| Objective:To investigate the intervention effect and safety influence of warming and activating meridian of TCM for the treatment of Rheumatoid Arthritis(RA),based on the literature research and preliminary work.Literature research for the first partMethods:Selected prescriptions for the treatment of RA from the literatures from October 31,2005 to October 31,2015 by searching the CNKI database,WANFANG database and VIP database to establish database for data summary and data mining on the traditional Chinese medicine inheritance platform system.Results:Totally 277 prescriptions used for treating rheumatoid arthritis were obtained.1.The analysis for the frequency of the herbs:The number of the herbs is 230.30 flavor of herbs frequency are more than 40 times and the first three are angelica,cassia twig and radix paeoniae alba.2.The commonly used drug combinations:According to the patterns of commonly-used drugs based on association rules,30 drug combinations frequency are more than 33 times and the first four are radix paeoniae alba and cassia twig,angelica and cassia twig,angelica and radix paeoniae alba,angelica and rhizoma chuanxiong.3.New prescriptions:8 new prescriptions were extracted,and they were mainly consisted of warming and activating meridian herbs.clinical research for the second partMethods:Selected 96 patients with RA confirmed to the inclusion criteria,using randomized control principle and divided equally into the treatment group and the control group.The control group were given Methotrexate(MTX)or Leflunomide(LEF)for treatment,and the treatment group were given additional Shaogan Fuzi decoction(SGFZ)combined with the control group,oral drugs,and both the two groups were treated for 12 weeks.Observing the changing expression level of the patients,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),interleukin-6(IL-6),interleukin-17(IL-17),transforming growth factor beta(TGF-?),vascular endothelial growth factor(VEGF)as well as the improved conditions of the patients,clinical symptoms,disease of activity score 28(DAS28),symptom and sign of traditional Chinese medicine(TCM)and health assessment questionnaire(HAQ)before the treatment and after the treatment.Also the Blood-routine,Urine-routine,Stool-routine,ECG,liver and kidney functions and purine nucleoside phosphorlyase(PNP),neutrophil gelatinase associated lipocalin(NGAL)were measured before and after the treatment in order to evaluate the safety of the treatment.Results:96 patients with rheumatoid arthritis were screened in the clinical trials.There were 12 cases exit the clinical trials included 4 cases for no telephone contect and 2cases for dropped up in treatment group as well as 3 cases for no telephone contect and 3 cases for dropped up in control group.A total of 84 effective cases accomplished the clinical trials which were 42 cases in treatment group and 42 cases in control group.1.Change of laboratory indexes:The levels of the ESR,CRP,IL-6,IL-17A and VEGF in RA patients' serum after treatment were lower than before,at the same time the level of the TGF-? after treatment was higher than before in both treatment group and control group(P<0.05,P<0.01);Compared between in treatment group and the control group,we can find out that the levels of IL-6,IL-17A were obviously decrease(P<0.01)and other indexes were no obvious difference(P>0.05).2.Clinical symptom evaluation:The duration of morning stiffness,joint tenderness,joint swelling,VAS score and the average hands grip force of RA patients after treatment were improved compared with before treatment in both treatment group and control group(P<0.01),When compared between in treatment group and control group,the former was better than the latter in shorten the duration of morning stiffness,decreasing the numbers of joint tenderness and VAS score(P<0.05,P<0.01).But both in decrasing the numbers of joint swelling and improving average hands grip force had no significant difference(P>0.05);3.Scoring for DAS28:Both the two groups can reduce DAS28 score of RA patients after comparison within group treatment(p<0.01)and the DAS28 score of the treatment group was lower than the control group(p<0.01).Moreover,the total effective rate of the treatment group was much better than that of the control group(p<0.01);4.Score of TCM symptoms:After the comparison within group treatment,both the total TCM symptoms score and the score of the eight dimensions of the two groups have reduced(p<0.05,p<0.01)than before.Compared with the control group,the total TCM symptoms score,Joint pain integral,joint tenderness integral,inhibited bending and stretching integral,Joints as cold integral,aversion to wind and limbs cold temperature integral was significantly reduced in the treatment group(p<0.05).While there was no significant difference between the two groups in the morning stiffness integral as well as the soreness and weakness of waist and knees integral(p<0.05).The results also showed that the effectiveness of treatment group was significantly higher than control group(P<0.05);5.The influence of HAQ score:The HAQ score in the two groups was significantly decreased after the comparison within group treatment,but the HAQ score in the treatment group was better than the control group after the comparison between groups treatment(p<0.05);6.Safety evaluation:In this study,blood,stool routine test,hepatorenal function and electrocardiogram of the patients chosen were all in normal range before and after treatment and there has no significant adverse reactions in the process.In the aspect of the influence of early-stage kidney damage index,there was also statistically significant difference between the two groups in terms of reducing PNP levels of RA patients(p<0.01),but the treatment group was much better than the control one(p<0.01).Meanwhile,both the treatment of the two groups can reduce the level of NGAL of the RA patients(p<0.01)and there is no significant difference between the two groups(p>0.05).Conclusions:Cold-dampness is one of the commonest syndrome of RA and warming and activating meridian of TCM is one of the main treatment methods.Under the theory of warming channels and dredging collaterals,using additional Shaogan Fuizi decoction on the treatment of RA patients can improve patients' clinical symptoms and quality of life and reduce the disease activity with no significant effect on liver and renal function.Besides,inflammatory cell factors and angiogenesis related factors may be involved in the intervention mechanism in the process. |
PDF Full Text Request