| Acute gastrointestinal bleeding caused by enhanced antiplatelet therapy after Percutaneous coronary intervention(PCI)is a common acute and severe clinical event with a high incidence,which seriously affects the final effect of PCI treatment and the long-term prognosis of patients.At present,in the clinical treatment of gastrointestinal bleeding after PCI,antithrombotic drugs are easy to cause stent thrombosis,the safety of conventional proton pump inhibitor(PPI)is questioned,and PPI and clopidogrel are in contradiction of competitive inhibition.This problem has been perplexing the clinic and needs to be solved urgently.Gastrointestinal bleeding after PCI belongs to the category of "blood syndrome" in Traditional Chinese medicine.Currently,there are few reports on the treatment of gastrointestinal bleeding after PCI by Traditional Chinese medicine,and it is difficult to give full play to the advantages of TCM syndrome differentiation to guide clinical practice.Therefore,starting from the above problems and on the basis of previous studies,this study adopted a prospective,multi-center,randomized controlled study method to observe the effectiveness and safety of Yiqi Zhixue granules in the treatment of gastrointestinal bleeding after PCI,which has certain practical significance.Objective:On the basis of previous research,this study aimed at PCI postoperative gastrointestinal bleeding problems existing in the contradiction between the bleeding and antithrombotic treatment,seize the PCI postoperative gastrointestinal bleeding in patients with deficiency of the basic pathogenesis of qi deficiency and blood stasis,the prospective,multicenter,randomized,controlled study method,observe the traditional Chinese medicine yiqi zhixue granules treatment efficacy and safety of the PCI postoperative gastrointestinal bleeding,This paper attempts to break through and solve this clinical problem,optimize the existing treatment plan of integrated Traditional Chinese and Western medicine,and provide more sufficient evidence-based medical evidence for the application of Traditional Chinese medicine in the field of gastrointestinal bleeding after PCI.Methods:From December 2020 to January 2022,90 patients with acute coronary syndrome who had successfully undergone gastrointestinal bleeding after PCI in Wangjing Hospital of China Academy of Chinese Medical Sciences,Beijing Chaoyang Hospital affiliated to Capital Medical University and Guang’anmen Hospital of China Academy of Chinese Medical Sciences and met the inclusion criteria were selected as the research objects.Use prospective,multicenter,randomized,controlled clinical research method,using SAS9.4 software generating random numbers table,patients were randomly divided into treatment group and control group,treatment group on the basis of foundation treatment combined with traditional Chinese medicine yiqi zhixue granules,the control group on the basis of foundation treatment combined with traditional Chinese medicine yiqi hemostatic agent particle simulation,the course of 7 days.The main efficacy indexes were hemostasis time(hours),and the secondary efficacy indexes were 72-hour rebleeding rate,7-day rebleeding rate,blood transfusion volume during treatment,the ADP MA value of thromboelastography,ADP inhibition rate and AA inhibition rate,and the changes of TCM efficacy scores of Qi deficiency syndrome and blood stasis syndrome.On this basis,the effects of Yiqi Zhixue granules on gastrointestinal bleeding after PCI and the occurrence of major adverse cardiac events were observed.Results:A total of 90 patients with gastrointestinal bleeding after PCI with acute coronary syndrome were included in this study and randomly divided into 45 patients in the treatment group and 45 patients in the control group.During the study,there were 4 cases of detachment(4 cases in the treatment group),and the reasons for detachment included disagreeing to continue(2 cases in the treatment group),loss of follow-up(1 case in the treatment group),and occurrence of adverse drug events(1 case in the treatment group).There were 4 cases of major adverse cardiac events(1 case in the treatment group and 3 cases in the control group),all of which were recurrent unstable angina pectoris.In terms of baseline comparability analysis,general baseline information,past medical history,family history and living habits,admission diagnosis,CRUSADE score,BARC score,bleeding site and gastrointestinal bleeding degree grading,and the use of antithrombotic drugs were evenly distributed between the two groups(P>0.05),showing comparability between the two groups.In terms of effectiveness analysis,hemostatic time comparison,the average hemostatic time of the treatment group was 27.81±17.68h,with a median of 24.35h,and that of the control group was 80.63±114.76h,with a median of 38.88h,with a statistically significant difference between groups(P<0.05).Comparison of 72 hour,7 day and 30 day rebleeding rates showed that the incidence of bleeding in the treatment group was basically similar to that in the control group,with 1 patient in each group having rebleeding,and there was no statistical significance between the two groups(P>0.05).Comparison of blood transfusion situation,In the treatment group,there were no blood transfusion patients on the first day of bleeding,On the second day of hemorrhage,2 patients received blood transfusion(4.44%)with an average transfusion volume of 150±70.71ml;on the third day of hemorrhage,2 patients received blood transfusion(4.55%)with an average transfusion volume of 250±212.13 mL,no patients received blood transfusion on the seventh and 30th days of hemorrhage;In the control group,there was no blood transfusion on the first day of bleeding.On the second day of bleeding,there was 1 case(2.38%)with an average blood transfusion volume of 200ml;on the third day of bleeding,there were 3 cases(6.98%)with an average blood transfusion volume of 266.67±115.47ml;on the seventh day of bleeding,there was 1 case(2.38%)with an average blood transfusion volume of 400±0.0ml.No patient was transfused on day 30 of hemorrhage.There was no significant difference between the two groups(P<0.05).The thromboelastography results showed that the inhibition rate of ADP,MA value and AA value of ADP were evenly distributed between the two groups on the first day of bleeding(P>0.05),and the groups were comparable.On the 7th day of bleeding,the MA value of ADP in the treatment group decreased,while the MA value of ADP in the control group increased,and the difference between the two groups was statistically significant(P<0.05).The inhibition rate of ADP and AA between the two groups showed no significant difference(P>0.05).The results of qi-deficiency syndrome score comparison showed that on the first day of treatment,the scores of qi-deficiency syndrome,such as shortness of breath,mental fatigue,fatigue,spontaneous sweating,lazy speech and total qI-deficiency syndrome score in the two groups were evenly distributed(P>0.05),and the groups were comparable.On the third day of treatment,the symptoms of shortness of breath,mental fatigue,fatigue,spontaneous sweating,lazy speech and the total score of Qi-deficiency syndrome in the treatment group were significantly improved(P<0.01),while the symptoms of Qi-deficiency in the control group were not significantly improved(P>0.05).In terms of comprehensive efficacy and effective rate of Qi deficiency syndrome,both the treatment group and the control group were ineffective,and there was no statistical significance between the two groups(P>0.05).On the 7th day of treatment,the symptoms of shortness of breath,mental fatigue,fatigue,spontaneous sweating,lazy speech and the total score of Qi-deficiency syndrome in the treatment group were significantly improved(P<0.01),In the control group,fatigue,spontaneous sweating,lazy speech symptoms and total scores of qi deficiency syndrome were improved(P<0.05),but no significant improvement in other symptoms(P>0.05).Comprehensive curative effect and effective rate of qi deficiency syndrome,in the treatment group,37 cases(90.24%)were effective,4 cases(9.76%)were ineffective,and there was no cured or obvious effect,the effective rate was 90.24%.In the control group,42 cases(100.00%)were invalid,and there were no cured,efficacious or effective cases,the difference between the groups was statistically significant(P<0.05).On the 30th day of follow-up,the symptoms of shortness of breath,mental fatigue,fatigue,spontaneous sweating,lazy speech and the total score of Qideficiency syndrome in the treatment group and the control group were improved(P<0.05),and the improvement degree in the treatment group was better than that in the control group,the difference was statistically significant(P<0.05).In terms of comprehensive efficacy and effective rate of qi-deficiency syndrome,in the treatment group,there were 2 cases(5.00%)with significant effect and 38 cases(95.00%)with effective rate.In the control group,2 cases(4.76%)were effective,and 40 cases(95.24%)were ineffective.(P<0.05).On the 7th day of treatment and 30th day of follow-up,the comprehensive efficacy and effective rate in the treatment group were significantly higher than those in the control group,and the difference was statistically significant(P<0.01).Comparison of the scores of blood stasis syndrome showed that on the first day of bleeding,the two groups had a balanced distribution of tingling,pain with fixed location and rejection,subcutaneous ecchymosis,bleeding,limb numbness or hemiplegia,tongue image,pulse image,and the total score of blood stasis syndrome(P>0.05),which was comparable between the groups.On the third day of treatment,the bleeding symptoms,tongue image and the total score of TCM blood stasis syndrome in the treatment group were improved(P<0.05),and the other symptoms showed a slightly improved trend,but there was no statistical significance in the improvement degree between the groups(P>0.05).The bleeding symptom and total score of blood stasis syndrome in the control group were improved(P<0.05),but the other symptoms were not significantly improved(P>0.05).The improvement degree of the treatment group was better than the control group,and the difference was statistically significant(P<0.05).In terms of comprehensive efficacy and blood stasis syndrome efficacy,both the treatment group and the control group were ineffective,and there was no statistical significance between the two groups(P>0.05).7 days of treatment,the treatment group subcutaneous ecchymosis,bleeding,or hemiplegia numbness symptoms,tongue and pulse condition,blood stasis of TCM score improved significantly(P<0.01),the control group in addition to bleeding symptoms and total score of blood stasis syndrome of traditional Chinese medicine to improve(P<0.05),the rest of the blood stasis symptom is no significant change(P>0.05),the improvement degree of the treatment group is better than that of the control group,the difference was statistically significant(P<0.05).Comprehensive curative effect and effective rate of blood stasis syndrome,in the treatment group,25 cases(60.98%)were effective,16 cases(39.02%)were ineffective,and there was no cured or obvious effect,the effective rate was 60.98%.The control group had no effect,there were statistically significant differences between the two groups(P<0.05).On the 30th day of follow-up,the other symptoms and the total scores of blood stasis syndrome in the treatment group were significantly improved except the tingling symptoms(P<0.01),while the subcutaneous ecchymosis,bleeding symptoms,tongue image and the total scores of blood stasis syndrome in the control group were improved(P<0.05),and the improvement degree in the treatment group was better than that in the control group,the difference was statistically significant(P<0.05).In terms of comprehensive efficacy and effective rate,39 cases(97.50%)were effective and 1 case(2.50%)was ineffective in the treatment group,there were no cured and obvious effect cases,the effective rate was 97.5%.In the control group,3 cases(7.14%)were effective,39 cases(92.86%)were ineffective,and there were no cured or obvious cases,the effective rate was 7.14%,the difference between the groups was statistically significant(P<0.05).On the 7th day of treatment and the 30th day of follow-up,the therapeutic effect of the treatment group was significantly better than the control group,and the difference was statistically significant(P<0.01).In terms of safety analysis,major adverse cardiac events were compared between the two groups.In this study,a total of 4 patients developed major adverse cardiac events,including 1 in the treatment group(2.22%)and 3 in the control group(6.67%).All 4 patients had recurrent unstable angina pectoris.There was no significant difference in the distribution of major adverse cardiac events between the two groups(P>0.05).Comparison of adverse drug events:a total of 7 patients in this study had adverse drug events,including 4 patients in the treatment group(8.89%)and 3 patients in the control group(6.67%).The main manifestations were nausea and vomiting,liver function and renal function examination showed no abnormality.There were no serious adverse drug events.There was no significant difference in the incidence of adverse drug events between 2 groups(P>0.05).Conclusion:Yiqi Zhixue granules can effectively treat gastrointestinal bleeding after PCI,and the hemostatic effect of combined Chinese and western medicine is better than that of western medicine alone.Yiqi Zhixue granules can significantly improve the TCM qi deficiency syndrome and blood stasis syndrome of patients.The incidence of major adverse cardiac events of Yiqi Zhixue granules was slightly lower than that of pantoprazole,with a certain downward trend,but no statistical difference,which needs to be further studied by expanding the sample size. |
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