Objective To evaluate the safety and tolerance of medicinal charcoal enteric-coated tablets in healthy volunteers. Methods A total of 44 healthy volunteers were randomly divided into 6 single-dose groups (0.5 g, 2 g, 4 g, 6 g, 8 g and 10 g) and a multiple-dose group (3 g, 3 times a day, for 14 days). The safety profile and tolerance were evaluated by observing symptoms, vital signs, and laboratory tests. Results No serious adverse event was reported for any volunteer. Abdominal distension occurred in 2 volunteers in the 4 g dose group and the 6 g dose group. One volunteer in the 8 g dose group experienced nausea and vomiting. Transient decrease in white blood cell count was observed in one volunteer in the 10 g dose group. Abdominal distension occurred in 2 volunteers of the multiple-dose group. Conclusion Based on our findings, the maximum tolerated dose of medicinal charcoal enteric-coated tablets in Chinese healthy volunteers is 10 g. The recommended dose for subsequent clinical trials is 3 g, 3 times a day.
Objective To evaluate the safety and tolerance of pegfilgrastin (PEG-G-CSF) in Chinese healthy volunteers. Methods Thirty healthy volunteers were randomly divided into five single-dose groups to receive PEG-G-CSF 15, 30, 50, 60 or 75μg/kg by hypodermic injection. The safety profile and tolerability were evaluated by observing symptoms, vital signs, laboratory tests and electro cardiogram. Results No serious adverse event was reported for any volunteer. Transient dizziness occurred in one person in the 50 μg/kg dose group, and mild dizziness and ostalgia was found in all six people in the 75μg/kg dose group, of whom one experienced transient fever and two experienced mild diarrhea. No clinically significant changes in laboratory tests and electrocardiogram were found during the follow-up period. Conclusions The maximum tolerated dose of PEG-G-CSF injection in Chinese healthy volunteers is 60 μg/kg. Doses below 60μg/kg can be well tolerated. The recommended dose for phase II clinical trials is 60 μg/kgone, one dose for each cycle of chemotherapy.
ObjectiveTo analyze the pathogenic bacteria distribution, structure and characteristics of drug resistance in patients with acute stroke complicated with pulmonary infection, in order to provide reference for the prevention of hospital infection and rational use of antimicrobial agents. MethodsA total of 864 clinical specimens of acute stroke complicated with pulmonary infection were chosen for study between January 2012 and December 2014. Separation and cultivation were done in accordance with the operation procedures regulated by the Ministry of Health. Drug sensitivity examination was done by Kirby-Bauer (k-b). Super-extensive spectrum β lactamase (ESBL) and methicillin resistant staphylococcus aureus (MRSA) were detected to analyze the bacterial species and resistance transition. ResultsA total of 864 samples were cultivated, in which G-bacteria accounted for 61.2%. The main pathogenic bacteria was Klebsiella pneumoniae bacteria, Escherichia coli, Pseudomonas aeruginosa, Acinetobacter baumanmii and Staphylococcus aureus. Imipenem had high antimicrobial activity to G-bacilli, especially to Escherichia coli and Klebsiella pneumoniae bacteria. Linezolid, vancomycin and teicoplanin had high antibacterial activity to staphylococcus aureus. Vancomycin resistant Staphylococcus aureus was not found. Ciprofloxacin had high antibacterial activity to Pseudomonas aeruginosa, while imipenem had low antibacterial activity to Pseudomonas aeruginosa. Amikacin had high antibacterial activity to acinetobacter. ConclusionG-bacilli are predominant in acute stroke complicated with pulmonary infection. ESBLs and MRSA detection rate is high, and we should pay attention to the rational use of antibiotics to reduce drug resistance.