ABSTRACT
This study aims to comprehensively summarize articles on the treatment of coronary heart disease angina pectoris with heart blood stasis syndrome(CHD-AP-HBSS) by Guanxin Shutong Capsules(GSC), and comprehensively evaluate the evidence and value of the formula in "6+1" dimensions based on multi-criteria decision analysis(MCDA) model and Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021) with quantitative and qualitative methods, which is expected to highlight the clinical characteristics and advantages of the prescription and serve as a reference for medical and health departments. The dimensions are grade A, B, C, or D. In terms of safety, according to the reports from the spontaneous reporting system of National Center for ADR Monitoring, and literature analysis, GSC mainly results in the adverse reactions of mild or moderate nausea, diarrhea, rash, palpitation, and headache, with favorable prognosis in patients. Nevertheless, severe adverse reactions have been reported after marketing. Thus, additional evidence for its safety should be accumulated, and the current safety is grade B. Meta-analysis proves that GSC in combination with conventional treatment is superior to conventional treatment alone in alleviating AP and symptoms indicated by electrocardiogram(ECG). Therefore, the effectiveness of the medicine is grade A. As for the pharmacoeconomic value, based on the assumption that the per capita disposable income in 2020 is the willingness-to-pay threshold, it is more economical for CHD-AP patients to use GSC combined with conventional treatment than conventional treatment alone. However, as the currently available clinical parameters fail to support the difference in indirect cost between the two groups, the accuracy in the cost of intervention plan needs to be further improved. Therefore, the economy of the prescription is grade B. GSC has been awarded 13 national invention patents and 1 utility model patent, and won a lot of national and provincial patent awards, marking the enterprise service awareness and innovativeness. As a result, it is grade A in aspect of innovation. A questionnaire on the suitability of GSC suggests that publicity and promotion influence patients' choice and thus additional efforts should be made in this aspect. The suitability of this formula is grade B. Both rural and urban residents can afford the medicine for the whole course and the price is close to that of similar Chinese patent medicines. In addition, it is accessible regardless of season and place, so accessibility is grade A. As a Mongolian empirical formula destined to treat heart stabbing pain, it has the effects of activating blood and resolving stasis, dredging channels and activating collaterals, and moving Qi to relieve pain, and boasts the empirical evidence of more than 2 000 human cases. With prominent characteristics of traditional Chinese medicine, it is grade B. Based on the MCDA model and CSC v2.0, GSC is comprehensively class A in the treatment of CHD-AP-HBSS. The result can serve as a reference for basic clinical medication management.
Subject(s)
Humans , Angina Pectoris/drug therapy , Capsules , Coronary Disease/drug therapy , Drugs, Chinese Herbal/adverse effectsABSTRACT
Through investigating the current research on the effect of Naoxintong Capsules in the treatment of cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris, this study conducted a clinical comprehensive evaluation in "6+1" dimensions [safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM)], so as to highlight the advantages and clinical value of Naoxintong Capsules. By combining qualitative and quantitative methods, we used the multi-criteria decision analysis(MCDA) model to measure each dimension, and the results thereby were divided into four grades of A, B, C, and D in high-to-low order. Through literature review and evaluation, the adverse effects of Naoxintong Capsules are mainly caused by the gastrointestinal system. Since the safety risk is controllable based on current research, the safety evaluation is grade B. The effectiveness of Naoxintong Capsules combined with conventional western medicine in the treatment of cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris is evaluated as grade A, as compared with conventional therapy alone. The economy of Naoxintong Capsules, compared with Tongxinluo Capsules, is assessed as grade B. According to literature reports, Naoxintong Capsules exhibits outstanding clinical innovation in optimizing the current anti-platelet therapy strategy for patients with coronary heart disease after percutaneous coronary intervention(PCI), and the innovation is class A. Given the capsule formulation is convenient for storage and transportation, and its usage is easy for patients to grasp and accept, the suitability is grade B. The accessibility is grade A considering the price level, availability, and affordability, and the characteristics of TCM are evaluated as grade A from the perspectives of theoretical characteristics and human experience. The results of the comprehensive drug evaluation showed that the clinical value of Naoxintong Capsules is class A for treating cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris. According to the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(trial 2021 version) issued by the National Health Commission, relevant policy results for basic clinical drug management can be formulated directly by procedure.
Subject(s)
Humans , Angina Pectoris , Capsules , Cerebral Infarction/drug therapy , Coronary Disease/drug therapy , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Percutaneous Coronary Intervention , QiABSTRACT
OBJECTIVE：To systematically evaluate the efficacy and safety of Kuanxiong aerosol in the treatment of coronary heart disease angina ，and to provide evidence-based reference for climical drug use . METHODS ：Retrieved from Cochrane Library，PubMed，Embase，CKNI，Wanfang data ，VIP，and CBM ，randomized controlled trials （RCTs）about Kuanxiong aerosol （trial group ）versus nitroglycerin （control group ）in the treatment of coronary heart disease angina were collected during the inception to Mar. 20th，2020. After literature screening and data extraction ，quality assessment was performed using the bias risk assessment tool recommended by the Cochrane System Evaluator Manual 5.1.0. Meta-analysis was performed by using Rev Man 5.3 statistical software. Sensitivity analysis was conducted for the stability of the result ，and trial sequential analysis （TSA）was performed by using TSA 0.9 software. RESULTS ：A total of 11 RCTs were included ，with a total of 1 847 cases. Meta-analysis showed that improvement rate of angina pectoris （within 3 min）[RR＝1.11，95％CI（1.02，1.22），P＝0.02] and total response rate of angina pectoris （within 5 min）[RR＝1.04，95％ CI（1.01，1.07），P＝0.01] in trial group were significantly higher than control group；the incidence of ADR [RR＝0.44，95％CI（0.35，0.57），P＜0.000 01] in trial group was significantly lower than control group. There was no statistical significance in total response rate of ECG [RR＝1.02，95％CI（0.97，1.09），P＝0.42] or the level of NO after treatment [SMD ＝－0.08，95％CI（－0.61，0.45），P＝0.76] between 2 groups. The results of sensitiv ity analysis and TSA showed that the efficacy evidence of Kuanxiong aerosol in the treatment of coronary heart disease pectoris was not accurate ，but the evidence of safety was accurate. CONCLUSIONS ：Kuanxiong aerosol can improve the efficacy in patients with coronary heart disease angina ，and the safety is better ，but the conclusions of efficacy needs to be further confirmed by enlarging sample size.
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Objective To observe the clinical efficacy of Jiangzhi Xiaoban Tables facilitating routine Western medicine therapy on coronary plaque and inflammatory factors in patients with coronary heart disease angina (CHDA) of blood stasis obstruction syndrome. Methods Totally 156 patients were divided into TCM group and control group with randomized parallel controlled method, with 78 cases in each group. The control group orally took aspirin enteric-coated tablets and trimetazidine hydrochloride tablets and received symptomatic treatment. On the basis of control group,TCM group received Jiangzhi Xiaoban Tablets,4 tablets per time,three times per day,for 12 weeks. Angina pectoris, TCM curative effect, electrocardiogram, TCM symptom scores, TPS, SSS, CADS and inflammatory factors before and after treatment in both groups were evaluated. Results 12 and 10 cases in TCM group and control group were lost, respectively. The total effective rate of angina pectoris was 89.39% (59/66) in the TCM group and 72.06% (49/68) in the control group. The total effective rate of TCM efficacy was 90.09% (60/66) in the TCM group and 67.65% (46/68) in the control group. TCM group better than the control group (P<0.05). Compared with before treatment, the numbers of ST segment down shift, T wave lowering and T wave inverting decreased in both groups (P<0.05). After treatment, the numbers of ST segment down shift, T wave lowering and T wave inverting in the TCM group were less than the control group (P<0.05). Compared with before treatment, SAQ scores in both groups increased, while TCM syndrome score decreased significantly. SAQ scores in the TCM group after treatment were higher than the control group, while TCM score were lower than the control group (P<0.05). Compared with before treatment, the TPS, SSS and CADS of the patients with blocking coronary lesions decreased in both groups (P<0.05). After treatment, the ratio of TPS, SSS and CADS of the patients with blocking coronary lesions in TCM group was lower than the control group (P<0.05). Compared with before treatment, the levels of hs-CRP, IL-6, TNF-α, TGF-β1 and MCP-1 decreased in both groups after treatment (P<0.05). The levels of hs-CRP, IL-6, TNF-α and TGF-β1 in the TCM group were better than the control group (P<0.05). Conclusion Jiangzhi Xiaoban Tables facilitating routine Western medicine therapy can stabilize coronary plaque of CHDA of blood stasis obstruction syndrome, which may realize cardiomyocyte protection by inhibiting inflammatory factors.
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Objective To compare the clinical effect of quick acting Kyushin pills and compound Danshen dripping pills in the treatment of coronary heart disease angina pectoris. Methods 98 patients with angina pectoris from December 2015 to April 2017 were randomly divided into group A (n=49) and group B (n=49) by random number table. A group on the basis of conventional therapy plus compound Danshen Pill, B group in the conventional treatment based on the use of available Kyushin Pills, recorded the treatment of two groups of patients with angina pectoris of coronary heart disease before and after 2 weeks of treatment, angina frequency (weekly), duration (weekly) changes. Results Two groups of patients with angina pectoris were successfully completed treatment, there was no significant difference in the frequency and duration of angina pectoris before treatment. After the two groups after 2 weeks of treatment duration, seizure frequency were significantly reduced than before (P<0.05), the above indexes in group B decreased than group A (P<0.05). Conclusion The use of conventional therapy based on the use of Kyushin Pills can significantly relieve angina pectoris in patients with coronary heart disease, and has positive significance for the protection of its efficacy and prognosis.
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Objective To compare the clinical effect of quick acting Kyushin pills and compound Danshen dripping pills in the treatment of coronary heart disease angina pectoris. Methods 98 patients with angina pectoris from December 2015 to April 2017 were randomly divided into group A (n=49) and group B (n=49) by random number table. A group on the basis of conventional therapy plus compound Danshen Pill, B group in the conventional treatment based on the use of available Kyushin Pills, recorded the treatment of two groups of patients with angina pectoris of coronary heart disease before and after 2 weeks of treatment, angina frequency (weekly), duration (weekly) changes. Results Two groups of patients with angina pectoris were successfully completed treatment, there was no significant difference in the frequency and duration of angina pectoris before treatment. After the two groups after 2 weeks of treatment duration, seizure frequency were significantly reduced than before (P<0.05), the above indexes in group B decreased than group A (P<0.05). Conclusion The use of conventional therapy based on the use of Kyushin Pills can significantly relieve angina pectoris in patients with coronary heart disease, and has positive significance for the protection of its efficacy and prognosis.
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Objective Analysis of nitroglycerin combined with predictive nursing in the clinical application of coronary heart disease patients. Methods From January 2015 to December 2016, 200 patients with coronary heart disease were treated with angina pectoris. The patients were randomly divided into observation group and control group (100 cases). The control group was treated with routine nursing mode, and the patients in the observation group were treated with predictive nursing mode. The differences of hospitalization time and quality of life scores between the two groups were observed. The anxiety and depression of the two groups were observed before and after treatment, and the satisfaction of the two groups was observed. Results The scores of hospitalization and quality of life in observation group were better than those in control group (P<0.05). There was no statistically significant difference between SAS score and SDS score before treatment, but SAS score and SDS score of observation group were significantly lower than those of control group (P<0.05). The satisfaction degree of the patients in the observation group was better than that in the control group (P<0.05). Conclusion Predictive nursing has a good effect in the clinical nursing of patients with coronary heart disease and angina pectoris. It can effectively improve the patients' anxiety and depression, shorten the hospital stay and improve the quality of life. It is worth to be used in clinical practice.