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Preliminary results of using ALAnerv® in subacute motor incomplete paraplegics.

Andone I, Anghelescu A, Daia C, Onose G - J Med Life (2015 Jul-Sep)

Bottom Line: As there is actually no effective curative solution for the devastating pathology following SCI, any medical approach susceptible to bring even limited improvements, such as treatment with ALAnerv® seemed to have proven, is worth being surveyed, under strict circumstances of ethics and research methodology.Considering the necessity for more statistical power concerning primary, secondary end-points, and safety issues, as well, continuing this research is needed.SCI = spinal cord injury, TSCI = traumatic spinal cord injury, BBB = blood brain barrier, CNS = central nervous system, SC = spinal cord, NSAIDs = non-steroidal anti-inflammatory drugs, SAIDs = steroidal anti-inflammatory drugs, AIS = American Spinal Injury Association Impairment Scale, SPSS = Statistical Package for Social Sciences, BATEH = Bagdasar-Arseni Teaching Emergency Hospital.

View Article: PubMed Central - PubMed

Affiliation: "Bagdasar Arseni" Teaching Emergency Hospital (BATEH), Bucharest, Romania; "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania.

ABSTRACT

Rationale: To assess whether using ALAnerv® contributes to improvements of outcomes obtained in post SCI patients.

Objective: A prospective controlled clinical survey also to evaluate the safety and efficacy of ALAnerv® (2cps/ day for 28 days) in motor incomplete (AIS/ Frankel C) paraplegic subacute patients.

Methods and results: 59 patients divided in study (treated with ALAnerv®) and control, groups. This survey's follow-up duration was of 28 days. Most of the studied patients were mid-aged (mean 43.75 years old) and respectively, men (64,29% in the study group; 58,06% in controls). We used descriptive statistics (functions: minimum, maximum, mean, median, standard deviation) and for related comparisons, parametric (Student t) and non-parametric (Mann-Whitney, Fisher's exact, chi-square) tests. The primary end-point: AIS motor values' evolution (P= 0.015 - Mann-Whitney), showed that patients treated with ALAnerv® - vs. controls - had a statistically significant better increase of such scores at discharge. Paraclinical parameters, mainly exploring systemic inflammatory status (secondary end-point): ESR dynamics (P=0.13) had no statistical significance; the plasma leucocytes number (P=0.018), the neutrophils' percentage (P=0.001) and fibrinogenemia (P= 0,017) proved in the treated group to have a statistically significant better evolution. We used "Statistical Package for Social Sciences" (SPSS).

Discussion: As there is actually no effective curative solution for the devastating pathology following SCI, any medical approach susceptible to bring even limited improvements, such as treatment with ALAnerv® seemed to have proven, is worth being surveyed, under strict circumstances of ethics and research methodology. Considering the necessity for more statistical power concerning primary, secondary end-points, and safety issues, as well, continuing this research is needed.

Abbreviations: SCI = spinal cord injury, TSCI = traumatic spinal cord injury, BBB = blood brain barrier, CNS = central nervous system, SC = spinal cord, NSAIDs = non-steroidal anti-inflammatory drugs, SAIDs = steroidal anti-inflammatory drugs, AIS = American Spinal Injury Association Impairment Scale, SPSS = Statistical Package for Social Sciences, BATEH = Bagdasar-Arseni Teaching Emergency Hospital.

No MeSH data available.


Related in: MedlinePlus

Frequency histograms of the AIS Motor Scores at admission
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Figure 2: Frequency histograms of the AIS Motor Scores at admission

Mentions: The initial comparison of the groups was done mainly in relation to motor AIS scores at admission and because of the sensible differences between specific means and medians, in order to work on sampling as adequately as possible, to enable the process of compatible comparative inputs, we eliminated 3 patients from the control group; the related histograms showing the scores values are represented in Fig. 2.


Preliminary results of using ALAnerv® in subacute motor incomplete paraplegics.

Andone I, Anghelescu A, Daia C, Onose G - J Med Life (2015 Jul-Sep)

Frequency histograms of the AIS Motor Scores at admission
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4556909&req=5

Figure 2: Frequency histograms of the AIS Motor Scores at admission
Mentions: The initial comparison of the groups was done mainly in relation to motor AIS scores at admission and because of the sensible differences between specific means and medians, in order to work on sampling as adequately as possible, to enable the process of compatible comparative inputs, we eliminated 3 patients from the control group; the related histograms showing the scores values are represented in Fig. 2.

Bottom Line: As there is actually no effective curative solution for the devastating pathology following SCI, any medical approach susceptible to bring even limited improvements, such as treatment with ALAnerv® seemed to have proven, is worth being surveyed, under strict circumstances of ethics and research methodology.Considering the necessity for more statistical power concerning primary, secondary end-points, and safety issues, as well, continuing this research is needed.SCI = spinal cord injury, TSCI = traumatic spinal cord injury, BBB = blood brain barrier, CNS = central nervous system, SC = spinal cord, NSAIDs = non-steroidal anti-inflammatory drugs, SAIDs = steroidal anti-inflammatory drugs, AIS = American Spinal Injury Association Impairment Scale, SPSS = Statistical Package for Social Sciences, BATEH = Bagdasar-Arseni Teaching Emergency Hospital.

View Article: PubMed Central - PubMed

Affiliation: "Bagdasar Arseni" Teaching Emergency Hospital (BATEH), Bucharest, Romania; "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania.

ABSTRACT

Rationale: To assess whether using ALAnerv® contributes to improvements of outcomes obtained in post SCI patients.

Objective: A prospective controlled clinical survey also to evaluate the safety and efficacy of ALAnerv® (2cps/ day for 28 days) in motor incomplete (AIS/ Frankel C) paraplegic subacute patients.

Methods and results: 59 patients divided in study (treated with ALAnerv®) and control, groups. This survey's follow-up duration was of 28 days. Most of the studied patients were mid-aged (mean 43.75 years old) and respectively, men (64,29% in the study group; 58,06% in controls). We used descriptive statistics (functions: minimum, maximum, mean, median, standard deviation) and for related comparisons, parametric (Student t) and non-parametric (Mann-Whitney, Fisher's exact, chi-square) tests. The primary end-point: AIS motor values' evolution (P= 0.015 - Mann-Whitney), showed that patients treated with ALAnerv® - vs. controls - had a statistically significant better increase of such scores at discharge. Paraclinical parameters, mainly exploring systemic inflammatory status (secondary end-point): ESR dynamics (P=0.13) had no statistical significance; the plasma leucocytes number (P=0.018), the neutrophils' percentage (P=0.001) and fibrinogenemia (P= 0,017) proved in the treated group to have a statistically significant better evolution. We used "Statistical Package for Social Sciences" (SPSS).

Discussion: As there is actually no effective curative solution for the devastating pathology following SCI, any medical approach susceptible to bring even limited improvements, such as treatment with ALAnerv® seemed to have proven, is worth being surveyed, under strict circumstances of ethics and research methodology. Considering the necessity for more statistical power concerning primary, secondary end-points, and safety issues, as well, continuing this research is needed.

Abbreviations: SCI = spinal cord injury, TSCI = traumatic spinal cord injury, BBB = blood brain barrier, CNS = central nervous system, SC = spinal cord, NSAIDs = non-steroidal anti-inflammatory drugs, SAIDs = steroidal anti-inflammatory drugs, AIS = American Spinal Injury Association Impairment Scale, SPSS = Statistical Package for Social Sciences, BATEH = Bagdasar-Arseni Teaching Emergency Hospital.

No MeSH data available.


Related in: MedlinePlus