| Objective:1.Evaluating the effect of Enbrel(Etanercept)in the treatment of moderately or severely active RA by the baseline TNF-? level in serum,investigating its influence on Enbrel`s pharmacodynamics.2.Investigating the pharmacokinetic characteristics of RA patients,and providing reference for individualized treatment of RA in China.Methods:It collects 35 patients who visited the clinic or ward of the Shan Xi Medical University second hospital and were diagnosed as moderately or severely active RA between 2015-5 to 2016-6.All the patients were given treatment of hypodermic injection of Enbrel for injection 50 mg per time,once per week,continuous administration,among which 15 patients were treated for a period of 24 weeks,6 patients were treated for 12 weeks and 14 patients were treated for 4 weeks.It is necessary to observe the symptoms and signs before the first administration and the 4th,8th,12 th,16th,20 th,24thweek after given medicine: rest pain,morning stiffness period,joint swelling,joint tenderness,HAQ,patients`s VAS score on overall evaluation of self-health conditions,doctor`s VAS score on overall disease conditions,etc,and examine blood routine,urine routine,ESR,liver and kidney functions.Examine RF before the first administration and the 12 th,24thweek after given medicine.Exsanguinate 4ml blood of the cubital vein and put it into collecting tubes before the first administration and the 2nd,4th,8th,12 th,16th,20 th,24th week after given medicine.The samples collected,after laid for half an hour under room temperature,should be centrifuged 10 min under a low temperature(4-8?)and a speed of3000r/min.The serum collected and centrifuged should be separately put into 3 EP tubes with 500 u L per tube and preserved in a refrigerator of-80?.And examine the TNF-?level and Enbrel`s drug concentration level with ELISA.Results:1.Comparison of the correlation between the TNF-? level at different treatment time points and DAS28,ESR,CRP,HAQ,RF The baseline TNF-? level is positively correlated with DAS28,ESR,CRP,HAQ,and RF(P<0.05).The baseline TNF-? level is positively correlated with DAS28,ESR,CRP and RF(P<0.05)and has no correlation with HAQ(P>0.05)after 12 weeks`treatment.The baseline TNF-? level is positively correlated with DAS28,CRP,HAQ and RF(P<0.05)and has no correlation with ESR(P>0.05)after 24 weeks`treatment.2.Comparison of the changes of disease activity indicators of the 3 groups patients after4 weeks` treatment The change rate of DAS28 score of low TNF-? group is better than that of high TNF-? group(P<0.05),The proportional difference among the 3 groups patients with clinical remission has no statistical significance(P>0.05),The change rate of HAQ score of low TNF-? group is better than that of middle and high TNF-? group(P<0.05),The proportion of patients with ACR20 remission is better than that of high TNF-?group(P < 0.05).The proportional difference among the 3 groups patients with ACR 50 and ACR 70 remission has no statistical significance(P>0.05).3.Comparison of the changes of serum TNF-? of the 3 groups patients after 4 weeks`treatment The change rate of TNF-? of low TNF-? group is better than that of high TNF-?group(P<0.05).4.Changes of serum medicine concentration of 3 groups in the treatment process The serum medicine concentration of high level TNF-? group is lower and middle level TNF-? group is moderate and low level TNF-? group is higher in the 2ndweek to the 24 thweek after given administration.The serum medicine concentration of patients is high in the 2ndweek after given administration and decreases in the 4thweek after given administration.4 weeks later,with the increase of administration times,the serum medicine concentration increases gradually.5.The correlation between the serum TNF-? concentration and medicine concentration at different time The serum TNF-? concentration at different treatment time points and the medicine concentration are negatively correlated.Conclusion:1.The baseline TNF-? level is positively correlated with disease activity indicators.2.Given the same treatment,the lower the baseline TNF-? level is,the more significantly the DAS28 and the HAQ score decrease and the earlier the patients get ACR20 remission.3.Given the same treatment,the lower the baseline TNF-? level is,the more significantly the TNF-? decreases.4.The lower the baseline TNF-? level is,the higher the Enbrel concentration at different treatment time points is.During the 2ndto 4thweek after given administration,the medicine concentration shows a downward trend and with the increase of administration times,the medicine concentration in patients gradually increase and then tend to be stable.5.The serum TNF-? concentration at different treatment time points is negatively correlated with the medicine concentration. |
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