| This thesis is composed of two parts.The first part is the systematic evaluation of the traditional Chinese medicine research of coronary heart disease coexisting psychological disorder.The second part is the clinical study of bupleurum plus dragon bone and oyster shell particles intervention on the coronary heart disease coexisting psychological disorder.Study 1:Objectives:To systematically evaluate randomized controlled clinical studies related literature on Traditional Chinese medicine in the treatment of coronary heart disease coexisting psychological disorder,qualitatively summarize the literature information,bias,clinical features and other information,quantify the synthetic analysis of effectiveness indicators to evaluate the effectiveness of Chinese medicine intervention on coronary heart disease coexisting psychological disorder.Methods:We developed a search strategy and then retrieved the database including CNKI,Wanfang data knowledge service platform,Vipu Chinese journal service platform,PubMed,Embase,Web of Science.The search deadline was set to December 31,2016.The screening and selection process of the target literature was strictly in accordance with the inclusion and exclusion criteria,and the process was independently performed by two researchers.After preliminary and full-text screening and other steps,the final chosen literature was systematically evaluated.Bias risk assessment was based on the Cochrane bias risk assessment tool.The target outcome indicators were merged for meta-analysis while the heterogeneity test was required before the statistics were merged.RevMan 5.3 software was used for data entry and analysis.The effectiveness was judged by the forest map,and the publication bias was judged by the funnel map.If the heterogeneity test suggested that the heterogeneity was large,sub-group analysis or sensitivity analysis was used to explore possible heterogeneity sources.Results:System evaluation results:A total of 25 randomized controlled clinical studies related literature on Traditional Chinese medicine in the treatment of coronary heart disease coexisting psychological disorder were selected and a total of 2214 subjects were included,of which 1131 in the treatment group and 1083 in the control group.25 studies referred to randomized grouping,with six studies referred to random number tables.None of the 25 studies suggested that the random allocation scheme was hidden.2 studies carried out blind measures on evaluators.25 studies did not have data loss,and the record was complete.None of the studies had a selective reporting tendency,all of which were identified as nonselective reports.4 studies referred to cases of withdrawal and drop-out.None of the studies provided the sample size estimation process,and only one study used intention-to-treat analysis,but no explanation.19 studies referred to inclusion criteria.25 studies described the baseline comparability of the two groups before the trial,24 studies described statistical methods,and 11 studies referred to informed consent or ethical approval.Meta analysis results:1.The effectiveness of anti-angina pectoris19 studies mentioned effectiveness of anti-angina pectoris,involving a total of 1659 subjects,of which 854 subjects were in the treatment group and 805 subjects in the control group.767 subjects in the treatment group and 577 subjects in the control group were shown to be effective.The heterogeneity test showed P = 0.02,I2=43%.The combined effect test showed Z = 9.12(p<0.00001),and the combined effect value showed RR = 1.25,95%Cl[1.19,1.31].4 of the studies involved bupleurum decoction plus dragon bone and oyster shell,heterogeneity test showed I2=24%,the combined effect showed RR = 1.29,95%CI[1.13,1.47].2 ECG improvement effectiveness11 studies mentioned the ECG improvement effectiveness,involving a total of 1018 subjects,of which 533 subjects were in the treatment group and 485 subjects in the control group.398 subjects in the treatment group and 274 subjects in the control group were shown to be effective.The heterogeneity test showed P = 0.49>0.1,I2 = 43%.The combined effect test showed Z = 6.21(p<0.00001),and the combined effect value showed RR=1.33,95%CI[1.22,1.46].3.Anxiety and depression improvement effectiveness12 studies mentioned the anxiety and depression improvement effectiveness,involving a total of 1020 subjects,of which 511 subjects were in the treatment group and 509 subjects in the control group.464 subjects in the treatment group and 338 subjects in the control group were shown to be effective.The heterogeneity test showed P<0.00001;I2 = 87%,which showed that heterogeneity was too large to accept,so subgroup analysis was introduced to explore heterogeneity sources:? control group medication included only conventional anti-angina drugs(group A),? control group medication included conventional anti-angina drugs and anti-anxiety and depression drugs.(group B)?control group medication included conventional anti-angina drugs and psychological intervention or other treatment measures(group C).Subgroup analysis showed I2 values were 15%,30%,42%respectively.Different medical measures in the control group may be the source of the overall heterogeneity.The combined effect of group A showed RR = 1.89,95%CI[1.62,2.22],while the group B showed RR= 1.09,95%CI[1.03,1.16],and group C showed RR = 1.42,95%CI[1.23-1.65].4.Improvement effectiveness of TCM syndromes8 studies mentioned the improvement effectiveness of TCM syndromes.involving a total of 634 subjects,of which 317 subjects were in the treatment group and 317 subjects in the control group.282 subjects in the treatment group and 212 subjects in the control group were shown to be effective.The heterogeneity test showed I2 = 54%>50%.When we applied the sensitivity analysis method to remove a specific article,the heterogeneity test of remaining literature showed I2 = 0,the combined effect test showed Z=5.63(p<0.00001)The pooling effect showed RR = 1.27,95%CI[1.17,1.37].Conclusions:The methodology quality of the literature included in this study needs to be further improved.Most of them have a certain degree of bias risk.Meta analysis showed that the treatment group was superior to the control group in improving the curative effect of anti-angina pectoris,ECG improvement and TCM syndromes.The meta-analysis of the effective rate of anti-angina pectoris with four studies related bupleurum decoction plus dragon bone and oyster shell showed that the Chinese medicine group was superior to the control group.The meta-analysis of anxiety and depression effectiveness showed that the heterogeneity of each study was large.Subgroups were divided according to the different interventions in each control group,and the meta-analysis of each subgroups showed that the effectiveness of anxiety and depression was better than that of the control group.Study 2:Objectives:To evaluate the effectiveness and safety of bupleurum plus dragon bone and oyster shell particles on the treatment of coronary heart disease with anxiety and explore its possible treatment mechanism on coronary heart disease with anxiety.Methods:This research relies on the Beijing Science and Technology Commission project,and simple randomized,double-blind,placebo-controlled parallel design was applied.After 2 weeks of placebo induction,64 subjects were randomized to two groups,and the distribution sequence was hidden.One group was given bupleurum plus dragon bone and oyster shell particles,1 bags/times,twice daily for oral administration.Another group was given same dose placebo,1 bags/times,twice daily for oral administration.Both groups received conventional anti-angina drugs.The treatment period was 6 weeks.The follow-up period was 4 weeks.During the follow-up period,both groups received only conventional anti-angina treatment.SPSS22.0 software was used for statistical analysis in this research.Allocation concealment and blindness were applied.The main evaluation indicators included angina pectoris frequency and duration,incidence of cardiovascular events in follow-up period,ECG NST and ?ST value,HAMA score,SAQ score,SCL-90 score,PSQI score,TCM syndrome score and single symptom score and safety indicators.The secondary evaluation indexes were peripheral blood Hs-CRP,IL-6,(3-TG,heart rate variability index SDNN,SDANN,SDNNidx,intestinal microbiological indicators:E.coli,Bifidobacterium and lactobacillus count.Results:1.Angina related indicators:After 6 weeks of treatment,compared with the control group,the frequency,duration of angina pectoris,NST,?ST values in treatment group decreased,the difference was statistically significant(P<0.05),while there was no significant difference between the two groups in incidence of cardiovascular events in follow-up period(P>0.05),2.Anxiety related indicators:After 6 weeks of treatment,compared with the control group,HAMA score decreased in treatment group,the difference was statistically significant(P<0.05).3.Quality of life related indicators:After 6 weeks of treatment,compared with the control group,SAQ scores increased in all five dimensions in treatment group,the difference was statistically significant(P<0.05).SCL-90 symptoms scores and somatization,compulsive,depression,anxiety,terror scores decreased in treatment group,the difference was statistically significant(P<0.05).Additionally,PSQI scores also decreased in treatment group,the difference was statistically significant(P<0.05).4.TCM syndrome related indicators:After 6 weeks of treatment,compared with the control group,the TCM syndrome scores decreased in treatment group,the difference was statistically significant(P<0.05).Single symptom scores of chest pain,chest tightness,irritability and impatience,fullness in chest and hypochondrium,oropharyngeal dryness and constipation all decreased,the difference was statistically significant(P<0.05).5.Inflammation related indicators:After 6 weeks of treatment,compared with the control group,hs-CRP,IL-6 levels decreased in treatment group,the difference was statistically significant(P<0.05).6.Platelet activation indexes:After 6 weeks of treatment,compared with the control group,?-TG levels decreased in treatment group,the difference was statistically significant(P<0.05).7.Heart rate variability indexes:After 6 weeks of treatment,compared with the control group,SDNN,SDANN,SDNNidx levels in treatment group increased,the difference was statistically significant(P<0.05).8.Intestinal microbiological indicators:After 6 weeks of treatment,compared with the control group,Lactobacillus,Bifidobacterium levels increased while the number of E.coli decreased in treatment group,the difference was statistically significant(P<0.05).9.Safety indicators:6 weeks during the treatment,no adverse events were observed in both groups.The treatment group showed 3 cases of diarrhea and 2 cases of nausea,the control group appeared 1 case of diarrhea,2 cases of palpitations.There was no statistically significant difference between the two groups(P>0.05).Conclusions:The treatment group was superior to the control group in decreasing the frequency and duration of angina pectoris,NST and ?ST values,improving quality of life and lowering TCM syndrome scores.There was no significant difference between the two groups in the safety indexes,suggesting that the treatment group was relatively safe.Compared with the control group,inflammatory factors,platelet activating factor,E.coli count decreased while heart rate variability indexes,Lactobacillus,Bifidobacteria increased in treatment group,suggesting that traditional Chinese medicine may affect the prognosis of coronary heart disease with anxiety by affecting the inflammatory mechanism,platelet activation mechanism,heart rate variability and intestinal microbes. |
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