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Isoprinosine |
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Clin Ther. 2004 Nov;26(11):1890-4.
Retrospective evaluation of interferon-beta treatment
in subacute sclerosing panencephalitis.
Anlar B, Aydin OF, Guven A, Sonmez FM, Kose G, Herguner
O.
Hacettepe University, Department of Pediatric Neurology, Ankara,
Turkey.
BACKGROUND: Few effective treatment methods are available for subacute sclerosing
panencephalitis (SSPE),an infection associated with the measles virus. Interferons
have shown some benefit in previous studies and clinical practice. OBJECTIVE:
The purpose of this study was to compare the efficacy of 2 different regimens
of interferon-beta(IFN-beta) in the treatment of SSPE in pediatric patients.
METHODS: We retrospectively compared the results obtained with 2 regimens
of IFN-beta1a: 60 microg administered intramuscularly once weekly (IFN-beta
1/wk), or 22 microg administered subcutaneously 3 times per week (IFN-beta
3/wk). All patients also received oral inosiplex 50 to 100 mg/kg daily,
a treatment known to have partial efficacy in SSPE. Patients who continued
treatment for at least 3 months and had at least 1 year of follow-up data
were evaluated. Clinical parameters included the Neurological Disability
Index (NDI), a measurement of mental, motor, and sensory functions; disease
stage; and mental status. Data obtained at 6 and 12 months were compared
with those at the time of diagnosis, and the percent change from baseline
was calculated. A satisfactory clinical response was defined as reduction
or stabilization of the NDI or stage improvement at 6 or 12 months. RESULTS:
Patients treated with IFN-beta 3/wk had increased survival time (P <
0.02) and higher clinical response rates compared with those treated with
IFN-beta 1/wk (P < 0.05). When stage 2 and stage 3 patients were evaluated
separately, survival was significantly longer (P = 0.007) and the rate of
progression slower in both stage groups with IFN-beta 3/wk. CONCLUSION:
The results obtained for this patient sample suggest that IFN-beta administered
subcutaneously times per week combined with inosiplex may be an effective
treatment option in SSPE. This treatment regimen warrants further study. |
Combined treatment
with subcutaneous interferon-alpha, oral isoprinosine, and lamivudine for
subacute sclerosing panencephalitis.
J Child Neurol. 2003 Feb; 18(2):104-8.
Aydin OF, Senbil
N, Kuyucu N, Gurer YK.
Department of Pediatric Neurology, Dr. Sami Ulus Children's Hospital, Ankara,
Turkey.
We compared patients with subacute sclerosing panencephalitis who received
treatment according to our protocol for at least 6 months (19 patients)
with the patients who could not receive any treatment (13 patients). The
treatment protocol consisted of oral isoprinosine (100 mg/kg/day), subcutaneous
interferon alpha-2a (10 mU/m2/three times a week), and oral lamivudine (10
mg/kg/day). There were no statistical differences between the two groups
according to Neurological Deficit Index, clinical stage, and average age
on admission and also on the final evaluation after treatment. The mortality
rates of both groups were similar: 3 (15.7%) for the treatment group and
6 (46%) for controls. The remission rates for the treatment and control
groups were 7 of 19 (36.8%) and 0 of 13 (0%), respectively, and the difference
was statistically significant (P = .036). The mean survival period of the
treatment group was significantly longer than that of the control group
(P = .01). In conclusion, this combination treatment protocol resulted in
higher remission rates and longer survival periods when compared with controls,
as well as a remission rate that was better than the spontaneous remission
rate of 5%. For this reason, and as well as because interferon-alpha therapy
has an easier route of application and a higher family compliance, we have
considered this an alternative protocol for patients with subacute sclerosing
panencephalitis.
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JAMA. 2000;284:1931-1938
The
June 21 issue of the New England Journal of Medicine reports a randomized,
placebo-controlled trial of inosine pranobex (isoprinosine), an experimental
immunomodulating agent. The study involved 866 persons infected with HIV,
the AIDS virus, in Sweden and Denmark. The report suggests that patients
in the isoprinosine arm of the trial were significantly less likely to progress
to AIDS than those patients in the placebo arm of the trial. According to
this report, during the 24-week trial, 17 patients in the placebo arm progressed
to AIDS as opposed to 2 patients in the isoprinosine arm. Although the raw
data from this study have not been submitted for review to FDA by the drug's
sponsor, Newport Pharmaceuticals Inc. of Laguna Beach, Calif., the FDA's
division of antiviral drug products has reviewed the report. The division
prepared a response to the study report which also appears in the same issue
of the journal. The division's response expresses a number of concerns about
this study and other studies conducted on isoprinosine, and states its belief
that more clinical investigation of this drug is needed before its value
to patients can be well enough evaluated to decide whether, and on whom,
it should be used. -MORE- Page 2, isoprinosine, T90-26 Isoprinosine has
been under development as a treatment for HIV-infection for approximately
5 years. Previous studies of isoprinosine's effectiveness in delaying or
preventing the onset of AIDS in HIV-infected patients conducted in the U.S.
and other countries have not demonstrated that the drug had any significant
effect in slowing disease progression in treated patients. For example,
the company reported in November of 1988 that a multicenter trial of the
drug involving 696 HIV-infected patients in the U.S. and the U.K. showed
no significant benefit in those treated with isoprinosine as opposed to
those given placebo. The sponsor is currently reanalyzing data from this
study in order to evaluate why it produced a different result than the Scandinavian
trial. There are also some issues concerning the design and analysis of
this latest Scandinavian study of isoprinosine. For example, the classification
system for determining endpoints was changed during the course of the study
was one of a number of changes in the study's implementation and analysis
that may have affected the study results, and may require additional, balanced
assessment. An editorial in the journal written by members of FDA's division
of anti-viral drug products also notes that the 24 weeks of the trial is
a relatively short study period. FDA believes that additional clinical testing
should be conducted. These could incorporate the use of pneumocystis prophylaxis
and retroviral treatments that have recently been developed as standard
therapies for HIV-individuals, in order to determine how isoprinosine therapy,
if proven effective, could be maximized in today's current therapeutic scene. |
Ugeskr Laeger 1994 May 30;156(22):3314-8
Controlled, clinical trial of isoprinosine administration
to HIV-infected patients. Results of a Danish/Swedish multicenter study.
The Scandinavian Isoprinosine Study Group
Thorsen
S, Pedersen C, Sandstrom E, Petersen CS, Norkrans G, Gerstoft J, Karlsson
A, Christensen KC, Hakansson C, Pehrson PO, et al.
Infektionsmedicinsk afdeling, Hvidovre Hospital, Kobenhavn
The safety and efficacy of isoprinosine in HIV-infected individuals were
assessed in a multicentre, randomized, double-blind, 24-week study phase,
followed by an optional 24-week open treatment phase. The results of the
double-blind phase have been reported separately. Of 866 HIV-seropositive
individuals randomized, 832 were eligible for efficacy analysis. On completion
of the double-blind phase, 596 patients started open treatment. All patients
were evaluated with regard to progression to AIDS. Within 48 weeks, 10/412
patients (2.4%) assigned isoprinosine and 27/420 (6.4%) assigned placebo
progressed to AIDS (p = 0.005; odds ratio: 2.8, 95% CI: 1.3-6.2). Intention-to-treat
analysis showed identical results. No severe adverse reactions or toxicities
were observed. We conclude that HIV-infected individuals without AIDS may
be safely and effectively treated with isoprinosine. |
Clin Immunol Immunopathol 1988 Jun;47(3):363-7
Pharmacologic immunoenhancement in the elderly: in vitro
effects of isoprinosine
Delafuente JC, Panush
RS
Department of Pharmacy Practice, College of Pharmacy, University of Florida,
Gainesville
The loss of immune competence that occurs with aging may be responsible
for increased morbidity and mortality in elderly individuals. Pharmacologic
modulation of the immune response might reverse the immunologic aberrations
associated with aging. We, therefore, investigated the effects of isoprinosine,
an immunoenhancing drug, on selected in vitro immune responses in elderly
subjects. Subjects studied were 65 years of age or older, and all had chronic
diseases. We chose this population since they were at greatest risk for
morbid events. Isoprinosine significantly enhanced mitogen-stimulated mononuclear
cell proliferation, did not affect unstimulated cell growth, and needed
to be present for the entire culture period for maximum effect. Isoprinosine
is a potent in vitro immunoenhancing agent in aged humans. |
Int J Immunopharmacol. 1986;8(4):437-41
Isoprinosine effects on interleukin-1 production in
acquired immune deficiency syndrome (AIDS)
Tsang
KY, Donnelly RP, Galbraith GM, Fudenberg HH
The in vitro effects of isoprinosine (ISO) on the production of IL-1 in
AIDS patients and normal controls were investigated in this study. IL-1
production from adherent cells was measured by an indirect method using
EL-4 cells. Five of eleven AIDS patients had depressed IL-1 production.
Various concentrations of ISO were used to treat the adherent cells in vitro
and the optimal concentration for stimulating IL-1 production was determined
to be 100 micrograms/ml/10(6) cells. IL-1 production was augmented to normal
or to near normal levels in four of five AIDS patients. Our results indicate
that depressed immunity seen in some AIDS patients may be partly due to
the depressed in IL-1 production and also that ISO can act as an immune
potentiation in enhancing the production of this lymphokine in vitro. |
Int J Immunopharmacol 1983;5(6):481-90
An in vitro study on the effects of isoprinosine on
immune responses in cancer patients
Tsang KY,
Fudenberg HH, Pan JF, Gnagy MJ, Bristow CB
The in vitro effects of Isoprinosine on the immune responses of cancer patients
were investigated. Forty seven patients with primary tumors (26 lung carcinoma,
14 breast adenocarcinoma, 7 melanoma) were studied. Concanavalin A (ConA)-induced
lymphocyte proliferation, natural killer cell (NK) activity, and monocyte
chemotaxis were measured. In 40 of the 47 patients (85%), ConA-induced lymphocyte
proliferation was depressed; NK activity was depressed in 32 (68%), and
monocyte chemotaxis was found to be depressed in 36 (77%). In the presence
of Isoprinosine, all three parameters were restored to normal or near normal
levels in those that were depressed. |
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Drug information |
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| Isoprinosine have both immunomodulating
and antiviral properties. It helps to treat acute and chronic viral infections.
Isoprinosine acts on the immune system to restore impaired cell-mediated
response to baseline in addition to enhancing humoral response. It has
also a direct antiviral activity. Isoprinosine can reduce the intensity
of symptoms and shorten the duration of the viral infection. In addition,
the occurrence of complications is reduced and the frequency and severity
of recurrences is minimised. Isoprinosine is an immunoenhancing agent
in aged humans.
1. How Does Isoprinosine Work? Isoprinosine is a synthetic
purine derivative with immunomodulatory and antiviral properties, which
result from an apparent in vivo enhancement of host immune responses due
to the drug.
The action of Isoprinosine can be summarized as follows:
Normalizes the cell-mediated immunity by stimulating the differentiation
of T-lymphocytes into T-cytotoxic cells and T-helper cells and increasing
lymphokine production
Increases production of IL-1 (interleukin-1) and IL-2 (interleukin-2)
and IFN-? (gamma interferon)
Increases NK cell (natural killer cell) function
Increases the humoral immune response by stimulating the differentiation
of B- lymphocytes into plasma cells and by enhancing antibody production
Increases the number of IgG and complement surface markers
Potentiates neutrophil, monocyte and macrophage chemotaxis and phagocytosis
Inhibits viral growth by suppressing viral RNA synthesis while potentiating
depressed lympocytic
RNA synthesis and translational ability
2. Other Benefits of Isoprinosine Treatment: Studies
have documented the ability of Isoprinosine to slow the progression of
AIDS in HIV-infected persons by increasing the total number and activity
of T-cells, T-helper cells and NK (natural killer) cells. The largest
study, which was published in The New England Journal of Medicine on June
21, 1990 found that HIV infected people with CD4 cells count over 500
experienced significant benefits from Isoprinosine therapy. T-lymphocyte
defects are common in cancer and AIDS patients according to a study in
Medical Oncological Tumor Pharmacotherapy in 1989, which found that Isoprinosine
and levamisole (another immune-boosting drug) mimic the actions of the
thymic hormones to promote T-cell development. Combinations of Isoprinosine,
low-dose Interleukin 1 and 2, and other immune-modulating hormones such
as Melatonin are suggested as possibly effective cancer therapies.
3. Prescribing Information: The prescribing physician
will ultimately decide about the details of therapy (dosing, duration,
etc.). According to dosing information obtained from published references;
patients with cancer can take 2000 mg to 3000 mg of Isoprinosine daily
for two months(2-3g/day; 4-6 tabs of 500 mg inosine pranobex). Then they
may stop taking Isoprinosine for two months, and then resume taking it
at the same dose for another two months.
Caution! Before starting to take this medicine,
it is vital that you should consult your doctor! Do not use it on your
own initiative, without medical advice.
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50 mg/ml sirup |
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