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OBJECT IVE To evaluate the efficacy ，safety and cost-effectiveness of Qili qiangxin capsule in the treatment of chronic heart failure ，and provide reference for drug selection and evaluation in relevant institutions. METHODS Meta-analysis was performed to investigate clinical efficacy and safety of Qili qiangxin capsule combined with routine treatment （combined treatment group）versus routine treatment （routine treatment group ）in the treatment of chronic heart failure. From the perspective of Chinese health care system ，a decision tree model was constructed. The time horizon of the model was 1 year. The effective rate obtained by meta-analysis was taken as the effect parameter ，and the total cost was calculated by drug cost and hospitalization cost ，to evaluate the cost-effectiveness of combined treatment versus routine treatment in the treatment of chronic heart failure. Subgroup analysis was carried out according to the course of treatment and literature quality ，and one-way sensitivity analysis and probability sensitivity analysis were adopted to check the robustness of basic analysis results. RESULTS Total of 72 literatures involving 9 575 patients were included in meta-analysis. Results of meta-analysis showed that effective rate ，left ventricular ejection fraction ， N-terminal fragment of the prohomone brain-type natriuretic peptide and 6 minute walking distance in combined treatment group were all better than those of routine treatment group ， while its safety was similar to routine therapy. The results of cost-effectiveness analysis showed that the cost of combined therapy was 1 867 yuan higher than that of routine therapy ，patients could get 0.016 QALYs more ，and the incremental cost-effectiveness ratio （ICER）was 117 861 yuan/QALY. If only high-quality literature were included for meta-analysis and the effectiveness parameters were obtained ，the ICERs of the combined therapy versus routine therapy were 102 162 yuan/QALY（based on all high-quality literature ）and 72 354 yuan/QALY（based on high-quality literature with treatment course of 24 weeks）. The results of the probability sensitivity analysis showed that taking twice China ’s per capita gross domestic product in 2020 as the willingness to pay threshold ，the probability of cost-effectiveness for Qili qiangxin capsule combined with routine therapy was 67.1％ . CONCLUSIONS Compared with routine therapy ，Qili qiangxin capsule combined with routine therapy has better clinical efficacy ，equivalent safety and cost-effective.
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Objective: A high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method was developed to study the pharmacokinetic behaviors of astragaloside, calycosin-7-glucoside, and formononetin in rat plasma after oral administration of Qili Qiangxin Capsule. Methods: SD rats were given 1.3 g/kg Qili Qiangxin Capsule suspension by gavage. Blood samples were collected from inner canthus at different time points. The concentration of the components was determined by HPLC-MS/MS. The chromatographic column was Agilent Zobrax XDB-C18 (50 mm × 4.6 mm, 3.5 μm); The mobile phase was 0.1% formic acid-water (A) and methanol solution containing 0.1% formic acid (B), gradient elution; And the scanning mode was multi-reflection monitoring (MRM) with positive ion mode. The pharmacokinetic parameters were calculated by DAS 3.0 software fitting. Results: The pharmacokinetic parameters tmax of astragaloside, calycosin-7-glucoside and formononetin in rat plasma were (0.67 ± 0.00), (0.67 ± 0.06), and (0.17 ± 0.00) h, Cmax were (120.46 ± 45.03), (31.49 ± 12.00), and (5.17 ± 1.13) ng/mL, AUC0—t were (320.92 ± 79.10), (103.26 ± 47.63), and (14.70 ± 5.48) h•ng/mL, t1/2 were (5.74 ± 0.78), (6.05 ± 3.34), and (5.07 ± 2.13) h, respectively. Conclusion: The method is proved to be specific and repeatable, which is suitable for determination of astragaloside, calycosin-7-glucoside, and formononetin in rat plasma for pharmacokinetic study.
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OBJECTIVE： To establish a method for the content determination of sinapine thiocyanate， quercetin and kaempferol in rat plasma， and to study pharmacokinetics of Qili qiangxin capsule in rats in vivo. METHODS： HPLC-MS/MS method was adopted. The determination was performed on ZOBRAX XDB-C18 column with mobile phase consisted of 0.1％ formic acid solution and acetonitrile containing 0.1％ formic acid （gradient elution） at the flow rate of 0.45 mL/min. The sample size was 10 μL. Quantitative ions were sinapine thiocyanate with m/z 310.2→251.2， quercetin with m/z 301.1→150.7， kaempferol with m/z 286.2→242.0， internal standard chloramphenicol with m/z 320.9→ 151.9. 0.083， 0.167， 0.333， 0.667， 1， 1.5， 2， 3， 4， 6， 8， 12， 24 h after intragastric administration of Qili qiangxin capsule 1.3 g/kg， blood samples were collected via intraocular canthal venous plexus of 6 rats. The blood concentrations of sinapine thiocyanate， quercetin and kaempferol were determined. The pharmacokinetic parameters were calculated and fitted by using DAS 3.0 software. RESULTS： The linear range of sinapine thiocyanate， quercetin and kaempferol 0.05-100， 0.1-200， 0.1-200 ng/mL（r＝0.999 4， 0.999 7， 0.999 9）； RSDs of precision test and matrix effect were all less than or equal to 11.55％ （n＝6）， RE of stability test is less than or equal to 14.69％ （n＝3）. The pharmacokinetic parameter of sinapine thiocyanate， quercetin and kaempferol included that cmax were（1.35±0.62），（3.23±1.26），（5.27±1.66） ng/mL； tmax were （1.50±0.00）， （0.67±0.00）， （0.67±0.00） h； t1/2 were （3.98±0.99），（3.33±0.41），（4.54±0.85） h； CL were （3 683.82±987.96）， （2 852.33±695.88），（1 611.85±129.59） mL/（h·kg）； AUC0-24 h were （3.98±1.21）， （10.96±3.42）， （13.59±5.35） h·ng/mL. CONCLUSIONS： Established method is highly sensitive， specific and reproducible， and suitable for the pharmacokinetic study of sinapine thiocyanate， quercetin and kaempferol in rat.
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Objective To investigate the effects of Qili-Qiangxin capsule on cardiac and pulmonary functions in heart failure patients with chronic pulmonary heart disease. Methods A total of 64 heart failure patients with chronic pulmonary heart disease were divided into two groups with the method of random sampling: a treatment group (33 patients) and a control group (31 patients). The patients in the control group received conventional treatment, those in the control group received Qili-Qiangxin capsule on this basis the treatment group for 7 days. The changes of the cardiac and pulmonary functions, and plasma N-terminal pro B-type natriuretic peptide (NT-proBNP) were compared between two groups. Results The total effective rate in the treatment group was significantly higher than that of the control group (90.90% vs. 77.42%; χ2=3.908, P<0.05). There were significant difference between two groups in left ventricular ejection fraction (50.73% ± 7.23%vs. 45.22%± 6.36%;t=3.229, P=0.002), stroke volume (63.64 ± 8.38 ml vs. 56.73 ± 8.15 ml;t=3.341, P=0.001), right ventricular end-diastolic diameter (48.39 ±5.56 mm vs. 52.61 ± 6.95 mm; t=2.690, P=0.009), mean pulmonary arterial pressure (21.73 ± 5.78 mmHg vs. 27.26 ± 6.16 mmHg; t=3.705, P=0.001), plasma NT-proBNP level (535.73 ± 175.78 pg/ml vs. 831.26 ± 228.26 pg/ml; t=5.824, P=0.000), forced expiratory volume in first second (60.32% ± 5.56% vs. 48.61% ± 4.67%; t=9.093, P=0.000), percentage of forced expiratory volume in first second to forced vital capacity (66.73%± 5.78%vs. 58.26%± 5.34%;t=6.078, P=0.000), arterial oxygen saturation (96.73%± 5.78%vs. 93.26%± 5.26%;t=2.507, P=0.015), arterial partial pressure of oxygen (82.73 ± 16.78 mmHg vs. 67.26 ± 13.26 mmHg;t=4.075, P=0.000) arterial partial pressure of carbon dioxide (46.73 ± 8.78 mmHg vs. 54.26 ± 9.26 mmHg; t=3.339, P=0.00). Conclusion Qili-Qiangxin capsule can improve cardiac and pulmonary functions in heart failure patients with chronic pulmonary heart disease.
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Objective To observe the therapeutic effect of Qili Qiangxin capsule combined with glucocorticoid for treatment of patients with dilated cardiomyopathy accompanied by refractory heart failure. Methods A prospective study was conducted. Forty-eight patients with dilated cardiomyopathy and refractory heart failure in Hebei Cangzhou Central Hospital were enrolled,and they were randomly divided into three groups:control group,treatmentⅠand treatmentⅡgroups(each,16 cases). All groups were treated with conventional anti-heart failure western treatment, meanwhile additionally prednisone was given to treatment groupⅠand groupⅡ,firstly 40 mg/d,then the dosage of 5 mg was decreased in every 5 days until reaching 5 mg per day;in treatment groupⅡ,besides the same treatment of group I,the traditional Chinese medicine therapy Qili Qiangxin capsule 4 granules(one capsule 0.3 g)each time and 3 times a day was added,2 months being the therapeutic course in all the patients. The clinical efficacy and cardiac functional indexes,such as the left ventricular end-diastolic volume(LVEDV),the left ventricular end-systolic volume(LVESV),the left ventricular ejection fraction(LVEF)and the plasma B type brain natriuretic peptide (BNP),etc. were observed in 1 week and 2 months after treatment. Meanwhile the electrocardiogram(ECG),aspartate transaminase(AST),alanine aminotransferase(ALT),urea nitrogen(BUN),serum creatinine(SCr),blood routine, urine routine examination and the adverse effects were investigated. Results The total effective rates in treatment groupⅠand treatment groupⅡwere significantly higher than those in the control group〔after treatment for 1 week:81.2%(13/16),81.2%(13/16)vs. 43.8%(7/16);after 2 months:87.5%(14/16),93.7%(15/16)vs. 50.0%(8/16), all P<0.05〕. After treatment,the LVEDV,LVESV and BNP were lowered and the LVEF was increased in the three groups,and the above indexes in treatment groupⅡwere improved more significantly than those in groupⅠ〔LVEDV (mL):142.4±33.0 vs. 174.8±52.5,LVESV(mL):111.6±23.7 vs. 132.4±29.0,LVEF:0.421±0.037 vs. 0.390±0.045,BNP(μg/L):1.944±0.751 vs. 3.038±1.905,all P<0.05〕. Conclusion Qili Qiangxin capsule combined with glucocorticoid may effectively improve the cardiac function and clinical symptoms in near and forward future in patients with dilated cardiomyopathy accompanied by refractory heart failure,thus it may elevate the patients' life quality.
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AIM:To investigate the effects of Qili Qiangxin capsule on serum adiponectin ( APN) , serum N-terminal pro-brain natriuretic peptide ( NT-proBNP) and heart function in the patients of coronary heart disease combined with congestive heart failure .METHODS: One hundred and twenty patients were randomly divided into treatment group and control group , and both groups were given anti-failure routine therapy .The patients in treatment group were treated with Qili Qiangxin capsule and the patients in control group were treated with placebo .The patients in the 2 groups were given a certain dose of the drugs for 6 months.The New York Heart Association (NYHA) heart function classification, left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD),left ventricular ejection frac-tion (LVEF), and 6-min walking test (6-MWT) were observed before and after treatment .The levels of APN, NT-proBNP were measured by ELISA before and after treatment .RESULTS:With the increase in the class of NYHA heart function , the serum concentrations of APN and NT-proBNP in the heart failure cases increased significantly .After 6-month treat-ment, the effective rate in experimental group was 91.7%and that in control group was 75.0%.A significant difference was found between the 2 groups (P<0.01).After treatment, LVEDD and LVESD in both groups were decreased signifi-cantly, and LVEF in both groups was increased significantly .The serum concentrations of APN and NT-proBNP decreased significantly (P<0.05).6-MWT result was improved significantly.Compared with control group, more obvious effect was observed in experimental group ( P<0.05) .CONCLUSION:Treatment with Qili Qiangxin capsule reduces the levels of APN and NT-proBNP in the patients with coronary heart disease combined with congestive heart failure .
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Objective: To study the chemical constituents in Qili Qiangxin Capsule (QQC) and to clear its material basis for efficacy. Methods: A rapid ultra-performance liquid chromatography/orthogonal acceleration time-of-flight mass spectrometry (UPLC/Q-TOF-MS/MS) method was established to identify the diterpenoid alkaloids in the active fraction of QQC. Using target compound screening method, the structures of monitored chemical constituents were identified by retention time, exact relative molecular mass, and cleavage fragments of MS/MS. Results: Twenty diterpenoid alkaloids were identified using XIC Manager, including 6 diester-diterpenoid alkaloids and 14 monoester-diterpenoid alkaloids. Conclusion: This method is simple and rapid for the identification of the constituents in QQC and the results are useful for the quality control of QQC.
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AIM: To evaluate the clinical efficacy and safety of Qili Qiangxin Capsule(Radix Astragali,Radix Aconiti lateralis praeparata,Radix et Rhizoma Salviae miltiorrhizae,Radix et Rhizoma Ginseng,Semen Lepidii,Semen Descurainiae,Flos Carthami,Pericarpium Citri reticulatae,Rhizoma Alismatis,Cortex Periplocae,Rhizoma Polygonati odorati,Ramulus Cinnamomi) with chronic heart failure(CHF).METHODS: Seven randomized controlled trials were reviewed.RESULTS: The meta-analysis indicated that the treatment group of Qili Qiangxin Capsule could decrease the cardiac functional grading of NYHA with 1.21 of the relative risk,and 95% confidence interval(CI) from 1.08 to 1.36;increase 6 minute walking distance with the weighted mean difference(WMD) was 37.39,and 95% confidence interval was from 22.58 to 52.20;raise left ventricular ejection fraction(WMD = 3.97[2.09,5.85]),decrease the left ventricular end-diastolic diameter(WMD = 2.81[1.41,4.22]),lower the level of B-type natriuretic peptide(WMD = 118.00[4.44,231.56]) and N-terminal pro-brain natriuretic peptide(WMD = 476.90[371.26,582.54]) in blood plasma and drop the score of Minnesota living with heart failure questionnaire(WMD =8.00[3.48,12.52]),but Qili Qiangxin Capsule for reduction in left ventricular end-diastolic volume,left ventricular end-systolic volume,heart rate and blood pressure also need to be confirmed.Besides,individual ca-ses occurred adverse reactions like dry cough,epigastric discomfort,gastric distention.However,It could be tolerated and hadn't significant statistical difference with comparison to control group.CONCLUSION: Qili Qiangxin Capsule is effective and safe for the patients of chronic heart failure in improving the heart function and living quality.