Effects Of Different Therapies Research Articles

Experience and technical exchange basic techniques and applications of three-layer moving cupping method

In the systematical study on moving cupping method by combination of the clinical practice, the time, speed and strength of moving cupping method are quantified. 15 basic manual techniques of moving cupping methods have been summarized and 10 clinical application protocols have been recommended. In accordance with acupuncture theory, the concept of “three-layer moving cupping method” has been submitted, in the knowledge that different manual techniques, different protocols in the clinical application can produce different therapeutic effects of different therapies like warming moxibustion, cupping method, scratching method, massage and herbal therapy.

09 Effects of different preconditioning therapies on arrhythmias and aortic blood flow in an in vivo rat model of ischaemia/reperfusion injury

ObjectiveThe aim of the present study was to compare the cardioprotective effects of different therapies including local, remote, pharmacological and oxidative preconditioning in ischaemia/reperfusion injury in rats.MethodologyRats were randomly assigned...

Posttreatment prognosis of patients with esthesioneuroblastoma

There is no Class I evidence to guide the appropriate management of esthesioneuroblastoma (EN). Most data currently guiding treatment come from small- or modest-sized series gathered at individual centers that have concluded that surgery with radiotherapy is the preferred treatment. In this study, the authors summarize the published literature on treatment outcomes in patients with EN. The objective was to ascertain what variables predict prognosis in these patients and to determine the relative effect of different therapies. The authors identified 205 published studies containing treatment outcomes for surgery, radiotherapy, chemotherapy, or multimodal treatment. Using Kaplan-Meier analysis, the survival of patients who received surgery was compared with that in those who received surgery and radiotherapy. Additionally, Kadish staging was compared with low- and high-grade Hyams criteria to assess for subgroup prognostic significance in survival differences. Nine hundred fifty-six patients met the inclusion criteria, with a median follow-up time of 3 years. Kaplan-Meier analysis demonstrated no difference in survival between patients who underwent surgery alone and those who underwent surgery plus radiotherapy at 5 years (78 vs 75%) or 10 years (67 vs 61%, respectively) (p = 0.3). Univariate analysis demonstrated worse survival in cases involving Kadish Grade C tumors, Hyams Grade 3 and 4 tumors, and in patients older than 65 years of age. Multivariate analysis demonstrated that Hyams Grade 3 and 4 lesions carried significant risk (proportional hazard = 4.83, p < 0.001) with 5- and 10-year survival of 47 and 31%. A biopsy should always be obtained in cases suspected of EN because histology is a strong prognostic indicator and will help guide appropriate treatment. Unimodal surgery and combined surgery/radiotherapy appear to be of equivalent efficacy with respect to survival in patients with EN. Chemotherapy should be considered in high-grade EN.

Testing Photobiomodulatory Effects of Laser Irradiation on Wound Healing: Development of an Improved Model for Dressing Wounds in Mice

To develop a suitable method for dressing skin wounds in BKS.Cg-m(+)/(+)Lepr(db) mice for subsequent use in laser irradiation of wounds. The healing of nonirradiated wounds (controls) was examined histologically to provide essential reference data. Dressing excisional skin wounds in mice has many advantages. However, previous studies using dressings such as Tegaderm W or OpSite, with or without adhesives, have shown that this is not easily achieved. In a pilot study, a full-thickness wound was made on the left flank in six diabetic and six nondiabetic mice, and five different methods were tried for dressing the wounds with Tegaderm HP to develop an optimized procedure. The optimized procedure was used in subsequent studies, with a total of 23 diabetic and 13 nondiabetic mice being controls for laser-irradiated mice. Measurements of healing outcomes from histologic sections of controls were statistically analyzed. The optimized procedure used Tegaderm HP with Cavilon and Fixomull Stretch strips for the first dressing, and with Mastisol for subsequent dressings. Wound closure by contraction was retarded in a large proportion of diabetic mice (approximately 80%) and a small proportion of nondiabetic mice. These wounds, described as "splinted," healed mainly by epithelial regeneration and granulation tissue formation. A simple, easy-to-perform procedure was developed for dressing wounds in diabetic and nondiabetic mice. It was found to cause splinting with wound healing mimicking that in human patients. This model is suitable for examining the effects of different therapies on wound healing, including lasers.

Visual evoked potentials and MBP gene expression imply endogenous myelin repair in adult rat optic nerve and chiasm following local lysolecithin induced demyelination

Multiple sclerosis (MS) patients may suffer from optic disturbances. Toxin-induced demyelinations have frequently been developed to investigate the cellular and structural aspects of demyelination and remyelination processes, separately. The present study describes functional consequence of lysolecithin (LPC)-induced lesion in the adult rat optic nerves and chiasm by recording the visual evoked potentials (VEPs) from the visual cortex and its correlation with myelin basic protein (MBP) expression in lesion site. Records of VEP were obtained at 2, 7, 14 and 28days post-injection. We observed that the VEPs generated by light stimuli progressively changed in both amplitude and latency after the lesion as well as in comparison with those generated in control animals. These observations were confirmed through measurement of mRNA expression level for MBP which is one of the important genes expressed in mature oligodendrocytes and Schwann cells. The level of MBP mRNAs in demyelinated chiasm and optic nerves decreased following lysolecithin injection with its least value on day 7, and then it increased to the control level 14days post-lesion. However, it continued to increase even after that and reached a maximum level 28days post lesion. Results of the present paper show that, LPC injection in the chiasm share functional and molecular alterations which are found in demyelinating disorders in both the optic nerves and chiasm and also these alterations were coming back to level of control animal on 28days post lesion, which is typically seen in myelin repair process. The present paper provides new insights into the experimental toxin-induced models that may be useful for evaluating the functional recovery of demyelinated optic nerves and chiasm following various repairing strategies. It also seems to be useful for studying the protective or remyelinating effects of different therapies in e.g. optic apparatus which is more affected by MS.

Induction and Maintenance Therapy for Patients with Mycosis Fungoidus (MF) and Sezary Syndrome (SS) in Large Cell Transformation Phase.

Abstract 4758 AimTo determine the frequency of transformation of cutaneous T-cell tumors (CTCL) and effect of different therapies. Materials and methodsRetrospective analysis of treatment results for 68 patients with two types of CTCL, MF and SS, selected from 263 patients T-cell lymphoma/leukemia treated at NCH during 9 years. All 68 patients have CD 3 +, CD 4+, CD 7-, CD 8-, CD 30- immunophenotype and T-cell clonality (rearranged genes for T-cell receptor). MF was diagnosed in 48 patients (24 men, 24 women) with median age 52 years (26 - 77), SS in 20 patients (12 men, 8 women), median age 61 years (23 -87). Half of the MF patients started surveillance at III - IV stages, 15 of 20 patients with SS - at stage IV. Treatment of CTCL in the indolent phase was conducted in accordance with their stage: monochemotherapy (leukeran or methotrexate) and biologically active agents (interferons, retinoids, monoclonal antibody) were used. Appearance of transformation to large cell lymphoma was consistent with tumor progression as determined by presence of two or more of the following: 1. rapid growth of tumors in MF or leukemization in SS; 2. presence of large anaplastic cells in blood or tumor biopsy; 3. increase in expression of Ki-67 (10-70%); 4. appearance of activation markers (CD30, CD25) in tumor cells, and 5. loss of certain linear T-cell markers. For treatment of patients in large cell transformation phase Promace-Cytabom or FNC protocols were used in 7 patients. Five patients received A-CHOP-14 (with alemtuzumab) and subsequent maintenance therapy (methotrexate 20 mg per week, 6-mercaptopurine 50-100 mg/day in combination with alpha interferon 3 million daily). Results and DiscussionThe overall median time of observation (before and during treatment) in 48 patients with MF was 96 months (8-264). For 13 patients who died it was 76 months (8-264), mortality rate was 27%. The overall median observation (before and during treatment) in 20 patients with SS was 60 months (6-123), for 8 who died, it was 62 months (6-94), mortality 40%. The median observation for treatment of MF was 30 months (from 3-122) for the SS, it was 18 months (1 - 85). Restraining aggressive therapy for an indolent process resulted in complete or partial remission, while maintaining a good quality of life. Large cell transformation phase was observed in 12 patients (7 of 48 patients with MF (14.5%) and 5 of 20 patients with SS (25%). Seven of the 12 patients died within 2-4 months due to septic complications during Promace-Cytabom or FNC protocols. The remaining 5 patients received A-CHOP-14 (6-7 courses) which reduced tumor formation and /or leukemization. However, the persistence of patches, plaque or erythrodermia was the reason for maintenance therapy. This combination led to further regression of skin manifestations and full or partial remission within 4-12 months. ConclusionBecause of the lack of a generally accepted treatment for GM and SS in Large Cell Transformation phase, even small successes should be discussed. The effectiveness of combining of polychemotherapy with maintenance therapy may be effective due to the presence of several distinct clones of tumor cells with different properties. Keywords: treatment of cutaneous T-cell lymphoma, Mycosis Fungoidus, Sezary Syndrome, Large Cell Transformation Phase, immunohistochemical markers of T-cell lymphomas. Disclosures:No relevant conflicts of interest to declare.

Indirect comparisons of therapeutic interventions.

Health political backgroundThe comparison of the effectiveness of health technologies is not only laid down in German law (Social Code Book V, § 139 and § 35b) but also constitutes a central element of clinical guidelines and decision making in health care. Tools supporting decision making (e. g. Health Technology Assessments (HTA)) are therefore in need of a valid methodological repertoire for these comparisons. Scientific backgroundRandomised controlled head-to-head trials which directly compare the effects of different therapies are considered the gold standard methodological approach for the comparison of the efficacy of interventions. Because this type of trial is rarely found, comparisons of efficacy often need to rely on indirect comparisons whose validity is being controversially debated. Research questionsResearch questions for the current assessment are: Which (statistical) methods for indirect comparisons of therapeutic interventions do exist, how often are they applied and how valid are their results in comparison to the results of head-to-head trials?MethodsIn a systematic literature research all medical databases of the German Institute of Medical Documentation and Information (DIMDI) are searched for methodological papers as well as applications of indirect comparisons in systematic reviews. Results of the literature analysis are summarized qualitatively for the characterisation of methods and quantitatively for the frequency of their application.The validity of the results from indirect comparisons is checked by comparing them to the results from the gold standard – a direct comparison. Data sets from systematic reviews which use both direct and indirect comparisons are tested for consistency by of the z-statistic.Results29 methodological papers and 106 applications of indirect methods in systematic reviews are being analysed. Four methods for indirect comparisons can be identified: Unadjusted indirect comparisons include, independent of any comparator, all randomised controlled trials (RCT) that provide a study arm with the intervention of interest. Adjusted indirect comparisons and metaregression analyses include only those studies that provide one study arm with the intervention of interest and another study arm with a common comparator. While the aforementioned methods use conventional metaanalytical techniques, Mixed treatment comparisons (MTC) use Bayesian statistics. They are able to analyse a complex network of RCT with multiple comparators simultaneously. During the period from 1999 to 2008 adjusted indirect comparisons are the most commonly used method for indirect comparisons. Since 2006 an increase in the application of the more methodologically challenging MTC is being observed.For the validity check 248 data sets, which include results of a direct and an indirect comparison, are available. The share of statistically significant discrepant results is greatest in the unadjusted indirect comparisons (25,5% [95% CI: 13,1%; 38%]), followed by metaregression analyses (16,7% [95% CI: -13,2%; 46,5%]), adjusted indirect comparisons (12,1% [95% CI: 6,1%; 18%]) and MTC (1,8% [95% CI: -1,7%; 5,2%]). Discrepant results are mainly detected if the basic assumption for an indirect comparison – between-study homogeneity – does not hold. However a systematic over- or underestimation of the results of direct comparisons by any of the indirectly comparing methods was not observed in this sample.DiscussionThe selection of an appropriate method for an indirect comparison has to account for its validity, the number of interventions to be compared and the quality as well as the quantity of available studies. Unadjusted indirect comparisons provide, contrasted with the results of direct comparisons, a low validity. Adjusted indirect comparisons and MTC may, under certain circumstances, give results which are consistent with the results of direct comparisons. The limited number of available reviews utilizing metaregression analyses for indirect comparisons currently prohibits empirical evaluation of this methodology.Conclusions/RecommendationsGiven the main prerequisite – a pool of homogenous and high-quality RCT – the results of head-to-head trials may be pre-estimated by an adjusted indirect comparison or a MTC. In the context of HTA and guideline development they are valuable tools if there is a lack of a direct comparison of the interventions of interest.

The role of lipoprotein-associated phospholipase A2 on cardiovascular disease risk assessment and plaque rupture: a clinical review

During the last several last decades, reduction in lipids has been the main focus to decrease the risk of coronary heart disease (CHD). Several lines of evidence, however, have indicated that lipids account only for the <50% of variability in cardiovascular risk in the United States. Therefore, for better identification of people at high cardiovascular risk, a more effective and complete approach is required. Our understanding of atherosclerosis has shifted from a focal disease resulting in symptoms caused by severe stenosis to a systemic disease distinguished by plaque inflammation with a potential to rupture and thrombosis, turning a substenotic atherosclerotic lesion into a complete occlusive lesion. Lipoprotein-associated phospholipase A(2) (Lp-PLA(2)) is a novel inflammatory biomarker that can provide much needed information about plaque inflammation and plaque stability. Lp-PLA(2) is among the multiple biomarkers that have been associated with increased CHD risk. In this present work, we review the evidence from previous studies addressing the effect of different therapies on decreasing Lp-PLA(2) and the role of direct Lp-PLA(2) inhibitors. This work also briefly reviews the evidence of Lp-PLA(2) clinical utility as a potential marker of vascular inflammation and formation of rupture prone plaques. Additionally, we also discuss the implication of available evidence in context of current cardiovascular inflammatory biomarkers recommendations and the evidence from epidemiologic studies addressing the relationship of Lp-PLA(2) and risk of cardiovascular disease.

Effects of Therapy for Dysphagia in Parkinson’s Disease: Systematic Review

This systematic review explores the effects of dysphagia treatment for Parkinson's disease. The review includes rehabilitative, surgical, pharmacologic, and other treatments. Only oropharyngeal dysphagia is selected for this literature search, excluding dysphagia due to esophageal or gastric disorders. The effects of deep brain stimulation on dysphagia are not included. In general, the literature concerning dysphagia treatment in Parkinson's disease is rather limited. Most effect studies show diverse methodologic problems. Multiple case studies and trials are identified by searching biomedical literature databases PubMed and Embase, and by hand-searching reference lists. The conclusions of most studies cannot be compared with one another because of heterogeneous therapy methods and outcome measures. Further research based on randomized controlled trials to determine the effectiveness of different therapies for dysphagia in Parkinson's disease is required.

Long-term progression and therapeutic response of visceral metastatic disease non-invasively monitored in mouse urine using β-human choriogonadotropin secreting tumor cell lines

Historically, the use of mouse models of metastatic disease to evaluate anticancer therapies has been hampered because of difficulties in detection and quantification of such lesions without sacrificing the mice, which in turn may also be dictated by institutional or ethical guidelines. Advancements in imaging technologies have begun to change this situation. A new method to non-invasively measure tumor burden, as yet untested to monitor spontaneous metastases, is the use of transplanted tumors expressing secretable human beta-chorionic gonadotropin (beta-hCG) that can be measured in urine. We describe examples of beta-hCG-transfected tumor cell lines for evaluating the effect of different therapies on metastatic disease, which in some cases involved monitoring tumor growth for >100 days. We used beta-hCG-tagged mouse B16 melanoma and erbB-2/Her-2-expressing human breast cancer MDA-MB-231 models, and drug treatments included metronomic low-dose cyclophosphamide chemotherapy with or without a vascular endothelial growth factor receptor 2-targeting antibody (DC101) or trastuzumab, the erbB-2/Her-2-targeting antibody. Both experimental and spontaneous metastasis models were studied; in the latter case, an increase in urine beta-hCG always foreshadowed the development of lung, liver, brain, and kidney metastases. Metastatic disease was unresponsive to DC101 or trastuzumab monotherapy treatment, as assessed by beta-hCG levels. Our results also suggest that beta-hCG levels may be set as an end point for metastasis studies, circumventing guidelines, which have often hampered the use of advanced disease models. Collectively, our data indicates that beta-hCG is an effective noninvasive preclinical marker for the long term monitoring of untreated or treated metastatic disease.

Beta-blockade as First-line Therapy in the Elderly Heart Failure Patient—the Proper Approach or Asking for Trouble?

After a long and tedious start, beta-blockade has undeniably become one of the pillars of heart failure therapy. Based on the positive results of large, controlled studies in patients with stable mild, moderate and advanced chronic heart failure, beta-blocking drugs have been approved for the treatment of this syndrome, and are well positioned in national and international guidelines for the treatment of heart failure [1]. Of importance, their beneficial effects are comparable irrespective whether patients are at low, intermediate or high risk of heart failure. The same is true for different age groups. Indeed, elderly heart failure patients clearly benefit from long term beta-blocker therapy. The latter is important, as the heart failure patient in the community is relatively old, on average 74 years, in contrast to the average age (around 60–62 years) of the typical patient recruited in heart failure drug trials, including most studies with beta-blocking agents [2–5]. In the latter studies, beta-blocking therapy has on average been well tolerated. Although one could argue that this may be related to the relatively young age in these studies, a more recent study in elderly heart failure patients, SENIORS, also indicated that these patients (average age 76 years) tolerated beta-blockade well, comparable to placebo [6]. Of importance, in each of these studies beta-blockade was administered in addition to optimal heart failure therapy, which includes ACE inhibition and /or angiotensin receptor blockade in approximately 90% of patients. It is conceivable that, in this way, patients may have been protected from a potential adverse effect of the betablocker, worsening heart failure, and therewith may have tolerated the beta-blocker so well. This, of course, would be a perfect argument in favour of always first prescribing an ACE inhibitor (or ARB in those patients who do not tolerate ACE inhibition) and then follow up with a beta-blocker; exactly as current guidelines mandate [1]. However, and despite the apparent logic, is it really always necessary to follow this order of treatment? The fact that ACE inhibitors have become first choice in heart failure is purely based on historical grounds, placebocontrolled ACE inhibitor trials being performed a decade before those with beta-blockade. The obvious beneficial effects of ACE inhibition in these early trials (with only digitalis and diuretics as background medication) has made it unethical in many eyes to conduct studies without the ACE inhibitor as concomitant therapy [7] The drawback of this is that it is difficult if not impossible to determine the specific effects of different therapies, such as beta-blockade, in heart failure as well as their usefulness as first-line therapy. With this in mind, are there grounds on which to expect a better (or at least similar) efficacy of beta-blockade than ACE inhibition in mild to moderate heart failure, usually the time when the choice of first-line therapy will be made? Cardiovasc Drugs Ther (2008) 22:347–350 DOI 10.1007/s10557-008-6126-7

Lung Injury and Recovery in a Murine Model of Unilateral Acid Aspiration

Acid aspiration is a complication of general anesthesia. Most animal models developed to define its pathophysiology have focused on the acute (< or =24 h) phase of the injury. The authors describe a model of acid aspiration allowing the study of this type of lung injury over time. The authors instilled hydrochloric acid (0.1 m, 1.5 ml/kg) or normal saline in the right bronchus of mice. Lung injury was evaluated at 6 h, 12 h, 24 h, and 2 weeks by assessing arterial blood gases, respiratory system compliance, lung wet weight normalized by body weight, lung myeloperoxidase activity, and histology. Twelve hours and 2 weeks after injury, a computed tomography scan was obtained. In the hydrochloric acid group, arterial oxygen tension decreased (P < 0.05) at 12 and 24 h, whereas it recovered at 2 weeks; respiratory system compliance was lower both at 24 h and 2 weeks (P < 0.05). Lung weight increased at 12 and 24 h (P < 0.05). Myeloperoxidase activity peaked between 6 and 12 h. Computed tomography at 12 h showed that almost 30% of the injured lung was abnormally aerated. Although reduced, the abnormalities were still present at 2 weeks as confirmed by a fibrotic scar well evident at histologic examination. The authors characterized a murine model of regional acid aspiration allowing long-term survival. Despite a partial recovery, at 2 weeks the injury persisted, with evidence of fibrosis and lung compliance reduction. This long-term, low-mortality model seems suitable for assessment of the effects of different therapies on lung injury and repair.

Health-Related Quality of Life in Austrian Elementary School Children

Health-related quality of life (HRQL) is frequently used as an outcome criterion to evaluate the quality and effect of different therapies. However, little is known about the HRQL of the general population, the prevalence of specific HRQL problems and about which factors have an impact on HRQL assessments. To examine children's HRQL from their own and their parents' perspectives. The study sample consisted of children attending the third and fourth grades of elementary school in the capital of Austria, Europe. One thousand four hundred twelve children and 1185 parents completed child- and parent-versions of the Pediatric Quality of Life Inventorytrade mark (PedsQLtrade mark). In addition to the PedsQL questions, children and parents were asked a number of questions with regard to sociodemographic information and specific problems that were hypothesized to be associated with the children's HRQL. Altogether, the children demonstrated a good HRQL and their PedsQL scores were similar to those of children from other developed countries. About 15% of children showed a notably low HRQL, and two-thirds of these children were from financially less privileged families. Multivariate regression analyses identified the following factors associated with the children's HRQL: the family's perceived financial situation, parents' quality of life, children's school performance, medical and/or psychologic problems (eg, dyslexia, recurrent stomachache or headaches), chronic disease, a recent life-event (eg, divorce/separation of parents), and parents' satisfaction with school. Assessing children's HRQL may be helpful to take preventive action and to identify those who are in urgent need of special services.

Monitoring ankylosing spondylitis therapy by dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging

The effects of different therapies on enthesitis/osteitis in active ankylosing spondylitis (AS) were evaluated by magnetic resonance imaging (MRI). The aim was to assess the role of quantitative MRI in the evaluation of AS treatment efficacy. Thirty patients with active spondylitis or bilateral sacroiliitis were selected and followed up for 1 year. Ten of the patients were treated only with non-steroidal anti-inflammatory drugs, 10 patients additionally received at baseline an intravenous pulse of glucocorticoids and 10 patients were treated with regular infusions of infliximab. Disease activity was measured according to clinical instruments and laboratory tests. For each patient, one selected inflamed lesion was followed from baseline through control visits quantitatively by diffusion-weighted imaging (DWI) measuring the apparent diffusion coefficient (ADC) and by dynamic contrast-enhanced imaging (DCEI) with evaluation of the enhancement factor (f(enh)) and enhancement gradient (g(enh)). Clinical and quantitative MRI parameters diminished significantly with regression of the inflammatory activity. The improvement in AS was most pronounced in patients treated with infliximab; after 12 months the ADC diminished from an average of 1.31 to 0.88 x 10(-3) mm(2)/s, f(enh) from 1.85 to 0.60, and g(enh) from 3.09 to 1.40 %/s. Diffusion-weighted imaging and DCEI were shown to be effective in quantifying changes in inflammation in skeletal lesions during the treatment of AS, and could therefore be convenient for assessing treatment efficacy. To the best of our knowledge this is the first time DWI was used to evaluate the activity of skeletal inflammation in rheumatic diseases such as AS.

Effectiveness of short-term and long-term psychotherapy on work ability and functional capacity — A randomized clinical trial on depressive and anxiety disorders

BackgroundInsufficient evidence exists about the effect of different therapies on work ability for patients with psychiatric disorders. The present study compares improvements in work ability in two short-term therapies and one long-term therapy. MethodsIn the Helsinki Psychotherapy Study, 326 outpatients with depressive or anxiety disorder were randomly assigned to long-term and short-term psychodynamic psychotherapy, and solution-focused therapy. The patients were followed for 3 years from the start of treatment. Primary outcome measures were the Work Ability Index (WAI), the Work-subscale (SAS-Work) of the Social Adjustment Scale (SAS-SR), Perceived Psychological Functioning Scale, the prevalence of patients employed or studying, and the number of sick-leave days. ResultsWork ability was statistically significantly improved according to WAI (15%), SAS-Work (17%), and Perceived Psychological Functioning Scale (21%) during the 3-year follow-up. No differences in the work ability scores were found between two short-term therapies. The short-term therapies showed 4–11% more improved work ability scores than long-term therapy at the 7 month follow-up point. During the second year of follow-up, no significant differences were found between therapies. After 3 years of follow-up, long-term therapy was more effective than the short-term therapies with 5–12% more improved scores. No differences in the prevalence of individuals employed or studying or in the number of sick-leave days were found between therapies during follow-up. ConclusionsShort-term therapies give benefits more quickly than long-term therapy on work ability but in the long run long-term therapy is more effective than short-term therapies. More research is needed to confirm these findings.

Use of Predictive Markers to Improve Cardiovascular Protection

Together with other modifiable cardiovascular risk factors, hypertension heavily contributes to the global burden of cardiovascular morbidity and mortality, as well as to the increase in individual absolute cardiovascular risk. Comparison of the effectiveness of different therapies in reducing the incidence of major cardiovascular events has classically required the evaluation of major 'hard' end points. In view of the long natural history of hypertension, however, it appears very useful to monitor modifications in measurable 'intermediate' end points or 'disease markers'. This approach may provide more accurate individual risk stratification and a better evaluation of the efficacy of a given treatment in preventing or modifying the course of target organ damage. This may represent a valuable and affordable strategy in clinical practice allowing the evaluation of both patient prognosis and the effectiveness of antihypertensive treatment over time.

Quality of life—evaluation criteria for children with chronic conditions in medical care

Health-related quality of life denotes the patients’ perception of well-being and function in physical, emotional, mental, social, and everyday life areas. In medicine, it is frequently used as an outcome criterion to evaluate the quality and effect of different therapies. It is also frequently used in epidemiological studies, as well as health economic research. Approaches to assess the quality of life include patients’ self-report versus report by other persons, multidimensional versus unidimensional assessment of well-being and function, as well as the use of generic versus disease-specific methods. In the past 20 years, a multitude of instruments to assess health-related quality of life has been developed, mostly for adults, complying with psychometric standards concerning the reliability, validity, and sensitivity of the scales. The current paper describes challenges to the assessment of the quality of life in children and adolescents, introduces widely used generic measures, and focuses on the application of these measures in the research context by using examples from a German prospective study in pediatric rehabilitation and an international project to develop a set of quality of life instruments for children with chronic conditions. The quality of life area has developed to be a major innovation also in public health. In terms of including the perspective of children and adolescents, efforts directed at assessments have increased recently, but much needs to be done to include these measures in epidemiological and clinical studies.

Quality of life in patients with functional dyspepsia: Short- and long-term effect of Helicobacter pylori eradication with pantoprazole, amoxicillin, and clarithromycin or cisapride therapy: A prospective, parallel-group study

Background: Quality of life (QOL) is impaired in functional dyspepsia (FD). Little is known about the effects of different therapies on the QOL profile in patients with this condition. Objectives: The aims of this study were to measure baseline QOL in patients with FD and to assess changes in QOL over time associated with Helicobacter pylori eradication and prokinetic treatment. The primary and secondary end points were the improvement in QOL 6 weeks and 1 year after successful eradication of the infection or prokinetic therapy. Methods: This 1-year, single-center, prospective, open-label, controlled, parallel-group trial was conducted at the Department of Gastroenterology, Ferencvdros Health Centre, Budapest, Hungary. The Functional Digestive Disorder Quality of Life (FDDQoL) Questionnaire (MAPI Research Institute, Lyon, France) was translated and validated previously in Hungarian. Male and female subjects aged 20 to 60 years were enrolled and classified as H pylori positive (HP+), H pylori negative (HP-) with FD, or healthy (control group). The HP+ patients received pantoprazole 40 mg BID + amoxicillin 1000 mg BID + clarithromycin 500 mg BID for 7 days, followed by on-demand ranitidine (150–300 mg/d) for 1 year. The HP- patients received the prokinetic cisapride 10 mg TID for 1 month, followed by on-demand cisapride (10–20 mg/d) for 1 year. The FDDQoL questionnaire was completed by all 3 groups on enrollment, at 6 weeks, and 1 year. Results: A total of 101 HP+ patients, 98 HP- patients, and 123 healthy controls were included in the study (185 women, 137 men; mean age, 39.0 ears). The mean (SD) baseline QOL scores were significantly lower in the HP+ group (53.3 [9.6]; 95% CI, 54.4-58.2) and the HP- groups (50.0 [9.8]; 95% CI, 58.0–62.0) compared with that in healthy controls (76.2 [8.7]; 95% CI, 74.6–77.8) (both, P < 0.001). Analysis of the short-term domain scores found that the HP+ group had significantly decreased scores in 6 of 8 domains: daily activities ( P = 0.005), anxiety level ( P = 0.02), diet ( P = 0.008), sleep ( P < 0.001), discomfort ( P = 0.004), and disease control ( P = 0.02); the HP- group had significantly decreased scores in 5 of 8 domains: daily activities ( P < 0.001), diet ( P = 0.004), sleep ( P = 0.005), discomfort ( P < 0.001), and disease control ( P = 0.02). Eradication of the infection was successful in 77/101 (76.2%) of the patients on intent-to-treat analysis and 77/94 (81.9%) on per-protocol analysis. Eradication was associated with an increase in mean (SD) QOL score to 70.8 (10.7) at 6 weeks (95% CI, 63.3–73.2; P < 0.001 vs baseline) and to 75.3 (9.3) at 1 year (95% CI, 73.2–77.5; P= 0.05 vs 6 weeks). In the HP- group, the QOL score increased to 73.3 (9.7) (95% CI, 71.3–75.4; P < 0.001 vs baseline) at 6 weeks of cisapride treatment and to 76.5 (8.5) at 1 year (95% CI, 74.5–78.4; P = 0.06 vs 6 weeks). Most of the impaired domain scores improved significantly after both treatments. The short-term effect size was 1.48 in HP+ and 1.35 in HP− patients. Adverse events (AEs) occurred in 22 (21.8%) patients in the HP+ group (nausea, 8 [7.9%] patients; diarrhea, 5 [5.0%]; loss of appetite, 5 [5.0%]; stomatitis, 5 [5.0%]; abdominal pain, 4 [4.0%]; bloating, 4 [4.0%]; headache, 4 [4.0%]; vomiting, 4 [4.0%]; constipation, 3 [3.0%]; and vaginitis, 3 [3.0%]). In HP− cases, AEs occurred in 9 (9.2%) patients (abdominal cramps, 7 [7.1%]; diarrhea, 4 [4.1%]; and nausea, 3 [3.1%]). Conclusion: In this study in patients with FD and healthy controls, eradication of H pylori infection in infected patients and cisapride treatment in uninfected patients reversed low QOL scores during the 1-year follow-up period.

Patient's perception of exacerbations of COPD—the PERCEIVE study

The evaluation of therapies requires the development of patient-reported outcomes (PROs) that help clinicians to understanding the symptoms, perceptions and feelings of patients with exacerbations of chronic obstructive pulmonary disease (COPD). With the aim of obtaining information on the perceptions of patients with COPD, their exacerbations and expectations of treatment, a random telephone contact survey in six countries was performed. From 83,592 households screened, 1100 subjects with symptoms compatible with COPD were identified. The most frequent symptom was shortness of breath (78%). The most frequent complaint was that due to their COPD: "they could not complete the activities they like to do" (54%); 17% (187) of individuals were afraid that their COPD would cripple, or eventually kill them. Exacerbations generated a mean of 5.1 medical visits/year (SD=4.6) with the mean duration of exacerbation symptoms being 10.5 days. Increased coughing was the exacerbation symptom having the strongest impact on well-being (42%). Fifty-five percent of patients declared that quicker symptom relief was the most desired requirement for treatment. New data are provided on the impact of COPD and its exacerbations on the daily life of patients. These data will help to develop PROs designed to evaluate the effectiveness of different therapies for exacerbated COPD.

Comparison of curative effect for hepatocellular carcinoma with tumor thrombosis in ported vein

目的 比较肝功能处于代偿期的肝癌合并门静脉癌栓患者不同治疗方法 的疗效并探讨影响其疗效的因素.方法 50例肝癌合并门静脉癌栓患者,根据不同的治疗方法 分为四组:保守治疗组12例、化疗组12例、手术切除组13例、手术切除加化疗组13例.结果 保守治疗组中位生存时间3.5个月;化疗组中位生存时间7.1个月;手术切除组中位生存时间10.3个月;而手术切除加化疗组中位生存时间13.4个月,术后0.5、1、2、3年生存率分别为53.7%、37.6%、30.7%、14.0%,明显高于其他三组(P＜0.05).单因素、多因素分析提示术后化疗次数是影响手术切除后疗效的重要因素.结论 门静脉癌栓患者手术切除加术后化疗的疗效最好。