Elsevier

Tubercle

Volume 67, Issue 1, March 1986, Pages 5-15

Original article
Controlled clinical trial of 4 short-course regimens of chemotherapy (three 6-month and one 8-month) for pulmonary tuberculosis: Final report

https://doi.org/10.1016/0041-3879(86)90027-9Get rights and content

Abstract

The bacteriological relapse rates up to 30 months after the start of chemotherapy have been compared for 4 daily short-course regimens for pulmonary tuberculosis. All 4 had the same initial 2-month intensive phase of streptomycin, isoniazid, rifampicin and pyrazinamide (SHRZ) followed by isoniazid plus rifampicin for 4 months (4HR), or isoniazid plus pyrazinamide for 4 months (4HZ), or isoniazid alone for 4 months (4H), or isoniazid alone for 6 months (6H).

In patients with fully sensitive strains pretreatment, the 6-month regimen with rifampicin throughout (4HR) was highly effective, only 2% of 166 patients relapsing bacteriologically in 24 months of follow-up after stopping chemotherapy. This regimen was significantly better than the 4H regimen which had a relapse rate of 10% in 156 patients (P<0.02) and the 4HZ regimen which had a relapse rate of 8% in 164 patients (P=0.05). The 6H regimen was also highly effective, only 3% of the 123 patients relapsing, compared with 10% of the 156 on the 4H regimen (P=0.06). The relapse rate of the regimen with pyrazinamide throughout (4HZ), was not significantly different from that of either of the regimens with isoniazid alone in the continuation phase. All except 3 (1 4HR, 1 4HZ, 1 4H) of the 36 relapses were with fully drug-sensitive strains.

In patients with strains resistant to isoniazid alone pretreatment none of the 23 on the 4HR or 4HZ regimens had an unfavourable bacteriological status at the end of chemotherapy compared with 8 of the 17 patients (P<0.005) on 4H or 6H regimens. Of the patients assessed, 3 of 20 receiving rifampicin or pyrazinamide throughout relapsed compared with 2 of 8 who did not.

Résumé

On a comparé les taux de rechutes bactériologiques jusqu'au 30ème mois après le début de la chimiothérapie, pour 4 régimes quotidiens de courte durée pour la tuberculose pulmonaire.

Les 4 régimes possédaient tous la même phase initiale intensive comportant streptomycine, isoniazide, rifampicine et pyrazinamide (SHRZ) suivie d'isoniazide et rifampicine pendant 4 mois (4HR), ou d'isoniazide et pyrazinamide pendant 4 mois (4HZ), ou d'isoniazide seul pendant 4 mois (4H), ou d'isoniazide seul pendant 6 mois (6H).

Chez les malades dont les souches avant traitement étaient pleinement sensibles, le régime de 6 mois avec rifampicine tout au long (4HR) s'est montré hautement efficace, 2% seulement des 166 malades ayant présenté une rechute bactériologique au cours des 24 mois d'observation après l'arrêt de la chimiothérapie. Ce régime s'est montré significativement meilleur que le régime 4H qui a eu un taux de rechute de 10% parmi ses 156 malades (P<0,02) et que le régime 4HZ qui a eu un taux de rechute de 8% parmi ses 164 malades (P=0,05). Le régime 6H a aussi été hautement efficace, 3% seulement des 123 malades ont rechuté contre 10% des 156 qui avaient reçu le régime 4H (P=0,06). Le taux de rechute avec le régime comportant du pyrazinamide tout au long (4HZ) n'a pas éte significativement différent de celui observé avec l'un ou l'autre des régimes qui comportaient de l'isoniazide seul dans la phase de continuation. Les 36 malades qui ont rechuté, sauf 3 (1 4HR, 1 4HZ, 1 4H) étaient tous porteurs de souches pleinement sensibles aux médicaments.

Chez les malades porteurs de souches résistentes à l'isoniazide seul avant traitement, aucun des 23 malades des groupes 4HR ou 4HZ ne présentait un état bactériologique défavorable à la fin de la chimiothérapie, contre 8 sur 17 malades (P<0,005) dans les régimes 4H ou 6H. Parmi les malades qui ont été contrôlés, 3 parmi les 20 qui avaient reçu de la rifampicine ou du pyrazinamide tout au long de la durée du traitement ont présenté une rechute; les rechutes ont éte de 2 parmi les 8 malades revus qui n'avaient pas reçu ces médicaments dans la phase de continuation.

Resumen

Se comparan las tasas de recaídas bacteriolágicas 30 meses después del comienzo de la quimioterapia con 4 esquemas de tratamiento diario de corta duracián para la tuberculosis pulmonar. Los cuatro tenían la misma fase inicial intensiva de 2 meses con estreptomicina, isoniacida, rifampicina y pirazinamida (SHRZ) seguida de 4 meses con isoniacida más rifampicina (4HR) ó 4 meses con isoniacida más pirazinamida (4HZ) o isoniacida sola por 4 meses (4H) o isoniacida sola por 6 meses (6H).

En los pacientes con cepas completamente sensibles antes del tratamiento, el esquema que incluía la rifampicina a to largo de todo el tratamiento (4HR) fue altamente efectivo: sólo el 2% de 166 pacientes tuvieron recaídas bacteriológicas en 24 meses de seguimiento después del término de la quimioterapia. Este esquema fue significativamente mejor que el esquema 4H con el cual se constató un 10% de recaídas en 156 pacientes (p<0,02) y que el esquema 4HZ en el cual la tasa de recaídas fue del 8% en 164 pacientes (p=0,05). El esquema 6H fue también altamente efectivo con sólo 3% de recaídas en 123 pacientes comparado con el 10% de 156 en el esquema 4H (p=0,06). La tasa de recaída del esquema que incluía la pirazinamida a to largo de todo el tratamiento (4HZ) no fue significativamente diferente de cada uno de los esquemas con isoniacida sola en la fase de continuación. Todas las 36 recaídas, a la excepción de 3 (1 4HR, 1 4HZ, 1 4H) se presentaron en enfermos con cepas completamente sensibles a los medicamentos.

En los pacientes con cepas resistentes a la isoniacida sola antes del tratamiento ninguno de los 23 de los esquemas 4HR ó 4HZ tuvo resultaclos desfavorables al final de la quimioterapia, comparado con 8 de los 17 pacientes (p<0,005) de los esquemas 4H ó 6H. Entre los pacientes evaluados, se constató una recaída en 3 de un total de 20 que recibieron rifampicina o pirazinamida a to largo de todo el tratamiento, comparaclos con 2 de 8 que no recibieron estos medicamentos en la fase de continuación.

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