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Objective:To compare the efficacy and safety between WangShiBaoChiWan and mosapride in the treatment of functional dyspepsia (FD).Methods:From September 2019 to September 2020, patients with postprandial fullness and early satiation who met the Rome Ⅳ criteria for FD diagnosis were enrolled from 15 hospitals, including the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical College. The subjects were randomly divided into WangShiBaoChiWan (experimental) group and mosapride (control) group in the ratio of 1∶1. The treatment regimens were WangShiBaoChiWan+ mosapride simulator, WangShiBaoChiWan simulator+ mosapride, respectively with a treatment period of 2 weeks. The primary efficacy outcome was the improvement rates of main symptoms before and after treatment, the secondary efficacy primary efficacy outcome was the total clinical effective rate and the change of the single symptom score. And the safety indicator included adverse events. Independent sample t-test, paired t-test and chi-square test were used for statistical analysis. Results:A total of 251 FD patients were enrolled in the full analysis set, including 124 in the experimental group and 127 in the control group; 241 FD patients were in the per-protocol analysis set, including 117 in the experimental group and 124 in the control group. The analysis of per-protocol analysis set showed that the improvement rates of the main symptoms of the experimental group and the control group were (66±29)% and (60±30)%, respectively, and the difference was not statistically significant ( P>0.05). The improvement rate of the main symptoms of the experimental group reached 117% of that of the control group, which exceeded the expected non-inferiority standard of 80%. The total clinical effective rates of the experimental group and the control group were 76.07% (89/117) and 75.81% (94/124), respectively, and the difference was not statistically significant ( P>0.05). The results of full analysis set showed that the incidence of adverse events of the experimental group and the control group was 1.62% (2/124) and 1.57% (2/127), respectively, and the difference was not statistically significant ( P>0.05). There were no serious adverse events in the two groups. Conclusion:The improvement rate of the main symptoms of WangShiBaoChiWan is not inferior to that of mosapride in the treatment of FD, and it has good safety.
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Objective:To investigate the value of modified early warning score (MEWS) combined with D-dimer test in the establishment of an acute pancreatitis severity evaluation model.Methods:The clinical data of 357 patients with acute pancreatitis who received treatment in the Second Affiliated Hospital of Anhui Medical University, China between January 2017 and December 2018 were collected for this study. The receiver operating characteristic curve was used to determine the optimal cut-off value of MEWS combined with D-dimer test for predicting non-mild acute pancreatitis. The relationship between MEWS and D-dimer level was analyzed using regression analysis. The area under the curve (AUC) was used to evaluate the ability of each factor to predict the severity of acute pancreatitis. The sensitivity and specificity of the new model to predict non-mild acute pancreatitis were calculated.Results:According to the receiver operating characteristic curve, the AUC of D-dimer, MEWS, and new model were 0.702, 0.628 and 0.734 respectively ( P < 0.05). The AUC of the new model in predicting non-mild acute pancreatitis was significantly higher than that of MEWS and D-dimer test (0.734 > 0.702 > 0.628, Z = 3.20, P < 0.01). Conclusion:The ability of the new model established based on MEWS and D-dimer to predict the severity of acute pancreatitis is stronger than that of each of MEWS and D-dimer. The new model is simple, convenient and more suitable for clinical use.
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4 holding time were observed among the three groups.After repeated doses,the PMs showed a significantly higher intragastric pH value than that of the homEMs or hetEMs.Conclusion The pharmacodynamic effects of omeprazole and its pharmacokinetics depend on the CYP2C19 genotype status in Chinese volunteers.
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Objective To evaluate the diagnostic accuracy of drug-induced liver injury over a 10-year period . Methods The 112 cases of drug-induced liver injury were retrospectively studied. Inter-national consensus criteria were applied to assess the causality of suspected drug hepatotoxicity,in which the chronological criteria and elimination of other causes were analysed. Results Among 1127 adult inpatients with acute hepatitis over 10-year period, 112 patients(10%) were recorded as drug-induced liver injury. Based on the causality assessment of 112 cases, either incompatible time to apparent onset of the reaction or incompatible course of the reaction was found in 60 cases(53.6%) and 20 cases(17.9%), respectively. The presence of other possible causes for the reaction was found in 34 patients (37.5%). Therefore, 26 cases(23.2%) of liver injury were related to the incriminated drug, 25 cases(22.3%) unrelated,61(54.5%) were considered to indeterminate cause. Conclusions The international consensus criteria were helpful to identify drug-related or unrelated liver injury, but more than half of reported hepatic adverse drug reactions are still in suspected condition. The current diagnostic methods for drug-induced liver injury are needed to be revised in clinical practice.