龙荔汤治疗非肌层浸润性膀胱癌前瞻性临床观察  

Prospective Clinical Study of Longli Decoction in Non-muscularis Invasive Bladder Cancer

作　　者：白慧明 曹宏文[1,2,3] 冯懿赓 高人杰 王丹 陈磊 BAI Hui-ming;CAO Hong-wen;FENG Yi-geng;GAO Ren-jie;WANG Dan;CHEN Lei(Department of Urology,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,200032;Shanghai Clinical Demonstration Base of Traditional Chinese Medicine Urology,Shanghai 200032;Shanghai Famous Traditional Chinese Medicine ZHOU Zhi-heng Urology Male Studio,Shanghai 200032)

机构地区：[1]上海中医药大学附属龙华医院泌尿外科,上海200032 [2]上海市中医泌尿男科临床示范基地,上海200032 [3]上海市名中医周智恒泌尿男科工作室,上海200032

出　　处：《中国中西医结合杂志》2022年第12期1458-1462,共5页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家自然科学基金面上项目(No.82174199)。

摘　　要：目的 观察龙荔汤治疗非肌层浸润性膀胱癌的疗效。方法 本研究将经尿道膀胱肿瘤切除术后、中医证型辨证为“瘀毒蕴结型”的非肌层浸润性膀胱癌患者108例,采用前瞻性队列研究方式,以有无服用临床经验方龙荔汤作为暴露因素,复旦大学附属中山医院54例病例设定为对照组,上海中医药大学附属龙华医院54例病例设定为治疗组,两组均采用术后表柔比星膀胱灌注,治疗组加口服龙荔汤,两组访视疗程均为1年,访视点为治疗后3、6、9、12个月,将膀胱癌复发率、复发时间作为主要疗效指标,对生活质量及中医证候进行评分比较,并采集安全性指标分析两组患者治疗期间不良事件的发生情况。结果 对照组总复发率为47.9%,治疗组总复发率为28.0%,治疗组复发率较对照组明显降低(P<0.05);对照组复发时间(8.04±3.21)个月,治疗组复发时间(10.28±1.49)个月,治疗组延缓复发(P<0.05)。生活质量方面,对照组EORTC评分由(149.3±42.7)分降至(131.1±38.0)分,治疗组EORTC评分由(160.9±49.5)分降至(107.6±43.7)分,两组治疗后生活质量均较治疗前有所改善,且治疗组改善情况明显优于对照组(P<0.01)。治疗组在改善患者中医临床症状方面明显优于对照组(P<0.01)。治疗组与对照组均未出现明显不良事件。结论 龙荔汤治疗非肌层浸润性膀胱癌,能够有效降低复发率,延缓复发时间,并且能够缓解膀胱灌注带来的不良反应。Objective To observe the efficacy of Longli Decoction in the treatment of non-muscle invasive bladder cancer. Methods This study identified 108 patients with non-muscle invasive bladder cancer as "accumulation of blood stasis toxicology syndrome" in Chinese medicine(CM) after transurethral bladder tumor resection. Using a prospective cohort study approach, the presence or absence of Longli Decoction was used as the exposure factor. Fifty-four cases in Zhongshan Hospital affiliated to Fudan University were recruited as the control group,and 54 cases in Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine were recruited as the treatment group. Both groups received postoperative epirubicin bladder perfusion, and the treatment group took Longli Decoction additionally. Both groups were treated for 1 year. Interviews were conducted at 3, 6, 9, and 12 months after treatment. The outcomes involved recurrence rate and time of bladder cancer,and the quality of life and CM symptoms. In addition, the data on safety indicators were collected to analyze the occurrence of adverse events during treatment in both groups. Results The overall recurrence rate was 47.9% in the control group and 28.0% in the treatment group, and the recurrence rate in the treatment group was significantly lower than that in the control group(P<0.05);the recurrence time was(8.04±3.21) months in the control group and(10.28±1.49) months in the treatment group, and the recurrence was delayed in the treatment group(P<0.05). Regarding the quality of life, the EORTC score decreased from(149.3±42.7) to(131.1±38.0) in the control group and from(160.9±49.5) to(107.6±43.7) in the treatment group, and the quality of life improved in both groups after treatment compared with baseline, and the improvement in the treatment group was significantly better than that in the control group(P<0.01). The treatment group was significantly more effective than the control group in improving the patients’ clinical symptoms in CM(P<0.01). Th

关 键 词：非肌层浸润性膀胱癌 龙荔汤 队列研究 中药复方 

分 类 号：R273[医药卫生—中西医结合]