龙柴降血方治疗骨髓增殖性肿瘤多中心随机对照研究  

Longchai Jiangxue Formula for Myeloproliferative Neoplasms:A Multicenter Randomized Controlled Trial

作　　者：邹吉轩 王德好 王子卿 丁晓庆[3] 邸海侠 曾英坚 付海英 孙岸弢[7] 李雨蒙 杨二鹏 牛继聪 王明镜[2] 谌海燕[3] 王国姿 邓少兰 王贺 张明辉[7] 胡晓梅[2] ZOU Ji-xuan;WANG De-hao;WANG Zi-qing;DING Xiao-qing;DI Hai-xia;ZENG Ying-jian;FU Hai-ying;SUN An-tao;LI Yu-meng;YANG Er-peng;NIU Ji-cong;WANG Ming-jing;CHEN Hai-yan;WANG Guo-zi;DENG Shao-lan;WANG He;ZHANG Ming-hui;HU Xiao-mei(Graduate School of Beijing University of Chinese Medicine,Beijing 100029;Hematology Department,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing100091;Hematology Department,Dongfang Hospital Affliated to Beijing University of Chinese Medicine,Beijing 100029;Hematology Department,Langfang Hospital of Chinese Medicine,Hebei 065000;Hematology Department,Jiangxi Provincial Hospital of Chinese Medicine,Nanchang 330006;Hematology Department,The Third Afiliated People's Hospital of Fujian University of Chinese Medicine,Fuzhou 350122;Hematology Department,Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing100053)

机构地区：[1]北京中医药大学研究生院,北京100029 [2]中国中医科学院西苑医院血液科,北京100091 [3]北京中医药大学附属东方医院血液科,北京100029 [4]廊坊市中医医院血液科,河北065000 [5]江西省中医院血液科,南昌330006 [6]福建中医药大学附属第三人民医院血液科,福州350122 [7]中国中医科学院广安门医院血液科,北京100053

出　　处：《中国中西医结合杂志》2024年第8期921-927,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：中国中医科学院科技创新工程重大攻关项目(No.CI2021A01702);国家自然科学基金面上项目(No.82174360)。

摘　　要：目的评价龙柴降血方治疗骨髓增殖性肿瘤(MPN)的临床疗效和安全性.方法采用多中心随机双盲对照研究设计,将100例MPN患者随机分为试验组和对照组,每组50例.两组均采用西医基础治疗+异功散治疗,试验组加用龙柴降血方治疗,治疗4个月.观察两组有效率、血细胞计数、骨髓增殖性肿瘤总症状评估量表(MPN-10)症状积分、疾病进展及血栓或出血事件.记录治疗过程中不良反应.结果试验组40例、对照组41例完成研究并纳入统计分析.与对照组比较,试验组有效率升高(86.5%vs.56.1%,P<0.05),血小板计数、红细胞压积水平降低(P<0.05),MPN-10总积分、早饱感以及夜间盗汗症状积分降低(P<0.05).两组患者治疗期间均未发生疾病进展及血栓或出血事件.与对照组比较,试验组肝功能异常比例降低(5.0%vs.9.7%,P<0.05),两组患者均未观察到除轻度肝功能异常外的不良反应.结论龙柴降血方可提高MPN患者治疗有效率,降低MPN患者血细胞计数,改善患者症状,且不增加不良反应,有较好的疗效和安全性.Objective To evaluate the efficacy and safety of Longchai Jiangxue Formula(LCJX)in the treatment of myeloproliferative neoplasm(MPN).Methods A multicenter double-blinded randomized controlled trial was conducted.One hundred patients with MPN were randomly assigned to the experimental group and control group,with 50 patients in each group.Both groups received conventional treatment and Yigong Formula.The experimental group received LCJX additionally.The treatment lasted for 4 months.The effective rate,blood cell counts,MPN-10 scores,disease progression,and thrombotic or bleeding events were observed.The adverse events were recorded during the treatment.Results A total of 40 cases in the experimental group and 41 cases in the control group completed the trial and were included for statistical analysis.Compared with the control group,the effective rate increased in the experimental group(86.5%vs.56.1%,P<0.05),the platelet count and hematocrits were decreased in the experimental group(P<0.05),the total MPN-10 scores,the symptom score of early satiety,and the symptom score of night sweats were all declined in the experimental group(P<0.05).No disease progression,thrombotic or bleeding events occurred during the treatment.Compared with the control group,the rate of hepatic dysfunction was decreased in the experimental group(5.0%vs.9.7%,P<0.05),and no adverse events except for mild hepatic dysfunction were observed in both groups during the treatment.Conclusions LCJX can increase the effective rate,decrease blood counts,and improve symptoms in the treatment of MPN,with no more adverse events.LCJX is proven to be effective and safe in the treatment of MPN.

关 键 词：骨髓增殖性肿瘤 原发性血小板增多症 真性红细胞增多症 中医药 龙柴降血方 中西医结合 

分 类 号：R273[医药卫生—中西医结合]