清热化湿方联合化疗治疗湿热蕴脾型进展期胰腺癌临床疗效观察

Evaluation of Efficacy of Qingre Huashi Decoction on Advanced Pancreatic Cancer Patients with Damp-Heat Accumulation

目的:回顾性分析清热化湿方治疗不可切除进展期湿热蕴结型胰腺癌的疗效性及安全性。方法:回顾性收集接受化疗和清热化湿方治疗的不可切除进展期湿热蕴结型胰腺癌患者217例。其中110例接受化疗方案,107例接受化疗+清热化湿方。研究终点为客观缓解率(overall response rate,ORR)、3/4级不良反应事件发生率、KPS评分、中医症状改善评分。结果:化疗组和中药组患者两组客观缓解率(Objective Response Rate,ORR)分别为25.4%和22.4%(P>0.05)。化疗组最常见3/4级不良反应为中性粒细胞减少(31.8%)、周围神经毒性(24.5%)、纳差(19%)、感染性发热(14.5%)及血红蛋白减少(11.8%)。中药组最常见3/4级不良反应为中性粒细胞减少(30.8%)、周围神经病变(15.9%)、感染性发热(11.2%)及血红蛋白减少(9.3%)。两组患者3/4级不良反应发生率比较,在纳差发生率上,中药组显著低于化疗组,差异有显著统计学意义(P=0.03)。在KPS评分,中药组改善率(79.4%)显著优于化疗组(50.9%),差异有显著统计学意义(P<0.001)。在中医临床症状改善方面,中药组(61.6%)也显著优于化疗组(34.5%),差异有显著统计学差异(P<0.001)。结论:对于不可切除的进展期胰腺癌湿热蕴结型患者,使用清热化湿方联合化疗治疗在改善临床症状、KPS评分、不良反应方面优于单纯化疗,显著降低化疗副作用,提高患者体力评分,显著改善患者中医临床症状。

Objective:To retrospectively analyze the efficacy and safety of Qingre Huashi decoction in the treatment of unresectable advanced pancreatic cancer with accumulation of damp-heat.Methods:A retrospective collection of 217 patients with unresectable advanced damp-heat accumulation type pancreatic cancer who received chemotherapy and Qingre Huashi decoction.Among them,110 patients received chemotherapy,and 107 received chemotherapy+Qingre Huashi decoction.The endpoints of the study were objective response rate(ORR),incidence of grade 3/4 adverse events,KPS score,and TCM symptom improvement score.Results:The objective response rate(ORR)of the chemotherapy group and the Chinese medicine group were 25.4%and 22.4%,respectively(P>0.05).The most common grade 3/4 adverse reactions in the chemotherapy group were neutropenia(31.8%),peripheral neurotoxicity(24.5%),anorexia(19%),infectious fever(14.5%),and decreased hemoglobin(11.8%).The most common grade 3/4 adverse reactions in the traditional Chinese medicine group were neutropenia(30.8%),peripheral neuropathy(15.9%),infectious fever(11.2%)and hemoglobin decrease(9.3%).The incidence of grade 3/4 adverse reactions in the two groups was compared,and the incidence of anorexia in the traditional Chinese medicine group was significantly lower than that in the chemotherapy group,and the difference was statistically significant(P=0.03).In the KPS score,the improvement rate of the traditional Chinese medicine group(79.4%)was significantly better than that of the chemotherapy group(50.9%),and the difference was statistically significant(P<0.001).In the improvement of TCM clinical symptoms,the TCM group(61.6%)was also significantly better than the chemotherapy group(34.5%),and the difference was statistically significant(P<0.001).Conclusion:For unresectable advanced pancreatic cancer patients with damp-heat accumulation type,the use of Qingre Huashi decoction combined with chemotherapy is better than chemotherapy alone in improving clinical symptoms,KPS score,and adverse reactions,significantly reducing chemotherapy side effects,and improving the patient’s physical score.Significantly improve the clinical symptoms of patients with traditional Chinese medicine.