为总结阶梯递进辨证论治疗效评价的研究阶段进展，验证个体医师辨证论治失眠核心处方的疗效和安全性，对比分析了“描述-探索-验证”3阶段中分别存在的科学问题和解决策略，以名中医辨证论治疗效的观察性研究为基础，进一步采用多中心、小样本的实用性随机对照试验设计进行疗效确认，以133例中医辨证分型属于痰热扰神证的原发性失眠患者为研究对象，随机分为清痰宁神方、香附温胆汤、黄连温胆汤3组治疗；均制备为中药复方颗粒服药28d。观察各组患者治疗前后总睡眠时间（TST）、入睡潜伏期（SL）的差异；比较各组患者治疗前后的匹兹堡睡眠质量指数（Pittsburgh sleep quality index，PSQI）评分、失眠严重程度指数量表（insomnia severity index，ISI）评分及治疗4周后的下降值，并计算睡眠效率（sleep efficiency，SE）及临床有效率。结果表明：经过4周治疗后，3组患者PSQI得分下降值分别为4.64、4.91、5.43；患者总睡眠时间平均延长1.22、1.14、1.62h，入睡潜伏期平均缩短43.81、55.44、53.37min，ISI 得分下降值分别为6.79、7.98、7.43分，SE分别提升15.18%、10.26%、14.80%，总有效率为73.81%、73.33%、76.09%，组间差异无统计学意义（P>0.05）。与观察性研究结果相比，疗效有所降低。研究表明名中医辨证论治有效核心处方对痰热扰神型失眠患者疗效确切、安全可靠，阶梯递进的辨证论治疗效评价研究方法可以逐步提高中医临床研究证据级别，最终得到客观的、科学的研究结论。
秦宇宁
,
何丽云
,
闫世艳
,
刘艳骄
,
王松龄
,
郭蓉娟
,
王平
,
艾艳珂
,
吕晓颖
,
雒琳
,
张艳宏
,
李新龙
,
李凌香
,
白贺天
,
刘保延
. 个体医师辨证论治疗效的评价方法——以失眠症为例[J]. 科技导报, 2023
, 41(14)
: 64
-74
.
DOI: 10.3981/j.issn.1000-7857.2023.14.008
To summarize the research phases of the efficacy evaluation of stepwise progressive evidence-based treatment, and to verify the efficacy and safety of the core prescriptions of evidence-based treatment of insomnia by individual practitioners, the scientific problems and solution strategies in the three stages of "description-exploration-validation" were compared and analyzed in this paper. Based on the observational study of the evidence-based treatment efficacy by famous TCM practitioners, the further validation of the efficacy was carried out through a multicenter blinded randomized controlled trial design. 133 insomnia patients with TCM classification of phlegm-heat-disturbing-the-mind were used as the study population. The patients were randomly divided into three treatment groups, namely Qing Tan Ning Shen Fang, Xiang Fu Wen Dan Tang and Huang Lian Wen Dan Tang; all of them were prepared as Chinese medicine compound granules and taken for 28 days. The differences in total sleep time (TST) and sleep latency (SL) were observed before and after treatment; the Pittsburgh Sleep Quality Index (PSQI) scores, Insomnia Severity Index (ISI) scores before and after treatment were compared between the groups. After 4 weeks of treatment, sleep efficiency (SE) and clinical efficiency were calculated. After 4 weeks of treatment, the decrease of PSQI score was 4.64, 4.91, and 5.43 in the three groups, respectively; the total sleep time was prolonged by 1.22, 1.14, and 1.62 hours, and the sleep latency was shortened by 43.81, 55.44, and 53.37 minutes on average, the decrease of ISI score was 6.79, 7.98, and 7.43 in the three groups, and the SE was improved by 15.18% and 10.26%, respectively. The overall effective rates were 73.81%, 73.33%, and 76.09%, with no statistically significant differences between groups (P>0.05). Compared with the results of the observational study, the efficacy was reduced. The effective core prescriptions of the famous TCM discriminative treatment are effective, safe and reliable for patients with phlegm-heat disturbed insomnia, and the stepwise progressive discriminative treatment efficacy evaluation research method can gradually increase the level of evidence of TCM clinical research and finally obtain objective and scientific research conclusions.
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