Release of amoxicillin-sulbactam sodium for CAP multicenter trial results

Business News Agency Aug. 28 News Recently, Spain Jinwu Pharmaceutical released a multi-center clinical trial of amoxicillin/sulbactam sodium (2:1) in the treatment of community-acquired pneumonia (CAP) in Shanghai.

With cefuroxime as the comparator drug, 316 patients from 8 hospitals across the country were enrolled in a randomized, multicenter clinical study to evaluate the efficacy and safety of amoxicillin-sulbactam sodium in the treatment of mild to moderate CAP. . The results showed that the cure rate and effective rate of the amoxicillin-sulbactam sodium group were 32.9% and 88.2%, and the cure rate and effective rate of the cefuroxime control group were 33.5% and 89.0%, respectively. Statistical significance, P>0.05. The bacterial clearance rate was 82.0% in the experimental group and 85.7% in the control group. There was no significant difference in the bacterial clearance rate between the two groups.

Professor Renmin Jiang, Department of Respiratory Medicine, Huadong Hospital Affiliated to Fudan University, pointed out that with the widespread use of β-lactam antibiotics, especially the third-generation cephalosporins, the problem of bacterial β-lactamase resistance has become increasingly prominent. The mechanism of drug resistance is the change of antibiotic target, the change of membrane pore protein, the change of bacterial cell wall and cell membrane permeability, and the generation of inactive enzyme. The main mechanism for bacterial resistance to β-lactam antibiotics is the latter.

According to China's drug resistance surveillance data, the incidence of extended-spectrum-lactamase (ESBL) of Escherichia coli and Klebsiella pneumoniae was 56.2% and 43.6%, respectively, which was significantly higher than the level of 10% to 20% of foreign countries. . The half-life of both amoxicillin and sulbactam sodium is roughly the same, and the combined use helps to protect amoxicillin from the hydrolysis of β-lactamase produced by bacteria, thereby exerting good antibacterial activity. A total of 26 prospective studies of 5961 CAP hospitalized patients in 10 European countries and data from China's bacterial drug resistance data show that the compound preparation maintains a high sensitivity to gram-positive bacteria and also maintains a higher level of gram-negative bacteria. Low resistance.