Clinical Studies on the Alpha-ethyl thioisonicotinamide (1314 Th) Resistance of Tubercle Bacilli (Report II)

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Chronic treatment-failure cases of pulmonary tuberculosis, who were excreting tubercle bacilli resistant to all of streptomycin (SM), isoniazid (INH) and PAS, were treated for 4 months with 1314Th alone (daily 0.5 gm, with "resistancedrugs"=SM, INH, PAS), with 1314Th+cycloserine (CS) (daily 0.5 gm), with 1314Th +kanamycin (KM) (weekly 2 gm), or with 1314Th+SM (weekly 2 gm). Degree of 1314Th resistance of tubercle bacilli was monthly determined in these cases. Drug resistance test for 1314Th was conducted by a direct method named by the authors as "the actual count method". The method consists of inoculating onto a series of egg media containing graded concentrations of the drug (0, 5, 10, 20, 30, 50, 100 and 200 μg/ml) each 0.02 ml of three dilutions, 100, 10-2 and 10-3, of sputum fluid, which was homogenized by addition of one volume of 5 % KOH (or 8 % NaOH). Count was made after 4 and 6 weeks and the degree of resistance was determined as the highest concentration of the drug, on which small inocula consisting of 10 to 100 (near fifty) viable cell units can grow. In other words, a series of media showing the nearest number of colonies to fifty pertube in the control were used for determination of the resistance levels. The results obtained are as follows: 1) Sputum conversion was obtained at a rate of 3/13 (23%) in the single use of 1314Th and at a rate of 7/12 (58%) in the combined use (Table 2). 2) Natural resistance to 1314Th showed a close correlation with the therapeutic effect of 1314Th (Table 1 and Fig. 1). The existence of the natural resistance more than 10 μg/ml markedly decreased the sputum conversion rate, and most cases of the sputum conversion were found in those cases showing a resistance level less than 5 pg/ml before the treatment (Table 1). 3) Resistance to 1314Th reached a level more than 20μg/ml in all cases with positive sputum after the treatment with 1314Th for 3 months and no significant clinical improvement was observed after this time. Therefore, the limit of the resistance in clinical sense seemed to be 20 or 30 μg/ml levels (Fig. 1). 4) Emergence of acquired resistance to 1314 Th was retarded by the combined uses of 1314Th +CS and/or 1314Th+KM (Fig. 2). These drugs (and SM also) were considered to be effective drugs for the combination with 1314Th. 5) Degrees of resistance to SM, INH and PAS, which had existed before the treatment with 1314Th, was not markedly affected by the use of 1314Th for 4 months (Table 3). 6) Even after the cease of 1314Th adminis tration, the resistance to 1314Th once established in tubercle bacilli remained stable through out 8 months of treatment period with other drugs.
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Clinical Studies on the Alpha-ethyl thioisonicotinamide (1314 Th) Resistance of Tubercle Bacilli (Report II)

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