Exploratory Clinical Study Of Jiedu Tongluo Granules In Intervention Of Post-stroke (cerebral Infarction) Depression

Background:At present,the incidence of stroke in China is relatively high,and ischemic stroke accounts for 60-80%of them.Its high disability rate,high mortality rate and equelae-post-stroke depression(PSD)are bring about double pressure to medical care and social economy.According to related documents and references the incidence of depression caused by stroke is approximately 30%to 60%.Modern research shows that depression is closely related to cerebral ischemia,transient cerebral ischemia,and white matter damage.In the treatment,Western medicine in the treatment of stroke recovery and sequelae is still lack of effective evidence-based drugs,most drugs have certain limitations.In clinical,we only use nticoagulation,anti-platelet aggregation,lowering blood pressure and lowering blood lipids and other basic drugs to treat PSD,and only be given symptomatic treatment according to conventional depression.The clinical efficacy which Chinese medicine treatment of ischemic stroke recovery period,sequelae-related diseases is exact,and have relatively small side effects,rich clinical experience,general clinical application.However,currently there are no listed Chinese medicine preparations that can be clinically applied in the treatment of post-stroke depression.Therefore,it has strong social and practical significance we do the research and develop a new Chinese medicines to treat stroke recovery and sequelae with both depressive symptoms.At the same time,the medicine with stable quality,conclusive curative effect,convenient application and limited dosage is also urgently need.The development of Jiedu Tongluo granules relied on a special platform for the creation of major new drugs for major national science and technology projects.It is the research and development result of Professor Liu Jlanxun,a senior researcher at China Academy of Chinese Medical Sciences.The basic experiments have been completed,and the results have been fruitful and have received a number of patents.This experiment was based on previous animal experiments and was part of the relevant clinical studies entrusted by the researcher Liu Jianxun at Department of Encephalopathy of Xiyuan Hospital and has passed an ethical review.Objective:The purpose of this study was to observe the clinical efficacy and safety of Jiedu Tongluo granules in differentiating and treating post-stroke depression,and to sum up experience to lay a foundation for further research and clinical promotion.Method:From December 2016 to January 2018,we selected 55 patients with post-stroke(infarction)depressive qi and blood stasis type who were treated in the encephalopathy department of Xiyuan Hospital.According to the random number table,it was divided into treatment group and control group with a ratio of 1:1.The treatment group received conventional treatment and Jiedu Tongluo granules.The control group received placebo granules based on the same conventional treatment as the treatment group.The two groups of drugs were each 1 bag,2 times a day orally,treatment for 8 weeks,8 weeks after the efficacy evaluation.Western medicine anticoagulation,antiplatelet aggregants,antihypertensives,lipid-lowering agents,and blood glucose control drugs may be used during the test period according to the subject’s condition;no psychotropic drugs and the same or related traditional Chinese medicines and treatments used in this experiment may be used.At the 0th,4th,and 8th weeks of treatment,the disabled and general conditions were recorded using the modified RANKIN scale and Barthel’s quality of life improvement scale;the NIHSS rating scale,Hamilton depression scale,and stroke Chinese medicine were used.The grading scale of syndrome scores was used to score and the changes in scores were observed;and possible adverse reactions were recorded.Observe the changes of score and evaluate its curative effects by SPSS20.0.The measurement datas are described by mean± standard deviation(x±s),Use t test and rank sum test and other methods,The count data is described by frequency and rate,and the method of chi square test and rank sum test is adopted.The difference is statistically significant when P≤0.05.Results:After 8 weeks of treatment,the NIHSS scores of the two groups were compared,and there was no statistical difference between the two groups(P>0.05).There was no statistical difference between the two groups(P>0.05).Comparison of TCM Stroke Syndrome Grading scores within the group:the treatment group was statistically significant(P=0.05),and the control group was not statistically significant(P=0.30);between the groups:the two groups had statistically significant differences(P=0.047).The effective rates of the treatment group and the control group were 57.14%and 22.22%,respectively,with statistical significance(p=0.00).The treatment group can reduce the score of Chinese medicine syndrome of stroke,and the control group cannot improve the score of Chinese medicine syndrome of stroke.The HAMD Depression Scale score within the change group was compared between the treatment group(P=0.00)and the control group(P=0.02).Both groups were statistically significant;between groups,there was a statistically significant difference between the two groups(P=0.00).The effective rates of the treatment group and the control group were 82.14%and 29.63%,respectively,with statistical significance(p=0.00).It was shown that both groups improved depression after stroke,and the treatment group was significantly better than the placebo group.Conclusions:The Jiedu Tongluo Granules can effectively improve the depression status of patients,reduce the score of the HAMD Depression Scale,at the same time reduce the symptoms of stroke in Chinese medicine and reduce the score of Chinese medicine syndrome of stroke,which has significant statistical significance and clinical significance.It has fewer adverse reactions and is worth promoting.