【摘要】 目的 探究血府逐瘀汤对晚期宫颈癌化疗患者的临床疗效和安全性。方法纳入2019年1月至2021年1月于长治市潞州区人民医院诊治，拟行TP方案（紫杉醇+顺铂）化疗的晚期宫颈癌患者。根据随机数字表法，将晚期宫颈癌患者分为对照组（给予TP方案治疗）和试验组（给予TP方案联合血府逐瘀汤治疗）。观察并比较两组患者血清肿瘤标志物水平（癌胚抗原、鳞状细胞癌抗原和糖类抗原125）、中医证候积分和临床疗效（客观反应率、疾病控制率和总生存期）。根据不良事件通用术语标准（CTCAE 4.03）评估药品不良反应发生情况。结果 研究共纳入92例晚期宫颈癌患者，每组各46例。治疗前，对照组和试验组晚期宫颈癌患者血清肿瘤标志物水平和中医证候积分差异均无统计学意义（P> 0.05）。治疗后，试验组和对照组血清肿瘤标志物水平和中医证候积分均较治疗前显著下降（P <0.05），且试验组的血清肿瘤标志物水平和中医证候积分均显著低于对照组（P <0.05）。在临床疗效方面，试验组和对照组的客观反应率差异无统计学意义（P> 0.05），而试验组疾病控制率和中位总生存期显著高于对照组（P <0.05）。在安全性方面，未观察到致命不良事件，大多数不良事件轻微且可控。此外，试验组和对照组恶心呕吐、贫血、血小板下降和肾功能损伤发生率差异均无统计学意义（P> 0.05），而试验组白细胞减少和肝功能损伤发生率显著低于对照组（P <0.05）。结论 血府逐瘀汤可显著提高晚期宫颈癌化疗患者疗效，降低血清肿瘤标志物表达水平，改善中医证候积分，提高疾病控制率，延长总生存期，且安全性较高。更多还原

【Abstract】 Objective To explore the clinical efficacy and safety of Xuefu Zhuyu decoction as an adjuvant chemotherapy in patients with advanced cervical cancer. Methods This study recruited advanced cer vical cancer patients who under went TP regimen(paclitaxel+cisplatin) chemotherapy in Luzhou District People’s Hospital in Changzhi City from January 2019 to January 2021. According to the random number table method, patients with advanced cervical cancer were divided into a control group(treated with TP regimen) and an test group(treated with TP regimen combined with Xuefu Zhuyu decoction). The serum tumor marker levels(carcinoembryonic antigen, squamous cell carcinoma antigen and carbohydrate antigen 125), traditional Chinese medicine syndrome scores and clinical efficacy [objective response rate, disease control rate and overall survival time] between two groups of patients were observed and compared. The occurrence of adverse drug reactions was assessed according to the Common Terminology Standard for Adverse Events(CTCAE 4.03). Results A total of 92 cases of advanced cervical cancer were included in this study, with 46 cases in each group.Before treatment, there was no significant statistical difference in the serum tumor marker levels and traditional Chinese medicine syndrome scores between the control group and the test group with advanced cervical cancer(P>0.05). After treatment, the serum tumor marker levels and traditional Chinese medicine syndrome scores in the test group and the control group significantly decreased compared to before(P<0.05), and they were significantly lower in the test group than those in the control group(P<0.05). In terms of clinical efficacy, there was no significant difference in objective response rate between two groups(P>0.05), while the disease control rate and median overall survival time of the test group were significantly higher than those of the control group(P<0.05). In terms of safety, no fatal adverse events were observed, and most adverse events were mild and controllable. In addition, there was no significant difference in the incidence of nausea and vomiting, anemia, thrombocytopenia and renal dysfunction between two groups(P>0.05), while the incidence of leukopenia and liver function injury in the test group were significantly lower than those in the control group(P<0.05). Conclusion Xuefu Zhuyu decoction can significantly improve the efficacy of chemotherapy patients with advanced cervical cancer, reduce serum tumor marker expression levels, improve traditional Chinese medicine syndrome scores, increase disease control rate, prolong overall survival, and has high safety.更多还原