Cinobufagin Combined with Thalidomide/Dexamethasone Regimen in the Treatment of Patients with Newly Diagnosed Multiple Myeloma of Phlegm and Stasis Obstruction： A Retrospective Study

ZHANG Weiguang; DING Haihua; CHEN Biqing; KONG Xiangtu; DAI Xingbin; XU Zuqiong; YANG Jing; LIU Xixi; LI Chencheng; HU Zhongxiao; ZHU Xuejun

doi:10.13288/j.11-2166/r.2024.01.014

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Cinobufagin Combined with Thalidomide/Dexamethasone Regimen in the Treatment of Patients with Newly Diagnosed Multiple Myeloma of Phlegm and Stasis Obstruction： A Retrospective Study

更新时间：2024-01-09

- Cinobufagin Combined with Thalidomide/Dexamethasone Regimen in the Treatment of Patients with Newly Diagnosed Multiple Myeloma of Phlegm and Stasis Obstruction： A Retrospective Study
- Journal of Traditional Chinese Medicine Vol. 65, Issue 1, Pages: 72-78(2024)
- 作者机构：
  
  1.南京中医药大学附属医院，江苏省南京市秦淮区汉中路155号，210029
  2.南京中医药大学第一临床医学院
  3.南京市浦口区中医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2024.01.014
  CLC：
- Received：02 August 2023，
  
  Revised：2023-10-25，
  
  Published：02 January 2024
- 稿件说明：
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张玮光,丁海花,陈碧清等.华蟾素联合沙利度胺/地塞米松方案治疗新诊断多发性骨髓瘤痰瘀痹阻型患者的回顾性临床研究[J].中医杂志,2024,65(01):72-78.

ZHANG Weiguang,DING Haihua,CHEN Biqing,et al.Cinobufagin Combined with Thalidomide/Dexamethasone Regimen in the Treatment of Patients with Newly Diagnosed Multiple Myeloma of Phlegm and Stasis Obstruction： A Retrospective Study[J].Journal of Traditional Chinese Medicine,2024,65(01):72-78.
张玮光,丁海花,陈碧清等.华蟾素联合沙利度胺/地塞米松方案治疗新诊断多发性骨髓瘤痰瘀痹阻型患者的回顾性临床研究[J].中医杂志,2024,65(01):72-78. DOI： 10.13288/j.11-2166/r.2024.01.014.

ZHANG Weiguang,DING Haihua,CHEN Biqing,et al.Cinobufagin Combined with Thalidomide/Dexamethasone Regimen in the Treatment of Patients with Newly Diagnosed Multiple Myeloma of Phlegm and Stasis Obstruction： A Retrospective Study[J].Journal of Traditional Chinese Medicine,2024,65(01):72-78. DOI： 10.13288/j.11-2166/r.2024.01.014.

摘要

目的

观察华蟾素片联合沙利度胺/地塞米松（TD）方案治疗新诊断多发性骨髓瘤痰瘀痹阻型患者的疗效及安全性。

方法

回顾性分析2015年6月1日至2019年7月31日江苏省中医院收治的50例新诊断多发性骨髓瘤痰瘀痹阻型患者的临床资料，根据治疗方案分为对照组（含硼替佐米/地塞米松方案）27例和观察组（华蟾素片联合TD方案）23例。两组患者均治疗2或3个疗程。主要结局指标为患者治疗后临床缓解情况（包括总缓解率、深度缓解率），患者1年、2年总生存率，不良反应。次要结局指标为治疗前后骨髓浆细胞比例，血红蛋白、血清β2-微球蛋白、乳酸脱氢酶、血肌酐、血尿素氮水平及骨痛积分、卡氏（KPS）评分。

结果

治疗后观察组和对照组总缓解率分别为69.57%（16/23）及70.37%（19/27），深度缓解率分别为56.52%（13/23）及55.56%（15/27），两组比较差异均无统计学意义（

＞0.05）。观察组和对照组1年总生存率分别为90.9%和92.4%，2年总生存率分别为81.8%和80.9%，组间差异均无统计学意义（

＞0.05）。治疗过程中，两组均未发生肾功能损伤。观察组周围神经损伤发生率为8.70%（2例），低于对照组的48.15%（13例），两组比较差异有统计学意义（

＜0.01）。与治疗前比较，两组患者治疗后骨髓浆细胞比例、β2-微球蛋白水平、血肌酐水平、骨痛评分降低，血红蛋白水平、KPS评分升高（

＜0.05或

＜0.01）。两组治疗后比较，观察组治疗后骨痛评分低于对照组，KPS评分高于对照组（

＜0.05）。

结论

华蟾素片联合TD方案与含硼替佐米/地塞米松方案治疗新诊断多发性骨髓瘤痰瘀痹阻型患者疗效相当，但华蟾素片联合TD方案在减轻患者疼痛、提高生活质量方面优于含硼替佐米/地塞米松方案，且安全性更好。

Abstract

Objective

To investigate the efficacy and safety of cinobufagin tablets combined with thalidomide/dexamethasone （TD） regimen in the treatment of newly diagnosed multiple myeloma （NDMM） with phlegm and stasis obstruction.

Methods

The clinical data of 50 patients with NDMM of phlegm and stasis obstruction who were hospitalized at the Jiangsu Province Hospital of Chinese Medicine from June 1st， 2015 to July 31th， 2019 were retrospectively analyzed， and they were divided into a control group （bortezomib/dexamethasone-containing regimen， 27 cases） and an observation group （cinobufagin tablets combined with TD regimen， 23 cases）. The clinical efficacy and safety were compared between the two groups after two or three courses of treatment. The primary outcomes were clinical remission rate including overall response rate and deep remission rate， one-year and two-year overall survival rate， and adverse effects. The secondary outcomes were the proportion of plasma cells in bone marrow， hemoglobin， β2-microglobulin， lactate dehydrogenase， serum creatinine， blood urea nitrogen， bone pain score， and KPS functional status score （KPS score） before and after treatment.

Results

In terms of clinical efficacy， there was no statistically significant difference （

＞0.05） in the overall response rate ［the observation group 69.57%（16/23）

the control group 70.37% （19/27）］ and deep remission rate ［the observation group 56.52% （13/23）

the control group 55.56% （15/27）］ between groups after the treatment. The one-year overall survival rates of the observation group and the control group were 90.9% and 92.4%， and the two-year overall survival rates were 81.8% and 80.9% respectively， with no statistically significant differences between groups （

＞0.05）. During the treatment， no renal function injury occurred in both groups. The incidence of peripheral nerve injury in the observation group was 8.70%， which was lower than 48.15% in the control group （

＜0.01）. After the treatment， the proportion of myeloma plasma cells， β2-microglobulin， serum creatinine level， and bone pain score decreased， while the hemoglobin level and KPS score increased in both groups （

＜0.05 or

＜0.01）. Compared between groups after treatment， the bone pain score of the observation group was lower than that of the control group， while the KPS score was higher than that of the control group （

＜0.05）.

Conclusion

The clinical efficacy of cinobufagin tablets combined with TD in the treatment of NDMM is equivalent to bortezomib/dexamethasone-containing regimen， but the former is more helpful in relieving the pain and improving the quality of life， and has better safety.

关键词

Keywords

references

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