豆根管食通口服液对食管癌患者近期生活质量的影响

目的：通过国际通用的生活质量量表评估豆根管食通口服液对中晚期食管癌患者生活质量的影响。方法：采用随机、对照的方法,临床观察了60例符合纳入标准的食管癌患者,分为对照组和治疗组,各30例。治疗组口服＂豆根管食通口服液＂治疗,每天三次,每次一支（10ml,1g/ml）,一个月为一个疗程,共两个疗程;对照组口服替加氟,每天四次,每次4片（200mg）,一个月为一个疗程,共两个疗程。治疗前、第一及第二疗程后分别测一次生活质量,量表采用欧洲癌症研究与治疗组织生活质量核心量表QLQ-C3（0V3.0）中文版进行问卷调查并行记分评定。统计采用SPSS11.0统计软件,计算所有数据以均数±标准差（x±s）表示。结果：豆根管食通口服液组在1疗程、2疗程后总体健康状况、各功能项目及绝大部分症状单项分别较前有明显改善,差异有显著性（P〈0.05）;而对照组对生活质量各个领域均无明显改善,差异无显著性（P〉0.05）,且腹泻（DI）项在治疗1、2疗程后与治疗前相比得分明显提高（症状加重）,差异具有显著性（P〈0.05）;组间比较,除个别症状单项因治疗前基础得分较低,治疗后得分减少不明显外,其余各项在1疗程、2疗程后对比具有显著性差异（P〈0.05）。结论：豆根管食通口服液能有效改善食管癌患者的生活质量。     

A prospective comparison of quality of life measures for patients with esophageal cancer

Among the most widely used instruments to assess quality of life (QOL) in patients with cancer are the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30) and the Functional Assessment of Chronic Illness Therapy, cancer instrument (FACT-G). This study compared these approaches in patients who had undergone esophagectomy for cancer. The EORTC core questionnaire and esophageal module and the FACT-G and esophageal scale were completed by 57 patients. Missing data, relationships between QOL scales and analyses of patients preferences were examined. There were 14/2736 (0.5%) missing items from EORTC questionnaires and 45/2565 (1.8%) from FACT instruments (p < 0.01). Relationships between corresponding generic EORTC and FACT scales were average to good (r 0.57) except for the social function scale (r = 0.01). EORTC symptom scores were moderately correlated with the FACT general scale, but poorly related to the FACT esophageal scale (r < 0.28). EORTC swallowing scores were moderately correlated with all FACT scales. The FACT-E and EORTC QLQ-C30 measure assess similar generic aspects of QOL (except social function). EORTC esophageal symptom scores relate poorly to FACT esophageal scales, except for swallowing. Choice of QOL measure after esophagectomy for cancer depends upon outcomes of interest. Future studies will determine which instruments are appropriate in each context.     

Validation of the Korean version of the EORTC QLQ-C30

This study evaluated the Korean version of the EORTC QLQ-C30 (version 3.0) in terms of psychometric properties and its validation. One hundred and seventy patients completed three questionnaires EORTC QLQ-C30, the Beck depression inventory (BDI), and a brief pain inventory (BPI). Multitrait scaling analyses demonstrated that all scales met multidimensional conceptualization criteria, in terms of convergence and discrimination validity. Cronbach's alpha coefficients for eight multiple-item scales were greater than 0.70, with the exception of cognitive functioning. All interscale correlations were statistically significant in the expected direction (p < 0.01). Multivariate analyses showed that physical and emotional functioning were significant explanatory variables for the global quality-of-life (QOL) scale (regression coefficients: 0.36, p < 0.001; and 0.37, p < 0.001; respectively). All scales were significantly associated with pain severity and interference of the BPI, and with the cognitive-affective and somatic scales of the BDI. The emotional-functioning scale was substantially correlated with the cognitive-affective scale and somatic scale of the BDI. These results demonstrate that the Korean version of the EORTC QLQ-C30 is a valid instrument for evaluating Korean-speaking patients with cancer, and can be used to distinguish clearly between subgroups of patients of differing performance status.     

EORTC QLQ量表评估影响食管癌患者生活质量的相关因素

目的评估食管癌化疗患者的生活质量并探究与生活质量相关的影响因素。方法自2004年11月1日至2005年12月31日采用EORTCQLQ问卷表访问133例食管癌患者。影响生活质量的因素经t检验和单变量方差检验处理。结果无论化疗有效与否,本研究入组患者化疗后第1周生活质量得分多稍有降低,但4周后可恢复至化疗前水平。年龄较轻、临床分期较早及KPS评分较高者生活质量较好。术后辅助化疗组患者生活质量相对较好。结论对食管癌化疗患者的生活质量进行分析,其结果对建立化疗食管癌患者生活质量的评价标准及临床医师选择合适的治疗方式有一定的指导意义。     

The domain structure of the EORTC QLQ-STO22 supported by Japanese validation data

This paper evaluates the scale structure of the EORTC QLQ-STO22 gastric cancer module using Japanese validation data. We additionally tested two single items regarding dumping syndrome. Of 246 patients who participated in phase II clinical trials of chemotherapy to treat advanced gastric cancer, we analyzed 206 who completed the pretreatment questionnaire. The factor analysis supported the scale structure hypothesized for the initial development phase conducted by the EORTC Quality of Life Group, not the alternations made in the final psychometric testing phase. The elicited scales exhibited high internal consistency and high clinical validity. Our data suggest that there is no need to examine the dumping syndrome items. This study revealed a slightly different scale structure of the QLQ-STO22 from that obtained in the European study. Extensive discussions with the EORTC Group are needed from both cross-cultural and clinical perspectives in order to establish a consensus on the various language versions of the QLQ-STO22.     

The impact of generalized malignant melanoma on quality of life evaluated by the EORTC questionnaire technique

Eighty-nine patients with generalized malignant melanoma, 63% men and median age 53 years, were included in a longitudinal quality of life (QOL) study before the start of chemotherapy. QOL was assessed by the EORTC core questionnaire technique (QLQ-C36), a study-specific melanoma (MM) module and the Hospital Anxiety and Depression (HAD) scale. The questionnaires displayed good psychometric qualities and were able to document the florid symptomatology of disseminated melanoma. They were well accepted by the patients. Before treatment the patients reported a relatively low symptom burden, good physical and social functioning, moderate psychological distress and a high overall QOL rating during the past week. Fatigue and pain were the most frequent symptoms reported. The QOL measurement differentiated between subgroups of patients differing in performance status and the tumour burden. We conclude that the EORTC questionnaire technique is feasible and clinically relevant in generalized malignant melanoma patients.This study was made possible by grants from the King Gustav V Jubilee Fund, Stockholm, Sweden.     

分子影像学肿瘤疗效评价标准及应用

基于肿瘤体积变化的实体瘤疗效评价标准--RECIST标准,具有一定的滞后性,难以满足对临床各种治疗手段的评价。18F-脱氧葡萄糖（18F-FDG）PET分子影像能反映细胞葡萄糖代谢,实现生物学水平早期评价肿瘤疗效,评价标准从EORTC、PERCIST到PREDIST,根据临床需求不断完善;更有针对骨转移瘤的MDA标准。该文详细概述以上4种分子影像学标准的评价方法及其临床应用。     

EORTC QLQ-C30 and FACT-BMT for the measurement of quality of life in bone marrow transplant recipients: a comparison

The purpose of the study was to compare two different quality-of-life self-rating instruments, namely the EORTC QLQ-C30, developed by the quality-of-life study group of the European Organisation for Research and Treatment of Cancer, and the FACT-BMT (version 3), the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation scale, which is the FACT-G(eneral measure) in combination with a module developed specifically for evaluating quality of life of bone marrow transplant (BMT) patients. Fifty-six BMT recipients completed both the EORTC QLQ-C30 and the FACT-BMT (German language version) during the same session. Questionnaire data were analyzed on a subscale basis using correlation analysis and multiple linear regression. Correlations between corresponding subscales of EORTC QLQ-C30 and the FACT-BMT ranged from r=0.30 for the emotional domain (poor agreement) to r=0.77 for global QOL (good agreement). This suggests that the instruments, despite considerable overlap, possibly focus on different aspects of QOL, in particular in addressing emotional and social issues of BMT patients. It appears that the FACT-BMT gives a more comprehensive overview regarding the multidimensional construct of quality of life. The EORTC QLQ-C30 gives more insight into the physical aspects of quality of life and helps to identify symptoms which effectively decrease quality of life from the patient's perspective. The QLQ-C30 might be improved by the incorporation of a BMT-specific module currently under development. We therefore conclude that neither of the two instruments can be replaced by the other in the assessment of QOL of BMT patients and that a direct comparison of results obtained with the two instruments is likely to be misleading.