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PubMed1999

In vivo administration of genistein has no effect on small intestinal epithelial proliferation and apoptosis, but a modest effect on clonogen survival.

The soya metabolite genistein possesses anti-proliferative, pro-apoptotic activities in intestinal epithelial cells in vitro and may reduce epithelial cancer incidence. This could involve cell cycle arrest/apoptosis in the proliferative or clonogenic cells. We investigated the effects of genistein on the small intestinal epithelium in vivo. No effect on the number or distribution of proliferative cells in the crypts was detected. Similarly, no change in spontaneous apoptotic cell incidence or the characteristic stem cell apoptotic response following low dose irradiation was observed. Genistein afforded a modest decrease in clonogen radiosensitivity. Hence, using a range of dosing protocols, sub-cutaneous administration of genistein for periods of up to 1 week did not alter intestinal epithelial homeostasis.

Animals↗
PubMed1995

Pharmacokinetics and bioavailability of rhIGF-I/IGFBP-3 in the rat and monkey.

Circulating IGF-I exists primarily as part of a ternary 150 kDa complex comprising equimolar amounts of IGF-I, IGFBP-3 and acid labile subunit (ALS). It is also known that in contrast to IGF-I and IGFBP-3 there exists a substantial quantity of unbound ALS in the circulation. As part of our preclinical development program, we have investigated the pharmacokinetic properties of a complex of human recombinant IGF-I and IGFBP-3. Systematic administration of rhIGF-I/IGFBP-3 results in binding of this binary complex to endogenous free ALS and thus leads to increased circulating levels of 150 kD ternary complex (IGF-I/IGFBP-3/ALS). In contrast to the administration of free IGF-I, IGF-I/IGFBP-3 dosing leads to increased systemic IGF-I exposure (i.e. increased area under the time vs. serum concentration curve or AUC) and decreased clearance (CL). Upon administration of equimolar doses of IGF-I/IGFBP-3 to the rat and monkey, it was found that in the monkey AUC was increased and CL decreased when compared to the rat. In addition, the pharmacokinetic profile suggests that saturation of excess ALS occurs at considerably lower doses of rhIGF-I/IGFBP-3 in the monkey than in the rat. Finally, the bioavailability of rhIGF-I/IGFBP-3 was assessed in the rat and found to be approximately 85% and 50% after intramuscular and sub-cutaneous administration, respectively. It was concluded that the formation of the 150 kD ternary complex had a significant impact on increasing the systemic exposure to rhIGF-I when administered as the binary complex (rhIGF-I/IGFBP-3). In addition, IGFBP-3 increases the therapeutic index of rhIGF-I even at doses that significantly exceed the saturation of ALS.

Animals↗
PubMed1984

[The effect of various cutaneously administered nitroglycerin preparations on coronary heart disease].

Sublingually administered nitroglycerin provides marked benefit in the treatment of angina pectoris due to occlusive coronary disease. Because of its brief duration of action, its usefulness as a prophylactic agent is limited. One way to prolong the beneficial effects is cutaneous administration of a nitroglycerin ointment, and the effects and duration of action of three different preparations of topical nitroglycerin on exercise performance have therefore been studied in a double-blind randomized manner in 44 patients with well documented coronary artery disease and stable angina pectoris. 30 mg 2% nitroglycerin ointment((Plantorgan Co.) produced significant improvement in maximal exercise capacity one and six hours after application; concomitantly there was a decrease in the sum of exercise induced ST-segment depression especially one hour, but less markedly six hours, later. 10 mg 2% nitroglycerin ointment (Pohl Boskamp Co.) also produced an increase in maximal exercise tolerance and a reduction in the degree of myocardial ischemia estimated by the magnitude of exercise-induced ST-segment depression one hour after application, but no clear effect could be measured four hours later. 25 mg nitroglycerin in the "transdermal therapeutic system" (Ciba Geigy) produced a significant improvement in maximal exercise capacity and a significant decrease in the sum of exercise-induced ST-segment depression one and five hours after cutaneous application. Side effects were not observed during these studies, and the topical compatibility of the different ointments was good.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Topical↗
PubMed1994

Anaphylaxis models in the guinea-pig.

Immediate hypersensitivity (or anaphylactic) reactions can be caused by large molecules which are directly immunogenic or by smaller molecules which bind to macromolecular carriers and act as haptens. To reproduce these reactions in animals, either systemic or local models are used in actively or passively sensitized animals, respectively. Several attempts have been made to detect the potential of new drugs and chemicals to induce anaphylactic reactions. Protocols using the inhalation of reactive low-molecular-weight compounds produced clinical symptoms in the guinea-pig. An intralaboratory validation study was initiated using a panel of six positive and one negative model compounds in a guinea-pig model combining systemic and local anaphylaxis. Anaphylactic reactions to positive model compounds were obtained only when the molecular weight was approximately 3000 or more. Overall, published results indicate that the potential to induce immediate hypersensitivity reactions can be detected as far as large-molecular-weight molecules are concerned--in contrast to the majority of low-molecular-weight drugs and chemicals.

Administration, Cutaneous↗
PubMed2000

Fish DNA vaccine against infectious hematopoietic necrosis virus: efficacy of various routes of immunisation.

The DNA vaccine, pIHNVw-G, contains the gene for the glycoprotein (G) of the rhabdovirus infectious hematopoietic necrosis virus (IHNV), a major pathogen of salmon and trout. The relative efficacy of various routes of immunisation with pIHNVw-G was evaluated using 1.8 g rainbow trout fry vaccinated via intramuscular injection, scarification of the skin, intraperitoneal injection, intrabuccal administration, cutaneous particle bombardment using a gene gun, or immersion in water containing DNA vaccine-coated beads. Twenty-seven days after vaccination neutralising antibody titres were determined, and 2 days later groups of vaccinated and control unvaccinated fish were subjected to an IHNV immersion challenge. Results of the virus challenge showed that the intramuscular injection and the gene gun immunisation induced protective immunity in fry, while intraperitoneal injection provided partial protection. Neutralising antibodies were not detected in sera of vaccinated fish regardless of the route of immunisation used, suggesting that cell mediated immunity may be at least partially responsible for the observed protection.

Administration, Buccal↗
PubMedDate not supplied

Risk of aluminum accumulation in patients with burns and ways to reduce it.

Severely burned patients experience a bone lesion consisting of markedly reduced bone formation and evidence of decreased resportion. The cause of the lesion may be multifactorial, but aluminum loading, which also occurs in patients with burns, has been documented to produce this type of injury in both humans and animals. To assess the risk of aluminum loading with patients with burns, we analyzed fluids, creams, and medication used in the management of acute burn injury for aluminum content. These substances were classified according to route of administration: cutaneous, enteral, or parenteral, to assess the risk of aluminum loading. Cutaneous exposure to aluminum is greatest from baths, which may provide up to 8 mg aluminum. However, the dynamics of aluminum entry into the blood via a damaged skin barrier are unclear. Enteral exposure to aluminum is no greater than daily dietary exposure. Parenteral sources of aluminum, especially 25% human serum albumin and calcium gluconate, provide the most significant risk of loading because of direct introduction of aluminum into the circulation. Substitution with a different brand of albumin and calcium chloride can reduce the parenteral aluminum load by as much as 95% and minimize any role aluminum may play in the pathogenesis of this bone lesion.

Administration, Topical↗
PubMed2000

Pharmacotherapy of smoking cessation.

Tobacco use is the number one cause of preventable diseases in the United States. Smoking accounts for more than 400,000 deaths yearly and 30% of all cancer deaths. Primary care physicians have access to 70% of smokers, approximately 60% of whom are perceived to be in excellent health. Recent advances in the pharmacotherapy of nicotine addiction, including nicotine nasal spray, nicotine inhaler, bupropion hydrochloride, and over-the-counter transdermal nicotine patches, have increased the treatment options physicians can offer to smokers. Physicians, especially those in primary care specialties, should familiarize themselves with these products to improve efforts to help their patients stop smoking. This article reviews scientific data on the efficacy of approved medications, benefits, adverse effects, and appropriate use of these products. We also discuss nicotine addiction and treatment for special populations, including women, ethnic minorities, light smokers, and patients with cardiovascular and pulmonary diseases.

Administration, Cutaneous↗
PubMed1999

Randomized comparative trial of nicotine polacrilex, a transdermal patch, nasal spray, and an inhaler.

BACKGROUND: There are several nicotine replacement products on the market, and physicians are likely to be asked with increasing frequency about which of these products their patients should use. OBJECTIVE: To provide a basis for rational advice by comparing nicotine polacrilex (gum), a transdermal patch, nasal spray, and an inhaler. DESIGN: Randomized trial with assessments at the quit date and 1, 4, and 12 weeks later. SETTING: Hospital smokers' clinic. PATIENTS: Male and female community volunteers (N = 504) smoking 10 or more cigarettes per day and seeking help to stop smoking. INTERVENTIONS: Patients were given brief advice, and purchased their nicotine replacement treatment at approximately half the regular retail price. MAIN OUTCOME MEASURES: Nicotine replacement treatment use, ratings of withdrawal symptoms, ratings of product characteristics and helpfulness, and biochemically validated continuous lapse-free abstinence. RESULTS: The products did not differ in their effects on withdrawal discomfort, urges to smoke, or rates of abstinence. The continuous validated 12-week abstinence rates were 20%, 21%, 24%, and 24% in the gum, patch, spray, and inhaler groups, respectively. Compliance with recommended nicotine replacement treatment use was high for the patch, low for gum, and very low for the spray and the inhaler. The spray was underused because of adverse effects more often than the other products. In the subjects using the spray, the level of use among abstainers at week 1 predicted outcome at week 12. The inhaler was rated as more embarrassing to use than the other products, but provided at least as much nicotine as the gum. CONCLUSION: When asked about nicotine replacement treatment products available, physicians should note that, despite low compliance with the recommended dose of the spray and inhaler and differences in product ratings, overall, there are no notable differences between the products in their effects on withdrawal discomfort, perceived helpfulness, or general efficacy.

Administration, Cutaneous↗
PubMed2003

Intentional clonidine patch ingestion by 3 adults in a detoxification unit.

Clonidine hydrochloride is an alpha(2)-adrenergic agonist commonly prescribed as an antihypertensive agent. It is also useful in ameliorating symptoms associated with opiate withdrawal and is frequently used in the detoxification setting. We report an episode in which 3 normotensive patients each ingested a single 0.1-mg clonidine patch in a detoxification unit.

Administration, Cutaneous↗
PubMed2004

A randomized trial of nortriptyline combined with transdermal nicotine for smoking cessation.

BACKGROUND: Smoking cessation rates with current therapy are suboptimal. Tricyclic antidepressants improve cessation rates. We hypothesized that addition of nortriptyline hydrochloride to transdermal nicotine would enhance cessation rates. METHODS: We conducted a randomized, double-blind, placebo-controlled trial at a Department of Veterans Affairs medical center. Subjects were aged 18 to 65 years, smoked 10 or more cigarettes per day, and did not have current major depression. Nortriptyline hydrochloride or matched placebo was started at 25 mg 14 days before quit day, titrated to 75 mg/d as tolerated, and continued for 12 weeks after quit day. Transdermal nicotine (21 mg/d) was started on quit day and continued for 8 weeks. The behavioral intervention consisted of 12 brief, individual visits. Withdrawal symptoms were measured by means of a daily diary, and smoking cessation was defined as self-reported abstinence, expired carbon monoxide level of 9 ppm or less, and a 6-month urine cotinine level less than 50 ng/mL (284 nmol/L). RESULTS: A total of 158 patients were randomized (79 to nortriptyline and 79 to placebo). There was no significant reduction in withdrawal symptoms. The cessation rates at 6 months were 23% (18/79) and 10% (8/79), respectively (absolute difference, 13%; 95% confidence interval, 1.3%-24.5%; P = .052). Nortriptyline caused frequent side effects, including dry mouth (38%) and sedation (20%). CONCLUSIONS: Nortriptyline combined with transdermal nicotine resulted in an increased cessation rate with little effect on withdrawal symptoms. This combination may represent an option for smokers in whom standard therapy has failed.

Administration, Cutaneous↗
PubMed2006

A controlled trial of naltrexone augmentation of nicotine replacement therapy for smoking cessation.

BACKGROUND: Many smokers remain refractory to current therapies, which only partially address weight gain after smoking cessation. Thus, this study evaluated whether naltrexone hydrochloride augmentation of nicotine patch therapy improves smoking abstinence and reduces postcessation weight gain more than nicotine patch therapy alone and at what dose. METHODS: Six-week double-blind placebo-controlled trial with follow-up in an outpatient research center. Four hundred individuals who smoked 20 or more cigarettes daily were randomly assigned to treatment for 6 weeks with a 21-mg nicotine patch and oral naltrexone hydrochloride (0, 25, 50, or 100 mg/d) after equal random treatment assignment and followed up for 1 year after randomization. The a priori specified primary end points were prolonged 4-week cigarette abstinence after a 2-week grace period in the intent-to-treat sample and weight gain in these abstainers. RESULTS: We found no significant differences in prolonged 4-week abstinence (P = .49) or 6-week continuous abstinence after the quit date (P = .12) during treatment in the intent-to-treat analysis. Among 295 treatment completers, the 100-mg dose was associated with higher continuous abstinence rates (71.6%) compared with placebo (48%) (odds ratio, 2.73; 95% confidence interval, 1.39-5.39; P<.01). Among continuous abstainers, the 25-mg naltrexone hydrochloride group gained significantly less weight (mean +/- SEM, 0.7 +/- 0.31 kg) than the placebo group (mean +/- SEM, 1.9 +/- 0.33 kg; P<.01). Similar naltrexone dose effects on weight were found for those with prolonged abstinence and treatment completers, irrespective of abstinence. CONCLUSIONS: The 100-mg dose of naltrexone hydrochloride appears the most promising for augmenting the efficacy of the nicotine patch on smoking cessation outcomes but requires further study. The significant weight reduction with low-dose naltrexone therapy suggests that it may be useful as a second-line treatment for weight-concerned smokers.

Administration, Cutaneous↗