Η ΔΠΙΓΡΑΗ ΣΗ ΘΔΡΑΠΔΙΑ ΜΔ α-λιποϊκο ΟΞΤ ΣΗΝ ΔΠΩΓΤΝΗ ΓΙΑΒΗΣΙΚΗ ΝΔΤΡΟΠΑΘΔΙΑ Αγάζνο Δπάγγεινο, Πέηξνπ Αιεμάλδξα, Νέκηδαο Ιωάλλεο, Υαηδήο Θεόδωξνο, Παπαληθνιάνπ Υξηζηίλα, Φαξξνύ Άλλα, Σεληνινύξεο Νηθόιανο Α Προπαιδευηική Παθολογική Κλινική και Διδική Νοζολογία, Ιαηρική χολή Πανεπιζηημίου Αθηνών, Γ. Ν. Α. Λαϊκό
ΚΤΡΙΟ ΣΟΥΟ Παξαθνινύζεζε ηεο επίδξαζεο ηνπ α-ιηπνϊθνύ (Nevralip ) νμένο ζε αζζελείο κε ζπκπηωκαηνινγία δηαβεηηθήο λεπξνπάζεηαο κεηά ρνξήγεζήο ηνπ γηα 40 εκέξεο ζηε δνζνινγία ηωλ 600 mg κία θνξά εκεξεζίωο αζζελείο (25 αζζελείο κε Γ2 θαη 5 αζζελείο κε Γ1) κε 1/1 αλαινγία αλδξώλ/γπλαηθώλ Μέζνο όξνο ειηθίαο 61.8 ± 11.1 έηε BMI.9 ± 6.2 kg/m 2
ΓΔΤΣΔΡΔΤΟΝΣΔ ΣΟΥΟΙ 1. Μέηξεζε γιπθόδεο λεζηείαο θαη ηξηγιπθεξηδίωλ πξηλ θαη κεηά ρνξήγεζεο ηνπ α-ιηπνϊθνύ. 2. Σελ επίδξαζε ζηελ πνηόηεηα δωήο ηωλ αζζελώλ 3. Σελ θαηαγξαθή ηεο ζπλνιηθήο εληύπωζεο
ΜΔΣΑΒΛΗΣΔ ΚΤΡΙΟΤ ΣΟΥΟΤ Neuropathy Symptoms Score (NSS). One total Score is calculated from the 5 questions of the questionnaire. The Score ranges from 0 (no neuropathic symptoms) to 10 (the most severe neuropathic symptoms). Subjective Peripheral Neuropathy Screen Questionnaire (SPNSQ) The questionnaire consists of 15 yes/ no (1 / 0) questions regarding the symptoms of their neuropathy. One total Score is calculated by summing the answers to the 15 questions. The score ranges from 0 (no neuropathic symptoms) to 15 (the most severe neuropathic symptoms). DN4 Questionnaire. The questionnaire consists of 10 yes/ no (1 / 0) items regarding the neuropathic pain. One total Score is calculated by summing the answers to the 10 items. The score ranges from 0 (no neuropathic pain) to 10 (the most severe neuropathic pain).
Μεηαβιεηέο δεπηεξεπόληωλ ζηόρωλ Fasting Glucose & Triglycerides. Quality of life parameters of patients: Brief Pain Inventory (BPI - Modified SF). The BPI consists of 11 items. The first 4 describe the severity of patients pain, while the other 7 describe the degree to which their pain interferes with common dimensions of feeling and function. The answers to all items range from 0 ( no pain in the case of the first four / no interference in the case of the other 7) to 10 ( pain as bad as you can imagine in the case of the first four / interferes completely in the case of the other 7). Two Scores are calculated: (a) The BPI severity score, which is the mean of the answers to the first 4 items and (b) the BPI interference score, which is the mean of the answers to the last 7 items. Neuropathic Pain Symptom Inventory (NPSI). In the case of NPSI, 6 Scores are calculated: A Total Intensity Score, which ranges from 0 (none) to 100 (worst imaginable), and five scores which correspond to the following dimensions of pain: Burning (superficial) spontaneous pain, Pressing (deep) spontaneous pain, Paroxysmal pain, Evoked pain, Paresthesia/dysesthesia. These five scores range from 0 (none) to 10 (worst imaginable). Sheehan Disability Scale (SDS). SDS includes three self-rated items, which measure impairment in functioning. The scale generates 3 scores: (a) a work disability score, (b) a social life disability score, and (c) a family life disability score. These three scores range from 0 (no disability) to 10 (worst imaginable disability). Patient Global Impression Improvement (PGI-I). In the 2nd Visit, the patient describes his/her condition, compared with how it was before the initiation of the treatment with NEVRALIP, using the following scale: Very much better, Much better, A little better, No change, A little worse, Much worse, Very much worse
ΓΔΙΚΣΗ ΤΜΠΣΧΜΑΣΧΝ ΝΔΤΡΟΠΑΘΔΙΑ (NSS) Diagram 1. NSS: Mean ± SD at both Study Visits. Minimum value=0 (no neuropathic symptoms), Maximum value=10 (the most severe neuropathic symptoms). Base: Total sample (N=). Mean difference 2.7, p-value<01
ΔΡΧΣΗΜΑΣΟΛΟΓΙΟ ΚΑΣΑΓΡΑΦΗ ΠΔΡΙΦΔΡΙΚΗ ΝΔΤΡΟΠΑΘΔΙΑ (SPNSQ) Diagram 2. Subjective Peripheral Neuropathy Screen Questionnaire Score: Mean ± SD at both Study Visits. Minimum value=0 (no neuropathic symptoms), Maximum value=15 (the most severe neuropathic symptoms). Base: Total sample (N=). Mean difference 4.9, p-value<01
ΔΡΧΣΗΜΑΣΟΛΟΓΙΟ DN4 Diagram 3. DN4 Questionnaire Score: Mean ± SD at both Study Visits. Minimum value=0 (no neuropathic pain), Maximum value=10 (the most severe neuropathic pain). Base: Total sample (N=). Mean difference 3.6, p-value<01
ΓΔΤΣΔΡΔΤΟΝΣΔ ΣΟΥΟΙ FASTING GLUCOSE Mean median SD Minimum Maximum N Mean difference Visit 1 (baseline) 149.8 148.0 64.2 69.0 39 3.3 Visit 2 (40 days after) 146.5 139.0 73.1 81.0 48 p-value 0.241 TRIGLYCERIDES Mean median SD Minimum Maximum N Mean difference Visit 1 (baseline) 151.7 135,0 76.2 57.0 39 10.3 Visit 2 (40 days after) 141.3 129.0 65.3 6 31 p-value < 01
ΜΔΣΑΒΛΗΣΔ ΓΔΤΣΔΡΔΤΟΝΣΧΝ ΣΟΥΧΝ BRIEF PAIN INVENTORY (BPI) BPI - Pain Severity Minimum value=0 (no pain), Maximum value=10 (pain as bad as you can imagine) Mean median SD Minimum Maximum N Mean difference Visit 1 (baseline) 4.3 4.5 2.0 0.5 7.8 2.1 Visit 2 (40 days after) 2.2 1.9 1.5 0.3 5.8 p-value < 01 BPI - Pain Interference Minimum value=0 (no interference), Maximum value=10 (interferes completely) Mean median SD Minimum Maximum N Mean difference Visit 1 (baseline) 5.7 6.1 2.5 1.1 9.3 2.2 Visit 2 (40 days after) 3.5 2.9 2.3 0.6 9.0 p-value < 01
NEUROPATHIC PAIN SYMPTOM INVENTORY (NPSI) NPSI Total intensity score (10) Minimum value=0 (none), Maximum value=100 (worst imaginable) Mean median SD Minimum Maximum N Mean difference Visit 1 (baseline) 43.6 44.0 18.0 9.0 88.0 22.4 Visit 2 (40 days after) 21.2 18.5 13.0 0.3 57.0 p-value < 01 Burning (superficial) spontaneous pain (1) Minimum value=0 (none), Maximum value=10(worst imaginable) Mean 5.4 --------- 2.4 Median 6.0 ---------- 2.0 SD 2,7 ------ 2.4 Minimum ------------ Maximum 1 --------------- 8.0 N ----- Mean difference 3.0 (p-value <01) Pressing (deep) spontaneous pain (2) Minimum value=0 (none), Maximum value=10(worst imaginable) Mean 3.7 --------- 1.8 Median 3.0 ---------- 1.5 SD 3.1 ------ 1.6 Minimum ------------ Maximum 1 --------------- 6.0 N ----- Mean difference 1.9 (p-value <01) Paroxysmal pain (2) Minimum value=0 (none), Maximum value=10(worst imaginable) Mean 5.1 --------- 2.3 Median 5.0 ---------- 1.5 SD 2.5 ------ 1.9 Minimum ------------ Maximum 9.0 --------------- 7.0 N ----- Mean difference 2.8 (p-value <01) Evoked pain (3) Minimum value=0 (none), Maximum value=10(worst imaginable) Mean 3.0 --------- 1.7 Median 2.7 ---------- 1.2 SD 2.5 ------ 1.4 Minimum ------------ Maximum 8.7 --------------- 4.3 N ----- Mean difference 1.3 (p-value <01) Paresthesia/dysesthesia (2) Minimum value=0 (none), Maximum value=10(worst imaginable) Mean 5.9 --------- 2.8 Median 6.5 ---------- 2.0 SD 2.7 ------ 2.4 Minimum ------------ Maximum 1 --------------- 1 N ----- Mean difference 3.2 (p-value <01)
SHEEHAN DISABILITY SCALE (SDS)
PATIENT GLOBAL IMPRESSION- IMPROVEMENT (PGI-I)
ΤΜΠΔΡΑΜΑΣΑ Βειηίωζε ζπκπηωκάηωλ δηαβεηηθήο λεπξνπάζεηαο Βειηίωζε πνηόηεηαο δωήο Μείωζε ηξηγιπθεξηδίωλ
ΔΤΥΑΡΙΣΧ!