Pani S P, Das L K, Vanamail P
Vector Control Research Centre (Indian Council of Medical Research), Pondicherry.
J Commun Dis. 2005 Mar;37(1):12-7.
A six-age class dosage schedule of Diethylcarbamazine (DEC) of 50mg (1-2 years), 100mg (3-4 years), 150mg (5-8 years), 200mg (9-11 years), 250mg (12-14 years) and 300mg for above 14 years is being adopted for annual single dose MDA for LF elimination treat Wuchereria bancrofti microfilaria carriers. In order to increase the community compliance as well as to make the distribution easier during MDA, a revised 3 age class dosage schedule of 100mg (2-4 years), 200mg (5-14 years) and 300mg for above 14 years was evaluated for its tolerability and efficacy. By this change, it was observed that the 4-8 years age class is receiving 50 mg higher and 11-14 years age class is receiving 50mg lesser dose compared to the earlier class schedule. Therefore, the safety aspect in the age class of 4-8 years and efficacy component in the age class of 11-14 years were assessed. Apparently "healthy" asymptomatic microfilaraemic volunteers between the age class of 4-8 and 11-14 years were recruited for the study. The incidence of side reaction in the 4-8 years age class was 50.0% with 150mg dose and 66.7% with 200mg (P>0.05). No life threatening adverse reactions was observed in any dosage schedule. Fever, headache and myalgia, the predominant adverse reactions were mild and similar in both schedules. The mean intensity of the three major specific adverse reactions (fever, headache and myalgia) also did not differ significantly (P>0.05). For the purpose of LF elimination, efficacy in terms of reduction in mean microfilaria load is important. In the 11-14 year age class considerable reduction in the geometric mean density (GMD) was observed by day 90 and 180 post-therapy in both groups (250mg group and 200mg group) compared to pre-therapy level. By day 360 post-therapy, the difference was statistically not significant (P>0.05) (reduction of 72.2% in 250mg and 69.6% reduction in 200mg). The reductions in GMD were statistically significant when compared to pre-therapy levels in both the old (250mg) and new (200mg) doses. Thus, three- age class dosage schedule is as safe and efficacious as the six- age class schedule.
为消除淋巴丝虫病(LF),针对班氏吴策线虫微丝蚴携带者进行年度单剂量大规模药物治疗(MDA)时,采用了六年龄组乙胺嗪(DEC)给药方案,即50毫克(1 - 2岁)、100毫克(3 - 4岁)、150毫克(5 - 8岁)、200毫克(9 - 11岁)、250毫克(12 - 14岁)以及14岁以上300毫克。为提高社区依从性并便于MDA期间的分发,对修订后的三年龄组给药方案(100毫克(2 - 4岁)、200毫克(5 - 14岁)以及14岁以上300毫克)的耐受性和疗效进行了评估。通过这一改变发现,与早期方案相比,4 - 8岁年龄组的剂量增加了50毫克,而11 - 14岁年龄组的剂量减少了50毫克。因此,对4 - 8岁年龄组的安全性和11 - 14岁年龄组的疗效进行了评估。招募了4 - 8岁和11 - 14岁之间明显“健康”的无症状微丝蚴血症志愿者参与研究。4 - 8岁年龄组中,150毫克剂量的副作用发生率为50.0%,200毫克剂量为66.7%(P>0.05)。在任何给药方案中均未观察到危及生命的不良反应。发热、头痛和肌痛这些主要不良反应较为轻微,且在两种方案中相似。三种主要特定不良反应(发热、头痛和肌痛)的平均强度也无显著差异(P>0.05)。对于消除LF而言,平均微丝蚴负荷降低方面的疗效很重要。在11 - 14岁年龄组中,与治疗前水平相比,治疗后第90天和180天,两组(250毫克组和200毫克组)的几何平均密度(GMD)均有显著降低。到治疗后第360天,差异无统计学意义(P>0.05)(250毫克组降低72.2%,200毫克组降低69.6%)。与旧剂量(250毫克)和新剂量(200毫克)的治疗前水平相比,GMD的降低具有统计学意义。因此,三年龄组给药方案与六年龄组方案一样安全有效。