目的 基于“黜浊培本”理论探讨健脾利湿化瘀法联合醋酸阿比特龙加泼尼松治疗转移性去势抵抗性前列腺癌（metastatic castration-resistant prostate cancer，mCRPC）的临床疗效和安全性。方法 共纳入符合标准的mCRPC患者62例，随机分为观察组33例，对照组29例。对照组患者口服醋酸阿比特龙，4片/次，1次/d；醋酸泼尼松片，1片/次，2次/d；如有骨转移，使用唑来膦酸治疗，每28天1次。观察组在对照组基础上联合“健脾利湿化瘀方”化裁治疗。两组均治疗6周期，28 d为1个周期。观察近期疗效（客观缓解率、疾病控制率）及前列腺特异性抗原（prostate-specific antigen，PSA）水平，国际前列腺症状评分（international prostate symptom score，IPSS）、骨痛数字评分（numeric rating scale，NRS）、中医临床症状评分、生活质量（functional assessment of cancer therapy-prostate，FACT-P）评分及不良反应情况。结果 观察组患者客观缓解率为45.45%、疾病控制率为72.73%，与对照组（37.93%、65.52%）比较差异无统计学意义。两组治疗后较治疗前中医临床症状评分明显下降（P＜0.05），且观察组较对照组下降程度更加明显（P＜0.05）；两组治疗后IPSS评分较治疗前明显下降（P＜0.05），且观察组下降程度更加明显（P＜0.05）；两组治疗后患者的生理状况、情感状况、附加关注评分均明显下降（P＜0.05），社会及家庭状况、功能状况评分明显升高（P＜0.05），观察组生活质量改善情况更明显（P＜0.05）；在PSA改善方面，治疗后两组均能有效降低总前列腺特异性抗原（total prostate specific antigen，tPSA）和游离前列腺特异性抗原（free prostate specific antigen，fPSA）水平（P＜0.05），且观察组t-PSA、f-PSA水平降低更明显（P＜0.05）；治疗后两组骨痛NRS评分较治疗前均明显下降（P＜0.05），且观察组骨痛NRS评分较对照组下降更明显（P＜0.05）；两组均未发生严重不良反应而导致停药的情况，经对症处理后不良反应均得到了改善，观察组在改善患者疲劳方面显示出了优势，差异具有统计学意义（P＜0.05）。结论 健脾利湿化瘀法联合醋酸阿比特龙治疗mCRPC可以降低PSA水平、缓解疲劳症状、缓解骨痛以及提高患者生活质量。

Objective Based on the theory of “Chuzhuo Peiben”, to explore the clinical efficacy of the method of strengthening the spleen, removing dampness and removing blood stasis combined with a new endocrine drug (abiraterone acetate) plus prednisone in the treatment of metastatic castration-resistant prostate cancer (mCRPC). Methods A total of 62 mCRPC patients who met the criteria for inclusion and exclusion were enrolled. They were randomly divided into 33 cases in the observation group and 29 cases in the control group. The control group received abiraterone acetate orally, four tablets per time, once a day; Prednisone acetate tablets, 1 tablet per time, 2 times/d; If bone metastases are present, treat with zoledronic acid once every 28 d. The observation group was combined with “invigorating spleen, invigorating dampness and removing stasis” on the basis of the control group. Both groups were treated for six cycles, 28 d was a cycle. The main observation indicators included short-term efficacy (objective remission rate, disease control rate); secondary observation indicators included prostate-specific antigen (PSA), international prostate symptom score (IPSS), bone pain numeric rating scale (NRS), Chinese medicine clinical symptom score and quality of life (functional assessment of cancer therapy-prostate, FACT-P) score and adverse reactions. Results The objective remission rate and disease control rate of observation group were 45.45% and 72.73% respectively, the difference was not statistically significant. The scores of Chinese medicine clinical symptom in both groups decreased significantly after treatment compared with before treatment (P < 0.05), and the decrease degree in observation group was more obvious than that in control group (P < 0.05); The IPSS scores in both groups decreased significantly after treatment compared with before treatment (P < 0.05), and the decrease degree in observation group was more obvious (P < 0.05). After treatment, the physiological status, emotional status and additional attention scores of patients in the two groups were significantly decreased (P < 0.05), the scores of social and family status and functional status were significantly increased (P < 0.05), and the improvement of quality of life in the observation group was more obvious (P < 0.05). In terms of PSA improvement, both groups can effectively reduce total prostate specific antigen (tPSA) and free prostate specific antigen (fPSA) after treatment (P < 0.05), and the t-PSA and f-PSA levels in the observation group were decreased more significantly (P < 0.05). After treatment, the NRS score of bone pain in the two groups decreased significantly compared with that before treatment (P < 0.05), and the NRS score of bone pain in the observation group decreased more significantly than that in the control group (P < 0.05). There were no serious adverse reactions leading to drug withdrawal in the two groups, and the adverse reactions were improved after symptomatic treatment. The observation group showed an advantage in improving fatigue, and the difference was statistically significant (P < 0.05). Conclusion The combination of “invigorating spleen, invigorating dampness and removing stasis method” combined with abiraterone acetate in the treatment of mCRPC can reduce PSA level, relieve fatigue symptoms, relieve bone pain and improve the quality of life of patients.

天津市中医药管理局中医中西医结合科研课题(2021106);天津市教委课题(2020KJ163)