1,I2>50%,indicating the heterogeneity;If the heterogeneity is larger,then the original group is divided into sub-group to carry out the test according to the different interventions;Z-test is employed to analyze the significance of merged effects with the significance level equating to 0.05.Finally,Forest Figure is used to display combined results,and the Funnel Graph is used to test the publication bias;Sensitivity analysis is carried out respectively by the conversion between the Fixed Effect Model and the Random Effects Model,or excluding the literature one by one method.2.Clinical Observation:Therapeutic schedule:All the eligible RA patients are cured by Tripterygium hypoglaucum decoction,which is used every day one decoction,two in the morning and evening after meals and last for 12 weeks.Observation content:① Clinical Symptoms:count the numbers of joint pain and swollen joint before and after the treatment for patients,and record the duration of morning stiffness;②Laboratory Index:record the ESR,RF and so on before and after treatment for patients;③ Assessment on Quality of Life:SF-36 gauge as an international scale is adopted in current research to evaluate the life quality,including the somatic function,bodily pain,total health,vitality,social function and emotional function and mental health,of which the first four items are physical health,while the rest of the four items belong to the mental health.Data management and statistical analysis:Applying PASW Statistics18.0 software to make the statistical analysis on these data,including the test of normality for the measurement data and the descriptive analysis for the enumeration data;Paired T test are used for the measurement data obeying the normal distribution,otherwise the Wilcoxon are used for the analysis.The analysis results show that the otherness of curative effect with the Tripterygium hypoglaucum treatment is significant with the significance level equating to 0.05.Results1.Systematic ReviewThis system evaluation includes 12 research items which all are published in Chinese in China,1 Multi-center trial and 11 Single center trial.There are 946 RA patients involved in this research.Experimental group sample size up to 80 cases,at least 20 cases.However,the the numbers of the control sample up to 79 cases,at least 20 cases.The comparison between the two groups on the basic information and course of baseline are comparable(>0.05).According to the difference intervening measurers,the 12 research items are further divided into tow sup-groups:Tripterygium hypoglaucum VS the western medicine,Tripterygium hypoglaucum+ western medicine VS western medicine.Thereinto,The intervention measures of Tripterygium hypoglaucum VS the western medicine are the Kunduz fairy capsule,Tripterygium hypoglaucum decoction,Tong bi mixture no.2,Tong bi mixture,The two rattan tong bi mixture and the fairy capsule.The intervention measures of the control group are LEF,LEF,MTX,MTX+SASP,MTX and MTX.Tripterygium hypoglaucum+western medicine VS western medicine:Kunduz fairy capsule+MTX,Tripterygium hypoglaucum decoction + MTX,Kunduz fairy capsule+MTX,Kunduz fairy capsule+MTX,Kunduz fairy capsule+LEF,Tripterygium hypoglaucum tablet+MTX andTripterygium hypoglaucum+LEF.The results by the systematic review of the literature on the KMSHT in treating RA with the randomized controlled show that the difference is not significant between the KMSHT and Western Medicine with the significance P=0.05 on the total efficiency,adverse reaction,TJC SJC,morning stiffness,ESR,eta.However,the difference is significant on DAS28,CRP,RF.Theanalysis results of Tripterygium hypoglaucum VS the western medicine show that the difference of the pair comparison among the Number of total effective rate,time of morning stiffness,joint tenderness and joint swelling,ESR,CRP,RF,DAS28,adverse reactions are not significant with the significance P=0.05.Similarly,the analysis results of Tripterygium hypoglaucum+western medicine VS western medicine show that the difference of the pair comparison among Total number of efficient,joint tenderness and joint swelling,morning stiffness time,DAS28,ESR,CRP,RF,hands mean grip strength,the doctor to evaluate disease,joint pain,joint swelling index outcome indicators are significant with the significance P=0.05,which indicate that Tripterygium hypoglaucum+western medicine is superior to western medicine in thetreatment of RA,but curative effect in adverse reactions,rest pain,joint function,patient assessment of disease outcome indicators is not significant at p<0.01level.2.Clinical ObservationThere are 50 patients but 47 available patients in active rheumatoid arthritis in this research.All of these patients were cured by Tripterygium hypoglaucum for 12 weeks.The rest of the three patients are off due to different reasons.Observation Results:On Clinical Symptoms:the differences on the Number of joint pain,joint swelling and morning stiffness time improved greatly,the ESR,RF decrease obviously are significant at the P<0.01.The results of the survival quality show that the survival qualities including the eight dimension have improved significantly at the level P<0.01.Specifically,physiological function score increase obviously to 281.64%,and emotional function follows with 133.95%,and then physiology,somatic pain,stamina,mental functions and social function follow up in turn respectively with degree 111.65%,105.58%,100.35%,85.02%,54.89%and 53.37%.Conclusion1.Systematic evaluationKMSHT significantly surpass Western Medicine on CRP,RF,DAS28(P<0.05),but has not significantly different with current Western Medicine on total efficiency,adverse reactions,tender joint count,swollen joint count,morning on six indicators stiff time,ESR,etc(P>0.05).MMSHT+Western Medicine significantly surpass the single Western Medicine on total efficiency,tender joint count,swollen joint count,morning stiffness,DAS28,ESR,CRP,RF,hands mean grip strength,rest pain,physicians assess disease,patient assessment of disease,joint improvement in pain index,joint swelling index outcomes.While,the difference between the two method above is not significant on adverse reactions,joint function,etc.It can be concluded that KMSHT has some clinical value in treating RA.But,it is also need to notice that there exist certain risks of bias due to the low quality of these literature.However,these results still can provide some evidence-base for effectiveness in treating RA with KMSHT.2.Clinical ObservationBy studying the 47 RA patients who receive the KMSHT treatment in 12 weeks,the clinical symptoms(including pain,joint count,swollen joint count,morning stiffness),laboratory parameters(ESR,RF),the Quality of life(including physical function,physical function,bodily pain,general health,energy,social function,role emotional and mental health)are all significantly improved compared with before treatment.In summary,the integrated effect of KMSHT in treating RA is significant,which may provide the theoretical basis for KMSHT in treating RA. |
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