Objective To observe the pharmacokinetic effect of amoxicillin and clavulanate potassium tablets on amoxicillin in Chinese healthy subjects under fasting and high fat and high calorie diet.Methods 71 healthy subjects were given a single dose of amoxicillin potassium clavulanate tablets(0.375 g)on fasting or high fat diet,and venous blood samples were collected at different time points.The concentrations of amoxicillin in human plasma were determined by HPLC-MS/MS method,and the pharmacokinetic parameters were calculated by non-atrioventricular model using PhoenixWinNonlin 8.0 software.Results The main pharmacokinetic parameters of amoxicillin potassium clavulanate tablets after fasting and high fat diet were(5 105.00±1 444.00),(4 593.00±1 327.00)ng·mL-1,and postprandial-fasting ratio 89.40％,90％confidence interval(79.55％-100.19％);t1/2 were(1.52±0.16),(1.39±0.22)h;AUC0-t were(12 969.00±1 841.00),(11 577.00±1 663.00)ng·mL-1·h,and postdietary/fasting ratio 89.20％,90％confidence interval(83.92％-94.28％);AUC0-∞ were(13 024.00±1 846.00),(11 532.00±1 545.00)ng·mL-1·h,and postprandial-fasting ratio 88.60％,90％confidence interval(83.48％-93.50％).The median Tmax(range)were 1.63(0.75,3.00)and 2.50(0.75,6.00)h,respectively,and the Tmax of postprandial medication was delayed(P＜0.01).Conclusion Compared with fasting condition,amoxicillin Tmax was significantly delayed after high fat diet,while Cmax,AUC0-t and AUC0-∞ were not significantly changed,indicating that food could delay the absorption of amoxicillin,but did not affect the degree of absorption.

Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P＜0.05).After continuation treatment,the remission rate was 54.59％(202 cases/370 cases),and the recurrence rate was 6.49％(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35％(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.

OBJECTIVE: To derive the Chinese medicine (CM) syndrome classification and subgroup syndrome characteristics of ischemic stroke patients. METHODS: By extracting the CM clinical electronic medical records (EMRs) of 7,170 hospitalized patients with ischemic stroke from 2016 to 2018 at Weifang Hospital of Traditional Chinese Medicine, Shandong Province, China, a patient similarity network (PSN) was constructed based on the symptomatic phenotype of the patients. Thereafter the efficient community detection method BGLL was used to identify subgroups of patients. Finally, subgroups with a large number of cases were selected to analyze the specific manifestations of clinical symptoms and CM syndromes in each subgroup. RESULTS: Seven main subgroups of patients with specific symptom characteristics were identified, including M3, M2, M1, M5, M0, M29 and M4. M3 and M0 subgroups had prominent posterior circulatory symptoms, while M3 was associated with autonomic disorders, and M4 manifested as anxiety; M2 and M4 had motor and motor coordination disorders; M1 had sensory disorders; M5 had more obvious lung infections; M29 had a disorder of consciousness. The specificity of CM syndromes of each subgroup was as follows. M3, M2, M1, M0, M29 and M4 all had the same syndrome as wind phlegm pattern; M3 and M0 both showed hyperactivity of Gan (Liver) yang pattern; M2 and M29 had similar syndromes, which corresponded to intertwined phlegm and blood stasis pattern and phlegm-stasis obstructing meridians pattern, respectively. The manifestations of CM syndromes often appeared in a combination of 2 or more syndrome elements. The most common combination of these 7 subgroups was wind-phlegm. The 7 subgroups of CM syndrome elements were specifically manifested as pathogenic wind, pathogenic phlegm, and deficiency pathogens. CONCLUSIONS There were 7 main symptom similarity-based subgroups in ischemic stroke patients, and their specific characteristics were obvious. The main syndromes were wind phlegm pattern and hyperactivity of Gan yang pattern.
Humans ; Syndrome ; Ischemic Stroke ; Medicine, Chinese Traditional ; Liver ; Phenotype

Objective: To analyze factors associated with unplanned revascularization (UR) risk in patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI). Methods: A total of 10,640 cases with CAD who underwent PCI were analyzed. Multivariate COX regressions and competing risk regressions were applied. Results: The patients who underwent UR following PCI in 30 days, 1, and 2 years accounted for 0.3%, 6.5%, and 8.7%, respectively. After multivariate adjustment, the number of target lesions [hazard ratio ( ) = 2.320; 95% confidence interval ( ): 1.643-3.277; < 0.001], time of procedure ( = 1.006; 95% : 1.001-1.010; = 0.014), body mass index ( = 1.104; 95% : 1.006-1.210; = 0.036), incomplete revascularization (ICR) ( = 2.476; 95% : 1.030-5.952; = 0.043), and age ( 1.037; 95% : 1.000-1.075; = 0.048) were determined as independent risk factors of 30-day UR. Factors, including low-molecular-weight heparin or fondaparinux ( = 0.618; 95% : 0.531-0.719; < 0.001), second-generation durable polymer drug-eluting stent ( 0.713; 95% : 0.624-0.814; < 0.001), left anterior descending artery involvement ( = 0.654; 95% : 0.530-0.807; < 0.001), and age ( = 0.992; 95% : 0.985-0.998; = 0.014), were independently associated with decreased two-year UR risk. While, Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery score ( = 1.024; 95% : 1.014-1.033; < 0.001) and ICR ( = 1.549; 95% : 1.290-1.860; < 0.001) were negatively associated with two-year UR risk. Conclusion Specific factors were positively or negatively associated with short- and medium-long-term UR following PCI.
Adult ; Aged ; China ; Coronary Artery Disease ; surgery ; Female ; Humans ; Male ; Middle Aged ; Myocardial Revascularization ; adverse effects ; statistics & numerical data ; Percutaneous Coronary Intervention ; adverse effects ; statistics & numerical data ; Risk Factors ; Treatment Outcome

Adult ; Aged ; Aged, 80 and over ; Air Pollutants ; adverse effects ; Blood Chemical Analysis ; Coke ; adverse effects ; Environmental Exposure ; Female ; Humans ; Immunoglobulins ; metabolism ; Male ; Middle Aged ; Polycyclic Aromatic Hydrocarbons ; adverse effects ; Young Adult

BackgroundThe Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients (PARIS) bleeding score is a novel score for predicting the out-of-hospital bleeding risk after percutaneous coronary intervention (PCI). However, whether this score has the same value in non-European and American populations is unclear. This study aimed to assess the PARIS bleeding score's predictive value of bleeding in patients after PCI in the Chinese population.

MethodsWe performed a prospective, observational study of 10,724 patients who underwent PCI from January to December 2013, in Fuwai Hospital, China. We defined the primary end point as major bleeding (MB) according to Bleeding Academic Research Consortium definition criteria including Type 2, 3, or 5. The predictive value of the PARIS bleeding score was assessed with the area under the receiver operating characteristic (AUROC) curve.

ResultsOf 9782 patients, 245 (2.50%) MB events occurred during the 2 years of follow-up. The PARIS bleeding score was significantly higher in the MB group than that of non-MB group (4.00 [3.00, 5.00] vs. 3.00 [2.00, 5.00], Z = 3.71, P < 0.001). According to risk stratification of the PARIS bleeding score, the bleeding risk in the intermediate- and high-risk groups was 1.50 times (hazard ratio [HR]: 1.50; 95% confidence interval [CI]: 1.160-1.950; P = 0.002) and 2.27 times higher (HR: 2.27; 95% CI: 1.320-3.900; P = 0.003) than that in the low-risk group. The PARIS bleeding score showed a moderate predictive value for MB in the overall population (AUROC: 0.568, 95% CI: 0.532-0.605; P < 0.001) and acute coronary syndrome (ACS) subgroup (AUROC: 0.578, 95% CI: 0.530-0.626; P = 0.001) and tended to be predictive in the non-ACS subgroup (AUROC: 0.556, 95% CI: 0.501-0.611; P = 0.054).

ConclusionThe PARIS bleeding score shows good clinical value for risk stratification and has a significant, but relatively limited, prognostic value for out-of-hospital bleeding in the Chinese population after PCI.

Acute Coronary Syndrome ; pathology ; surgery ; Aged ; Blood Platelets ; physiology ; China ; Female ; Hemorrhage ; diagnosis ; prevention & control ; Humans ; Male ; Middle Aged ; Percutaneous Coronary Intervention ; methods ; Prognosis ; Prospective Studies

BackgroundResidual SYNTAX score (rSS) and its derived indexes including SYNTAX revascularization index (SRI) and clinical rSS had been developed to quantify and describe the extent of incomplete revascularization. This study was conducted to explore the utility of the three scores among real-world patients after percutaneous coronary intervention (PCI).

MethodsFrom January 2013 to December 2013, patients underwent PCI treatment at Fuwai Hospital were included. The primary endpoints were all-cause death and major adverse cardiovascular and cerebrovascular events. The secondary endpoints were myocardial infarction, revascularization, stroke, and stent thrombosis. Kaplan-Meier methodology was used to determine the outcomes. Cox multivariable regression was to test the associations between scores and all-cause mortality.

ResultsA total of 10,344 patients were finally analyzed in this study. Kaplan-Meier survival analysis indicated that greater residual coronary lesions quantified by rSS and its derived indexes were associated with increased risk of adverse cardiovascular events. However, after multivariate analysis, only clinical rSS was an independent predictor of 2-year all-cause death (hazard ratio: 1.02, 95% confidence interval: 1.01-1.03, P < 0.01). By receiver operating characteristic (ROC) curve analysis, clinical rSS had superior predictability of 2-year all-cause death than rSS and SRI (area under ROC curve [AUC]: 0.59 vs. 0.56 vs. 0.56, all P < 0.01), whereas rSS was superior in predicting repeat revascularization than clinical rSS and SRI (AUC: 0.62 vs. 0.61 vs. 0.61; all P < 0.01). When comparing the predictive capability of rSS ≥8 with SRI <70%, their predictabilities were not significantly different.

ConclusionsThis study indicates that all three indexes (rSS, clinical rSS, and SRI) are able to risk-stratify patients and predict 2-year outcomes after PCI. However, their prognostic capabilities are different.

Aged ; Coronary Artery Disease ; surgery ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Myocardial Infarction ; surgery ; Percutaneous Coronary Intervention ; methods ; Proportional Hazards Models ; Risk Assessment ; Treatment Outcome

Background: The patterns of nonadherence to antiplatelet regimen in stented patients (PARIS) thrombotic risk score are a novel score for predicting the risk of coronary thrombotic events (CTEs) after percutaneous coronary intervention (PCI) with drug-eluting stents. However, the prognostic value of this score has not been fully evaluated in non-Euro-American PCI populations. Methods: We performed a prospective, observational study of 10,724 patients who underwent PCI in Fuwai hospital, China and evaluated the PARIS thrombotic risk score's predictive value of CTEs in the PCI population. The area under the receiver operating characteristic curve (AUROC) was used to assess the predictive value of the PARIS score for CTE. Results: Among 9782 patients without in-hospital events, a total of 95 CTEs occurred during the 2-year follow-up. The PARIS score was significantly higher in patients with CTEs (3.38 ± 2.04) compared with patients without events (2.53 ± 1.70, P < 0.001). According to the risk stratification of the PARIS thrombotic score, the risk of CTEs in the high-risk group was 3.14 times higher than that in the low-risk group (hazard ratio [HR], 3.14; 95% confidence interval [CI], 1.92-5.13; P < 0.001). However, the risk of CTEs in the intermediate-risk and low-risk groups was not significant (HR, 1.39; 95% CI, [0.86-2.24]; P = 0.184). The PARIS score showed prognostic value in evaluating CTEs in the overall population (AUROC, 0.621; 95% CI, 0.561-0.681), the acute coronary syndrome (ACS) population (AUROC, 0.617; 95% CI, 0.534-0.700; P = 0.003), and the non-ACS population (AUROC, 0.647; 95% CI, 0.558-0.736; P = 0.001). Conclusions In a real-world Chinese population, the PARIS thrombotic risk score shows a modest prognostic value for CTEs in patients after PCI. This score also has a predictive value for CTEs in the ACS and non-ACS subgroup populations.
Acute Coronary Syndrome ; pathology ; prevention & control ; Aged ; Asian Continental Ancestry Group ; Coronary Thrombosis ; pathology ; prevention & control ; Female ; Humans ; Male ; Middle Aged ; Percutaneous Coronary Intervention ; adverse effects ; Platelet Aggregation Inhibitors ; therapeutic use ; Prognosis ; Prospective Studies ; Risk Assessment ; Thrombosis ; prevention & control

Background: It remains undetermined whether second-generation drug-eluting stents (G2-DESs) outperform first-generation DESs (G1-DESs) in patients with acute coronary syndrome (ACS). We aimed to compare the efficacy and safety of G1-DES and G2-DES in ACS patients in a high-volume cardiovascular center. Methods: In 2013, 10,724 consecutive patients underwent percutaneous coronary intervention in our institution. We included 4037 patients with ACS who underwent exclusively G1-DES or G2-DES implantation (n = 364 and n = 3673, respectively). We used propensity score matching to minimize the imbalance between the G1-DES and G2-DES groups and followed patients for 2 years. The efficacy endpoints were major adverse cardiac events (MACEs) and its components including target vessel-related myocardial infarction (TV-MI), target vessel revascularization/target lesion revascularization (TVR/TLR), and cardiac death. The safety endpoint was stent thrombosis. Continuous variables were compared by Mann-Whitney U-test, and categorical variables were compared using Pearson's Chi-square or Fisher's exact test. Kaplan-Meier curves were constructed to compare the event-free survival rates, and multivariate Cox proportional hazards regression analysis was used to assess whether stent type was an independent risk factor for the efficacy and safety endpoints. Results: At the 2-year follow-up, the results for MACE and it components, as well as stent thrombosis, were similar for G1-DES and G2-DES (MACE, 5.2% vs. 4.3%, χ = 0.514, P = 0.474; TV-MI, 0.8% vs. 0.4%, P = 0.407; TVR, 4.9% vs. 3.7%, χ = 0.939, P = 0.333; TLR, 3.8% vs. 2.5%, χ = 1.610, P = 0.205; cardiac death, 0.3% vs. 0.5%, P = 0.670; and stent thrombosis, 0.5% vs. 0.4%, P > 0.999). Kaplan-Meier analysis indicated similar event-free survival rates between G1-DES and G2-DES after propensity score matching (all: log-rank P > 0.05). Multivariate analysis demonstrated that stent type was not an independent risk factor for the efficacy and safety endpoints (MACE, hazard ratio [HR] = 0.805, 95% confidence interval [CI]: 0.455-1.424, P = 0.456; TV-MI, HR = 0.500, 95% CI: 0.101-2.475, P = 0.395; TVR, HR = 0.732, 95% CI: 0.403-1.330, P = 0.306; TLR, HR = 0.629, 95% CI: 0.313-1.264, P = 0.193; cardiac death, HR = 1.991, 95% CI: 0.223-17.814, P = 0.538; and stent thrombosis, HR = 0.746, 95% CI: 0.125-4.467, P = 0.749). Conclusion G1-DES and G2-DES have similar efficacy and safety profiles in ACS patients at the 2-year follow-up.
Acute Coronary Syndrome ; surgery ; Aged ; Coronary Thrombosis ; surgery ; Drug-Eluting Stents ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Myocardial Infarction ; surgery ; Percutaneous Coronary Intervention ; methods ; Prospective Studies

BACKGROUND: There is scanty evidence concerning the ability of Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) and Acute Catheterization and Urgent Intervention Triage Strategy and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (ACUITY-HORIZONS) scores to predict out-of-hospital bleeding risk after percutaneous coronary interventions (PCIs) with drug-eluting stents (DES) in patients receiving dual antiplatelet therapy. We aimed to assess and compare the long-term prognostic value of these scores regarding out-of-hospital bleeding risk in such patients. METHODS: We performed a prospective observational study of 10,724 patients undergoing PCI between January and December 2013 in Fuwai Hospital, China. All patients were followed up for 2 years and evaluated through the Fuwai Hospital Follow-up Center. Major bleeding was defined as Types 2, 3, and 5 according to Bleeding Academic Research Consortium Definition criteria. RESULTS: During a 2-year follow-up, 245 of 9782 patients (2.5%) had major bleeding (MB). CRUSADE (21.00 [12.00, 29.75] vs. 18.00 [11.00, 26.00], P < 0.001) and ACUITY-HORIZONS (9.00 [3.00, 14.00] vs. 6.00 [3.00, 12.00], P < 0.001) risk scores were both significantly higher in the MB than non-MB groups. Both scores showed a moderate predictive value for MB in the whole study cohort (area under the receiver-operating characteristics curve [AUROC], 0.565; 95% confidence interval [CI], 0.529-0.601, P = 0.001; AUROC, 0.566; 95% CI, 0.529-0.603, P < 0.001, respectively) and in the acute coronary syndrome (ACS) subgroup (AUROC: 0.579, 95% CI: 0.531-0.627, P = 0.001; AUROC, 0.591; 95% CI, 0.544-0.638, P < 0.001, respectively). However, neither score was a significant predictor in the non-ACS subgroup (P > 0.05). The value of CRUSADE and ACUITY-HORIZONS scores did not differ significantly (P > 0.05) in the whole cohort, ACS subgroup, or non-ACS subgroup. CONCLUSIONS CRUSADE and ACUITY-HORIZONS scores showed statistically significant but relatively limited long-term prognostic value for out-of-hospital MB after PCI with DES in a cohort of Chinese patients. The value of CRUSADE and ACUITY-HORIZONS scores did not differ significantly (P > 0.05) in the whole cohort, ACS subgroup, or non-ACS subgroup.
Acute Coronary Syndrome ; therapy ; Aged ; Angina, Unstable ; therapy ; Drug-Eluting Stents ; Female ; Humans ; Male ; Middle Aged ; Myocardial Infarction ; therapy ; Percutaneous Coronary Intervention ; Platelet Aggregation Inhibitors ; adverse effects ; Postoperative Hemorrhage ; chemically induced ; diagnosis ; epidemiology ; surgery ; Practice Guidelines as Topic ; Prognosis ; Prospective Studies ; Research Design ; Risk ; Risk Assessment ; Treatment Outcome