大补元煎加味辅助治疗气血两虚型转移性 去势抵抗性前列腺癌临床研究
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R273;R737.25

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浙江省医药卫生科技计划项目(2023RC056)


Clinical Study on Modified Dabuyuan Decoction as an Adjuvant for Metastatic Castration-Resistant Prostate Cancer of Qi and Blood Deficiency Type
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    摘要:

    目的:观察气血两虚型转移性去势抵抗性前列腺癌(mCRPC) 采用大补元煎加味辅助方案治疗的 临床疗效及安全性。方法:选取2020年9月—2024年9月在浙江定海医院就诊的110例气血两虚mCRPC患者, 按随机数字表法分为对照组及大补元煎联合组各55例。对照组根据mCRPC诊疗共识予常规用药。大补元煎联 合组在对照组治疗方案的基础上加用大补元煎加味治疗。2组均治疗21天为1个周期,连续治疗6个周期。研 究随访截止至治疗结束后10个月,总观察窗口为14.5个月。观察比较2组实体瘤及骨转移情况、中医证候积 分(包括面色苍白或萎黄、神疲乏力、气短懒言、头晕目眩、唇甲色淡)、血清前列腺特异性抗原(PSA) 水 平、中医临床疗效及不良反应发生情况。结果:治疗6个周期后,大补元煎联合组中医证候积分各症状评分及 总分均低于对照组,差异均有统计学意义(P<0.05)。治疗6个周期后,2组血清总前列腺特异性抗原(tPSA) 和游离前列腺特异性抗原(fPSA) 水平均较治疗前下降,且大补元煎联合组血清tPSA和fPSA水平均低于对照 组,差异均有统计学意义(P<0.05)。治疗6个周期后,实体瘤疗效总有效率大补元煎联合组56.36% (31/ 55),对照组36.36% (20/55),2组比较,差异有统计学意义(P<0.05);中医临床疗效总有效率大补元煎组 76.36%(42/55),对照组56.36%(31/55),2组比较,差异有统计学意义(P<0.05)。2组不良反应发生率、出 血相关不良事件及凝血功能比较,差异均无统计学意义(P>0.05)。结论:大补元煎加味辅助治疗气血两虚型 mCRPC患者临床疗效良好,能下调肿瘤标志物水平,降低不良反应发生率。

    Abstract:

    Abstract:Objective:To observe the clinical efficacy and safety of modified Dabuyuan Decoction as an adjuvant for metastatic castration-resistant prostate cancer (mCRPC) of qi and blood deficiency type. Methods: A total of 110 mCRPC patients of qi and blood deficiency type treated at Zhejiang Dinghai Hospital from September 2020 to September 2024 were selected and randomly divided into a control group and a Dabuyuan Decoction combination group using the random number table medthod, with 55 cases in each group. The control group received conventional treatment according to the mCRPC diagnosis and treatment consensus. The Dabuyuan Decoction combination group received modified Dabuyuan Decoction in addition to the control group's treatment regimen.Both groups were treated for 21 days per cycle,for a total of 6 cycles.The study follow-up lasted until 10 months after the end of treatment, with a total observation window of 14.5 months.Solid tumor and bone metastasis status,traditional Chinese medicine syndrome scores (including pale or sallow complexion,fatigue and lack of strength,shortness of breath and reluctance to speak, dizziness and blurred vision, pale lips and nails), serum prostate-specific antigen (PSA) levels, traditional Chinese medicine clinical efficacy, and adverse reactions were observed and compared between the two groups. Results: After 6 cycles of treatment, the scores for individual symptoms and the total traditional Chinese medicine syndrome score in the Dabuyuan Decoction combination group were lower than those in the control group,with significant differences (P<0.05).After 6 cycles of treatment,serum total PSA (tPSA) and free PSA (fPSA) levels in both groups decreased compared to before treatment,and the Dabuyuan Decoction combination group had lower tPSA and fPSA levels than the control group,with significant differences (P<0.05).After 6 cycles of treatment,the total effective rate for solid tumor efficacy was 56.36% (31/55) in the Dabuyuan Decoction combination group and 36.36% (20/55) in the control group,with significant difference between the two groups (P<0.05).The traditional Chinese medicine clinical efficacy rate was 76.36% (42/55) in the Dabuyuan Decoction combination group and 56.36% (31/55) in the control group,with significant difference between the two groups (P<0.05).There were no significant differences in the incidence of adverse reactions,bleeding-related adverse events,or coagulation function between the two groups (P>0.05). Conclusion: Modified Dabuyuan Decoction as an adjuvant demonstrates good clinical efficacy in mCRPC patients of qi and blood deficiency type, reduces tumor marker levels, and lowers the incidence of adverse reactions.

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彭卫星,王江.大补元煎加味辅助治疗气血两虚型转移性 去势抵抗性前列腺癌临床研究[J].新中医,2026,58(6):45-51

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  • 在线发布日期: 2026-03-31
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