芪慈三苓汤对非肌层浸润性膀胱癌术后患者复发率影响的临床研究

Clinical study of effects of Qici Sanling Decoction on postoperative recurrence rate of patients with non-muscle invasive bladder cancer

目的观察芪慈三苓汤联合吡柔比星灌注治疗非肌层浸润性膀胱癌术后患者的临床疗效。方法将100例TUR-Bt术后非肌层浸润性膀胱癌患者分为治疗组(66例)和对照组(34例)。对照组予吡柔比星膀胱灌注方案,治疗组在对照组治疗措施基础上加服芪慈三苓汤治疗。两组疗程均为1年、随访1年,观察肿瘤复发情况及用药安全性,比较相关症状及生活质量量表评分(QLQC30及QLQ-BLS24子量表)、相关免疫功能指标(NK、CD4^+及CD8^+)的变化情况。结果 (1)治疗后1年内,治疗组、对照组总复发率分别为15.6%、25.0%,组间总复发率比较,治疗组明显低于对照组(P<0.05)。(2)治疗后组间比较,疲乏、疼痛、失眠、便秘、躯体功能、情绪功能及总体健康状况评分差异有统计学意义,治疗组改善情况明显优于对照组(P<0.05)。(3)组间治疗后比较,排尿症状、肠道症状、治疗相关问题、性生活质量评分差异有统计学意义,治疗组改善情况明显优于对照组(P<0.05)。(4)组间治疗后比较,NK、CD4^+及CD8^+的水平差异有统计学意义,治疗组改善情况明显优于对照组(P<0.05)。(5)两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论芪慈三苓汤联合吡柔比星灌注治疗非肌层浸润性膀胱癌术后患者,能明显降低肿瘤复发率,提高其全身免疫水平,减轻化疗药物灌注的副作用,提高其总体生活质量。

Objective To observe the clinical efficacy of Qici Sanling Decoction combined with Pirarubicin in the treatment of non-muscle invasive bladder cancer.Methods 100 TUR-BT postoperative patients with non-muscle invasive bladder cancer were randomly divided into the treatment group（ 66 cases） and control group（ 34 cases）.The control group was treated with Pirarubicin by intravesical instillation and the treatment group was orally treated with Qici Sanling Decoction based on the treatment for the control group,with a course of 1 year,and the patients were followed-up for 1 year after treatment.The tumor recurrence and medication safety were observed.The changes on correlative symptoms,life quality scale（ QLQ-C30 and QLQ-BLS24 sub-scales）,immune function indexes such as NK cells,CD4~＋and CD8~＋were compared.Results（1）Within 1 year after treatment,the recurrence rates were 15.6% in the treatment group and 25.0% in the control group,the recurrence rate in the treatment group was obviously lower than that in the control group（ P〈0.05）.（2） After treatment,there were statistically significant differences on the scores of fatigue,pain,insomnia,constipation,physical function,emotional function and overall health condition between the two groups,and the improvement in the treatment group was obviously better than that in the control group（ P〈0.05）.（3） After treatment,there were statisticallysignificant differences on the scores of urination symptoms,intestinal symptoms,treatment relative problems and sexual life quality between the two groups,and the improvement in the treatment group was obviously better than that in the control group（ P〈0.05）.（4）After treatment,there were statistically significant differences on the levels of NK cells,CD4＋and CD8＋between the two groups,and the improvement in the treatment group was obviously better than that in the control group（ P〈0.05）.（5） There was no statistically significant difference on the incidence rate of adverse reactions between thetwo groups（ P〉0.05）.Conclusion Qici Sanling Decoction combined with Pirarubicin in treating postoperative patients with non-muscle invasive bladder cancer can significantly reduce the cancer recurrence rate,enhance the systemic immunity,alleviate the side effects caused by chemotherapy drug instillation and improve the overall quality of life.