中国中医药临床案例成果库 | 临床研究
扶正解毒方治疗持续性或慢性免疫性血小板减少症气不摄血证患儿临床疗效研究
Efficacy of
Fuzheng Jiedu Formula in children with continuous or chronic immune thrombocytopenia and pattern of qi failing to control bloodDOI：10.3969/j.issn.1006-2157.2021.07.010
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扶正解毒方治疗持续性或慢性免疫性血小板减少症气不摄血证患儿临床疗效研究
摘要
目的,2,研究扶正解毒方对持续性或慢性免疫性血小板减少症气不摄血证患儿的临床疗效和安全性。,方法,2,选取2017年2月—2020年9月就诊于北京中医药大学东直门医院余惠平教授门诊的持续性或慢性免疫性血小板减少症气不摄血证患儿，共120例，按入组时间顺序编号，随机分为试验组60例和对照组60例，2组患者均服用多维片及复方芦丁片，试验组在此基础上给予扶正解毒方配方颗粒，对照组给予中药安慰剂（扶正解毒方颗粒模拟剂），2组患者均每日服药1剂，上下午分服，共治疗6个月。比较2组患者治疗前及治疗6个月后的总有效率、中医证候疗效、血小板计数、中医证候积分、出血分级以及不良反应发生情况。,结果,2,与治疗前比较，治疗6个月后试验组临床疗效的总有效率为63.33%，对照组为13.16%，差异具有统计学意义（,P,<,0.05）。试验组中医证候有效率为96.67%，对照组为50.00%，差异具有统计学意义（,P,<,0.01）。与治疗前比较，试验组患儿治疗1、3、6个月后血小板计数升高，差异具有统计学意义（,P,<,0.01）。与治疗前比较，治疗后2组患儿主症及次症的中医证候积分均降低（,P,<,0.05，,P,<,0.01）。治疗6个月后，与对照组比较，试验组患儿主症及次症的中医证候积分均降低（,P,<,0.01）。比较2组治疗前后出血分级变化，试验组患儿出血状况的总改善率为98.33%，对照组为55.26%，差异具有统计学意义（,P,<,0.01）。,结论,2,扶正解毒方可以改善持续性或慢性免疫性血小板减少症气不摄血证患儿的临床症状，升高血小板计数，且安全性高。
Abstract
Objective,2,To study the clinical efficacy and safety of ,Fuzheng Jiedu, Formula (Reinforcing Healthy Qi and Removing Toxin Granules, FZJDF) in children who suffer fromcontinuous or chronic immune thrombocytopenia with pattern of qi failing to control blood.,Methods,2,120 children who suffer from continuous or chronic immune thrombocytopenia with pattern of qi failing to control blood were selected from the outpatients of Professor Yu Huiping in Dongzhimen Hospital of Beijing University of Chinese Medicine from February 2017 to September 2020. They were randomly divided into experimental group (,n,=60) and control group (,n,=60) according to the time sequence. Patients in both groups were given multi-vitamin tablets and compound rutin tablets. The experimental group was additionally given FZJDF, and the control group was given the placebo (the simulant granule of FZJDF). Two groups were daily treated with one prescription divided into two doses, one in the morning and one in the afternoon, and the treatment course was 6 months. The total effective rate, TCM pattern effetiveness, platelet count, TCM pattern scores, haemorrhage grading and adverse reactions of the two groups were compared before and 6 months after treatment.,Results,2,The total effective rate was 63.33% in the experimental group and 13.16% in the control group after the treatment for 6 months. The difference was statistically significant (,P,<,0.01). The effective rate of TCM pattern was 96.67% in the experimental group and 50.00% in the control group. The differenceswere statistically significant (,P,<,0.01). Comparing with before treatment, the efficacy of improving platelet count in the experimental group was increased after the treatment for 1, 3, 6 months, The difference was statistically significant (,P,<,0.01). TCM pattern scores (primary and secondary symptoms) of patients were both reduced after treatment in two groups compared with those before treatment (,P,<,0,., 05,P,<,0.01). At six months after treatment, TCM pattern scores (primary and secondary symptoms) of patients in the experiment group were all lower than those in the control group (,P,<,0.01). Comparing the haemorrhage grade scale of two groups, the total improvement rate of the experimental group was 98.33% and it was better than that (55.26%) in the control group. The difference was statistically significant (,P,<,0.01).,Conclusion,2,FZJDF demonstrates its benefits for children who suffer from continuous or chronic immune thrombocytopenic purpura with pattern of qi failing to control blood. It can increase the platelet count with high safety profile.
关键词
扶正解毒方儿童免疫性血小板减少症
Keywords
Fuzheng Jiedu Formulachildrenimmune thrombocytopenia
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