One-year Treatment Research Articles

One-year denosumab treatment in patients with rheumatoid arthritis

One-year denosumab treatment in patients with rheumatoid arthritis

Intestinal healing after anti-TNF induction therapy predicts long-term response to one-year treatment in patients with ileocolonic Crohn's disease naive to anti-TNF agents.

IntroductionObjective assessment of Crohn’s disease (CD) activity in patients treated with anti-tumour necrosis factor (anti-TNF) antibodies is crucial for the prediction of its long-term results. Mucosal healing estimated endoscopically has a strong predictive value; however, only combined assessment together with transmural healing in magnetic resonance enterography (MRE) gives full information about the whole spectrum of inflammatory lesions in CD.AimTo assess the usefulness of intestinal healing phenomenon in CD, defined as improvement both in endoscopy and MRE, after anti-TNF induction therapy, in predicting long-term results of 1-year treatment.Material and methodsTwenty-six patients with ileocolonic CD were enrolled into the study. In this group a parallel assessment of disease activity was estimated before and after induction doses of anti-TNF antibodies with ileocolonoscopy and MRE by using appropriate scores. Subsequently the patients were treated until 12 months and then followed-up. The associations between intestinal healing (assessed in MRE and endoscopy), and mucosal and transmural healing with long-term results of 1-year anti-TNF therapy were analysed statistically.ResultsThe median time of follow-up was 29 months (interquartile range – IQR: 14–46). Intestinal healing was significantly associated with favourable therapeutic outcomes (p = 0.02) and had 75% (IQR: 35–97%) sensitivity and 72% (IQR: 46–90%) specificity in predicting long-term remission. Other parameters were not useful (transmural healing) or their usefulness was of borderline significance (mucosal healing).ConclusionsDynamic assessment of intestinal healing is an accurate method in predicting long-term outcomes in CD patients responding to 1-year anti-TNF therapy.

One-year treatment persistence with local estrogen therapy in postmenopausal women diagnosed as having vaginal atrophy.

Estrogen therapy is considered to be the most effective treatment of vaginal atrophy (VA) symptoms. This retrospective study compares rates of pharmacy refill-based treatment persistence in women treated for VA with local estrogen therapy (LET) creams versus low-dose vaginally administered tablets. Study cohort included treatment-naive women aged 45 years or older within the IMS PharMetrics Plus claims database who filled one or more prescriptions for a LET cream or tablet between January 1, 2010 and September 30, 2012. Index LET was the first observed LET claim in pharmacy records. Persistence was defined as the number of consecutive days of treatment available of the index LET during the 12-month follow-up period. In adjusted analyses, we compared the risks of discontinuation of index therapy. Of 30,197 women eligible for analysis, 12,187 (40.4%) initiated treatment with conjugated estrogens vaginal cream, 11,574 (38.3%) initiated treatment with estradiol vaginal cream, and 6,436 (21.3%) initiated treatment with 10-μg vaginal estradiol tablets (formulation introduced in 2010). Cohorts were comparable on age, geography, and baseline comorbidities. During the 12-month follow-up period, 86.2% to 89.4% of cream users discontinued LET after the first prescription compared with 57.8% of tablet users (P < 0.0001). A greater proportion of tablet initiators than cream users were fully (100%) persistent during the 12-month follow-up period. Mean treatment duration was 103.4 days for tablets versus 44.6 to 48.1 days for creams (P < 0.0001). After adjustment for baseline characteristics, tablet initiators had a lower risk of discontinuation compared with cream users (P < 0.0001). Low-dose LET tablets, compared with cream formulations, are associated with greater persistence in the treatment of VA.

Intravitreal Bevacizumab Versus Ranibizumab for Treatment of Neovascular Age-Related Macular Degeneration: Findings from a Cochrane Systematic Review

To summarize the relative effects of bevacizumab (Avastin; Genentech, Inc, South San Francisco, CA) and ranibizumab (Lucentis; Genentech, Inc.), using findings from a Cochrane Eyes and Vision Group systematic review. Neovascular age-related macular degeneration (NVAMD) is the most common cause of uncorrectable vision loss among the elderly in developed countries. Bevacizumab and ranibizumab are the most frequently used anti-vascular endothelial growth factor (VEGF) agents injected intravitreally to treat NVAMD. For this systematic review, we included only randomized controlled trials in which the 2 anti-VEGF agents had been compared directly. The primary outcome was 1-year gain in best-corrected visual acuity (BCVA) of ≥15 letters. We followed Cochrane methods for trial selection, data extraction, and data analyses. Relative effects of bevacizumab versus ranibizumab are presented as estimated risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs). We identified 6 eligible randomized controlled trials with 2809 participants. The proportion of eyes that gained ≥15 letters of BCVA by 1 year was similar for the 2 agents when the same regimens were compared (RR, 0.90; 95% CI, 0.73-1.11). The mean change in BCVA from baseline also was similar (MD,-0.5 letter; 95% CI,-1.6 to+0.6). Other BCVA and quality of life outcomes were similar for the 2 agents. One-year treatment cost with ranibizumab was 5.1 and 25.5 times the cost for bevacizumab in the 2 largest trials. Ocular adverse events were uncommon (<1%), and rates were similar for the 2 agents. We found no important difference in effectiveness or safety between bevacizumab and ranibizumab for NVAMD treatment, but there was a large cost difference.

Efficacy of nilotinib as third-line treatment in a patient with very late Chronic Myeloid Leukemia and a possibile cardiologic contraindication

We report a case of a patient with chronic myeloid leukemia who was treated with nilotinib after failure to imatinib and dasatinib. The patient, diagnosed in 1998, was cytogenetically resistant to imatinib. She was switched to dasatinib and achieved a major cytogenetic response, but 3 years later a mutant clone emerged responsible for cytogenetic relapse. The mutation we detected was V299L, that is resistant in vitro to dasatinib, while maintaining a good sensitivity to nilotinib. As the patient was not eligible for allotransplat, we decided to switch to nilotinib, despite a ECG abnormality (wandering pace-maker). After one-year treatment, the patient is in complete cytogenetic response with a low BCR-ABL/ABL transcript ratio. On mutational analysis, the V299L mutation has disappeared. Any cardiologic toxicity has not been observed so far. This case proves that ECG abnormalities do not represent an absolute contraindication to nilotinib and that nilotinib can be effective as third-line BCR-ABL inhibitor.

The effect of melatonin treatment on postural stability, muscle strength, and quality of life and sleep in postmenopausal women: a randomized controlled trial.

BackgroundMelatonin is often used as a sleeping aid in elderly adults. As previous studies suggest a protective role of melatonin against osteoporosis, it is important to document its safety. Treatment should not cause any hangover effect that could potentially lead to falls and fractures. We therefore aimed to evaluate the effect of melatonin on balance- and muscle function.Methods and patientsIn a double-blind placebo-controlled study, we randomized 81 postmenopausal women with osteopenia to receive 1 or 3 mg melatonin, or placebo nightly for 12 months. Postural balance as well as muscle function was measured. In addition, we assessed quality of life and sleep at baseline and after 12 months treatment.ResultsCompared to placebo, one-year treatment with melatonin did not affect postural balance or risk of falls. Furthermore, no significant changes between groups were observed in muscle strength in neither upper- nor lower extremities. Treatment did not affect quality of life or sleep. However, in the subgroup of women with sleep disturbances at baseline, a trend towards an improved sleep quality was seen (p = 0.08).ConclusionTreatment with melatonin is safe in postmenopausal women with osteopenia. There is no hangover effect affecting balance- and muscle function following the intake of melatonin. In women with a good quality of sleep, melatonin has no effect, however in poor quality of sleep, small doses of melatonin trended towards improving the quality.Trial registration(# NCT01690000)

One-Year Post-Discharge Resource Utilization and Treatment Patterns of Patients with Acute Coronary Syndrome Managed with Percutaneous Coronary Intervention and Treated with Ticagrelor or Prasugrel

Our objective was to compare 1-year real-world healthcare resource utilization (HRU), associated charges, and antiplatelet treatment patterns among patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI) and treated with ticagrelor or prasugrel. Using the ProMetis-Lx database, adult ACS-PCI patients treated with ticagrelor or prasugrel post-discharge were identified between 1 August 2011 and 31 May 2013 and propensity matched to adjust for baseline differences. Before matching, ticagrelor-treated patients (n=2991) were older with increased baseline ischemic and bleeding risks compared with prasugrel-treated patients (n=12,797). After matching, ticagrelor patients had higher all-cause HRU (2.5 vs. 2.4 per patient per month; P=0.012) and cardiovascular (CV) HRU (0.4 vs. 0.3 per patient per month; P=0.026), with the difference in CV rehospitalizations (17.7 vs. 15.7%; P=0.011) primarily driven by congestive heart failure (CHF) (4.9 vs. 3.8%; P=0.02). All-cause charges within 1year did not significantly differ between groups ($US5456 vs. 4844 per patient per month; P=0.37), but dyspnea-related total charges were significantly higher with ticagrelor ($US139 vs. 95 per patient per month; P=0.005). Although infrequent, switching was slightly higher with ticagrelor (8.3 vs. 6.0%; P<0.001) at 1year, and mean persistence was slightly longer with prasugrel (150 vs. 159days; P=0.002), with no significant difference in mean adherence (61 vs. 63%; P=0.17). Overall monthly HRU was slightly lower with prasugrel than with ticagrelor, with no significant difference in bleeding HRU. Prasugrel was associated with slightly higher pharmacy charges, but lower dyspnea charges, resulting in no significant difference in total charges. Patients receiving prasugrel tended to use it for longer than those receiving ticagrelor as less switching occurred. These findings may aid decision making, but must be tempered due to inherent study limitations.

One-year multidrug treatment for tuberculosis of the cervical spine in children.

To review the clinical and radiological features and treatment outcome in 22 children who underwent one-year antitubercular multidrug treatment for tuberculosis of the cervical spine. Records of 13 boys and 9 girls aged 2 to 12 (mean, 9.1) years who underwent one-year antitubercular multidrug treatment for tuberculosis of the cervical spine were reviewed. Tuberculosis involved the atlantoaxial region (C1-C2) in 7 patients, mid-cervical region (C3-C7) in 8, cervicodorsal region (C6-T3) in 3, contiguous multilevels in 2, and non-contiguous multifocal areas in 2. The mean number of vertebrae involved was 2.8 (range, 1-8). The mean symptom duration was 2.5 (range, 0.25-6) months. Three patients had neurological deficits. Antitubercular multidrug treatment included an intensive phase for 2 months and a continuation phase for 10 months, using isoniazid, rifampicin, pyrazinamide, and ethambutol. At a mean of 2.25 (range, 0.5-5) years after treatment, no patient had recurrence, pain, or dynamic instability. Full range of movement was achieved after a mean of 2.7 (range, 1-4) months in all but 3 patients. In the 3 patients with neurological deficits, recovery was achieved after a mean of 8 (range, 5-14) weeks. Soft tissue swelling resolved after a mean of 11 (range, 8-12) weeks. Remineralisation of vertebrae occurred after a mean of 2 (range, 2-6) months. Spontaneous vertebral fusion occurred in only 6 of 22 patients after a mean of 36 (range, 18-72) months. Three patients developed kyphotic deformity. Antitubercular multidrug treatment is a viable option for children with tuberculosis of the cervical spine, even in the presence of neurological deficits. Development of deformity is not common; interbody fusion is usually delayed. Patients with contiguous multilevel involvement with vertebral erosion or collapse should be closely monitored for development of late deformity.

Commentary: One-year multidrug treatment for tuberculosis of the cervical spine in children.

likely to cause deformity, neurological deficit, and growth alteration in children than in adults,1 owing to a lack of restraint, greater mobility, and cartilaginous open physeal plates at both ends of the vertebra in the paediatric cervical spine.2 In this issue, Agarwal et al.3 report the short-term outcome in 22 children (mean age, 9.1 years) after one-year antitubercular multidrug treatment for tuberculosis of the cervical spine. The study shows excellent clinical outcome with chemotherapy alone in 86% of patients and reversal of neurological impairment in all 3 affected patients. This finding is consistent with a Cochrane Database Systemic Review,4 guidelines of the Royal College of Physicians5 (which demonstrated no additional benefit of surgical debridement or resection of the spinal focus and bone grafting on top of chemotherapy, compared with chemotherapy alone), and a report from the Medical Research Council Working Party on Tuberculosis of the Spine6 (which showed 24 of 30 patients in one study and 74 of 85 patients in another in Korea had complete resolution of myelopathy and function after medical treatment). Agarwal et al.3 reported that the only obvious complications were kyphosis (n=2), kyphoscoliosis (n=1), and scoliosis (n=1) attributed to contiguous multilevel involvement at the mid-cervical or cervicodorsal region. The period of immobilisation Commentary: One-year multidrug treatment for tuberculosis of the cervical spine in children

Effect of treatment and HIV drug resistance of 81 cases of HCV/HIV co-infected individuals who had received AIDS second-line antiretroviral treatment in Henan province

To understand the one-year effect of HCV/HIV co-infected patients who had received AIDS second-line antiretroviral treatment after failure virologically, on the first-line therapy. HCV and HIV antibody positive patients who had experienced virological failure but received at least one-year AIDS first-line treatment, were recruited from May to October 2012 in Xincai, Queshan and Weishi of Henan province. 6-months and 12-months follow-up programs were carried out after the regimen had been changed to AIDS second-line antiretroviral treatment, CD4⁺ T lymphocyte count, HIV-1 virus load and HIV-1 drug resistance were performed. Eighty-one cases of eligible patients were selected and followed by an amelioration of CD4 median at 6-month and 12-month follow-up period. Data showed that the baseline, 6-months and 12-months CD4 medians were 266 cells/µl, 275 cells/µl and 299 cells/µl (χ² = 8.214, P = 0.009). The ratio of HIV virus load suppression patients at 6-months and 12-months follow-up increased to 46.84% and 50.00%, respectively. Frequencies of HIV drug resistance also decreased at the baseline, 6-months and 12-months, with ratios as 66.67%, 26.58% and 27.63% (χ² = 29.362, P = 0.000), respectively. Ratios of patients that holding NRTI and NNRTI drug resistance appeared coinstantaneous decrease at the baseline, 6-months and 12-months, as 51.85%, 18.99% and 17.11% (χ² = 14.230, P = 0.005). At the baseline, the ratios of patients resisted to 3TC, ABC and FTC were all more than 50%, with AZT, D4T and DDI between 41%-44% while TDF appeared as 33.33%, then all of them declined to 12%-18% at the 6-month and 12-month follow-up periods. 65.43% of the patients resisted to both NVP and EFV but declined to 24%-27% at 6 months and 12 months. HCV/HIV co-infected patients experienced virological failure of AIDS first-line therapy were ameliorated after changing to use second-line antiretroviral treatment for 6-months, but did not show constant positive effect at the 12-month end point.

COMPARATIVE EFFICIENCY AND TOLERABILITY OF CURRENT THERAPIES FOR EARLY RHEUMATOID ARTHRITIS

Objecti v e : to compare the efficiency and safety of four treatment regimens using methotrexate (MT), leflunomide (LEF), and a combination of MT and glucocorticoids (GC) for early rheumatoid arthritis (RA) (disease duration <2 years). Subjects and methods. 141 patients with early RA (of them there were 122 women; mean age 51 years; mean disease duration 7.8 months; mean DAS28 6.0) were randomized to 4 treatment groups: 1) MT 10–20 mg/week (n = 35); 2) MT 10–20 mg/week + oral GC equivalent to 10 mg/day of prednisolone (n = 34); 3) MT 10–20 mg/week + oral CG + single intravenous administration of methylprednisolone (MP) 1000 mg at baseline (n = 35); 4) LEF 20 mg/day (n = 37). The patients were matched for main clinical and demographic characteristics. The duration of treatment was 1 year. Its efficiency was evaluated according to the European League Against Rheumatism (EULAR) criteria. Results . 125 patients completed one-year treatment. At this time, 11.4% of the patients achieved remission (DAS28 <2.6) in the MT group, 37.5% in the MT+GC group, 29.4% in the MT+GC+MP group, and 16.2% in the LEF group. Adverse events, mainly of mild intensity, were recorded in 9 patients in each MT group. A total of 7 patients had to discontinue treatment because of its inefficiency. Conclusion. All the four therapy regimens demonstrated a significant efficiency in patients with early RA; the total remission rate was 24%. The combination of MT and GC produced the most pronounced effect. The tolerability of treatment was good in all groups.

Efficacy of pirfenidone for idiopathic pulmonary fibrosis: An Italian real life study

In this retrospective Italian study, which involved all major national interstitial lung diseases centers, we evaluated the effect of pirfenidone on disease progression in patients with IPF. We retrospectively studied 128 patients diagnosed with mild, moderate or severe IPF, and the decline in lung function monitored during the one-year treatment with pirfenidone was compared with the decline measured during the one-year pre-treatment period. At baseline (first pirfenidone prescription), the mean percentage forced vital capacity (FVC) was 75% (35-143%) of predicted, and the mean percentage diffuse lung capacity (DLCO) was 47% (17-120%) of predicted. Forty-eight patients (37.5%) had mild disease (GAP index stage I), 64 patients (50%) had moderate IPF (stage II), and 8 patients (6.3%) had severe disease (stage III). In the whole population, pirfenidone attenuated the decline in FVC (p = 0.065), but did not influence the decline in DLCO (p = 0.355) in comparison to the pre-treatment period. Stratification of patients into mild and severe disease groups based on %FVC level at baseline (>75% and ≤75%) revealed that attenuation of decline in FVC (p = 0.002) was more pronounced in second group of patients. Stratification of patients according to GAP index at baseline (stage I vs. II/III) also revealed that attenuation of decline in lung function was more pronounced in patients with more severe disease. In this national experience, pirfenidone reduced the rate of annual FVC decline (p = 0.065). Since pirfenidone provided significant treatment benefit for patients with moderate-severe disease, our results suggest that the drug may also be effective in patients with more advanced disease.

Observing the determinants of the psychotherapeutic process in depressive disorders. A clinical case study within a psychodynamic approach.

This paper focuses on the relationship between depressive disorders, personality configurations, and mental functioning. A one-year treatment of a young man with the diagnosis of Depression is presented: the clinical and empirical points of view are described in depth through an assessment at the beginning and at one year after of an oriented psychodynamic psychotherapy. SCID I and II and HAMRS were administered to the patient in assessment phase. In the same phase he filled in BDI-II, and DEQ; the psychotherapist completed SWAP-200. These clinician instruments were used again after 1 year of the treatment. The PDM point of view is also presented. All sessions are audiotaped: 12 verbatim transcripts were coded with the Defense Mechanisms Rating Scale and CCRT. The results show a decrease in depressive symptoms, a change in some personality configurations, but a substantial invariance of the introjective profile, and a modification in mental functioning.

Long-term effect of molsidomine, a direct nitric oxide donor, as an add-on treatment, on endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: Results of the MEDCOR trial

ObjectiveThe MEDCOR trial is a double-blind, randomized study aiming at demonstrating the superiority of molsidomine (direct NO donor) over placebo, used as add-on treatments, on improving endothelial function (EF) after 12 months, in stable angina patients undergoing percutaneous coronary intervention. MethodsEF was assessed by peripheral vasodilator response (i.e. Endoscore) using arterial tonometry and by several biomarkers, in terms of changes versus baseline after a one-year treatment. ResultsThe change in Endoscore was +75 ± 130% in placebo group and +39 ± 145% in molsidomine group (p = 0.143). There was a decrease in sICAM-1 with molsidomine (−6%) and an increase with placebo (+6%). The MPO activity/antigen ratio slightly increased with placebo (+9%) and strongly decreased with molsidomine (−42%) (p = 0.020). ConclusionThe MEDCOR trial was not able to demonstrate significant differences between molsidomine and placebo for all parameters, except the MPO activity/antigen ratio which significantly decreased with molsidomine (p = 0.020 versus placebo).

MP26-18 MULTI-ISTITUTIONAL CONTROLLED STUDIES DO NO REFLECT THE PATIENT'S COMPLIANCE TO BCG ENCOUNTERED IN CLINICAL PRACTICE. RESULTS ON 411 PATIENTS

You have accessJournal of UrologyBladder Cancer: Non-invasive I1 Apr 2015MP26-18 MULTI-ISTITUTIONAL CONTROLLED STUDIES DO NO REFLECT THE PATIENT'S COMPLIANCE TO BCG ENCOUNTERED IN CLINICAL PRACTICE. RESULTS ON 411 PATIENTS Vincenzo Serretta, Cristina Scalici Gesolfo, Vincenza Alonge, Fabrizio Di Maida, Lorenzo Rocchini, Marco Moschini, Andrea Gallina, and Renzo Colombo Vincenzo SerrettaVincenzo Serretta More articles by this author , Cristina Scalici GesolfoCristina Scalici Gesolfo More articles by this author , Vincenza AlongeVincenza Alonge More articles by this author , Fabrizio Di MaidaFabrizio Di Maida More articles by this author , Lorenzo RocchiniLorenzo Rocchini More articles by this author , Marco MoschiniMarco Moschini More articles by this author , Andrea GallinaAndrea Gallina More articles by this author , and Renzo ColomboRenzo Colombo More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1140AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES BCG maintenance for at least one year is advocated by urological guidelines as the best intravesical regimen in high-risk non muscle invasive bladder cancer (NMIBC), conservatively treated. Noteworthy, a relevant percentage of patients does not complete the planned treatment. The aim of this study was to analyze the reasons for treatment interruption and low compliance. METHODS Consecutive patients affected by T1HG NMIBC undergoing conservative management with adjuvant BCG entered the study. The Connaught BCG strain was administered intravesically according to the South West Oncology Group schedule for one year, 81mg diluted in 50 ml of saline solution, starting 21-30 days after TUR. Toxicity and causes of treatment interruption were recorded. RESULTS Between 2000 and 2012, intravesical BCG with 1-year maintenance regimen was proposed to 411 patients. Out of them, 380 (92,5%) completed the induction cycle and 308 (81%) started the maintenance. A total of 215 (52.3%) completed the scheduled one-year treatment. Toxicity requiring treatment interruption was recorded in 25 (6.1%) patients only. In 60 patients (14.6%) a delay of one or more instillations was necessary. Grade-I toxicity, not requiring therapy interruption or delay, was recorded in 193 (46.9%) cases. In our experience, the patient's compliance registered during the induction cycle reached 92%, confirming the low toxicity and the good patients' acceptance of the 6-week induction. However, between the end of the induction course and the first maintenance instillation, 50 patients (13%) became reluctant to treatment for many personal reasons unrelated to toxicity and 22 (6%) were excluded for suspicious bladder lesion at cystoscopy. Moreover, patients' compliance to maintenance decreased from 81% at 3 months to 56.6% at 12 months. Surprisingly, the rate of drop-out (15%) remained stable at 6 and 12 months. Mild toxicity and social discomfort were the mean reasons for dropout during maintenance (60%). CONCLUSIONS Severe toxicity caused BCG interruption in a limited amount of cases. Almost 60% of treatment interruptions was attributable to low grade toxicity, inadequately considered by the urologists. The personal difficulties related to the prolonged treatment and the limited patients' awareness of the therapeutic value of maintenance were other important reasons. A structured periodical counseling and a timely recognition and therapy of mild but persistent symptoms, might significantly ameliorate patients' acceptance of BCG maintenance. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e300 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Vincenzo Serretta More articles by this author Cristina Scalici Gesolfo More articles by this author Vincenza Alonge More articles by this author Fabrizio Di Maida More articles by this author Lorenzo Rocchini More articles by this author Marco Moschini More articles by this author Andrea Gallina More articles by this author Renzo Colombo More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Effect of one-year post-operative alendronate treatment on periprosthetic bone after total knee arthroplasty. A seven-year randomised controlled trial of 26 patients.

Total knee arthroplasty (TKA) is known to lead to a reduction in periprosthetic bone mineral density (BMD). In theory, this may lead to migration, instability and aseptic loosening of the prosthetic components. Bisphosphonates inhibit bone resorption and may reduce this loss in BMD. We hypothesised that treatment with bisphosphonates and calcium would lead to improved BMD and clinical outcomes compared with treatment with calcium supplementation alone following TKA. A total of 26 patients, (nine male and 17 female, mean age 67 years) were prospectively randomised into two study groups: alendronate and calcium (bisphosphonate group, n = 14) or calcium only (control group, n = 12). Dual energy X-ray absorptiometry (DEXA) measurements were performed post-operatively, and at three months, six months, one, two, four, and seven years post-operatively. Mean femoral metaphyseal BMD was significantly higher in the bisphosphonate group compared with controls, up to four years following surgery in some areas of the femur (p = 0.045). BMD was observed to increase in the lateral tibial metaphysis in the bisphosphonate group until seven years (p = 0.002), and was significantly higher than that observed in the control group throughout (p = 0.024). There were no significant differences between the groups in the central femoral metaphyseal, tibial medial metaphyseal or diaphyseal regions of interest (ROI) of either the femur or tibia. Bisphosphonate treatment after TKA may be of benefit for patients with poor bone quality. However, further studies with a larger number of patients are necessary to assess whether this is clinically beneficial.

Impaction of health education with PDCA model combined with ABC management on compliance and quality of life in patients with ovarian cancer chemotherapy

Objective To investigate the impaction of health education with PDCA model combined with ABC management on compliance and quality of life in patients with ovarian cancer chemotherapy. Methods Totals of 124 ovarian cancer patients were selected from May 2011 to December 2013 in our hospital. Patients were randomly divided into observation group and control group, with 62 cases in each group. The control group was given general health education, and the observation group was treated by PDCA model combined with ABC management. The compliance, quality of life and treatment satisfaction were compared between the two groups. Results In the observation group, the medication compliance, nutritional support, functional training and rehabilitation of compliance were significantly better than those in the control group (χ2=8.382, 7.225, 7.314, 10.098, respectively; P 0.05). After one-year treatment, the score of quality of life was (66.75±5.42) in the observation group and (49.55±5.17) in the control group. The difference was statistically significant (t=9.251, P<0.05). The satisfaction score in the observation group was (91.35±3.48) and (63.53±4.12) in the control group. The difference was statistically significant (t=11.521, P<0.05). Conclusions The health education with PDCA model combined with ABC management can improve the quality of life in patients with ovarian cancer. It can also strengthen the cooperation between nurses and patients, so that patients′ satisfaction is improved. Key words: Ovarian cancer; Health education; Quality of life; Compliance; PDCA model; ABC management

One-year treatment with liraglutide improved renal function in patients with type 2 diabetes: a pilot prospective study.

Unlike GLP-1, liraglutide is not cleared by the glomerulus and its pharmacokinetic is not altered in patients with mild renal impairment. The aim of our study was to analyze the effects of liraglutide on renal function in patients with type 2 diabetes. A twelve-month longitudinal prospective post-marketing study was performed. According to eGFR (estimated glomerular filtration rate) calculated with CKD-EPI equation, 84 consecutive patients were divided in Group A (eGFR > 90 ml/min) and Group B (eGFR < 90 ml/min). BMI, glucose, HbA1c, serum creatinine, microalbuminuria, and eGFR were evaluated at baseline and after 12 months of treatment. A reduction in fasting plasma glucose (p < 0.01), HbA1c (p < 0.003), BMI (p < 0.01), and systolic (p < 0.01) and diastolic blood pressure (p < 0.006) was recorded irrespective of eGFR category. Concerning renal function, creatinine levels had a trend to decrease in both groups. eGFR did not change in Group A, while it increased in Group B (p < 0.05) independently from the concomitant changes of other parameters. Moreover, seven out of 41 patients of Group B had increased eGFR levels which reached the normal values (>90 ml/min). At baseline, five patients had pathological microalbuminuria, but at 12 months three of them returned to normal albuminuria (p < 0.006). Total microalbuminuria levels improved in both groups (p < 0.02). According to preliminary data in animals, our study shows that liraglutide is effective in preserving eGFR in diabetic patients, increasing it in those with reduced renal function. This was associated with a decrease of frequency of patients positive to microalbuminuria. Further studies are needed to confirm these data.

Low persistence of simvastatin and ezetimibe fixed combination in the lipid lowering therapy

The high cholesterol level is a well-known modifiable cardiovascular risk factor. Adequate patient adherence is important to decrease the cardiovascular risk. The aim of the authors was to evaluate the persistence on one-year treatment with the free or fixed combination of simvastatin and ezetimibe and rosuvastatin. Information from the National Health Insurance Found prescriptions database on pharmacy-claims between October 1, 2012 and September 30, 2013 was analyzed. The authors identified patients who filled prescriptions for fixed or free combinations of simvastatin and ezetimibe and rosuvastatin prescribed for the first time. The subjects have not received antilipemic therapy with similar drugs during the year preceding the study. Using Kaplan-Meier technique, the authors constructed persistence curves with a 95% confidence interval for point estimates calculated on a log scale. Patients who were still persistent at the closing date of the study were considered censored. For the modelling of the curves, the authors used semi-parametric Cox's regression where antihypertensive therapy was the only (categorical) explanatory variable, and the patients taking the fixed combination of simvastatin and ezetimibe were regarded as the reference group. 204,699 patients met the inclusion criteria. During the study period, antilipemic therapy with simvastatin and ezetimibe free combination 10,030 and 7,613 fixed combination of these agents and 187,056 patients with rosuvastatin was started by patients. One-year persistence rate in patients taking simvastatin and ezetimibe as a free combination was 10.97%, whereas it was 24.35% in those on the fixed combination and 30.47% in those on rosuvastatin monotherapy. The hazard ratio of discontinuation of simvastatin and ezetimibe free combination was 1.73 [95% confidence interval: 1.61-1.85], p<0.0001 compared to fixed combination and 0.80 [95% confidence interval: 0.78-0.82], p<0.0001 compared to rosuvastatin. Considering only the 360-day study period, the mean duration of persistence was 107 days in patients on the free, 164 days in those taking the free combination of simvastatin and ezetimibe and 185 days those taking rosuvastatin. This study demonstrated that one-year persistence of free and fixed combination of simvastatin and ezetimibe was significantly lower compared to rosuvastatin.

Kushenin Combined with Nucleos(t)ide Analogues for Chronic Hepatitis B: A Systematic Review and Meta-Analysis.

Objective. To evaluate the efficacy and safety of Kushenin (KS) combined with nucleoside analogues (NAs) for chronic hepatitis B (CHB). Methods. Randomized controlled trials (RCTs) of KS combined with NAs for CHB were identified through 7 databases. Frequencies of loss of serum HBeAg, HBeAg seroconversion, undetectable serum HBV-DNA, ALT normalization, and adverse events at 48 weeks were abstracted by two reviewers. The Cochrane software was performed to assess the risk of bias in the included trials. Data were analyzed with Review Manager 5.3 software. Results. 18 RCTs involving 1684 subjects with CHB were included in the analysis. KS combined with NAs including lamivudine (LAM), entecavir (ETV), adefovir dipivoxil (ADV), and telbivudine (TLV) showed different degree of improvement in CHB indices. KS combined with NAs increased the frequency of loss of serum HBeAg, HBeAg seroconversion, undetectable HBV-DNA levels, and ALT normalization compared with single agents. It also decreased serum ALT and AST level after one-year treatment. However, KS combined with TLV did not show a significant difference in CHB indices. The side-effects of KS combined with NAs were light and of low frequency. Conclusion. KS combined with NAs improves the efficacy of NAs in CHB.