二重盲検法による急性単純性膀胱炎に対する塩酸Doxycycline静注剤の効果判定

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  • A DOUBLE BLIND CLINICAL EVALUATION OF PT-122 M IN THE TREATMENT OF ACUTE SIMPLE CYSTITIS
  • ニジュウ モウケンホウ ニヨル キュウセイ タンジュンセイ ボウコウエン ニ

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The clinical effect of PT-122 M was evaluated by the double blind comparative trial comparing with that of DOX capsule in the cases of acute cystitis. <BR>The materials were divided into two groups at random. One group (A), 71 cases, was administrated PT-122 M and inert placebe DOX, the other (B), 72 cases, active DOX capsule and inert PT-122 M placebo ampule at the same time.<BR>There was no significant difference in the clinical and bacteriological background between two groups.<BR>The clinical effect of two groups was determined according to symptoms, urinalysis and bacteriological findings. Excellent effect was observed in 23.9% of group A and 22.2% of B. Good effect was oberved in 62.1% of A and 55.6% of B. Statistical analysis by chi-square test of FISHER exact probability test revealed no significant difference between two groups.<BR>The relapse and reinfection rate after 7 days of the treatment was in 14% of group A and 18.6% of B, showing no statistical significance. Total side effect rate of PT-122 M and DOX capsule was in 26.8% of group A and 38.9% of B. Nausea was observed in 6% of group A and 19% of B and the difference was statistically significant at 5% level. This study revealed that PT-122 M had the same clinical effect on acute simple cystitis as DOX capsule and less side effect than DOX capsule.

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