偏头痛缓解期基于患者报告的评价量表临床应用的研究

摘要

Objective The end of the report further validation based on migraine patients ( pa-tients reported outcomes, PRO) evaluation questionnaire of clinical application. Method The multi-center, prospective, randomized, double-blind, positive drug parallel contrast research method was performed. By 15 clinical research centers, from February 2012 to February 2014, 357 patients in accordance with the in-clusion criteria were collected. Data were input and managed by EPIDATA database. SPSS16. 0 was used for data analysis. The number of headache attack, days of headache, PRO scale scores, and four dimen-sions scores were observed at the following time points: before treatment, after treatment for 4, 8 and 12 weeks, follow-up visit. Chi-square test and rank-sum test were used to analyze frequences;Measurement data were expressed as and analyzed using matching t test. Correlation analysis was used to observe the cor-relation . Result Both the number of headache attack and days of headache were improved after treatment for 4, 8 and 12weeks compared with baseline and there were significant differences (P<0. 01). There was significant difference in PRO scale scores before and after treatment (P<0. 01); PRO scale four dimen-sions scores were significant different after treatment in comparison with before treatment(P<0. 01). At each time point, correlation coefficient between headache days, attack frequency and PRO scale scores was large than 0. 5, with moderate relevant; correlation coefficient between headache days, attack frequency and PRO scale four dimensions scores was larger than 0. 7, with strong relevant. Conclusion Migraine PRO scale could exactly reflect patients with significant changes in headache days, the number of attacks, and the PRO scale could imply treatment effect from multiple time points and multiple dimensions.%目的：进一步验证偏头痛缓解期基于患者报告的结局( Patients-reported outcomes, PRO)评价量表的临床应用。方法采用多中心、前瞻性、随机、双盲、阳性药平行对照研究方法,由15家临床研究中心参加,收集2012年2月至2014年2月符合纳入标准的病例357例,通过EPIDA-TA数据库录入与管理,二次录入。采用SPSS 16.0进行数据分析,观察其在纳入时,治疗4周、8周、12周及随访时头痛发作次数、天数及PRO量表评分、四个维度评分变化。计数资料描述其频数,采用χ2检验和秩和检验；计量资料采用表示,治疗前后变化采用配对t检验；用相关分析法比较其相关性。结果与基线期比较,治疗4周、8周、12周及随访时头痛发作次数、天数均有改善,差异有统计学意义(P<0.01)；治疗前后PRO量表总分比较有显著性差异(P<0.01)；治疗后PRO量表四个维度与纳入时比较具有显著性差异(P<0.01)；各时点头痛发作天数、发作次数与PRO量表总分的相关系数均>0.5,呈中等强度相关；与PRO量表头痛情况维度相关系数均>0.7,呈强相关。结论偏头痛PRO量表可确切反应头痛天数、次数有显著变化的病例,PRO量表可以从多个时点、多个维度较全面科学地反应治疗效果。