| ObjectiveObserve the clinical efficacy of Fuzheng Jiedu Decoction in the treatment of pe rsistent and chronic immune thrombocytopenia(ITP)in children.Study the clinical characteristics of antinuclear antibodies(ANA)and antinuclear antibody spectrum(A NAs)in children with ITP and their influence on the efficacy and prognosis of ITP.Study the outcome of anti-nuclear antibody and anti-nuclear antibody spectrum treate d by Fuzheng Jiedu Decoction.MethodFrom August 2018 to January 2021,90 children in the Pediatric Clinic of Don gzhimen Hospital of Beijing University of Chinese Medicine who met the diagnostic criteria for persistent and chronic ITP were tested for antinuclear antibody and anti nuclear antibody spectrum,and their clinical characteristics were counted.15 childre n with ANA and/or AN As positive and 15 children with ANA and ANAs negative were divided into ANA positive group and ANA negative group for dynamic analysi s.All were treated with Fuzheng Jiedu Decoction for 6 months and followed up for 3 months.The platelet count,TCM syndrome score scale and bleeding grading sca le were collected and sorted out in the two groups.The ANA positive group was r echecked for ANA and ANAs after treatment.The clinical data of 1 month of treat ment,3 months of treatment,6 months of treatment,and 3 months of follow-up we re counted,and SPSS 26.0 statistical analysis software was used for statistical analy sis.Result1.The positive rates of ANA and ANAs in 90 children with ITP were 27.8%a nd 20.0%,respectively.There was significant agreement between the two tests(k=0.201,P<0.05),which was a low degree of agreement.88.0%of ANA-positive patien ts had low titer.Among ANAs,anti-Ro52 antibody(38.9%),anti-U1-snRNP antibod y(27.8%),and anti-mitochondrial M2 subtype antibody(22.2%)were the most com mon.2.There was no significant difference in age,course of disease,platelet count b etween ANA and/or ANAs positive children and ANA and ANAs negative children in 90 ITP children(P>0.05).The positive rates of male and female children were 32.7%and 44.7%,respectively.There was no significant difference in the positive rat e of different genders and different age groups(P>0.05).The positive rate of femal e children aged 10—14 years group(87.5%)was significantly higher than that of ?4 years old group and 5—9 years old group.The difference between the three grou ps was statistically significant(P<0.05).There was no significant difference in the p ositive rate of male children in different age groups(P>0.05).The positive rate of children aged 10—14 years was statistically significant between genders(P<0.05).3.The total effective rate of Fuzheng Jiedu Decoction for 6 months is 55.6%.Although the efficacy(33.3%)of treatment for 1 month and 3 months is the same,the complete response rate is different,indicating that the efficacy is still fluctuate d.There was no significant difference between the ANA-positive group and the AN A-negative group for 1 month,3 months,and 6 months of treatment(P>0.05).4.Using repeated measures design analysis of variance to analyze the platelet co unts before and after treatment in the ANA positive group and the ANA negative g roup,the in-subject effect test showed that the platelet counts of different treatment times were significantly different(P<0.05),and the interaction between treatment ti me and grouping was not statistically significant(P>0.05).The inter-subject effect te st showed that there was no significant difference in platelet count between the two groups(P>0.05).The parameter estimates showed that there was no significant diff erence in platelet count between the two groups at the time of enrollment,1 month,3 months,and 6 months of treatment(P>0.05).There was a statistically significant difference in platelet counts between ITP children and the platelet counts after 1 month,3 months,and 6 months of treatment(P<0.05).The difference between the remaining two groups was not statistically significant(P>0.05).The multiple com parison results of the ANA positive group were not statistically significant(P>0.05).The platelet count of the ANA-negative group at entry was significantly different f rom the platelet counts after 3 months of treatment and 6 months of treatment(P<0.05),and there was no statistical significance in the pairwise comparison of the of her groups(P>0.05).5.The negative rate of ANA and ANAs in the ANA-positive group was 23.1%after 6 months of treatment.There was no significant difference in the positive rate of ANA and ANAs before and after treatment(P>0.05).6.After treatment,the total bleeding improvement rate was 95%,the bleeding w as significantly improved by 15%,the bleeding was improved by 80%,and the blee ding was not improved by 5%.There was no significant difference in the improve ment rate of bleeding grading between the ANA-positive group and the ANA-negati ve group(P>0.05).7.After treatment,the TCM syndromes have been improved to varying degrees,with 11.1%clinical recovery,59.3%effective and 29.6%effective.There was no s ignificant difference between the ANA-positive group and the ANA-negative group i n the effective rate of TCM syndromes and the total score(P>0.05).The total scor es of TCM syndromes before and after treatment were significantly different betwee n the two groups(P<0.05).The main symptom and secondary symptom of the two groups,except for the secondary symptom,loose stools,were significantly improve d before and after treatment(P<0.05).8.Follow-up for 3 months,the total effective rate of the ANA positive group w as 40%,the recurrence rate was 30%,the total effective rate of the ANA negative group was 60%,and there was no recurrence.The difference between the two was not statistically significant(P>0.05).There was no significant difference in platelet c ount between the two groups(P>0.05).ConclusionFuzheng Jiedu Decoction has a definite clinical effect in the treatment of persis tent and chronic ITP.Platelet count,bleeding symptoms,and TCM syndromes have all been significantly improved.With the extension of the course of treatment,the e ffect is more obvious,with high safety and stable effect.The test results of ANA a nd ANAs in children with ITP are similar to those of AID,but there are also diffe rences.ITP is a diagnosis of exclusion,and ANA and ANAs testing is necessary,es pecially for children with older females who should be strictly screened to reduce missed diagnosis and misdiagnosis.Whether it is positive or not may have a negati ve impact on the short-term curative effect of Fuzheng Jiedu Decoction,but has no significant effect on the long-term curative effect.Therefore,ANA and ANAs have a certain influence on the efficacy of Fuzheng Jiedu Decoction in treating children with persistent and chronic ITP.It is speculated that it may be a pathological prod uct that will hinder the effectiveness of Fuzheng Jiedu Decoction in the short term.After a period of treatment with Fuzheng Jiedu Decoction,the pathological products are reduced,and the curative effect is significantly improved,which is not signific antly different from the curative effect of ANA negative group.And ANA-positive I TP children treated with Fuzheng Jiedu Decoction,ANA can partially turn negative.It is speculated that Fuzheng Jiedu Decoction may exert its therapeutic effect by regulating the body's immune system and reducing autoimmune reactions.However,whether turning negative indicates a good prognosis of the disease still needs to be further expanded in the sample size to extend the follow-up time for research. |
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