肌萎缩侧索硬化中医疗效评价量表(ALS-SSIT量表)的效能评价

Performance evaluation of traditional Chinese medicine evaluation scale (ALS-SSIT scale) for therapeutic efficacy in amyotrophic lateral sclerosis

目的:评价肌萎缩侧索硬化(amyotrophic lateral sclerosis,ALS)中医疗效评价量表(ALS-SSIT量表)的可行性、信度、效度和灵敏度。方法:总结中医治疗ALS的经验以及征询专家建议,制定适用于评价中医治疗ALS疗效的量表(ALS-SSIT量表)。采用ALS-SSIT量表于入组当日以及随访6个月时,对160例接受中医治疗的ALS患者进行疗效评价,并以SF-36和ALSFRS-R量表作为参照,评估ALS-SSIT量表的可行性、信度、效度和灵敏度。结果:ALS-SSIT量表的接受率和完成率均高于99%,入组当日以及随访6个月时的重测信度分别为0.917和0.918,内容效度和灵敏度(总评分、各领域评分和各条目评分)均较高,与SF-36量表和ALSFRS-R量表之间存在线性相关性,能够较好地反映ALS患者病情的变化。结论:ALS-SSIT量表评价中医治疗ALS疗效的可行性、信度、效度和灵敏度均较好,适于临床推广应用。

Objective:To evaluate the feasibility,reliability,validity and sensitivity of ALS-SSIT scale-a traditional Chinese medicine(TCM)evaluation scale for therapeutic efficacy in amyotrophic lateral sclerosis(ALS).Methods:To summarize the experience in traditional Chinese medicine(TCM)in the treatment of ALS and consult experts’suggestions,and then develop a scale(ALT-SSIT scale)suitable for evaluating the efficacy of TCM in the treatment of ALS.The performance of ALS-SSIT scale was evaluated on the day of enrollment and after 6-month of follow-up in 160 patients with ALS who received traditional Chinese medicine treatment.The SF-36 and ALSFRS-R scales were used as references to evaluate the feasibility,reliability,validity and sensitivity of ALS-SSIT scale.Results:The acceptance and completion rates of ALS-SSIT scale were both higher than 99%.The test-retest reliabilities of ALS-SSIT scale were 0.917 and 0.918 on the day of enrollment and after 6-month of follow-up,respectively.The content validity and sensitivity(total score,score of each field and score of each item)were higher.There was a linear correlation between ALS-SSIT scale and SF-36 and ALSFRS-R scales,which means that ALS-SSIT scale could better reflect the changes in disease condition.Conclusion:The feasibility,reliability,validity and sensitivity of ALS-SSIT scale in evaluating the efficacy of TCM in the treatment of ALS are satisfactory,which is suitable for clinical application.