TE-031 (A-56268), a new macrolide antibiotics, was administered on a long-term basis (6 months) to 12 patients with diffuse panbronchiolitis (DPB). The causative microorganism was identified as H. influenzae in 5 cases, P. aeruginosa in 4 cases and B. catarrhalis in one case. The clinical picutre of those patients was monitored, and some basic studies were also carried out.
Clinically, all of the patients showed improvement in the symptoms and the various laboratory test values. Bacteriologically, as well, both H. influenzae and B. catarrhalis were eradicated. In addition, P. aeruginosa was eradicated from 2 of the 4 cases, reduced in one case and unchanged in one case. Hhowever, even in that one case in which P. aeruginosa was unchanged, the disease symptoms were alleviated. There were no instance of microbial replacement.
In spite of the long-term administraiton of TE-031, There were no side effects.
As the basic studyk, the DPB patients were examined for the presence of antibodies directed at viruses having affinity for the respiratory organs. It was found that a high perventage of the patients showed a high titer of antibodies for influenza virus type III and type II. It was thus surmised that it is likely that viral infection is involved in the progress of this disease.
From the standpoint of the progress of DPB, the NK activity was investigated as part of the natural host defense mechanisms. It was found that, compared with healthy controls, the level of NK activity was higher in DPB patients and that it was even higher in patients on long-term TE-031 administration.
On the basis of the above results, it is surmised that TE-031 elevates the NK. activity, and thereby accelerates the nonspecific defense mechanisms of the host. Patients with DBP thus acquire added protection against viral infection, which could play a role in the progress of DPB. Therefore, without viral-caused lesions in the airways to attach to, bacteria are less likely to colonize the mucosa and establish superinfection. It is surmised that, as a result of these direct and indirect mechanisms, TE-031 brings about improvement in the prognosis of DPB.