An open-label, prospective study of an oral polyvalent bacterial lysate (Luivac) in the treatment of recurrent respiratory tract infections in Thai patients.

An open-label, non-comparative study was performed in the Department of Otolaryngology, Siriraj Hospital, Bangkok, Thailand, to assess the safety, tolerability, acceptability and efficacy of an oral polyvalent bacterial lysate (Luivac) in the treatment of recurrent respiratory tract infections (RTIs) in Thai patients. Thirty-three patients were included in this study, 18 males and 15 females, with a mean age of 34.0 +/- 14.7 years. The mean number of RTIs during the 12-month period preceding the study was 9.5 per patient. During the study each patient received one tablet of Luivac daily for 28 days followed by a treatment-free period of 28 days. This was followed with another 28 days on Luivac, after which there was a 28-day treatment-free follow-up period. This study lasted 4 months with five scheduled patient visits (V1-V5). Laboratory studies were done at baseline (V1) and after treatment (V4), which included complete blood count and serum immunoglobulins (IgA, IgE, IgG and IgM). The incidence of all adverse events was 15.2% and no case was related to the studied drug. There were no clinical relevant changes in laboratory parameters after treatment. The reduction rate of RTIs per month at the end of the study period was 63.5% when compared to the average RTIs rate per month during the 12 months preceding the study. A comparison of the first study period (V1-V3) and the second study period (V3-V5) showed a reduction in duration of RTIs (23.1%), in the clinical infection score (17.5%), in the number of antibiotics used (2.1%), in the number of symptomatic treatments (3.5%), and in the number of days absent from school or work (50.0%). Overall tolerability and acceptability were assessed as very good and good in 96.8% of the patients. This study suggests that oral polyvalent bacterial lysate (Luivac) was safe and also showed a tendency to be effective in preventing RTIs in Thai patients with or without risk factors for recurrent RTIs. Other clinical advantages were reduction in the severity and duration of infection as well as in reduction of the cost of treatment and the number of days absent from school or work.

An open-label, non-comparative phase IIIb study of oral gatifloxacin in the treatment of acute, uncomplicated bacterial sinusitis in Thai patients.

This was an open-label, non-comparative phase IIIb study of oral gatifloxacin in the treatment of acute, uncomplicated bacterial sinusitis in Thai patients. The study was conducted at three otolaryngologic centers in Thailand, i.e. Siriraj Hospital, Srinakarind Hospital, and Bhumipol Hospital, during the period of November 1999 through October 2000. Thirty patients with symptoms and signs of acute maxillary sinusitis, which were confirmed by abnormal radiological findings, were included. Documentation of infection was made by pre- and post-therapy culture and susceptibility testing. All patients received gatifloxacin 400 mg tablet orally once daily for 10 days. Symptoms and signs were evaluated on four occasions, i.e. before treatment started (day 0, V1), day 3-5 (V2), the third (V3) on day 11-14 (V3), and day 21-28 (V4). Primary outcome measures were the changes in the percentage of patients who had general clinical symptoms (i.e. fever, malaise, chill, sore throat, headache, cough, and halitosis), and also the clinical symptoms and signs of sinusitis (i.e. sinus pain, sinus tenderness, purulent nasal discharge, facial pressure, nasal congestion, postnasal drip, and anosmia). The clinical responses were classified as cure, improvement, relapse or failure at the end of treatment (V3) and at follow up (V4). Treatment success was defined as cure or improvement. The safety of gatifloxacin was assessed from vital signs, general physical examination, hemato-biochemical parameters, and adverse events reported. There were 13 males and 17 females, with a mean age of 34.7 + 12.2 years (range 21-70). The mean duration of symptoms was 2.4 + 8.8 weeks. At V1,23 patients (76.7%) had headache, 19 patients (63.3%) had cough, and 14 patients (46.7%) had halitosis. At V3 and V4 all these symptoms had resolved, except in 1 patients who still had cough. The percentages of patients who had symptoms and sign of sinusitis at V1 were as follows : purulent nasal discharge 90%, nasal congestion 86.7%, postnasal drip 86.7%, sinus pain 80%, facial pain 66.7%, and sinus tenderness 63.6%. After 3-5 days of treatment (V2), the percentages of patients who had symptoms and signs of sinusitis decreased significantly for every symptom and sign. The same was true at V3 and V4. The total percent improvement in radiological findings was 83.4% (41.7% resolution, 41.7% improvement). Pretreatment cultures were positive in 23 out of 30 patients (76.7%). The most common pathogens were Hemophilus influenzae (18.4%), Streptococcus pneumoniae (9.4%), other Streptococcus species (9.4%), Klebsiella pneumoniae (6.3%) and coagulase negative Staphylococcus (6.3%). The anaerobes found were Peptostreptococcus prevotii (9.4%), Fusobacterium nucleatum (9.4%), Bacteroides species (6.1%) and Prevotella species (3.1%). Bacteriological responses at V3 were 30.4% eradication, 65.2% presumed eradication, and 4.4% persistence. Clinical responses at V4 were 88.9% cured, 7.4% relapsed, and 3.7% failed. Adverse events were found in 4 patients (13.3%) which were transient and resolved spontaneously. Adverse events found were nausea, vomiting, dry mouth, constipation, agitation and tremor. This study showed the efficacy and safety of a 10-day course of oral gatifloxacin 400 mg once daily in the treatment of acute uncomplicated bacterial sinusitis. 88.9% of patients experienced a cure, and bacteriological eradication was achieved in 95.6%. The excellent profile of gatifloxacin makes it suitable for the treatment of community acquired acute bacterial sinusitis. The once daily regimen enhances patient compliance.

Adverse reactions to allergen injection : The siriraj experience.

A retrospective review of the medical records of adult patients, who had skin testing and allergen immunotherapy at the ENT Allergy Clinic, from January 1987 to December 1999 was performed, to ascertain the incidence of adverse reactions to allergen injection. For skin prick testing, 5,879 patients with 82,306 skin tests were recorded with no adverse systemic reaction. For intradermal testing, 5,490 patients with approximately 109,800 tests were recorded and two patients developed mild systemic reactions which were probably related to the test. The systemic reaction rate to intradermal skin testing was therefore 36.4 per 100,000 patients or 2.2 systemic reactions per 100,000 intradermal tests. The overall reaction rate to both types of allergy skin test in 11,369 patients tested for aeroallergens was 0.018% or 17.6 systemic reactions per 100,000 patients. Concerning immunotherapy 42,810 allergen injections were recorded, the rate of excessive local reactions was 4.8% (4.08% were immediate and 0.77% were delayed types), the rate of systemic allergic reactions was 0.08%. None of the reactions was fatal. In a prospective study conducted from January 2000 to December 2001, 4,764 allergen injections were performed with 27 systemic reactions occurring in 23 patients (7 men and 16 women). Twenty-two events were classified as mild to moderate (0.46%) and 5 events were acute severe reactions (0.11%). No cases of hypotension and laryngeal edema were observed and none of the reactions was fatal. The possible risk factors for developing a systemic reaction during immunotherapy in this study were :- vaccines comprising grass/weed pollen or house-dust mite, an increased dose, symptomatic asthmatics, prior systemic reactions and changing to a new vial. The incidence of adverse reaction after allergen injection and the possible causative factors associated with immunotherapy in our clinic are similar to other reports from western countries. In order to minimize the number and the severity of systemic reaction, an allergen injection should be performed by physicians and personnel who are well aware of the risks and well trained to recognize and manage the systemic reactions immediately.

An open-label study of the efficacy and safety of a herbal secretolytic preparation as a sole therapy in patients with sinusitis.

This is an open-label, non-comparative controlled study of the efficacy and safety of a herbal secretolytic preparation (Sinupretฎ) as a single therapy in patients with sinusitis. The study was conducted at the Department of Otolaryngology, Siriraj Hospital, Bangkok, during the period January - December 2000. Thirty-nine patients with symptoms and signs of sinusitis, which were confirmed by abnormal endoscopic findings and abnormal radiological findings, were included. All patients received Sinupretฎ, two sugar-coated tablets orally three times a day for 21 days. Symptoms and signs were evaluated on three occasions; the first (day 0, V1) before the treatment started, the second (V2) on day 14, and the third (V3) on day 21. There were no other additional adjunctive treatments. Primary outcome measures were the change in the percentage of patients who had three main symptoms (i.e. nasal obstruction, nasal discharge and sinus headache), abnormal endoscopic findings (i.e. mucosal swelling and nasal secretion), and abnormal radiological findings (i.e. air-fluid level, opacification, and mucoperiosteal thickening). Global assessment was rated by the patients using a visual analogue scale (VAS). The clinical response was classified as cure, improvement, failure, and relapse. Treatment success was defined as cure or improvement. Adverse events were also recorded. There were 14 males and 25 females, with a mean age of 39.7 + 14.1 years (16-75). Twenty three patients had chronic sinusitis (CS) and 16 patients had acute sinusitis (AS). The duration of symptoms in the CS group was 16.4 + 25.6 months (1-96), and in the AS group was 21.3 + 9.4 days (7-30). At V1, 34 patients (87.2%) had nasal discharge, 26 patients (66.7%) had obstruction, and 25 patients (64.1%) had sinus headache. At This is an open-label, non-comparative controlled study of the efficacy and safety of a herbal secretolytic preparation (Sinupretasาa single therapy in patients with sinusitis. The study was conducted at the Department of Otolaryngology, Siriraj Hospital, Bangkok, during the period January - December 2000. Thirty-nine patients with symptoms and signs of sinusitis, which were confirmed by abnormal endoscopic findings and abnormal radiological findings, were included. All patients received Sinupretฎ, two sugar-coated tablets orally three times a day for 21 days. Symptoms and signs were evaluated on three occasions; the first (day 0, V1) before the treatment started, the second (V2) on day 14, and the third (V3) on day 21. There were no other additional adjunctive treatments. Primary outcome measures were the change in the percentage of patients who had three main symptoms (i.e. nasal obstruction, nasal discharge and sinus headache), abnormal endoscopic findings (i.e. mucosal swelling and nasal secretion), and abnormal radiological findings (i.e. air-fluid level, opacification, and mucoperiosteal thickening). Global assessment was rated by the patients using a visual analogue scale (VAS). The clinical response was classified as cure, improvement, failure, and relapse. Treatment success was defined as cure or improvement. Adverse events were also recorded.V3, the percentage of patients who had symptoms decreased signiticantly to 64.1%, 41.0% and 38.5% for these three symptoms respectively. The same was true for the percentage of patients who had abnormal endoscopic findings. The percentage of patients showing radiological evidence of improvement was 61.5% (33.3% normal, 28.2% improvement), with no change in 38.5% of patients. Treatment success was recorded in 31 out of 39 patients (79.4% : cure 23.0%, improvement 56.4%). In four patients (10.3%) treatment failed and in four other patients (10.3%) there was a relapse in symptoms and signs. Adverse events were reported in 4 patients (10.3%), which were mild and resolved spontaneously. This study shows the efficacy and safety of a 3-week course of a herbal secretolytic preparation (Sinupretฎ) in the treatment of sinusitis, either acute or chronic. The incidence of adverse events was low and they were tolerated by the patients. The use of this herbal secretolytic preparation as a sole treatment is effective in most cases of uncomplicated sinusitis. This can decrease the risk of adverse drug reactions from antibiotic therapy and is a cheaper treatment.

A survey of allergic rhinitis in Thais.

The incidence of allergic rhinitis in the Thai population was surveyed in two province, Nan in the North and Khonkean in the North-East Thailand. Histories were taken from all subjects and ENT examinations and allergy skin prick tests to six common aeroallergens were made. Total IgE in serum was also assayed in some. Altogether 649 subjects were included on our survey, 338 were children and 311 were adults. Positive skin prick tests to at least 2 allergens and a history of persistent rhinitis or of other allergic symptoms were considered as criteria to identify atopic persons. According to the above criteria, 134 or 20.68% of them had allergies. The incidence of allergic rhinitis in children and in adults was not much different (20.61% in children and 22.78% in adults). These figures are similar to figures reported from other countries. This has confirmed the general belief that alleries are common world-wide. The prevalence of allergic rhinitis in Bangkok is now being surveyed in order to study the effect of air pollution. This will be reported in the future.

A study of mediator cells in chronic rhinitis patientes by nasal scraping method: The first report in Thais.

A study of mediator cells by nasal scraping method was performed for the first time in Thai population i.e. 154 chronic rhinitis patients and 43 healthy volunteer with no nasal symptoms. There were 67 males and 87 females, ages ranged from 8 – 70 years old with the average of 35.5 in the chronic rhinitis group. In the normal volunteer group, there were 21 males and 22 females, ages ranged from 17 – 74 years old with the average of 35. All chronic rhinitis were skin tested by intracutaneous method to a panel of common inhalants. The result of the skin test we graded into 0 – 4+ If the patients had 2+ – 4+ skin test result, they were classified as having allergic rhinitis (AR), while patients who had 0 – 1 were classified as non-allergic rhinitis (NAR). The average number of basophilic metachromatic cells (BMC) in normal volunteers, AR and NAR patients were 2.35 + 10.73 (0 – 57), 121.74 + 198.73 (0 – 1,177) and 11.33 + 32.05 (0 – 117) cells respectively. This findings confirm that AR patients have more BMC on their nasal surface than NAR patients and normal people. When comparing the average number of BMC according to the skin test result in chronic rhinitis patients we found that the average number of BMC in patients with 0, 2+, 3+ and 4+ skin test results were 11.33 + 32.05, 54.54 + 100.49, 110.00 + 84.68 and 135.71 + 212.54 cells respectively. Statistical analysis showed that the number weaker positive and negative results. The sensitivity of nasal scraping method in diagnosing AR was found to be 61.27 percent with the specificity of 90.91 percent, the positive predictive value was 94.56 percent and the efficiency of test was 69.54 percent. We concluded that the study of BMC by nasal scraping method is easy to perform with minimal trauma to the patient, the instrument used is simple and less expensive, the interpretation of result is also accurate and can be repeated. Therefore this method should be considered as another tool to diagnose AR especially in the place where skin test is not available.