BFluid Mechanism of Action

Pharmacology: BFLUID Injection was administered to intact rats and dogs and laparotomized vitamin B₁-starved rats, and its effects in the provision of vitamin B₁ and electrolytes and its nutritional effects were compared against those of AMINOFLUID Injection. In intact rats and dogs, blood levels of vitamin B₁ remained at preadministration levels in the BFLUID Injection group. In laparotomized vitamin B₁-starved rats, recovery of vitamin B₁ levels to the normal range was observed after BFLUID Injection infusion. Therefore, it was concluded that BFLUID Injection is useful for the provision of vitamin B₁. BFLUID Injection and AMINOFLUID Injection were found to be comparable in terms of the provision of electrolytes and nutrition.
Pharmacokinetics: (Reference data in rats): BFLUID Injection containing ¹⁴C-labeled glucose was administered intravenously to intact rats. The radioactivity was rapidly distributed throughout the body, with particularly high levels observed in the liver (which plays an active role in glucose metabolism) and in the brain (which utilizes a large amount of glucose). The main route of excretion of the administered radioactivity was in the expired air as ¹⁴CO₂, accounting for 62.8% of the administered dose up to 24 hr. Radioactivity was also excreted in the urine (4.9%). The glucose was utilized mainly as an energy source and expired in the breath.
CLINICAL STUDIES: A comparative clinical study of BFLUID was conducted at 16 institutions in Japan. This study included a total of 110 patients who had undergone gastrointestinal surgery. The clinical effects were evaluated in 97 of the 110 patients (46 patients in the BFLUID group and 51 patients in the control group). Blood levels of vitamin B₁ were maintained in the BFLUID group, in contrast to the decreased levels of vitamin B1 observed in the control group. Levels of serum proteins (total protein, albumin, prealbumin, transferrin, and retinol-binding protein) showed similar trends in both groups.
Safety was evaluated in 102 of the 110 patients (50 patients in the BFLUID group and 52 patients in the control group). Adverse events were defined as findings related to signs and symptoms, abnormal changes in vital signs, abnormal changes in laboratory data, and metabolic acidosis. Adverse events for which a relationship to administration of the study drug could not be ruled out were defined as adverse reactions.
For vital signs and laboratory data, adverse events were also defined as values outside the normal range (the standard range for healthy subjects at each facility) after the start of infusion in comparison with postoperative preinfusion values. In addition, if the Investigator or the Co-investigators noted any abnormal changes in outcome variables not specified in the protocol, the changes were handled as adverse events.
A total of 17 (34.0%) of the 50 patients in the BFLUID Injection group experienced 32 adverse reactions, showing no statistically significant difference with the findings in the control group (17 of 52 subjects [32.7%], 36 adverse reactions).
Adverse events are also commonly observed after surgical procedures for gastrointestinal diseases, and their frequencies were comparable to the results for the control group. (Refer to the tables as follows.)
Vitamin B₁ deficiency was not observed in either the BFLUID Injection group or the control group during the 5-day infusion period. (See Table 5.)

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With special regard to the deviations of laboratory values shown in the tables previously, all deviations cannot be judged to be "medically significant adverse reactions" because postoperative fluctuations in laboratory values were not taken into consideration. Therefore, an "abnormal value for which treatment was required" was defined as a "medically significant adverse reaction". A total of 8 (16.0%) of the 50 patients in the BFLUID Injection group experienced 11 medically significant adverse reactions, showing no statistically significant difference with the findings in the control group (8 of 52 patients [15.4%], 10 adverse reactions). (See Table 6.)

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