Posaconazole vs. fluconazole as invasive fungal infection prophylaxis in China: a multicenter, randomized, open-label study.

BACKGROUND: Invasive fungal infection (IFI) is common in neutropenic patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). Posaconazole is a broad-spectrum triazole antifungal drug with efficacy in prevention of IFI; however, it has not been previously studied as prophylaxis in a Chinese population. METHODS: This multicenter, randomized study in China enrolled AML and MDS patients with persistent chemotherapy-induced neutropenia. Prophylaxis with posaconazole or fluconazole was administered for a maximum of 12 weeks, or until patients recovered from neutropenia and achieved complete remission or an IFI occurred. The primary endpoint was incidence of proven, probable, or possible IFI during treatment. Clinical failure rate, all-cause mortality and time to first systemic antifungal treatment were secondary endpoints. RESULTS: Patients were randomized to receive posaconazole (n = 129) or fluconazole (n = 123); 117 patients in each group were included in the statistical analysis. The incidence of proven, probable or possible IFI was 9.4% (11/117) and 22.2% (26/117) in the posaconazole and fluconazole groups, respectively (p = 0.0114). The clinical failure rate was numerically lower in the posaconazole group (37/117 (31.6%; 95%CI: 23.3 - 40.9)) than in the fluconazole group (49/117 (41.88%; 95% CI: 32.8 - 51.4)) (p = 0.168). Patients receiving posaconazole had a later onset of first systematic antifungal treatment than those receiving fluconazole (p = 0.0139). The most common important adverse events were liver function abnormalities (11 patients (8.8%) on posaconazole and 6 (5.0%) on fluconazole (p = 0.221)). CONCLUSIONS: Posaconazole demonstrates efficacy as prophylaxis against IFI in high-risk neutropenic Chinese patients and is well tolerated during long-term use (ClinicalTrials. gov number, NCT00811928).

[Lower limb hemodynamic evaluation in patients with diabetic foot using 99mTc-methylene diphosphonate three-phase bone scintigraphy].

OBJECTIVE: To evaluate the efficacy of (99m)Tc-methylene diphosphonate (MDP) bone scintigraphy in diagnosis of diabetic foot. METHODS: (99m)Tc-MDP three-phase bone imaging was performed in 56 patients with diabetic foot and 36 non-diabetic control subjects, each foot was analyzed independently. The radioactive concentration per pixel hence the foot to tibia ratio (R(m/t)) was calculated and the time-radioactivity curve of each region of interest generated. From the curve the perfusion time (Tp) was read and the velocity of uptake rate (V) of the foot calculated. The indices such as R(m/t), Tp and V were compared between the two groups by t test, and the diagnostic indices such as sensitivity, specificity, accuracy, positive prediction value and negative predictive value were compared using u test. RESULTS: In the control group, the Tp, V and R(m/t) were 32.9+/-9.8 s, 2.301+/-0.754 counts/s and 0.85+/-0.29, respectively, which were 36.1+/-15.3 s, 1.574+/-0.341 counts/s and 0.72+/-0.31 respectively in the diabetic group. Tp was not significantly different (t=1.693, P>0.05) between the two groups, as was V (t=8.396, P<0.001) and R(m/t)(t=2.759, P<0.01). When V was used as the index, the sensitivity, specificity, and accuracy were 80.2%, 82.8% and 81.5%, respectively, and those for R(m/t) were 65.2%, 68.8% and 67.3%, respectively. By comparison, the sensitivity (u=2.3274, P<0.05) and specificity (u=2.4068, P<0.05) of V were significantly higher than those of R(m/t). CONCLUSIONS: (99m)Tc-MDP three-phase bone imaging can identify decreased uptake rate and R(m/t) in the diabetic foot, and the former index can be more sensitive and specific to define the hemodynamics in the diabetic foot. This technique may detect hemodynamic abnormity in early stage and greatly assist the diagnoses and treatment.