| Objective:Through learning from teachers and collecting medical records,We observe the changes of various scale scores before and after the treatment of patients with Qi and blood deficiency type insomnia b y Huang Chunhua tutor with the addition of Bazhen Decoction combin ed with Ganoderma lucidum extract;use modern medical statistical m ethods to explore its effectiveness and safety,To develop new tre atments and new ideas that can effectively treat insomnia,and prov ide evidence-based medicine basis for clinical application for furt her clinical promotion.Methods:A total of 83 patients with insomnia of Qi and blood deficiency w ere collected from the outpatient department of Deputy Chief Physicia n Huang Chunhua,Department of Encephalopathy,Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from January 2020 to January 2021.According to the prescribed intake and discharge cr iteria and exclusion criteria,a total of 80 eligible patients were f inally included in this study.According to the design principle of op en clinical randomized controlled trial,all patients were randomly d ivided into Bazhen Decoction combined with Ganoderma lucidum extract tablet group(treatment group)and Ganoderma lucidum extract tablet group(control group).The observation and treatment period of patient s in both groups was 4 weeks.In this process,We collect all the patie nt’s disease information,including general information(name,gende r,age,course of disease,etc.),past history,four-diagnosis inform ation and past medication status at the first visit,and Pittsburgh Sleep Quality Scale(PSQI)before and after treatment.And scores of the TCM Syndrome Integral Scale,Hamilton Anxiety Scale(HAMA)and De pression Scale(HAMD)scores before and after the treatment.Spss26.0statistical software was used for data analysis.The main curative ef fect evaluation indicators are the PSQI total score reduction rate an d the TCM syndrome curative effect index.According to the prescribed criteria,when the total PSQI score reduction rate exceeds 25%,it i s judged as an effective case,When the total PSQI score reduction rat e less than 25%,it can be judged as invalid;TCM Syndrome Curative E ffect Index ≥30%,it is judged to be valid,otherwise it is invalid.The secondary observation indicators include the Hamilton Anxiety Sca le(HAMA)and Depression Scale(HAMD).At the same time,observe and r ecord the adverse reactions in detail.Result:1.The general data of 80 patients in the two groups included bas ic information such as gender,age,disease course,PQI score at firs t diagnosis,TCM syndrome score,HAMA and HAMD score,etc.,and there was no difference between the two groups at baseline(P > 0.05),sug gesting that the data of the two groups were comparable.2.Improvement of insomnia: the total effective rate of the treat ment group was 97.5%,which was higher than 80% of the control group,and the difference between the two groups was statistically signific ant(P < 0.01);after 4-week treatment cycle,the PSQI scores of the two groups were decreased,and the difference between before and after the group was significant(P < 0.01),and the PSQI scores and total scores of the treatment group were lower than those of the control g roup,There was significant difference between the two groups(P < 0.05).3.Improvement of TCM syndromes: The total effective rate of TCM syndromes in the therapy group was 97.5%,while that in the control g roup was only 62.5%.There was a obvious difference in the total effe ctive rate between the two groups(P<0.01).After 4 weeks of treatmen t,the scores of various syndromes and total scores of the two groups were decreased,and the difference of the score is significant(P <0.01);and the scores of TCM syndromes and total scores of the therap y group were lower than those of the control group,with significant difference between the groups(P < 0.05).4.Anxiety and depression: 87.5% and 82.5% of the patients in the treatment group and the control group with different degrees of anxi ety at initial diagnosis were respectively;Some 82.5 percent and 85 p ercent,respectively,had some form of depression.After 4 weeks of tr eatment,the scores of anxiety and depression in both groups decrease d,and there was significant difference between the two groups before and after treatment(P < 0.01).The HAMA score and HAMD score in the treatment group were lower than those in the control group,and there was a difference between the two groups(P < 0.05).5.During the entire observation process,no major adverse events occurred in the two groups of patients.Only 3 patients experienced mild dry mouth,bitterness,nausea,and loss of appetite,which were common reactions to taking traditional Chinese medicine.Conclusion:1.The use of Bazhen Decoction combined with Ganoderma lucidum e xtract tablets can obviously reduce the PSQI scores of patients with insomnia with deficiency of both qi and blood,and improve the patien t’s subjective sleep quality.Its clinical comprehensive efficacy is better than single-agent Ganoderma lucidum extract tablets.2.The use of Bazhen decoction combined with Ganoderma lucidum e xtract tablets can obviously reduce the TCM syndrome scores of patien ts with insomnia with deficiency of both qi and blood.It can effecti vely improve the symptoms of patients with palpitations,frequent dre ams and easy awakening,fatigue,lack of breath and lazy speech.Amon g them,the curative effect of medical syndromes is better than that of single-agent Ganoderma lucidum extract tablets.3.The use of Bazhen Decoction combined with Ganoderma lucidum e xtract tablets can effectively improve the anxiety and depression of patients with qi and blood deficiency type insomnia,which may be rel ated to the improvement of the patient’s sleep quality.4.Bazhen Decoction combined with Ganoderma lucidum extract in t he treatment of insomnia with deficiency of both qi and blood is safe and effective,It convenient to take,and can be used for reference and clinical application in the industry. |
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