龙柴降血方治疗原发性血小板增多症随机对照研究
Longchai Jiangxue Formula for the Treatment of Essential Thrombocythemia:A Randomized Controlled Study
孙妍 1杨二鹏 2李雨蒙 2牛继聪 2陈科 2邹吉轩 1王明镜 2刘为易 2吕妍 2陈卓 2胡晓梅2
作者信息
- 1. 北京中医药大学研究生院(北京 100029);中国中医科学院西苑医院血液科(北京 100091)
- 2. 中国中医科学院西苑医院血液科(北京 100091)
- 折叠
摘要
目的 评价龙柴降血方治疗原发性血小板增多症(ET)的有效性、抗凝作用和对阿司匹林抵抗(AR)的影响.方法 纳入2021年10月—2022年12月在中国中医科学院西苑医院血液科就诊符合纳入标准的原发性血小板增多症患者72例,采用随机数字表法分为对照组和观察组,每组36例.对照组予羟基脲≤1.0g/d或短效干扰素≤900万U/w或长效干扰素≤180 μg/w,阿司匹林≤100mg/d;观察组在此用药基础上加用龙柴降血方.治疗周期为4个月.观察治疗前后患者血小板计数、骨髓增殖性肿瘤总症状评估量表(MPN-10)评分、有无疾病进展及血栓形成或出血事件.采用凝血酶原时间(PT)、纤维蛋白原浓度(FIB)、D-二聚体(D-Di)、活化部分凝血活酶时间(APTT)、血小板计数(PLT)、凝血指数(CI)、血栓最大振幅(MA)评估患者是否存在高凝状态,并观察龙柴降血方的抗凝作用.应用血栓弹力图中花生四烯酸(AA)诱导的AA抑制率,评估ET患者是否存在AR以及龙柴降血方对AR的影响.结果 72例患者中,7例患者脱落,可评价患者65例,观察组32例,对照组33例.与对照组比较,观察组有效率升高,PLT计数及MPN-10积分下降(P＜0.05).治疗期间两组患者均未出现疾病进展及血栓或出血事件.两组患者中,29例(44.62％)患者处于高凝状态,对照组14例,观察组15例.与对照组比较,观察组治疗后高凝状态的患者比例显著降低(P＜0.05).两组患者AR发生率为46.15％(30/65),对照组16例,观察组14例.与对照组比较,观察组AA抑制率显著升高(P＜0.05).两组未出现明显不良反应.结论 龙柴降血方能有效地降低原发性血小板增多症患者的血细胞计数,改善症状,提高有效率,并能改善ET患者高凝状态和阿司匹林抵抗.
Abstract
Objective To evaluate the efficacy,anticoagulant role,and effect on aspirin resistance(AR)of Longchai Jiangxue Formula(LCJX)in treating essential thrombocythemia(ET).Methods Seventy-two patients with ET met the inclusion criteria at the Department of Hematology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,from October 2021 to December 2022,and were assigned to the control group and the observation group,with 36 cases in each group by using the method of randomized numerical table.The control group was given hydroxycarbamide≤1.0 g/d or pegylated interferon-α2a(PEG-INF α-2a)≤180 g/w or IFN-α-2b ≤ 9 million U/w,and aspirin ≤ 100 mg/d.The observation group added LCJX based on the control group treatment.Platelet counts,myeloproliferative neoplasm(MPN)-10 scores,disease progression and thrombosis or bleeding events were observed before and after treatment.Prothrombin time(PT),fibrinogen(FIB),D-Dimer(D-Di),activated partial thromboplastin time(APTT),platelet count(PLT),coagulation index(Cl),and maximal amplitude(MA)of thromboelastography(TEG)were used to assess the presence of hypercoagulable state in the patients as well as the effect of LCJX on coagulation function.Arachidonic acid(AA)-induced AA inhibition in TEG was applied to assess the occurrence of AR in patients with ET and the role of LCJX on AR.Results Among 72 patients,7 patients dropped off and 65 patients could be evaluated,32 in the observation group and 33 in the control group.Compared with the control group,the observation group showed a higher effective rate and lower PLT count and MPN-10 score(P＜0.05).No disease progression or thrombotic or bleeding events occurred in both groups during the treatment period.Of the two groups,29 patients(44.62％)were in a hypercoagulable state,14 cases in the control group and 15 cases in the observation group.Compared with the control group,the proportion of patients with hypercoagulable state was significantly lower in the observation group after treatment(P＜0.05).The incidence of AR in ET patients was 46.15％(30/65),16 patients in the control group and 14 in the observation group.Compared with the control group,the incidence of AA inhibition was significantly higher in the observation group(P＜0.05).No obvious adverse reactions occurred in the two groups.Conclusion LCJX can effectively reduce blood cell counts,improve symptoms,increase efficiency,and improve hypercoagulable state and AR in patients with ET.
关键词
原发性血小板增多症/龙柴降血方/血小板计数/高凝状态/阿司匹林抵抗/中西医结合/随机对照试验Key words
essential thrombocythemia/Longchai Jiangxue Formula/platelet count/hypercoagulable state/aspirin resistance/integrative medicine/randomized controlled trial引用本文复制引用
基金项目
国家自然科学基金面上项目(82174360)
中国中医科学院科技创新工程重大攻关项目(CI2021A01702)
中国中医科学院科技创新工程重大攻关项目(CI2021A01708)
中国中医科学院科技创新工程重点协同攻关项目(CI2023C027YL)
出版年
2024
国家科技期刊平台
NSTL
万方数据