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PubMed2006

Multicenter phase I study of repeated intratumoral delivery of adenoviral p53 in patients with advanced non-small-cell lung cancer.

PURPOSE: To determine the feasibility, safety, humoral immune response, and biologic activity of multiple intratumoral injections of Ad5CMV-p53, and to characterize the pharmacokinetics of Ad5CMV-p53 in patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Fifteen patients with histologically confirmed NSCLC and p53 mutations were enrolled onto this phase I trial. Nine patients received escalating dose levels of Ad5CMV-p53 (1 x 10(9) to 1 x 10(11) plaque-forming units) as monotherapy once every 4 weeks. Six patients were treated on a 28-day schedule with Ad5CMV-p53 in combination with intravenous administration of cisplatin (80 mg/m2). Patients were monitored for toxicity, vector distribution, antibody formation, and tumor response. RESULTS: Fifteen patients received a total of 63 intratumoral injections of Ad5CMV-p53 without dose-limiting toxicity. The most common treatment-related toxicity was a transient fever. Specific p53 transgene expression was detected using reverse-transcriptase polymerase chain reaction in biopsied tumor tissues throughout the period of treatment despite of the presence of neutralizing antiadenovirus antibody. Distribution studies revealed that the vector was detected in the gargle and plasma, but rarely in the urine. Thirteen of 15 patients were assessable for efficacy; one patient had a partial response (squamous cell carcinoma at the carina), 10 patients had stable disease, with three lasting at least 9 months, and two patients had progressive disease. CONCLUSION: Multiple courses of intratumoral Ad5CMV-p53 injection alone or in combination with intravenous administration of cisplatin were feasible and well tolerated in advanced NSCLC patients, and appeared to provide clinical benefit.

Aged↗
PubMed1999

[Effects of mouth wash on the removing beclomethasone dipropionate delivered by pressurized aerosol metered-dose inhaler in the mouth].

Effects of mouth wash (mouth rinsing and gargling) on the removal of drug residues in both mouth and pharynx after the use of pressurized aerosol metered-dose inhaler (MDI) were studied. The concentration of beclomethasone dipropionate (BM) in mouth wash after a splay of Becotide inhaler was measured by the method using HPLC. The total amount of the removed BM was measured by a sum of the concentrations of BM in 4 or 5 times of mouth washes in the following 4 kinds of methods. In method 1, mouth wash was done with 5 times of water change after a splay of MDI on wetted mouth. In method 2, mouth wash was done with 5 times of change water on dried mouth. In method 3, mouth wash was done with 4 times of change saliva on wetted mouth. In these methods, the actual inhalation of BM was not done. In method 4, mouth wash was done with 5 times of change water after a splay and a inhalation on wetted mouth. The mouth wash procedures removed totally 47.9%, 51.1%, 31.3%, and 33.3% of a splayed amount of BM in each method, respectively. It was required for the removal of 90% of the totally recovered BM to do one time of mouth wash in method 1, two times in method 2, three times in method 3, and two times in method 4, respectively. These data suggest that the mouth wash procedure is shown to have prophylactic benefit for candidiasis induced by steroid delivered by MDI.

Administration, Inhalation↗
PubMed1977

A one-year trial of triamcinolone acetonide aerosol in severe steroid-dependent asthma.

Twenty-three steroid-dependent severely asthmatic patients, ranging in age from 20 to 67 years, tolerated reduction in their oral dosage of steroids during a one-year trial of triamcinolone acetonide aerosol. Sixteen patients maintained their initial one-second forced expiratory volume without oral therapy with steroids, two required resumption of daily steroid dosage because of lethargy and arthralgia, and four required 2.5 to 20 mg of prednisone every other day to control their asthma. Five-day oral courses of steroids were occasionally required because of episodes of asthma from a variety of external causes. One patient failed to benefit within two months and withdrew from the study. One patient had precipitins to Candida albicans prior to the study, and he developed transient oropharyngeal culture-positive thrush, which subsided with use of a gargle containing nystatin. None of the other patients had oral candidiasis, and laryngoscopic examination revealed no lesions attributed to the aerosol. The mean fasting cortisol level did not increase throughout the one-year trial. Thus, the use of triamcinolone acetonide aerosol (2,000 microgram or less daily) can eliminate or greatly reduce oral requirements for steroids in patients with severe steroid-dependent asthma. Side effects are mild, but adrenal recovery may be exceedingly slow.

Administration, Oral↗
PubMed2005

A combined therapeutic approach to manage oral halitosis: a 3-month prospective case series.

BACKGROUND: Clinical research assessing different therapeutic protocols aimed at treating oral halitosis is scarce. The aim of this study was to evaluate the effects of a combined mechanical and pharmacological approach to treat oral halitosis on clinical and microbiological outcomes on patients followed for 3 months. METHODS: Nineteen subjects with oral malodor participated. At baseline, all subjects completed a questionnaire and carried out an examination including full-mouth organoleptic and volatile sulfur compound (VSC) levels and the Winkel tongue coating index. Standard periodontal outcome variables were assessed at six teeth. Standardized microbiological samples of subgingival plaque, unstimulated saliva, and tongue coating were obtained for culture analysis. The treatment protocol included supragingival prophylaxis; instructions in oral hygiene (toothbrushing, interproximal cleaning, and tongue scraping); and gargling with a mouthrinse containing chlorhexidine, cetylpiridinium chloride, and zinc lactate. The same outcome variables were registered 1 and 3 months after baseline. RESULTS: Statistically significant reductions in organoleptic scores (P <0.001), VSC levels (P <0.05), and tongue coating index (P <0.05) were observed after 1 and 3 months. Mean probing depth and plaque levels also demonstrated significant reductions after 3 months (P <0.05). Total anaerobic counts were significantly reduced at all three locations after 1 month (P <0.05), and in samples from tongue coating and subgingival plaque at 3 months (P <0.05). Aerobic counts were significantly reduced in saliva at 1 month (P <0.05), and the anaerobic/aerobic ratio significantly increased in the tongue samples. Among the selected pathogens evaluated, Porphyromonas gingivalis was the most affected of the three microflora evaluated. CONCLUSIONS: The evaluated therapeutic approach demonstrated its efficacy in the management of oral halitosis, demonstrating statistically significant improvements in both organoleptic and VSC values at 1 and 3 months. The proposed clinical protocol significantly affected the microbial composition in tongue coating, saliva, and subgingival microflora.

Adult↗
PubMed1999

Pharmacokinetics of zanamivir after intravenous, oral, inhaled or intranasal administration to healthy volunteers.

OBJECTIVE: The objective of these studies was to examine the clinical pharmacokinetics and safety of zanamivir, an influenza A and B virus neuraminidase inhibitor, when administered to healthy volunteers. DESIGN: The safety, tolerability and pharmacokinetics of zanamivir administered by a number of routes were assessed in randomised, double-blind and placebo-controlled studies. The study of absolute oral bioavailability had an open design. STUDY PARTICIPANTS: The participants in these studies were healthy male or female volunteers. INTERVENTIONS: Zanamivir was administered as single or multiple doses by the intravenous, oral, inhaled (nebuliser and dry powder) and intranasal routes. Serum and urine samples were obtained for determination of pharmacokinetic parameters, and nasal washes and throat gargles were performed to assess drug concentrations in the nose and throat. Safety was evaluated by monitoring adverse events, vital signs and laboratory parameters. RESULTS: Zanamivir was well tolerated at all doses by all routes; no serious adverse events were reported. The kinetics of zanamivir were linear with single intravenous doses up to 600 mg, and there was no evidence of modification in the kinetics after repeated twice-daily administration. Approximately 90% of zanamivir was excreted unchanged in the urine. The elimination of zanamivir from the serum was a first-order process with a half-life of approximately 2 hours and, at 16 L, the volume of distribution was similar to that of extracellular water. The absolute oral bioavailability of zanamivir was low, averaging 2%. After intranasal or oral inhaled administration, a median of 10 to 20% of the dose was systemically absorbed, with maximum serum concentrations generally reached within 1 to 2 hours. The median serum half-life ranged between 2.5 and 5.05 hours, suggesting that the elimination rate is limited by absorption. There was no evidence of modification in the kinetics after repeated inhaled administration. CONCLUSIONS: Zanamivir is a well tolerated drug. The low level of absorption of the drug after inhaled administration results in low serum concentrations, and therefore there is modest systemic exposure to zanamivir after inhalation. Zanamivir is not metabolised, and the potential for clinically relevant drug-drug interactions is very low.

Administration, Inhalation↗
PubMed2002

Retention of specific yolk IgY in the human oral cavity.

INTRODUCTION: The increasing prevalence of antibiotic-resistant bacteria emphasises the need for new treatments that can replace traditional antibiotics. Oral immunotherapy with yolk antibodies from hyperimmunised hens is a new promising treatment strategy, primarily for infections in the mouth and gastrointestinal tract. Several studies show that bacterial and viral infections can be prevented with egg yolk immunoglobulin (IgY) in a dose-dependent manner. Oral treatment could potentially be used against many frequently encountered diseases (e.g. common cold, tonsillitis and caries). GROUP STUDIED: Healthy volunteers. STUDY DESIGN: We studied the presence of yolk anti-Pseudomonas aeruginosa antibodies in saliva from healthy volunteers over time after 1 or 2 minutes' mouth rinse, performed in the evening, with an aqueous IgY antibody preparation. The test persons rinsed the mouth with 8.0ml phosphate buffered saline before gargling with the antibody preparation 8 and 24 hours later. Statistical analysis was performed with the Mann-Whitney U test. METHODS: The antibody titres in the mouth rinses were tested for their specific activity against P. aeruginosa by ELISA. RESULTS AND CONCLUSION: The next morning there were still active antibodies detected in the saliva from 18 of 19 subjects. After 24 hours, active antibodies could be detected in saliva from only a few of the subjects. A 2-minute mouth rinse resulted in higher mean ELISA absorbance values than a 1-minute rinse.

Administration, Oral↗
PubMed2005

In vitro corrosion of dental Ag-based alloys in polyvinylpyrrolidone iodine solution.

The corrosion and tarnish behaviors of three Ag-based alloys (Ag-Pd-Cu-Au alloy, Ag-In alloy, and Ag-Sn-Zn alloy) in polyvinylpyrrolidone iodine (povidone-iodine) solution were examined. The degree of tarnish was evaluated by visible-ray spectrocolorimetry. Corrosion potential measurements and analyses of corrosion products by X-ray diffractometry were carried out to elucidate the corrosion mechanism. The corrosion rate of the three Ag-based alloys in povidone-iodine solution at its practical concentration used as a gargle solution was so fast that the alloys tarnished within 10 seconds of immersion with the formation of AgI. Thermodynamic consideration and the results of surface analysis by X-ray diffractometry revealed that the main anodic and cathodic reactions were Ag + I(-)-->AgI + e- and I2 + 2e(-)-->2I- respectively.

Anti-Infective Agents, Local↗
PubMed1978

Oropharyngeal excretion of Epstein-Barr virus by patients with lymphoproliferative disorders and by recipients of renal homografts.

In an attempt to associate oropharyngeal excretion of Epstein-Barr (EB) virus with lymphoproliferative disorders other than infectious mononucleosis, we tested throat gargles collected from adult subjects for the EB virus. Nine (16%) of 55 healthy persons were positive. High EB virus-excretion rates were found among patients with active acute lymphocytic leukemia (6/6, 100%), among renal homograft recipients during the third to 12th month after transplantation (26/30, 87%), and among critically ill patients with leukemia-lymphoma (14/19, 74%). Moderately high excretion rates were found among patients with myeloma (7/16, 44%), patients with poorly differentiated lymphocytic lymphoma (5/11, 44%), critically ill patients with solid cancers (15/37, 41%), and patients with chronic myelogenous leukemia (8/21, 38%). Our data suggested that the higher than normal excretion rate is realted to the basic disease process and to the general health status but not to the duration of cancer chemotherapy.

Antineoplastic Agents↗
PubMed1999

Clinical evaluation of a new A.S. mouth wash 881010 as an antismoking agent: a placebo-controlled double-blind trial.

OBJECTIVE: The objective of this study was to assess the effectiveness of a new antismoking (A.S.) preparation manufactured by the Arab Pharmaceutical Manufacturing (APM) Company as an aid to smoking cessation. SUBJECTS, MATERIAL AND METHODS: The design of this clinical study involved 137 Jordanian healthy male smokers. Seventy-four male smokers were given the A.S. mouth wash (active ingredient 0.5% silver nitrate) and 63 male smokers received the placebo solution in a double-blind fashion. Mouth wash solutions were administered three times daily by gargling for one minute and for a period of two weeks. The daily number of cigarettes smoked by volunteers, nicotine, and cotinine concentrations in saliva, plasma, and urine were considered in this study as markers of smoking cessation. RESULTS: Means +/- SD of the number of cigarettes smoked before treatment (zero time) were 21.45 +/- 8.21, and 22.49 +/- 9.50 cigarettes in A.S. mouth wash- and placebo-treated groups, respectively. As compared to placebo, the A.S. mouth wash resulted in a significant (p < 0.05) reduction in the number of daily cigarettes smoked by volunteers during and after treatment. Means +/- SD of the number of cigarettes smoked by A.S. mouth wash-treated volunteers were 8.68 +/- 7.55, 7.87 +/- 6.80, and 10.14 +/- 8.29 cigarettes, and in placebo-treated individuals were 15.91 +/- 8.21, 15.70 +/- 9.58 and 17.03 +/- 9.06 cigarettes, one week, two weeks after treatment, and four weeks after stopping treatment, respectively. Furthermore, a significant number of volunteers either totally stopped or reduced smoking cigarettes after treatment with the A.S. mouth wash. Concerning nicotine and cotinine levels in biological fluids, a trend of a decrease in their levels was observed but it was found not statistically significant. Apart from reversible brownish to blackish discoloration of teeth and gums, no other side-effects were observed after treatment with the A.S. mouth wash. CONCLUSION: In conclusion, the A.S. mouth wash 881010 is generally safe, easy to administer, and effective as an aid to smoking cessation.

Adult↗
PubMed1999

The prescribing pattern of outpatient polyclinic doctors.

OBJECTIVE: This study aims to analyse the prescribing pattern of doctors working in a government outpatient polyclinic in Singapore. DESIGN: Retrospective study of 1 week of prescription scripts in 1996. MAIN OUTCOME MEASURES: Number, types and duration of drugs prescribed; combination of drugs; age distribution; bad handwriting. RESULTS: Two thousand six hundred and seventy-nine scripts were analysed. The age of patients ranged from 1 to 93 years with a mean of 43.8 years. There were 44.0% males and 56.0% females. The overall mean of 'total number of drugs prescribed' was 2.8 items. The means of 'number of drug items prescribed for more than 1 week' by age-group were: < 20 years = 0.2, 20 to < 40 years = 0.5, 40 to < 60 years = 1.3 and > 60 years = 2.4. One way analysis of variance showed significant difference between the means of each age-group. Post hoc analysis revealed that the oldest age group accounted for most of this significant result. The top 10 drugs prescribed in descending order were: antihistamines, paracetamol, throat medications (eg. lozenges, gargles, etc), nifedipine, beta-blockers, antacids, mist benadryl expectorant, Procodin cough syrup (containing codeine and promethazine), amoxycillin and vitamin B. Nifedipine and beta-blockers were the most commonly prescribed anti-hypertensives. Non-steroidal anti-inflammatory drugs were usually prescribed with antacids. One hundred and twenty (4.5%) scripts were illegible. CONCLUSION: This study provides a baseline data for monitoring future prescribing trends. There may be a need to re-evaluate the appropriateness of nifedipine as the first line anti-hypertensive drug and the usefulness of NSAID-antacid and amoxycillin-cloxacillin combinations. The prevalence of illegible handwriting was high.

Adolescent↗
PubMed2000

[The evaluation of periodontal status by the chemical composition of the oral media].

Twelve patients aged 21-38 years with gingivitis and periodontitis and 9 subjects with intact periodontium were examined. Air from the oral cavity was collected with a special device, liquid samples were collected by gargling with sterile water. Chemical composition of the air and washings was analyzed by chromato-mass-spectrometry, gas adsorption and gas liquid chromatography. Inflammation of periodontal tissues was associated with a sharp increase in the oral air concentration of methylethylketone. The concentrations of isovaleric, n-valeric, and n-enanthic aldehydes increased appreciably. Ethanol predominated over n-butyl alcohol. The levels of dimethylsulfide and isoprene increased several times. In the washings from the oral cavity, the content of microorganism's vital activity products (fatty acids) was increased. Possible metabolic mechanisms of the detected shifts are discussed.

Adult↗
PubMed2000

[Antimicrobial action of ozone in the treatment of mandibular fracture].

During experiment in vitro and in the clinical environment in patients with the mandibula fracture there were studied up antimicrobic action of the ozonized distilled water, the ozone concentration in which had constituted 0.3 mg/l. Ozonecontaining solution was used in the form of small baths and gargles instead of conventional antiseptic solutions. While local application the pronounced antimicrobic action of ozone was noted. Additionally there was established immunomodulating action of ozone on the local immunity factors in oral cavity, demonstrated by the rise of the secretory immunoglobulin A (SIgA) level and by lowering of the serum immunoglobulins in saliva. This had witnessed the rise of resistance and lowering of expression of the mucosal inflammatory changes. In patients, to whom the conventional treatment was done, the immunologic indexes dynamics was opposite, witnessing presence in them posttraumatic immunodepression. The comparison of data, obtained in the clinic and in experiment, permits to suggest, that antimicrobic action of ozone is mostly mediated via the local immunity activization.

Abscess↗
PubMed2001

[Critical pathway for the treatment of acute myelogenous leukemia].

Based on analysis of data from 10 patients newly diagnosed as having acute myelogenous leukemia (AML), we developed a critical pathway (CP) to prevent infection and thus shorten the period of hospitalization. This CP shows laboratory test results, vital signs, chemotherapy regimen, concomitant supportive care and oral medications, gargling with antiseptic mouthwash, other anti-infection measures, diet, room conditions, patient education in anti-infection measures, outcome, and variance on the vertical axis and time on the horizontal axis. After introduction of the CP, 9 of the newly diagnosed AML patients did not experience severe treatment-related complications during a mean hospitalization of 29 days until remission and 95 days until discharge. These results suggest that the present CP makes it possible to shorten the hospital stay, reduce treatment costs, and improve the quality of life of AML patients.

Acute Disease↗
PubMed2001

Clinical evaluation of human placental extract (placentrex) in radiation-induced oral mucositis.

To evaluate human placental extract in the treatment of radiation mucositis involving the oral/oropharyngeal region, a prospective randomized study was carried out in 120 patients with squamous cell carcinoma of the head and neck from August 1997 to March 1999. The study was conducted in patients receiving radical external radiation therapy, planned for = > 60 Gy/30 F/6 weeks, who developed grade 2 radiation mucositis (patchy mucositis) during radiation treatment. The patients were randomized in two groups of 60 patients each to receive either placentrex treatment (placentrex group) or conventional treatment (control group). Placentrex treatment was given as Inj Placentrex 2 ml by deep intramuscular injection 5 days a week for 15 injections. Conventional treatment given in the control group was disprin gargles and betamethasone oral drops. A subjective decrease in pain was observed in 48/60 (80%) of patients in the placentrex group compared with 22/60 (36.7%) in the control group. The progression to grade 3 radiation mucositis was 24/60 (40%) in the placentrex group compared with 52/60 (86.7%) in the control group. The subjective improvement in difficulty in swallowing was seen in 56/60 (93%) of patients in the placentrex group compared with 9/60 (15%) of patients in the control group. Only one patient in the placentrex group compared with three in the control group required interruption of radiation therapy because of severe radiation reactions. Human placental extract appears to be effective in the management of radiation-induced oral/oropharyngeal mucositis and especially in controlling subjective symptoms.

Abnormalities, Radiation-Induced↗
PubMed2000

[Study of prevention and treatment on acute radioactive injury with huoxue yiqi yangyin recipe].

OBJECTIVE: To reduce the acute toxic and side-effect of radiotherapy with Huoxue Yiqi Yangyin recipe (HYYR). METHODS: Seventy-two nasopharyngeal carcinoma patients that using radiotherapy were divided into two groups: HYYR group (A) and the control group (B) using Wisk lotion for gargling or apply at the skin lesion. RESULTS: The injury on mucous membrane of mouth cavity and skin were 47.2%, 91.7%, 13.9%, 33.3% in group A and B respectively, the degree of injury was different (P < 0.01). The acute reaction of the mucous membrane of mouth cavity did not occur until the cumulative radiation were 41.4 +/- 9.4, 30.9 +/- 8.9 in group A and B respectively, there was significant difference between the two groups (P < 0.01). CONCLUSION: HYYR can reduce the acute radioactive reaction of the skin and mucous membrane of mouth cavity and inhibition of bone marrow.

Aged↗
PubMed2001

Evaluation of influenza virus detection by direct enzyme immunoassay (EIA) and conventional methods in asthmatic patients.

Throat gargle specimens of fifty-seven acute asthmatic patients (age range 18-40 years) were collected for the study. Thirty-four patients were found influenza virus positive in acute asthma cases. Influenza virus was isolated by conventional culture method on MDCK cell-line and by enzyme immunoassay test (EIA). The EIA negative specimens were retested after virus amplification on MDCK cell-line. Virus shedding and virus surface receptors assay was carried out to determine influenza virus titre. Airway functions were measured by spirometry. A good relationship was observed between the degree of airflow limitation and presence of influenza virus infection (p < 0.001; r = 0.85). A comparable difference in % FEV1 was observed in relation to the symptoms. The patients with greater viral antigen load had lower % FEV1. Two specimens, which were EIA negative, turned out to be positive after amplification on MDCK cell-line. The sensitivity was 98% and specificity was 100%. It was concluded that EIA method is a useful diagnostic tool as it detects influenza viral antigen quickly as compared to conventional methods.

Adolescent↗
PubMed2003

[Food residues identified in the pharynx of a patient with a cleft palate].

Solid food residues were identified in the pharynx of a 17-month-old infant with a cleft palate at the time of anesthesia induction, although nothing-by-mouth directions for more than four hours had been strictly followed. Preoperative airway management, e.g. gargling and nose blowing, is necessary in patients with a cleft palate even after an appropriate period of fasting because food residues may remain in the nose due to the anatomical abnormality.

Anesthesia, General↗
PubMed2003

[Nursing measures against adverse reaction from anti-cancer chemotherapy].

Combination chemotherapy for leukemia develops bone marrow suppression. Infection or hemorrhage disorders the treatment, and may influence the clinical result. The caring staff must understand the pathology of bone marrow suppression. Visitors observe the hospital rules. Foods are also limited, city water and uncooked foods are prohibited. To keep oral cavity clean, pretreatment of some decayed teeth, and frequent gargling with sterilized water are needed. Defecation control is important. Sitz bath or shower toilet is helpful. Hand cleaning is essential for before a meal, after defecation and after a going out. Bathing is fundamental to cleaning body. No bathing is dirty. Medical catheters are checked up every day. Thrombocytopenia(< 30,000/microliter) develops a spontaneous bleeding. Severe thrombocytopenia(< 10,000/microliter) does a fatal organ bleeding.

Antineoplastic Agents↗