Duration Of Observation Period Research Articles

Interstitial pneumonia with autoimmune features: monocentric prospective study

To study demographic, clinical, serological and morphological features of interstitial pneumonia with autoimmune features (IPAF), compare survival in IPAF and interstitial lung disease in connective tissue diseases (CTD-ILD), and identify predictors of mortality and transformation to CTD in the IPAF group. The IPAF group included 48 patients (75.0% women, median age 57.5 years), CTD-ILD - 49 patients (79.6% women, median age 60.0 years). The analysis of demographic, clinical, laboratory and instrumental data was performed, as well as comparison of survival with the Kaplan-Meier method and the log-rank test in the IPAF and CTD-ILD groups. In the IPAF group, predictors of mortality and the development of CTD were studied with multivariate regression analysis. Duration of observation period did not differ significantly in the IPAF and CTD-ILD groups (40.0 and 37.0 months, respectively). Clinical criteria of IPAF were observed in 25 (52.1%) patients, serological - in 44 (91.7%), morphological - in 44 (91.7%). Mortality in the IPAF group was significantly higher than in the CTD-ILD group (29.2 and 6.1%, respectively; p=0.023). The presence of diabetes mellitus, CT-pattern of usual interstitial pneumonia, and an initial low forced vital capacity value were independent predictors of mortality in the IPAF group. During the observation period, the development of CTD was noted in 4 (8.3%) patients with IPAF. The independent predictor of the CTD development was the increased C-reactive protein level. IPAF is characterized by a lower survival rate compared to CTD-ILD, and a relatively low risk of CTD transformation.

Phacoemulsification in patients after previous implantation of a complete intrastromal ring into a corneal transplant

BACKGROUND: The MyoRing implantation into a corneal transplant can significantly compensate for irregular post-keratoplastic astigmatism. However, the cataract that occurs in this category of patients and the lack of information in the literature on its phacoemulsification and the calculation of a toric intraocular lens (tIOL) power in them determines the relevance of our study.
 AIM: The aim of the study is to conduct a clinical and functional analysis of phacoemulsification in patients after previously performed implantation of a MyoRing into a corneal transplant.
 MATERIALS AND METHODS: We operated on 21 patients (21 eyes) who had previously undergone the MyoRing implantation into a corneal transplant. According to keratotopography, all patients were diagnosed with a regular form of corneal astigmatism. All patients underwent phacoemulsification with tIOL implantation. When calculating the tIOL power, its diopter value was corrected depending on the average value of the corneal transplant keratometry according to the keratotopogram data. The observation period duration was 6 months.
 RESULTS: One month after the procedure, there was an increase in uncorrected visual acuity by 0.2 0.9 LogMAR, best corrected visual acuity by 0.3 1.0 LogMAR, the spherical component of refraction up to 0.4 0.44 D, the cylindrical component of refraction up to 0.62 0.18 D, all of which did not change later on.
 CONCLUSIONS: Phacoemulsification with tIOL implantation, with its power calculated taking into account an additional correction for its diopter value, is an effective, predictable and safe method of treating patients after previously performed MyoRing implantation into a penetrating corneal transplant.

The prevalence of comorbid and concomitant diseases in psoriatic arthritis patients, data from Russian register

Psoriatic arthritis (PsA) is a heterogeneous inflammatory arthritis associated with psoriasis (Ps); it belongs to the group of spondyloarthritis and is accompanied by damage to both the spine and peripheral joints, as well as the development of enteritis and dactylitis. In addition to skin and joint damage, PsA has numerous comorbid conditions that are pathogenetically related to the underlying disease, such as inflammatory bowel disease (IBD) and autoimmune eye disease, as well as cardiovascular diseases, obesity and metabolic syndrome, diabetes, osteoporosis, malignancies, mental disorders, and various concomitant diseases. We present data of the prevalence of these pathological conditions among the cohort of PsA patients included in the Russian register.Objective– to study the prevalence of comorbid and concomitant diseases in PsA patients.Materials and methods. The Russian multicenter, observational study with retrospective and prospective data collection of PsA patients included 614 patients with the established diagnosis psoriatic arthritis, corresponding to the CASPAR criteria, from 39 subjects of the Russian Federation, female/male – 331 (54%)/283 (46%). The average age was 45.2±0.52 years, duration of PsA – 5.7±0.27 years, Ps – 15.71±0.56. Duration of observation period: January 2016 – November 26, 2019. The diagnosis of comorbid and concomitant diseases was confirmed by medical specialists in accordance with the ICD-10 code. The analysis of the frequency and structure (%) of these diseases was carried out.Results. The majority of PsA patients had limited Ps: the area of Ps skin lesion (BSA, Basic Surface Area) was less than 3% in 372 (61.5%) patients, BSA from 3% to 10% – in 185 (30.6%), BSA>10% – in 47 (7.8%). Comorbid and concomitant diseases were detected in 297 (48%) of 614 patients. 183 (61.6%) patients had 2 or more diseases in addition to Ps and PsA. Diseases of the circulatory system were detected in 229 (77.1%) PsA patients with comorbid and concomitant diseases (arterial hypertension – in 194 (65.3%), coronary heart disease – in 22 (7.4%)). Diseases of the endocrine system, metabolic disorders were detected in 156 (52.5%) patients with PsA (diabetes mellitus in 44 (14.8%), hyperlipidemia in 44 (14.8%), metabolic syndrome in 36 (12.1%), obesity in 7 (2.4%), and others). Gastrointestinal diseases were observed in 62 (20.9%) patients. Diseases of the biliary system – in 33 (11.1%) patients. Diseases of the musculoskeletal system and connective tissue that are not associated with PsA – in 44 (14.8%). Diseases of the genitourinary system – in 23 (7.7%) patients. Respiratory diseases – in 17 (5.7%) patients. Infectious diseases – in 11 (3.7%). Eye diseases were detected – in 10 (3.4%) patients. Hematological diseases were diagnosed in 6 (2.0%) patients. Depression – in 4 (1.3%) patients.Conclusions. Among 297 patients with PsA with comorbid and concomitant diseases, diseases of the circulatory system are the most common (in 77.1%), less often – diseases of the endocrine system, metabolic disorders (in 52.5%) and diseases of the digestive system (in 32%). Uveitis (2.7%), IBD (1.3%), and depression (1.3%) were rarely detected in our cohort. The majority of patients in the Russian registry had mild forms of Ps (61.5%), and severe Ps (BSA>10%) was observed only in 7.8%. Thus, PsA is associated with a high prevalence of comorbid and concomitant diseases, especially cardiovascular. When choosing a treatment, these diseases should be taken into account. In connection with the new possibilities of therapy, it is necessary to evaluate the potential impact of therapy on patients with comorbid and concomitant diseases in real clinical practice.

Long-term evaluation of climatotherapy for psoriasis.

Climatotherapy (CT) is a treatment with immediate high clearance rate for chronic psoriasis, but evidence of long-term effects is scarce. Assessment of the impact of a single CT treatment on disease activity and quality of life was carried out at 4- to 6-month follow-ups. A prospective study of patients with psoriasis undergoing 4 weeks of CT in Israel describes long-term outcomes of CT. Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores were assessed before CT and at an average of 5 months after return. Assessment of the eligibility for CT takes place twice a year. A total of 49 patients (28/21 M/F) participated. Pretreatment PASI was 2.6 to 18.7 (mean 8.1 ± 3.8) vs control PASI 0 to 16.9 (mean 5 ± 2.8), (P < .0001). Mean ΔPASI was 3.2 (39.5% reduction). PASI 75 was achieved by 11/49 patients; 10/49 had increased PASI. The mean DLQI score was 16.1 (range 2-30); 10.6 at follow-up (range 0-28), and 33 patients achieved DLQI minimal clinically important difference (P < .0001). Age, sex, number of previous CT, and duration of observation period did not affect endpoints. CT and unmonitored self-treatment induces PASI 75 in one-fifth patients at follow-up 4 to 6 months later. Six of 10 patients report a clinically important improvement of patients' quality of life as measured by DLQI.

The peculiarities of heart remodeling in patients after myocardial infarction with ST-segment elevation depending on the Lys198Asn polymorphism of endothelin 1 gene

Objective — to investigate clinical and genetic aspects of associations of Lys198Asn endothelin 1 (EDN 1) gene polymorphism with the development of remodeling after myocardial infarction with ST-segment elevation (STEMI). Material and methods. The study involved 91 patients with STEMI, 70 (77 %) male and 21 (23 %) female, at average age (60.3 ± 9.4) years old after selective coronary angiography with infarct-related artery stenting. Polymerase chain reaction was used to determine allele polymorphism Lys198Asn of EDN 1 gene. The observation period duration was 6-month. Results and discussion. The association with the STEMI onset in male patients with Lys198Asn + Asn198Asn genotype of EDN 1 gene was in 3.19 times higher, then in female (c2 = 4.01, p = 0.043); at arterial hypertension presence — in 3.72 times (c2 = 4.31, p = 0.038), in tobacco smokers — in 2.06 (c2 = 4.66, p = 0.031), which was associated with more severe damages of the coronary arteries. In the acute STEMI period, the structural and functional data depending on polymorphous locus Lys198Asn of EDN 1 gene did not differ. After 6-month observations, in Asn-careers in comparison with Lys198sLys-careers, the increase in the left ventricular size and cavity volumes, and myocardial mass, as well as left atrium diameter. That is, there was a tendency to a progressive process of myocardial remodeling and the development of chronic heart failure. Conclusions. In patients after STEMI polymorphous Lys198Asn + Asn198Asn of EDN 1 gene in comparison with Lys198Lys genotype associated with the individual propensity to the formations of left ventricular dilatation and hence, the unfavorable (maladaptive) post infarctional remodeling.

Cost-Effectiveness Models in Age-Related Macular Degeneration: Issues and Challenges.

Age-related macular degeneration (AMD) is a common ophthalmic condition that can have few symptoms in its early stage but can progress to major visual impairment. While there are no treatments for early-stage AMD, there are multiple modalities of treatment for advanced disease. Given the increasing prevalence of the disease, there are dozens of analyses of cost effectiveness of AMD treatments, but methods and approaches vary broadly. The goal of this review was to identify, characterize, and critique published models in AMD and provide guidance for their interpretation. After a literature review was performed to identify studies, and exclusion criteria applied to limit the review to studies comparing treatments for AMD, we compared methods across the 36 studies meeting the review criteria. To some extent, variation was related to targeting different audiences or acknowledging the most appropriate population for a given treatment. However, the review identified potential areas of uncertainty and difficulty in interpretation, particularly regarding duration of observation periods and the importance of visual acuity as an endpoint or a proxy for patient-reported utilities. We urge thoughtful consideration of these study characteristics when comparing results.

METHODS FOR THE ASSESSMENT OF BODY MASS INDEX IN CHILDREN AND ADULTS IN AUTOMATIC SYSTEM OF OBESITY AND OVERWEIGHT PREVENTION

Aim. To invent the method of body mass index (BMI) trend evaluation for children and adults for automatic system of overweight and obesity prevention. Material and methods. Into the analysis we included anthropometric data from four population-based studies, differing by the duration of observation period and age diapason. Data processing and statistical analysis were done with multidimensional regression analysis in procedure SAS PROG GLM at the variant with repeated measurements. Results. As a result of the analysis of age-related dynamics of anthropometric parameters we invented a system of BMI (increase) trend (of the Kettle index), that make it to reveal the persons (children and adults) with excessive income of BMI in its upper limits during short time intervals. This information about a child or an adult is a subject for automatic registration and is being reported to the physician. Conclusion. The proposed method makes possible to screen the persons with excessive weight gain. As a result of physician and patients' partnership it is possible to do on-time primary and secondary prevention of excessive body weight and obesity in children as in adults.

The effect of disease modifying therapies on brain atrophy in patients with relapsing-remitting multiple sclerosis: a systematic review and meta-analysis.

BackgroundThe aim of the present meta-analysis was to evaluate the effect of disease-modifying drugs (DMD) on brain atrophy in patients with relapsing-remitting multiple sclerosis (RRMS) using available randomized-controlled trial (RCT) data.MethodsWe conducted a systematic review and meta-analysis according to PRISMA guidelines of all available RCTs of patients with RRMS that reported data on brain volume measurements during the study period.ResultsWe identified 4 eligible studies, including a total of 1819 RRMS patients (71% women, mean age 36.5 years, mean baseline EDSS-score: 2.4). The mean percentage change in brain volume was found to be significantly lower in DMD versus placebo subgroup (standardized mean difference: -0.19; 95%CI: -0.27–-0.11; p<0.001). We detected no evidence of heterogeneity between estimates (I2 = 30%, p = 0.19) nor publication bias in the Funnel plots. Sensitivity analyses stratifying studies according to brain atrophy neuroimaging protocol disclosed no evidence of heterogeneity (p = 0.16). In meta-regression analyses, the percentage change in brain volume was found to be inversely related with duration of observation period in both DMD (meta-regression slope = -0.03; 95% CI: -0.04–-0.02; p<0.001) and placebo subgroups (meta-regression slope = -0.05; 95% CI: -0.06–-0.04; p<0.001). However, the rate of percentage brain volume loss over time was greater in placebo than in DMD subgroup (p = 0.017, ANCOVA).ConclusionsDMD appear to be effective in attenuating brain atrophy in comparison to placebo and their benefit in delaying the rate of brain volume loss increases linearly with longer treatment duration.

Public health impact of human papillomavirus vaccination on prevention of cervical cancer in France

To evaluate the cervical cancer (CC) reduction at individual and population level following different prevention strategies (age-specific vaccination and/or screening) in France. A lifetime Markov model was constructed with 11 health states covering the progression from human papillomavirus (HPV) infection to the development of precancerous lesions, CC and death. A screening module took into account the effects of detection and early treatment. Cohorts of girls were entered into the model at age 11 years; the model was run for 95 years using one-year cycles. Vaccination combined with screening substantially reduced the incidence of precancerous lesions and CC compared with screening alone. Vaccination was beneficial regardless of age at vaccination, but the greatest benefit was obtained with an early vaccination. The clinical results were the best for vaccination at 11-13 years when lifetime horizon was considered, and for vaccination at 15-17 years for shorter observation period. The model results indicate that HPV vaccination offers additional protection against CC when combined with screening. The optimum starting age for vaccination varies depending on the observation period duration.

Estimating the necessary duration of observation period in studying winter river runoff

A procedure for determining the minimal representative observation period at hydrological gages is proposed as required for studying the regularities in river runoff formation in rivers in the drainage basin of the Votkinsk Reservoir. Data of hydrological gages with long observational series were used as an example to show, by the division of these series into intervals and analysis of the obtained deviations from long-term mean values, that such minimal period can be taken to be 40 years long.

Unruptured Intracranial Aneurysms

The preventive treatment of unruptured aneurysms has been performed for decades despite the lack of evidence of a clinical benefit. Reports of observational studies such as the International Study of Unruptured Intracranial Aneurysms (ISUIA) suggest that preventive treatments are rarely justified. Are these reports compelling enough to guide clinical practice? The ISUIA methods and data are reviewed and analysed in a more conventional manner. The design of the appropriate clinical research program is approached by steps, reviewing potential problems, from the formulation of the precise research question to the interpretation of subgroup analyses, including sample size, representativity, duration of observation period, blinding, definition of outcome events, analysis of cross-overs, losses to follow-up, and data reporting. Unruptured intracranial aneurysms observed in ISUIA ruptured at a minimal annual rate of 0.8% (0.5-1%), despite multiple methodological difficulties biased in favour of a benign natural history. Available registries do not have the power or the design capable of providing normative guidelines for clinical decisions. The appropriate method to solve the clinical dilemma is a multicentric trial comparing the incidence of a hard clinical outcome events in approximately 2000 patients randomly allocated to a treatment group and a deferred treatment group, all followed for ten years or more. Observational studies have failed to provide reliable evidence in favour or against the preventive treatment of unruptured aneurysms. A randomized trial is in order to clarify what is the role of prevention in this common clinical problem.

Predictors of weight loss in Parkinson's disease

The objective of this study was to examine the change of body weight (BW) among Parkinson's disease (PD) patients and controls over years and determine the predictors of weight loss among PD patients. Studies on weight loss in PD studies are cross-sectional, have a short follow-up, or lack in clinical detail. We examined the percentage of BW change over years among 49 PD patients and 78 controls. The controls were from another study on longitudinal evolution of BW and body composition in the elderly. We determined the BW, Hoehn and Yahr (HY) stage, and dyskinesia status of 49 consecutive nondemented PD patients with symptom duration of 6.1 +/- 0.7 years (mean +/- SEM) and ascertained their BW at the time of diagnosis and 2.4 +/- 0.2 years before the diagnosis from medical records. We collected data again 7.2 +/- 0.5 years after the first visit. The PD group lost 7.7% +/- 1.5% of BW over the entire symptomatic period (13.1 +/- 0.8 years), while the control group lost only 0.2% +/- 0.7% of BW over 9.9 +/- 0.1 years; weight loss was clinically significant (>5%) in 55.6% of PD patients vs. 20.5% of the controls (both P values < 0.001, adjusted for sex, baseline age, and observation period duration). PD patients lost weight in both the early and advanced phases. While worsening of parkinsonism was the most important factor, age at diagnosis, emergence of visual hallucinations, and possibly dementia were also associated with weight loss. We demonstrated significant weight loss in PD patients compared to controls over approximately 1 decade. Neurodegeneration involving both motor and nonmotor systems may be associated with weight loss in PD.

COMPARATIVE ASSESSMENT OF EFFECT OF COMBINED DRUGS OF ACE INHIBITOR AND DIURETIC (“NOLIPREL FORTE” AND “CAPOZIDE”) ON CARDIOVASCULAR REMODELING IN HYPERTENSIVE PATIENTS

Aim. To assess antihypertensive efficacy and effect on cardio-vascular remodeling of combined drugs of ACE inhibitor and diuretic, “Noliprel forte” (NF) and “Capozide” (CA), in hypertensive high risk patients. Material and methods. 50 hypertensive (II grade) patients (25 men and 25 women, 19-65 years old) with high cardio-vascular risk took part in comparative opened randomized study. No one of patients received antihypertensive therapy before study. All patients were randomized for therapy with one of combined drug of ACE inhibitors and diuretic. 25 patients took NF (perindopril 4 mg and indapamide 1,25 mg), and 25 patients -CA (captopril 50 mg and hydrochlorothiazide 25 mg). Duration of observation period was 6 months. Before study, after 3 and 6 months of therapy ambulatory blood pressure monitoring (ABPM), echocardiography, cardiac and vessel Dopplerography, ultrasound scanning of general carotid arteries with detection of intima-media thickness (IMT), pulse wave speed (PWS) were held in all patients. Blood bio-chemical analysis was done also. Results. After 3 months 2 patients in NF group and 4 ones in CA group were required to reinforce of ther-apy with additional administration of perindoprile 4 mg and captopril 50 mg respectively. As a result of 6-month of therapy in NF group systolic dlood pressure (BP) decreased in 14,0% (р&lt;0,001) and diastolic BP – на 12,9% (р&lt;0,001). CA reduced systolic BP by 17,9% (р&lt;0,0001) and diastolic BP – by 17,5% (р&lt;0,001). 76% and 70% of patients in NF and CA groups, respectively, reached target BP level. Positive dynamic of daily profile of BP was observed according to ABPM data. Cerebral blood flow did not worsen despite of BP decrease. Both drugs decreased in thickness of inter-ventricular septum and left ven￾tricular mass. Besides, NF decreased in thickness of left ventricular posterior wall. Both drugs reduced in IMT and decreased in PWS. NF therapy did not change of blood biochemical parameters. CA therapy, opposite, resulted in significant growth of plasma uric acid by 39,6%. Conclusion. 6-month therapy with NF showed high antihypertensive efficacy for both of drugs, which did not accompany with cerebral blood flow disturbances. Both drugs also showed an ability for positive effect on cardio-vascular remodeling (with NF priority), improvement of artery wall elasticity. NF, unlike CA, did not increase in plasma uric acid level.

Nasal provocation test with lysine-aspirin for diagnosis of aspirin-sensitive asthma

Nasal provocation tests (NPTs) with lysine-aspirin (L-ASA) have been recently introduced for assessment of aspirin-induced asthma (AIA). They differ in dose and means of aspirin instillation, duration of observation period, and criteria for positivity. Thus far they have not become a routine part of clinical diagnosis. Fifty-one patients with AIA, confirmed by oral challenge test, were recruited to undergo diagnostic NPTs with L-ASA. In 10 of these patients (19.6%), NPTs could not be performed because of total obstruction of at least one nostril or marked fluctuations in nasal flows, leaving 41 patients with AIA for the study. Control groups consisted of 13 aspirin-tolerant asthmatic patients and 10 healthy subjects. L-ASA at a total dose of 16 mg of acetylsalicylic acid applied bilaterally into the inferior nasal conchae caused significant fall in inspiratory nasal flow in at least one nostril (>40%), which was measured by anterior rhinomanometry, and clinical symptoms of watery discharge and nasal blockage in 35 of 41 patients with AIA, one of 10 healthy subjects, and none of 13 aspirin-tolerant asthmatic patients. No relationship was found between the baseline nasal flow values and the intensity of response to L-ASA. No systemic reactions, including bronchospasm, were noticed, even in patients whose initial FEV 1 was lower than 70% of predicted value. This test is highly specific (95.7%) and sensitive (86.7%), but negative results do not exclude possible intolerance to aspirin (predictive value of a negative result 78.6%). In conclusion, the NPT described is a simple, safe, and quick test for diagnosis of AIA. It can be used in patients with unstable asthma. It may be a method of choice to confirm hypersensitivity to aspirin manifested only by symptoms from the upper respiratory tract. Patients suspected of aspirin intolerance who have negative NPT results should undergo bronchial or oral challenge tests with aspirin. (J Allergy Clin Immunol 1998;101:581-6.)

Update of the morbidity experience of employees potentially exposed to chlorpyrifos.

OBJECTIVES: Chlorpyrifos, an organophosphate ingredient of several important insecticides, has been manufactured at The Dow Chemical Company for 25 years. A previous morbidity study among employees of The Dow Chemical...

Application of statistical methods to forecasting of natural groundwater tables

Several statistical methods that can be used for forecasting the groundwater table regime are described in this paper. The choice of the method depends on: duration of observation period; hydrogeological conditions, especially degree of drainage and lithological contents of vadose and saturated zones; and duration of the lead period.

Effects Of Prednisolone Injection On The Liver Of The Mouse Inoculated With The Adult Worms Of Clonorchis Sinensis Intraperitoneally

In order to understand the effect of prednisolone injection on the histopathological changes of the mouse liver and the chronological changes of the worm structure of Clonorchis sinensis, when this fluke was inoculated to the mouse intraperitoneally. The recovery rate, survival rate, location and size of the inoculated worms as well as the histopathological changes of the liver were investigated for the comparison among the groups of mice, which were classified by number of worms and the duration of observation period. The result obtained were summarized as follows. 1. The recovery rate and survival rate of the worms decreased especially 28 days after the inoculation. 2. Most of worms (45.5%) were collected from the peritoneal cavity, and some of worms were found tightly adherent to the capsules of the liver, spleen, intestine and diaphragm. 3. The mean worm size after inoculation was constantly smaller than that before inoculation. 4. Remarkable atrophy in the reproductive organs of the worm, such as spermatheca, testes, vitelline gland and ovary was frequently observed at the 10th day of inoculation. 5. Histopathologically the liver failed to show any parasitic worm inside the intrahepatic biliary system. However, multiple well formed egg-containing granulomas were present along the liver capsule. These necrotic granulomas were occasionally found under the fibrotic liver capsule. Focal necrosis and focal phlebitis together with vascular dilatation were prominent features of the liver. 6. The worms recovered in the capsule of the liver were degenerated and necrotized. Usually, there were remarkable capsulitis and granuloma formation around the eggs.