口服含砷中药复方青黄散治疗骨髓增生异常综合征患者生存期分析

Overall survival of patients with myelodysplastic syndrome treated with oral arsenic-containing compound Qinghuang Powder

目的分析接受口服含砷中药复方青黄散治疗的骨髓增生异常综合征患者生存期,并探讨影响患者生存期的因素。方法对2015年1月至2016年12月在中国中医科学院西苑医院接受复方青黄散治疗的170例骨髓增生异常综合征患者进行电话和门诊随访,随访截至2018年4月1日,终极指标为生存期。生存资料的描述采用Kaplan-Meier分析。影响服用复方青黄散患者生存的预后因素采用单变量分析,不同预后因素的组间生存分布采用Log-rank检验,组间中位生存期比较采用非参数检验,组间生存分布采用Log-rank检验,年生存率的比较采用χ^2检验。结果170例骨髓增生异常综合征患者中位生存期为54个月,1、3、5以及10年生存率分别为100%、85.88%、38.23%以及5.88%。44例伴原始细胞增多患者中,13例患者治疗后原始细胞比例下降。所有170例患者中,仅2例原始细胞增多患者进展为急性髓细胞白血病。分析各因素对位生存期的影响,结果显示,年龄≤60岁患者位生存期(55个月)显著长于年龄>60岁患者(47个月),差异具有统计学意义(χ^2=4.576,P=0.032);女性患者中位生存期(55个月)显著长于男性患者(47个月),差异具有统计学意义(χ^2=6.166,P=0.013);染色体核型预后很好/好患者中位生存期(57个月)显著长于预后中等患者(43个月),差异具有统计学意义(χ^2=4.133,P=0.042)。分析各因素对年生存率的影响,结果显示,≤60岁患者3年生存率显著高于>60岁患者,差异具有统计学意义(χ^2=6.98,P=0.01),女性患者5年生存率显著高于男性患者,差异具有统计学意义(χ^2=6.98,P=0.01),预后很好/好核型患者3年和5年生存率最高,预后差/很差核型患者次之,差异具有统计学意义(χ^2=6.952,P=0.031),预后中等患者最低,差异具有统计学意义(χ^2=6.239,P=0.044),IPSS-R危度对患者1、3、5以及10年生存率均无显著影响(P>0.05)。结论复方青黄散治疗骨髓增生异常综合征,可使患者获得长期生存,高危/极高危MDS患者仍可以从复方青黄散治疗中获益。

Objective To analyze the overall survival of patients with myelodysplastic syndrome treated with oral arsenic-containing compound Qinghuang Powder and to explore the factors affecting the overall survival of these patients.Methods A total of 170 patients with myelodysplastic syndrome who received treatment of compound Qinghuang Powder at our hospital were followed by phone calls or outpatient visits from January 2015 to October 2016.The deadline of the follow-up time was April 1,2018.The primary outcome was the overall survival of patients.Kaplan-Meier analysis was used for descripting survival data and single variable analysis was used for prognostic factor analysis.Log-rank test was used for survival distribution comparison in different subgroups according to the prognostic factor.Non-parametric test was used for median overall survival comparison in different subgroups.Chi-square test was used for survival rate comparison in different subgroups. Results The median overall survival of 170 patients with myelodysplastic syndrome was 54 months,and the 1-, 3-,5-,and 10-year overall survival rates were 100%,85.88%,38.23%,and 5.88%,respectively.Of the 44 patients with excess blasts,the proportion of excess blasts decreased in 13 patients.Of all 170 patients,there were only 2 patients with excess blasts progressing to acute myeloid leukemia.When the effects of various factors on median overall survival were analyzed,the results showed that the median overall survival was significantly longer in patients aged ≤ 60 years old (55 months) than in those > 60 years old (47 months,χ^2=4.576,P=0.032),in female patients (55 months) than in male patients (47 months,χ^2=6.166,P=0.013),and in patients with very good/good karyotype (57 months) than in those with moderate karyotype (43 months,χ^2=4.133,P=0.042).When the effects of various factors on the annual overall survival rate were analyzed,the results showed that the 3-year overall survival rate of patients aged ≤ 60 years old was significantly higher than that of patients > 60 years old (χ^2=6.98,P=0.01),and the 5-year overall survival rate of female patients was significantly higher than that of male patients (χ^2=6.98,P=0.01). The 3- and 5-year overall survival rates were the highest in patients with good/very good karyotype,followed by patients with poor/very poor karyotype,and the lowest in patients with moderate karyotype (χ^2=6.952,P=0.031;χ^2=6.239,P=0.044).IPSS-R risk had no significant effect on the 1-,3-,5-,and 10-year survival rates (P > 0.05). Conclusions Oral arsenic-containing compound Qinghuang Powder could improve the long-term overall survival of patients with myelodysplastic syndrome.Patients with very-high-risk/high-risk myelodysplastic syndrome can still benefit from the treatment of compound Qinghuang Powder.