We report a case of cutaneous and subcutaneous phaeohyphomycosis caused by Exophiala jeanselmei after renal transplantation in Guangdong. A 66-year-old man who had a renal transplantation 6 years ago was admitted in October 2011 for the presence of 16 nodules (0.5-1.5 cm) found on his right middle finger, wrist and forearm for 5 months. Microscopic examination of the purulent exudate showed segmented and branched brown mycelium, and tissue biopsy and PAS staining showed fungal hyphae. The isolate was processed for morphological identification and molecular sequence analysis. A black colony was found after culture of the isolate on SDA at 26 degrees Celsius;, and small culture identified the isolate as Exophiala jeanselmei. ITS sequence analysis of the isolate showed a 100% homology with Exophiala jeanselmei. E-test strip was used in drug sensitivity test, and the isolate was sensitive to amphotericin B, voriconazole, itraconazole and fluconazole, but resistant to 5-flucytosine and caspofungin. Good response was obtained with surgical intervention, local injection and systemic antifungal treatment.
Aged ; Exophiala ; pathogenicity ; Humans ; Kidney Transplantation ; adverse effects ; Male ; Phaeohyphomycosis ; etiology ; Postoperative Complications

OBJECTIVE To systematically review the background of bioequivalence assessment of nasal sprays and nasal aerosols and the guiding considerations for the bioequivalence assessment of these complex drug-device combination products by regulatory authorities in the United States, the European Union(EU) and China. METHODS This article provided detailed explanations on the innovative weight of evidence assessment approach adopted by the US Food and Drug Administration(FDA), and the statistical rationale, methods and considerations for the bioequivalence assessment of nasal sprays and nasal aerosols. Using the calculation methods described in the draft guidance for budesonide inhalation suspension and the draft guidance for fluticasone nasal spray propionate issued by FDA, the statistical parameters of two-sided and one-sided population bioequivalence calculation were realized through R language programming, and pseudo-code for the population bioequivalence (PBE) calculation programs was provided. This article also presented a comprehensive review of published guidelines and summaries review principles of the EU and China for nasal sprays and nasal aerosols equivalence assessment. RESULTS & CONCLUSION Nasal sprays/nasal aerosols is the focus of innovative and generic drug development in recent years. This paper provided valuable considerations references for the research and development, quality control and bioequivalence evaluation of generic preparations of nasal sprays/nasal aerosols.