| Objective: to observe the efficacy and safety of self-made Jiawei Yixin Decoction in the treatment of cardiac neurosis with qi and yin deficiency syndrome through clinical trial research,and to obtain clinical evidence to further clarify the treatment of cardiac neurosis with Jiawei Yixin Decoction(self-made)at the same time,the etiology and pathogenesis of qi-yin deficiency type cardiac neurosis and the mechanism of action of prescriptions were studied and explored,in order to provide guidance and reference for clinical application.Methods: this study is a randomized controlled study,the patients with qi-yin deficiency type cardiac neurosis were collected from the outpatient department of geriatrics of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine from March 2021 to March 2022.Spss21.0 software generates a random number table.according to the ratio of 1:1,patients are divided into treatment group and control group on average.there were 37 cases in the treatment group and 37 cases in the control group.during the treatment period,one patient in the treatment group and one patient in the control group were lost to follow-up.among the patients finally admitted,there were 36 in the treatment group and 36 in the control group.the treatment group was given Jiawei Yixin Decoction(self-made): 1 dose per day,decocted in water,taken in the morning and evening.150 ml each time.take it continuously for two weeks.the control group was given Yixinshu capsule(manufacturer: Guizhou Xinbang Pharmaceutical,drug specification: 0.4g× 36 capsules,drug batch No: z52020038)orally,3 capsules at a time,3 times a day.take it continuously for two weeks.after 2 weeks,the outpatient follow-up was conducted to understand and record the TCM syndrome score,TCM single symptom score,HAMA score,HAMD score,before and after treatment.through the collection and sorting of clinical research data and the application of statistical methods,the curative effect was evaluated.and timely record whether there are adverse events in the research process.Result:1 TCM Syndrome Evaluation1.1 TCM syndrome efficacy and score: the results showed that in the treatment group,the clinical cure rate of TCM syndrome was 0.00%,the effective rate was 11.11%,the effective rate was 83.33% and the ineffective rate was 5.56%;in the control group,the clinical cure rate of TCM syndrome(0.00%),significant efficiency(0.00%),effective rate(38.89%)and ineffective rate(61.11%);the total effective rate of the treatment group(94.44%)was significantly higher than that of the control group(38.89%).there was significant difference between the two groups after treatment(P < 0.01),indicating that the improvement of TCM syndrome in the treatment group was significantly greater than that in the control group;after treatment,the TCM syndrome scores of the two groups were lower than those before treatment,and the difference was statistically significant(P < 0.05).the score of TCM syndrome in the treatment group was significantly improved compared with that in the control group(P < 0.01),suggesting that the treatment effect of TCM syndrome in the treatment group was more prominent than that in the control group.1.2 TCM single symptom score: in order to further compare the improvement of TCM single symptoms between the two groups,the change of TCM single symptom score scale was used to intuitively reflect the improvement.there was no significant difference in TCM single symptom scores between the treatment group and the control group before treatment(P > 0.05).After treatment,rank sum test was used to compare the two groups.except for red tongue less moss in the treatment group(P > 0.05),the difference of other indexes in the treatment group was statistically significant(P < 0.05).in other words,the treatment group has a certain effect on improving palpitation,shortness of breath,chest tightness,chest pain,dizziness,headache,insomnia,sweating,anxiety and tension,dry mouth,fatigue,thin or rapid pulse and loose stool.after treatment,compared with the control group,the control group had significant differences in palpitation,shortness of breath,chest tightness,sweating,anxiety,tension and fatigue(P <0.05).it shows that the control group has a certain effect on the improvement of the above symptoms.compared with the symptoms of chest pain,dizziness,headache,insomnia,dry mouth,red tongue less moss,thin or rapid pulse,loose stool,P > 0.05,indicating that the effect of improving the above indicators is not very obvious.after treatment,the two groups were compared by rank sum test,it was found that there was no significant difference in palpitation,chest tightness,sweating,anxiety and tension,red tongue less moss(P > 0.05).combined with the above analysis,it shows that the patients in the treatment group and the patients in the control group have obvious curative effects in improving the symptoms of palpitation,chest tightness,sweating,anxiety and tension.the improvement of red tongue less moss was not obvious in the above two groups.for the improvement of symptoms and indicators of shortness of breath,chest pain,dizziness,headache,insomnia,dry mouth,fatigue,thin or rapid pulse and loose stool,the treatment group was significantly better than the control group(P < 0.05).2 Mental state evaluation2.1 Efficacy evaluation of HAMA: the results showed that the effective rate of HAMA in the treatment group was 11.11%,the effective rate was 55.56%,the ineffective rate was 33.33%,and the deterioration rate was 0.00%;in the control group,the effective rate of HAMA was0.00%,the effective rate was 41.67%,the ineffective rate was 58.33%,and the deterioration rate was 0.00%;the total effective rate of the treatment group(67.67%)was significantly higher than that of the control group(41.67%).there was significant difference between the two groups after treatment(P < 0.05),indicating that the improvement of anxiety in the treatment group was significantly greater than that in the control group;after treatment,the anxiety scores of the two groups were lower than those before treatment,and the difference was statistically significant(P < 0.05).the anxiety score of the treatment group was significantly improved compared with that of the control group(P < 0.05),suggesting that the treatment effect of the treatment group on anxiety is more prominent than that of the control group.2.2 Efficacy evaluation of HAMD: the results showed that the effective rate of HAMD in the treatment group was 8.33%,the effective rate was 41.67%,the ineffective rate was 50.00%,and the deterioration rate was 0.00%;in the control group,HAMD had significant efficiency(0.00%),effective efficiency(22.22%),ineffective efficiency(77.78%)and deterioration rate(0.00%);the overall effective rate in the treatment group(50.00%)was significantly higher than that in the control group(22.22%).there was significant difference between the two groups after treatment(P < 0.05),indicating that the improvement of depression in the treatment group was significantly greater than that in the control group;the depression scores of the two groups after treatment were lower than those before treatment,and the difference was statistically significant(P < 0.05).the depression score of the treatment group was significantly improved compared with that of the control group(P < 0.05),suggesting that the treatment effect of the treatment group on depression was more prominent than that of the control group.3 Safety evaluation: during the study period,no adverse reactions occurred in the treatment group and the control group,indicating that both drug groups are safe in the short term.Conclusion: Jiawei Yixin Decoction(self-made)has significant clinical effect in the treatment of cardiac neurosis(qi and yin deficiency syndrome),can significantly improve the mental and psychological state of patients,and has obvious curative effect on the improvement of related TCM syndromes.compared with the Yixinshu Capsule treatment in the control group,the two groups achieved certain clinical efficacy in improving cardiac neurosis.according to the evaluation of various TCM syndromes,the Jiawei Yixin Decoction(self-made)group had better effects on shortness of breath,chest pain,dizziness,headache,insomnia,dry mouth,fatigue,thin or rapid pulse,and improvement of loose stool syndrome have more prominent curative effect.during medication,no patient experienced any adverse reactions,indicating that the patient has a good tolerance to the drug.through this study,the efficacy and safety of Jiawei Yixin Decoction(self-made)in the treatment of cardiac neurosis with qi and yin deficiency syndrome was verified,and the experience is worthy of clinical promotion and reference. |
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