结肠癌辅助化疗期中医症状量表信度效度检验与临床实践应用分析

目的评价《中医症状量表》的信度效度，观察健脾补肾序贯方对结肠癌辅助化疗期患者中医症状严重程度的改善情况。方法纳入中国中医科学院西苑医院111例结肠癌根治术后患者用于量表的信度、效度评价，计算量表的克朗巴赫α系数（Cronbach'sα）以评估量表一致性，应用因子分析评价量表的结构效度。本研究是一项随机、对照、双盲安慰剂、多中心临床研究的二次分析，在2018年12月—2021年12月期间，对纳入的400例结肠癌根治术后的患者进行1： 1的随机分配为试验组和安慰剂组。试验组口服健脾补肾序贯方，安慰剂组口服健脾补肾序贯方模拟剂，在接受XELOX方案辅助化疗期间加载服用。二次分析主要比较两组患者中医症状改善情况、中医症状随时间变化情况，评价健脾补肾序贯方对症状改善的疗效。结果结肠癌辅助化疗期《中医症状量表》共包括11个症状条目。量表Cronbach'sα系数为0.698，重测信度为0.730，共筛选出4个公因子，总方差累计贡献率60.753%，因子载荷均大于最小可接受值。临床研究部分统计结果分析显示，试验组与安慰剂组在呕吐评分中差异有统计学意义（Z=2.069，P=0.039）。重复测量结果显示，在服用健脾补肾序贯方后呕吐（P=0.003）、麻木（P<0.001）、腹泻（P=0.023）、便秘（P=0.007）、怕冷（P=0.024）、夜尿（P=0.001）、自汗（P=0.017）、口腔溃疡（P=0.002）差异有统计学意义。结论《中医症状量表》具有良好的信度、效度，可应用于临床评价结肠癌辅助化疗期间中医症状的改善情况。健脾补肾序贯方能够有效改善结肠癌患者辅助化疗期间呕吐严重程度。

英文摘要:

Objective To evaluate the reliability and validity of Chinese Medicine Symptom Scale （CM-SS），observing the improvement of CM symptoms severity in colon cancer patients during adjuvant chemotherapy by Jianpi Bushen Sequential Formula. Methods A total of 111 colon cancer patients after radical operation from Xiyuan Hospital，China Academy of Chinese Medical Sciences were included in the study to assess the reliability and validity of scale. The Cronbach's alpha coefficient（Cronbach's alpha）of the scale was calculated to assess the internal consistency，and factor analysis was applied to evaluate the structural validity of the scale.This study was a secondary analysis of a randomized，controlled，double-blind placebo，multicenter clinical trial. Between December 2018 and December 2021，400 patients after radical colon cancer surgery were included and randomly assigened in a 1： 1 ratio to the experimental group and placebo group. The experimental group received the oral administration of Jianpi Bushen Sequential Formula，while the placebo group received placebo. Both groups received these interventions during the XELOX adjuvant chemotherapy period. The secondary analysis primarily focused on comparing the improvement of CM symptoms between the two groups，as well as the changes in these symptoms over time. The efficacy of Jianpi Bushen Sequential Formula in improving symptoms was evaluated. Results The TCM-SS for colon cancer during adjuvant chemotherapy includes 11 symptom items. Scale Cronbach's α The coefficient is 0.698，and the retest reliability is 0.730. A total of 4 common factors are selected，with the cumulative contribution rate of total variance of 60.753%.The factor load is greater than the minimum acceptable value.Analysis of the statistical results in the clinical study section showed a statistically significant difference in the vomiting scores between the test and control groups（Z=2.069，P=0.039）.Repeated measurements showed statistically significant differences in vomiting（P=0.003），numbness（P<0.001），diarrhea（P=0.023），constipation（P=0.007），fear of cold（P=0.024），nocturia（P=0.001），spontaneous sweating（P=0.017），and mouth ulcers（P=0.002）over time after taking the Jianpi Bushen Sequential Formula. Conclusions The CM-SS has good reliability and validity and can be used to evaluate the improvement of TCM symptoms during adjuvant chemotherapy of colon cancer. In addition，Jianpi Bushen Sequential Formula can effectively alleviate the severity of vomiting symptoms of colon cancer patients during adjuvant chemotherapy .

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