真实世界下含砷中药复方为主治疗骨髓增生异常综合征EB2疗效及有效患者的临床特征分析  

Clinical Efficacy and Characteristics of Arsenic-containing Chinese Herbal Compounds in the Treatment of Myelodysplastic Syndrome-EB2 in the Real World

作　　者：刘青果 高琰 张盛琪 张朝畅 唐旭东[1] 孟博 LIU Qing-guo;GAO Yan;ZHANG Sheng-qi;ZHANG Chao-chang;TANG Xu-dong;MENG Bo(Hematology Department,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091;Beijing University of Chinese Medicine,Beijing 100105)

机构地区：[1]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,北京100105

出　　处：《世界中西医结合杂志》2022年第12期2496-2502,共7页World Journal of Integrated Traditional and Western Medicine

基　　金：国家自然基金面上项目(81673819);国家自然基金面上项目(82074258);中国中医科学院科技创新工程重大攻关项目(CI2021A01701)。

摘　　要：目的探究真实世界下含砷中药复方为主治疗骨髓增生异常综合征(Myelodysplastic syndromes,MDS)EB2患者的疗效及有效患者的临床特征。方法通过回顾性分析统计2020年10月—2022年3月中国中医科学院西苑医院门诊治疗的32例EB2患者的临床特征,按照中医辨证证型,采用含砷中药复方配合雄激素进行治疗,以3个月为1个疗程,共治疗2个疗程评价疗效。分析疗效及有效患者治疗前后的临床特征。结果(1)含砷中药复方配合雄激素治疗MDS-EB2,2个疗程(6个月)后,3例患者达到完全缓解(Complete Remission,CR)(9.3%),2例患者达到部分缓解(Partial Remission,PR)(6.3%),10例患者达到血液学改善(Haematologic Remission,HI)(31.3%);3例患者达到病情进展(Pro-gressiondisease,PD)(9.4%);32例患者治疗总改善率(CR+PR+HI)为46.9%,总有效率[CR+PR+HI+病情稳定(Stable Disease,SD)]为56.3%。(2)含砷中药复方为主治疗MDS-EB2,年龄≤65岁的疗效较好,有效率达61.5%;女性的有效率达64.29%,远高于男性;气阴两虚证患者疗效最佳,治疗有效率达69.2%;IPSS-R积分5分以下的有效率达92.3%。(3)运用Kaplan-Meier结果表明,染色体不发生突变的患者和IPSS-R危险等级在极高危以下的患者生存状况更佳(P<0.05)。结论(1)含砷中药复方为主治疗MDS-EB2安全有效,可以有效提升外周血血象计数,改善患者生存质量,提高生存率;(2)含砷中药复方为主治疗有效的MDS-EB2患者的特征:中医辨证为气阴两虚型、女性、染色体核型正常、IPSS评分在5分以下,这些患者的预后相对较好。Objective To explore the clinical efficacy of arsenic-containing Chinese herbal compounds in the treatment of myelodysplastic syndrome-EB2(MDS-EB2)in the real world and the clinical characteristics of effective patients.Methods The clinical characteristics of 32 EB2 patients treated in the outpatient department of Xiyuan Hospital from October 2020 to March 2022 were analyzed retrospectively.According to the syndrome differentiation of traditional Chinese medicine(TCM),arsenic-containing Chinese herbal compounds combined with androgen were used for treatment.Three months were taken as a course of treatment,and after two courses of treatment,the curative efficacy was evaluated.The curative efficacy and clinical characteristics of effective patients before and after treatment were analyzed.Results(1)After two courses of treatment(six months)of MDS-EB2 with arsenic-containing Chinese herbal compounds combined with androgen,three patients achieved(Complete Remission,CR)(9.3%),two patients achieved Partial Remission(PR)(6.3%),10 patients achieved Haematologic Remission(HI)(31.3%),and three patients achieved Pro-gressiondisease(PD)(9.4%).The total improvement rate(CR+PR+HI)of 32 patients was 46.9%,and the total effective rate(CR+PR+HI+Stable Disease)was 56.3%.(2)In the treatment of MDS-EB2 mainly by the arsenic-containing Chinese herbal compounds,patients aged less than 65 years showed better curative effect,with an effective rate of 61.5%.Theeffective rate for female patients was 64.29%,much higher than that of males.The patients with deficiency of both qi and yin showed the best curative effect,with the effective rate of 69.2%.The effective rate for those with IPSS-R score below 5 was 92.3%.(3)The Kaplan-Meier results showed that the patients without chromosome mutation and those with extremely high IPSS-R risk had better survival(P<0.05).Conclusion(1)Arsenic-containing Chinese herbal compounds are safe and effective in the treatment of MDS-EB2,which can effectively increase the peripheral blood count,improve the qual

关 键 词：含砷中药复方 真实世界 临床特征 伴原始细胞增多骨髓增生异常综合征 疗效 

分 类 号：R551.3[医药卫生—血液循环系统疾病]