IBS-SSS、AR及IBS-QOL在IBS临床疗效评价中的反应度分析

Analysis of Response of IBS-SSS,AR,and IBS-QOL in IBS Clinical Effect Evaluation

目的观察肠易激综合征(irritable bowel syndrome,IBS)临床研究中常用疗效评价指标的反应度,为IBS相关中医药临床试验临床疗效评价指标的应用提供参考。方法采用随机、双盲、安慰剂对照临床试验设计,将58例腹泻型IBS(diarrhea-predominant IBS,IBS-D)患者分为试验组(28例)及对照组(30例)。试验组口服中药肠安Ⅰ号方,对照组口服肠安Ⅰ号方安慰剂。疗程为8周。以临床研究为依托,以"排便相关症状"为有意义的临床变化,对症状指数进行主成分分析,以IBS症状严重程度量表(IBS symptom severity scale,IBS-SSS)、IBS生活质量量表(IBS quality of life,IBS-QOL)积分为因变量,症状指数的主成分值、焦虑子量表(hospital anxiety and depression scale a,HADa)与抑郁子量表(HADd)的积分为自变量,分析其线性回归关系;以完全缓解(adequate relief,AR)值为因变量,症状指数主成分值为自变量,考察两者间的Logistic回归关系;以症状指数的主成分值A、B为衡量指标,在试验组或对照组中选择有疗效的一组,并以此组患者进行反应度分析。结果试验组治疗后主成分A与B疗效比较,差异有统计学意义(P<0.05),故以试验组数据作为参照标准,考察IBS-SSS、AR、IBS-QOL的反应度。(1)IBS-SSS与排便相关症状、焦虑积分存在线性相关关系,其效应尺度为1.59,临床反应度较高。(2)AR的单次应答与排便相关症状存在线性相关关系。(3)IBS-QOL与排便相关症状线性相关关系不明显,与焦虑积分有一定关联,效应尺度为0.61,具有中等反应度。在IBS-QOL量表的各个维度中,心境恶劣、健康担忧两个维度能反映临床变化,效应尺度分别为0.50、0.70。结论 IBS-SSS临床反应度较好,适合在临床疗效评价中使用;AR的单次应答与排便相关症状相关,但需注意其"有临床意义"的界定;IBS-QOL具有中等临床反应度,建议观察周期较长的临床研究使用。

Objective To observe the response of common indices for clinical effect evaluation on irritable bowel syndrome（ IBS）,thereby providing reference for IBS related clinical indices in clinical trials of Chinese medicine（ CM）. Methods A randomized,double-blinded,placebo control trial was set up. Totally 58 diarrhea-predominant IBS（ IBS-D） patients were randomly assigned to the test group（ 28 cases） and the control group（ 30 ca-ses）. Patients in the test group took Chang＇an Recipe Ⅰ（ CR Ⅰ）,while those in the control group took CR Ⅰ placebo. The therapeutic course for all was 8 weeks. Defecation related symptoms was taken as significance in clinics.Principal component analysis was performed in symptoms index. IBS symptom severity score（ IBS-SSS） and IBS quality of life（ IBS-QOL） were taken as dependent variables. Main component value and the integral of hospital anxiety and depression scale a（ HADa） and hospital anxiety and depression scale d（ HADd） were taken as independent variables. Their linear correlation was analyzed. Adequate relief（ AR） value was taken as dependent variable,while symptoms index was taken as independent variable. Their Logistic regression correlation was analyzed.Main component value A and B of symptoms index were taken as measurement index. A group with efficacy was selected from the test group or the control group,and response analyzed in patients of this group. Results There was statistical difference in main component value of A and B in the test group after treatment（P〈0. 05）. So data of the test group were taken as referential standard,the responsibilities of IBS-SSS,AR,IBS-QOL were observed.（ 1） The score of IBS-SSS had a linear regression with defecation related symptoms and anxiety scores,and its responsibility was higher with an effect size of 1. 59.（ 2） Response to each AR was linearly related to defecation related symptoms.（ 3） The score of IBS-QOL was not obviously correlated with defecation related symptoms,but with moderate response to anxiety state（ an effect size of 0. 61）. Domains of dysphoria and worries about health could reflect clinical changes with the effect size of 0. 50 and 0. 70 respectively. Conclusions IBS-SSS had better clinical response,which was suitable for IBS clinical effect evaluation. Response to each AR was related with defecation related symptoms. But attention should be paid to its clinical meaning. IBS-QOL had a moderate effect size. It was suggested to be used in long-term clinical research.