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临床试点研究:克拉霉素在多菌型麻风病治疗中的疗效

Clinical pilot study: Clarithromycin efficacy in multibacillary leprosy therapy.

作者信息

Gunawan Hendra, Sasmojo Muljaningsih, Putri Helena Eka, Avriyanti Erda, Hindritiani Reti, Suwarsa Oki

机构信息

Department of Dermatology and Venereology, Faculty of Medicine, Universitas Padjadjaran - Dr. Hasan Sadikin Hospital, Bandung, West Java, Indonesia.

出版信息

Int J Mycobacteriol. 2018 Apr-Jun;7(2):152-155. doi: 10.4103/ijmy.ijmy_58_18.

Abstract

BACKGROUND

Rifampicin is one of the important components in the multidrug therapy (MDT)-World Health Organization regimen for leprosy. Clarithromycin is one of the alternative therapies of rifampicin.

METHODS

This clinical pilot study was to compare the efficacy of 2,000 mg clarithromycin to 600 mg rifampicin in combination with dapsone and clofazimine for 3 months in multibacillary (MB) leprosy patients. They were divided into an MDT-MB regimen group that consists of rifampicin-dapsone-clofazimine and clarithromycin-dapsone-clofazimine (CDC) regimen group, each group consisted of seven patients.

RESULTS

The morphological index (MI) was reduced insignificantly after 3 months therapy in MDT-MB group (P = 0.248). While in the CDC group, the MI decrement showed a significant result (P = 0.004). The comparison of MI reduction in MDT-MB and CDC groups showed an insignificant difference (P = 0.130). Skin discoloration was occurred in both groups, whereas mild-nausea was presented in the CDC group, in addition, red-colored urine was developed in the MDT-MB group.

CONCLUSION

We concluded that 2,000 mg clarithromycin is as effective as 600 mg rifampicin in combination with dapsone and clofazimine regimen in MB leprosy patients. Hence, clarithromycin can be considered as an alternative therapy for leprosy patients who resistance and/or allergy to rifampicin.

摘要

背景

利福平是世界卫生组织麻风病联合化疗方案中的重要组成部分之一。克拉霉素是利福平的替代疗法之一。

方法

本临床试点研究旨在比较2000毫克克拉霉素与600毫克利福平联合氨苯砜和氯法齐明治疗3个月对多菌型(MB)麻风病患者的疗效。将患者分为由利福平-氨苯砜-氯法齐明组成的联合化疗-多菌型方案组和克拉霉素-氨苯砜-氯法齐明(CDC)方案组,每组各7名患者。

结果

联合化疗-多菌型方案组治疗3个月后形态学指数(MI)下降不显著(P = 0.248)。而在CDC组,MI下降显示出显著结果(P = 0.004)。联合化疗-多菌型方案组和CDC组MI降低的比较显示差异不显著(P = 0.130)。两组均出现皮肤变色,而CDC组出现轻度恶心,此外,联合化疗-多菌型方案组出现红色尿液。

结论

我们得出结论,2000毫克克拉霉素与600毫克利福平联合氨苯砜和氯法齐明方案治疗MB麻风病患者的效果相同。因此,克拉霉素可被视为对利福平耐药和/或过敏的麻风病患者的替代疗法。

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