[仑氨西林治疗浅表化脓性皮肤及软组织感染的临床评价。一项比较阿莫西林的双盲研究]

[Clinical evaluation of lenampicillin in the treatment of superficial suppurative skin and soft tissue infection. A double-blind study comparing amoxicillin].

作者信息

Fujita K, Takahashi H, Mizoguchi A, Takeshima M, Sasaki J, Nonami E, Harada S, Sato K, Hyang Y S, Horie N

出版信息

Jpn J Antibiot. 1985 Jul;38(7):1794-818.

Abstract

A double-blind controlled clinical study between lenampicillin (LAPC), a newly developed oral ampicillin (ABPC) prodrug, and amoxicillin (AMPC) was conducted for the treatment of suppurative skin and soft tissue infection as grouped in 6 disease types. LAPC or AMPC were orally administered at a daily dose of 1,000 mg, in 4 equally divided doses. Each group was treated for 14 days. The results indicated that LAPC was equal to AMPC in evaluations of effectiveness and usefulness, although incidence of severe side effects was slightly lower in LAPC. The number of cases studied was 235 (115 in the LAPC group, 120 in the AMPC group). Among these, 10 patients (4 in LAPC, 6 in AMPC) were excluded and 12 patients (5 in LAPC, 7 in AMPC) dropped out. Final global improvement rating was evaluated in 213 patients (106 in LAPC, 107 in AMPC). General usefulness rating was evaluated in 215 patients (106 in LAPC, 109 in AMPC), and overall safety rating was evaluated in 231 patients (115 in LAPC, 116 in AMPC). Final global improvement rating of LAPC was, "cured", 55.7% and "cured" and "remarkably improved", 79.2%. The rate increased to 88.7% when "improved" was included. On the other hand, in the AMPC group, "cured" was 50.5%, and "cured" and "remarkably improved" was 76.6%. The rate increased to 91.6% when "improved" was included. No significant difference was found between the 2 drug groups. In overall safety rating of LAPC, "safe" was 93.9%, while in the AMPC group, "safe" was 94.0%. No significant difference was found between the 2 drug groups. Side effects were noted in 2 of 115 patients (1.7%) among the LAPC group and in 5 of 116 patients (4.3%) among the AMPC group. Incidence of severe side effects was slightly lower in LAPC (P less than 0.1). General usefulness rating of LAPC was, "remarkably useful", 56.6% and the rate increased to 86.8% when "useful" was included. In the AMPC group, "remarkably useful" was 51.4%, and increased to 84.4% when "useful" was included. No significant difference was found between the 2 drug groups.

摘要

进行了一项双盲对照临床研究，比较新开发的口服氨苄西林（ABPC）前体药物仑氨西林（LAPC）和阿莫西林（AMPC）治疗化脓性皮肤和软组织感染的效果，共分为6种疾病类型。LAPC或AMPC均口服给药，每日剂量为1000mg，分4次等量服用。每组治疗14天。结果表明，LAPC在有效性和实用性评估方面与AMPC相当，尽管LAPC的严重副作用发生率略低。研究病例数为235例（LAPC组115例，AMPC组120例）。其中，10例患者（LAPC组4例，AMPC组6例）被排除，12例患者（LAPC组5例，AMPC组7例）退出研究。最终对213例患者（LAPC组106例，AMPC组107例）进行了整体改善评分。对215例患者（LAPC组106例，AMPC组109例）进行了总体实用性评分，对231例患者（LAPC组115例，AMPC组116例）进行了整体安全性评分。LAPC的最终整体改善评分为“治愈”55.7%，“治愈”加“显著改善”79.2%。若计入“改善”，该比例增至88.7%。另一方面，AMPC组“治愈”为50.5%，“治愈”加“显著改善”为76.6%。若计入“改善”，该比例增至91.6%。两药物组之间未发现显著差异。LAPC的整体安全性评分为“安全”93.9%，而AMPC组“安全”为94.0%。两药物组之间未发现显著差异。LAPC组115例患者中有2例（1.7%）出现副作用，AMPC组116例患者中有5例（4.3%）出现副作用。LAPC的严重副作用发生率略低（P小于0.1）。LAPC的总体实用性评分为“非常有用”56.6%，若计入“有用”，该比例增至86.8%。AMPC组“非常有用”为51.4%，若计入“有用”，增至84.4%。两药物组之间未发现显著差异。