中成药宁泌泰应用后健康相关生活质量的评估

杨晓峰  王倩倩

（枣庄市立医院，山东  枣庄，277100）

中图分类号：R289.9     文献标识码：A    文章编号：1674-7860（2016）09-0140-04   证型：IDGB

【摘  要】目的：采用膀胱癌特异性健康相关生活质量调查量表FACT-BL评价膀胱癌患者接受吡柔比星膀胱灌的健康相关生活质量（health related quality oflife，HRQOL），比较患者加用宁泌泰治疗后的HRQOL有无差别，为临床肿瘤治疗提供参考。方法：按照随机对照研究方案，选择2010年6月－2014年6月治疗的120例膀胱癌患者，病理诊断为尿路上皮癌，TNMⅠ期～Ⅱ期，接受膀胱部分切除术或经尿道等离子膀胱肿瘤电切术。设计随机数字表法随机划分研究对象，分为行吡柔比星灌注加用宁泌泰治疗组（61例）和吡柔比星灌注组（59例）。用问卷调查的方式完成FACT-BL量表，对FACT-BL量表各个领域（躯体状况、社会/家庭状况、精神状况、功能状况）的评分和总体评分进行统计学分析。结果：回收有效问卷115份，其中吡柔比星灌注加用宁泌泰组59例，单用吡柔比星灌注组56例。有效问卷参与者一般临床资料如年龄、性别比例、家庭收入、居住地、医疗付费方式、随访时间、肿瘤病理分期、手术方式方等面差异均无统计学意义（均P＞0.05）。吡柔比星灌注加用宁泌泰组和单用吡柔比星灌注组患者复发率[8.2%（5/61）比22.0%（13/59）]和不良反应发生率[6.5%（4/61）比47.6%（28/59）]差异均有统计学意义(均P＜0.05)。HRQOL评分方面，吡柔比星灌注加用宁泌泰组在躯体状况[（30.3±2.3）分比（20.3±2.1）分]、社会/家庭状况[（22.4±2.7）分比（15.1±4.3）分]和膀胱癌特异性模块[（88.6±5.3）分比（73.3±6.5）分]的得分及FACT-BL量表的总分[（92.3±16.7）分比（83.6±17.0）分]高于单用吡柔比星灌注组，差异有统计学意义(均P＜0.05)。结论：吡柔比星灌注加用宁泌泰治疗患者健康相关生活质量高于单用吡柔比星灌注治疗患者。

【关键词】健康相关生活质量；膀胱肿瘤；化学疗法；局部灌注；吡柔比星；中成药

【Abstract】Objective: Toassess the health related quality of life (HRQOL) in bladder patients after thetreatment of pirarubicin bladder perfusion by using specific HRQOLquestionnaire FACT-BL and compare thedifference of patients HRQOL after applying Chinese patent drug Ningmitai, with a prospect of providingreferences for the clinical treatment of cancer. Methods: A prospective randomizedcontrolled clinical trial was carried out. A total of 120 patients with bladdertransitional cell carcinoma(TNM I-II), treated from June 2010 to June 2014 andunderwent partial cystectomy or transurethral resection of bladder tumor, wererandomly divided into pirarubicin bladder perfusion combined with Chinesepatent drug Ningmitai group (61 cases) and pirarubicin bladder perfusion (59cases). HRQOL was assessed using FACT-BL. The following scores were calculatedfrom the FACT-BL questionnaire and list: physical well-being, social/familywell-being, emotional well-being, and functional well being; total FACT-G,overall bladder-specific subscale and total FACT-BL were analyzedstatistically.Results: A total of115 patients answered questionnaires, 59 patients were in the combinedmedication group and 56 patients were in single medication group. Thecomparison between two groups revealed no significant differences in thepercent of males, age, education, family monthly income, payment modes of medicalexpense, follow-up years and pathological stage(P>0.05), but there was significant difference in recurrencerates [8.2%（5/61）vs 22.0%（13/59）] and incidence of adverse reaction [6.5%（4/61）vs 47.6%（28/59）] between the twogroups(P<0.05). Patients in combinedmedication group got significantly higher scores in physical well-being[（30.3±2.3）points vs（20.3±2.1）points],social/family well-being[（22.4±2.7）points vs（15.1±4.3）points] and total FACT-BL [（92.3±16.7）points vs（83.6±17.0）points] thanthose in single medication group (P<0.05).Conclusions: The HRQOL of patients treated by pirarubicin bladder perfusioncombined with Chinese patent drug Ningmitai was better than that of patientstreated by pirarubicin bladder perfusion.

【Keywords】Health relatedquality of life; Bladder cancer; Chemotherapy; Regional perfusion; Pirarubicin;Chinese patent drug

doi:10.3969/j.issn.1674-7860.2016.09.068

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