N-CWS和BCG膀胱灌注对非肌层浸润性膀胱癌术后疗效及生活质量评价：一项基于2年临床随访的回顾性研究

Efficacy and quality of life evaluation of intravesical instillation of Nocardia rubra cell wall skeleton versus bacille Calmette-Guérin after surgery for non-muscle invasive bladder cancer： a retrospective study based on 2-year clinical follow-up

摘要:

目的 探讨红色诺卡菌细胞壁骨架（nocardia rubra cell wall skeleton，N-CWS）和卡介苗（bacillus calmette-guerin，BCG）膀胱灌注对非肌层浸润性膀胱癌（non-muscle invasive bladder cancer，NMIBC）患者手术的疗效和生活质量的影响。方法 纳入2016年4月至2021年4月在四川省人民医院泌尿外科收治的86例中高危NMIBC患者，均行手术治疗，并具有完整的临床资料和随访数据。根据膀胱灌注药物，将患者分成N-CWS组（n=41）和BCG组（n=45）。随访2年比较2组患者生活质量、临床疗效及不良反应等指标。结果 N-CWS组患者6个月复发率为4.88%，低于BCG组的6.67%，差异无统计学意义（χ²=0.125，P=0.723）；N-CWS组患者1年复发率为9.76%，低于BCG组的17.78%，差异无统计学意义（χ²=1.150，P=0.284）；N-CWS组患者2年复发率为21.95%，低于BCG组的28.89%，差异无统计学意义（χ²=3.268，P=0.071）。灌注后6个月N-CWS组患者角色功能、情绪功能及整体功能明显高于BCG组（P<0.05）；N-CWS组患者疼痛、泌尿系统症状评分和治疗产生问题评分明显低于BCG组（P<0.05）。灌注后1年N-CWS组患者角色功能、情绪功能及整体功能明显高于BCG组（P<0.05）；N-CWS组患者疼痛、泌尿系统症状评分和治疗产生问题评分明显低于BCG组（P<0.05）；灌注后2年N-CWS组患者情绪功能高于BCG组（P<0.05），其余各项评分2组比较差异均无统计学意义。N-CWS组患者尿路刺激征、血尿、关节疼痛及发热等不良反应事件发生率明显低于BCG组（P<0.05）。结论 与BCG治疗相比，N-CWS应用于NMIBC术后膀胱灌注治疗疗效相当，可有效提高生活质量，且安全性高，临床可进一步研究并推广。

Abstract:

Objective To investigate the effect of intravesical infusion of Nocardia rubra cell wall skeleton（N-CWS） versus bacille Calmette-Guérin（BCG） on the treatment outcome and quality of life of patients with non-muscle invasive bladder cancer（NMIBC）.Methods A total of 86 patients with intermediate- to high-risk NMIBC who were admitted to the urology department of Sichuan Provincial People's Hospital from April 2016 to April 2021 were enrolled，and all the patients underwent surgical treatment and had complete clinical and follow-up data. According to the drug used for intravesical infusion，the patients were divided into N-CWS group（n=41） and BCG group（n=45）. After two years of follow-up，the two groups were compared in terms of quality of life，clinical outcome，and adverse reactions.Results Compared with the BCG group，the N-CWS group had lower 6-month recurrence rate（4.88% vs. 6.67%，χ²=0.125，P=0.723），1-year recurrence rate（9.76% vs. 17.78%，χ²=1.150，P=0.284），and 2-year recurrence rate（21.95% vs. 28.89%，χ²=3.268，P=0.071）. Compared with the BCG group at 6 months after intravesical infusion，the N-CWS group had significantly higher role function，emotional function，and overall function（P<0.05） and significantly lower scores of pain，urinary system symptoms，and problems caused by treatment（P<0.05）. At 1 year after intravesical infusion，compared with the BCG group，the N-CWS group had significantly higher role function，emotional function，and overall function（P<0.05） and significantly lower scores of pain，urinary system symptoms，and problems caused by treatment（P<0.05）. At 2 years after intravesical infusion，the N-CWS group had a significantly higher emotional function than the BCG group（P<0.05），and there were no significant differences in the other scores between the two groups. Compared with the BCG group，the N-CWS group had significantly lower incidence rates of the adverse events such as urinary tract irritation，hematuria，joint pain，and pyrexia（P<0.05）.Conclusion N-CWS has a comparable clinical effect to BCG in the intravesical infusion treatment of NMIBC after surgery and can effectively improve quality of life with a favorable safety profile，and therefore，it holds promise for clinical application.