Oligozoospermia に対するMecobalamin の臨床効果 - 二重盲検比較試験による検討 -

Abstract

男子不妊症396例(25施設)に対するMethyl-B12の有用性を, 6, 000 μg/日投与群, 1, 500 μg/日投与群, Placebo投与群の12週間投与による二重盲検比較試験により検討した.WHOの規定とも合致することから, 精子数20×100/ml以下の症例について治療効果の検討を試みた.運動率50%以下, LH 13.5 mIU/ml以下の正常範囲にとどまる症例では, 精子数の正常化した症例がPlacebo群に比して6, 000 μg群, 1, 500 μg群で有意に多く認められ, 精子数, 運動率, LH値の3パラメーターを変化させながら治療効果が有効となる条件を検討したところ, 計57.1%の症例で治療効果が期待できる効果となった.また重篤な副作用は認められず, 安全性の高い薬剤であることが確認された.以上の結果から, 上記の条件における乏精子症に本剤, とくに6, 000 μg/日投与は有効な薬剤であると考える

The clinical efficacy of mecobalamin in the treatment of male infertility was investigated by means of a multicenter collaborative study with 25 participating institutions. The study was carried out as a double-blind, comparative trial using three administration groups: 6, 000 micrograms of mecobalamin per day, 1, 500 micrograms of mecobalamin per day and a placebo group for 12 wk. The following results were obtained. 1. The total number of evaluated subjects was 375, consisting of 125 in the 6, 000 micrograms/day mecobalamin group, 124 in the 1, 500 micrograms/day mecobalamin group and 126 in the placebo group. There were no significant differences among the three administration groups in terms of the patient's background factors. 2. When all of the patients were analyzed, there were no statistically significant differences among the three administration groups in terms of the efficacy in relation to the sperm count or the motility rate. 3. However, it was decided to perform a more detailed analysis of the therapeutic efficacy in patients whose pretreatment sperm counts were 20 x 10(6)/ml or less. The reasons for this decision were two-fold: 1) There was a large degree of fluctuation in patients whose pretreatment sperm counts showed a mean value of more than 20 x 10(6)/ml for two or more determinations, and it was surmised that this fluctuation might have masked any therapeutic effect in those cases. 2) The WHO definition of oligozoospermia was recently decided as a sperm count of 20 x 10(6)/ml or less.(ABSTRACT TRUNCATED AT 250 WORDS)