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 ALSSSIT 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.