| Research BackgroundIn recent years,the prevalence and mortality of cardiovascular diseases in China are still at a high level,among which,coronary atherosclerotic heart disease(CHD)has the highest mortality rate.Percutaneous coronary intervention(PCI)is an important method to treat CHD,which can rapidly open the occluded vessels and restore the blood supply to the heart.However,20-40%of post-PCI patients can still have angina pectoris on top of conventional post-operative Western medical treatment,which seriously affects the quality of survival and long-term prognosis of patients.Studies have shown that the inflammatory response after PCI is closely related to in-stent restenosis,thrombosis,microcirculatory impairment,and progression of non-target lesions,and studies of anti-inflammatory thrombosis with canakinumab have shown that targeting inflammation independently of lipid levels is an effective strategy to reduce recurrent cardiovascular events and has important prognostic value.Therefore,interfering with the release of inflammatory factors and blocking the subsequent inflammatory cascade is one of the main measures to reduce the recurrence of angina pectoris after PCI.In this study,we conducted a meta-analysis of Randomized Controlled Trials(RCTs)of TCM interventions on inflammatory factors after PCI,and based on this,we conducted a prospective,randomized,double-blind,placebo-controlled clinical trial to evaluate the clinical efficacy of Yiqi Liangxue Shengji formula granules on recurrent angina pectoris in patients after PCI,and to explore its effect on inflammatory factors IL-6 and TNF-α after PCI.Objectives1.To perform a meta-analysis of RCTs of inflammatory factors in patients after PCI with Chinese medicine intervention in order to systematically evaluate the effect of Chinese medicine treatment on inflammatory factors in patients after PCI.2.To observe the effect of Yiqi Liangxue Shengji formula granules on the recurrence rate of angina pectoris in patients after PCI within 2 months.To explore the effect of Yiqi Liangxue Shengji formula granules on inflammatory factors IL-6 and TNF-α in post-PCI patientsResearch methods1.Meta-analysis:RCTs on the effect of Chinese medicine on inflammatory factors in patients after PCI were searched by computer in PubMed,Cochrane Library,Embase,Web of Science,Clinical Trials,CNKI,Wanfang database,VIP,CBM,ChiCTR,and other databases from the time of library construction to September 2022.The quality evaluation tool used for the study was the Cochrane Risk of the bias assessment tool and the Meta-analysis software used for the study was Revman 5.4.publication bias was detected using Stata MP 17 software with Begg’s rank correlation test,and Egger’s linear regression method.2.Clinical study on the intervention of Yiqi Liangxue Shengji formula granules for recurrent angina pectoris in patients after PCI(1)82 patients with coronary heart disease with evidence of Qi deficiency,blood stasis,and stasis-heat interconnection who attended the Eastern Hospital of Beijing University of Traditional Chinese Medicine from April 2021 to October 2022 for parallel PCI were included,and after the patients signed the informed consent form,the patients were randomly divided into 2 groups according to the randomized number table using the district group randomization method.The experimental group was treated with Yiqi Liangxue Shengji formula granules particles based on conventional treatment after PCI,and the control group was treated with placebo particles based on conventional treatment after PCI for 8 weeks,and the efficacy was evaluated after the treatment.(2)The primary efficacy index was the recurrence rate of angina within 2 months after PCI,and the occurrence of readmission due to angina after PCI was recorded;the secondary efficacy index was the Chinese medicine evidence score within 24 hours after PCI(before the Chinese medicine intervention)and 2 months after PCI,the Seattle angina questionnaire(SAQ),the SF-36 quality of life scale score,the SF-36 quality of life scale score,and the SF-36 quality of life scale score,The SF-36 Quality of Life Scale scores,IL-6 and TNF-αlevels were measured in blood collected from patients within 24 hours(before Chinese medicine)and at the 4th week after the procedure.(3)All data were processed using SPSS27.0 statistical software.The measurement data were first tested by normality test,and if they obeyed normal distribution,the data were expressed by mean ± standard deviation,and the measurement data that did not obey normal distribution were expressed by nonparametric rank sum test and expressed by quartiles,and the count data were expressed by chi-square test.P<0.05 indicated that the differences were statistically significant.Results1.Meta-analysis results:A total of 1005 papers were searched,and after initial screening and rigorous selection,22 papers were finally included,with a total of 2257 subjects.n=1518,SMD=-0.83,95%CI(-0.94,-0.73),P=0.01,I2=52%],interleukin-6(IL-6)levels[n=1106,SMD=-1.60,95%CI(-2.14,-1.06),P<0.00001,I2=93%],tumor necrosis factor(TNF-α)levels[n=944,SMD=-1.47,95%CI(-1.99,-0.96),P<0.00001,I2=92%],Matrix metalloproteinase-9(MMP-9)levels[n=220,SMD=-0.76,95%CI(-1.45,-0.08),P=0.03,I2=83%,Soluble CD40 ligand(sCD40L)levels[n=151,MD=-1.02,95%CI(-1.36,-0.68),P=0.56,I2=0%],soluble interleukin-2 receptor(sIL-2R)levels[n=592,SMD=-0.52,95%CI(-0.69,-0.36),P=0.48,12=0%],elevated T-lymphocyte(CD3+)levels[n=592,SMD=-0.52 n=592,SMD=-0.52,95%CI(-0.69,-0.36),P<0.00001,I2=0%],decreased endothelin-1 levels[n=528,MD=-1.36,95%CI(-2.06,-0.66),P<0.00001,I2=92%],increased nitric oxide levels[n=468,MD=1.43,95%CI(1.23,1.64),P=0.47,I2=0%],and reduced post-PCI adverse cardiovascular events(major adverse cardiovascular events,MACE)[n=1221,RR=0.34,95%CI(0.25,0.46),P=0.75,I2=0%].2.Clinical study results:(1)General data:A total of 82 patients were included in the study.Statistical results showed that there was no statistical difference between the two groups in terms of age,gender,BMI,disease type,cardiovascular risk factors,history of infarction,history of PCI,number of lesion branches,Gensini score,stent and drug balloon use,and postoperative routine medication use at baseline(P>0.05),which were comparable.(2)In terms of postoperative recurrent angina and readmission:within 2 months after surgery,the recurrence rate of angina in the treatment group was lower than that in the control group,and the difference was statistically significant(P<0.05);2 months after surgery,the readmission rate in the treatment group was lower than that in the control group,and the difference between the two groups was not statistically significant(P>0.05).(3)Chinese medicine evidence score:the Chinese medicine evidence score after PCI(before the Chinese medicine intervention)was not statistically different between the two groups(P>0.05)and was comparable.After the intervention,the TCM symptoms scores of both groups were lower than before(P<0.05),and the improvement in the treatment group was better than that in the control group(P<0.05).(4)SAQ score:There was no statistical difference in SAQ score between the two groups after PCI(before Chinese medicine treatment)(P>0.05),which was comparable.The SAQ scores of both groups after the intervention were significantly lower(P<0.05)than those before the treatment in terms of angina stable state,angina attack and disease awareness,while there was no statistical significance(P>0.05)in terms of treatment satisfaction(TS)and somatic limitation(PL),and the improvement in the treatment group was not statistically significant compared with the control group(P>0.05).(5)SF-36 quality of life scale:There was no statistical difference in the SF-36 quality of life scale scores between the two groups of patients after PCI(before the Chinese medicine intervention),and the equilibrium was comparable.The total scores of physical health assessment(PCS),mental health assessment(MCS)and SF-36 scale improved in both groups after the intervention compared with before(P<0.05),and the improvement in the treatment group was not statistically significant compared with the control group(P>0.05).(6)Levels of inflammatory factors IL-6 and TNF-α:The levels of IL-6 and TNF-α in the two groups were not statistically different after PCI(before the Chinese medicine intervention)and were comparable.After the intervention,IL-6 levels improved in both groups compared with before(P<0.05),and the improvement in the treatment group was not statistically significant compared with the control group(P>0.05).TNF-α levels in both groups did not improve significantly after the intervention(P>0.05).ConclusionMeta-analysis conclusion:This study suggests that combining Chinese herbal medicine with conventional treatment after PCI can reduce the levels of postoperative inflammatory factors hs-CRP.IL-6.TNF-α,MMP-9,sCD40L.SIL-2R and increase the levels of activated T lymphocytes(CD3+);it can decrease the levels of ET-1 and increase the levels of NO,which have a regulatory effect on vascular endothelium;Chinese herbal medicine treatment can reduce the incidence of recurrent angina,recurrent myocardial infarction,readmission and heart failure and arrhythmia after PCI,and Chinese medicine is well tolerated in patients with CHD.2.Clinical study conclusion:Combining the treatment with the Yiqi Liangxue Shengji formula granules on top of the conventional treatment after PCI can reduce the recurrence rate of angina within 2 months after PCI;improve patients’ postoperative Qi deficiency,blood stasis,and stasis-heat interconnection symptoms;and have a tendency to decrease the improvement of patient’s quality of life and inflammatory factors in the short term,but it is not statistically significant compared with placebo. |
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