腹部手術施行患者におけるエノキサパリンナトリウム短期使用の有効性および安全性評価

抄録

Enoxaparin sodium (EXP) is useful in preventing the development of venous thromboembolism (VTE) after abdominal surgery. In a phase III clinical study (EXP-P3-study), EXP was administered for 14 days after surgery; however, the dosing period recommendations in Japan remain unclear. In our hospital, EXP was administered for a period of 5 days, and the efficacy and safety of this treatment were retrospectively surveyed to assess whether short-term administration of EXP was useful in patients.

The subjects included 152 patients who were administered EXP after abdominal surgery. The mean dosing duration of EXP was 4.3 ± 1.1 days. Among the subjects, one patient developed VTE, and 3 developed a major hemorrhage (2.0％). The efficacy rate of EXP in preventing VTE was 99.3％.

In the EXP-P3-study, the incidences of VTE in patients administered or not administered EXP were 1.2％ and 19.4％, respectively. In the cohort of the present study, the incidence of VTE was markedly controlled as compared to that in patients who were not administered EXP. The major hemorrhage rates of the EXP-administered group and non-EXP-administered group were 4.6％ and 2.6％, respectively, in the EXP-P3-study. In the current study, the major hemorrhage rate was similar to that of the non-EXP-administered group in the EXP-P3-study.

In conclusion, the present study suggests that administration of EXP for 5 days was not less effective compared with administration for 14 days. Therefore, it is suggested that 5-day administration of EXP was useful in preventing the development of VTE after abdominal surgery.