Correlation Between Serum Anti-M2 Level And Disease Condition And Prognosis In Patients With PBC

Aims:1.To explore the efficacy of UDCA in the treatment of PBC patients and its effect on anti-M2 level2.Study the relationship between anti-M2 level and development and prognosis of patients with PBC Methods:A historical cohort study of patients diagnosed with primary biliary cholangitis was performed in the First Hospital of Jilin University from October 1,2008 to October 1,2018.According to the inclusion and exclusion criteria,566 patients with PBC were enrolled,including 278 patients who underwent UDCA(15 mg/kg/day)for more than 6 months and had long-term follow-up of inpatient/outpatient medical records.Subjects were divided into anti-M2 positive group(<20U/ml)and anti-M2 negative group(?20U/ml),anti-M2 high concentration group(?150U/ml)and anti-M2 low concentration group(<150U/ml).Baseline clinical and laboratory data,liver histology,outcome/prognosis,survival(whether death or liver transplantation,recorded follow-up time,and time to death)were recorded for statistical analysis and comparison.Results:A total of 566 patients with PBC were included in the study.The male to female ratio was 1:6,with an average age of(58.94±11.30)years.Among them,548(96.82%)patients were positive for anti-M2 antibody,and 18(3.18%)patients were negative for anti-M2 antibody.There was no significant difference in ALP,r-GT and pathological stage between the anti-M2 antibody positive group and the negative group(P>0.05),but the positive rate of gp210(62.5%vs31.10%)and sp100(37.50%vs19.44%)in the anti-M2 negative group was significantly higher than that in the anti-M2 positive group.The difference was statistically significant(P < 0.05).The 278 patients with PBC were followed up for a mean follow-up of 5.26 ±2.70 years(median 5.58 years,range 6 months to 8.3 years).There were 35 end-point events,29 liver disease-related deaths,and 6 liver transplantation cases.There was no significant difference in clinical stage,pathological stage,APRI score and Mayo score between the high concentration group and the low concentration group(P>0.05).103 patients with PBC had clinical data after 1 year of UDCA treatment.They were divided into response group(47 cases)and non-responder group(56 cases)according to Paris Standard-I.The results showed that the anti-M2 in the response group showed a downward trend accounting for 46.81%,the increase trend accounted for 17.02%,no change accounted for 36.17%,but regardless of the level or status of anti-M2,there was no significant difference between the response group and the non-response group(P>0.05).According to the single factor Log-Rank test and multivariate COX model analysis,the baseline anti-M2 level was not a risk factor for prognosis and survival(P>0.05).126 patients with PBC had long-term monitoring of anti-M2 levels.By the end of follow-up,there was no significant difference in the anti-M2 trend between the normal liver function group(r-GT and ALP)(P>0.05).In addition,there was no significant difference in anti-M2 levels between normal and abnormal liver function in different clinical stages(P>0.05).This study compared the changes of anti-M2 after 1 month,4 months,6 months,1 year and 2 years after UDCA treatment.The results showed that the anti-M2 level decreased after treatment for 1 year,and the difference was statistically significant(P<0.05).However,the change of the mean resistance M2 is within the range of 10%,so it is regarded as no change.Among them,25 patients had continuous monitoring of anti-M2 levels.The mean anti-M2 values??were 137.55,148.38,134.85,and 129.70 at baseline,2 years,4 years,and 6years,respectively,and their rise or fall were within 10%.In other words,the anti-M2 level did not change significantly with the treatment time.Conclusion:We concluded that anti-M2 antibody has important diagnostic value for PBC,but it is not related to the severity of PBC patients' condition and long-term prognosis,and anti-M2 levels do not change significantly with UDCA treatment time.