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KMID : 0311219760070010077
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Yonsei Reports on Tropical Medicine
1976 Volume.7 No. 1 p.77 ~ p.87
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Chemotherapeutic Evaluation of Tiberal (Ro7-0207) in Entamoeba histolytica, Giardia lamblia, and Trichomonas vaginalis Infections using Double Blind Trial Method wersus Metronidazole
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Cho, Kee-Mok/趙基穆
Lee, Kun-Soo/Chang, Jae-Kyung/Soh, Chin-Thack/李健秀/張在景/蘇鎭琸
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Abstract
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The efficacy of Tiberal was assessed in 60 asymptomatic E. histolytica cyst carriers, 40 oligosymptomatic E. histolytica cyst passers, 20 hepatic amoebiasis patients, 30 Giardia lamblia infections and 20 trichomonal vaginitis patients using double blind trial method (Tiberal versus metronidazole versus placebo, or Tiberal versus metronidazole).
The regimen of drugs was for those below 6 years of age 250 mg, between 7 and 12 years 500 mg, and over 12 years 1 gm, daily, divided into 2 doses for 7 consecutive days.
In the results of asymptomatic E. histolytica cyst carriers, a cure was obtained in 18 out of 20 cases in the group on Tiberal, and in 14 out of 20 cases in the group on metronidazole; 2 cases relapsed in the Tiberal group, and 3 cases relapsed and 1 ´case failed to respond to treatment in the metronidazole group. In oligosymptomatic E. histolytica cyst passers, the cyst became negative from the 5th day of treatment in both groups, but relapse occurred in 2 out of 20 cases in the Tiberal group and 3 out of 20 cases in the metronidazole group during 1?4 weeks after the completion of medication. In the treatment of hepatic .amoebiasis, the clinical and parasitological effects of both Tiberal and metronidazole were similarly satisfactory; the stools remained free of E. histolytica and none of the patients was observed to have relapsed during the follow-up period of 6 months. In .Giardia lamblia infections, all became negative after treatment and no relapse was encountered in the group on Tiberal, but the parasite again appeared in 1 out of 10 cases on metronidazole. In the trial of trichomonal vaginitis, both drugs gave excel-lent therapeutic results with rapid clinical improvement and disappearance of the parasite, but after completing therapy, one patient relapsed in the Tiberal group and one patient in the metronidazole group, after 2 months and 2 weeks respectively, among 10 patients in each group.
Tolerance of Tiberal was satisfactory, but side effects appeared in 4 cases receiving metronidazole. These were dizziness, nausea, epigastralgia and skin rash. The symptoms were generally mild and transitory, but skin rash rapidly developed and disappeared when treatment was discontinued.
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