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NEUROLOGY 1996;46:1016-1021
© 1996 American Academy of Neurology

Interferon-alpha is effective in HTLV-I-associated myelopathy

A multicenter, randomized, double-blind, controlled trial

S. Izumo, MD, I. Goto, MD, Y. Itoyama, MD, T. Okajima, MD, S. Watanabe, MD, Y. Kuroda, MD, S. Araki, MD, M. Mori, MD, M. Nagataki, MD, S. Matsukura, MD, T. Akamine, MD, M. Nakagawa, MD, I. Yamamoto, MD and M. Osame, MD

From the Third Department of Internal Medicine, Faculty of Medicine, Kagoshima University (Drs. S. Izumo and M. Osame); Department of Neurology, Neurological Institute, Kyushu University (Drs. I Goto and Y. Itoyama); Third Department of Internal Medicine, Oita Medical University (Dr. T. Okajima); Department of Internal Medicine, Karatsu Red Cross Hospital (Dr. S. Watanabe); Department of Internal Medicine, Saga Medical School (Dr. Y. Kuroda); First Department of Internal Medicine, Kumamoto University Medical School (Dr. S. Araki); Department of Neurology, Nagasaki-Chuo National Hospital (Dr. M. Mori); First Department of Internal Medicine, Nagasaki University School of Medicine (Dr. S. Nagasaki); Third Department of Internal Medicine, Miyazaki Medical College (Dr. S. Matsukura); Department of Neurology, Miyazaki prefectural Hospital (Dr. T. Akamine); Department of Neurology, National Sanatorium Okinawa Hospital (Dr. M. Nakagawa); Faculty of Pharmaceutical Sciences, Okayama University (Dr. I. Yamamoto), Japan.
Received February 24, 1995. Accepted in final form September 13, 1995.
Address correspondence and reprint requests to Dr. Shuji Izumo, Center for Chronic Viral Diseases, Faculty of Medicine, Kagoshima University, Sakuragaoka 8-35-1, Kagoshima 890, Japan.

A double-blind, multi-center study was performed on patients with HTLV-I-associated myelopathy (HAM) to evaluate the therapeutic effect of treatment with natural interferon-alpha (HLBI). Forty-eight HAM patients were enrolled and treated with either 0.3 MU (n equals 15), 1.0 MU (n equals 17), or 3.0 MU (n equals 16) of HLBI for 28 days. Clinical evaluation included motor dysfunction, urinary disturbances, and changes of neurologic signs. The frequency of therapeutic response judged as excellent to good 4 weeks after starting therapy and 4 weeks after completion of therapy were 7.1% (1 of 14) and 8.3% (1 of 12) in the 0.3-MU group, 23.5% (4 of 17) and 26.7% (4 of 15) for the 1.0-MU group, and 66.7% (10 of 15) and 61.5% (8 of 13) for the 3.0-MU group. The therapeutic benefit in the 3.0-MU group was significantly higher than in the 0.3-MU group. There was no significant difference in the incidence of symptomatic side effects between groups. Abnormal laboratory data were obtained for some patients in the 1.0-MU and 3.0-MU groups; however, the treatment schedule could be continued in most patients. These results suggest that HAM patients may be safely treated with HLBI 3.0 MU every day for 4 weeks with favorable clinical effects.

NEUROLOGY 1996;46: 1016-1021




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