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
邹吉轩 1王德好 1王子卿 1丁晓庆 2邸海侠 3曾英坚 4付海英 5孙岸弢 6李雨蒙 7杨二鹏 7牛继聪 7王明镜 7谌海燕 2王国姿 3邓少兰 4王贺 5张明辉 6胡晓梅7
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. 北京中医药大学附属东方医院血液科(北京 100029)
- 3. 廊坊市中医医院血液科(河北 065000)
- 4. 江西省中医院血液科(南昌 330006)
- 5. 福建中医药大学附属第三人民医院血液科(福州 350122)
- 6. 中国中医科学院广安门医院血液科(北京 100053)
- 7. 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.
Abstract
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Key words
myeloproliferative neoplasms/essential thrombocythemia/polycythemia vera/Chinese medicine/Longchai Jiangxue Formula/integrative medicine引用本文复制引用
基金项目
中国中医科学院科技创新工程重大攻关项目(CI2021A01702)
国家自然科学基金面上项目(82174360)
出版年
2024
国家科技期刊平台
NSTL
万方数据