Kulaksizoglu Haluk, Toktas Gökhan, Kulaksizoglu Isinn Baral, Aglamis Erdogan, Unlüer Erdinç
Department of Urology, SSK Istanbul Teaching Hospital, 11 Kisim Zambak Apt Daire-4 Ataköy, 34750 Istanbul, Turkey.
Eur Urol. 2002 Oct;42(4):350-5. doi: 10.1016/s0302-2838(02)00351-2.
In this prospective study our aim was to establish the time it takes cystectomized patients' to adapt to their new health status.
A total of 68 patients, having radical cystectomy for bladder cancer (64 males and 4 females) were enrolled in the study. The mean age of the group was 55.4 +/- 8.0 years (range 38-70 years). Continent urinary diversion was applied to 17 while the rest had incontinent urinary diversions. There was no statistical difference between those who had continent and incontinent diversions in regard to pre-operative stage. All patients were given a Beck's Depression Inventory (BDI), an EORTC-QLQ C-30 Version 2 (European Organization for Research on Treatment of Cancer Quality of Life Questionnaire C-30 Version 2) quality of life measurement scale pre-operatively, and post-operatively 3, 6, 12 and >12 months (every 6 months). Log-rank and Student's t-test was used for statistical analysis of the results.
The mean follow-up of the study group was 27.7 +/- 7.3 months (range 12-46 months). Five patients at the first 3rd-month control, seven at the 6th-month control and eight at the 12th-month control did not appear for interview, but their available results were also included in the overall assessment. The mean functional score of the study group, evaluated by QLQ C-30, was 80 +/- 25.4 pre-operatively. There is dramatic decrease at the 3rd-month control (56.9 +/- 25.1; p < 0.01). The overall functional score after 12 months (80 +/- 20) is back to the pre-operative value. The mean symptom score of the group pre-operatively was 29.5 +/- 16.7, which showed similar results at 3 and 6 months post-operatively of 29.8 +/- 16.7 and 30.6 +/- 19.4, respectively (p > 0.05). At the 12th-month and thereafter the symptom scores of the patients decreased significantly in comparison to both the pre-operative and the post-operative 3-6 months (23.4 +/- 13.7 and 21.8 +/- 18.5, respectively; p < 0.01 for all). The self-rating general health status of this group was lowest pre-operatively with a mean of 49.8 +/- 26.5. Interestingly, there was a statistically significant increase in the general health status assessment of the patients even at the early post-operative period of 3 months (61.4 +/- 17.2; p < 0.01). The increase in the well-being of the patients increased linearly until the 12th-month control and stabilized thereafter. There was a 23% pre-operative depression rate, which comes down to 16% at the 12th-month control. The peak depression scores suggesting depression are observed at the 3rd-month controls. There is a gradual decrease in depression score starting from the 6th-month controls and all reach minimum scores after 12 months. Ninety-six percent of the study group showed scores even lower than the pre-operative ones. The mean pre-operative and post-operative 12th-month control scores were 11.5 +/- 7.7, and 8.1 +/- 6.8, respectively (p < 0.01).
Both psychological and health-related quality of life measures come to baseline values and stabilize after the 12th-month period, suggesting that the time frame for the adaptation of patients is 12 months in patients undergoing radical cystectomy surgery. Therefore, we believe it is better to perform any quality of life assessment as an end-point criterion for comparison of treatment modalities in radical cystectomy patients after 12 months.
在这项前瞻性研究中,我们的目的是确定膀胱切除术后患者适应新健康状况所需的时间。
本研究共纳入68例因膀胱癌接受根治性膀胱切除术的患者(64例男性,4例女性)。该组患者的平均年龄为55.4±8.0岁(范围38 - 70岁)。17例患者采用可控性尿流改道术,其余患者采用不可控性尿流改道术。在术前分期方面,接受可控性和不可控性尿流改道术的患者之间无统计学差异。所有患者在术前、术后3个月、6个月、12个月及>12个月(每6个月)均接受贝克抑郁量表(BDI)和欧洲癌症研究与治疗组织生活质量问卷C - 30第2版(EORTC - QLQ C - 30 Version 2)生活质量测量量表评估。结果采用对数秩检验和学生t检验进行统计学分析。
研究组的平均随访时间为27.7±7.3个月(范围12 - 46个月)。在第3个月的首次随访中,有5例患者未前来接受访谈,第6个月随访时有7例,第12个月随访时有8例,但他们可获得的结果也被纳入总体评估。通过QLQ C - 30评估,研究组术前的平均功能评分为80±25.4。在第3个月随访时显著下降(56.9±25.1;p < 0.01)。12个月后的总体功能评分(80±20)恢复到术前水平。该组术前的平均症状评分为29.5±16.7,术后3个月和6个月分别为29.8±16.7和30.6±19.4,结果相似(p > 0.05)。在第12个月及之后,与术前及术后3 - 6个月相比,患者的症状评分显著下降(分别为23.4±13.7和21.8±18.5;均p < 0.01)。该组患者术前的自评总体健康状况最低,平均分为49.8±26.5。有趣的是,即使在术后3个月的早期(61.4±17.2;p < 0.01),患者的总体健康状况评估也有统计学意义的增加。患者的幸福感增加一直呈线性直至第12个月随访,之后趋于稳定。术前抑郁率为23%,在第12个月随访时降至16%。提示抑郁的抑郁评分峰值出现在第3个月随访时。从第6个月随访开始抑郁评分逐渐下降,12个月后均达到最低分。研究组96%的患者评分甚至低于术前。术前和术后12个月随访的平均评分分别为11.5±7.7和8.1±6.8(p < 0.01)。
心理和与健康相关的生活质量指标在12个月后恢复到基线值并趋于稳定,这表明接受根治性膀胱切除术的患者适应期为12个月。因此,我们认为在12个月后对根治性膀胱切除术患者进行任何生活质量评估作为比较治疗方式的终点标准会更好。