The clinical efficacy and safety of Netilmicin (NTL) and Sisomicin (SISO) were compared in thisrandamized, double-blind study of 226 patients with respiratory tract infections.
Patients were assigned to treatment with either 100mg of NTL or 75mg of SISO by intramuscularinjection twice a day for 7 to 14 days.
The results obtained were as follows:
1) Patients subject to analysis: One hundred and eighty-nine patients were adopted for evaluationof clinical efficacy by committee members. Of these patients, 96 were treated with NTL and 93 with SISO. The number of patients treated with NTL and SISO was, respectively, 63 and 57 inpneumonia, 0 and 2 in pulmonary abscess, and 33 and 34 in chronic respiratory tract infections.
Two hundreds and seventeen patients were adopted for analysis of clinical efficacy by controllersafter judgement of clinical efficacy by doctors in charge. Of these patients, 107 were treated with NTLand 110 with SISO. The number of patients treated with NTL and SISO was 80 and 70 in pneumonia, 5 and 12 in pulmonary abscess, and 22 and 28 in chronic respiratory tract infections, respectively.
2) Clinical efficacy: The clinical efficacy rate (excellent and good responses) in all cases judgedby committee members was 65% in NTL group and 71% in SISO group, respectively. For pneumoniathe efficacy rate was 79% in NTL group and 75% in SISO group, with no significant difference betweenthe two. For chronic respiratory tract infections the efficacy rate was 36% in NTL group and 65% in SISO group, and difference was significant (p<0.05).
The clinical efficacy rate in all cases judged by doctors in charge was 67% in NTL group and 67%in SISO group, respectively. For pneumonia the efficacy rate was 74% in NTL group and 73% in SISOgroup. For pulmonaly abscess the efficacy rate was 80% in NTL group and 42% in SISO group. Forchronic respiratory tract infections the efficacy rate was 41% in NTL group and 64% in SISO group. Overall, or judged by doctors in charge there was no statistical difference between NTL and SISO.
3) Degree of symptomatic improvement: There was no statistically significant difference in thedegree of improvement.
4) Bacteriological efficacy: There was no significant difference in the bacteriological efficacy.
5) Adverse reactions: The adverse reactions of NTL group and SISO group were similar in typeand frequency, except that the eosinophilia was observed significantly more frequently in patientstreated with NTL than in those with SISO (p<0.1), judged by committee members.
6) Utility: There was no significant difference in the utility judged by doctors in charge.
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