Assessment of Bowel Preparation Using Low-Volume Sulphate-Based Preparations in Comparison with Macrogols: A Multicenter, Randomized, Comparative Clinical Study of the 3rd Phase

Oral sulphate solution (OSS: sodium sulphate, potassium sulphate and magnesium sulphate) is a low-volume osmotic agent for cleansing the intestines.Aim: in a multicentre, prospective, randomized, 3rd phase study with two parallel groups, the effectiveness, safety and tolerability of OSS was evaluated in comparison with Macrogol 4000 with electrolytes (a reference preparation for bowel cleansing in Russia) in adult patients who were scheduled for routine diagnostic colonoscopy.Methods. This study was conducted in three Russian research centres during the March–December, 2015 period. Men and women over the age of 18 scheduled to undergo routine diagnostic colonoscopy were randomly assigned either to the OSS group or to the Macrogol group with a fractional use mode before the colonoscopy. The colonoscopy researchers were not aware of which preparation had been taken by the patients. Anonymized video records were centrally analysed by three experts. The primary end point was the proportion of patients with a successful bowel preparation for colonoscopy ≥6 points, as determined by the Boston Bowel Preparation Scale of quality assessment (BBPS scale).Results. 296 patients were randomized in the study (147 patients were treated with OSS, 149 patients received Macrogol); 294 participants were included in the Intention to Treat population (ITT-population), and 274 participants were included in the population of patients who completed the study according to the protocol (Per-Protocol; PP-population) (139 patients received OSS, 135 patients received Macrogol). The proportion of patients with a successful bowel preparation (BBPS ≥6 scores) was high in both groups (OSS [PP-population]: 97.2 % (95 % confidence interval [CI] 89.5–99.3), Macrogol [PP-population]: 97.7 % (95 % CI: 90.7–99.4)). The corrected difference between the groups was -0.5 % (95 % CI: -4.2–3.3), thereby demonstrating “no less effective” of OSS as compared to Macrogol. Compliance with the drug use regime was higher in the OSS group than in the Macrogol group (95.7 % versus 82.3 %, respectively, p-value = 0.0011, ITT-population).The most common symptom reported in patients was nausea (27.9 % in the OSS group and 12.9 % in the Macrogol group). The proportion of patients who developed nausea was significantly higher in the OSS group than in the Macrogol group (25.2 % compared with 10.2 % when taking the first dose of the preparation (p = 0.0008) and 19.7 % compared with 6.8 % when taking the second dose of the preparation (p = 0.0016)). Differences in other symptoms (bloating, abdominal pain or abdominal discomfort) between the groups were not significant, with the severity of symptoms being generally mild. The safety profile of the investigated preparations in patients with inflammatory bowel disease (IBD) in remission did not differ from that in the general patient population.The differences in terms of secondary endpoints were not identified, including BBPS assessment for different sections of the colon, the level of polyp detection, the duration and completeness of colonoscopy, and the investigator’s satisfaction with the procedure. The analysis by subgroups also did not reveal any significant differences.Conclusion. In this study, the “not less effectiveness” of the sulphate solution was demonstrated as compared to Macrogol in a fractional use mode. Both preparations were well tolerated. Despite the higher incidence of nausea in the OSS group, the patients showed significantly higher compliance with the OSS mode as compared to that of Macrogol.This study is registered with the ClinicalTrials.gov Registry of Clinical Trials, No. NCT02321462

Assessment of Bowel Preparation Using Low-Volume Sulphate-Based Preparations in Comparison with Macrogols: A Multicenter, Randomized, Comparative Clinical Study of the 3rd Phase

Oral sulphate solution (OSS: sodium sulphate, potassium sulphate and magnesium sulphate) is a low-volume osmotic agent for cleansing the intestines.Aim: in a multicentre, prospective, randomized, 3rd phase study with two parallel groups, the effectiveness, safety and tolerability of OSS was evaluated in comparison with Macrogol 4000 with electrolytes (a reference preparation for bowel cleansing in Russia) in adult patients who were scheduled for routine diagnostic colonoscopy.Methods. This study was conducted in three Russian research centres during the March–December, 2015 period. Men and women over the age of 18 scheduled to undergo routine diagnostic colonoscopy were randomly assigned either to the OSS group or to the Macrogol group with a fractional use mode before the colonoscopy. The colonoscopy researchers were not aware of which preparation had been taken by the patients. Anonymized video records were centrally analysed by three experts. The primary end point was the proportion of patients with a successful bowel preparation for colonoscopy ≥6 points, as determined by the Boston Bowel Preparation Scale of quality assessment (BBPS scale).Results. 296 patients were randomized in the study (147 patients were treated with OSS, 149 patients received Macrogol); 294 participants were included in the Intention to Treat population (ITT-population), and 274 participants were included in the population of patients who completed the study according to the protocol (Per-Protocol; PP-population) (139 patients received OSS, 135 patients received Macrogol). The proportion of patients with a successful bowel preparation (BBPS ≥6 scores) was high in both groups (OSS [PP-population]: 97.2 % (95 % confidence interval [CI] 89.5–99.3), Macrogol [PP-population]: 97.7 % (95 % CI: 90.7–99.4)). The corrected difference between the groups was -0.5 % (95 % CI: -4.2–3.3), thereby demonstrating “no less effective” of OSS as compared to Macrogol. Compliance with the drug use regime was higher in the OSS group than in the Macrogol group (95.7 % versus 82.3 %, respectively, p-value = 0.0011, ITT-population).The most common symptom reported in patients was nausea (27.9 % in the OSS group and 12.9 % in the Macrogol group). The proportion of patients who developed nausea was significantly higher in the OSS group than in the Macrogol group (25.2 % compared with 10.2 % when taking the first dose of the preparation (p = 0.0008) and 19.7 % compared with 6.8 % when taking the second dose of the preparation (p = 0.0016)). Differences in other symptoms (bloating, abdominal pain or abdominal discomfort) between the groups were not significant, with the severity of symptoms being generally mild. The safety profile of the investigated preparations in patients with inflammatory bowel disease (IBD) in remission did not differ from that in the general patient population.The differences in terms of secondary endpoints were not identified, including BBPS assessment for different sections of the colon, the level of polyp detection, the duration and completeness of colonoscopy, and the investigator’s satisfaction with the procedure. The analysis by subgroups also did not reveal any significant differences.Conclusion. In this study, the “not less effectiveness” of the sulphate solution was demonstrated as compared to Macrogol in a fractional use mode. Both preparations were well tolerated. Despite the higher incidence of nausea in the OSS group, the patients showed significantly higher compliance with the OSS mode as compared to that of Macrogol.This study is registered with the ClinicalTrials.gov Registry of Clinical Trials, No. NCT02321462

Pink salmon in Norway: the reluctant invader

In 2017, Norway experienced an invasion of the Pacific salmonid pink salmon (Oncorhynchus gorbuscha) in numbers never before seen in rivers all along the coast. Significant numbers were also caught in other parts of northwestern Europe. Pink salmon has been observed in variable numbers in Norwegian waters in the summer and autumn of most years since 1960, after the first successful Russian introduction of pink salmon fry in rivers draining to the White Sea in northwest Russia in 1959. With the exception of 1960, pink salmon have been most abundant in odd years, based on the odd-year broodline of the 2-year life salmonid. Even-year fish has generally been less abundant, but in recent years, significant numbers of this broodline have also been caught. In this paper we review the available information on pink salmon in Norwegian rivers and discuss (1) to what extent the presence of this species in Norway has been driven by Russian introductions and natural reproduction in Russian, and lately in Norwegian, rivers, and (2) the likelihood of reproducing populations of pink salmon being established in more Norwegian rivers. Considering the continued propagule pressure in terms of adult pink salmon entering and spawning in Norwegian rivers, it is puzzling that self-propagating populations apparently only have been established in some rivers in the northernmost part of the country. The potential impact of pink salmon on native salmonids and river ecosystems is discussed briefly. Extensive research is required to understand the mechanisms that determine the fate of pink salmon as an alien species, and specifically the possible impact of pink salmon on native salmonids and the environment in the recipient rivers and in the ocean

Pink salmon in Norway: the reluctant invader

In 2017, Norway experienced an invasion of the Pacific salmonid pink salmon (Oncorhynchus gorbuscha) in numbers never before seen in rivers all along the coast. Significant numbers were also caught in other parts of northwestern Europe. Pink salmon has been observed in variable numbers in Norwegian waters in the summer and autumn of most years since 1960, after the first successful Russian introduction of pink salmon fry in rivers draining to the White Sea in northwest Russia in 1959. With the exception of 1960, pink salmon have been most abundant in odd years, based on the odd-year broodline of the 2-year life salmonid. Even-year fish has generally been less abundant, but in recent years, significant numbers of this broodline have also been caught. In this paper we review the available information on pink salmon in Norwegian rivers and discuss (1) to what extent the presence of this species in Norway has been driven by Russian introductions and natural reproduction in Russian, and lately in Norwegian, rivers, and (2) the likelihood of reproducing populations of pink salmon being established in more Norwegian rivers. Considering the continued propagule pressure in terms of adult pink salmon entering and spawning in Norwegian rivers, it is puzzling that self-propagating populations apparently only have been established in some rivers in the northernmost part of the country. The potential impact of pink salmon on native salmonids and river ecosystems is discussed briefly. Extensive research is required to understand the mechanisms that determine the fate of pink salmon as an alien species, and specifically the possible impact of pink salmon on native salmonids and the environment in the recipient rivers and in the ocean

Pink salmon in Norway: the reluctant invader

In 2017, Norway experienced an invasion of the Pacific salmonid pink salmon (Oncorhynchus gorbuscha) in numbers never before seen in rivers all along the coast. Significant numbers were also caught in other parts of northwestern Europe. Pink salmon has been observed in variable numbers in Norwegian waters in the summer and autumn of most years since 1960, after the first successful Russian introduction of pink salmon fry in rivers draining to the White Sea in northwest Russia in 1959. With the exception of 1960, pink salmon have been most abundant in odd years, based on the odd-year broodline of the 2-year life salmonid. Even-year fish has generally been less abundant, but in recent years, significant numbers of this broodline have also been caught. In this paper we review the available information on pink salmon in Norwegian rivers and discuss (1) to what extent the presence of this species in Norway has been driven by Russian introductions and natural reproduction in Russian, and lately in Norwegian, rivers, and (2) the likelihood of reproducing populations of pink salmon being established in more Norwegian rivers. Considering the continued propagule pressure in terms of adult pink salmon entering and spawning in Norwegian rivers, it is puzzling that self-propagating populations apparently only have been established in some rivers in the northernmost part of the country. The potential impact of pink salmon on native salmonids and river ecosystems is discussed briefly. Extensive research is required to understand the mechanisms that determine the fate of pink salmon as an alien species, and specifically the possible impact of pink salmon on native salmonids and the environment in the recipient rivers and in the ocean

Pink salmon in Norway: the reluctant invader

In 2017, Norway experienced an invasion of the Pacific salmonid pink salmon (Oncorhynchus gorbuscha) in numbers never before seen in rivers all along the coast. Significant numbers were also caught in other parts of northwestern Europe. Pink salmon has been observed in variable numbers in Norwegian waters in the summer and autumn of most years since 1960, after the first successful Russian introduction of pink salmon fry in rivers draining to the White Sea in northwest Russia in 1959. With the exception of 1960, pink salmon have been most abundant in odd years, based on the odd-year broodline of the 2-year life salmonid. Even-year fish has generally been less abundant, but in recent years, significant numbers of this broodline have also been caught. In this paper we review the available information on pink salmon in Norwegian rivers and discuss (1) to what extent the presence of this species in Norway has been driven by Russian introductions and natural reproduction in Russian, and lately in Norwegian, rivers, and (2) the likelihood of reproducing populations of pink salmon being established in more Norwegian rivers. Considering the continued propagule pressure in terms of adult pink salmon entering and spawning in Norwegian rivers, it is puzzling that self-propagating populations apparently only have been established in some rivers in the northernmost part of the country. The potential impact of pink salmon on native salmonids and river ecosystems is discussed briefly. Extensive research is required to understand the mechanisms that determine the fate of pink salmon as an alien species, and specifically the possible impact of pink salmon on native salmonids and the environment in the recipient rivers and in the ocean

Size Distribution of Inactivated Tick-Borne Encephalitis Virus Particles Revealed by a Comprehensive Physicochemical Approach

Tick-borne encephalitis virus (TBEV) is an enveloped RNA virus, a member of the genus Flavivirus (family Flaviviridae). Here, we provide a detailed analysis of the size and structure of the inactivated TBEV vaccine strain Sofjin-Chumakov. Four analytical methods were used to analyze individual TBEV particles—negative staining TEM, cryo-EM, atomic force microscopy (AFM), and nanoparticle tracking analysis (NTA). All methods confirmed that the particles were monodisperse and that their mean size was ~50 nm. Cryo-EM data allowed us to obtain a 3D electron density model of the virus with clearly distinguishable E protein molecules. STEM-EELS analysis detected phosphorus in the particles, which was interpreted as an indicator of RNA presence. Altogether, the described analytical procedures can be valuable for the characterization of inactivated vaccine virus samples

Pink salmon in Norway: the reluctant invader

In 2017, Norway experienced an invasion of the Pacific salmonid pink salmon (Oncorhynchus gorbuscha) in numbers never before seen in rivers all along the coast. Significant numbers were also caught in other parts of northwestern Europe. Pink salmon has been observed in variable numbers in Norwegian waters in the summer and autumn of most years since 1960, after the first successful Russian introduction of pink salmon fry in rivers draining to the White Sea in northwest Russia in 1959. With the exception of 1960, pink salmon have been most abundant in odd years, based on the odd-year broodline of the 2-year life salmonid. Even-year fish has generally been less abundant, but in recent years, significant numbers of this broodline have also been caught. In this paper we review the available information on pink salmon in Norwegian rivers and discuss (1) to what extent the presence of this species in Norway has been driven by Russian introductions and natural reproduction in Russian, and lately in Norwegian, rivers, and (2) the likelihood of reproducing populations of pink salmon being established in more Norwegian rivers. Considering the continued propagule pressure in terms of adult pink salmon entering and spawning in Norwegian rivers, it is puzzling that self-propagating populations apparently only have been established in some rivers in the northernmost part of the country. The potential impact of pink salmon on native salmonids and river ecosystems is discussed briefly. Extensive research is required to understand the mechanisms that determine the fate of pink salmon as an alien species, and specifically the possible impact of pink salmon on native salmonids and the environment in the recipient rivers and in the ocean