Isoprinosine scientific update |
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Orv Hetil. 1993 May 9;134(19):1015-9.
Pár A, Beró T, Brasch G, Gógl A, Kamarás G, Méhesfalvi E, Ozsvár Z, Paál M, Szipöcs I, Telegdy L.
Pésci Orvostudományi Egyetem I. Belgyógyászati Klinika, Pécs.
Isoprinosine therapy in chronic hepatitis C (multicenter placebo-controlled double-blind prospective study)
A placebo controlled clinical trial. Thirty two patients with chronic C hepatitis have been enrolled in a double blinded study to assess the therapeutic effect on an orally given antiviral-immunomodulatory drug, Isoprinosine. Seventeen patients were given Isoprinosine (3 g/day) and fifteen were on placebo. The treatment has been lasted for four months, when patients examined monthly. Clinical signs, liver function tests and side effects were evaluated. At the end of the trial, side effects and elevated serum alanine aminotransferase (ALT/GPT) levels occurred with higher frequency in Isoprinosine-treated patients. The results show that this antiviral drug has no beneficial effect in chronic C hepatitis.
Int J Oral Maxillofac Surg. 2001 Aug;30(4):318-22
Femiano F, Gombos F, Scully C.
Stomatology Clinic, II University of Medicine and Surgery, Napoli, Italy.
Oral proliferative verrucous leukoplakia (PVL); open trial of surgery compared with combined therapy using surgery and methisoprinol in papillomavirus-related PVL.
Proliferative verrucous leukoplakia (PVL) is a unique oral white lesion in which human papillomavirus (HPV) may play a role. PVL behaves far more aggressively than other forms of leukoplakia with a high rate of recurrence after surgical excision, and relentless progression to verrucous hyperplasia and to verrucous or squamous cell carcinomas. The treatment of PVL is usually by surgery, but there is often early recurrence. This study was an open trial of surgery in 25 patients with oral HPV-positive PVL, compared with combined therapy using surgery and methisoprinol in another group of 25 patients with oral PVL. Six months postoperatively there was a significant difference, with 18 recurrences in the patients treated by surgery alone compared to only two recurrences in the patients treated also with methisoprinol (isoprinosine or inosine pranobex), a synthetic agent with immunomodulatory properties and some antiviral activity against HPV. Eighteen months postoperatively there were no further recurrences in the patients treated by surgery alone but another two recurrences in the patients treated with methisoprinol. Overall, by 18 months follow-up, there were 18 recurrences in the group treated by surgery alone, compared with four in those also receiving methisoprinol. The use of this antiviral agent appeared to offer a significant enhancement to the surgical management of PVL.
J Neurol. 2008 Dec;255(12):1861-71. Epub 2008 Oct 14.
Garg RK.
Department of Neurology, Chhatrapati Shahuji Maharaj Medical University, Uttar Pradesh, Lucknow, India.
Subacute sclerosing panencephalitis.
Subacute sclerosing panencephalitis (SSPE) is a subacute encephalopathy of childhood and young adolescence. Infrequently, SSPE can occur in adults and pregnant women. It is caused by an aberrant measles virus, known as the SSPE virus. SSPE virus differs from wild-type measles viruses in the form of several mutations affecting the viral genome. The matrix gene is most commonly affected by these mutations. The characteristic clinical manifestations of SSPE include behavioral changes, cognitive decline, myoclonic jerks, seizures, abnormalities in vision, bilateral pyramidal signs and coma. Ocular changes may occur in up to 50% of patients. The most characteristic ophthalmological lesion is necrotizing retinitis. Cortical blindness can be the early feature of SSPE. The diagnosis of SSPE is often difficult in the early stages. In a typical case diagnosis is based on clinical, electroencephalographic, and cerebrospinal fluid findings. At present, there is no effective treatment to completely cure SSPE. Oral isoprinosine and intrathecal or intraventricular alpha-interferon may prolong survival to some extent. Immunization against measles is currently the most effective strategy against SSPE.
BJOG. 2006 Sep;113(9):1088-91.
Georgala S, Katoulis AC, Befon A, Georgala C, Rigopoulos D.
First Department of Dermatology and Venereology, 'A. Sygros' Hospital, Athens, Greece.
Oral inosiplex in the treatment of cervical condylomata acuminata: a randomised placebo-controlled trial.
Conventional therapies for human papillomavirus infection aim to remove clinically apparent lesions, while latent infection may remain, representing a threat for transmission and carcinogenesis. The use of a systemic agent may more effectively control the virus. We conducted a randomised placebo-controlled study to investigate the efficacy and safety of oral inociplex in the treatment of cervical condylomata acuminata (CA) that had been resistant to conventional therapies. Thirty-eight white European women, aged 20-43 years, with genital warts of the cervix, refractory to at least one conventional therapy, were randomly assigned to receive either inosiplex, 50 mg/kg daily peros for 12 weeks (group 1), or placebo (group 2). Of the 17 evaluable group 1 women, 4 responded to the treatment completely, 7 responded partially and 6 did not respond. Of the 19 group 2 women, none responded to the treatment completely, 3 responded partially and 16 did not respond. The therapeutic difference between women receiving active and placebo therapy was statistically significant (chi(2)= 6.69, P < 0.01) and remained significant when an intention-to-treat analysis was performed (chi(2)= 7.69, P < 0.01). None of the complete responders experienced recurrence during the 12-month follow up. Adverse effects were mild and resolved upon completion of therapy. Compared with placebo, inosiplex showed considerable efficacy with insignificant and reversible adverse effects and without recurrences. Inosiplex may represent an efficacious and safe alternative systemic form of therapy for cervical genital warts.
Int Conf AIDS. 1989 Jun 4-9; 5: 219 (abstract no. Th.B.O.46).
Hidovre
Denmark
Isoprinosine reduced clinical progression in HIV infected patients in a double blind placebo controlled study.
To determine the influence of isoprinosine (Imunovir) on the clinical course of HIV infection. METHODS: A total of 866 HIV infected patients from Sweden and Denmark were randomised and stratified according to CD4-count to receive either isoprinosine 1 g t.i.d. (n=429) or matching placebo (n=437) for 6 months. At baseline the study population consisted of 765 asymptomatic patients and 101 symptomatic patients. Patients with AIDS were not included. RESULTS: Eight hundred and thirty-three patients were eligible for efficacy analysis. There were no significant differences between the two groups with respect to CD4-count or clinical status at baseline. Progression to AIDS according to CDC revised definition: TABULAR DATA, SEE ABSTRACT VOLUME. During treatment no significant differences in CD4-count occurred. No serious side effects were observed. Minor adverse reactions occurred with equal frequencies in both groups. CONCLUSION: Isoprinosine offers a potential treatment modality, particularly in the asymptomatic HIV infected patients. However, the mode of action remains to be clarified.
J Gastrointestin Liver Dis. 2006 Dec;15(4):389-91.
Krastev Z, Antonov K, Jelev DT.
Clinic of Gastroenterology, St.Ivan Rilsky University Hospital, Medical University, Sofia, Bulgaria
The prevention of an expected hepatic flare in HBe negative patients after lamivudine discontinuation.
The treatment with lamivudine leads to drug resistant mutations in 19 to 70% cases after 1- and 5-year therapy, respectively, associated with the risk of
severe rebound of liver disease with alaninaminotransferase flare. In this situation, adefovir should be added, but this drug is not available in every
country. We report three cases where we avoided the expected hepatic flare-ups by using IFN and isoprinosine. Based on this empirical experience, we suggest
that the new drug has to be administered one month before discontinuation of lamivudine. Prospective trials are mandatory.
Acta Derm Venereol. 2006;86(5):422-4.
Georgala S, Katoulis AC, Befon A, Georgala K, Stavropoulos PG.
1st Department of Dermatology and Venereology, "A. Sygros" Hospital, 5, Dragoumi Str.
Inosiplex for Treatment of Alopecia Areata: a Randomized Placebo-controlled Study.
Treatment of alopecia areata remains unsatisfactory. We decided to test if systemic therapy
with inosiplex (Isoprinosine(R)), an immunomodulator could influence the disease. Thirty-two
subjects with recalcitrant alopecia areata, aged 16-48 years (mean 30.3+/-5.1 years), were
randomized into two treatment groups of 16 subjects each. They were assigned to receive either
oral inosiplex (group 1), or placebo (group 2) on a double-blind basis. Inosiplex dosage was
50 mg/kg/day in five divided doses for 12 weeks. Of the 15 evaluable patients in group 1, 5
(33.3%) had full remission, 8 (53.3%) responded partially and 2 (13.3%) did not respond. Of
the 14 evaluable patients in the placebo group, none had full remission, 4 (28.5%) responded
partially and 10 (71.4%) did not respond. The therapeutic difference between patients
receiving active and placebo therapy was statistically significant (?2=7.82, p<0.01). Compared
with placebo, oral inosiplex showed considerable efficacy in alopecia areata with
insignificant side-effects. Larger studies are required, however, before inosiplex may be
recommended as an efficacious and safe alternative systemic form of therapy for recalcitrant
alopecia areata.
Int J Antimicrob Agents. 2000 Apr;14(3):181-91.
Masihi KN.
Robert Koch Institute, Nordufer 20, D-13353, Berlin, Germany.
Immunomodulatory agents for prophylaxis and therapy of infections.
The advent of the antibiotic era ushered in a shift towards non-pathogen-specific therapy of infectious diseases. This led to an overt emphasis on targeting microbial pathogens while strategies directed towards enhancing host immunity were neglected. In an effort to decrease sole reliance on antimicrobials, the time has come for a critical reappraisal of nonantibiotic, albeit immune response-enhancing substances. The diverse array of natural, synthetic, and recombinant immunomodulators discussed in this review succinctly demonstrate the potential of these agents to stimulate host defense mechanisms for prophylaxis and treatment of various microbial infections.
J Helminthol. 2001 Sep;75(3):251-7.
Lawton P, Walchshofer N, Sarciron ME.
Departement de Parasitologie et Mycologie Medicale, Faculte de Pharmacie, Lyon, France.
In vitro effects of isoprinosine and a dipeptide methyl ester on Echinococcus multilocularis protoscoleces.
A protoscoleces/vesicles in vitro maintenance test with assessment of viability by eosin exclusion was used to evaluate the quantitative and qualitative activities of isoprinosine, its active component inosine and the dipeptide methylester L-Phe-Phe-OMe on isolated protoscoleces of Echinococcus multilocularis for 24 and 48 h. Isoprinosine and inosine showed dose- and time-dependent activity, the latter displaying a more rapid effect than the former. A high activity was shown with L-Phe-Phe-OMe, when compared to praziquantel. Ultrastructural alterations were much more striking with L-Phe-Phe-OMe, with an effect similar to that of praziquantel, whereas the chemotherapeutic activity of inosine and isoprinosine appeared to be directed against a metabolic target, with a lethal effect not immediately visible at the ultrastructural level. Thus, the previously reported in vivo activities of these drugs result largely from a direct effect on the parasite.
No To Hattatsu. 2004 Jan;36(1):70-4.
Oshiro S, Minema H, Shiroma N, Hirayasu K, Nakada Y.
Department of Pediatrics, Okinawa Seishi Ryogoen, Naha, Okinawa.
Five patients with subacute sclerosing panencephalitis treated with intraventricular alpha-interferon and inosinpranobex.
We followed up 5 patients with subacute sclerosing panencephalitis (SSPE) for 14 to 81 months. They were treated with alpha-interferon (INF-alpha) and oral inosinpranobex (INP) in an early stage of Jabbour stage II and within 5 months after the onset. On admission, Ommaya reservoir was implanted for the intrathecal administration of INF-alpha. The dose was 1 x 10(5) U/m2 initially and daily increased to 1 x 10(6) U/m2. A total dose of 30 x 10(6) U/m3 was given to them over a 4-weeks to 6-weeks period. After discharge, a dose of 15 x 10(6) U/m2 in three patients was given weekly and a dose of 30 x 10(6) U/m2 in the other patients. In addition, all patients received oral INP. One patient showed mild progression and remained in early stage of Jabbour stage II. In the remaining 4 patients, the disease progressed to Jabbour stage III. Despite the small number of patients studied here, the results suggest that treatment with INF-alpha plus oral INP is ineffective in an early stage of SSPE.
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Drug category:Immunostimulators
 Isoprinosine scientific update
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