A surveillance study of bacteriologic profile in rhinosinusitis.

Objective: To review the types of bacteria found in rhinosinusitis and the prevalence of a beta-lactamase producing organism in a tertiary care hospital during the year 2004 and compared with our previous reports. Methods: Charts of patients who underwent endoscopic sinus surgery or maxillary antral puncture or endoscopic-guided culture at the Rhinology & Allergy Division, Department of Otolaryngology and the Department of Microbiology, Siriraj Hospital from January 2004 to December 2004 were reviewed. Information regarding the patient’s age, site of specimens, culture and sensitivity results were obtained. Results: There were 162 specimens and 29 bacterial species isolated. There were 50.4% positive aerobic cultures, gram-negative bacteria were more common than gram-positive bacteria (68.5% vs 31.5%). Common aerobes were Pseudomonas aeruginosa (16.2%), non-fermentative gram negative rod: NF-GNR (10.8%), Coagulase- negative Staphylococcus aureus :CNS (9.9%) and Klebsiella pneumoniae (9.9%).The most common anaerobes were Peptostreptococcus sp., Bacteroides fragilis and Fusobacterium sp. Conclusion: Contrary to our previous studies, gram negative organisms play a more important role than gram positive organisms. The causative pathogens of rhinosinusitis should be studied continuously because rapid progress in the development of new antimicrobial agents has a significant impact on their bacteriologic profile.

Development of a health-related quality of life questionnaire for Thai patients with rhinoconjunctivitis.

The objective of this study was to develop a disease-specific questionnaire for patients with rhinoconjunctivitis. All patients were recruited at the Out-Patient Clinic at Siriraj Hospital. Related topics were gathered from several sources, and a list of 63 items was produced. In phase I, the first version of the questionnaire was completed by 363 patients. Forty-eight items were identified by clinical impact analysis during the item removal process, two more questions were then added, giving a total of 50. Two hundred and forty-three patients completed the second version questionnaire in phase II. The average time taken to complete the questionnaire was 6.38 minutes. The item removal process in phase II was achieved by a multi-step process. There were 36 items in the third version questionnaire which consisted of six dimensions and two independent items as follows: symptoms (17 items), physical functioning (3 items), role limitations (3 items), sleep (3 items), social functioning (3 items), emotions (5 items), general health (1 item), and absenteeism (1 item). The scores of each item ranged from 1 to 5; a lower score indicating a better quality of life. Data from the selected 36 items was extracted to test the validity and reliability of the final version. The floor and ceiling effects of the scores for each dimension were low. Multitrait multi-item analysis was conducted to examine construct validity. The scaling success of convergent and divergent validity was 100% and 94%, respectively. Internal consistency determined by Cronbach's alpha coefficient, was satisfactory (0.79-0.87). The study indicates that the questionnaire is suitable for use in clinical settings. While the test results are encouraging, further work needs to be done on the test-retest reliability and on responsiveness.

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.

A comparative study of the major allergenic components in house dust extracts between siriraj and commercially prepared extracts.

The quantity and concentration of major allergens in mite allergenic extracts are crucial for skin testing, which is the recommended standard method for the diagnosis of house dust mite allergic disease. The purposes of this study were 1) To compare the constituents of major mite allergens in 3 types of mite extracts, i.e., extracts from mite reared in-house (Dermatophagoides pteronyssinus and Dermatophagoides farinae), extracts from commercial mite products and commercial ready-made mite extracts. These in-house extracts were prepared either with or without the preservative, glycerine. The concentrations of the major constituents of group 1 and 2 allergens of the extracts were determined by a two-site monoclonal based ELISA. 2 ) Biological assays were also carried out to determine the relative potency of the extracts in 120 allergic patients by skin prick test. It was found that the mean concentrations of Der p1, Der f1 and group 2 mite allergens in extracts from mites reared in-house were 102, 195 and 94 ตg/ml, respectively, compared to 169, 238 and 91 ตg/ml, respectively in commercial mite extracts. The commercial with product had the lowest concentrations of mite allergens (1 ตg/ml). Comparison of mite extracts with and without glycerine preservative showed no significant difference in concentrations of major allergens. Reduction of allergens concentration from 10,000 to 1,000 PNU/ml also reduced the concentration of mite allergen proportionately. Siriraj mite extracts were stable for at least 1 year at 4 oC without any significant change in composition or concentration. In conclusion, mite reared in-house can be used as raw material for preparation of mite allergenic vaccine.

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.

Clinical and histopathological classification of nasal polyps in Thais.

One hundred and forty five patients with nasal polyps (NP) who underwent a first operation at the Department of Otolaryngology, Faculty of Medicine Siriraj Hospital during the 2-year period January 1998 to December 1999, were studied to determine the incidence of clinical and histolopathologic types of NP in Thai patients. The clinical types of NP were classified into 5 groups, using Stammberger's criteria i.e. isolated polyps (IP); antrochoanal polyps (ACP); NP and chronic rhinosinusitis (NPCRS) associated with non-eosinophilic infiltration; NPCRS associated with eosinophilic infiltration or NP with asthma (NPA); and NP with specific diseases (NPSD). The histopathologic types were classified into 4 types, using Hellquist's criteria i.e. Type I, edematous, eosinophilic (allergic) polyps; Type II, chronic inflammatory (fibroinflammatory) polyps; Type III, polyps with hyperplasia of seromucinous glands; and Type IV, polyps with stromal atypia. There were 86 males (59.3%) and 59 females (40.7%), with a male : female ratio = 1.5 : 1. The mean age was 36.1 + 16.5 years, ranging from 9 to 74 years. The mean duration of symptoms was 63.6 + 75.2 months, ranging from 1-420 months. The clinical classification study showed that 17 patients (11.7%) had IP, 13 patients (8.9%) had ACP, 105 patients (72.4%) had NPCRS, 5 patients (3.5%) had NPA, and 5 patients (3.5%) had NPSD (one case of Katargener's syndrome, bronchiectasis, aspirin intolerance, immotile cilia syndrome, and AIDS respectively). The histopathologic study showed that 17 specimens (11.7%) were Type I, 118 specimens (81.4%) were Type II, 9 specimens (6.2%) were Type III, and 1 specimen (0.7%) was Type IV. In the group of patients with NPCRS (105 patients), the most common histopathologic type was type II (86 patients, 81.9%). Type I and Type III were found in 12 patients (11.4%) and 7 patients (6.7%) respectively. The incidence of eosinophilic polyps in the groups of NPCRS was only 18.1% (Type I + Type III). This finding is different from that of NP in the western countries, in which the incidence of eosinophilic polyps is 80-90%. The pathogenetic mechanism underlying this difference is still not known. Is this difference due to racial or genetic factors, or geographic differences? The answers to these question are to be studied further.

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.

The relationship between deviated nasal septum and middle ear pressure.

The Nose/Ear Distress Syndrome is defined as the combination of nasal septal deformity and eustachian dysfunction in the absence of any other pathology (McNicoll and Scanlan,1979). Until now, there have been few literatures strongly mentioned about it in the scientific role, and this relationship has not been studied in Thai people. The relationship between deviated nasal septum (DNS) and middle ear pressure (MEP) was then studied with the audiometry, tympanometry, rhinomanometry, and acoustic rhinometry. A total of 80 patients with DNS was recruited and divided into 2 groups; The allergic rhinitis group (n = 40) and the control group (n = 40). Each group could be further divided into 2 subcategories: (a) DNS to Right (nasal airflow: right side< left side) (n = 44) (b) DNS to left (nasal airflow: left side< right side) (n = 36). The mean of patient's age was 33.5 years (range: 11-56 years). The mean of minimal cross-sectional area in patients with DNS and its length from anterior nostril (after decongestion) were 0.7 cm2; 1.6 cm on the left side and 0.7 cm2;1.4 cm on the right side, respectively. The mean of MEP (n = 80) was - 17.3 daPa (S.D.=13.4) on the left side and - 18.7 daPa (S.D.=14.3) on the right side. In each subcategory of both groups, there were no significant differences in MEP between both sides (p > 0.05) although there were significant differences in airflow and resistance (p < 0.05). Furthermore, the difference of nasal airflow or nasal resistance between both sides did not significantly correlate with the difference of MEP (p > 0.05). The number of patients who had auditory symptom was 9 (22.5%) in the control group and 4 (10%) in the allergic rhinitis group. There were no significant differences in incidence of auditory symptom between both groups (p > 0.05). Between the patients who had auditory symptom (n = 13) and had no auditory symptom (n = 67), the difference of nasal airflow, nasal resistance, and MEP between both sides did not differ significantly (p > 0.05). In summary, we found no relationship between DNS and MEP in this study.

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.

Ear diseases and hearing in the Thai elderly population. Part I. A comparative study of the accuracy of diagnosis and treatment by general practitioners vs ENT specialists.

The prevalence of ear disease and hearing disability in elderly Thais in 14 urban communities around Siriraj Hospital was studied. The accuracy of diagnosis and treatment of common ear diseases and of screening for hearing loss in the elderly between general practitioners (GP) and Ear, Nose and Throat (ENT) specialists was also compared. Elderly people aged 60 years or more who had registered with the health care program had their ear and hearing check-up performed by GPs and ENT specialists from mobile team. Altogether, 980 subjects were included, 332 were males, 648 were females, (male:female ratio 1:2). Their ages ranged from 60-96 years with an average age of 68.5 years. The prevalence of ear disease diagnosed by ENT specialists was 16.3 per cent (95% CI = 14.0-18.6), 12.5 per cent was external ear disease and 2.7 per cent middle ear disease. The most common ear problem was impacted ear wax (8%), the second most common problem was otitis externa (4.3%). Compared with an ENT specialist, the ability of a GP to diagnose ear diseases had a sensitivity of 46.5 per cent and a specificity of 80.3 per cent, the positive predictive value of their diagnoses was 31.5 per cent. The efficacy of the treatment of ear diseases in 51 elderly people by GPs and in 63 elderly people by ENT specialists was statistically significantly different (p = 0.02). Hearing screening by the GP using whisper or the watch test performed in 650 elderly people revealed abnormal findings (could not hear) in 70 cases or 10.8 per cent. Hearing screening using pure tone audiometry in 980 elderly people showed abnormal hearing level in 508 cases (52.4%). 9.5 per cent of them had a bilateral moderate to severe degree of hearing impairment. There was no difference in the level of hearing impairment between males and females or between right and left ears. The prevalence of hearing loss increases with increasing age. Tympanometry performed by an acoustic impedance machine in 980 of the elderly showed a conductive hearing loss in 85 cases (9.1%). The authors conclude that the prevalence of ear disease in elderly people living in the urban community around Siriraj Hospital is quite high. Although the ear diseases commonly encountered were not serious, if left untreated they may lead to complication and decreased hearing. Therefore, the proficiency of GPs in the management of common ear diseases in every community should be regularly maintained. Hearing impairment is very prevalent and increases with age. Thus, screening for hearing loss using an audiometer and/or acoustic impedance is recommended for all senior citizens in their community at least once a year. Early detection of elderly persons who could benefit from a properly fitted hearing aid will certainly improve the quality of life and may prevent psychiatric and functional impairment of the Thai elderly population.

Ear diseases and hearing in the Thai elderly population. part II. A one year follow-up study.

The ear and hearing survey of the Thai elderly in 14 urban communities around Siriraj Hospital was repeated one year after the first survey in order to detect any changes. Altogether 556 elderly people came for follow-up examination, 191 were males, 365 were females, the average age was 68.2 years (60-88 years). Ear disease was diagnosed by ENT specialists in 80 cases which implied that the prevalence of ear disease was 14.4 per cent. This was not statistically significantly different from the prevalence of ear disease in the survey conducted in the previous year and although the elderly who had ear diseases in the first survey had already been treated, the prevalence did not decrease. Some elderly people only had ear diseases in this survey. Hearing evaluation by pure tone audiometry was performed in 549 elders. There were 12.4 per cent who had bilateral, moderate to severe hearing loss which was 2.9 per cent higher than in the previous survey. The hearing level had also deteriorated in 14.3 per cent of the elderly people. Tympanometry was performed in 556 cases and showed that 10.5 per cent had a conductive hearing loss. When audiometry and tympanometry of the same elderly people were evaluated together, 49.2 per cent of them had a sensorineural hearing loss, 3 per cent had a conductive hearing loss and 6.5 per cent had a conductive or mixed type hearing loss. When the results of audiometry were compared with the self identification/perception of their hearing reported by the elderly in the questionnaires, they were not reliable. In conclusion, a one-year follow-up study of the prevalence of ear disease and hearing impairment in the elderly showed that the prevalence of ear disease was still high and had not changed significantly. Concerning hearing impairment, not only had the prevalence increased, but also the severity of hearing loss. Therefore, the authors stress the need to implement the "Ear and Hearing Care" program for the elderly both in rural and urban communities at least once a year in order to improve quality of life of the elderly Thai people and to prevent complications of ear disease.

Nasal airway resistance in asymptomatic Thai population.

Active anterior rhinomanometry was performed for the first time on one hundred and forty-six Thai adults without nasal symptoms. The subjects were divided into two groups : group I – with normal rhinoscopic appearance and Group II – with slight septal deformity. Transnasal airflow and nasal airway resistance (NAR) were measured by ATMOS Rhinomanometer 220 in each subject before and after decongestion. The statistical analysis showed that the nasal airflow and ANR in both groups were not significantly different. The normal NAR at a differential pressure of 75 Pascals in Thai adults was 0.22 + 0.10 Pa/cc/sec before decongestion and 0.16 + 0.06 Pa/cc/sec after decongestion. This value is slightly lower than the average NAR reported in Caucasian and in Negroid Nigerians. We also found that NAR in female subjects was significantly higher than in males. There was no correlation between NAR and age and weight, but a statistically significant inverse correlation with the height of the subject was observed.