ABSTRACT
Objective To compare the efficacy of uniform multi-drug therapy (UMDT) versus routine multi-drug therapy (RMDT) for the treatment of multi-bacillary (MB) leprosy patients based on bacterial index changes and frequencies of leprosy reaction.Methods This study recruited newly diagnosed leprosy patients after taking informed consent in three districts of Guizhou province as well as in one district of Yunnan province from November 2003 to June 2005.The patients received 6-month UMDT or 2-year RMDT.Clinical follow up and bacterial reexamination were carried out once a year.Changes of bacterial index (BI) and frequencies of leprosy reaction were compared between the patients receiving RMDT and UMDT.Results A total of 166 patients received UMDT and 170 received RMDT in this study.Among the UMDT-treated patients,114 were skin smear positive,and 83 had been followed up for 42 months; of the RMDT-treated patients,149 underwent all the bacterial examinations during a 48-month follow up.The mean bacterial index decreased from 2.84 before treatment to 0.33 at the end of the 42-month follow up in the 83 patients,and from 2.55 to 0.26 at the end of the 48-month follow up in the 149 patients,with no significant difference in the changes of bacterial index between the two groups (t =0.77,P ＞ 0.05).Bacterial index became negative in 73.5％ (61/83) of the UMDT-treated patients and in 77.2％ (115/149) of the RMDT-treated patients (x2 =0.40,P＞ 0.05)at the end of follow up.During the follow up peroid,the incidence of type Ⅰ leprosy reaction was 14.6％ (13/89) in the UMDT group,significantly higher than that in the RMDT group (3.4％ (5/149),x2 =10.08,P＜ 0.01 ).Conclusions There is no significant difference in mean bacterial index changes and bacterial clearance rate during the follow up peroid between UMDT- and RMDT-treated patients.The incidence of type Ⅰ leprosy reaction is higher in the UMDT group than in the RMDT group,and further investigation is needed to clarify the mechanisms underlying the phenomenon.
ABSTRACT
Objective To assess the efficacy of 6-month uniform multidrug therapy in various types of leprosy. Methods A field trial was conducted among 166 patients with different types of leprosy. All patients were treated with uniform multidrug therapy for 6 months, then followed up for 2 years. Clinical and bacterio-logical improvements were evaluated. Results Among the 166 patients, 31 dropped out due to various reasons,and 135 completed the 6-month treatment and 2-year follow-up. Among the 135 patients, 45 (33.3%) were skin smear negative, and the other smear-positive 90 had an average bacterial index (BI) of 2.91±1.45 (range: 0.1-6.0) before treatment. At the end of the 2-year follow-up, the 45 skin smear-negative patients showed 93.3% improvement in skin lesions and 80.0% improvement in nerve impairments, and the smear-posi-tive 90 patients showed 95.6% improvements in skin lesions and 77.8% improvement in nerve impairments.Skin smear turned negative in 49 (54.4%) out of the smear-positive 90 patients with the average BI declining to 0.66±0.99. The annual decrease in BI reached 0.9 during the first 2.5 years after the beginning of treat-ment. Twenty-five patients developed leprosy reaction during the follow-up, including 13 cases of type Ⅰ leprosy reaction and 12 cases of type Ⅱ leprosy reaction. Relapse was noted in 1 patient with muhibacillary leprosy 13 months after the termination of treatment. Conclusions The short-term efficacy of uniform multidrug therapy is similar to that of 2-year treatment with routine multidrug therapy. However, further studies are required to survey the incidence of leprosy reaction and relapse in patients treated with uniform multidrug therapy.