Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Eight patients with advanced, previously treated non-small cell lung cancer inhaled natural leukocyte interferon-alpha (IFN-alpha) from a dosimeter-equipped jet nebulizer. Single doses of IFN ranged from 1 x 10(6) to 120 x 10(6) IU. Serum IFN was undetectable after single doses of 1 x 10(6) to 18 x 10(6) IU, but 60 x 10(6) IU resulted in measurable levels of circulating IFN in 3 out of 6 patients. All 5 patients who inhaled 120 x 10(6) IU had between 11 and 35 IU of IFN per milliliter of serum for at least 12 h. No systemic or local side effects were observed after 1 x 10(6) to 18 x 10(6) IU, but doses of 60 x 10(6) to 120 x 10(6) IU resulted in temperature rise, headache, and malaise. All symptoms started within 3-6 h, reached their peak by 8-10 h, and lasted until 12-24 h after inhalation. A decrease (greater than 20%) in peak expiratory flow following inhalation was temporarily found in 2 patients. We conclude that IFN, given by inhalation, penetrates into the blood stream, thus causing systemic side effects similar to those described after systemic IFN administration and, in addition, occasionally reversible airflow obstruction.
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PMID:Pharmacokinetics and toxicity of inhaled human interferon-alpha in patients with lung cancer. 254 97

Eight patients were treated with leukocyte interferon for a variety of neurological malignancies that had failed or recurred after conventional therapy. Three patients with malignant astrocytoma received intratumoral interferon in dosages up to 9 million units 3X/week, with total dosages of up to 160 million units. Interferon was administered intraventricularly in 4 patients with leptomeningeal metastases and one patient with multiple brain metastases. Dosages increased from 1 to 10 million units 3X/week, and total dosages of up to 113 million units were given intraventricularly. Acute side effects of fever, nausea, vomiting, and headache occurred almost exclusively with intraventricular injections, and these subsided after the initial injection. Fatigue, loss of appetite, weight loss, and hematologic toxicity developed a few weeks after onset of treatment, independent of the dose given. A modest tumor regression was seen on CT scans of one patient with a malignant astrocytoma, who was treated with interferon for 8 months. In all 4 patients with leptomeningeal metastases, the CSF became free of malignant cells for 6 to 10 weeks, while clinical improvement was less dramatic.
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PMID:Phase I clinical trial of intralesional or intraventricular leukocyte interferon for intracranial malignancies. 298 29

A patient with condyloma acuminatum is described who was treated successfully with human leukocyte interferon. An increase in body temperature, headache, nausea and myalgia proved to be the most serious side effects during treatment.
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PMID:Condyloma acuminatum treated with human leukocyte interferon. 371 81

The clinical and immunologic effects of a biosynthetic human leukocyte interferon, recombinant leukocyte A interferon (IFL-rA), are reported in eight patients with advanced cancer. Single escalating doses from 3 X 10(6) units to 198 X 10(6) units were given by intramuscular injection in a phase I study. Major toxic effects included pyrexia, fatigue, myalgia, and headache. Data on the effects of IFL-rA on lymphocyte subpopulations and peripheral blood mononuclear-cell surface beta 2-microglobulin are presented. Four of eight patients had objective tumor regression, indicating that further investigation of this biologically active material is warranted.
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PMID:Clinical and immunologic effects of recombinant leukocyte A interferon in eight patients with advanced cancer. 617 42

Sixteen patients with advanced cancer were treated with recombinant-DNA-produced pure leukocyte A interferon (IFLrA) intramuscularly in doses ranging from 3 to 198 X 10(6) units. with interval periods of 72 to 96 hours between doses. At the two lowest doses of 3 and 9 million units, there was a cross-over evaluation between IFLrA and partially pure leukocyte interferon (IFN-C) produced from human cells. THe maximum observed serum concentration of IFLrA measured by enzyme immunoassay and bioassay increased with increasing doses. The mean serum concentrations of IFLrA and IFN-C were similar. Clinical effects produced by IFLrA and IFN-C were similar, including fever, chills, myalgias, headache fatigue, and reversible leukopenia and granulocytopenia. Eight patients had transient and mild numbness of the hands or feet, or both. Three patients developed low titers of antibody to IFLrA, Seven of 16 patients showed objective evidence of tumor regression during the study.
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PMID:Recombinant leukocyte A interferon: pharmacokinetics, single-dose tolerance, and biologic effects in cancer patients. 617 59

The clinical, virologic, biochemical, and immunologic effects of a biosynthetic human leukocyte interferon, recombinant leukocyte A interferon (rIFN-A or HuIFN-alpha 2) are reported in nine patients with chronic hepatitis B virus infection and circulating Dane particle-associated polymerase activity. Eight-day courses of rIFN-A were given starting at a dose of 3 X 10(6) units per day and reaching 68 X 10(6) units per day in two patients. Major toxic side effects included fever, fatigue, gastrointestinal symptoms, myalgias, and headache. Most courses of rIFN-A were associated with a reduction in Dane particle-associated polymerase activity, but in no case was this change permanent. There were also changes in lymphocyte subpopulations at the higher dosage levels of rIFN-A. Because of the reproducible, statistically significant effect on viral replication, further study with this and other biosynthetic interferon species is warranted.
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PMID:Acute Dane particle suppression with recombinant leukocyte A interferon in chronic hepatitis B virus infection. 663 Oct 76

Thirteen patients with malignant tumors were entered into a phase I trial with recombinant DNA human alpha 2 interferon (IFN alpha 2). The patients were given I.M. escalating doses of IFN alpha 2 ranging from 1-10(6) to 200-10(6) IU with a 72 hours washout between injections. In the majority of the patients, subjective symptoms were noted: fever, headache, chills, nausea, myalgias. Asthenia, anorexia, drowsiness appeared after the highest doses and disappeared without any sequellae. Leucopenia and thrombopenia were seen in 11 out of 13 patients. Hepatocellular toxicity was observed in 9 cases. Cardiac and vascular functions were not impaired by IFN alpha 2. The pharmacokinetic studies showed a maximum serum concentration between 4 and 6 hours after injection and the peak value was directly proportional to the dose. No neutralizing INF alpha 2 serum factor was detected during the treatment. The peak value for serum beta 2 microglobulin occurred 48 hours after and the N.K. activity was variably modified by IFN alpha 2 injections. A major clinical response was observed in 1 case, a minor response in 3 cases and a stabilisation of the disease in 4 cases.
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PMID:[Phase-1 study of the tolerance for increasing doses of recombinant human alpha 2 interferon in patients with advanced cancer]. 671 13

Eighty-one patients with a variety of refractory disseminated malignant neoplasms have been treated in the first multiple fixed-dose phase I trial of recombinant leukocyte A interferon (IFL-rA). Each patient received IFL-rA by intramuscular injection, three times weekly for 28 days. Dosages were escalated in different patients from 1 to 136 x 10(6) units per injection. The toxic reactions seen with IFL-rA resembled those of nonrecombinant leukocyte interferon and included fever, chills, fatigue, anorexia, myalgia, headache, occasional nausea and vomiting, and dose-dependent reversible leukopenia and hepatic transaminase elevations. The pharmacokinetics of IFL-rA were also comparable with nonrecombinant leukocyte interferon. Objective evidence of antitumor activity was seen in non-Hodgkin's lymphoma, chronic lymphocytic leukemia, Hodgkin's disease, breast cancer, and melanoma, indicating that IFL-rA, the first genetically engineered biological response modifier available for testing in cancer patients, is biologically active in vivo.
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PMID:A multiple-dose phase I trial of recombinant leukocyte A interferon in cancer patients. 675 47

The aim of this double-blind, placebo-controlled, comparative study was to differentiate the clinical efficacy and tolerability of human leukocyte interferon-alpha incorporated (2 x 10(6) IU/g) in a hydrophilic cream and in a gel to heal males afflicted with first episodes of genital herpes. Patients (n = 60), aged 18-40 years (mean 23.2) with culture-confirmed diagnosis of herpes genitalis were randomized to three parallel groups. Each patient was allocated a precoded 40-g tube, containing either preparation or placebo. Cream or gel was applied three times daily for 5 consecutive days. The duration of the active treatment was two weeks. Patients were examined after 48 hours in initial treatment, and thereafter two times a week. A reepithelialized lesion with some residual erythema was recorded as healed. The study demonstrated that patients treated with leukocyte interferon-alpha cream had both significantly shorter mean duration of lesions than gel and placebo recipients (5.3 days vs. 8 days, 13 days respectively; p < 0.001) and a higher number of healed patients (80% vs. 55%, 20% respectively; p < 0.001). Of the 60 patients, 49 (82%) complained of no drug-related side effects. Eleven patients predominantly in the cream/gel groups reported non-objective transitory increase in their body temperature (> 38 degrees C) with moderate headache, malaise and myalgia. The study was followed-up for 24 months after the first day of the treatment, and out of 31/60 cured patients, 4 had a relapse after 18 months. In conclusion the study affirmed that human leukocyte interferon-alpha (2 x 10(6) IU/g) in a hydrophilic cream is more efficacious than its incorporation in gel or placebo, thus suggesting that leukocyte interferon-alpha in a hydrophilic cream, with a profile of non-objective mild to moderate drug-induced indications, may be considered an alternative and effective treatment modality to cure male patients afflicted with first episodes of genital herpes.
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PMID:Human leukocyte interferon-alpha in a hydrophilic cream versus in a gel for the treatment of genital herpes in males: a placebo-controlled, double-blind, comparative study. 935 Jan 1

This placebo-controlled, double-blind study was aimed to evaluate the clinical efficacy, safety and tolerability of human leukocyte interferon-alpha (2 x 10(6) IU/g) incorporated in a hydrophilic gel (hydroxyethylcellulose, 1%) to cure intravaginal warts in women. Preselected, subjects (n=60) who ranged between 18 and 50 years of age (mean 23.7), harbouring 275 vaginal warts (mean 4.6) with clinical, histopathological and polymerase chain reaction (PCR) confirmed diagnosis of human papillomavirus (HPV) infections were randomly divided into 2 parallel groups. A precoded tube (45 g), active or placebo, with disposable applicators and instructions was given to each patient for one week's usage. Patients were demonstrated how to inject 4 g of the trial medication deep into the vagina 2 times daily for 5 consecutive days per week. During the 4-week treatment period, patients were examined on a weekly basis. Cure was defined as absence of clinical signs of infection, as well as PCR and Southern blot hybridization confirmed negative HPV DNA on molecular assay. By the cessation of the therapy 41.7% patients and 44.4% intravaginal warts were cured. Code disclosure revealed that interferon-alpha (2 x 10(6) IU/g) in gel had cured 73.3% patients, and 79.3% intravaginal warts, while placebo healed 10% patients and 8.1% lesions (active gel versus placebo; P<0.0001). Fifty-one patients (85%) complained of no drug-related adverse reactions. Nine patients (15%) mostly in the interferon-alpha gel experienced non-objective, mild headache, tenderness, with transient increase in their body temperature (>38 degrees C). In conclusion, the findings showed that along with non-objective mild side effects, human leukocyte interferon-alpha (2 x 10(6) IU/g) in a hydrophilic gel is significantly more effective than placebo to cure intravaginal warts in women.
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PMID:Human leukocyte derived interferon-alpha in a hydrophilic gel for the treatment of intravaginal warts in women: a placebo-controlled, double-blind study. 987 27


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