| Objective To observe the clinical efficacy of combining Chaihu Longgu Muli decoction with Dex Zopiclone Tablets in the treatment of post-ischemic stroke insomnia(PISI)with evidence of liver qi stagnation.Methods Using the randomized number table method,72 patients who met the inclusion criteria were randomly divided into 36 patients in the treatment group(Chaihu Longgu Muli decoction + Dexzopiclone Tablets)and 36 patients in the control group(Dexzopiclone Tablets),and the treatment course was 28 days,and the TCM symptom scores,Pittsburgh Sleep Quality Index Scale(PSQI)scores,National Institutes of Health Stroke Scale(NIHSS)scores,and clinical efficacy and safety were observed before and after treatment.The clinical efficacy and safety of the treatment were observed before and after the treatment by using the Chinese medicine symptom score,Pittsburgh Sleep Quality Index Scale(PSQI)score and National Institutes of Health Stroke Scale(NIHSS)score.Results(1)Total clinical efficacy: the total clinical efficiency was 88.57% in the treatment group and 74.29% in the control group,respectively,and the treatment group was better than the control group(P < 0.05)(2)Total efficacy of TCM symptoms: after treatment in both groups,the TCM symptom scores decreased significantly,and the treatment group was better than the control group(P < 0.05).The total effective rate of TCM symptoms was 91.43% in the treatment group and 71.43% in the control group,respectively,and the treatment group was significantly better than the control group(P< 0.05).(3)PSQI scores: After treatment in both groups,the total PSQI scores were significantly lower,significantly in the treatment group compared with the control group(P < 0.05).Within-group comparison: all factor scores improved in both groups after treatment compared with those before treatment(P < 0.05);between-group comparison: statistically significant in sleep quality,time to sleep,sleep disturbance and daytime dysfunction scores in both groups after treatment(P < 0.05),and not statistically significant in sleep duration and sleep efficiency(P > 0.05).(4)NIHSS score: After treatment in both groups,the NIHSS scores were statistically significant compared with those before treatment(P < 0.05),and there was no statistically significant difference between the groups(P >0.05).(5)Safety and adverse reaction evaluation: No significant abnormalities were found in the general vital signs examination of patients in both groups before and after treatment,and there were no significant adverse reactions and other abnormalities during the drug administration.Conclusion Chaihu Longgu Muli decoction combined with Dexzopiclone Tablets was superior to the Dexzopiclone Tablets alone group in improving the total clinical efficacy,TCM clinical symptoms,sleep quality,time to sleep,sleep disturbance and daytime dysfunction scores in patients with PISI with liver qi stagnation evidence,but the efficacy was comparable in improving sleep duration,sleep efficiency and degree of neurological deficits.The safety of Chaihu Longgu Muli decoction combined with dexzopiclone tablets was good during the study,with no significant adverse effects and reliable efficacy,which is worthy of clinical promotion. |
