初回治療肺結核症に対する6カ月短期化学療法の成績 : その効果, 副作用と受容性について6年間の経験から

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The incidence of tuberculosis in Japan, 33.7 per 100, 000 in 1997, is very high comparedwith USA or Western European countries. The decrease in the incidence has slowed downfrom the early 1980s, and the average annual rate of decrease has been 3.8% in the last5 years. About 9 percent of tuberculosis patients defaulted from the nine month regimen (6HRS or E/3HR) in urban areas. Regimens shorter than nine month are needed to achievehigh effectiveness of tuberculous chemotherapy. Out of 1128 new pulmonary tuberculosispatients, six-hundred twenty started treatment with six-month (2HRZS or E/4HRE) in Fukujuji Hospital, JATA, in Tokyo from January 1991 to December 1996. Out of 620, four-hundred twenty eight were both smear and culture positive, 136 were smear negativeand culture positive and 56 were bacilli negative. Out of 564 bacilli positive cases, 530were susceptible to INH and RFP. Out of 530 drug susceptible cases three hundred ninetythreepatients completed the regimen. Ninety-three percent of these patients had convertedto negative at two months of chemotherapy and all of them at five months. Outof 450, two-hundred ninety five completed 6 month regimen, one-hundred fifty-fivewere changed their regimen or prolonged duration of chemotherapy. Out of 295, nine patients (3.1%) relapsed after the completion of 6-month chemotherapy. Mean follow? upperiod was 17.2 months and the median was 15.5 months. The relapse rate was 2.2 per 100person-years. Six of the relapsed cases were complicated with Diabetes Mellitus. Relapserate was higher in patients with Diabetes Mellitus than in patients without (6/54, 7.9 per 100person-years vs 3/237, 0.8 per 100 person-years) (p<0.001). Drug-induced hepatotoxicity was defined as elevated serum transaminase level with clinical symptoms of hepatitis orelevated serum transaminase level more than 5 times of upper limit of normal range withor without symptoms. Drug-induced hepatotoxicity developed in 43 (8.0%) of 535 withinitial normal liver function test results, this rate was similar to that in patients treatedwith nine-month regimen (34/420, 8.1%). But the frequency of hepatotoxicity of morethan 400 IU/m/ of serum transaminase level was higher in patients treated with PZA-containingregimen than with nine-month regimen (16/536, 3.0% vs 4/420, 1.0%), but this deferencewas not statistically significant. Hepatotoxicity developed in 13/85 (15.3%) ofpatients treated with PZA-containing regimen with abnormal liver function tests at thebeginning of chemotherapy, and this frequency was similar to 7/65 (10.8%) in patientswith nine-month regimen. The relapse rate in patients with Diabetes Mellitus was statisticallyhigher than in without Diabetes Mellitus (7.9 νs 0.8 per 100 person-years). Weconcluded that the six-month regimen was highly effective, but the frequency of severehepatotoxicity was relatively higher than in nine-month regimen and the duration of chemotherapywas not enough for patients complicated with Diabetes Mellitus. Furtherstudy is needed for sufficient chemotherapy in patients with Diabetes Mellitus.

初回治療肺結核症に対する6カ月短期化学療法の成績 : その効果, 副作用と受容性について6年間の経験から

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