The possible approaches to this include defining multibacillary disease, for example, as present until BI negativity on skin smears or biopsy by which time most of the complications likely to occur will have occurred. Disease could also be defined by years until further relapse, reaction and neuritis are unlikely, but this, in fact, is uncertain at this point in time. Finally, we could have 2 registries - one for leprosy, the bacterial infection and another for leprosy, the disease. The problem here again is, of course, defining what constitutes disease.
Antibacterial Therapy：
The current standard regimens for the treatment of leprosy recommended by WHO are：
For paucibacillary disease： Rifampicin 600 mg monthly, supervised and 100 mg of dapsone daily, self-administered, for a total of 6 months therapy completed within 9 months.
For multibacillary dis6ase WHO recommends the same approach as for paucibacillary, except that clofazimine 300 mg once monthly, supervised and 50 mg daily self-administered is added. Therapy is also continued for a longer period of time. Until recently, it was recommended that the patient complete 24 months of therapy within 36 months, but now the recommendation has been changed to 12 months of therapy completed within 18 months. This recommendation was based on the results of an ongoing clinical trial and a review of a number of literature reports following up on patients who had taken less than the recommended course of therapy and were reevaluated after varying periods of time.
Finally, for single lesion paucibacillary leprosy the current WHO recommendation is 600 mg of refampicin + 400 mg of ofloxacin + 100 mg of minocycline (ROM) given as a single dose.
When one looks at any type of antibacterial therapy there are several things that are of concern. First of all, the duration of therapy. Ideal therapy would be a single dose of treatment for all types of leprosy. This is unlikely with the drugs currently available, but looking at regimens now under study we might ask whether a single dose of treatment monthly would be any better than daily therapy as now utilized from a control point of view since all patients would still have to be seen monthly, but with therapy as now constituted, therapy between doses it self-administered. Thus the amount of supervision given would in effect be unchanged even if you needed to give only, say, a single dose of ROM monthly.
Secondly, one is always concerned about the safety of antibacterial regimens. At this time, both the standard WHO regimens and all those under investigation appear to be relatively safe. '
Thirdly, one must look at efficacy. With any new regimen one must be concerned about whether the relapse rate will be worse with longer term follow-up than with the present regiments. Also of concern is whether the relapse rate in high BI patients, which has been reported to be higher in some series, will be a significant problem. Finally, what would an acceptance relapse rate be after, for example, 10 years.
