Stratified Threshold Values of QuantiFERON Assay for Diagnosing Tuberculosis Infection in Immunocompromised Populations

Background. The detection of latent tuberculosis (TB) is essential for TB control, but T-cell assay might be influenced by degree of immunosuppression. The relationship between immunocompetence and interferon (IFN)-γ response in QuantiFERON-TB Gold (QFT) is uncertain, especially in HIV-negative populations. Methods and Results. QFT has been performed for healthy subjects and TB suspected patients. Of 3017 patients, 727 were diagnosed as pulmonary TB by culture. The absolute number of blood lymphocyte in TB patients was significantly associated with QFT. Definitive TB patients were divided into eight groups according to lymphocyte counts. For each subgroup, receiver operating characteristic curve analysis was conducted from 357 healthy control subjects. The optimal cut-off for the patient group with adequate lymphocyte counts was found, but this was reduced for lymphocytopenia. Conclusions. The lymphocyte count was positively associated with QFT. Positive criteria should be calibrated in consideration of cell-mediated immunocompetence and risk of progression to active TB

Clinical Study Stratified Threshold Values of QuantiFERON Assay for Diagnosing Tuberculosis Infection in Immunocompromised Populations

Background. The detection of latent tuberculosis (TB) is essential for TB control, but T-cell assay might be influenced by degree of immunosuppression. The relationship between immunocompetence and interferon (IFN)-γ response in QuantiFERON-TB Gold (QFT) is uncertain, especially in HIV-negative populations. Methods and Results. QFT has been performed for healthy subjects and TB suspected patients. Of 3017 patients, 727 were diagnosed as pulmonary TB by culture. The absolute number of blood lymphocyte in TB patients was significantly associated with QFT. Definitive TB patients were divided into eight groups according to lymphocyte counts. For each subgroup, receiver operating characteristic curve analysis was conducted from 357 healthy control subjects. The optimal cut-off for the patient group with adequate lymphocyte counts was found, but this was reduced for lymphocytopenia. Conclusions. The lymphocyte count was positively associated with QFT. Positive criteria should be calibrated in consideration of cell-mediated immunocompetence and risk of progression to active TB

Clinical efficacy and safety of micafungin in Japanese patients with chronic pulmonary aspergillosis: a prospective observational study.

Aspergillosis has been the prevailing deep-seated mycosis in Japan since the 1990s. Although micafungin (MCFG) has been approved in Japan for the management of patients with such infections caused by Candida and Aspergillus species, there are relatively few reports on its use in patients with chronic pulmonary aspergillosis (CPA). Therefore, we conducted a prospective observational study to evaluate the efficacy and safety of the use of MCFG in Japanese patients with CPA. The efficacy of the antifungal was assessed on the basis of improvements in clinical symptoms and radiological findings. In addition, adverse events, including abnormal laboratory findings were determined. The overall clinical efficacy rate was 68.4% (26/38 patients), which is comparable to the results obtained in clinical trials for marketing approval conducted in Japan. Although adverse drug reactions were observed in six patients (15.8%), they were not serious. The most common of these reactions was abnormal liver functions. No relationship between the incidence of adverse drug reactions and age of the patients, MCFG dose, or duration of treatment was observed. Consequently, MCFG has favorable efficacy and safety profiles in Japanese CPA patients with various backgrounds

Intravenous micafungin versus voriconazole for chronic pulmonary aspergillosis: A multicenter trial in Japan.

Chronic pulmonary aspergillosis (CPA) is slowly progressive inflammatory pulmonary syndrome due to Aspergillus spp. The evidence regarding CPA treatment is limited. We conducted a randomized, multicenter, open-label trial comparing intravenous micafungin (MCFG) of 150-300 mg once daily with intravenous voriconazole (VRCZ) of 6 mg/kg twice on Day 1 followed by 4 mg/kg twice daily for the treatment of 107 in patients with CPA to compare the efficacy and safety of both drugs as initial treatment in Japan. Treatment effectiveness was defined by clinical, mycological, radiological and serological responses 2 weeks after the initial administration and at the end of therapy. The total of 50 and 47 patients were assigned to the MCFG and VRCZ groups, respectively. The difference in efficacy rates between MCFG and VRCZ was not significant, either after 2 weeks [68.0% vs. 58.7%; the absolute difference, 9.3% with a 95% confidence interval (CI), -9.97 to 28.58, P = 0.344] or at the end of therapy (60.0% vs. 53.2%; the absolute difference, 6.8% with a 95% CI, -12.92 to 26.54, P = 0.499). In the safety evaluation, fewer adverse events occurred in the MCFG than VRCZ group (26.4% vs. 61.1%, P = 0.0004). MCFG was as effective as VRCZ and significantly safer than as an initial treatment of CPA. (UMIN Clinical Trials Registry number, UMIN000001786.)