苏复宁洗液膀胱灌注预防膀胱癌术后复发的临床研究

Clinical study of intravesical instillation with Sufuning lotion for prevention of postoperative recurrence of bladder cancer

目的探讨苏复宁洗液膀胱灌注预防膀胱癌术后复发的有效性及安全性。方法收集2010年1月至2016年6月山西省肿瘤医院泌尿外科经尿道膀胱肿瘤电切术后膀胱癌患者240例，采用抽签法随机分为试验组（120例）和对照组（120例）。试验组术后即刻膀胱灌注苏复宁洗液250 mg/次；对照组术后即刻膀胱灌注吡柔比星（THP）30 mg/次。两组患者术后每周灌注化疗1次，共8次；以后每个月灌注化疗1次，共1年。比较两组膀胱癌复发率、无进展生存（PFS）率、总生存（OS）率和近期不良反应。结果两组患者随访6-60个月，中位随访时间36.5个月，试验组失访6例，对照组失访8例。试验组肿瘤累积复发率26.3%（30/114），对照组肿瘤累积复发率25.0%（28/112），两组比较差异无统计学意义（χ^2=0.142，P=0.781）。试验组和对照组5年PFS率分别为73.7%（84/114）和75.0%（84/112），差异无统计学意义（χ2=2.011，P=0.615）；5年OS率分别为95.6%和92.9%，差异无统计学意义（χ^2=1.611，P=0.425）。两组主要不良反应是化学性膀胱炎和血尿，试验组化学性膀胱炎及血尿发生率低于对照组（χ^2=5.991，P=0.018；χ^2=4.925，P=0.036），血液学不良反应发生率低于对照组（χ^2=4.891，P=0.032）。结论苏复宁洗液膀胱灌注预防膀胱癌术后复发是安全、有效的。

Objective To investigate the efficacy and safety of intravesical instillation with Sufuning （SFN） lotion for prevention of postoperative recurrence of bladder cancer.Methods A total of 240 bladder cancer patients who were diagnosed as bladder cancer and accepted trans-urethral resection of bladder tumor from January 2010 to June 2016 in Shanxi Provincial Cancer Hospital were randomly divided into the experimental group （120 cases） and the control group （120 cases） according to the envelope method. The patients in the experimental group were treated with SFN lotion for immediate intravesical instillation （250 mg for once）, and the patients in the control group were treated with pirarubicin （THP） for immediate intravesical instillation （30 mg for once）. The patients of two groups were treated with intravesical chemotherapy once a week for 8 times, and the chemotherapy was performed once a month for 1 year. The recurrence rate, progression-free survival （PFS） rate, overall survival （OS） rate and recent side effects were compared between the two groups.Results The patients were followed up for 6 to 60 months. The median follow-up time was 36.5 months. In the experimental group, 6 patients were lost and 8 patients were lost in the control group. The experimental group, the total recurrence rate was 26.3% （30/114）. The control group, the overall recurrence rate was 25.0% （28/112） （χ^2= 0.142, P= 0.781）. Five years of PFS rate in the experimental group and the control group was 73.7%（84/114） and 75.0% （84/112） respectively, and there was no significant difference between the two groups （χ^2= 2.011, P= 0.615）. Five years of OS rate in the experimental group and the control group was 95.6% and 92.9% respectively, and there was no significant difference between the two groups （χ^2= 1.611, P= 0.425）. The major side effects included chemical cystitis and hematuria. The incidence of chemical cystitis and hematuria in the experimental group was significantly lower than that in the control group （χ^2= 5.991, P= 0.018; χ^2= 4.925, P= 0.036）. There was a statistically significant difference of the hematological side effects （blood routine changes） between the two groups （χ^2= 4.891, P= 0.032）.Conclusion It is safe and effective for intravesical instillation of SFN lotion to prevent the recurrence of bladder cancer.