Case records of 1,098 patients treated with amikacin at 79 research centers in 10 countries in a program of worldwide clinical trials were reviewed. Of the 697 patients eligible for use in evaluation of efficacy of the drug, 81% were cured, as evidenced by clinical remission and eradication of the infecting pathogen. The usual dosage was 7.5 mg/kg administered intramuscularly at 12-hr intervals. This dosage was modified in patients with renal impairment. Amikacin was effective in 90% of 322 patients with genitourinary infections, 85% of 97 patients with septicemia, 70% of 73 patients with infections of skin, soft tissue, or bone (excluding burns), and 69% of 68 patients with infections of the lower respiratory tract. Amikacin was effective in treatment of 88% of 85 infections due to gentamicin-resistant pathogens. The drug was generally well tolerated, and no side effects were reported in 80.6% of the 1,098 patients evaluated. Amikacin shares with other aminoglycosides the risk of ototoxicity and nephtotoxicity; previous exposure to gentamicin was a major factor in the development of such adverse effects. Other adverse reactions were relatively infrequent and in most cases were characterized as mild and transient.
IN THIS study, the principle of using a physiological fluid load to produce a disturbance in the sleep of normal subjects has been utilized both for the evaluation of the non-barbiturate hypnotic, ethchlorvynol ('Arvynol': Pfizer) and to compare its hypnotic effect with glutethimide ('Doriden': Ciba). The (Reinert, I962). No effect on the human fcetus has been noted in the U.S.A. where this hypnotic has been available for over 6 years. MethodsThis study was carried out in four phases on healthy adult subjects of both sexes with no history of insomnia or recent disease.In the first phase each subject was given one of five treatments on each of five different nights in a randomized order. These treatments were a placebo, 250 mg. glutethimide, 500 mg. glutethimide, zoomg. ethchlorvynol and 500 mg. ethchlorvynol. Each subject was instructed to take the hypnotic and a water load (i i pints) on retiring and note this time and the time of first waking. However, after the first night of the experiment it became apparent that ij pints of water produced a disturbance of sleep irrespective of whether the subjects received either a hypnotic or a placebo. Therefore, for the following four nights the water load was reduced to i pint but this amount was later found to be inadequate.Further experiments (phase 2) demonstrated that I pint of milk produced a more consistent disturbing effect on sleep. In our experience the majority of subjects prefer milk to water and the use of a one-pint bottle ensures the correct volume being taken.In phase 3 ethchlorvynol was compared with a placebo and in the final phase with both glutethimide and a placebo. ResultsThe results of the water-load experiment can be seen in Table i, which shows the Mnean sleeping time obtained following a i '-pint water load (Ist night only); a 3-pint water load (nights 2-5 inclusive); and the effects over all five nights. In this phase, 7I subjects participated. As these preliminary trials demonstrated that the technique in this form was not suitable for our purpose phase 2 was carried out as a small pilot review, with six subjects only (all males) with an intermediate fluid load of i pint of milk. This second investigation was organized as a cross-over trial on two nights only with a placebo and 500 mg. ethchlorvynol. The results (Table 2) show a difference between sleeping times for the hypnotic and placebo which suggested that this modified procedure was more suitable and that with larger numbers, statistically valid results could be obtained.Phase 3 was organized as a cross-over study with 500 mg. ethchlorvynol and a placebo in 24 subjects (12 male and 12 female). On the first night half of each group received the placebo and the other half the active tablet, the alternate treatment being given on the second night. It was also decided to take the difference in time between retiring to bed and actually getting up to empty the bladder rather than the time of first waking, since previous experience had shown that some subjects were minimally roused but did ...
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