Phytomedicine : international journal of phytotherapy and phytopharmacology · 2025
Effects of Chinese herbal medicine on the secondary prevention of chemotherapy-induced thrombocytopenia in malignant solid tumors, a randomized clinical trial.
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Yang Yanan, Ge Weilin, Luo Wei, Yang Yi, Duo Hong, Kuang Xunjie, Xiao He, Jiang Hongmei, Xiong Kai, Zhao Hong, Yang Xueqin
Аннотация
OBJECTIVE: Thrombocytopenia is the main limiting toxicity of chemotherapy, which has not been adequately addressed until now. However, no exact studies have been conducted on the secondary prevention of chemotherapy-induced thrombocytopenia.The aim of this study is to explore the effect of Chinese herbal medicine on the secondary prevention of chemotherapy-induced thrombocytopenia (CIT) in malignant solid tumors.
METHODS: This study was a prospective randomized controlled trial. The participants were divided into two groups: treatment group and control group. In the treatment group, chemotherapy was combined with Danggui Buxue Decoction (DBD) with extra flavor. The control group received chemotherapy alone. From May 2019 to May 2022, ninety patients with previous history of ≥grade 1 CIT were recruited.The CIT severity after chemotherapy, effect of CIT on chemotherapy, and economic impact of CIT were compared by statistics.
RESULTS: CIT severity differed significantly between the treatment and control groups (χ2=29.514, p<0.001). Grade 3-4 CIT was significantly reduced in the treatment group compared with the control group (6.67 % vs. 57.78 %, χ2 =26.914, p<0.001)). With the self-controlled study method, no significant decrease in platelets was seen in the treatment group compared with platelets before enrollment (z=0.308, p=0.758). Meanwhile, platelets in the control group appeared to be significantly decreased(z=3.514, p<0.001). There was no significant difference between the two groups regarding the number of chemotherapy cycles (F=0.294, p=0.589). However, due to CIT, dose downregulation, chemotherapy termination, and regimen changes were more prevalent in the control group(42.2 % vs. 68.9 %; 15.6 % vs. 62.2 %; 15.6 % vs. 40.0 %; both p<0.05). Thus the overall cost was significantly lower than that of the control group (F=12.825, p=0.001). Moreover, there was no significant difference between the treatment and the control group in any other respect adverse side effect.
CONCLUSION: Chinese herbal medicines (DBD) may prevent further CIT and minimize its adverse effects on chemotherapy, including dose downregulation, chemotherapy termination, and regimen changes . It could be considered as an effective and economical treatment option for secondary prevention of CIT. (ChiCTR1900022996).
METHODS: This study was a prospective randomized controlled trial. The participants were divided into two groups: treatment group and control group. In the treatment group, chemotherapy was combined with Danggui Buxue Decoction (DBD) with extra flavor. The control group received chemotherapy alone. From May 2019 to May 2022, ninety patients with previous history of ≥grade 1 CIT were recruited.The CIT severity after chemotherapy, effect of CIT on chemotherapy, and economic impact of CIT were compared by statistics.
RESULTS: CIT severity differed significantly between the treatment and control groups (χ2=29.514, p<0.001). Grade 3-4 CIT was significantly reduced in the treatment group compared with the control group (6.67 % vs. 57.78 %, χ2 =26.914, p<0.001)). With the self-controlled study method, no significant decrease in platelets was seen in the treatment group compared with platelets before enrollment (z=0.308, p=0.758). Meanwhile, platelets in the control group appeared to be significantly decreased(z=3.514, p<0.001). There was no significant difference between the two groups regarding the number of chemotherapy cycles (F=0.294, p=0.589). However, due to CIT, dose downregulation, chemotherapy termination, and regimen changes were more prevalent in the control group(42.2 % vs. 68.9 %; 15.6 % vs. 62.2 %; 15.6 % vs. 40.0 %; both p<0.05). Thus the overall cost was significantly lower than that of the control group (F=12.825, p=0.001). Moreover, there was no significant difference between the treatment and the control group in any other respect adverse side effect.
CONCLUSION: Chinese herbal medicines (DBD) may prevent further CIT and minimize its adverse effects on chemotherapy, including dose downregulation, chemotherapy termination, and regimen changes . It could be considered as an effective and economical treatment option for secondary prevention of CIT. (ChiCTR1900022996).