(The) rapeutic effect of rifampicin for the leprosy patients
DDS는 우수한 항나제로서 오늘날 임상적으로 널리 사용되고 있으나, 아직도 그 독성과 부작용에 대한 보고(Graham, 1975)와 함께 오랜 기간의 치료를 요하기 때문에 오는 불규칙적 복용, 복용중단해서 오는 재발등의 보고(Quagliato등, 1970)가 있으며 한편 설폰(sulfone) 내성 인나균(人癩菌)의 출현에 관한 보고도 있다(Pettit 및 Rees, 1966: Pearson등, 1976). 따라서 많은 연구자들은 더욱 강력하고 효과적이며 단기간내에 치료효과를 볼 수 있는 새로운 항나제의 개발에 노력하고 있다.
Opromolla(1963)에 의해 처음으로 경구용 rifamycin SV를 10명의 나종양형 나환자 치료에 사용한 이래 rifampicin의 나병 치료효과에 관해서는 다양한 보고가 있으며, 근래에 새로운 항나제로서 각광을 받기 시작하였으나 아직도 rifampicin의 나병 치료에 있어서 유효 투여량, 적정투여기간 및 장기 치료효과등에 대하여 연구자들간에 논란이 되고 있다.
이에 저자는 1970년 1월부터 1976년 6월까지 세계 기독교 선명회 특수피부진료소에 등록된 나종양형 나환자 96예를 대상으로하여 DDS와 함께 rifampicin의 나병 치료효과를 비교 관찰하고자 세균학적 및 임상적 치료성적을 중심으로 비교검토한 바 다음과 같은 성적을 얻었다.
1. 신환자군의 rifampicin 단독투여 및 rifampicin과 DDS 병용투여군에서 25개월에서 36개월간 투여한 8예 및 2예 가운데 각각 3예 및 1예의 균음전예를 관찰할 수 있었으며 세균지수의 무변화 또는 악화됨 예는 관찰할 수 없었다. 한편 DDS 단독투여군에서는 25개월에서 36개월간 치료한 30예 가운데 2예의 균음전화를 관찰할 수 있었으며, 2예에서 세균지수의 무 변화를 관찰할 수 있었다.
구환자군에서는 rifampicin 단독투여군 및 rifampicin과 DDS 병용투여군의 치료 25개월에서 36개월까지 관찰한 4예 및 7예 가운데 각각 1예 및 5예의 균음전예를 나타냈으며 rifampicin 단독투여군에서만 1예의 세균지수 무변화를 나타냈다.
2. 신환자군의 rifampicin 단독투여군에서 치료 36개월 후에 있어서 평균세균지수의 감소는 3.3이었으며, rifampicin과 DDS병용투여군에서는 2.4, DDS 단독투여군에서는 1.4로서 rifampicin투여군의 평균세균지수 감소가 DDS 단독투여군에 비하여 현저함을 보였다.
구환자군의 평균세균지수의 감소는 치료 36개월 후에 rifampicin 단독투여군에서 1.2, rifampicin과 DDS 병용투여군에서 1.8의 감소를 보였다.
3. Rifampicin 단독투여 또는 rifampicin과 DDS 병용투여가 나종양형 나환자와 임상적 증상의 호전에 있어 DDS 단독투여시 보다 신속하며 우수한 치료효과를 나타냈다.
4. Rifampicin투여시 수반되는 부작용으로는 신경염을 수반한 신경통 및 ENL을 관찰할 수 있었으나 DDS 단독투여시에 비하여 낮은 발생율을 보였다.
이상의 성적으로 미루어 보아 나병치료에 있어서 rifampicin은 DDS에 비하여 신속하고 현저한 치료효과를 관찰할 수 있었다.
DDS is an excellent antileprosy drug and has been a drug of choice to treat leprosy clinically. However, there are many reports that after taking DDS, mild toxic and hypersensitive reactions have been observed. Also, DDS requires such a long therapeutic period to be effective that partients take treatment irregularly and finally stop medication altogether. Because of this, relapses are often reported (Quagliato et al, 1970). Also, sulfone-resistant M. leprae have been reported (Pettit and Rees, 1966, Pearson, 1976). Therefore, there has been much research done to find more efficient and potent antileprosy drugs.
Since Opromolla(1963) firsts introduced rifamycin SV as an antileprosy drug to 10 lepromatous type leprosy patients there have been many reports about the antileprosy effects of rifampicin. Nowadays rifampicin is appearing as a new antileprosy drug, but there is still much discussion about the most effective
dosage, the duration of treatment, and therapeutic effects of rifampicin. In this study, ninety-six lepromatous type leprosy patients who had been registered at the World Vision Leprosy Research and Treatment Center from Jan. 1970 to June 1976 were treated with DDS and rifampicin. The therpeutic effects after taking rifampicin were compared with those after taking DDS by means of comparing the respective patients' bacteriological and clinical evaluations.
Materials and Methods
Ninety-six lepromatous type leprosy patients, who were registered at the World Vision Leprosy Research and Treatment Center from January 1970 to June 1976 were selected. These patients were divided into two groups: the new patient group and
the old patient group.
1. New Patient Group: For the new patient group, fifty-four patients were selected who had never been treated from the onset of their disease to the beginning of this study. These patients were divided into three classes. The first class( Ⅰ ) included fourteen patients who had been treated with rifampicin only, the second class( Ⅱ ) included ten patients who had been treated with rifampicin combined with DDS, and the third class( Ⅲ ) included thirty lepromatous type leprosy patients were selected who had been treated with DDS only since the beginning of their treatment.
2. Old Patient Group: For the old patient group, forty-two lepromatous type leprosy patients were selected who had been treated with DDS and other antileprosy drugs for one year or more before the start of the study and had shown no change in their symptoms from taking DDS or other antileprosy drugs. We divided these patients into two classes. One( Ⅳ ) included nine patients who had been treated with rifampicin only and the other included thirty-three patients who had been treated with rifampicin combined with DDS( Ⅴ ).
1. Administration of antileprosy drugs; Each of the classes was subdivided into three subclasses which were treated for 12 months(C), 13-24 months(B) and 25-36 months(A) respectively. In classes Ⅰ, patients were given 150-300 mg of rifampicin per day. In classes Ⅱ and Ⅴ, patients were given a dose of 150-300 mg of
rifampicin per day and 200-300 mg of DDS per week. In class Ⅲ, DDS was administered in dose or 350-600 mg per week.
2. Method of Evaluation
a. Bacteriological Evaluation; The bacteriological evaluation was based on a comparision of the change of the Bacterial Index(B.I.), Granularity Index(G.I.) and Solid Fragmented and Granulearity(S.F.G.) value of the patients in the new and old
b. Clinical evaluation; The clinical evaluation was based on the clinical improvement in the lepromatous infiltrations and nodules from the start of the study. The degree of clinical improvement was graded as deterioration of the condition, no change, a easily visible improvement, a marked diminution of the
cutaneous signs, and a complete disappearance of all cutaneous signs.
1. Among new patient groups, 3 out of 8 patients treated with rifampicin alone and 1 out of 2 patients treated with rifampicin and DDS together became B.I. negative after thirty-six months treatment No aggrevated or stationary cases in B.I. were observed. Among the 30 cases who were treated with DDS alone for
thirty-six months, 2 cases were found to be B.I, negative and 2 cases without changes in B.I. inspite of the treatment. In tHe old patient group of 7 patients treated with rifampicin alone and 7 patients treated with a combination of rifampicin and DDS, 4 cases and 5 cases respectively were found to be negatively converted. I case among the cases who received rifampicin alone showed no change in B.I.
2. In the new patient group, the decrease in average B.I. of the patients who were treated with rifampicin only was 3.3, while the decrease on average B.I. of the patients treated with a combination of rifampicin and DDS was 2.4 and that of the patients treated with DDS only was 1.4 after taking drugs for thirty six months. With this, the decrease in average B.I. of the group treated with rifampicin was more pronounced than that of the group treated with DDS.
In the old patient group, the decrease in average B.I. of the patients treated with rifampicin alone was 1.2 and of the patients treated with rifampicin combined with DDS, 1.8, after taking drugs for thirty-six months
3. When looking at the clinical symptoms of lepromatous type leprosy patients, the regimen of rifampicin alone or rifampicin combined with DDS proved more effective and faster than giving the patients DDS alone.
4. The side reactions after taking rifampicin were neuralgia and E.N.L., but these were more mild and of lower frequency than the side reactions after taking DDS alone.
From the above results, it is concluded that rifampicin has greater and faster therapeutic effects in the control of leprosy than DDS.