“健脾利湿化瘀方”联合治疗去势抵抗性前列腺癌的临床研究

Clinical study of the “nourishing spleen removing dampness and eliminating blood stasis prescription” in the treatment of castration-resistant prostate cancer

关键词:  健脾利湿化瘀方  去势抵抗性前列腺癌  国际前列腺症状评分  生活质量  免疫功能

Key words:  nourishing spleen removing dampness and eliminating blood stasis prescription  castration-resistant prostate cancer  IPSS  quality of life  immune function

摘要:

[目的] 通过多中心随机对照试验，观察“健脾利湿化瘀方”联合治疗去势抵抗性前列腺癌（CRPC）的临床疗效。[方法] 收集符合纳入标准的CRPC患者120例，随机分为对照组（单纯西医治疗组）和治疗组（在对照组的基础上予以口服健脾利湿化瘀加减方）各60例。观察治疗前和治疗后2、4、6、8周5个时间段，两组患者的血清前列腺特异抗原（PSA）、血清游离睾酮、淋巴细胞亚群分析、最大尿流率、中医临床症状评分、卡氏（KPS）评分和国际前列腺癌症状评分等疗效评价指标，并观察血常规、肝肾功能损伤等安全性指标的变化。[结果] 与对照组相比，治疗组在治疗后4周有效地降低患者总前列腺特异抗原（tPSA）值、游离前列腺特异抗原（fPSA）值；使KPS评分趋于平稳；在治疗后4周，增大最大尿流率，改善患者的临床症状；尤其在前列腺癌中医临床症状和国际前列腺症状评分的改善方面，治疗组显著优于对照组，明显改善患者乏力、尿频、尿痛等临床症状，提高患者生活质量。[结论] “健脾利湿化瘀方”联合治疗方案能更好地降低患者PSA值，明显改善CRPC患者的尿频、尿痛和精神萎靡等中医临床症状、生理状况、功能状况，提高最大尿流率以及减轻患者前列腺癌相关临床症状，减轻患者不良情绪，增进社会家庭关系。

Abstract:

[Objective] To observe the clinical curative effects of "nourishing spleen removing dampness and eliminating blood stasis prescription" combined with standard Western Medicine in the treatment of castration resistant prostate cancer (CRPC).[Methods] The 120 patients with castration resistant prostate cancer standard cases were enlisted,which were randomly divided into control group (standard Western Medicine treatment group) and treatment group (treated with nourishing spleen removing dampness and eliminating blood stasis prescription on the basis of the control group),and each group had 60 cases. After 2 weeks,4 weeks,6 weeks and 8 weeks treatment,the curative evaluation indexes including serum prostate specific antigen (PSA),serum free testosterone,lymphocyte subsets,maximum urine flow rate,Traditional Chinese Medicine (TCM) clinical symptoms score,KPS score,and international prostate cancer symptom score (IPSS) were compared between two groups at no-treatment and other 4 times periods,and safety indicators including blood routine,liver function and kidney function were observed.[Results] Combined with control group,tPSA and fPSA values of treatment group reduced significantly,after 4 weeks treatment,KPA value tended to be stable,maximum urine flow rate and the clinical symptoms improved. Especially in terms of improvement of clinical TCM clinical symptoms score and IPSS,the treatment group was significantly better than the control group. Nourishing spleen removing dampness and eliminating blood stasis prescription can significantly improve clinical symptoms such as fatigue,frequent urination,and dysuria,and improve the quality of life of patients.[Conclusion] Nourishing spleen removing dampness and eliminating blood stasis prescription combined with castration treatment can significantly reduce PSA value,improve the clinical symptoms such as such as frequent urination,dysuria,and mental depression,physiology and function in patients,improve the maximum urinary flow rate,and reduce symptoms of prostate cancer patients,reduce the patients with bad mood,and promote social relationships.