| Objective: Through this clinical study,to evaluate the clinical efficacy and safety of Yiyuan Shengxue recipe in the treatment of primary immune thrombocytopenia(ITP),so as to provide a more scientific clinical basis for the wide application of Yiyuan Shengxue recipe.Methods: 62 patients with primary immune thrombocytopenia who were treated in the Department of Hematology of Gansu Provincial Hospital of traditional Chinese Medicine from December 2019 to December 2020 met the inclusion and exclusion criteria of the study.and signed the informed consent form of primary immune thrombocytopenia.In a randomized controlled study,62 patients with ITP were randomly divided into experimental group(n=30)and control group(n=32).During the study,the patients in the experimental group were treated with prednisone acetate tablets combined with Yiyuan Shengxue recipe,while the patients in the control group were treated with prednisone acetate tablets only for 4 cycles(8 weeks).The clinical efficacy of Yiyuan Shengxue prescription in the treatment of ITP was evaluated by analyzing the platelet count,total effective rate,hormone side effects,TCM syndrome scores and physical status of the two groups before and after treatment.At the same time,the liver and kidney function and adverse reactions of the two groups before and after treatment were analyzed to evaluate the safety of Yiyuan Shengxue recipe.The statistical data of this study were calculated and analyzed by SPSS26.0 software.If the results show that there is no statistical significance,on the contrary,there is statistical significance.Results: Among the 62 ITP patients in this study,3 cases were lost in the course of the study,2 cases in the control group and 1 case in the experimental group.Finally,59 patients completed the clinical study and entered the medical statistics,of which 30 patients in the control group completed the study and 29 patients in the experimental group completed the study.The specific results are as follows:(1)at the end of 8 weeks of treatment,the total effective rate of the treatment group(89.66%)was compared with that of the control group(83.33%),and there was no statistical difference(P > 0.05).(2)after 2 weeks of treatment,compared with the platelet count before treatment,the platelet count in the treatment group and the control group increased significantly(P < 0.05).There was no significant difference in platelet count between the treatment group and the control group(P>0.05).At 4weeks of treatment,compared with the platelet count at 2 weeks of treatment,the platelet count did not decrease significantly in the treatment group(P>0.05),but decreased in the control group(P < 0.05).There was no significant difference in platelet count between the control group and the treatment group(P>0.05).At 8 weeks of treatment,compared with the platelet count at 4 weeks of treatment,the platelet count in the treatment group did not decrease significantly(P > 0.05),but that in the control group decreased significantly(P < 0.05).The decrease of platelet count in the control group was significantly higher than that in the treatment group(P < 0.05).(3)when the hormone side effect treatment was completed,the incidence of hormone side effect was 24.14% in the treatment group and 56.66% in the control group.The hormone side effect in the treatment group was lower than that in the control group(P < 0.05).(4)after 8 weeks of treatment,the physical condition scores of the patients in the test group and the control group were improved compared with those before treatment(P<0.05),and the improvement in the test group was more obvious than that in the control group(P<0.05).(5)after 8 weeks of treatment,the scores related to TCM syndromes were compared respectively,the curative effect of TCM syndrome in the treatment group was significantly better than that in the control group(P<0.05).According to the scores related to TCM syndromes,it was found that at 8 weeks of treatment,the scores of primary and secondary symptoms in the control group and treatment group were lower than those before treatment(P<0.05).However,there was no significant difference in the scores of bleeding and spontaneous sweating between the treatment group and the control group(P > 0.05).The scores of purple spot,fatigue,dizziness,pallor,lack of food,loose stool and shortness of breath in the treatment group were lower than those in the control group(P<0.05).After 8 weeks of treatment,the total scores of TCM syndromes in the control group and treatment group were significantly lower than those before treatment(P < 0.05),and the total scores of TCM syndromes in the treatment group were significantly lower than those in the control group(P<0.05).(6)Safety evaluation 1 case of mild abnormal liver function occurred in each of the two groups,which returned to normal after symptomatic treatment.The liver and renal functions of other patients fluctuated within the normal range,and no other serious adverse reactions or events or complications were found.Conclusion:(1)Yiyuan Shengxue Formula combined with prednisone acetate tablets can not only relieve the clinical symptoms of traditional Chinese medicine,but also reduce the side effects of hormone in patients with ITP.(2)Yiyuan Shengxue prescription can better assist prednisone acetate tablets to maintain platelet count,and the long-term effect is better,but also can improve the quality of life of patients.(3)Yiyuan Shengxue recipe is effective in the prevention and treatment of primary immune thrombocytopenia with no blood intake,no obvious adverse reactions and no adverse events,so its clinical application is worth popularizing. |
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