Clinical observation of Zengye Jiedu Decoction in prevention and treatment of chemotherapy⁃induced oral mucositis in adult patients with <italic style="font-style: italic">Ph/BCR‑ABL1‑</italic>negative acute lymphoblastic leukemia

CHU Xiaoge; HAO Jie; TIAN Jianhui; LUO Bin; MA Wenhuan; LIU Zhanyun; WANG Jin

doi:10.16305/j.1007-1334.2024.z20240630009

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Clinical observation of Zengye Jiedu Decoction in prevention and treatment of chemotherapy⁃induced oral mucositis in adult patients with Ph/BCR‑ABL1‑negative acute lymphoblastic leukemia

更新时间：2024-12-23

- Clinical observation of Zengye Jiedu Decoction in prevention and treatment of chemotherapy⁃induced oral mucositis in adult patients with Ph/BCR‑ABL1‑negative acute lymphoblastic leukemia
- Shanghai Journal of Traditional Chinese Medicine Vol. 58, Issue 12, Pages: 109-113(2024)
- 作者机构：
  
  上海市北站医院血液科（上海瑞金医院血液病医疗联合体成员单位）（上海 200070）
  1.上海中医药大学附属市中医医院肿瘤一科（上海 200071）
  2.上海市北站医院中医科（上海　200070）
  3.上海交通大学医学院附属瑞金医院血液科（上海 200025）
  4.Department of Hematology， Ruijin Hospital， Shanghai Jiao Tong University School of Medicine， Shanghai 200025， China
- 作者简介：
- 基金信息：
- DOI：10.16305/j.1007-1334.2024.z20240630009
  CLC：
- Published：10 December 2024，
  
  Received：30 June 2024，
- 稿件说明：
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楚小鸽,郝杰,田建辉,等.增液解毒汤防治成人Ph/BCR⁃ABL1阴性急性淋巴细胞白血病化学疗法相关性口腔黏膜炎的临床观察[J].上海中医药杂志,2024,58(12):109-113.

CHU Xiaoge,HAO Jie,TIAN Jianhui,et al.Clinical observation of Zengye Jiedu Decoction in prevention and treatment of chemotherapy⁃induced oral mucositis in adult patients with Ph/BCR‑ABL1‑negative acute lymphoblastic leukemia[J].Shanghai Journal of Traditional Chinese Medicine,2024,58(12):109-113.
楚小鸽,郝杰,田建辉,等.增液解毒汤防治成人Ph/BCR⁃ABL1阴性急性淋巴细胞白血病化学疗法相关性口腔黏膜炎的临床观察[J].上海中医药杂志,2024,58(12):109-113. DOI： 10.16305/j.1007-1334.2024.z20240630009.

CHU Xiaoge,HAO Jie,TIAN Jianhui,et al.Clinical observation of Zengye Jiedu Decoction in prevention and treatment of chemotherapy⁃induced oral mucositis in adult patients with Ph/BCR‑ABL1‑negative acute lymphoblastic leukemia[J].Shanghai Journal of Traditional Chinese Medicine,2024,58(12):109-113. DOI： 10.16305/j.1007-1334.2024.z20240630009.

摘要

目的

观察增液解毒汤防治成人

Ph/BCR

ABL1

阴性急性淋巴细胞白血病（ALL）患者化学疗法（以下简称“化疗”）相关性口腔黏膜炎（OM）的临床疗效，以及其对血清炎症因子水平的影响。

方法

选择120例热毒伤阴型成人

Ph/BCR

ABL1

阴性ALL化疗患者，随机分为试验组（60例）和对照组（60例），对照组给予化疗及复方氯己定含漱液含漱治疗，试验组在对照组治疗措施的基础上加用增液解毒汤口服，两组均连续治疗14 d。比较两组OM发生率、口腔黏膜炎症分级及疼痛视觉模拟评分（VAS）、血清炎症因子［白细胞介素（IL）-10、IL-6、肿瘤坏死因子-α（TNF-α）］水平的变化情况，观察OM临床疗效及不良反应发生情况

。

结果

①最终完成试验者119例，其中试验组59例、对照组60例。②试验组、对照组OM发生率分别为18.64%、38.33%，试验组OM发生率低于对照组（

0.05）。③两组口腔黏膜炎症分级比较，试验组轻于对照组（

0.05）。④治疗前后组内比较，两组OM疼痛VAS降低（

0.05）；组间治疗后比较，试验组OM疼痛VAS低于对照组（

0.05）。⑤试验组OM总有效率（90.91%）高于对照组（82.61%），差异有统计学意义（

0.05）。⑥血清IL-6、TNF-α水平的时间和分组因素存在交互效应（

0.05），二者在治疗7 d时均呈上升趋势（

0.05），治疗后较治疗7 d时下降（

0.05）；治疗后试验组血清TNF-α、IL-6水平低于对照组（

0.05），血清IL-10水平组间及组内变化均不明显（

0.05）。

结论

增液解毒汤可有效防治成人

Ph/BCR

ABL1

阴性ALL化疗相关性OM，缓解黏膜疼痛，抑制炎症因子TNF-α、IL-6的表达，减轻口腔黏膜炎症反应，安全有效。

Abstract

Objective

To observe the clinical efficacy of Zengye Jiedu Decoction in preventing and treating chemotherapy-induced oral mucositis （OM） and its effect on serum inflammatory cytokine levels in adult patients with

Ph/BCR

ABL1

-negative acute lymphoblastic leukemia （ALL）.

Methods

A total of 120 adult

Ph/BCR

ABL1

-negative ALL patients with yin damage due to heat toxicity undergoing chemotherapy were selected and randomly divided into a trial group （

=60） and a control group （

=60）. The patients in the control group received chemotherapy along with compound chlorhexidine （CHX） mouthwash， while the patients in the trial group received Zengye Jiedu Decoction orally in additional to control group's treatment regimen. Both groups were treated for 14 consecutive days. The incidence of OM， OM inflammation grading， pain visual analog scale （VAS） scores， and changes in serum inflammatory cytokine levels ［interleukin （IL）-10， IL-6， tumor necrosis factor-α （TNF-α）］ were compared between the two groups. The clinical efficacy of OM treatment and the occurrence of adverse reactions were also monitored.

Results

①A total of 119 patients completed the trial， with 59 patients in the trial group and 60 patients in the control group. ②The incidence of OM in the trial group was 18.64%， significantly lower than 38.33% in the control group （

0.05）. ③The OM inflammation grading in the trial group was significantly milder than that in the control group （

0.05）. ④Both groups showed a decrease in OM pain VAS scores after treatment （

0.05）， with the trial group showing significantly lower pain VAS scores than the control group （

0.05）. ⑤The total effective rate of OM in the trial group was 90.91%， significantly hig

her than 82.61% in the control group （

0.05）. ⑥There was an interaction effect between time and grouping factors on serum IL-6 and TNF-α levels （

0.05）. Both levels showed an upward trend on day 7 of treatment （

0.05） and decreased after treatment compared to day 7 of treatment （

0.05）. After treatment， serum levels of TNF-α and IL-6 in the trial group were lower than those in the control group （

0.05）. Changes in serum IL-10 levels were not significant between or within groups （

0.05）.

Conclusion

Zengye Jiedu Decoction is effective in preventing and treating chemotherapy-induced OM in adult patients with

Ph/BCR

ABL1

-negative ALL， alleviating mucosal pain， inhibiting the expression of inflammatory cytokines TNF-α and IL-6， and reducing oral mucosal inflammatory responses. It is safe and effective.

关键词

口腔黏膜炎急性淋巴细胞白血病化学疗法增液解毒汤中医药疗法炎症因子临床试验

Keywords

oral mucositisacute lymphoblastic leukemiachemotherapyZengye Jiedu Decoctiontraditional Chinese medicine therapyinflammatory cytokinesclinical trial

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Clinical observation of Zengye Jiedu Decoction in prevention and treatment of chemotherapy⁃induced oral mucositis in adult patients with Ph/BCR‑ABL1‑negative acute lymphoblastic leukemia

DOI：10.16305/j.1007-1334.2024.z20240630009

摘要

Abstract

关键词

Keywords

references