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口服外科领域中头孢氨苄缓释制剂(L-凯复定)的基础与临床研究(作者译)

[Fundamental and clinical studies of sustained release cephalexin (L-Keflex) in the field of oral surgery (author's transl)].

作者信息

Morihana T, Ueda K, Muraoka M, Tsushima T, Kodama M, Nagata K, Nakao K, Shimada K

出版信息

Jpn J Antibiot. 1980 Apr;33(4):514-21.

PMID:6997536
Abstract

L-Keflex is a newly manufactured cephalexin product in order to maintain effective blood level of the drug for a long period of time. The results of the fundamental and clinical studies are as follows: 1. Mean blood levels of the drug after its single oral dose of 1 g in fasting in 22 cases before operations were: 7.19 mcg/ml at 2 hours (peak), 4.35 mcg/ml at 4 hours, 4.21 mcg/ml at 6 hours, 2.47 mcg/ml at 8 hours and 1.81 mcg/ml at 12 hours, respectively. Existence of the drug in blood was observed for a long period of time. 2. The distribution into the tissues of L-Keflex was generally good. The tissue levels in 19 of 22 samples ranged from 1.30 to 18.0 mcg/g, but 3 samples did not detect the drug in the tissues. Tissue level/blood level ratios were 0.19 approximately 2.67. 3. Half of 30 cases with mild dental infections was treated with a daily dose of 1 g with clinical response of 60.0%, and the other half with 2 g was 78.6% in clinical response. The overall efficacy rate was 69.0%. 4. As a side effect of the drug, only one of 52 cases (fundamental 22 cases, clinical 30 cases) complained of edema on both eyelids. No. abnormality was observed in blood finding, hepatic and/or renal function. From the above results, it is considered that L-Keflex is an effective antibiotic product in infections in the field of oral surgery. Also, L-Keflex has an advantage in that its administration frequence (b.i.d) is less than that of regular cephalexin (q.i.d.).

摘要

L-头孢氨苄是一种新生产的头孢氨苄产品,目的是使药物在较长时间内保持有效的血药浓度。基础研究和临床研究结果如下:1. 22例手术前空腹单次口服1g该药后的平均血药浓度:2小时时为7.19 mcg/ml(峰值),4小时时为4.35 mcg/ml,6小时时为4.21 mcg/ml,8小时时为2.47 mcg/ml,12小时时为1.81 mcg/ml。药物在血液中存在的时间较长。2. L-头孢氨苄在组织中的分布总体良好。22个样本中有19个样本的组织浓度范围为1.30至18.0 mcg/g,但有3个样本在组织中未检测到该药物。组织浓度/血药浓度比值约为0.19至2.67。3. 30例轻度牙科感染患者中,一半每日剂量为1g,临床有效率为60.0%,另一半每日剂量为2g,临床有效率为78.6%。总有效率为69.0%。4. 作为该药的副作用,52例患者(基础研究22例,临床研究30例)中只有1例抱怨双眼睑水肿。血液检查、肝和/或肾功能未观察到异常。从上述结果来看,认为L-头孢氨苄是口腔外科感染领域的一种有效抗生素产品。此外,L-头孢氨苄的优势在于其给药频率(每日两次)低于常规头孢氨苄(每日四次)。

相似文献

1
[Fundamental and clinical studies of sustained release cephalexin (L-Keflex) in the field of oral surgery (author's transl)].口服外科领域中头孢氨苄缓释制剂(L-凯复定)的基础与临床研究(作者译)
Jpn J Antibiot. 1980 Apr;33(4):514-21.
2
[Double-blind comparison of L-keflex and cephalexin (Keflex) in dental infections (author's transl)].
Jpn J Antibiot. 1980 Nov;33(11):1194-214.
3
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Jpn J Antibiot. 1978 Feb;31(2):59-71.
4
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[Clinical experience with sustained release cefalexin (S-6437) for pediatric use in pediatrics (author's transl)].小儿用头孢氨苄缓释剂(S-6437)的临床经验(作者译)
Jpn J Antibiot. 1977 Nov;30(11):881-7.