ABSTRACT
Background & objectives: Biapenem is a newly developed carbapenem to treat moderate and severe bacterial infections. This multicenter, randomized, parallel-controlled clinical trial was conducted to compare the clinical efficacy, bacterial eradication rates and safety of biapenem and meropenem in the treatment of bacterial lower respiratory tract infections and urinary tract infections (UTIs) at nine centres in China. Methods: Patients diagnosed with bacterial lower respiratory tract infections or UTIs were randomly assigned to receive either biapenem (300 mg every 12 h) or meropenem (500 mg every 8 h) by intravenous infusion for 7 to 14 days according to their disease severity. The overall clinical efficacy, bacterial eradication rates and drug-related adverse reactions of biapenem and meropenem were analyzed. Results: A total of 272 enrolled cases were included in the intent-to-treat (ITT) analysis and safety analysis. There were no differences in demographics and baseline medical characteristics between biapenem group and meropenem group. The overall clinical efficacies of biapenem and meropenem were not significantly different, 94.70 per cent (125/132) vs. 93.94 per cent (124/132). The overall bacterial eradication rates of biapenem and meropenem showed no significant difference, 96.39 per cent (80/83) vs. 93.75 per cent (75/80). Drug-related adverse reactions were comparable in biapenem and meropenem groups with the incidence of 11.76 per cent (16/136) and 15.44 per cent (21/136), respectively. The most common symptoms of biapenem-related adverse reactions were rash (2.2%) and gastrointestinal distress (1.5%). Interpretation & conclusions: Biapenem was non-inferior to meropenem and was well-tolerated in the treatment of moderate and severe lower respiratory tract infections and UTIs.
ABSTRACT
Background & objectives Diagnosis for Mycoplasma pneumoniae usually relies on serological tests. PCR technology has some advantages but also limitations. The optimal selection for these tests still needs discussion. This paper reviews the overall diagnostic accuracy of PCR versus serological assays for diagnosis of M. pneumoniae infections and to identify factors associated with heterogeneity of results. Methods: MEDLINE and Embase databases were searched. Articles meeting the selection criteria were retrieved for data collection and analysis. Studies were assessed for methodological quality using QUADAS. Hierarchial summary receiver operating characteristic (HSROC) model was used to estimate summary ROC curve. Results: Initial meta-analysis showed a summary estimate of sensitivity (SEN) 0.62 (95% CI, 0.45-0.76), and specificity (SPE) 0.96 (95% CI, 0.93-0.98). Subgroup analyses were performed to identify factors associated with heterogeneity. For different gene targets, reference standards, subjects (children or adults) and different PCR types, these aspects can generate results of heterogeneity. The 16s rDNA target and adult subjects and real-time PCR may have better test results for PCR. Interpretation & conclusions Commercial PCR tests generated consistent results with high specificity but a lower and more variable sensitivity. The findings suggest commercial PCR tests having superiorities in diagnosing M. pneumoniae infections but still cannot replace serology. PCR plus serology could be good screening tests for reliable and accurate diagnosis of M. pneumoniae.