[Cost-effectiveness analysis of Chaiyin Granules in treatment of influenza].

This study aimed to evaluate the cost-effectiveness of Chaiyin Granules compared with Oseltamivir Phosphate Capsules in the treatment of influenza(exogenous wind-heat syndrome). Based on a randomized, double-blind, positive drug parallel control clinical trial, this study evaluated the pharmacoeconomics of Chaiyin Granules with cost-effectiveness analysis method. A total of 116 patients with influenza from eight hospitals(grade Ⅱ level A above) in 6 cities were selected in this study, including 78 cases in the experimental group with Chaiyin Granules and Oseltamivir Phosphate Capsules placebo, and 38 cases in the control group with Oseltamivir Phosphate Capsules and Chaiyin Granules placebo. The total cost of this study included direct medical cost, direct non-medical cost, and indirect cost. The remission time of clinical symptoms, cure time/cure rate, antipyretic onset time/complete antipyretic time, viral nucleic acid negative rate, and traditional Chinese medicine(TCM) syndrome curative effect were selected as the effect indicators for cost-effectiveness analysis. Four-quadrant diagram was used to estimate the incremental cost-effectiveness ratio. The results showed that Chaiyin Granules were not inferior to Oseltamivir Phosphate Capsules in the remission time of clinical symptoms of influenza(3.1 d vs 2.9 d, P=0.360, non-inferiority margin was 0.5 d). Compared with Oseltamivir Phosphate Capsules, Chaiyin Granules would delay the remission time of clinic symptoms of influenza for 1 d, but could save 213.9 yuan. 1 d delay in cure time could save 149.3 yuan; 1% reduction in the cure rate could save 8.2 yuan; 1 d delay in antipyretic onset time could save 295.4 yuan; 1 d delay in complete antipyretic time could save 114.3 yuan; 1% reduction in the 5-day cure rate of TCM syndrome could save 19.2 yuan. Different from other indicators, there was no statistically significant difference between two groups in the effect of negative conversion rate of viral nucleic acid, but the cost was lower and the effect was superior, and the pharmacoeconomics was not different from that of Oseltamivir Phosphate Capsules in the field of influenza treatment.

Burosumabe para o tratamento de hipofosfatemia ligada ao cromossomo X em adultos e crianças / Burosumabe for or treatment of hypophosphatemia linked to or chromosome X in adults and infants

CONTEXTO: A hipofosfatemia ligada ao cromossomo X (HLX) é considerada uma doença ultrarrara, cronicamente debilitante e deformante. É uma doença causada por mutações no gene regulador do fosfato com homologia às endopeptidases do cromossomo X (PHEX), que leva a perda de função do mesmo, gerando erros na detecção de fosfato e aumento dos níveis de fator de crescimento de fibroblastos 23 (FGF23). Os maiores achados clínicos na XLH são hipofosfatemia, retardo no crescimento, raquitismo e/ou osteomalácia. Anormalidades esqueléticassão sinais precoces de HLX. Fraturas, perdas auditivas, problemas dentários e osteomalácia podem aparecer além da perda de qualidade de vida associada. O tratamento convencional é realizado com administração de fosfato e vitamina D. Esta não é uma terapia com alvo no mecanismo fisiopatológico da doença, resumindo-se à tentativa de minorar a hipofosfatemia e o excesso de hormônio da paratireoide. A reposição oral de fosfato e vitamina D são insuficientes para atender aos objetivos do tratamento, não logrando alterar a densidade mineral óssea da coluna e quadril em adultos e estão associados a efeitos adversos importantes. Considera-se a possibilidade de inibição da atividade do FGF23 como uma medida terapêutica única para doenças hipofosfatêmicas causadas pelo excesso de FGF23. O burosumabe é um anticorpo monoclonal, sendo o primeiro medicamento desenvolvido para inibir a FGF23 e com isso aumentar a reabsorção de fosfato do rim, para que pela produção de vitamina D, melhore a absorção intestinal de cálcio e fosfato reduzindo os danos causados pela HLX. Agências internacionais aprovaram seu uso inicialmente nas populações pediátricas, em que o benefício clínico na melhora da HLX está mais estabelecido. Alguns países ampliaram o uso para a população adulta. TECNOLOGIA: burosumabe (CRYSVITA®). PERGUNTA: O uso de burosumabe para o tratamento da hipofosfatemia ligada ao cromossomo X é eficaz e seguro quando comparado ao tratamento com fosfato e vitamina D ou placebo? EVIDÊNCIAS CIENTÍFICAS: Em revisão sistemática da literatura, o demandante selecionou seis estudos clínicos que avaliaram o uso do burosumabe no tratamento da HLX. Três destes foram realizados em pacientes pediátricos e três em pacientes adultos. Há algumas limitações inerentes aos estudos de fase 2 e 3 selecionados. Os resultados apresentados demostram benefícios clínicos especialmente na melhora do raquitismo em crianças, da mobilidade e crescimento com tratamento com burosumabe em relação ao tratamento com fosfato e vitamina D. O estudo de Imel, et al., 2019 mostrou melhora do Escore Radiographic Global Impression of Change (RGI-C) ­ global ­ diferença média dos mínimos quadrados em 40 semanas: 1,1 (IC95% 0,8 ­ 1,5; ; p <0,0001) favorecendo o tratamento com burosumabe. O estudo de Carpenter et al., 2018, avaliou o mesmo escore em 40 semanas e obteve os seguintes resultados de acordo com a posologia: burosumabe, duas vezes por mês (+1,66 ± 0,09); burosumabe, uma vez por mês (+1,47 ± 0,14); burosumabe, todos os pacientes (+1,56 ± 0,08). Ao avaliar a gravidade do raquitismo pelo escore Thatcher, a diferença média dos mínimos quadrados em 40 semanas de acordo com a posologia foi: burosumabe, duas vezes por mês: -1,06 ± 0,11; p< 0,0001; burosumabe, uma vez por mês: -0,73 ± 0,10; p<0,0001 1; burosumabe, todos os pacientes: -0,89 ± 0,0,07. Em adultos também houve benefícios com o uso do medicamento, porém menos consistentes que na população pediátrica. Insogna et al., 2018, avaliaram a cura completa de fraturas ativas ou pseudofraturas em 24 semanas. Os seguintes resultados foram observados: burosumabe (43,1%) versus placebo (7,7%); Odds ratio OR 16,8 (IC95% não reportado); p<0,0001. Os estudos em adultos foram comparados com placebo, logo os resultados favoráveis ao burosumabe foram esperados. Em relação à segurança, tanto na população pediátrica quanto adulta, o burosumabe não acarretou nenhum evento adverso grave nos estudos realizados. AVALIAÇÃO ECONÔMICA: O demandante realizou uma análise de custo-efetividade. O modelo foi construído em uma planilha MS Excel com base em uma estrutura de Markov com horizonte temporal de toda a vida. Dois modelos de custo-efetividade foram apresentados, um considerando a população pediátrica (idades de 1 a 17 anos) e outro a população adulta (idade ≥18 anos). A razão de custo-efetividade incremental (RCEI) do burosumabe em relação ao uso de fosfato e vitamina D em pediatria foi de R$ 2.401.312,64/QALY e para a população adulta de R$ 2.534.873,52 /QALY. Nas análises de sensibilidade univariada para ambas as populações o modelo se mostrou sensível ao custo do burosumabe e idade de início do tratamento. O modelo possui limitações, entre elas a ausência de dados de incidência da HLX na população brasileira e os dados disponíveis no DATASUS relacionados a procedimentos e tratamentos provavelmente estão subestimados em relação a doença. Por tratar-se de doença rara, a falta de registro de dados e suas implicações podem impactar no modelo e suas análises de sensibilidade. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: A análise de impacto orçamentário (AIO) realizada pelo demandante previu população de pacientes elegíveis para o tratamento com burosumabe baseada em referências internacionais pela ausência de dados registrados no Brasil. Foi adotado um horizonte de 5 anos. O demandante apresentou um cenário base com incorporação de burosumabe para 100% dos pacientes. No cenário ­base os impactos orçamentários em cinco anos foram: R$ 197.249.738,34 para a população pediátrica e R$ 224.968.284,47 para a população adulta. Um outro cenário considerando que 50% seriam diagnosticados e tratados com burosumabe ou fosfato e vitamina D em 5 anos foi apresentado: R$ 98.624.869,17 para a população pediátrica e R$ 67.490.485,34 para a população adulta. O cenário 3 considerou a introdução gradual do burosumabe em 20%, 40%, 50% e 75%, chegando a 100% no quinto ano, assim o impacto em 5 anos foi de: R$ 65.209.976,69 para a população pediátrica R$ 48.026.685,80 para a população adulta. Apesar desse cenário ser o mais próximo do real, a disseminação pode ser maior já que há ausência de tratamento eficaz para a doença. Além disso, a AIO têm provavelmente subestimativas da população por usar uma média internacional e não considerar a incidência da doença ao longo do horizonte temporal. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: De acordo com os critérios adotados nessa análise, não foram localizados medicamentos em desenvolvimento clínico para a doença. DISCUSSÃO: A análise da evidência clínica apresentada sugere que a tecnologia proposta apresenta efetividade superior à única alternativa disponível atualmente para tratamento da HLX no SUS, com confiabilidade moderada, corroborando atuais recomendações para seu uso em diretrizes internacionais. Por ser uma doença rara, com limitações de dados brasileiros disponibilizados, as análises econômicas submetidas pelo demandante indicam limitações metodológicas, reduzindo a confiabilidade das conclusões a respeito de custo-efetividade e impacto orçamentário no cenário brasileiro podendo ter os valores subestimados. RECOMENDAÇÃO PRELIMINAR DA CONITEC: Os membros do plenário não consideraram como robustas as evidências científicas de eficácia e segurança do borusomabe. Além disso, foi considerado elevado o valor de custo-efetividade incremental, assim como o impacto orçamentário. Sendo assim, no dia 7 de outubro de 2020, em sua 91ª reunião de plenário, os membros da Conitec foram desfavoráveis à recomendação de incorporação no SUS do "Burosumabe para o tratamento de hipofosfatemia ligada ao cromossomo X em adultos e crianças". CONSULTA PÚBLICA: a Consulta Pública nº 56 foi realizada entre os dias 04/11/2020 e 30/11/2020. Foram recebidas 619 contribuições, sendo 103 pelo formulário para contribuições técnico-científicas e 516 pelo formulário para contribuições sobre experiência ou opinião. Após apreciação das contribuições recebidas, o Plenário da Conitec entendeu que houve argumentação suficiente para mudança de entendimento acerca de sua recomendação preliminar. A maioria das contribuições foram contra recomendação e se concentraram nos seguintes benefícios do medicamento: eficácia do tratamento; melhora dos sintomas; melhora dos níveis de fosfato e qualidade de vida. Desse modo, a Comissão mudou a recomendação inicial. RECOMENDAÇÃO FINAL DA CONITEC: Os membros da Conitec presentes na 94ª reunião ordinária, no dia 04 de fevereiro de 2021, consideraram que os benefícios clínicos do tratamento foram mais acentuados na população pediátrica apresentando desfechos consistentes. Diante do exposto, os membros presentes deliberaram, por unanimidade, a recomendação do burosumabe para o tratamento de hipofosfatemia ligada ao cromossomo X em crianças conforme protocolo Clínico e Diretrizes Terapêuticas (PCDT) e recomendar a não incorporação do burosumabe para o tratamento de hipofosfatemia ligada ao cromossomo X em adultos. Assim, foi assinado o Registro de Deliberação nº 589/2021. DECISÃO: incorporar o burosumabe para o tratamento da hipofosfatemia ligada ao cromossomo X em crianças conforme Protocolo Clínico e Diretrizes Terapêuticas (PCDT) e não incorporar o burosumabe para o tratamento da hipofosfatemia ligada ao cromossomo X em adultos, do Sistema Único de Saúde - SUS, conforme Portaria nº 01, publicada no Diário Oficial da União nº 34, seção 1, página 93, em 22 de fevereiro de 2021.

Cost-effectiveness of root caries preventive treatments.

INTRODUCTION: With a growing number of individuals retaining their teeth lifelong, often with periodontitis-induced root surface exposure, there is the need for cost-effective management strategies for root caries lesions. The present study aimed to assess the cost-effectiveness of root caries preventive treatments. METHODS: Patients were simulated over 10 years using a Markov model. Four treatments were compared: No treatment, daily 225-800ppm fluoride rinses, chlorhexidine (CHX) varnish (2×/year), silver diamine fluoride (SDF) varnish (2×/year). Data from a systematic review were submitted to network meta-analysis for inferring relative efficacies of treatments. The health outcome was years of teeth being free of root caries. A mixed public-private payer perspective within 2016 German healthcare was taken, with costs being estimated from fee item catalogues or based on market prices. Populations with different numbers of teeth and tooth-level risks were modelled. Monte-Carlo microsimulations, univariate- and probabilistic sensitivity analyses were performed. RESULTS: In populations with 16 teeth at risk and low tooth-level risk for root caries, providing no preventive treatment was least costly, but also least effective (130 Euro, 144 years). SDF ranked next, being more costly (180 Euro), but also more effective (151 years). Payers willing to invest 8.30 Euro per root caries-free tooth-year found SDF most cost-effective. CHX varnish and fluoride rinse were not cost-effective. In populations with more teeth and high tooth-level risk, SDF was the most effective and least costly option. CONCLUSIONS: Root caries preventive treatments (like SDF) are effective and might even be cost-saving in high risk populations. CLINICAL SIGNIFICANCE: Application of SDF can be recommended as a cost-saving treatment for prevention of root caries in patients with high risk of root caries.

Fluoride Rinses, Gels and Foams: An Update of Controlled Clinical Trials.

AIM: The aim of this conference paper was to systematically review the quality of evidence and summarize the findings of clinical trials published after 2002 using fluoride mouth rinses, fluoride gels or foams for the prevention of dental caries. METHODS: Relevant papers were selected after an electronic search for literature published in English between 2003 and 2014. The included papers were assessed for their risk of bias and the results were narratively synthesized due to study heterogeneity. The quality of evidence was expressed according to GRADE. RESULTS: A total of 19 papers were included (6 on fluoride mouth rinse, 10 on fluoride gel and 3 on fluoride foam); 6 had a low risk of bias while 2 had a moderate risk. All fluoride measures appeared to be beneficial in preventing crown caries and reversing root caries, but the quality of evidence was graded as low for fluoride mouth rinse, moderate for fluoride gel and very low for acidulated fluoride foam. No conclusions could be drawn on the cost-effectiveness. CONCLUSIONS: This review, covering the recent decade, has further substantiated the evidence for a caries-preventive effect of fluoride mouth rinse, fluoride gel and foam, previously established in systematic reviews. The lack of clinical trials free from bias is, however, still a concern, especially for fluoride mouth rinses and fluoride foam. There is also a scientific knowledge gap on the benefit and optimal use of these fluoride supplements in combination with daily tooth brushing with fluoride toothpaste.

In vitro assessment of artificial saliva formulations on initial enamel erosion remineralization.

OBJECTIVES: Various formulations of artificial saliva are present in the literature and little guidance is available on the standardization of type of saliva for use in in vitro protocols for erosive studies. The aim of this study was to evaluate the remineralizing capacity of different formulations of artificial saliva on initial enamel erosive lesion. METHODS: Bovine enamel blocks were subjected to short-term acidic exposure by immersion in citric acid 0.05 M (pH 2.5) for 15s, resulting in surface softening without tissue loss. Then 90 selected eroded enamel blocks were randomly and equally divided into 6 groups according to saliva formulation (n=15): Saliva 1 (contain mucin); Saliva 2 (Saliva 1 without mucin); Saliva 3; Saliva 4; Saliva 5 (contain sodium carboxymethyl cellulose) and control (C) (deionized water). After demineralization enamel blocks were subjected to remineralization by immersion in the saliva's formulations for 2h. Enamel remineralization was measured by superficial hardness test (% superficial hardness change). The data were tested using ANOVA and Tukey's test (p<0.05). RESULTS: All the tested formulations of artificial saliva resulted in significantly higher enamel remineralization compared to control (p<0.001). Saliva 3 showed higher percentage of enamel remineralization than Saliva 5 (p<0.05). CONCLUSIONS: Besides the variety of artificial saliva for erosion in vitro protocols, all the formulations tested were able to partially remineralize initial erosive lesions.

Clinical assessment of a new dentifrice with 8% arginine and calcium carbonate on dentin hypersensitivity in an Indian population using a new measuring device: the Jay Sensitivity Sensor Probe.

PURPOSE: To compare a new tactile hypersensitivity testing device [Jay Sensitivity Sensor (Jay) Probe] to three currently available methods of hypersensitivity testing: tactile hypersensitivity by the Yeaple probe, air blast (Schiff's Scale), and their overall hypersensitivity in the absence of any stimuli using the visual analog scores (VAS) during a clinical trial comparing the desensitizing potential of a dentifrice containing 8% arginine, calcium carbonate, and 1,000 ppm MFP (Colgate Sensitive Pro-Relief; Test) against a commercially available fluoride dentifrice (Colgate Cibaca; Negative control). METHODS: This 8-week clinical study enrolled 100 adults with dentin hypersensitivity (DH) to evaluate the desensitizing potential of a dentifrice with 8% arginine, calcium carbonate, and 1000 ppm MFP against a commercially available fluoride dentifrice, on an Indian population. This study included a new DH testing device (Jay Probe) in addition to the current three methods of dentin hypersensitivity testing. Subjects were randomly assigned a dentifrice and were evaluated for DH after 2-week, 4-week and 8-week use of assigned dentifrice. RESULTS: At the end of the 8-week period, the results showed a significant improvement in dentin hypersensitivity in the Test group as compared to the Negative control group. The mean tactile hypersensitivity scores at the 8-week examinations were 39.67 and 38.33 by the Yeaple and Jay Probes, respectively, for the Test group and 15.72 and 15.00 for the Negative control group. These observations were consistent with the other hypersensitivity examinations by air blast and VAS.

Cariotester, a new device for assessment of dentin lesion remineralization in vitro.

This study aimed to evaluate the potential of a new device (Cariotester) for monitoring of incipient carious lesion remineralization in root dentin by topical fluoride in vitro. Demineralized bovine dentin specimens were treated by fluoride solutions (APF or neutral NaF) and remineralized for 4 weeks. Cariotester was used to measure penetration depth (CTR depth) of the indenter into the de- and remineralized specimen surface. The specimens were assessed by transverse microradiography (TMR) to determine lesion parameters (depth: LD, mineral loss: ΔZ). Pearson's correlation analysis showed an overall significant relationship between CTR depth and both TMR parameters. CTR depth appeared to distinguish the positive effect that topical fluoride application had on the remineralization of the outer zone of dentin lesions. Cariotester had the potential to serve as a quantitative tool for monitoring of incipient carious lesion remineralization in root dentin.

Assessment of the effects of a stannous fluoride dentifrice on gingivitis in a two-month positive-controlled clinical study.

OBJECTIVE: The purpose of this study was to evaluate the anti-gingivitis effectiveness of a 0.454% stannous fluoride test dentifrice relative to a marketed positive-control triclosan-containing dentifrice in adults with gingivitis. METHODS: This was a two-month, randomized and controlled, double-blind, parallel group, single-center investigation involving 150 adults with existing mild to moderate gingivitis. Pre-treatment gingivitis levels were assessed at baseline using the Lobene Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI). Qualified subjects were randomly assigned to either a 0.454% stannous fluoride test dentifrice or a marketed, positive-control 0.30% triclosan/copolymer dentifrice. Subjects then brushed for two months unsupervised in the home setting with their assigned dentifrice per manufacturer's instructions. At Month 2, subjects were re-evaluated for gingivitis via MGI and GBI examinations. RESULTS: All 150 enrolled subjects completed the trial and were evaluable. Both the stannous fluoride test and triclosan/copolymer control dentifrices provided statistically significant reductions in average MGI, GBI, and number of bleeding sites relative to pre-treatment (p < 0.0001) at Month 2. The adjusted mean improvement from baseline at Month 2 for the stannous fluoride test dentifrice group was 65% greater for number of bleeding sites, 62% greater for GBI, and 45% greater for MGI compared to the triclosan/copolymer positive-control group, with groups differing significantly (p < 0.0001) via each of the three gingivitis measures. Both dentifrices were well-tolerated. CONCLUSION: An advanced stannous fluoride test dentifrice provided superior reductions in gingival inflammation and gingival bleeding compared to a commercially available triclosan/copolymer positive-control dentifrice after two months of tooth brushing.

Comparison of patient acceptance of sodium phosphate versus polyethylene glycol plus sodium picosulfate for colon cleansing in Japanese.

BACKGROUND AND AIM: In Japan, patient acceptance of bowel preparation methods before colonoscopy remains unknown. This study was conducted to evaluate the patient acceptance of sodium phosphate (NaP) tablets and polyethylene glycol solution (PEG) with sodium picosulfate. METHODS: One hundred patients were randomized into one of the following two groups: the NaP tablet first-use group or the PEG with sodium picosulfate first-use group in a crossover design trial. Patient acceptance and incidence of adverse events were evaluated using a questionnaire. Colon-cleansing effectiveness was also evaluated. RESULTS: Patients' overall impressions of the preparations were significantly different between the NaP tablet (77.9%, 67/86) and PEG with sodium picosulfate (60.5%, 52/86; P = 0.001). Nausea incidence as an adverse event was significantly different between the two regimens (P = 0.03). Colon-cleansing effectiveness was not significantly different between the two regimens. CONCLUSIONS: The results of this crossover study showed that patient acceptance was similar to those previously reported in a parallel-group comparison. In Japanese patients, preference for and acceptance of NaP tablets was significantly higher than that for PEG with sodium picosulfate solution.

Pediatric dosimetry for intrapleural lung injections of (32)P chromic phosphate.

Intracavitary injections of (32)P chromic phosphate are used in the therapy of pleuropulmonary blastoma and pulmonary sarcomas in children. The lung dose, however, has never been calculated despite the potential risk of lung toxicity from treatment. In this work the dosimetry has been calculated in target tissue and lung for pediatric phantoms. Pleural cavities were modeled in the Monte Carlo code MCNP within the pediatric MIRD phantoms. Both the depth-dose curves in the pleural lining and into the lung as well as 3D dose distributions were calculated for either homogeneous or inhomogeneous (32)P activity distributions. Dose-volume histograms for the lung tissue and isodose graphs were generated. The results for the 2D depth-dose curve to the pleural lining and tumor around the pleural cavity correspond well with the point kernel model-based recommendations. With a 2 mm thick pleural lining, one-third of the lung parenchyma volume gets a dose more than 30 Gy (V(30)) for 340 MBq (32)P in a 10 year old. This is close to lung tolerance. Younger children will receive a larger dose to the lung when the lung density remains equal to the adult value; the V(30) relative lung volume for a 5 year old is 35% at an activity of 256 MBq and for a 1 year old 165 MBq yields a V(30) of 43%. At higher densities of the lung tissue V(30) stays below 32%. All activities yield a therapeutic dose of at least 225 Gy in the pleural lining. With a more normal pleural lining thickness (0.5 mm instead of 2 mm) the injected activities will have to be reduced by a factor 5 to obtain tolerable lung doses in pediatric patients. Previous dosimetry recommendations for the adult apply well down to lung surface areas of 400 cm(2). Monte Carlo dosimetry quantitates the three-dimensional dose distribution, providing a better insight into the maximum tolerable activity for this therapy.

Evaluation of in vivo denture plaque assessment methods.

BACKGROUND: Measurement and assessment of denture plaque can provide valuable information regarding an individual's oral health status and assessment of new treatments or products. Current methods tend to rely on subjective indices or image analysis derived planimetric (area measurement) assessment of stained plaque on dentures. Plaque indices are most commonly used to assess plaque coverage without image capture. This is not ideal because the methods are subjective, examiner bias may occur, there is no reproducibility between studies, the methods have lower accuracy and sensitivity than image analysis, and there is no record. To the authors' knowledge, no standardised published method of denture plaque assessment is currently employed for product development and testing. METHOD: In this study visual and planimetric plaque assessment methods were compared using reference dentures. In addition, an in vivo study compared these methods for evaluating denture cleanser efficacy. RESULTS AND CONCLUSIONS: The results show that blinded image scoring is more representative of the true plaque area coverage than 'live' denture scoring, detecting significant decreases in plaque coverage. Planimetric analysis provides a more sensitive and less subjective technique with greater differentiation between treatments. However, analysis is very time consuming. Thus, a number of recommendations are made regarding quantification of denture plaque for the assessment of cleanser products.

Oral sodium phosphates solution versus polyethylene glycol for colon cleansing prior to radiological assessment.

A clean bowel environment is essential prior to radiological assessment of the colon. The objectives were to determine patient compliance and acceptability, physician satisfaction, overall clinical effectiveness and tolerability with the use of oral sodium phosphates (Fosfosoda) and polyethylene glycol solutions as bowel cleansing agents in a relatively large cohort of Spanish patients requiring radiologic examination of the colon. This was an observational survey involving 592 patients (> or =18 years and approximately 60% women) who received Fosfosoda or polyethylene glycol solutions according to data sheet instructions. Parameters measured included mucosal cleansing (presence of solid residues), patient acceptability (including any adverse effects to treatment) and compliance with the treatment regimen, and physician-rated satisfaction with the procedure. The date from the study demonstrated that Fosfosoda and polyethylene glycol solutions were found to be equally well tolerated in this study, although patients receiving Fosfosoda found it easier to complete the treatment regimen. Fosfosoda was significantly superior to polyethylene glycol solutions with regards to mucosal cleansing with 52% achieving an 'excellent' result compared with only 36% of the polyethylene glycol group (relative risk:1.43; 95% confidence interval: 1.12-1.82). Physician-rated assessment of the bowel cleansing procedure also significantly favored Fosfosoda (p = 0.014). In conclusion, while Fosfosoda and polyethylene glycol solutions were equally well tolerated when given to patients prior to radiologic examination of the colon, Fosfosoda was shown to be significantly more effective in terms of bowel cleansing. Based upon the available evidence this could provide significant cost benefit for Fosfosoda.

The impact of a simple, low-cost oral care protocol on ventilator-associated pneumonia rates in a surgical intensive care unit.

OBJECTIVE: The purpose of this study was to determine the effects of a simple low-cost oral care protocol on ventilator-associated pneumonia rates in a surgical intensive care unit. DESIGN: Preintervention and postintervention observational study. SETTING: Twenty-four bed surgical/trauma/burn intensive care units in an urban university hospital. PATIENTS: All mechanically ventilated patients that were admitted to the intensive care unit between June 1, 2004 and May 31, 2005. INTERVENTIONS: An oral care protocol to assist in prevention of bacterial growth of plaque by cleaning the patients' teeth with sodium monoflurophosphate 0.7% paste and brush, rinsing with tap water, and subsequent application of a 0.12% chlorhexidine gluconate chemical solution done twice daily at 12-hour intervals. MEASUREMENTS AND MAIN RESULTS: During the preintervention period from June 1, 2003 to May 31, 2004, there were 24 infections in 4606 ventilator days (rate = 5.2 infections per 1000 ventilator days). After the institution of the oral care protocol, there were 10 infections in 4158 ventilator days, resulting in a lower rate of 2.4 infections per 1000 ventilator days. This 46% reduction in ventilator-associated pneumonia was statistically significant (P = .04). Staff compliance with the oral care protocol during the 12-month period was also monitored biweekly and averaged 81%. The total cost of the oral care protocol was US$2187.49. There were 14 fewer cases of ventilator-associated pneumonia, which led to a decrease in cost of US$140 000 to US$560 000 based on the estimated cost per ventilator-associated pneumonia infection of US$10 000 to US$40 000. There was an overall reduction in ventilator-associated pneumonia without a change to the gram-negative or gram-positive microorganism profile. CONCLUSIONS: The implementation of a simple, low-cost oral care protocol in the surgical intensive care unit led to a significantly decreased risk of acquiring ventilator-associated pneumonia.

An audit of dentine hypersensitivity treatments in six general dental practices in Scotland.

AIMS: This investigation sought to: (a) determine the agents used by nine dentists to treat dentine hypersensitivity and measure their effectiveness; (b) evaluate the adoptive ease and apparent success of the most effective treatment when used by all nine dentists; and (c) validate a novel categorical ranking score for dentine hypersensitivity. METHODS: A clinical audit methodology was used in the setting of general dental practice. In the initial data-collection round, patients presenting with dentine hypersensitivity were treated using the dentist's favoured regimen. Evaluation of agent effectiveness was made by patient completion of a pre- and post-treatment visual analogue scale (VAS) for the frequency (f) and severity (s) of hypersensitivity. A four-point categorical ranking scale (CRS) was also used to assess the impact of hypersensitivity upon lifestyle (L) (1=No sensitivity/effect on what I eat/drink; 2=Sometimes sensitive, rarely interfering with what I eat/drink; 3=Sometimes sensitive, occasionally interfering with what I eat/drink; 4=Always sensitive, always interfering with what I eat/drink). The most successful treatment was determined and used by all participating dentists. Its effectiveness was then assessed using the same criteria. RESULTS: Four agents were routinely used to treat hypersensitivity: (Duraphat (D) (Colgate), Duraphat & Sensodyne (DS) (GlaxoSmithKline), Sensodyne (S) (GlaxoSmithKline), Seal & Protect (SP) (De Trey, Dentsply). All produced statistically significant (P<0.001) reductions in VAS (Tukey) and CRS (Kruskal-Wallis) scores, except for DS and S. Of these, the greatest percentage reduction was seen for SP (f=72.01%, s=71.19%, L=45.98%). When SP was applied by all dentists, similar percentage reductions were seen (f=68.74%, s=75.85%, L=38.33%). The CRS, in both data-collection rounds, correlated well with the corresponding VAS scores (Spearman R for f=0.77 (P<0.001) and for s=0.80 (P<0.001). CONCLUSION: For the dentists in this audit, the use of SP was found to be reliable and predictable. The CRS provided a simple and reliable measure of dentine hypersensitivity. Subject to validation in a larger study, this could be used in a future audit as an alternative to multiple VAS scores.

A quality improvement project comparing two regimens of medication for colonoscopy preparation.

As part of an ongoing performance evaluation and Quality Improvement (QI) program at the U. S. National Naval Medical Center in Bethesda, Maryland, two bowel preparations that were concurrently in use (Fleet Phospho-soda and Colyte/Dulcolax) were evaluated for patient tolerance and preference, efficacy, and cost. Anonymous patient questionnaires were distributed during a three-phase assessment that took place over an 18-month period. This approach identified preconceived ideas regarding bowel preparations and contributed to development of objective information regarding the bowel preparations currently available. The outcome of this QI project altered the previous routine and resulted in the adoption of Fleet Phospho-soda as the preferred medication for colon preparation prior to colonoscopy, based on superior bowel cleansing as judged by the physicians, higher patient preference and compliance, similar tolerance, and lower cost.

Influence of socioeconomic level and dentifrice brand on the oral hygiene habits and the fluoride dentifrice ingestion.

The aim of this study was to evaluate the influence of socioeconomic level and dentifrice brand on the brushing habits and the fluoride ingestion. The sample was composed of 124 Brazilian children aged 3-9 years, from different socioeconomic levels (SEL). It was used a crossover study with the children using two dentifrice brands: Tandy Uva/T (1,100 ppm NaF) and Super Branco/SB (1,500 ppm MFP). Each child brushed his/her teeth with both dentifrice brands with weekly intervals between the brushes. The oral hygiene habits considered in this study were the Dentifrice Amount Placed on toothbrush (ADP), Dentifrice Amount Ingested (ADI), Fluoride Amount Ingested (FAI) and Brushing Time (TB). The data obtained were submitted to ANOVA test. It was observed that there was influence of SEL on the ADP and TB. The high SEL children showed a higher ADP and TB. The dentifrice brand influenced significantly the ADP, ADI, AFI and TB; the dentifrice T showed a higher ADP, ADI, but a lower AFI and TB. The results showed a significant interaction between SEL and dentifrice brand as ADI, AFI and TB. Although the children ingested a higher amount of T dentifrice they ingested a higher amount of fluoride from the SB dentifrice.

Clinical results: implications for prevention and treatment in general dental practice.

The widespread use of fluoride containing toothpastes is recognised s being a major factor in the declining caries experience in the industrialised world. The implications of continuing research in relation to advice given to patients is discussed. It is the opinion of the author that general dental practitioners need to be fully updated in knowledge of clinical results, as part of their duty of care.

Assessment of mucus glycoprotein erosion by measurement of sialic acid in gastric secretions: pathophysiologic and therapeutic aspects.

The quantification of mucus glycoproteins (GPs) faces paramount difficulties in terms of methods and interpretation. Mucus glycoprotein erosion, however, might be quantified in gastric juice by measurement of GP-bound sialic acid. Basal sialic acid content was low in normal healthy subjects (N) and in nonulcer dyspepsia (NUD) patients. They were five to six times higher in duodenal ulcer (DU), or more in Zollinger-Ellison patients. Pentagastrin stimulation induced a five- to sixfold rise in N and NUD patients although it did not affect DU patient sialic acid contents. Relationships between sialic acid content and pepsin output in DU indicate that pepsin exerts a variable mucolytic activity depending on disease evolution. In addition to pepsin, duodenogastric reflux exerts a potent mucolytic effect. Therapeutically, highly selective vagotomy without recurrent ulcer markedly reduced mucus erosion. The reduction of mucus erosion by protective drugs has been observed in some cases but in other cases sialic acid measurement did not allow to verify a protective effect. Adherent mucus analysis by high-performance liquid chromatography (HPLC) should allow one to appreciate GP fractions qualitatively. Combination of both methods should allow further determination of the mucus protective role, simultaneously investigating the adherent mucus quality and eroded GPs.

Assessment of calcitriol and inorganic phosphate therapy before cure of oncogenous osteomalacia by resection of a mixed mesenchymal tumor.

A 57 year old white male with oncogenous osteomalacia due to a mixed mesenchymal tumor was evaluated by sequential histologic and metabolic studies over a period of 33 mos prior to identifying the location of the tumor. On the basis of these studies we conclude: (i) disorders of the enterohepatic circulation and/or acceleration of metabolism of calcitriol are not responsible for its diminished level in oncogenous osteomalacia, (ii) the Von Kossa stain is preferred to the modified Masson in evaluating osteomalacia, (iii) avascular necrosis of the femoral head may be part of the syndrome, (iv) heterogeneity may be the hallmark of the responsible mesenchymal tumor and account for the different histological interpretations in the literature, (v) in compliant patients with oncogenous osteomalacia, calcitriol and Pi therapy may be effective.