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A randomized double-blinded placebo-controlled clinical trial on protective effects of pentoxifylline on gentamicin nephrotoxicity in infectious patients

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Abstract

Background and objective

Renal toxicity has limited gentamicin use in clinical practice. The aim of the present clinical trial was to assess the possible nephroprotective effects of pentoxifylline (PTX) against gentamicin nephrotoxicity.

Materials and methods

A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted on patients who had the indication for systemic gentamicin for at least 7 days. Sixty people were selected and randomly assigned. For patients in the intervention and control groups, 400 mg PTX sustained release tablet and placebo were given orally three times daily, respectively. Demographic, clinical, laboratory, and therapeutic information of patients were recorded. malondialdehyde (MDA) and tumor necrosis factor-alpha (TNF-α) levels in serum were measured on days 0 and 7.

Results

The incidence of nephrotoxicity in the placebo group was 19.6 times higher than that in the PTX group (OR = 19.6, 95%CI = 3.08–114.32; P value = 0.001). The mean ± SD time onset of ATN was 4.00 ± 2.32 and 5.58 ± 1.59 days in PTX and placebo recipients, respectively (P value < 0.001). No significant differences were observed for hypokalemia, hypomagnesemia, potassium and magnesium wasting between the two groups. The mean ± SD levels of serum MDA and TNF-α at day 7 were significantly lower in the PTX compared to those in the placebo group (P value < 0.001 for both indexes).

Conclusion

The co-administration of 400 mg PTX orally three times daily along with gentamicin was both well-tolerated and effective in preventing the nephrotoxicity of gentamicin in patients with different infectious diseases.

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Availability of data and materials

The data that support the findings of this study are available from the corresponding author upon reasonable request. Identifying/confidential patient data would not be shared.

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Authors and Affiliations

  1. Resident of Clinical Pharmacy, Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran

    Seyed Ruhollah Mousavinasab

  2. Infectionlogist Fellowship Prevention and Control of Nosocomial Infection, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

    Zohreh Akhoundi-Meybodi

  3. Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran

    Laleh Mahmoudi

  4. Department of Clinical Pharmacy, Faculty of Pharmacy, Shiraz University of Medical Sciences, 7146864685, Shiraz, Iran

    Iman Karimzadeh

Authors
  1. Seyed Ruhollah Mousavinasab
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Correspondence to Iman Karimzadeh.

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Ethical approval

This study received the Ethics ID (IR.SUMS.REC.1398.762) by the Ethics Committee of Shiraz University of Medical Sciences. This study was also approved in the Iranian Registry of Clinical Trials (IRCT20161010030246N5).

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The study was approved by the Ethics Committee of the Shiraz University of Medical Sciences (IR.SUMS.REC.1398.762).

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Mousavinasab, S.R., Akhoundi-Meybodi, Z., Mahmoudi, L. et al. A randomized double-blinded placebo-controlled clinical trial on protective effects of pentoxifylline on gentamicin nephrotoxicity in infectious patients. Clin Exp Nephrol 25, 844–853 (2021). https://doi.org/10.1007/s10157-021-02032-9

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  • DOI: https://doi.org/10.1007/s10157-021-02032-9

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