ABSTRACT
To systemically evaluate the effect of Qishen Yiqi Dripping Pills combined with Western medicine on adverse cardiovascular events and quality of life after percutaneous coronary intervention(PCI). A total of 7 Chinese and English databases including CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were searched by computer to collect the randomized controlled trials(RCTs) on Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients with coronary heart disease after PCI with the retrieval time from the database establishment to April 1, 2020. Two researchers independently conducted li-terature screening, data extraction and bias risk assessment. Then, Meta-analysis was performed by using RevMan 5.3 software. A total of 31 RCTs were included, involving 3 537 patients. The results of Meta-analysis showed that in terms of major adverse cardiovascular events(MACE) after PCI, the combination of Qishen Yiqi Dripping Pills could significantly reduce the recurrence of angina pectoris, incidence of arrhythmia, heart failure and re-revascularization, and the effect was better than that of Western medicine treatment alone. However, there was no significant difference between the two groups in the improvement of non-fatal myocardial infarction, cardiac death, stent restenosis, stroke and other adverse cardiovascular events. In terms of improving left ventricular ejection fraction(LVEF), 6 min walking test(6 MWT), high-sensitivity C-reactive protein(hs-CRP) and Seattle angina pectoris scale(SAQ), the combination of Qishen Yiqi Dripping Pills and Western medicine treatment had obvious advantages over Western medicine treatment alone in increasing LVEF, 6 MWT and SAQ, and reducing the level of hs-CRP, with statistically significant differences. There were few adverse reactions in both groups, and there was no significant difference between the two groups. The main manifestations were gastrointestinal reactions, rash, gingiva and other small bleeding, and no serious adverse reactions occurred. The above reactions could disappear after drug withdrawal or symptomatic treatment. The application of Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients after PCI could reduce the occurrence of MACE, improve the clinical efficacy, quality of life and prognosis in a safe and reliable manner. However, due to the quantity and quality limitations of included studies, more standardized, rigo-rous and high-quality clinical studies are still needed to further verify the above conclusions.
Subject(s)
Humans , Drugs, Chinese Herbal/adverse effects , Medicine , Percutaneous Coronary Intervention/adverse effects , Quality of Life , Stroke Volume , Ventricular Function, LeftABSTRACT
Objective: To discuss the myocardial protection effect of Qishen Yiqi dropping pills on patients with Qi deficiency and blood stasis syndrome after PCI and the control effect and mechanism on cardiac adverse events. Method: One hundred and twenty-five patients were randomly divided into control group (61 cases) and observation group (64 cases) by random number table after PCI. Patients in control group got Tigrillo tablets, 90 mg/time, 2 times/days, aspirin enteric-coated tablets, 100 mg/time, 1 time/day, and bisoprolol fumarate tablets, 5 mg/time, 1 time/day. In addition to the therapy of control group, patients in observation group were also given Qishen Yiqi dropping pills, 0.5 g/time, 3 times/days, 3 days before operation. A course of treatment was 6 months, and follow-up were carried out for 6 months. Before treatment, and at the 24th, 72th hour after treatment, cardiac troponin I (cTnI) and creatine kinase isoenzyme (CK-MB) were detected. During the first week after operation, and at the 6th month after operation, left ventricular ejection fraction (LVEF), settling velocity (SV), wall motion score index (WMSI), percentage of normal myocardium and myocardial perfusion score index (PS) were recorded. After 12 months of the operation, recurrence of angina pectoris, severe arrhythmia, heart failure, revascularization, non-fatal myocardial infarction, cardiogenic death and in-stent restenosis (ISR) were all recorded. During the first week after the operation, and at the 6th month after operation, six-minute walking test (6 MWT), Seattle angina scale (SAQ) and Qi deficiency and blood stasis syndrome were all scored. Before the operation, and at 48 hours and 6 months after operation, levels of tumor necrosis factor (TNF-α), interleukin-6 (IL-6), plasma soluble intercellular adhesion molecule-1 (sICAM-1), high-sensitivity C-reactive protein (hs-CRP), superoxide dismutase (SOD), malondialdehyde (MDA) and endothelin-1 (ET-1) were all detected. Result: At the 24th, 72th hour after treatment, levels of cTnI and CK-MB in control group were lower than those in observation group (Pth hour after operation and the 6th month after operation, levels of TNF-α, IL-6, s ICAM-1 hs-CRP, MDA and ET-1 were lower than those in control group (PPth months after operation, LVEF, SV and percentage of normal myocardium were higher than those in control group (PPPPth month after operation, score of six-minute walking test was higher than that in control group (PPPConclusion: Qishen Yiqi dropping pills has anti-inflammatory and antioxidant effects, and can ameliorate intradermal function, prevent and treat myocardial injury, reduce rate of MACE, relieve symptoms, and improve activity ability and quality of life of patients.
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Objective: To evaluate the efficacy and safety of Qishen Yiqi dropping pills in the treatment of chronic heart failure. Method: Eight databases were searched at home and abroad, and the randomized controlled trials of Qishen Yiqi dropping pills in the treatment of chronic heart failure were screened. Literature quality of the included studies was evaluated by the bias risk assessment tool of Cochrane collaboration network, and the Meta-analysis was performed by RevMan 5.3 software. Result: A total of 606 related literature were retrieved, and 11 studies were eventually included, involving 931 patients. The quality of the included literature was generally low. Meta-analysis results showed that efficacy of Qishen Yiqi dropping pills combined with conventional western medicine was better than conventional western medicine alone in improving B-type natriuretic peptide[weighted mean difference (WMD)=-29.47, 95% confidence interval (CI) (-37.29,-21.64), PPPP=0.005], 6-minute walk test[WMD=50.13, 95%CI (22.32, 77.93), P=0.000 4]. In terms of safety indicators, one study intended to observe safety indicators, but it was not reported in the actual literature, and the remaining studies did not find adverse reactions of Qishen Yiqi dropping pills combined with conventional western medicine. Conclusion: The results of this study support the clinical use of Qishen Yiqi dropping pills combined with conventional western medicine in the treatment of chronic heart failure, but in view of the limitations in the quantity and quality of clinical studies, the positive results are only used as a reminder and reference for clinical diagnosis and treatment. In the future, more high-quality researches are needed to further confirm its efficacy.
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Objective To recognize the chemical profile of Qishen Yiqi Dropping Pills (QYDP) comprehensively, systematically and rapidly; ultra high performance liquid chromatography-quadrupole/orbitrap high resolution mass spectrometry (UHPLC-Q-Orbitrap HRMS) was employed to identify the main chemical composition of this preparation. Methods A gradient elution for separation was achieved through ACQUITY UPLC® BEH C18 column (100 mm × 2.1 mm, 1.7 μm) with acetonitrile-water (containing 0.1% formic acid) as the mobile phase. Then, the novel Q-Orbitrap MS technology was employed to detect the information of accurate mass and multistage fragment ions. Chemical constituents were characterized by comparing their relative retention time and mass data with that of the reference substance, meanwhile the reference literature, Mass Bank database, and Chemical Book network database were also consulted. Results A total of 53 ingredients were finally identified in this study, including 14 organic acids, 10 flavones, 10 authraquinones, 2 saponins, 7 amino acids, and 10 others. Conclusion An efficient method was established in this work to identify the main chemical ingredients of QYDP rapidly and accurately; Meanwhile, this research will lay a scientific foundation for the further research on pharmacodynamic material basis, quality control, and clinical application of this medicine.
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AIM To establish a UPLC-MS/MS combined with pattern recognition method for the simultaneous content determination of danshensu,protocatechuic acid,protocatechuic aldehyde,caffeic acid,rosmarinic,salvianolic acid B,salvianolic acid A,tanshinone Ⅰ,cryptotanshinone,tanshinone ⅡA and ursolic acid in Qishen Yiqi Dropping Pills (Astragali Radix,Salviae miltiorrhizae Radix et Rhizoma,Notoginseng Radix et Rhizoma,etc.).METHODS The analysis of 50％ methanol extract of this drug was performed on a 40 ℃ thermostatic ACQUITY UPLC(R) BEH C1s column (2.1 mm ×50 mm,1.8 μm),with the mobile phase comprising of acetonitrile-0.1％ formic acid flowing at 0.2 mL/min in a gradient elution manner.Then SIMCA14.0 software was adopted in the pattern recognition.RESULTS Eleven constituents showed good linear relationships within their own ranges (r ≥ 0.999 6),whose average recoveries were 98.45％-101.38％ with the RSDs of 1.70％-2.40％.The quality deviations of ten batches of samples were all within 2 std (standard deviation).CON CLUSION This simple,sensitive and accurate method can be used for the quality control of Qishen Yiqi Dropping Pills.
ABSTRACT
AIM To establish a UPLC-MS/MS combined with pattern recognition method for the simultaneous content determination of danshensu,protocatechuic acid,protocatechuic aldehyde,caffeic acid,rosmarinic,salvianolic acid B,salvianolic acid A,tanshinone Ⅰ,cryptotanshinone,tanshinone ⅡA and ursolic acid in Qishen Yiqi Dropping Pills (Astragali Radix,Salviae miltiorrhizae Radix et Rhizoma,Notoginseng Radix et Rhizoma,etc.).METHODS The analysis of 50％ methanol extract of this drug was performed on a 40 ℃ thermostatic ACQUITY UPLC(R) BEH C1s column (2.1 mm ×50 mm,1.8 μm),with the mobile phase comprising of acetonitrile-0.1％ formic acid flowing at 0.2 mL/min in a gradient elution manner.Then SIMCA14.0 software was adopted in the pattern recognition.RESULTS Eleven constituents showed good linear relationships within their own ranges (r ≥ 0.999 6),whose average recoveries were 98.45％-101.38％ with the RSDs of 1.70％-2.40％.The quality deviations of ten batches of samples were all within 2 std (standard deviation).CON CLUSION This simple,sensitive and accurate method can be used for the quality control of Qishen Yiqi Dropping Pills.