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三味生火丹治疗化疗相关难治性血小板减少症的临床研究

Clinical Study of San Wei Sheng Huo Decoction in the Treatment of Refractory Chemotherapy-Induced Thrombocytopenia

  • 摘要:
      目的  研究以三味生火丹为主方治疗化疗相关难治性血小板减少症(refractory chemotherapy-induced thrombocytopenia, RCIT)的疗效和安全性。
      方法  采用回顾性研究方法,收集以三味生火丹为主方治疗的RCIT患者,检测治疗后不同时间点外周血中血小板(platelet, PLT)水平变化,分析有效率及显效率,分析不同程度RCIT治疗前后外周血PLT计数的增长差异,评估安全性。
      结果  共纳入35例RCIT,以三味生火丹为主方治疗后2周有效率74.29%,显效率14.29%;2个月有效率84.38%,显效率60.50%,1年率有效92.31%,显效率80.77%。治疗后各时间点PLT计数均较治疗前升高(P<0.01)。亚组分析,用药后2个月外周血PLT提升值在重度组达51.02×109 L-1,高于中度组36.58×109 L-1P<0.05),且差异持续至用药后1年。治疗期间未发生明显中药相关不良反应。
      结论  三味生火丹治疗RCIT起效快,且持久稳定,对重度RCIT疗效更显著。

     

    Abstract:
      Objective  To investigate the efficacy and safety of treating refractory chemotherapy-induced thrombocytopenia (RCIT) with San Wei Sheng Huo Decoction (SWSHD) as the main formula.
      Methods  A retrospective study was conducted and the data of RCIT patients treated with SWSHD as the main formula were collected. Changes in peripheral blood platelet (PLT) levels at different time points of treatment were examined and the significant effective rate (SER) and effective rate (ER) were analyzed. We measured the increase in peripheral blood PLT count before and after treatment, analyzed the differences in PLT count increase for different degrees of RCIT treatment, and evaluated the safety of the treatment.
      Results  A total of 35 cases of RCIT were included in the study. With SWSHD as the main treatment formula, the 2-week ER and SER were 74.29% and 14.29%, respectively, the 2-month ER and SER were 84.38% and 60.50, respectively, and the 1-year ER and SER were 92.31% and 80.77%, respectively. PLT count increased at all time points after treatment compared with that before treatment (P<0.01). Subgroup analysis showed that, 2 months after treatment started, peripheral blood PLT counts increased by as much as 51.02×109 L-1 in the severe RCIT group, higher than that of the moderate RCIT group at 36.58×109 L-1 (P<0.05), and the difference persisted until 1 year after the treatment. No obvious traditional Chinese medicine-related adverse reaction was observed during the treatment.
      Conclusion  SWSHD takes effect rapidly and its effect is long-lasting and stable. Furthermore, SWSHD has a more significant effect on severe RCIT.

     

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