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| 厚朴通闭汤口服联合吡柔比星膀胱灌注化学治疗对非肌层浸润性膀胱癌术后患者疗效的随机对照研究 |
| 唐鹏飞1,黄正楠2,颜轶麟2,蔡金明2,张芳2,王松坡3,沈兵1,2* |
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(1. 南京医科大学附属上海一院临床医学院泌尿外科, 上海 200080;
2. 上海交通大学附属第一人民医院泌尿外科中心, 上海 200080;
3. 上海交通大学附属第一人民医院中医科, 上海 200080
*通信作者) |
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| 摘要: |
| 目的 观察厚朴通闭汤口服联合吡柔比星膀胱灌注化学治疗对非肌层浸润性膀胱癌术后患者的疗效。方法 选择2018年1月至2019年12月于上海交通大学附属第一人民医院行经尿道膀胱肿瘤切除术治疗的非肌层浸润性膀胱癌患者95例，随机分为观察组（49例）和对照组（46例），对照组术后采用吡柔比星膀胱灌注化学治疗，观察组在对照组基础上辅以厚朴通闭汤口服，总疗程均为1年。所有患者术后均随访1年，比较两组患者的膀胱癌复发情况、中医证候改善情况、生活质量、尿常规指标、血常规指标、肝肾功能指标、不良反应发生情况等。结果 术后经过1年的辅助治疗，观察组患者复发率（18.37%，9/49）低于对照组（36.96%，17/46），整体中医证候改善率（79.59%，39/49）高于对照组（41.30%，19/46），生活质量各项评分中情绪功能、疲倦、疼痛、总健康状况及尿路症状评分均优于对照组，差异均有统计学意义（P均<0.05）；观察组患者外周血白细胞计数和丙氨酸转氨酶水平均低于对照组（P均<0.05），两组患者其他血常规及肝肾功能指标差异均无统计学意义（P均>0.05）；两组患者尿白细胞和红细胞水平差异均无统计学意义（P均>0.05），但观察组患者尿蛋白水平低于对照组（P<0.05）。治疗期间，观察组总不良事件发生率（36.73%，18/49）低于对照组（60.87%，28/46），差异有统计学意义（P<0.05）。结论 厚朴通闭汤口服联合吡柔比星膀胱灌注化学治疗可预防非肌层浸润性膀胱癌患者术后肿瘤复发，改善由肿瘤带来的中医证候，提高患者的生活质量，并减轻化学治疗相关不良反应。 |
| 关键词: 膀胱肿瘤 非肌层浸润性膀胱癌 中西医结合疗法 厚朴通闭汤 吡柔比星 化学治疗 |
| DOI：10.16781/j.0258-879x.2021.10.1107 |
| 投稿时间：2021-04-08修订日期：2021-06-19 |
| 基金项目:国家自然科学基金（82072821，92059112），上海市综合医院中西医结合专项（ZHYY-ZXYJHZX-1-201705），上海市松江区科学技术委员会自然科学基金（20SJKJGG250）. |
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| Houpo Tongbi decoction combined with pirarubicin intravesical chemotherapy in postoperative patients with non-muscle-invasive bladder cancer: a randomized control trial |
| TANG Peng-fei1,HUANG Zheng-nan2,YAN Yi-lin2,CAI Jin-ming2,ZHANG Fang2,WANG Song-po3,SHEN Bing1,2* |
(1. Department of Urology, Shanghai General Hospital of Nanjing Medical University, Shanghai 200080, China;
2. Department of Urology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China;
3. Department of Traditional Chinese Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China
*Corresponding author) |
| Abstract: |
| Objective To observe the efficacy of oral Houpo Tongbi decoction combined with pirarubicin intravesical chemotherapy in the treatment of postoperative patients with non-muscle-invasive bladder cancer (NMIBC). Methods Ninety-five NMIBC patients who underwent transurethral resection of bladder tumor (TURBT) in Shanghai General Hospital of Shanghai Jiao Tong University from Jan. 2018 to Dec. 2019 were randomly divided into observation group (n=49) and control group (n=46). The control group only received pirarubicin intravesical chemotherapy, while the observation group received oral Houpo Tongbi decoction combined with pirarubicin intravesical chemotherapy. The total course of treatment was 1 year. All patients were followed up for 1 year. The recurrence, improvement of traditional Chinese medicine (TCM) symptoms, quality of life, urine routine, blood routine, liver and kidney function and adverse events were compared between the 2 groups. Results After 1 year of adjuvant treatment, the recurrence rate in the observation group (18.37%, 9/49) was significantly lower than that in the control group (36.96%, 17/46) (P<0.05). The overall improvement rate of TCM symptoms was significantly higher in the observation group (79.59%, 39/49) than in the control group (41.30%, 19/46) (P<0.05). The quality of life results showed that the emotional function, fatigue, pain, general health status and urinary tract symptom were significantly better in the observation group compared with the control group (all P<0.05). The peripheral white blood cell count and alanine aminotransferase level in the observation group were significantly lower than those in the control group (both P<0.05), and there were no significant differences in other blood routine or liver and kidney function indexes between the 2 groups (all P>0.05). There were no significant differences in the levels of white blood cell or red blood cell in urine (both P>0.05), while the urine protein level of the observation group was significantly lower than that of the control group (P<0.05). During the treatment period, the total incidence of adverse events in the observation group (36.73%, 18/49) was significantly lower than that in the control group (60.87%, 28/46) (P<0.05). Conclusion Houpo Tongbi decoction combined with pirarubicin intravesical chemotherapy can reduce the postoperative recurrence of NMIBC, alleviate TCM symptoms caused by tumor, improve quality of life, and reduce chemotherapy-related adverse events. |
| Key words: urinary bladder neoplams non-muscle-invasive bladder cancer integrated traditional Chinese and Western medicine Houpo Tongbi decoction pirarubicin chemotherapy |
