Safety and Efficacy of Cerebrolysin in Infants with Communication Defects due to Severe Perinatal Brain Insult: A Randomized Controlled Clinical Trial

BACKGROUND AND PURPOSE: The neuroregenerative drug Cerebrolysin has demonstrated efficacy in improving cognition in adults with stroke and Alzheimer's disease. The aim of this study was to determine the efficacy and safety of Cerebrolysin in the treatment of communication defects in infants with severe perinatal brain insult. METHODS: A randomized placebo-controlled clinical trial was conducted in which 158 infants (age 6-21 months) with communication defects due to severe perinatal brain insult were enrolled; 120 infants completed the study. The Cerebrolysin group (n=60) received twice-weekly Cerebrolysin injections of 0.1 mL/kg body weight for 5 weeks (total of ten injections). The placebo group (n=60) received the same amount and number of normal saline injections. RESULTS: The baseline Communication and Symbolic-Behavior-Scale-Developmental Profile scores were comparable between the two groups. After 3 months, the placebo group exhibited improvements in the social (p<0.01) and speech composite (p=0.02) scores, with 10% and 1.5% increases from baseline, respectively. The scores of the Cerebrolysin group changed from concern to no concern, with increases of 65.44%, 45.54%, 358.06%, and 96.00% from baseline in the social (p<0.001), speech (p<0.001), symbolic (p<0.001), and total (p<0.001) scores. CONCLUSIONS: Cerebrolysin dramatically improved infants' communication especially symbolic behavior which positively affected social interaction. These findings suggest that cerebrolysin may be an effective and feasible way equivalent to stem cell therapy.

Study of the effect of pentoxifylline in hepatlc ischemia-reperfusion injury in albino rats

Hepatic ischemia reperfusion injury [IRI] is a common pathological process of traumatic surgical diseases in the liver, liver transplantation, shock and infection. Inflammatory mediators are implicated in the pathogenesis of IRI. Pentoxifylline [PTX] is a derivative of methylxanthine, acts as a phosphodiesterase inhibitor and therapy elevares the levels of cAMP. Interest in PTX has been recently reawakened because of its reported suppressive action on immune functions, particularly on cytokine production. It has been shown to be beneficial in organ transplantation. Pentoxifyllin probably acts primarily by inhibiting tumor necrosis factor-alpha [TNF-alpha]. We hypothesized that PTX treatment would attenuate hypoxic ischemic liver injury. Thirty-six male albino rats were used throughout this experiment. Animals were divided into 2 main groups; each comprised 18 rats [sham-operated and IRI groups]. Group [1] sham-operated [exposed to anesthesia and laparotomy], this group is subdivided into 3 equal subgroups. Subgroup 1A: Sham-operated received daily intra-gastric saline, subgroup IB: sham-operated +PTX [8mg/kg/day] for 6 successive weeks before exposure to anesthesia and laparotomy, subgroup IC: as IB but received PTX [16mg/kg/day]. Group [II]: IRI group, divided into 3 equal subgroups, sub- group llA received intra-gastric saline for 6 weeks before the induction of IRI ,subgroup 116, received 8mg/kg/day PTX intra-gastrically for 6 weeks before induction of IRI, subgroup IIB, recieved 8mg/kg/day PTX intra-gastrically for 6 weeks before induction of IRI, subgroup IIC, received PTX [16 mg/kg/day] before induction of IRI. It was found that IRI produced significant increase in plasma alanine transaminase [ALT], malondialdehyde [MDA], TNF-alpha and hepatic tissue calcium content as compared to sham-operated animal groups. Intra- gastric administration of PTX in the small or large doses for 6 weeks before induction of IRI produced no significant change in the hepatic tissue calcium, plasma MDA, ALT and plasma TNF-alpha as compared to sham control group, but it produced significant decrease as compared to IRI control group. On the light of the present study, these preliminary results with PTX are encouraging to recommend further human studies in hepatic patients especially whom are given PTX for associated cardiovascular problems

Experimental study of the possible effect of valsartan on insulin resistance in fructose- fed albino rats

Insulin resistance [IR] is a consequence of high fructose fed diet in rats. The current study was carried out to declare if tumor necrosis factor alpha [TNF-alpha] exerts a partial role the development of IR in non-obese rat model; fructose fed rats [FFR] like that happens in obese rat models. We evaluate the influence of valsartan [a selective blocker of angiotensin receptor type-1] in comparison to metformin [a known insulin sensitizer] on enhancement of insulin sensitivity in FFR. Rats were divided into 2 equal groups [36 rats /group], one group received high fructose diet to induce insulin resistance and the other included standard diet fed rats. Each group is further divided into 3 equal subgroups, [standard diet+ saline], [FFR+ saline], [Standard diet + metformin], [FFR+ metformin]. [Standard diet+ valsartan] and [FFR+ valsartan]. In all rats, body weight, fasting serum glucose, fasting serum insulin, insulin sensitivity test, fasting glucose insulin ratio [FGIR], serum TNF-alpha and serum malondialdehyde [MDA] were measured. Result revealed that administration of valsartan to FFR produced a comparable improvement of insulin resistance. In addition valsartan treatment in FFR produced significant decrease in serum TNF-alpha and MDA. It could be concluded that TNF-alpha and angiotensin II might regulate insulin sensitivity in non-obese FFR

Comparative study of non-steroidal anti-inflammatory drugs [NSAIDs] and their interaction with drugs affecting prostaglandins

This experimental study was carried out to evaluate the possible therapeutic and toxic effects of a more or less recent non-steroidal anti-inflammatory drug [NSAID], tenoxicam, in management of rheumatoid arthritis model in rats in comparison with indomethacin, being a standard one and piroxicam as a member of its group [oxicams]. In addition, a possible interaction between tenoxicam and both the anti- hypertensive drugs, captopril and clonidine, was also studied. This study was carried out in rats in which rheumatoid like-arthritis was induced experimentally by collagen II and complete Freund's adjuvant mixture