Early Efficacy Predictors of Bushen Shengxue Prescription Combined with Western Medicine in Treatment of Aplastic Anemia

ZHANG Chaochang; LIU Jian; WANG Wenru; LI Rui; LIU Qifeng; WANG Jinhuan; WAN Jiangwei; XU Ruirong; LIU Feng; MA Rou; TANG Xudong

doi:10.13422/j.cnki.syfjx.20222429

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Early Efficacy Predictors of Bushen Shengxue Prescription Combined with Western Medicine in Treatment of Aplastic Anemia

更新时间：2023-06-20

- Early Efficacy Predictors of Bushen Shengxue Prescription Combined with Western Medicine in Treatment of Aplastic Anemia
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 29, Issue 14, Pages: 64-72(2023)
- 作者机构：
  
  1.中国中医科学院西苑医院，北京 100091
  2.中国中医科学院研究生院，北京 100700
  3.北京中医药大学研究生院，北京 100029
  4.吉林省人民医院，长春 130021
  5.黑龙江中医药大学附属第一医院，哈尔滨 150040
  6.河南中医药大学第一附属医院，郑州 450099
  7.山东中医药大学附属医院，济南 250011
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20222429
  CLC： R22;R242;R2-031;R287
- Published：20 July 2023，
  
  Published Online：26 October 2022，
  
  Received：03 June 2022，
- 稿件说明：
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张朝畅,刘健,王文儒等.补肾生血方联合西药治疗再生障碍性贫血早期疗效预测指标[J].中国实验方剂学杂志,2023,29(14):64-72.

ZHANG Chaochang,LIU Jian,WANG Wenru,et al.Early Efficacy Predictors of Bushen Shengxue Prescription Combined with Western Medicine in Treatment of Aplastic Anemia[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(14):64-72.
张朝畅,刘健,王文儒等.补肾生血方联合西药治疗再生障碍性贫血早期疗效预测指标[J].中国实验方剂学杂志,2023,29(14):64-72. DOI： 10.13422/j.cnki.syfjx.20222429.

ZHANG Chaochang,LIU Jian,WANG Wenru,et al.Early Efficacy Predictors of Bushen Shengxue Prescription Combined with Western Medicine in Treatment of Aplastic Anemia[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(14):64-72. DOI： 10.13422/j.cnki.syfjx.20222429.

摘要

目的

探讨补肾生血方联合西药治疗再生障碍性贫血（AA）早期疗效的预测指标，为中医补肾治法联合西药治疗AA提供预后参考指标。

方法

本研究为回顾性研究，选取2018年9月至2021年3月于中国中医科学院西苑医院等19家医院就诊并采用补肾生血方联合西药治疗6个月有效的126例患者，评价其治疗4个月时的疗效，根据治疗4个月时的疗效评价结果将其分为4个月有效组和4个月无效组，分析比较两组患者治疗前在年龄、性别、疾病分型［包括重型AA（SAA）、非重型AA（NSAA）］、病程、骨髓有核细胞增生程度及基线血象水平［包括白细胞（WBC）、中性粒细胞（ANC）、血红蛋白（HGB）、血小板（PLT）、网织红细胞（RET）］、T淋巴细胞及亚群、T-box转录因子（T-bet）、GATA家族转录因子-3（GATA-3）表达水平指标上的差异。

结果

4个月有效组在20岁≤年龄

40岁及60岁≤年龄

80岁患者占比较高（

0.05）；两组患者在性别、疾病分型（SAA/NSAA）、病程、有无合并症等方面均差异无统计学意义。4个月有效患者治疗前HGB、WBC、ANC、PLT基线水平明显高于治疗4个月无效患者（

0.05）；两组患者在治疗前RET水平上差异无统计学意义。二元Logistic回归分析显示治疗前PLT水平是起效时间的独立影响因素；其他指标均不是影响起效时间的因素。利用受试者工作特征（ROC）曲线分析治疗前PLT水平对起效时间预测价值，曲线下面积（AUC）为0.691，以40.5×10

个/L为临界值，预测4个月内起效的灵敏度为0.569，特异度为0.893；将两组患者按年龄（

14且

20岁、≥20且

40岁、≥40且

60岁、≥60且

80岁）和治疗前PLT水平（PLT

40×10

个/L、PLT≥40×10

个/L）进行分层，4个月有效组各年龄层患者治疗前PLT≥40×10

个/L的患者所占的比例均明显高于4个月无效组（

0.05）。4个月有效和无效患者治疗前骨髓有核细胞增生程度差异无统计学意义。4个月有效患者治疗前总T淋巴细胞水平明显低于4个月无效患者（

0.05）；两组患者治疗前辅助T细胞（Th）1细胞、Th2细胞、CD4

T细胞、CD8

T细胞水平差异无统计学意义。4个月有效患者治疗前T-bet表达水平明显高于4个月无效患者（

0.05）；两组患者治疗前GATA-3表达水平差异无统计学意义。

结论

年龄≥20且

40岁及年龄≥60且

80岁患者，治疗前HGB、WBC、ANC、PLT水平较高，尤其是PLT≥40×10

个/L的患者，治疗前总T淋巴细胞较低或T-bet表达水平较高的患者，补肾生血方联合西药治疗起效更快。

Abstract

Objective

To investigate the predictive indicators of early efficacy of Bushen Shengxue prescription combined with western medicine in the treatment of aplastic anemia， and provide prognosis indicators for the treatment of aplastic anemia （AA） with kidney-tonifying therapy in traditional Chinese medicine （TCM） combined with western medicine.

Method

A total of 126 patients treated by Bushen Shengxue prescription combined with western medicine in 19 hospitals including Xiyuan Hospital of the China Academy of Chinese Medical Sciences from September 2018 to March 2021 were selected for a retrospective study. The therapy was proven to be effective after six months of treatment. According to the efficacy after 4 months of treatment， the patients were assigned into a 4-month effective group and a 4-month ineffective group. The age， sex， disease severity （including severe aplastic anemia and non-severe aplastic anemia）， course of disease， degree of bone marrow nucleated cell proliferation， baseline hemogram levels ［including white blood cell count （WBC）， absolute neutrophil count （ANC）， hemoglobin （HGB）， platelets （PLT）， and reticulocytes （RET）］， T lymphocytes subsets， and the expression levels of T-box transcription factor （T-bet） and GATA-binding protein-3 （GATA-3） were compared between the two groups before treatment.

Result

The proportions of patients within the age ranges of ［20， 40） and ［60， 80） were higher in the 4-month effective group （

0.05）. The sex， disease severity， course of disease， and comorbidities had no significant differences between the two groups. The 4-month effective group had higher baseline levels of HGB， WBC， ANC， and PLT than the 4-month ineffective group （

0.05）， and there was no significant difference in the RET level between the two groups before treatment. Binary Logistic regression analysis showed that the PLT level before treatment was an independent factor affecting the onset time， while other indicators did not affect the onset time. The receiver operating characteristic （ROC） curve was established to analyze the value of PLT level before treatment for predicting the onset time， and the area under the curve was 0.691. With the critical value of 40.5×10

/L， the sensitivity and specificity of the prediction that the therapy will take effect within 4 months were 0.569 and 0.893， respectively. The two groups of patients were graded according to age ｛（14， 20），［20， 40），［40， 60）， and ［60， 80）｝ and PLT level before treatment （PLT

40×10

/L， PLT≥40×10

/L）. The proportion of the patients with PLT≥40×10

/L before treatment in the 4-month effective group was significantly higher than that in the 4-month ineffective group （

0.05）. The degree of bone marrow nucleated cell proliferation before treatment had no significant difference between the two groups. The level of total T lymphocytes in the 4-month effective patients was lower than that in the 4-month ineffective patients before treatment （

0.05）. The levels of Th1 cells， Th2 cells， CD4

T cells， and CD8

T cells showed no significant differences between the two groups before treatment. The T-bet expression level in the 4-month effective group was higher than that in the 4-month ineffective group before treatment （

0.05）， while the expression level of GATA-3 showed no significant difference between the two groups before treatment.

Conclusion

Bushen Shengxue prescription combined with western medicine will achieve faster effect for the patients within the age ranges of ［20， 40） or ［40， 60）， with higher levels of HGB， WBC， ANC， and PLT （especially those with PLT≥40×10

/L）， lower level of total T lymphocytes， or higher T-bet expression level before treatment.

关键词

再生障碍性贫血补肾生血方中西医结合治疗早期疗效预测指标

Keywords

aplastic anemiaBushen Shengxue prescriptionintegrated traditional Chinese and western medicine treatmentearly efficacypredictive indicators

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