ABSTRACT
BACKGROUND: Many studies have shown gemcitabine and cisplatin are radiosensitizers. Concurrent chemoradiation seems to be an efficient approach for treatment of advanced head and neck cancer (HNC), but toxicity is significant. OBJECTIVE: To evaluate safety and explore efficacy of alternating chemotherapy with gemcitabine and cisplatin concurrent with radiotherapy in patients with advanced non-metastatic HNC. PATIENTS AND METHODS: Twenty-eight patients diagnosed with advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN) in stages III (28%), IVa (36%), and IVb (36%) were treated with gemcitabine: 100mg/m(2) alternating with cisplatin: 50mg/m(2) concurrent with radiotherapy at doses of 2 Gy/day until completing 70 Gy. While awaiting for concurrent treatment, eleven patients received induction chemotherapy with cisplatin: 100mg/m(2) and 5-FU: 1000 mg/m(2). Toxicity, especially in relation to mucositis, xerostomy, dysphagia, leucopenia and radiodermitis was evaluated. RESULTS: 5-year progression-free survival was 27.8 ± 17.2% (CI-95: 0-61.5) and overall survival was 55.9 ± 11% (CI: 34.4-77.5). Overall response rate was 93%; complete response was 64.3% and partial response was 28.6%. Extensive surgery for primary site was avoided in 19 patients (70.4%). Grade 3-4 adverse events were mucositis (46.4%), leucopenia (14.2%), dysphagia (25%), xerostomy (10.7%) and radiodermitis (3.6%). Response rates and toxicity were not significantly different among those patients with and without induction chemotherapy, but survival was higher in patients receiving induction. CONCLUSIONS: Gemcitabine alternating with cisplatin concurrent with radiotherapy is an active and safe treatment that deserves further study.
Subject(s)
Antimetabolites, Antineoplastic/therapeutic use , Antineoplastic Agents/therapeutic use , Carcinoma, Squamous Cell/drug therapy , Chemoradiotherapy/methods , Cisplatin/therapeutic use , Deoxycytidine/analogs & derivatives , Head and Neck Neoplasms/drug therapy , Radiation-Sensitizing Agents/therapeutic use , Adult , Antimetabolites, Antineoplastic/administration & dosage , Antineoplastic Agents/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Squamous Cell/radiotherapy , Cisplatin/administration & dosage , Deglutition Disorders/chemically induced , Deoxycytidine/therapeutic use , Disease Progression , Female , Fluorouracil/administration & dosage , Follow-Up Studies , Head and Neck Neoplasms/radiotherapy , Humans , Induction Chemotherapy/methods , Leukopenia/chemically induced , Male , Middle Aged , Neoplasm Staging , Radiodermatitis/etiology , Radiotherapy Dosage , Remission Induction , Safety , Stomatitis/chemically induced , Survival Rate , Treatment Outcome , Xerostomia/chemically induced , GemcitabineABSTRACT
Despite extensive research, the effects of alpha-tocopherol supplementation remain controversial. Few studies have been focused on obese and overweight people. We examined the effects of alpha-tocopherol (AT) on the oxidative status and metabolic profile in overweight women. Sixteen overweight women between the ages of 40-60 years old, received AT, 800 IU/day during 12 weeks, followed by a 6-week washout period. Blood samples were taken at the beginning and then every 6 weeks until the end of the study. AT, retinol, malondialdehyde (MDA), total antioxidant status (TAS), selenium-dependent glutathione peroxidase (GPx) and CuZn-superoxide dismutase (SOD) were quantified to evaluate the oxidative stress. The metabolic profile was estimated by measuring glycated hemoglobin (HbA1c) in erythrocytes and glucose, phosphate, magnesium, lipid and lipoprotein concentrations in serum. Under AT administration HbA1c, serum- MDA levels and erythrocyte GPx activity were markedly reduced. TAS, AT and Mg2+ concentrations in serum and SOD activity in erythrocytes were higher after AT treatment. Body weight; glucose, lipid and retinol concentrations, or blood cells count were unchanged. Lipid peroxidation was considerably reduced in AT treated women and also improved serum antioxidant status was observed, but the imbalanced response between erythrocyte SOD and GPx activities could affect normal response to oxidative stress.
Subject(s)
Antioxidants/pharmacology , Overweight/blood , Oxidative Stress/drug effects , Vitamins/pharmacology , alpha-Tocopherol/pharmacology , Adult , Antioxidants/pharmacokinetics , Female , Glutathione Peroxidase/blood , Glycated Hemoglobin , Humans , Lipid Peroxidation/drug effects , Magnesium/blood , Malondialdehyde/blood , Middle Aged , Superoxide Dismutase/blood , Vitamins/blood , Vitamins/pharmacokinetics , alpha-Tocopherol/blood , alpha-Tocopherol/pharmacokineticsSubject(s)
Diabetes Mellitus, Type 2/drug therapy , Glyburide/therapeutic use , Hypoglycemic Agents/therapeutic use , Metformin/therapeutic use , Adult , Aged , Blood Glucose/metabolism , Combined Modality Therapy , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/diet therapy , Drug Combinations , Exercise Therapy , Female , Follow-Up Studies , Humans , Male , Middle AgedSubject(s)
Diabetes Mellitus, Type 2/drug therapy , Glyburide/therapeutic use , Hypoglycemic Agents/therapeutic use , Metformin/therapeutic use , Adult , Aged , Blood Glucose/metabolism , Combined Modality Therapy , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/diet therapy , Drug Combinations , Exercise Therapy , Female , Follow-Up Studies , Humans , Male , Middle AgedSubject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Diclofenac/therapeutic use , Hyperalgesia/drug therapy , Vitamin B Complex/therapeutic use , Animals , Behavior, Animal/drug effects , Carrageenan , Female , Hot Temperature , Hyperalgesia/chemically induced , Pain Measurement/drug effects , Rats , Rats, WistarABSTRACT
The aim of this study was to identify the effect of glycine on insulin secretion and action in healthy first-degree relatives of Type 2 diabetes mellitus patients. A randomized, double-blind, placebo-controlled clinical trial was performed in 12 healthy, non-obese volunteers who were first-degree relatives of Type 2 diabetes mellitus patients. Six volunteers received a morning dose of glycine 5 g orally and the other six received placebo. At baseline without drugs and after pharmacological intervention, a metabolic profile and, to assess insulin secretion and action, a hyperglycemic-hyperinsulinemic clamp study were performed. There were no significant differences in baseline metabolic profile, insulin secretion or action between groups. Changes from baseline of early (p < 0.05), late (p < 0.05), and total insulin (p < 0.02) responses were higher in the glycine group than in controls. There were no significant differences in the changes from baseline of insulin action between groups. In conclusion, a morning dose of glycine 5 g orally increased early, late and total insulin responses without changes in insulin action in healthy first-degree relatives of Type 2 diabetes mellitus patients.
Subject(s)
Diabetes Mellitus, Type 2 , Family Health , Glycine/administration & dosage , Insulin/blood , Insulin/metabolism , Administration, Oral , Adolescent , Adult , Female , Humans , Insulin Resistance , Insulin Secretion , Male , Reference ValuesSubject(s)
Formaldehyde , Inflammation/prevention & control , Pain Measurement/drug effects , Pain/prevention & control , Vitamin B Complex/pharmacology , Animals , Behavior, Animal/drug effects , Female , Inflammation/chemically induced , Naloxone/pharmacology , Narcotic Antagonists/pharmacology , Pain/chemically induced , Rats , Rats, WistarSubject(s)
Cefaclor/pharmacokinetics , Cephalosporins/pharmacokinetics , Adult , Area Under Curve , Cefaclor/blood , Cephalosporins/blood , Half-Life , Humans , Male , MexicoSubject(s)
Cefixime/therapeutic use , Cephalosporins/therapeutic use , Typhoid Fever/drug therapy , Adolescent , Adult , Anti-Bacterial Agents/pharmacology , Child , Child, Preschool , Feces/microbiology , Female , Humans , Male , Microbial Sensitivity Tests , Salmonella typhi/drug effects , Typhoid Fever/microbiologySubject(s)
Anti-Inflammatory Agents/therapeutic use , Dexamethasone/therapeutic use , Low Back Pain/drug therapy , Vitamin B Complex/therapeutic use , Adolescent , Adult , Anti-Inflammatory Agents/adverse effects , Dexamethasone/adverse effects , Female , Humans , Male , Pain Measurement , Spasm/drug therapy , Vitamin B Complex/adverse effectsABSTRACT
An intervention study with mass treatment against taeniasis to prevent neurocysticercosis due to Taenia solium in a rural community in Mexico was performed in 1991-96. Information and biological samples were obtained at the beginning of the study, at 6 months and at 42 months after mass treatment with praziquantel at a single dose of 5 mg/kg. Prevalence rates of taeniasis were measured by the detection of Taenia coproantigens and Taenia eggs in faeces; neurocysticercosis was suggested by clinical data and by serum antibodies in humans and also in swine. A reduction of 53% after 6 months and of 56% after 42 months for human taeniasis was seen after treatment. Late-onset general seizures decreased 70%. Anti-cysticercus antibodies in the human population were reduced by 75% after 42 months. Antibodies in pigs also showed a significant reduction of 55% after 6 months. In conclusion, an impact of mass chemotherapy against taeniasis to control cysticercosis in the short and long term was demonstrated. Praziquantel for tapeworm treatment should not be given at doses lower than 10 mg/kg. Late-onset convulsive crisis and specific antibodies are good indicators of neurocysticercosis and of exposure to the parasite, respectively.
Subject(s)
Anthelmintics/therapeutic use , Neurocysticercosis/prevention & control , Praziquantel/therapeutic use , Taeniasis/drug therapy , Zoonoses , Adolescent , Adult , Aged , Animals , Child , Child, Preschool , Female , Humans , Male , Mexico/epidemiology , Middle Aged , Prevalence , Swine , Swine Diseases/epidemiology , Swine Diseases/transmissionABSTRACT
The main objective of this research was to compare the efficacy and security of bisoprolol (B), a new cardioselective beta-blocker, that does not have intrinsic sympathomimetic activity, and metoprolol associated to hydrochlorothiazide (HCTZ), in the treatment of patients with mild to moderate hypertension. Sixty-two hypertensive patients (47 females and 15 males) aged 20 to 70 years (mean 52.5 +/- 10.4) were included in a double-blind, placebo controlled and randomized clinical trial. After a two-weeks wash out period and a similar placebo phase, patients were randomly assigned to receive either a once-daily dosing of B (10 mg) with 6.25 mg of HCTZ, or M (100 mg) plus 6.25 mg of HCTZ during four-weeks. If there was no reduction below 90 mmHg at the end of this period, the dosing of either beta-blocker was doubled. After eight weeks of treatment, the mean decreases in systolic/diastolic blood pressures from baseline were 31.8/21.2 and 28.0/20.6 mmHg for B/HCTZ and M/HCTZ, respectively (p < 0.0001). There were no clinically significant changes from baseline in laboratory parameters in either group. Reduction in blood pressure with B/HCTZ is associated with adverse events and metabolic changes similar to those observed with other antihypertensive drugs.
Subject(s)
Antihypertensive Agents/therapeutic use , Bisoprolol/therapeutic use , Hydrochlorothiazide/therapeutic use , Hypertension/drug therapy , Metoprolol/therapeutic use , Adult , Aged , Double-Blind Method , Drug Therapy, Combination , Female , Humans , Longitudinal Studies , Male , Middle AgedSubject(s)
Diabetes Mellitus, Type 2/metabolism , Glycated Hemoglobin/metabolism , Glycine/pharmacology , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle AgedSubject(s)
Anti-Inflammatory Agents, Non-Steroidal/antagonists & inhibitors , Anti-Inflammatory Agents, Non-Steroidal/toxicity , Anti-Ulcer Agents/therapeutic use , Duodenal Ulcer/prevention & control , Misoprostol/therapeutic use , Stomach Ulcer/prevention & control , Adult , Anti-Ulcer Agents/adverse effects , Diclofenac/toxicity , Double-Blind Method , Duodenal Ulcer/chemically induced , Duodenal Ulcer/pathology , Female , Humans , Male , Middle Aged , Misoprostol/adverse effects , Stomach Ulcer/chemically induced , Stomach Ulcer/pathologyABSTRACT
The role of vitamin B complex preparations as an analgesic adjuvant is controversial. Therefore, the purpose of the present study was to characterize the potentiation of the antinociceptive effect of diclofenac by a vitamin B complex preparation and its individual components by using the pain-induced functional-impairment model in the rat (PIFIR). Pain was produced by the intraarticular injection of uric acid in the right hind limb. Oral administration of diclofenac resulted in a dose-dependent antinociceptive effect. Oral administration of a vitamin B complex preparation containing thiamine (vitamin B(1)), pyridoxine (vitamin B(6)), and cyanocobalamin (vitamin B(12)) in a 1:1:0.01 proportion did not produce any antinociception by itself, but it significantly potentiated the effect of diclofenac. Coadministration of diclofenac with either thiamine or pyridoxine resulted in an antinociceptive effect similar to that of diclofenac alone. On the other hand, coadministration of cyanocobalamin significantly increased diclofenac-induced antinociception. It is concluded that the potentiation of diclofenac-induced antinociception in the PIFIR model is due to cyanocobalamin.
Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/pharmacology , Diclofenac/pharmacology , Vitamin B Complex/pharmacology , Animals , Dose-Response Relationship, Drug , Drug Synergism , Male , Rats , Rats, WistarABSTRACT
An open, prospective study, including 15 young women with primary dysmenorrhea was carried out to asses the prophylactic administration of Ibuprofen for the treatment of severe and disabling primary dysmenorrhea. The study lasted six months, representing a total of 90 cycles, the inclusion criteria were: 1) severe and disabling primary dysmenorrhea, 2) Failure with previous conventional treatments, 3) regular menstrual cycles, 4) without active sexual life, 5) voluntary participation. The treatment schedule included 400 mg of ibuprofen every 8 hours, starting 24 hours before the menstrual cycle during 4 days of menstruation for six consecutive cycles. The intensity of the pain was recorded every eight hours using a linear analogue scale from 0 to 10 where 0 was absence of pain and 10 was severe or disabling pain. Results showed that the mean of initial intensity of the menstrual cramp experienced in the cycle before the treatment (control) was 9.47 +/- 0.5. During the prophylactic treatment the means of initial intensity of the pain were significantly lower, between 7.84 +/- 0.37 and 7.21 +/- 0.52. A statistically significant progressive decrease of pain was recorded during the duration of treatment. After 48 hours of treatment the intensity of the pain was recorded as three (mild). We conclude that the prophylactic administration of ibuprofen is an effective treatment for selected women experiencing severe and disabling primary dysmenorrhea.