Zhonghua nei ke za zhi · 2005
[Clinical study of teicoplanin in the treatment of patients with gram-positive cocci: the Chinese experience].
Клиническое исследование IV фазыАннотация на английскомСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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He Li-xian, Pan Jue, Chen Shi-yao, Wang Ai-xia, Xie Can-mao, Shen Zheng-yi
Аннотация
OBJECTIVE: To evaluate the efficacy and safety of Teicoplanin (TEC) in the treatment of Chinese patients with moderate and severe Gram positive (G(+)) coccus infections.
METHODS: A prospective, multicenter, non-comparator control, open-label drug clinical trial of phase IV was conducted.
RESULTS: Totally 156 cases with established and highly suspected G(+) coccus infections are enrolled. Mean age was 53.6 +/- 20.9 (9-93). The infections included: lower respiratory tract infections (66.0%), sepsis (9.0%), catheters-associated infections (5.1%), endocarditis (1.9%), leucopenia with fever (14.1%), bone-joint infections (1.3%), skin-soft tissue infections (7.7%), and other infections (10.9%). Eighty seven point eight percent of the patients suffered from severe underlying diseases, 28.2% (44/156) had immunocompromised conditions. 69.2% had received antibiotics previously (57.4% with cephalosporins and 28.7% with carbapenem, respectively). One hundred and thirty strains of G(+) cocci were isolated from 123 patients (78.8%). Among them methicillin-resistant Staphylococcus aureus (MRSA) accounted for 90.7% (49/54) and methicillin-resistant coagulase-negative Staphylococcus (MRCNS) 88.2% (30/34). The TEC susceptibility test for 105 strains showed that all of the Staphylococci and Enterococci were susceptible. In 121 strains tested for vancomycin, all of the Staphylococci but only 78.3% (18/23) of the Enterococci were susceptible. There were 18 strains of Gram negative bacilli and 1 strain of Candida A. isolated concomitantly with G(+) cocci from 17 cases. The total clinical effectiveness was 82.1% by ITT (156 cases) analysis and 85.2% by PP (135 cases) analysis, respectively. Bacteriologic eradication rate was 87.7%. Thirty three patients with negative culture result were empirically treated with TEC and had 96.8% of clinical effectiveness. The efficacy of TEC to different infections was similar. The total adverse effects, such as decrease in blood cells and transient abnormal liver functions, accounted only for 1.28%.
CONCLUSIONS: Teicoplanin was a very effective antibiotic for G(+) coccus infections and safe for patients. In highly suspected infections with methicillin-resistant Staphylococci or Enterococci, TEC may be a choice for initial empirical treatment.
METHODS: A prospective, multicenter, non-comparator control, open-label drug clinical trial of phase IV was conducted.
RESULTS: Totally 156 cases with established and highly suspected G(+) coccus infections are enrolled. Mean age was 53.6 +/- 20.9 (9-93). The infections included: lower respiratory tract infections (66.0%), sepsis (9.0%), catheters-associated infections (5.1%), endocarditis (1.9%), leucopenia with fever (14.1%), bone-joint infections (1.3%), skin-soft tissue infections (7.7%), and other infections (10.9%). Eighty seven point eight percent of the patients suffered from severe underlying diseases, 28.2% (44/156) had immunocompromised conditions. 69.2% had received antibiotics previously (57.4% with cephalosporins and 28.7% with carbapenem, respectively). One hundred and thirty strains of G(+) cocci were isolated from 123 patients (78.8%). Among them methicillin-resistant Staphylococcus aureus (MRSA) accounted for 90.7% (49/54) and methicillin-resistant coagulase-negative Staphylococcus (MRCNS) 88.2% (30/34). The TEC susceptibility test for 105 strains showed that all of the Staphylococci and Enterococci were susceptible. In 121 strains tested for vancomycin, all of the Staphylococci but only 78.3% (18/23) of the Enterococci were susceptible. There were 18 strains of Gram negative bacilli and 1 strain of Candida A. isolated concomitantly with G(+) cocci from 17 cases. The total clinical effectiveness was 82.1% by ITT (156 cases) analysis and 85.2% by PP (135 cases) analysis, respectively. Bacteriologic eradication rate was 87.7%. Thirty three patients with negative culture result were empirically treated with TEC and had 96.8% of clinical effectiveness. The efficacy of TEC to different infections was similar. The total adverse effects, such as decrease in blood cells and transient abnormal liver functions, accounted only for 1.28%.
CONCLUSIONS: Teicoplanin was a very effective antibiotic for G(+) coccus infections and safe for patients. In highly suspected infections with methicillin-resistant Staphylococci or Enterococci, TEC may be a choice for initial empirical treatment.