摘要
目的探索健脾益气摄血方治疗免疫性血小板减少症(ITP)的效应及机制。方法采用中央随机对照、多中心临床试验方法,纳入272例免疫性血小板减少症脾不统血证患者。其中,健脾益气摄血方组104例、健脾益气摄血方联合强的松组(联合组)103例、强的松组65例。共治疗21 d,每周访视1次,统计止血、血小板数值以及中医证候(单项症状)疗效;检测外周血象变化、凝血功能变化、与免疫相关的血液神经递质变化、血小板活化功能与NK细胞分子标志物表达比例。结果治疗后各组出血程度均较治疗前减轻,健脾益气摄血方组、联合组的疗效早于强的松组出现。治疗后各组血小板减少程度评分较治疗前减少,疗效优势为联合组>强的松组>健脾益气摄血方组。健脾益气摄血方组、联合组中医证候总疗效优于强的松组(P<0.05)。各组各项中医证候评分优于治疗前。在食后腹胀评分上,健脾益气摄血方组与联合组的疗效出现早于强的松组。各组血小板计数均较治疗前升高,联合组与强的松组高于健脾益气摄血方组(P<0.05)。强的松组凝血酶原时间小于健脾益气摄血方组。健脾益气摄血方组、联合组疗后β-内啡肽测定值较治疗前均升高。3组治疗后血管活性肠肽均较治疗前下降。结论健脾益气摄血方能够有效改善"脾不统血证"ITP患者的出血症状,提升患者外周血小板计数,可有效改善ITP患者中医证候与单项症状。其疗效机制可能与调节脑-肠轴的肽类神经递质有关。
Objective To explore the effect and mechanism of action of Jianpi Yiqi Shexue therapy(spleen-fortifying qi-tonifying blood-securing formula, or JYS formula) in treating immune thrombocytopenia(ITP). Methods A central, randomized, controlled, multi-center clinical trial design was used, and 272 ITP patients with spleen failing to contain blood were enrolled. Among them, 104 cases were treated with the investigational product, JYS formula, 103 cases received combination treatment of JYS formula and prednisone(combination group) and 65 cases were treated with prednisone only. The treatment lasted 21 days with 1 visit per week. Hemostasis, platelet count and TCM pattern(single symptom) efficacy;peripheral blood count, coagulation, immunity-retated blood neurotransmitters, platelet activation and NK cell molecular marker expression ratio of all subjects were evaluated and analyzed.Results Aftertreatment, the degree of bleeding was reduced in all groups, and the efficacy of the TCM experiment group and the combination group was earlier than that of the prednisone group. After treatment, the degree of thrombocytopenia in all groups decreased, and the efficacy in the combination group was greater than the other two mono-treatment groups. The total efficacy of TCM pattern in the JYS formula group and the combination group were better than prednisone group(P<0.05). Symptom relief in all three groups was observed compared with before treatment. On the score of abdominal bloating after eating, the curative effect of the JYS formula group and the combination group was earlier than that of predniso group. The average prothrombin time in prednisone group was shorter than that in the JYS formula group. Platelet count increased in all groups, and the counts in combination group and in prednisone group were higher than that in JYS formula group. β-endorphins were increased after treatment in both JYS formula group and combination group. All of the three groups showed different degrees of decline in vasoactive intestinal peptide after treatment. Conclusion Jianpi Yiqi Shexue formula could effectively relieve the bleeding symptoms of ITP patients due to "spleen failing to contain blood" and elevate the peripheral platelet count. Jianpi Yiqi Shexue formula can effectively improve TCM patterns and single symptoms in ITP patients. The therapeutic mechanism may be related to the regulating effect on peptide neurotransmitter in brain-gut axis.
作者
张玲
陈科
张雅月
王冲
张佳诺
马薇
陈信义
Zhang Ling;Chen Ke;Zhang Yayue;Wang Chong;Zhang Jianuo;Ma Wei;Chen Xinyi(Yunnan University of Traditional Chinese Medicine,Yunnan 650500,China; Beijing Shunyi District Chinese Medicine Hospital,Beijing 101300,China; Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China)
出处
《北京中医药大学学报》
CAS
CSCD
北大核心
2020年第4期343-352,共10页
Journal of Beijing University of Traditional Chinese Medicine
基金
国家重点基础研究发展计划(973计划)资助项目(No.2013CB531705)。
关键词
健脾益气摄血方
免疫性血小板减少症
脑肠肽
效应机制
Jianpi Yiqi Shexue formula
immune thrombocytopenia(ITP)
brain-gut peptide
efficacy and mechanism of action
