| ObjectiveTo evaluate the curative effect, side-effect and therapeutic advantage of liang xue qing re sheng ban prescription with glucocorticoid on patients with immune thrombocytopenia(ITP) of blood hot type.To clarify the regulatory T cells in the pathogenesis of ITP and to provide the basis for Integrated Traditional and Western Medicine in the treatment of ITP.MethodsUsing randomised controlled clinical trial, we selected30ITP patients of blood hot type that met the study criterion and randomly divided them into two groups. the treatment group of15cases were treated by liang xue qing re sheng ban prescription with glucocorticoid. the control group of15cases were treated by only glucocorticoid. the Course of treatment was3months. We observed the changes of body weight, blood pressure, blood routine test, urine routine test, stool routine test, heart function, lung function, liver function, kidney function, blood glucose, blood lipid, chest X-ray and side effect of glucocorticoid in two groups before and after treatment. we evaluated the change of platelet after treatment, the clinical efficacy, the syndrome efficacy of Traditional Chinese Medicine(TCM), Hemostatic function and compared glucocorticoid side effects of two groups after treatment. Using flow cytometry (FCM), We tested mean fluorescence intensity (MFI) of peripheral platelet associated antibody (PAIg) and the ratio of CD4+cells/Lymphocyte cells, CD4+CD25+cells/CD4+cells, CD4+CD25+FoxP3+cells/CD4+CD25+cells of24patients with ITP and10healthy adults and compared the differences of PAIg and Treg between the ITP group and the normal control group.Results1.The mean platelet count of the two groups was significantly higher after treatment than those before treatment and the difference was statistically significant (P<0.05). The mean platelet count was slightly higher in treatment group than those in the control group before treatment, but the statistical analysis showed no significant difference (P>0.05). The mean platelet count was significantly higher in the treatment group than that of the control group after treatment and the difference was statistically significant(P<0.05). The D-value of mean platelet between before treatment and after treatment was significantly higher in the treatment group than that of the control group and the difference was statistically significant(P<0.05).2.11of15cases in the treatment group were complete response (CR),3cases were response (R) and1case of no response (NR). The total effective rate was93.3%.7of15cases in the control group were CR,2cases R,6cases NR. The total effective rate was60.0%in the control group. The CR rate was much higher in the treatment group than that in the control group, but the statistical analysis showed no significant difference(P>0.05). The total effective rate of the treatment group was higher than that of the control group and the difference was statistically significant (P <0.05).3. As the syndrome efficacy of TCM, in the treatment group9cases cure,2case significantly effective,2cases effective,2case ineffective. The total effective rate was86.7%. In the control group,1cases cure,2case significantly effective,2cases effective,10case ineffective. The total effective rate was33.3%. the cure rate was much higher in the treatment group than that in the control group and the difference was statistically significant(P<0.05).The total effective rate in treatment group was higher than that in control group and the difference was statistically significant(P<0.05).4. As the hemorrhage grade and scores, there was1case of0hemorrhage grade,13cases of1grade,1case of2grade, the average hemorrhage score was1.00±0.38in the treatment group before treatment. After treatment there were14cases of0hemorrhage grade,1case of1grade,0case of 2grade. The average hemorrhage score was0.07±0.26. The hemorrhage score was significantly better after the treatment than that before treatment and the difference was statistically significant (P<0.05). In the control group before treatment, there were5cases of0hemorrhage grade,9cases of1grade,1case of2grade. The average hemorrhage score0.73±0.59. There were13cases of0hemorrhage grade,2cases of1grade,0case of2grade after treatment and the average hemorrhage score was0.13±0.35. The hemorrhage score was significantly better after treatment than that before treatment and the difference was statistically significant(P <0.05). The average hemorrhage score was significantly lower in the treatment group than that in the control group after treatment, but there was no statistical difference (P>0.05).5. As the mean side effect scores of glucocorticoid, the treatment group were1.20±1.66before treatment and2.27±1.94(much higher than before) after treatment. the control group were1.00±1.90before treatment and4.13±2.59(much higher than before) after treatment. There was no significant difference in the mean side effect scores of glucocorticoid between two groups before treatment (P>0.05). The mean side effect scores of glucocorticoid were much lower in the treatment group than that in the control group after treatment and the difference was statistically significant (P<0.05). The D-value of mean side effect scores of glucocorticoid between before treatment and after treatment was much lowerer in the treatment group than that of the control group, but the difference was not statistically significant(P>0.05).6. As The mean fluorescence intensity (MFI) of PAIgG, PAIgA, PAIgM in ITP group was107.9±95.5,81.7±51.5,119±63.7. The MFI of PAIgG, PAIgA, PAIgM in the normal control group was77.9±16.7,41.8±2.5,81.4±22.7. The MFI of PAIgA in the ITP group was significantly higher than that of the the normal human and showed statistically significant difference (F<0.05). The MFI of PAIgM in the ITP group was significantly higher than that of the normal human and showed statistically significant difference (P<0.05). The MFI of PAIgG in the ITP group was significantly higher than that of normal human, but there was no statistical difference(P>0.05). There was a great difference in positive rate of diagnosis of ITP between different combination of PAIg subtype and the diagnosis rate was significantly higher by using combination of PAIg subtypes than by using two or single PAIg subtype. the order is combination of PAIg subtypes>PAIgG+PAIgA>PAIgG+PAIgM>IgG>IgA>IgM。7. The ratio of CD4+cells/lymphocyte in the ITP group was (29.67±11.90)%and was much lower than (38.67±5.22)%in the normal control group. The difference was statistically significant (P<0.05). The ratio of CD4+CD25+cells/CD4+T cells in the ITP group was (4.12±3.94)%and was much lower than (7.32±3.87)%in the normal control group. The difference was statistically significant (P<0.05). The ratio of CD4+CD25+FoxP3+cells/CD4+CD25+cells in the ITP group was (3.28±1.56)%and was much lower than (10.39±9.88)%in the normal control group. The difference was statistically significant (P<0.05).ConclusionLiang xue qing-re sheng ban prescription with glucocorticoid can improve platelet count, the recent efficacy in patients with ITP of blood hot type, and it can reduce side effects (toxicity) of glucocorticoid and improve the patient compliance. the combination of TCM and western medicine of glucocorticoid has obvious advantages over glucocorticoid treatment. PAIg is higher in ITP patients than that in the normal adults, PAIg plays an important role in the pathogenesis of ITP. detection of PAIg is helpful for the diagnosis of ITP. The Treg ratio in ITP patients is significantly lower than that in the normal adults; The regulatory T cells plays an important role in the pathogenesis of ITP and further study is needed. |
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