| Objective:Evaluate the effectiveness and safety of "Jiaotai anshen prescription" by observing the changes in the TCM Syndrome scores,Pittsburgh Sleep Quality Index scores,single TCM symptoms,and laboratory indicators of patients who have insomnia with incoordination between heart and kidney,before and after treatment.Method:The subjects of the study were insomniacs with incoordination between heart and kidney who met the inclusion criteria of this clinical study in the outpatient department and ward of encephalopathy of our hospital from January 2019 to December 2019.A total of 88 subjects meeting the inclusion criteria were included in the study using the randomized control method,and were randomly divided into the observation group(44 cases)and the control group(44cases).In the observation group,44 patients were given the traditional Chinese medicine decoction "Jiaotai anshen prescription" for internal use,while in the control group,44 patients were given the western medicine "Estazolam tablets" for treatment,with a four-week course of treatment.Using blood routine,liver function,renal function and electrocardiogram as safety indexes,evaluate the effectiveness and safety of "Jiaotai anshen prescription" by observing and comparing the PSQI score,TCM syndrome score,single TCM symptom changes and clinical efficacy of the two groups of insomniacs before and after treatment.Results:1.A total of 88 patients were enrolled in this clinical study,83 of whom completed clinical observation,there were 3 cases of shedding in the observation group and 2 cases of shedding in the control group,with a total shedding rate of 5.68%.2.Before treatment,there were no statistically significant differences in age,gender,course of disease,education level,occupation,degree of insomnia,distribution of single TCM symptoms,PSQI score and TCM syndrome score between the two groups(P >0.05).3.After treatment,in the observation group,6 cases were cured,19 cases showed obvious effect,11 cases were effective and 5 cases were ineffective.In the control group,2 cases were cured,10 cases showed obvious effect,21 cases were effective,and 9 cases were ineffective.The total effective rate was 87.80% in the observation group and 78.57% in the control group.The clinical efficacy of the two groups was compared,and the difference was statistically significant(P <0.01).4.Compared before and after treatment,both groups can improve TCM syndrome score and PSQI score.The change of TCM syndrome score,in the observation group decreased from 25.46±8.89 to 15.88±7.41,in the control group decreased from 27.26±8.20 to19.43±7.64,the difference between the two groups was statistically significant(P < 0.05).About the change of PSQI score,in the observation group decreased from 13.12±2.43 to6.17±2.54,in the control group decreased from 13.29±2.29 to 7.74±2.16,the difference between the two groups was statistically significant(P <0.01).5.During clinical observation,no adverse events occurred.All patients' laboratory indicators such as blood routine,liver function,renal function and electrocardiogram werewithin the normal range,and the difference was not statistically significant(P > 0.05).The safety evaluations of 83 patients were all grade 1.Conclusion:1.Jiaotai anshen prescription has obvious effect in treating patients with Insomnia-caused-by-incoordination-between-heart-and-kidney and has more advantages in reducing TCM syndrome score,Pittsburgh Sleep Quality Index score and improving clinical symptoms than using estazolam tablets alone.2.Jiaotai anshen prescription has no obvious adverse reactions and has good safety. |
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