We investigated the efficacy and safety of sitafloxacin (STFX) in patients with mild to moderate community-acquired pneumonia or secondary infections of chronic respiratory tract diseases. The results showed that the efficacy rate was 96.5% (111/115) in patients analyzed for efficacy. The efficacy rate by STFX administration method was 93.9% (46/49) at 50mg b.i.d., 100% (37/37) at 100mg q.d. and 96.6% (28/29) at 100mg b.i.d. In chest X-rays, the image improvement rate in 102 patients with shadows before treatment was 94.1% (96/102). The image improvement rate by STFX administration method was 90.5% (38/42) at 50mg b.i.d., 97.1% (33/34) at 100mg q.d. and 96.2% (25/26) at 100mg b.i.d. Side effects occurred in five out of 115 patients (4.3%). Abnormalities in hepatic function test values appeared in two patients and abnormalities in renal function test values appeared in three patients. In four cases, the abnormalities were very mild and STFX administration was continued without any treatment. In the other patient, the abnormal value rapidly returned to normal after STFX administration was discontinued.

These findings indicated that STFX can be used safety in routine practice by adjusting the administration within the approved dose based on patient characteristics. Good therapeutic effects can be expected in patients with respiratory tract infections.

Because of the refractory and recurrent nature of febrile neutropenia (FN), definite diagnosis and early empiric treatment with antibiotics are important for FN patients. With this background, guidelines for FN treatment have been published in Japan and overseas, although a treatment method appropriate for clinical practice in Japan has not yet been established. Therefore, we conducted a survey of actual practice, including trends in prescription of antibiotics for FN, in the hope that it would help establish a definitive treatment for FN in Japan. The survey results confirmed that FN patients under care of hematology departments accounted for the largest proportion, followed by pediatrics (hematology), pulmonary medicine, medical oncology, and respiratory surgery, and the proportions of patients diagnosed with FN and those receiving antibiotics in hematology departments are larger than in other departments. Across all departments, cefepime (CFPM) is most frequently used as the initial treatment of choice, accounting for 35.9% of prescriptions, followed by meropenem (MEPM) (24.3%). These drugs are selected because they exhibit high potency and wide coverage against organisms that are presumed to cause FN, and their costs are covered by insurance, while the existence of insurance coverage is the major determining factor for treatment in Japan. Among second-line drugs, MEPM is most frequently used, accounting for 46.3% of prescriptions. The guidelines are commonly used as the basis for treatment, accounting for 52.0% of all departments, especially the guidelines established by the Japan Febrile Neutropenia Study Group. On the other hand, the percentage of departments that have introduced a hospital protocol and clinical path is only 13.0% in total. To provide appropriate treatment for FN patients, insurance coverage and introduction of a hospital protocol and clinical path based on guidelines and evidence are essential. The current situation, in which these are not implemented, is not desirable. The survey results show that the guidelines need to be revised to more closely reflect the actual situation in Japan and hospital protocols and clinical paths need to be introduced.

We have retrospectively analyzed the safety of 4 hours administration of liposomal amphotericin B (L-AMB) compared to less than or equal to 3 hours administration in patients with chronic necrotizing pulmonary aspergillosis (CNPA).

The elevation of serum creatinine in the group with 4 hours administration of L-AMB in patients with CNPA was equal to the group with shorter administration time (less than or equal to three hours). During the administration of L-AMB, the group with 4 hours administration of LAMB had significantly a safer profile in relation to hypokalemia during L-AMB treatment than the group with shorter administration time. Additionally, white cell counts, platelet counts, serum creatinine, AST, ALT were not significantly different between L-AMB 4 hours administration group and less than or equal to 3 hours administration group.

As the group with 4 hours administration of L-AMB had significantly a safer profile in relation to hypokalemia during L-AMB treatment, this modality can be one of the safer ways in the treatment of CNPA. As L-AMB is one of the fungicidal agents, 4 hours administration of L-AMB can be an optimal way of treating CNPA.

Sitafloxacin (STFX, Gracevit® 50mg, fine granules 10%), a new quinolone antibacterial agent, was approved in January 2008, and the use-results survey was performed for 2 years from December 2008 to November 2010. In total, 3558 case cards were collected from 287 medical institutions and 3331 cases were subjected to a safety evaluation and 3225 were subjected to an efficacy evaluation. Incidence of adverse drug reactions (ADRs) was 4.44% (148/3331 cases). Major ADRs were diarrhea (55 cases) and hepatic function disorders (39 cases), and the incidences were 1.65% and 1.17%, respectively.

Serious ADRs were observed in 5 cases (7 episodes); gastrointestinal haemorrhage, hepatic function abnormal, white blood cell count decreased, drug eruption, hypoglycemia, pneumonia, and superinfection in one case each.

Efficacy rate was 92.9% (2997/3225 patients) in total with a range of 91.4 to 97.8% by type of infection such as respiratory tract and urinary tract. Eradication rate of indicated strains was 91.5% (808/883 strains) including Gram-positive bacteria at 92.3% (310/336 strains), Gram-negative bacteria at 90.7% (458/505 strains), anaerobes at 100.0% (28/28 strains) and atypical bacteria at 85.7% (12/14 strains).

In conclusion, this use-results survey confirmed that STFX is a useful antibacterial agent with no serious problems in its safety profile and efficacy rates of over 90% against all infections.