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[从肾缺血大鼠功能和形态学变化方面比较两种环孢素A制剂——康苏普伦和山地明——的效果]

[Comparison of the effects of 2 preparations of cyclosporin A-- Consupren and Sandimmune--from the aspect of functional and morphologic changes in rats with renal ischemia].

作者信息

Bohdanecká M, Chadimová M, Schück O, Petrásek B, Reitschlägerová V

机构信息

Nefrologická klinika, Centrální izotopové pracovistĕ a Interni katedra Institutu klinické a experimentální medicíny, Praha.

出版信息

Cas Lek Cesk. 1994 Jan 31;133(3):71-5.

PMID:8137375
Abstract

BACKGROUND

Cyclosporine A is in transplantology an irreplaceable immunosuppressive agent. Its only manufacturer preparation Sandimmune--was the Swiss firm Sandoz. In 1990 the Czech firm Galena introduced cyclosporine A with the name Consupren on the market. The objective of the present investigation was to assess whether the nephrotoxic effect of the two preparations is comparable, or whether it differs.

METHODS AND RESULTS

In a group of 65 rats after unilateral nephrectomy and 45-minute ischaemia of the remaining kidney the nephrotoxic action of cyclosporine preparations Sandimmune (Sandoz) and Consupren (Galena, CZ) administered in doses of 10 mg/kg body weight/24 hours throughout the experiment was investigated. The functional and morphological examination was made 3 or 21 days following nephrectomy. After three days the serum levels of creatinine, urea, sodium, osmolality and their urinary excretion as well as the intensity of proteinuria and morphological findings using light and electron microscopy did not differ in the two groups. The same was found during follow-up after 21 days; the small difference in the serum creatinine level only (Sandimmune 96.0 +/- 9.7 mumol/l, Consupren 111.4 +/- 11.2 mumol/l; p < 0.005) may be associated with the significantly higher cyclosporin levels following Consupren administration.

CONCLUSIONS

The findings of the investigation support the idea that even after ischaemic kidney damage the nephrotoxicity of Consupren is not higher than that of Sandimmune.

摘要

背景

环孢素A在移植学中是一种不可替代的免疫抑制剂。其唯一的厂家制剂山地明(Sandimmune)由瑞士山德士公司生产。1990年,捷克的加莱纳公司(Galena)将环孢素A以康苏普伦(Consupren)的名称推向市场。本研究的目的是评估这两种制剂的肾毒性作用是否相当,或者是否存在差异。

方法与结果

在一组65只大鼠中,切除一侧肾脏并对剩余肾脏进行45分钟缺血处理后,研究了在整个实验过程中以10毫克/千克体重/24小时的剂量给予环孢素制剂山地明(山德士公司)和康苏普伦(加莱纳公司,捷克)的肾毒性作用。在肾切除术后3天或21天进行功能和形态学检查。术后3天,两组的血清肌酐、尿素、钠、渗透压水平及其尿排泄量,以及蛋白尿强度和光镜及电镜下的形态学表现均无差异。21天随访时情况相同;仅血清肌酐水平存在微小差异(山地明96.0±9.7微摩尔/升,康苏普伦111.4±11.2微摩尔/升;p<0.005),这可能与给予康苏普伦后环孢素水平显著较高有关。

结论

研究结果支持这样一种观点,即即使在肾脏缺血损伤后,康苏普伦的肾毒性也不高于山地明。

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