| Objective To observe the clinical efficacy and adverse reactions of Shugan Kaiqiao Decoction via control experiment,and to provide an effective judgment for the future use of Shugan Kaiqiao Decoction in the treatment of this disease.Methods Following the principle of randomized controlled trials,90 patients with post-stroke depression(Liver-qi Stagnation Type)who met the inclusion criteria were selected and divided into the treatment group and the control group with an average of 45 patients.All the patients were from the outpatient and inpatient departments of the Ningxia Hui Autonomous Region TCM Hospital and TCM Research Institute Encephalopathy Department from December2019 to December 2020.In the trial,4 patients in the treatment group and 6 patients in the control group were excluded due to irregular drug taking,and the final number of patients who completed the experiment was 80.General routine treatment: inhibiting platelet aggregation,stabilizing plaque and limb function exercise.Treatment group: routine treatment added with Sugan Kaiqiao Decoction(200 ml/bag),one does per day,400 ml decocted in water,one bag time,two bags per day,taking warm half an hour after breakfast and dinner;Control group: routine treatment plus sertraline hydrochloride tablet(50 mg/tablet),one tablet per night;Each course of treatment lasted for one week with total 4 courses.Experimental observation indexes: depression degree evaluation(HAMD),neurological impairment evaluation(NIHSS),quantitative evaluation scale of TCM syndrom.The data obtained were analyzed by SPSS20.0.Results(1)Baseline data comparison: gender,age,basic diseases,illness degree(HAMD,NIHSS)and HAMD before treatment,NIHSS and TCM syndrome score,no statistical significance(p>0.05),can be used as comparative objects.(2)Comparison of efficacy after 4weeks:(1)HAMD:the therapeutic effect was compared according to the score reduction rate.The proportion of total effective people in the treatment group was 92.68%,and the treatment score decreased from(24.17±3.049)to(11.32±4.245).While the proportion of total effective people in the control group was 76.92%,and the treatment score decreased from(23.21±4.053)to(14.03±5.013).(2)NIHSS:the treatment group score decreased from(16.17 + 2.365)to(5.61 +/-3.293),and the control group score decreased from(15.74 + 2.613)to(8.62 +/-3.290).Intra-group and inter-group comparison were made(p<0.001)with statistical significance(p<0.001).(3)TCM syndrome score: the therapeutic effect was compared according to the score reduction rate.The total effective number in the treatment group accounted for 97.56%.And the scores before and after treatment were(15.24±3.367)and(5.80±2.552),respectively.The total effective population in the control group accounted for 87.18%,and the pre and post scores were(14.67±3.390)and(8.62±3.438).From the degree of depression,degree of nervous function defect and three aspects of syndromes data analysis,the differences between the two groups after treatment were statistically significant(p<0.05).All can improve the depressive state,neurological function and clinical symptoms of patients.However,the therapeutic effect in the treatment group was better than that in the control group,indicating that Shugan Kaiqiao Decoction has clinical significance.(3)In this study,one person in the treatment group developed epigastric discomfort with mild symptoms.No drug intervention or withdrawal was used.The discomfort symptoms disappeared 2 days later,while the other patients did not show any discomfort symptoms.There was no abnormality in routine examination before and after treatment in both groups.Conclusion(1)Compared with sertralin hydrochloride,Shugan Kaiqiao Decoction can effectively improve the symptoms of patients with post-stroke depression(liver-qi stagnation type),and no obvious adverse reactions were observed in the clinical application process.(2)Shugan Kaiqiao Decoction can effectively reduce the scores of HAMD,NIHSS and TCM syndrome. |
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