调和肝脾方辅助造血干细胞移植治疗血液系统疾病的临床研究

作者	单位
吴远彬	广东省中医院血液科
吴万垠	广东省中医院肿瘤科
刘琨	广东省中医院血液科
梁冰	广东省中医院血液科
李达	广东省中医院血液科
康颖	广东省中医院血液科
江志生	广东省中医院血液科
胡永珍	广东省中医院血液科
郭坤元	南方医科大学珠江医院血液科
陈瑶	广州中医药大学第二临床医学

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中文摘要:

目的观察调和肝脾方辅助造血干细胞移植治疗血液系统疾病的临床疗效及患者生存情况,为中医药介入造血干细胞移植过程开拓新的方法与思路。方法以实施异基因造血干细胞移植为主的27例血液系统疾病患者为研究对象,随机分为2组,治疗组(14例)从预处理开始至造血重建期间,在常规移植治疗基础上,口服调和肝脾方;对照组(13例)不予中药,余同治疗组。随访至2009年12月31日(中位随访时间为25个月),观察两组患者的造血重建时间、植入情况、治疗相关病死率、复发率、预处理相关并发症及移植物抗宿主病(GVHD)的发生情况、生存时间、生存概率等。结果两组生存时间(月)(41.6±6.5vs21.0±5.9)、生存概率(78.6%vs30.8%)及1～3年累积生存率(80.8%vs46.2%,69.3%vs34.6%,69.3%vs34.6%)比较,治疗组均优于对照组;治疗相关病死率(0vs30.8%)及死亡风险比较,治疗组低于对照组,差异有统计学意义(均P<0.05)。随着时间的延长,两组的累积生存率逐渐下降,患者所经历的死亡风险愈来愈大。两组在造血重建时间(天)(17.9±7.9vs18.1±6.8)、植入情况、预处理相关并发症的发生率(14.3%vs23.1%)、GVHD发生情况及复发率(21.4%vs23.1%)比较,差异均无统计学意义(P>0.05)。结论调和肝脾方可以降低造血干细胞移植治疗血液系统疾病的治疗相关病死率,延长生存期,提高累积生存率,起到了增效减毒之功效。

英文摘要:

Objective To observe the clinical efficacy and the survival of hematopathy patients by Tiaohe Ganpi Recipe (TGR) in assisting the hematopoietic stem cell transplantation (HSCT),thus finding out new thinking ways and methods for Chinese medicine in intervening HSCT. Methods Twenty-seven hematopathy patients scheduled to receive HSCT were randomly assigned to two groups,thirteen in the control group and fourteen in the treatment group. They were treated with the conventional treatment of HSCT,but TGR was additionally given to patients in the treatment group during the whole course. All patients were followed up till December 31,2009 (with the median follow-up time of twenty-five months). The hemopoietic rebuilding time,the implantation state,the therapy correlated mortality,the recurrence rate,preconditioning correlated complications,and graft-versus-host disease (GVHD),the survival time,the survival probability,and so on in the two groups were observed and compared. Results Better results were obtained in the treatment group in the survival time (41.6±6.5 months vs 21.0±5.9 months),the survival probability (78.6% vs 30.8%),the 1-3-year cumulative interval survival rate (80.8% vs 46.2%,69.3% vs 34.6%,and 69.3% vs 34.6%,respectively),the therapy correlated mortality (0 vs 30.8%),and the death risk (all P<0.05). As time went by,the cumulative survival rate decreased and the death risk increased gradually in both groups. There was insignificant difference in the hemopoietic rebuilding time (17.9±7.9 days vs 18.1±6.8 days),the implantation state,the occurrence rate of preconditioning correlated complications (14.3% vs 23.1%),GVHD occurrence,and the recurrence rate (21.4% vs 23.1%,P>0.05). Conclusion TGR could lower the therapy correlated mortality,prolong the survival time,and improve the cumulative survival rate in the HSCT treatment of hematopathy patients,playing efficacy enhancing and toxicity reducing effect.

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