ABSTRACT
ObjectiveTo evaluate the clinical efficacy and safety of Yangxin Dawayimicol honey ointment （YDHO） in the treatment of insomnia with the syndrome of Qi stagnation and blood stasis. MethodEighty insomnia patients who met the inclusion criteria in the Department of Encephalopathy of the Third Affiliated Hospital of Henan University of Chinese Medicine from November 2019 to October 2020 were randomly divided into an experimental group （48 cases） and a control group （32 cases）. The experimental group was treated with YDHO + Xuefu Zhuyu capsule simulators，and the control group was treated with Xuefu Zhuyu capsules + YDHO simulators for eight weeks. The changes in Pittsburgh sleep quality index（PSQI）score，traditional Chinese medicine （TCM） syndrome score，insomnia severity index （ISI），neurotransmitter indexes ［γ-aminobutyric acid（GABA），glutamic acid（Glu），and 5-hydroxy tryptamine（5-HT）］，serum inflammatory indexes ［interleukin-6（IL-6）and interleukin-10（IL-10）］， and safety index of the two groups were compared. ResultThe total effective rate was 97.83%（45/46） in the experimental group， higher than 68.75%（22/32） in the control group（Z=-4.292，P<0.01）. The experimental group was superior to the control group in PSQI score，ISI score，TCM syndrome score， and sleep duration（P<0.05）. The curative effects were equivalent between the two groups in shortening the time to fall asleep. The experimental group showed increased serum content of GABA，5-HT， and IL-10 and reduced content of Glu and IL-6，with few adverse reactions （P<0.05）. ConclusionYDHO is effective，safe， and reliable in the treatment of insomnia with Qi stagnation and blood stasis syndrome.
ABSTRACT
Objective:To study the distribution of ischemic stroke treatment with data mining technology and evaluate its clinical efficacy. Method:China National Knowledge Infrastructure Database（CNKI），China Science and Technology Reader's Digest Database（VIP），Wanfang Data，Chinese Biomedical Literature Database（Sino Med）were retrieved from January 1978 to December 2018. The clinical observation and study literatures on the treatment of ischemic stroke with the combination of traditional Chinese medicine and Western medicine were retrieved in the four databases. After standardized and hierarchical collection and processing of all syndromes，treatment methods，prescriptions and other information in the literatures，a database of syndrome elements and treatment of ischemic stroke was established. Syndrome factors and treatment methods were analyzed by scale evaluation and hierarchical classification methods. Kendall's tau-b correlation analysis，principal component analysis and other statistical methods were used to describe the correlation and distribution of syndrome factors and treatment methods of ischemic stroke. Result:The results of heterogeneity analysis showed that the included literatures were homogeneous and could be combined with subsequent statistics. A total of 450 syndromes and treatment methods were included in this study，and 1 287 single syndrome elements and 1 562 single treatment methods were obtained after unified and standardized splitting. Besides the corresponding syndrome elements and treatment methods，phlegm-dampness-invigorating Qi（-0.52） and Qi deficiency-invigorating Qi（-0.56） were also highly correlated. The study team represented the importance of syndrome and treatment elements with class Ⅰ，Ⅱ，Ⅲ from high to low. Qi deficiency，blood stasis and fire heat，phlegm，viscera excess were class Ⅰ syndrome elements；Yin deficiency，endogenous wind were class Ⅱ syndrome elements；Yin deficiency and Yang deficiency were class Ⅲ syndrome elements；Removing phlegm dampness，clearing heat，clearing the hollow viscera and extinguishing wind，promoting blood circulation to remove blood stasis，tonifying Qi were class Ⅰ treatment of ischemic stroke，and removing phlegm dampness，clearing heat，clearing the hollow viscera were more likely to appear simultaneously； and extinguishing wind，activating blood circulation and removing blood stasis，and benefiting Qi were more likely to appear simultaneously. Nourishing Yin and regulating Qi were class Ⅱ therapies of ischemic stroke，which were highly correlated and often appear simultaneously. Inducing resuscitation，tonifying Yang and dredging collaterals were class Ⅲ，Ⅳ，Ⅴ therapies. Conclusion:Qi deficiency，blood stasis，phlegm dampness，fire heat and viscera excess were the main syndromes of ischemic stroke，while Qi deficiency and blood stasis，phlegm heat and viscera excess were the main syndromes. Eliminating phlegm and dampness，clearing heat，clearing the hollow viscera，promoting blood circulation and removing blood stasis，extinguishing wind and benefiting Qi were the main therapies for the treatment of ischemic stroke. In clinical treatment for ischemic stroke，the therapies for relieving phlegm and dampness，clearing heat and relieving organs are often used in combination，and the therapies for promoting blood circulation and removing blood stasis were often used in combination with the therapies for invigorating Qi and extinguishing wind for the synergistic effect.