异丙肌苷
Methisoprinolum, Methisoprinol (Inosine Pranobex)

[别名] 异丙酯肌苷、Isoprinosina、Inosiplex、Viruxan、Delimmum, Methisoprinol。

[药理作用] 该药是一种新型的生物学反应调节剂。原为抗病毒药，对人体疱疹、流感、鼻病毒感染有效，用于单纯疱疹病毒感染的患者疗效显著。体外实验表明，它能增强PHA（植物血凝素）或抗原的免疫反应，促进T淋巴细胞的分化和增强，且可通过激活TH细胞或巨噬细胞而刺激B淋巴细胞分化和产生抗体。在体内具有抗病毒和抗肿瘤活性。临床研究证明，口服该药可减少各种病毒感染的发病持续时间和严重性。它对艾滋病及肿瘤病人免疫功能的恢复较显著。该药片剂或滴眼剂可使疱疹病毒角膜炎、葡萄膜炎的症状和体征有较大的改善。该药还具有代谢迅速、毒副反应轻微、服用方便等优点。

[毒副作用]

1．临床应用中未见明显毒副反应，仅用大剂量时偶有短暂的恶心。
2．因该药的肌苷部分最后转变为尿酸，可使血清和尿中尿酸短暂升高。
3．用药未见肝功能、血液学参数、嘌呤代谢等有异常。

[适应证] 为肿瘤的辅助治疗剂。用于恶性淋巴瘤、骨髓瘤、早期恶性黑色素瘤有一定疗效。与手术合用治疗食道癌、胃癌、直肠癌、甲状腺癌术后患者，可提高细胞免疫功能，使其恢复到术前健康水平。与放疗、化疗合用，可减轻毒副反应，提高疗效。也用于艾滋病、免疫缺陷病等。用于多发性口角炎、病灶性生殖器炎。

[剂型与规格] 片剂：500mg，2.5g。

[用法与用量] 口服：2.5g/次，2次/d，连服l～2个月为一疗程。

[注意事项]

l、用药前应行细胞免疫指标检查。
2、置干燥处保存。

[-产[-地址国家-] 以色列
[-所属类别-] 抗癌药物->治疗骨髓瘤药物
[-处方药-] 处方药
[-包装规格-] 100片/瓶，500毫克/片
[-原产地址英文商品名-] Imunovir-100Tablets x 500mg/bottle
[-原产地址英文药品名-] Methisoprinol
[-原产地址英文化合物名称-] Isoprinosine
[-中文参考商品译名-] 异丙肌苷 100片x500毫克/片
[-中文参考药品译名-] inosine pranobex
[-中文参考化合物名称-] 异丙肌苷, Isoprinosine, Imunovir, methisoprinol, inosiplex, inosine pranobex
[-曾用名-] 异丙酯肌苷
[-临床试验期-] 完成
[-中文适应病症参考翻译1-] 肿瘤
[-中文适应病症参考翻译2-] 艾滋病
[-中文适应病症参考翻译3-] 免疫缺陷
[-中文适应病症参考翻译4-] 多发性口角炎
[-中文适应病症参考翻译5-] 病灶性生殖器炎

ISOPRINOSINE
Isoprinosine is the main product of Newport Pharmaceuticals of Costa Rica. The active ingredient identified in the pharmacopoeias is Methisoprinol (Inosine Pranobex). It is a non-toxic immune system stimulant prescribed in the treatment of numerous viral illnesses including herpes simplex, hepatitis, eruptive diseases of infancy and other viral afflictions related with immuno-deficiencies.

Methisoprinol was patented in the United States in 1969. Later, to protect the company’s intellectual property, the patent was registered in sixty-two countries.

Isoprinosine is an immunestimulant drug prescribed for the treatment of several viral diseases including herpes simplex, Herpes Zoster, viral hepatitis, childhood eruptive diseases, and other viral infections that occur with immunodeficiencies.

In 1982 Isoprinosine received in France the renown "Le Prix Galien". At that time, Isoprinosine was considered the main therapeutic innovation introduced in the French market.

The drug has demonstrated clinical activity against influenza symptoms, common cold, viral encephalitis, herpes and severe manifestations of immunodeficiencies. Besides, it is a non-toxic drug with an excellent record of clinical security in short and long term therapeutic treatments.

ISOPRINOSINE

RESEARCH & DEVELOPMENT

Newport pharmaceuticals, along the years, has published more than one thousand seven-hundred and fifty clinical studies about ISOPRINOSINE. Some have been published in scientific magazines of excellent reputation such as the New England Journal of Medicine and Lancet.

The clinical studies on ISOPRINOSINE have been conducted by independent scientists and doctors at prestigious research centers in the United States and Europe.

The following therapeutic indications have abundant scientific support in published clinical studies:

Primary and secondary breathing infections in adults and children
Hepatitis and immunodepression
Labial herpes, genital herpes, Keratis Herpes, Herpes Zoster
Chicken pox
Citomegalovirus and Epstein Bar infection
Measles
Subacute sclerosing panencephalitis
Papilloma
In June of 1990, it was published in the New England Journal of Medicine the double blind clinical study called "The efficacy of Pranobex in the prevention of the Acquired immunodefieiency Syndrome in patients infected by the virus of human immunodeficiency". It included eight-hundred and sixty-six patients, who had not completely developed AIDS. The investigation was carried out in twenty-one distinguished hospitals of Sweden and Denmark. The technical conclusion was : Isoprinosine delays the onset of AIDS in patients infected with HIV virus.

Inosine Pranobex
 
Other common name(s): Isoprinosine®, Imunovir®, methisoprinol, inosiplex, inosinpanobex

Scientific/medical name(s): none

Description

Inosine pranobex is a drug that may mimic the actions of immune-stimulating hormones made in the thymus gland. It is used primarily in European countries, mainly as a treatment for viral infections. It is not used for cancer treatment by conventional oncologists in Europe or anywhere else, but is occasionally recommended on alternative medicine Web sites as an anticancer treatment or for enhancing immunity of people living with cancer.

Overview

Available scientific evidence does not support claims that inosine pranobex is effective in treating cancer. The drug is not approved by the U.S. Food and Drug Administration (FDA) and cannot be sold legally in pharmacies in the United States.

How is it promoted for use?

Proponents claim inosine pranobex strengthens the immune system and fights viral infections. They also say it may lower the risk of infection in people being treated for cancer, who often have weakened immune systems. Some assert that it may boost the effects of interferon, which is a drug sometimes used against viral infections and certain types of cancer. Inosine pranobex may also increase the activity of helper T-cells and natural killer cells (types of white blood cells), which may help stop tumors from growing. Some practitioners recommend it as an alternative to conventional cancer therapy. Others suggest that inosine pranobex be used along with mainstream cancer treatment

At one time inosine pranobex was promoted as a way for athletes to improve their endurance and performance, although studies have not borne this out. More recently, it has been promoted for possible use against chronic fatigue syndrome. It is currently used (mostly in European countries) to treat people with AIDS and other viral diseases, including herpes, shingles, warts, influenza, the common cold, and viral infections of the liver (hepatitis) and brain (encephalitis).

What does it involve?

Inosine pranobex is taken as a capsule or tablet. There is no standard dosage, although some studies have used between 1 and 4 grams per day. Some practitioners recommend a maximum of 3 grams per day for autoimmune diseases, with the daily dose divided up and spread evenly throughout the day (for instance, 1 gram every 8 hours for a total of 3 grams per day.) Some further suggest that the dose be "pulsed," that is, taken for a week or 2 then stopped for up to a month before restarting.

What is the history behind it?

Inosine pranobex was patented in the late 1960s, and has been studied against a number of viral conditions as far back as the early 1970s. In 1981, the FDA refused to allow the drug to be marketed in the United States, citing a lack of evidence that it was effective. Today it is sold in Europe and elsewhere as a treatment for a number of viral diseases including herpes, influenza, and viral hepatitis.

What is the evidence?

A number of animal and laboratory studies—done mostly in Europe—have found that inosine pranobex increases the activity of helper T-cells and natural killer cells. Although a substantial increase in activity of these immune system cells could slow the growth of tumors, there is no reliable clinical evidence that inosine pranobex is of any clinical value in the treatment of people with cancer.

Thus far, very few studies have looked at the effectiveness of inosine pranobex against cancer in people. A French study found no difference in survival or recurrence rates between 60 lung cancer patients treated with surgery alone and another 60 treated with surgery and inosine pranobex. In another, much smaller study, researchers concluded that inosine pranobex combined with the chemotherapy drug 5-fluorouracil was not effective in the treatment of metastatic colorectal cancer. The most recent clinical trial, published in 2003, reported no benefit in patients with melanoma (a type of skin cancer). A 1978 article reported no benefit of inosine pranobex in treating pediatric cancer patients with herpes virus infections. There appears to be little current research on the use of inosine pranobex against cancer.

Based on a large study conducted in Sweden and Denmark, researchers reported in 1990 that inosine pranobex delays the onset of AIDS in people with HIV infection. However, the FDA pointed out several important flaws in the study and noted that other large studies have not found inosine pranobex to be helpful. The FDA concluded that more study was needed before its value for HIV-infected patients could be sufficiently evaluated. There has been substantial progress in treatment of HIV infection and AIDS since 1990, and researchers in this field have since turned their attention to more promising drugs.

Several small studies have suggested that inosine pranobex may be effective, when combined with interferon, to treat subacute sclerosing panencephalitis, a fairly rare brain infection caused by the measles virus. Some studies suggest inosine pranobex may be useful as a treatment for genital warts. More research is needed to confirm these findings.

Are there any possible problems or complications?

This product is sold as a dietary supplement in the United States. Unlike companies that produce drugs (which must provide the FDA with results of detailed testing showing their product is safe and effective before the drug is approved for sale), the companies that make supplements do not have to show evidence of safety or health benefits to the FDA before selling their products. Supplement products without any reliable scientific evidence of health benefits may still be sold as long as the companies selling them do not claim the supplements can prevent, treat, or cure any specific disease. Some such products may not contain the amount of the herb or substance that is written on the label, and some may include other substances (contaminants). Though the FDA has written new rules to improve the quality of manufacturing processes for dietary supplements and the accurate listing of supplement ingredients, these rules do not take full effect until 2010. And, the new rules do not address the safety of supplement ingredients or their effects on health when proper manufacturing techniques are used.

Most such supplements have not been tested to find out if they interact with medicines, foods, or other herbs and supplements. Even though some reports of interactions and harmful effects may be published, full studies of interactions and effects are not often available. Because of these limitations, any information on ill effects and interactions below should be considered incomplete.

The safety of inosine pranobex has not been studied extensively, although it seems to be fairly well tolerated. Some studies have reported possible side effects including dizziness, stomach upset, and heartburn. Inosine pranobex increases blood levels of uric acid, which can increase the risk of gout or kidney stones. Interactions with other drugs are unknown. Talk with your doctor and pharmacist about all the medicines and supplements you are taking before adding inosine pranobex.

Information on pregnancy and breast-feeding is not available. Relying on this type of treatment and avoiding or delaying conventional medical care for cancer, may have serious health consequences.
 
Imunovir  Information

Imunovir (Inosine Pranobex) is an immunomodulator of the potentiator type which has demonstrated an enhancing effect on the function and number of various cells of the immune system, particularly T lymphocytes, which are responsible for defending the body against viral and fungal infections . Imunovir's ability to enhance the functions of various cells within the immune system seems likely to be accountable for its clinical efficacy. It is our belief that therapy with an agent capable of enhancing certain aspects of the immune response system is a logical approach to the treatment of disorders associated with an underlying cellular immune defect. These include viral diseases and immune deficiency states. Imunovir is also known in different parts of the world as Isoprinosine, Viruxan, Prinosine and Virimun. It is approved for a variety of viral infections resulting from depression of the immune system. A partial list includes Aolpecia areata, CMV, EBV, Hepatitis acute and non-chirrotic chronic active B, Influenza, Measles Mumps, Viral conjunctivitis and subacute sclerosing panencephalitis (SSPE). A study published in the 11th volume of the Journal of Chronic Fatigue Syndrome, entitled "Clinical Improvement in Chronic Fatigue Syndrome Is Associated With Enhanced Natural Killer Cell-Mediated Cytotoxicity: The Results of a Pilot Study with Isoprinosine". However, its use in this indication is still considered investigational. Imunovir is approved for the treatment of SSPE in Canada. Imunovir is available in 500 mg tablets and is supplied in bottles of 100 tablets. It is a prescription-only medication.