Not only COVID-19: a systematic review of anti-COVID-19 measures and their effect on healthcare-associated infections.

BACKGROUND: Healthcare-associated infections (HAIs) burden healthcare globally. Amid the SARS-CoV-2 pandemic, intensified infection control measures, such as mask usage and hand hygiene, were implemented. AIM: To assess the efficacy of these measures in preventing HAIs among hospitalized patients. METHODS: Using the PICO framework (Population, Intervention, Comparison, Outcome), the study focused on hospitalized patients and the effectiveness of anti-COVID-19 measures in preventing HAIs. A systematic review of literature published in 2020-2022 was conducted, examining interventions such as mask usage, hand hygiene, and environmental cleaning. FINDINGS: This systematic review analysed 42 studies: two in 2020, 21 in 2021, and 19 in 2022. Most studies were from high-income countries (28). Most studies (30 out of 42) reported a reduction in HAIs after implementing anti-COVID-19 measures. Gastrointestinal infections and respiratory tract infections showed significant reduction, unlike bloodstream infections and urinary tract infections. Some wards, like cardiology and neurology, experienced reduced HAIs, unlike intensive care units and coronary care units. There was an increase in studies reporting no effect of hygiene measures on HAIs in 2022, eventually indicating a shift in effectiveness over time. CONCLUSION: Anti-COVID-19 measures have shown selective efficacy in preventing HAIs. The study emphasizes the need for context-specific strategies and increased focus on regions with limited resources. Continued research is essential to refine infection control practices, especially in high-risk settings.

Recombinant human granulocyte- colony stimulating factor in women with unexplained recurrent pregnancy losses: a randomized clinical trial.

STUDY QUESTION: Does administration of recombinant human granulocyte colony stimulating factor (rhG-CSF) in the first trimester improve pregnancy outcomes, among women with a history of unexplained recurrent pregnancy loss? SUMMARY ANSWER: rhG-CSF administered in the first trimester of pregnancy did not improve outcomes among women with a history of unexplained recurrent pregnancy loss. WHAT IS KNOWN ALREADY: The only previous randomized controlled study of granulocyte colony stimulating factor in recurrent miscarriage in 68 women with unexplained primary recurrent miscarriage found a statistically significant reduction in miscarriage and improvement in live birth rates. A further four observational studies where G-CSF was used in a recurrent miscarriage population were identified in the literature, two of which confirmed statistically significant increase in clinical pregnancy and live birth rates. STUDY DESIGN, SIZE, DURATION: A randomized, double-blind, placebo controlled clinical trial involving 150 women with a history of unexplained recurrent pregnancy loss was conducted at 21 sites with established recurrent miscarriage clinics in the United Kingdom between 23 June 2014 and 05 June 2016. The study was coordinated by University of Birmingham, UK. PARTICIPANTS/MATERIALS, SETTING, METHODS: One hundred and fifty women with a history of unexplained recurrent pregnancy loss: 76 were randomized to rhG-CSF and 74 to placebo. Daily subcutaneous injections of recombinant human granulocyte - colony stimulating factor 130 µg or identical appearing placebo from as early as three to five weeks of gestation for a maximum of 9 weeks. The trial used central randomization with allocation concealment. The primary outcome was clinical pregnancy at 20 weeks of gestation, as demonstrated by an ultrasound scan. Secondary outcomes included miscarriages, livebirth, adverse events, stillbirth, neonatal birth weight, changes in clinical laboratory variables following study drug exposure, major congenital anomalies, preterm births and incidence of anti-drug antibody formation. Analysis was by intention to treat. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 340 participants were screened for eligibility of which 150 women were randomized. 76 women (median age, 32[IQR, 29-34] years; mean BMI, 26.3[SD, 4.2]) and 74 women (median age, 31[IQR, 26-33] years; mean BMI, 25.8[SD, 4.2]) were randomized to placebo. All women were followed-up to primary outcome, and beyond to live birth. The clinical pregnancy rate at 20 weeks, as well as the live birth rate, was 59.2% (45/76) in the rhG-CSF group, and 64.9% (48/74) in the placebo group, giving a relative risk of 0.9 (95% CI: 0.7-1.2; P = 0.48). There was no evidence of a significant difference between the groups for any of the secondary outcomes. Adverse events (AEs) occurred in 52 (68.4%) participants in rhG-CSF group and 43 (58.1%) participants in the placebo group. Neonatal congenital anomalies were observed in 1/46 (2.1%) of babies in the rhG-CSF group versus 1/49 (2.0%) in the placebo group (RR of 0.9; 95% CI: 0.1-13.4; P = 0.93). LIMITATIONS, REASONS FOR CAUTION: This trial was conducted in women diagnosed with unexplained recurrent pregnancy loss and therefore no screening tests (commercially available) were performed for immune dysfunction related pregnancy failure/s. WIDER IMPLICATIONS OF THE FINDINGS: To our knowledge, this is the first multicentre study and largest randomized clinical trial to investigate the efficacy and safety of granulocyte human colony stimulating factor in women with recurrent miscarriages. Unlike the only available single center RCT, our trial showed no significant increase in clinical pregnancy or live births with the use of rhG-CSF in the first trimester of pregnancy. STUDY FUNDING/COMPETING INTEREST(S): This study was sponsored and supported by Nora Therapeutics, Inc., 530 Lytton Avenue, 2nd Floor, Palo Alto, CA 94301, USA. Darryl Carter was the co-founder and VP of research, Nora Therapeutics, Inc. and held shares in the company. He holds a patent for the use of recombinant human granulocyte colony stimulating factor to reduce unexplained recurrent pregnancy loss. Mark Joing, Paul Kwon and Jeff Tong were or are employees of Nora Therapeutics, Inc. No other potential conflict of interest relevant to this article was reported. TRIAL REGISTRATION NUMBER: EUDRACT No: 2014-000084-40; ClinicalTrials.gov Identifier: NCT02156063. TRIAL REGISTRATION DATE: 31 Mar 2014. DATE OF FIRST PATIENT'S ENROLMENT: 23 Jun 2014.

Cultivation of marine shrimp in biofloc technology (BFT) system under different water alkalinities.

The aim of this study was to evaluate the influence of different levels of alkalinity for the superintensive cultivation of marine shrimp Litopenaeus vannamei in biofloc system. A total of 12 experimental circular units of 1000L were used supplied with 850L water from a nursery, populated at a density of 165 shrimps.m-3 and average weight of 5.6 g. The treatments, in triplicate, consisted in four levels of alkalinity in the water: 40, 80, 120 and 160 mg.L-1 of calcium carbonate. To correct the alkalinity was used calcium hydroxide (CaOH). It was observed a decrease in pH of the water in the treatments with lower alkalinity (p<0.05). The total suspended settleable solids were also lower in the treatment of low alkalinity. No significant difference was observed in other physico-chemical and biological parameters in the water quality assessed, as well as the zootechnical parameters of cultivation between treatments (p≥0.05). The results of survival and growth rate of shrimps were considered suitable for the cultivation system used in the different treatments. The cultivation of marine shrimp Litopenaeus vannamei in biofloc at density of 165 shrimps.m-3 can be performed in waters with alkalinity between 40 and 160 mg.L-1 of CaCO3, without compromising the zootechnical indexes of cultivation.

Cultivation of marine shrimp in biofloc technology (BFT) system under different water alkalinities / Cultivo de camarões marinhos em sistema de bioflocos (BFT) sob diferentes alcalinidades da água

AbstractThe aim of this study was to evaluate the influence of different levels of alkalinity for the superintensive cultivation of marine shrimp Litopenaeus vannamei in biofloc system. A total of 12 experimental circular units of 1000L were used supplied with 850L water from a nursery, populated at a density of 165 shrimps.m–3 and average weight of 5.6 g. The treatments, in triplicate, consisted in four levels of alkalinity in the water: 40, 80, 120 and 160 mg.L–1 of calcium carbonate. To correct the alkalinity was used calcium hydroxide (CaOH). It was observed a decrease in pH of the water in the treatments with lower alkalinity (p<0.05). The total suspended settleable solids were also lower in the treatment of low alkalinity. No significant difference was observed in other physico-chemical and biological parameters in the water quality assessed, as well as the zootechnical parameters of cultivation between treatments (p≥0.05). The results of survival and growth rate of shrimps were considered suitable for the cultivation system used in the different treatments. The cultivation of marine shrimp Litopenaeus vannamei in biofloc at density of 165 shrimps.m–3 can be performed in waters with alkalinity between 40 and 160 mg.L–1 of CaCO3, without compromising the zootechnical indexes of cultivation.

ResumoO objetivo deste trabalho foi avaliar a influência de diferentes níveis de alcalinidade para o cultivo do camarão marinho Litopenaeus vannamei em sistema superintensivo em bioflocos. Foram utilizadas 12 unidades experimentais circulares de 1000L abastecido com 850L de água provenientes de um berçário intensivo, povoadas a uma densidade de 165 camarões.m-3 e peso médio 5,6g. Os tratamentos em triplicata consistiram de quatro níveis de alcalinidade na água: 40, 80, 120 e 160 mg.L–1 de carbonato de cálcio. Para correção da alcalinidade, foi utilizado cal hidratada (CaOH). Foi observado um decréscimo no pH da água nos tratamentos de menor alcalinidade (p<0,05). Os sólidos suspensos sedimentáveis totais também foram menores nos tratamentos de menor alcalinidade. Não foi observada diferença significativa nos demais parâmetros físico-químicos e biológicos de qualidade de água avaliados, assim como nos parâmetros zootécnicos do cultivo entre os tratamentos (p≥0,05). Os resultados de sobrevivência e taxa de crescimento dos camarões foram considerados adequados para o sistema de cultivo utilizado nos distintos tratamentos. O cultivo do camarão marinho Litopenaeus vannamei em bioflocos na densidade de 165 camarões.m–3 pode ser realizado em águas com alcalinidade entre 40 a 160 mg.L–1 de CaCO3, sem comprometer os índices zootécnicos do cultivo.

Is body weight-support treadmill training effective in increasing muscle trophism after traumatic spinal cord injury? A systematic review.

STUDY DESIGN: Systematic review. OBJECTIVE: To determine the effectiveness of body weight-support treadmill training (BWSTT) for muscle atrophy management in people with spinal cord injury (SCI). SETTING: Studies from multiple countries were included. METHODS: The following databases were consulted from January to October 2013: PubMed, Institute for Scientific Information (ISI), Science Direct and Lilacs. The methodological quality of the articles included was classified according to Jovell and Navarro-Rubio. RESULTS: A total of five studies were included. These studies reported a significant association between BWSTT and increased trophism of the lower limb muscles of humans with SCI, which was observed as an increase in the cross-sectional area. Moreover, improvements in the ability to generate peak torque, contract the knee extensors and ankle plantarflexors with reduction of body weight support were observed after BWSTT. CONCLUSION: The results were considered inconclusive because of the low methodological quality of the articles, which was because of the absence of sample homogeneity, thereby providing a low level of evidence for clinical practice.

Neoplastic superior vena cava obstruction: combined approach.

Primary adult cardiac tumors are rare entities with a low indices. In 90% of cases are benign. Among malignant tumors angiosarcomas are the most common. In 80% of cases they arises in the right atrium, more often in younger males as compared to benign tumors. The majority of them manifests as locally already advanced disease, precluding macroscopically complete surgical resection. Moreover, the presence of macro- and micrometastasis makes the prognosis always prohibitive. The duration of symptoms is in the order of months and the median survival ranges from 6 to 11 months. Death cause is usually a complication of locally recurrent disease: tamponade, hemopericardium are common. Treatment is multidisciplinary. The combination of chemo- and radiotherapy with surgery aims to increase survival. In the management of unresectable tumors, due to anatomic reason or Iocoregional spread, an important role is played by pre-operatory chemotherapy or chemo-radiation to increase short term survival.

Endodontics versus implantology: to extirpate or integrate?

An increasingly frequent dilemma in restorative dentistry is the question of whether to retain a badly damaged tooth and restore it, or to remove and possibly replace it. Given the ethical difficulties inherent in testing this question, it is unlikely that we will ever see a properly designed clinical trial that will provide an answer. One of the most strongly debated components of this question is whether endodontic treatment and restoration can compete with a dental implant-borne prosthesis in terms of longevity and success. In the current paper, the authors will attempt to: (i) answer this question based on our current understanding of the dental literature; and (ii) provide practitioners with guidelines that might be applied to their daily practices.

Botulinum toxin type A therapy for cervical dystonia.

BACKGROUND: Cervical dystonia is characterized by involuntary posturing of the head and frequently is associated with neck pain. Disability and social withdrawal are common. In recent years, Botulinum toxin Type A (BtA) has become the first line therapy. However its true efficacy, in particular the potential effect size, is still unclear. OBJECTIVES: To determine whether botulinum toxin (BtA) is an effective and safe treatment for cervical dystonia. SEARCH STRATEGY: We searched the Cochrane Movement Disorders Group trials register (June 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2003, MEDLINE (1977 to June 2003), EMBASE (1977 to June 2003) and reference lists of articles. We also contacted drug manufacturers and researchers in the field. SELECTION CRITERIA: Randomised studies comparing BtA with placebo in adults with cervical dystonia. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials. MAIN RESULTS: We found thirteen high quality eligible studies. They were short term (6 to 16 weeks). Eight trials, enrolling 361 patients, used the BtA formulation Botox(r) and five, enrolling 319 patients, used the BtA formulation Dysport. The dose and technique of administration varied significantly between studies.Meta-analysis showed statistically and clinically significant improvements on objective rating scales: (Peto OR 4.31; 95% confidence interval (CI) 2.68 to 6.94) and subjective rating scales (Peto OR 6.58; 95% CI 4.55 to 9.54); and for pain relief in subjective scales (Peto OR 11.92; 95% CI 6.32 to 22.5). However, for many of the outcomes, we could use data from only a few studies. Only adverse events clearly associated with the mechanism of action of BtA were more frequent in the treatment group. These included neck weakness, dysphagia, dry mouth/sore throat and voice changes/hoarseness. Sub-group and sensitivity analyses showed a clear dose-response relationship for subjective and objective benefit and for frequency and severity of adverse events. Indirect comparisons between trials that used Dysport against placebo and trials that used Botox against placebo showed no significant differences between Dysport and Botox in terms of benefits or adverse events. AUTHORS' CONCLUSIONS: A single injection cycle of BtA is effective and safe for treating cervical dystonia. Enriched trials (using patients previously treated with BtA), suggest that further injection cycles continue to work for most patients.

Botulinum toxin type A versus anticholinergics for cervical dystonia.

BACKGROUND: Cervical dystonia is the most common form of focal dystonia. It is characterized by involuntary posturing of the head and frequently is associated with neck pain. Disability and social withdrawal are common. Most cases are idiopathic and generally cervical dystonia is a life-long disorder. Botulinum toxin Type A (BtA) is now the first line therapy. Before BtA, anticholinergics were the most widely accepted treatment, so it is important to understand how these two treatments compare. OBJECTIVES: To compare the clinical efficacy and safety of BtA versus anticholinergic drugs in the treatment of cervical dystonia. SEARCH STRATEGY: We searched the Cochrane Movement Disorders Group trials register (June 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2003), MEDLINE 1977 to June 2003), EMBASE (1977 to June 2003) and reference lists of articles. We also contacted manufacturers and researchers in the field. SELECTION CRITERIA: Randomised studies comparing BtA versus any anticholinergic drug for the treatment of cervical dystonia. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials. MAIN RESULTS: We found only one trial suitable for inclusion and accordingly no meta-analysis was performed. It compared BtA versus trihexyphenidyl in 66 patients with cervical dystonia. Although this was a relatively small trial with short duration, the results can probably be generalized for the population, since the trial appears to be unbiased and produced clear clinically significant results. The results favoured BtA, and the difference was similar in size to that obtained in a systematic review comparing BtA with placebo. BtA was better tolerated. AUTHORS' CONCLUSIONS: The available evidence suggests that BtA injections provide more objective and subjective benefit than trihexyphenidyl to patients with cervical dystonia. We could not draw any conclusions about other anticholinergic drugs. Future trials should explore the role of anticholinergic drugs in patients that do not get benefit with BtA.

Botulinum toxin type A versus botulinum toxin type B for cervical dystonia.

BACKGROUND: Cervical dystonia is the most common form of focal dystonia. It is characterized by involuntary posturing of the head and frequently is associated with neck pain. Disability and social withdrawal are common. Most cases are idiopathic, and generally it is a life-long disorder. In recent years, botulinum toxin type A (BtA) has become first line therapy for cervical dystonia. However, not all patients respond well to BtA, and 5 to 10% become resistant to it. Botulinum toxin B (BtB) is an alternative to BtA and offers the potential to help patients who do not respond to BtA. At present there is no compelling theoretical reason why it should not be as effective as, or even more effective than, BtA. OBJECTIVES: To compare the clinical efficacy and safety of BtA versus BtB in cervical dystonia. SEARCH STRATEGY: Studies for inclusion in the review were identified using the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, by handsearching the Movement Disorders Journal and abstracts of international congresses on movement disorders and botulinum toxin, by communication with other researchers in the field, by searching reference lists of papers found using the above search strategies, and by contact with authors and drug manufacturer. SELECTION CRITERIA: Studies were considered eligible for inclusion in the review if they evaluated the efficacy of BtA versus BtB for the treatment of cervical dystonia. Trials must have been randomised and placebo-controlled. DATA COLLECTION AND ANALYSIS: A paper pro-forma was used to collect data from the included studies using double extraction by two independent reviewers. Each trial was assessed for internal validity by each of the two reviewers. Differences were settled by discussion. The outcome measures used included improvement in symptomatic rating scales, subjective evaluation by patients and clinicians, changes in pain scores, changes in quality of life assessments, and frequency and severity of adverse events. MAIN RESULTS: We cannot give any results since we have only identified two ongoing trials and there are no preliminary results or interim analyses available for them. The full results of these trials are expected in late 2004 or 2005. AUTHORS' CONCLUSIONS: It is currently not possible to make definitive comparisons between BtA and BtB for the treatment of cervical dystonia; uncontrolled comparisons should be regarded with suspicion.

Botulinum toxin type B for cervical dystonia.

BACKGROUND: Cervical dystonia is the most common form of focal dystonia. It is characterized by involuntary posturing of the head and frequently is associated with neck pain. Disability and social withdrawal are common. Most cases of cervical dystonia are idiopathic and generally it is a life-long disorder. In recent years, Botulinum toxin type A (BtA) has become the first line therapy. However, some patients become resistant to it. This problem led to the study of another Botulinum toxin (Bt) serotype, Bt type B (BtB) to address the issues of clinical efficacy, effect size, and safety of BtB in the treatment of cervical dystonia. OBJECTIVES: To determine whether botulinum toxin (BtB) is an effective and safe treatment for cervical dystonia. SEARCH STRATEGY: We identified studies for inclusion in the review using the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE; and by handsearching the Movement Disorders Journal and abstracts of international congresses on movement disorders and botulinum toxin, by communication with other researchers in the field, by searching reference lists of papers found using the above search strategies, and by contacting authors and drug manufacturers. SELECTION CRITERIA: We considered studies eligible for inclusion in the review if they evaluated the efficacy of BtB for the treatment of cervical dystonia in randomized, placebo-controlled trials. DATA COLLECTION AND ANALYSIS: We used a paper pro forma to collect data from the included studies with double extraction by two independent reviewers. Both reviewers assessed each trial for internal validity and settled differences by discussion. The outcome measures used included adverse events, improvement in symptomatic rating scales, subjective evaluation by patients and clinicians, changes in pain scores, changes in quality of life assessments. MAIN RESULTS: Studies were short term (16 weeks) employing a single BtB injection session. All were multicentre and conducted in the US. All patients included had previously received BtA. The trials differed with respect to whether or not the patients were still responding to BtA but other entry criteria were similar. All studies used a dose of 10,000 Units of BtB in one group and the technique of administration was the same. Meta-analysis of three trials enrolling 308 participants showed statistically and clinically significant improvements in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score at week four with a Peto odds ratio (OR) for the number of patients who had at least a 20% improvement of 4.69 (95% CI 2.06 to 10.69) and a weighted mean difference of -5.92 (95% CI -9.61 to -2.23). Subjective rating scales (Patient Global Assessment of Change, Investigator Global Assessment of Change, and Patient Analog Pain Assessment) also improved. Adverse events clearly associated with the mechanism of action of BtB included dysphagia and dry mouth and the number of patients with any adverse event were more frequent in BtB treatment groups. Subgroup analyses showed a clear dose-response relationship for subjective and objective benefit, for frequency and severity of adverse events, and a greater benefit for BtA resistant patients than BtA responders in the primary outcome. The duration of effect was about 16 weeks. We found three eligible studies enrolling 308 participants. Studies were short term (16 weeks) employing a single BtB injection session. All were multicentre and conducted in the US. All patients included had previously received BtA. The trials differed with respect to whether or not the patients were still responding to BtA but other entry criteria were similar. Patient groups were appropriately selected and well matched. From the methodological point of view these trials were probably not subjected to important selection, performance or attrition bias and all studies used an intention-to-treat analysis.The dose varied significantly between studies although all used 10,000 Units of BtB in one group and the technique of administration was the same. The primary outcome in all trials was change in TWSTRS total score at week four and other efficacy outcomes were similar between studies. The number of dropouts was small and balanced in all trials. Reasons for withdrawals were given. One randomized double-blind placebo-controlled study was excluded because data couldn't be extracted for the outcomes. Meta-analysis showed statistically and clinically significant improvements with a Peto odds ratio (OR) of 20% in TWSTRS total score at week four (OR 4.69; 95% CI 2.06 to 10.69) and a weighted mean difference of -5.92 (95% CI -9.61 to -2.23). Subjective rating scales (Patient Global Assessment of Change, Investigator Global Assessment of Change, and Patient Analog Pain Assessment) also improved. The weighted mean difference for changes in these subjective scales varied between -13% to -21%. However, for many of the outcomes, we could not combine data from all studies. Only adverse events clearly associated with the mechanism of action of BtB were more frequent in the treatment group. These included dysphagia and dry mouth. The number of patients with any adverse event was more frequent with BtB. Subgroup analyses showed a clear dose-response relationship for subjective and objective benefit and for frequency and severity of adverse events. Subgroup analyses showed a greater benefit for the BtA resistant patients than BtA responders in the primary outcome. The duration of effect was about 16 weeks. These trials did not measure quality of life nor did they establish the long term duration of effect or immunogenicity AUTHORS' CONCLUSIONS: A single injection of BtB was effective and safe for treating cervical dystonia. Long-term uncontrolled studies suggested that further injection cycles continue to work for most patients. Future research should explore technical factors such as the optimum treatment intervals and use of image or electromyographic guidance for administration. Other issues include service delivery, quality of life, long-term efficacy and safety, and the relative indications for BtA, BtB and other treatments such as deep brain stimulation.

Botulinum toxin type A therapy for hemifacial spasm.

BACKGROUND: Hemifacial spasm is characterised by unilateral involuntary contractions of muscles innervated by the facial nerve. The usual cause is a vessel touching the facial nerve near its origin from the brain stem. Although it is a benign condition it can cause significant cosmetic and functional disability. It is a chronic disease and spontaneous recovery is very rare. The two treatments routinely available are microvascular decompression and Botulinum Toxin type A (BtA) muscular injections. OBJECTIVES: To determine whether botulinum toxin (BtA) is an effective and safe treatment for hemifacial spasm. SEARCH STRATEGY: We searched the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE (1977 to December 2003), EMBASE (1977 to December 2003), and reference lists of articles. We also contacted drug manufacturers and researchers in the field. SELECTION CRITERIA: Randomised studies comparing BtA with placebo in people with hemifacial spasm. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials. MAIN RESULTS: We found only one small randomised, placebo-controlled trial involving 11 people. It was a crossover trial during which patients underwent four sets of injections, comparing placebo with three different doses of BtA - formulation Botox(r) (low dose: one-half of the intermediate dose; intermediate dose; and high dose: twice the intermediate dose), and one of placebo. In this trial BtA was superior to placebo. AUTHORS' CONCLUSIONS: The findings of this single eligible trial support the results of large, open, case-control studies showing a benefit rate between 76 and 100%. This effect size probably makes it very difficult to perform new large placebo controlled trials for hemifacial spasm. Despite the paucity of good quality controlled data, all the studies available suggest that BtA is effective and safe for treating hemifacial spasm. Future trials should explore technical factors such as the optimum treatment intervals, different injection techniques, doses, Bt types and formulations. Other issues include service delivery, quality of life, long-term efficacy, safety, and immunogenicity. BtA should be compared with surgical microvascular decompression.

Botulinum toxin type A therapy for blepharospasm.

BACKGROUND: Blepharospasm is a focal dystonia characterized by chronic intermittent or persistent involuntary eyelid closure due to spasmodic contractions of the orbicularis oculi muscles. Other facial and neck muscles are also frequently involved. Most cases are idiopathic and blepharospasm is generally a life-long disorder. Its severity can range from repeated frequent blinking to persistent forceful closure of the eyelids with functional blindness. Botulinum toxin type A (BtA) is the current first line therapy. OBJECTIVES: To determine whether botulinum toxin (BtA) is an effective and safe treatment for blepharospasm. SEARCH STRATEGY: We identified studies for inclusion in the review using the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, handsearches of the Movement Disorders Journal and abstracts of international congresses on movement disorders and botulinum toxin, communication with other researchers in the field, reference lists of papers found using above search strategies, and contact with authors and drug manufacturers. SELECTION CRITERIA: Studies were eligible for inclusion in the review if they evaluated the efficacy of BtA for the treatment of blepharospasm. They must have been randomised and placebo-controlled. DATA COLLECTION AND ANALYSIS: We used a paper pro-forma to collect data from the included studies using double extraction by two independent reviewers. The two reviewers separately assessed each trial for internal validity and they settled differences between them by discussion. The outcome measures used included adverse events, improvement in symptomatic rating scales, subjective evaluation by patients and clinicians, and changes in quality of life assessments. MAIN RESULTS: We found few controlled trials. They were of short duration and enrolled small numbers of patients. Because of their poor internal validity, the characteristics of the populations studied, and the types of interventions and outcomes, none of the trials fitted our criteria for inclusion. However, all these trials found BtA to be superior to placebo as did large case-control and cohort studies, which reported that around 90% of patients benefited. AUTHORS' CONCLUSIONS: There are no high quality, randomised, controlled efficacy data to support the use of Bt for blepharospasm. Despite this, other studies suggest that BtA is highly effective and safe for treating blepharospasm and support its use. The effect size (90% of patients benefit) seen in open studies makes it very difficult and probably unethical to perform new placebo-controlled trials of efficacy of BtA for blepharospasm. Future trials should explore technical factors such as the optimum treatment intervals, different injection techniques, doses, Bt types and formulations. Other issues include service delivery, quality of life, long-term efficacy, safety, and immunogenicity.

Mercury fluxes in a natural forested Amazonian catchment (Serra do Navio, Amapá State, Brazil).

Mercury (Hg total) fluxes were calculated for rainwater, throughfall and stream water in a small catchment located in the northeastern region of the Brazilian Amazon (Serra do Navio, Amapá State), whose upper part is covered by a natural rainforest and lower part was altered due to deforestation and activities related to manganese mining. The catchment area is 200 km from the nearest gold mining (garimpo). Minimum and maximum Hg concentrations were measured monthly from October 1996 to September 1997 and were 3.5-23.4 ng l(-1) for rainwater, 16.5-82.7 ng l(-1) for throughfall (March-August 1997) and 1.2-6.1 and 4.2-18.8 ng l(-1) for stream water, in natural and disturbed areas, respectively. In the natural area, the inputs were 18.2 microg m 2 year(-1) in rainwater and 72 microg m(-2) year(-1) in throughfall. This enrichment was attributed to dry deposition. The stream output of 2.9 microg m(-2) year(-1) indicates that Hg is being recycled within the forest as other chemical species or is being retained by the soil system, as confirmed by the cumulative Hg burden in the 0-10 cm surface layer, which was 36480 microg m(-2). When the disturbed area of the catchment was included, the stream output was 9.3 microg m(-2), clearly indicating the impact of the deforestation of the lower part of the basin on the release of mercury. The Hg burden in the disturbed area was 7560 microg m(-2) for the 0-10 cm surface layer.

Association of responsiveness to the major pollen allergen of Parietaria officinalis with HLA-DRB1* alleles: a multicenter study.

Parietaria, a plant belonging to the family of Urticaceae, is a major source of allergenic pollen in Europe. In the context of a multinational study, we investigated whether in allergic subjects antibody response towards Par o 1, the major allergen from P. officinalis, was associated with defined HLA-DRB1* alleles. The study population consisted of 234 allergic patients: 65 from Bulgaria, 30 from Israel, 99 from Italy, and 40 from Spain. In the Italian study group, the prevalence of ST positivity to Parietaria was 77%. In Parietaria ST-positive subjects, the prevalences of IgG and IgE serum Ab towards Par o 1 were 91% and 75%, respectively. HLA-DRB1*1101 and/or 1104 were significantly positively associated with the presence of IgG Ab and with high levels of IgE Ab towards this allergen (p = 0.0007 and p = 0.012, respectively). In the Spanish study group, the positive association of DR1100 with responsiveness to Par o 1 was confirmed (p = 0.02, RR = 4, and p = 0.002, RR = 7, for IgG and IgE Ab, respectively). None of the Bulgarian patients had IgE Ab to Par o 1, whereas IgG Ab response was observed in 7 out of 65 subjects and was positively associated with DRB1*1101 and/or 1104 (p = 0.025). In the Israeli study group, responsiveness to Par o 1 was not associated with specific HLA-DRB1* alleles. In conclusion, this study shows that in allergic patients from three European populations antibody response to the major allergen from the pollen of Parietaria is associated with HLA-DRB1*1101 and/or 1104. Our data suggest that this association is stronger in subjects monosensitized to Parietaria.

Characterization of a dominant antigenic determinant of Par o I encoded by recombinant DNA.

BACKGROUND: The pollens from Parietaria judaica and Parietaria officinalis are a major cause of pollinosis in Europe. Par o I (13.5 kDa) and Par j I (12 kDa), the major allergens from these species, are highly crossreactive. METHODS: We have immunoscreened a P. judaica pollen cDNA expression library with a rabbit antiserum specific for Par j I and with a serum pool from allergic patients. An immunopositive clone containing a 26 bp insert was further characterized. The insert sequence was determined and the beta-galactosidase fusion protein was partially purified by electroelution from sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) gels. RESULTS: This fusion protein specifically and extensively inhibited Par o I and Par j I binding of a rabbit antiserum and of a serum pool obtained from allergic patients. The antifusion-protein antiserum obtained in a rabbit (anti 6a) specifically precipitated radioiodinated purified Par o I in the double antibody radioimmunoassay (DARIA) and competed with antibodies of sera from allergic patients for the binding to Parietaria pollen extract allergens by enzyme linked immunosorbent assay (ELISA). We investigated the prevalence of antibody response towards the 6a epitope in patients naturally sensitized to Parietaria. The presence of 6a specific IgE antibodies was assessed in the sera of 33 patients using inhibition assays. All sera had antibodies with this specificity: the extensive percentage of inhibition reached suggested that they dominated individual ab response. CONCLUSION: In conclusion, the antibody response induced by natural exposure to the pollen of Parietaria appears to be higly focused on a single linear antigenic determinant of the major allergens which may play a relevant role in the development of clinical allergy. This report is, to our knowledge, the first description of a dominant linear epitope of a major allergen.

[Typing of human papillomavirus (HPV) in the male and female genitalia]. / Estudo do tipo de papilomavírus humano (HPV) no aparelho genital feminino e masculino.

Diagnosis and typing of HPV was started in November 1990 at the Virology department of the National Health Institute, Lisbon. Eighty one samples from 70 patients were studied, 57 from women observed at the cervico-vulvar out patient unit of the Gynecology department of Sta Maria Hospital, Lisbon, and 13 from male contacts of some of these women. Forty nine women (86%) had colposcopic, histological or cytological evidence of HPV infection. Eleven men (85%) have clinical signs of infection and 2 (15%) had had sexual intercourse with infected partners with clinical evidence of infection. HPV DNA was detected in 43 patients (61%). Forty two were infected with HPV 6/11 (98%) and one with HPV 16 (2%). These preliminary results suggest that genital infection by HPV must also be considered a public health problem in the field of sexually transmitted diseases in Portugal.

[Outbreak of human leptospirosis by recreational activity in the municipality of São José dos Campos, São Paulo. Seroepidemiological study]. / Surto de leptospirose humana por atividade recreacional no município de São José dos Campos, São Paulo. Estudo soroepidemiológico.

An outbreak of human leptospirosis due to recreational activities occurred at São José dos Campos, São Paulo, Brazil in November 1987. It involved a group of persons who had participated in a gathering in a suburb club which had a swimming pool fed with natural water. Epidemiological investigation was carried out and laboratory tests from the patients were done. It was observed that a high prevalence of the pomona serotype (91%) was found in the serological analyses, while the presence of the agent of the infection could not be found in the water club swimming pool.

Modulation of the heart rate by thyroid hormone in the newborn rat.

Confirming the literature data the authors describe that the heart rate is smaller in the newborn rats than in adult ones and increases until the adult values during the first two weeks of life. On the other hand, the blood thyroid hormone exhibits the same pattern, showing an early postnatal increment. As, according the Adolph's data (1967), the heart rate enhancement is not due to the catecholamines, the authors suppose that such enhancement might conceivably depend on thyroid hormone increment.