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1.
Background
In the context of improving perioperative pain management and shortening hospital stays, potent oral analgesics, such as slow release opioids, are gaining increasingly in importance.Objective
The aim of this study was to compare the use and effectiveness of different opioids in postoperative pain treatment in Germany.Materials and methods
Using data from the QUIPS database, the records of 5249 patients were evaluated. The total study population was divided into four groups: group 1 (10?mg oxycodone with or without naloxone 5?mg), group 2 (20?mg oxycodone with or without naloxone 10?mg), group 3 (piritramide) and group 4 (tramadol). Maximum pain intensity, pain-related interference with sleep and respiration, vomiting, postoperative fatigue, desire for more pain treatment and satisfaction with pain management were evaluated.Results and discussion
The differences in pain intensity were statistically significant between groups. Patients with piritramide reported more pain, more interference with sleep and respiration and more fatigue compared to those from the other groups. In the group with 10?mg oxycodone, the desire for additional pain medication was the lowest. Postoperative vomiting and satisfaction with pain management differed significantly between the four groups. Procedure-specific analysis has shown that differences between sub-groups were also significant following cholecystectomy and total knee arthroplasty.Conclusions
In summary, our findings suggest that postoperative pain treatment with slow release oral oxycodone does not show disadvantages compared to tramadol or piritramide with regard to pain-related impairments and opioid-induced side effects. This hypothesis needs to be further analyzed in controlled studies.2.
Merja Kokki Moona Kuronen Toivo Naaranlahti Timo Nyyssönen Ira Pikkarainen Sakari Savolainen Hannu Kokki 《Advances in therapy》2017,34(1):236-251
Introduction
Opioids are needed for postoperative pain in spine surgery patients, but opioid-induced constipation is a harmful adverse event. The aim of this clinical trial was to compare the use of a controlled-release oxycodone-naloxone combination product with oxycodone controlled-release tablets in these patients. The main outcome measure was the prevalence of constipation at 7 days postoperatively assessed with a Bowel Function Index questionnaire. A follow-up assessment at 21 days after surgery was also included.Methods
A total of 180 patients undergoing spine surgery, 91 having preoperative opioids in use and 89 opioid-naïve, were randomized to receive twice-daily oxycodone 10 mg or oxycodone-naloxone 10/5 mg controlled-release tablets for the first 7 postoperative days. Patients were followed-up for 21 days after surgery.Results
At baseline, prevalence of constipation was common both in the opioid-naïve—25/87 (29%) and on-opioid groups 43/90 (48%) (P = 0.009). This increased at 7 days postoperatively with no difference between the groups, 54/89 with oxycodone and 54/88 with oxycodone-naloxone had constipation. At 21 days, constipation was less than in the baseline in both groups, in the opioid-naïve group the prevalence of constipation was 3/43 (7%) in patients with oxycodone-naloxone compared to 9/44 (21%) with oxycodone (effect size 0.68; P = 0.068). Both study compounds provided similar pain relief and were well tolerated.Conclusion
In patients presented for back surgery, the prevalence of constipation was significantly higher than that in the community. In opioid-naïve subjects, oxycodone-naloxone was beneficial concerning constipation; but this was not distinguishable in subjects with chronic opioid use. The analgesic efficacy of oxycodone and oxycodone-naloxone was similar. Trial registration: European Clinical Trials Database (EudraCT no. 2012-001816-42) and ClinicalTrials.gov database (Identifier: NCT02573922).3.
Manuel Dómine Gómez Nieves Díaz Fernández Blanca Cantos Sánchez de Ibargüen Luis Zugazabeitia Olabarría Joaquina Martínez Lozano Raúl Poza de Celis Rafael Trujillo Vílchez Ignacio Peláez Fernández Jaume Capdevila Castillón Susana Traseira Lugilde Emilio Esteban González 《Advances in therapy》2017,34(1):136-147
Introduction
Bone metastasis is the most common cause of cancer-related pain, and metastatic bone pain (MBP) is not only severe but also progressive in many patients. The aim of this study was to investigate the association between pain management and performance status in patients with metastatic bone cancer in the Spanish clinical setting.Methods
A 3-month follow-up prospective, epidemiologic, multicenter study was conducted in 579 patients to assess the evolution of their performance, the impact of pain control on sleep and functionality, and the degree of pain control according to analgesic treatment.Results
In patients with MBP, Eastern Cooperative Oncology Group (ECOG) status (1.5 ± 0.7–1.3 ± 0.7 and 1.3 ± 0.8; p < 0.001) and pain (6.5 ± 1.4–2.8 ± 1.9 and 2.1 ± 1.9; p < 0.001) improved significantly from baseline to months 1 and 3, as did functionality and sleep, after a treatment change consisting of increasing the administration of opioids. Evolution of ECOG and pain were closely related. ECOG and pain outcomes were significantly more favorable in patients treated with opioids versus non-opioid treatment, and in patients who did not need rescue medication versus those who did.Conclusions
MBP is currently poorly managed in Spain. ECOG improvement is closely and directly related to pain management in MBP. Opioid treatment and a lack of requirements for rescue medication are associated with better ECOG and pain outcomes in MBP patients.Funding
Mundipharma Pharmaceuticals S.L.4.
Ryan N. Hansen An Pham Scott A. Strassels Stela Balaban George J. Wan 《Advances in therapy》2016,33(9):1635-1645
Introduction
Recovery from orthopedic surgery is oriented towards restoring functional health outcomes while reducing hospital length of stay (LOS) and medical expenditures. Optimal pain management is a key to reaching these objectives. We sought to compare orthopedic surgery patients who received combination intravenous (IV) acetaminophen and IV opioid analgesia to those who received IV opioids alone and compared the two groups on LOS and hospitalization costs.Methods
We performed a retrospective analysis of the Premier Database (Premier, Inc.; between January 2009 and June 2015) comparing orthopedic surgery patients who received post-operative pain management with combination IV acetaminophen and IV opioids to those who received only IV opioids starting on the day of surgery and continuing up to the second post-operative day. The quarterly rate of IV acetaminophen use for all hospitalizations by hospital served as the instrumental variable in two-stage least squares regressions controlling for patient and hospital covariates to compare the LOS and hospitalization costs of IV acetaminophen recipients to opioid monotherapy patients.Results
We identified 4,85,895 orthopedic surgery patients with 1,74,805 (36%) who had received IV acetaminophen. Study subjects averaged 64 years of age and were predominantly non-Hispanic Caucasians (78%) and female (58%). The mean unadjusted LOS for IV acetaminophen patients was 3.2 days [standard deviation (SD) 2.6] compared to 3.9 days (SD 3.9) with only IV opioids (P < 0.0001). Average unadjusted hospitalization costs were $19,024.9 (SD $13,113.7) for IV acetaminophen patients and $19,927.6 (SD $19,578.8) for IV opioid patients (P < 0.0001). These differences remained statistically significant in our instrumental variable models, with IV acetaminophen associated with 0.51 days shorter hospitalization [95% confidence interval (CI) ?0.58 to ?0.44, P < 0.0001] and $634.8 lower hospitalization costs (95% CI ?$1032.5 to ?$237.1, P = 0.0018).Conclusion
Compared to opioids alone, managing post-orthopedic surgery pain with the addition of IV acetaminophen is associated with shorter LOS and decreased hospitalization costs.Funding
Mallinckrodt Pharmaceuticals.5.
Sebastiano Mercadante Paolo Marchetti Arturo Cuomo Augusto Caraceni Rocco Domenico Mediati Massimo Mammucari Silvia Natoli Marzia Lazzari Mario Dauri Mario Airoldi Giuseppe Azzarello Mauro Bandera Livio Blasi Giacomo Cartenì Bruno Chiurazzi Benedetta Veruska Pierpaola Costanzo Daniela Degiovanni Flavio Fusco Vittorio Guardamagna Vincenzo Iaffaioli Simeone Liguori Vito Lorusso Sergio Mameli Rodolfo Mattioli Teresita Mazzei Rita Maria Melotti Valentino Menardo Danilo Miotti Stefano Moroso Stefano De Santis Remo Orsetti Alfonso Papa Sergio Ricci Alessandro Fabrizio Sabato Elvira Scelzi Michele Sofia Giuseppe Tonini Federica Aielli Alessandro Valle On behalf of the IOPS MS study group 《Advances in therapy》2017,34(1):120-135
Introduction
An ongoing national multicenter survey [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] is evaluating the characteristics of breakthrough cancer pain (BTP) in different clinical settings. Preliminary data from the first 1500 cancer patients with BTP enrolled in this study are presented here.Methods
Thirty-two clinical centers are involved in the survey. A diagnosis of BTP was performed by a standard algorithm. Epidemiological data, Karnofsky index, stage of disease, presence and sites of metastases, ongoing oncologic treatment, and characteristics of background pain and BTP and their treatments were recorded. Background pain and BTP intensity were measured. Patients were also questioned about BTP predictability, BTP onset (≤10 or >10 min), BTP duration, background and BTP medications and their doses, time to meaningful pain relief after BTP medication, and satisfaction with BTP medication. The occurrence of adverse reactions was also assessed, as well as mucosal toxicity.Results
Background pain was well controlled with opioid treatment (numerical rating scale 3.0 ± 1.1). Patients reported 2.5 ± 1.6 BTP episodes/day with a mean intensity of 7.5 ± 1.4 and duration of 43 ± 40 min; 977 patients (65.1%) reported non-predictable BTP, and 1076 patients (71.7%) reported a rapid onset of BTP (≤10 min). Higher patient satisfaction was reported by patients treated with fast onset opioids.Conclusions
These preliminary data underline that the standard algorithm used is a valid tool for a proper diagnosis of BTP in cancer patients. Moreover, rapid relief of pain is crucial for patients’ satisfaction. The final IOPS-MS data are necessary to understand relationships between BTP characteristics and other clinical variables in oncologic patients.Funding
Molteni Farmaceutici, Italy.6.
Jiun-Cheng Hsu Po-Han Chen Kuo-Chin Huang Yao-Hung Tsai Wei-Hsiu Hsu 《Journal of Medical Ultrasonics》2017,44(4):297-303
Purpose
The gray-level histogram of ultrasound is a promising tool for scanning the hypoechogenic appearance of supraspinatus tendinopathy, and the aim of this study was to test the hypothesis that the gray-level value of the supraspinatus tendon in the painful shoulder has a lower value on B-mode images even though in different ultrasound devices.Methods
Sixty-seven patients who had unilateral shoulder pain with rotator cuff tendinopathy underwent bilateral shoulder ultrasonography, and we compared the mean gray-level values of painful shoulders and contralateral shoulders without any pain in each patient using two ultrasound devices. The echogenicity ratio (symptomatic/asymptomatic side) of two ultrasound devices was compared.Results
A significant difference existed between the symptomatic shoulder and contralateral asymptomatic shoulder (p < 0.001) on the mean gray-level value measurements of each device. The symptomatic-to-asymptomatic tendon echogenicity ratio of device A was 0.919 ± 0.090 in the transverse plane and 0.937 ± 0.081 in the longitudinal plane, and the echogenicity ratio of device B was 0.899 ± 0.113 in the transverse plane and 0.940 ± 0.113 in the longitudinal plane.Conclusions
The decline of the mean gray-level value and the echogenicity ratio of the supraspinatus tendon in the painful shoulder may be utilized as a useful sonographic reference of unilateral rotator cuff lesions.Level of evidence
Diagnostic level III.7.
Maria?Glezer 《Advances in therapy》2018,35(7):1103-1113
Introduction
Trimetazidine (TMZ) has been shown to reduce angina symptoms and to increase exercise capacity in randomized clinical trials, but more extensive data would be useful to assess its effects in real-world clinical practice and in patients with different durations of disease.Methods
CHOICE-2 was a Russian, multicenter, 6-month, open-label, prospective observational study that assessed the effect of adding TMZ modified release 35 mg bid to antianginal treatment in a real-world setting. The present analysis of CHOICE-2 results explored the effects of adding TMZ to background antianginal therapies with regard to the duration of stable angina.Results
A total of 741 patients with known durations of disease were divided into four groups according to stable angina pectoris (AP) duration, ranging from less than 1 year to more than 9 years. Addition of TMZ led to a significant decrease in the frequency of angina attacks and in the use of short-acting nitrates in all groups. In patients with recently diagnosed angina (AP duration < 1 year), the average number of angina attacks per week decreased significantly from 3.75 ± 4.63 to 0.67 ± 1.51 and in those with advanced disease (AP duration > 9 years) from 5.63 ± 5.24 to 1.32 ± 2.07. Angina-free walking distance also improved significantly. Addition of TMZ also improved patient well-being. Results were achieved rapidly (within 2 weeks), were maintained over 6 months, and were obtained in all patient groups regardless of angina duration.Conclusion
TMZ added to other antianginal therapies proved to be effective for reducing angina attacks and short-acting nitrate use, increasing angina-free walking distance, and improving patient well-being in a real-life setting, irrespective of angina duration, including patients with recently diagnosed angina. This provides an opportunity for intensification of treatment early on in the disease process, with the aim of decreasing angina burden and improving patient quality of life.Funding
Servier.Trial Registration
ISRCTN identifier ISRCTN65209863.Plain Language Summary
Plain language summary available for this article.8.
Introduction
To present short-term safety and efficacy data of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) treated with Aquablation.Methods
Men with LUTs secondary to BPH (60–150 cc) underwent Aquablation treatment from February 2016 to December 2017 across 17 investigational sites in the USA from two contemporary investigational device exemption (IDE) studies called WATER (NCT02505919) and WATER II (NCT03123250).Results
One hundred seven males with mean age of 67.3?±?6.5 years were treated with Aquablation; mean prostate volume was 99.4?±?24.1 cc. The pooled results show that large prostates have an average procedure time of less than 36 min and discharge on average 1.6?±?1 days. The IPSS decreased by 16.7?±?8.1 points at 3 months and Qmax increased by 11.2?±?12.4 ml/s. The Clavien-Dindo (CD) grade 2 or higher event rate at 3 months was 29%. A non-hierarchical breakdown for CD events yielded 18% grade 2 and 19% grade 3 or higher.Conclusion
Men with LUTS secondary to BPH (60–150 cc) in a pooled analysis were treated safely and effectively with Aquablation up to 3 months postoperatively.Trial Registration
ClinicalTrials.gov identifiers, NCT02505919 and NCT03123250.Funding
PROCEPT BioRobotics.9.
Purpose
The use of receptor-targeted antibodies conjugated to photosensitizers is actively being explored to enhance treatment efficacy. To facilitate clinical testing, we evaluated cetuximab conjugated to IRDye700DX (IR700) in cynomolgus macaques.Procedures
Total IR700 and intact cetuximab-IR700 were measured in 51 tissues at 2 and 14 days after intravenous injection of 40 and 80 mg/kg cetuximab-IR700, respectively, and compared with an unlabeled cetuximab-dosed control group (two each per sex per time point per group).Results
The IR700 retrieved from all tissues at 2 and 14 days after dosing was estimated at 34.9?±?1.8 and 2.53?±?0.67 % of the total dose, respectively. The tissues with the highest levels of intact cetuximab-IR700 at 2 days after dosing were the blood, lung, and skin. Formalin-fixed paraffin-embedded tissue sections at 2 days after dosing showed the highest IR700 signals in the axillary lymph node, mammary gland, and gall bladder.Conclusions
Both IR700 and intact cetuximab-IR700 biodistributions were consistent with known epidermal growth factor receptor (EGFR) expression, and changes between 2 and 14 days were consistent with rapid metabolism and excretion of the cetuximab-IR700.10.
Susanne V. Fleig Bettina Weger Hermann Haller Florian P. Limbourg 《Advances in therapy》2018,35(3):353-366
Introduction
We conducted a prospective, non-interventional, multicenter study to examine the effect of a fixed-dose combination of perindopril/amlodipine in patients with arterial hypertension.Methods
Patients who were previously untreated or required a change in medication were treated with a fixed combination of perindopril/amlodipine (3.5/2.5 or 7.0/5.0 mg) for 12 weeks. Changes in office, home and ambulatory blood pressure (BP) were recorded. Adherence was assessed by the Hill-Bone medication adherence scale.Results
Overall, 1814 patients (mean age 60.0 ± 13.4 years) were included in 614 German practices, and data of 1770 patients were analyzed. At study entry, 97.7% of patients received perindopril/amlodipine at a daily dose of 3.5 mg/2.5 mg, and 47.9% of patients remained on this dose during the study period. Treatment with perindopril/amlodipine decreased mean office BP from 163.7/95.4 to 133.6/80.3 mmHg (p < 0.0001), resulting in a hypertension control rate of 69.1%. Blood pressure control was comparable in previously untreated and treated patients (70.3 vs. 68.1%), and in younger and older patients (70.6 < 65 vs. 66.3% ≥ 65 years). Ambulatory BP measurements were available in a subgroup of patients (n = 167), and mean 24 h ambulatory BP decreased from 150.6 ± 12.6/88.9 ± 8.8 to 132.4 ± 11.9/79.4 ± 8.5 mmHg (p < 0.0001). Furthermore, the proportion of patients with severe hypertension European Society of Hypertension/European Society of Cardiology (ESH/ESC) grade II or III decreased from 64.4 to 3.9%, and patients with pre-existing isolated systolic hypertension (n = 284) converted to normal BP in 67.6% of cases. Nearly half of the patients (47.2%) were perfectly adherent during the study. In previously treated patients, the percentage of patients with perfect adherence increased from 20.6% prior to study to 43.5% at final visit (p < 0.0001). Adverse drug reactions were documented for 4.9% of patients.Conclusion
A fixed-dose combination of perindopril/amlodipine shows significant blood pressure reduction and improvement in medication adherence in a primary care setting.Trial Registration
ISRCTN26323538.Funding
Servier Deutschland GmbH.11.
Jae Yong Choi Chul Hyoung Lyoo Jae Hoon Lee Hanna Cho Kyeong Min Kim Jin Su Kim Young Hoon Ryu 《Molecular imaging and biology》2016,18(4):479-482
Purpose
[18F]AV-1451 is a positron emission tomography (PET) radioligand for detecting paired helical filament tau. Our aim was to estimate the radiation dose of [18F]AV-1451 in humans.Procedures
Whole-body PET scans were acquired for six healthy volunteers (three male, three female) for 128 min after injection of [18F]AV-1451 (268?±?31 MBq). Radiation doses were estimated using the OLINDA/EXM software.Results
The estimated organ doses ranged from 7.81 to 81.2 μSv/MBq. The critical organ for radiation burden was the liver. Radiation doses to the reproductive and blood-forming organs were 14.15, 8.43, and 18.35 μSv/MBq for the ovaries, testes, and red marrow, respectively. The mean effective dose was 22.47?±?3.59 μSv/MBq.Conclusions
A standard single injection of 185 MBq (5 mCi) results in an effective dose of 4.7 mSv in a healthy subject. Therefore, [18F]AV-1451 could be used in multiple PET scans of the same subject per year.12.
A. Craig Lockhart Yongjian Liu Farrokh Dehdashti Richard Laforest Joel Picus Jennifer Frye Lauren Trull Stefanie Belanger Madhuri Desai Syed Mahmood Jeanne Mendell Michael J. Welch Barry A. Siegel 《Molecular imaging and biology》2016,18(3):446-453
Purpose
The purpose of this study was to evaluate the safety, dosimetry, and apparent receptor occupancy (RO) of [64Cu]DOTA-patritumab, a radiolabeled monoclonal antibody directed against HER3/ERBB3 in subjects with advanced solid tumors.Procedures
Dosimetry subjects (n?=?5) received [64Cu]DOTA-patritumab and underwent positron emission tomography (PET)/X-ray computed tomography (CT) at 3, 24, and 48 h. Evaluable RO subjects (n?=?3 out of 6) received [64Cu]DOTA-patritumab at day 1 and day 8 (after 9.0 mg/kg patritumab) followed by PET/CT at 24 h post-injection. Endpoints included safety, tumor uptake, and efficacy.Results
The tumor SUVmax (±?SD) was 5.6?±?4.5, 3.3?±?1.7, and 3.0?±?1.1 at 3, 24, and 48 h in dosimetry subjects. The effective dose and critical organ dose (liver) averaged 0.044?±?0.008 mSv/MBq and 0.46?±?0.086 mGy/MBq, respectively. In RO subjects, tumor-to-blood ratio decreased from 1.00?±?0.32 at baseline to 0.57?±?0.17 after stable patritumab, corresponding to a RO of 42.1?±?3.Conclusions
[64Cu]DOTA-patritumab was safe. These limited results suggest that this PET-based method can be used to determine tumor-apparent RO.13.
Frerichs I Schiffmann H Oehler R Dudykevych T Hahn G Hinz J Hellige G 《Intensive care medicine》2003,29(5):787-794
Objective
The aim of our study was to determine the effect of the irregular spontaneous breathing pattern and posture on the spatial distribution of ventilation in neonates free from respiratory disease by the non-invasive imaging method of electrical impedance tomography (EIT). Scanning of spontaneously breathing neonates is the prerequisite for later routine application of EIT in babies with lung pathology undergoing ventilator therapy.Design
Prospective study.Setting
Neonatal intensive care unit at a university hospital.Patients
Twelve pre-term and term neonates (mean age: 23 days; mean body weight: 2,465 g; mean gestational age: 34 weeks; mean birth weight: 2,040 g).Interventions
Change in body position in the sequence: supine, right lateral, prone, supine.Measurements and results
EIT measurements were performed using the Göttingen GoeMF I system. EIT scans of regional lung ventilation showing the distribution of respired air in the chest cross-section were generated during phases of rapid tidal breathing and deep breaths. During tidal breathing, 54.5±8.3%, 55.2±10.5%, 59.9±8.4% and 54.2±8.5% of inspired air (mean values ± SD) were directed into the right lung in the supine, right lateral, prone and repeated supine postures respectively. During deep inspirations, the right lung ventilation accounted for 52.6±7.9%, 68.5±8.5%, 55.4±8.2% and 50.5±6.6% of total ventilation respectively.Conclusion
The study identified the significant effect of breathing pattern and posture on the spatial distribution of lung ventilation in spontaneously breathing neonates. The results demonstrate that changes in regional ventilation can easily be determined by EIT and bode well for the future use of this method in paediatric intensive care.14.
Automatic adjustment of pressure support by a computer-driven knowledge-based system during noninvasive ventilation: a feasibility study 总被引:1,自引:1,他引:0
Objective
To evaluate the feasibility of using a knowledge-based system designed to automatically titrate pressure support (PS) to maintain the patient in a “respiratory comfort zone” during noninvasive ventilation (NIV) in patients with acute respiratory failure.Design and setting
Prospective crossover interventional study in an intensive care unit of a university hospital.Patients
Twenty patients.Interventions
After initial NIV setting and startup in conventional PS by the chest physiotherapist NIV was continued for 45?min with the automated PS activated.Measurements and results
During automated PS minute-volume was maintained constant while respiratory rate decreased significantly from its pre-NIV value (20?±?3 vs. 25?±?3?bpm). There was a trend towards a progressive lowering of dyspnea. In hypercapnic patients PaCO2 decreased significantly from 61?±?9 to 51?±?2?mmHg, and pH increased significantly from 7.31?±?0.05 to 7.35?±?0.03. Automated PS was well tolerated. Two system malfunctions occurred prompting physiotherapist intervention.Conclusions
The results of this feasibility study suggest that the system can be used during NIV in patients with acute respiratory failure. Further studies should now determine whether it can improve patient-ventilator interaction and reduce caregiver workload.15.
N. López-Vilanova J. Pavía M. A. Duch A. Catafau D. Ros S. Bullich 《Molecular imaging and biology》2017,19(2):305-314
Purpose
Human dosimetry studies play a central role in radioligand development for positron emission tomography (PET). Drawing regions of interest (ROIs) on the PET images is used to measure the dose in each organ. In the study aspects related to ROI delineation methods were evaluated for two radioligands of different biodistribution (intestinal vs urinary).Procedures
PET images were simulated from a human voxel-based phantom. Several ROI delineation methods were tested: antero-posterior projections (AP), 3D sub-samples of the organs (S), and a 3D volume covering the whole-organ (W). Inter- and intra-operator variability ROI drawing was evaluated by using human data.Results
The effective dose estimates using S and W methods were comparable to the true values. AP methods overestimated (49 %) the dose for the radioligand with intestinal biodistribution. Moreover, the AP method showed the highest inter-operator variability: 11 ± 1 %.Conclusions
The sub-sampled organ method showed the best balance between quantitative accuracy and inter- and intra-operator variability.16.
Introduction
Sclerotherapy is a common technique for the removal of intradermal veins. This study examined the rationale for prescribing micronized purified flavonoid fraction (MPFF) in clinical, etiological, anatomic, pathophysiologic (CEAP) class C1 patients with dilated intradermal veins scheduled for sclerotherapy.Methods
In a national, multicenter, observational program, physicians recruited CEAP C1s patients scheduled for sclerotherapy. The decision to prescribe adjuvant MPFF (1000 mg/day for 6 weeks beginning 2 weeks before sclerotherapy) was made according to usual practice. Disease severity and treatment outcomes were assessed at baseline and 4 weeks post-sclerotherapy using a visual analog scale (VAS) as well as quality-of-life (CIVIQ-14) and patient satisfaction (Darvall) questionnaires.Results
A total of 70 physicians recruited 1150 patients: 1071 (93%) women, 79 (7%) men. Mean age (±?SD) was 40.7?±?10.7 years (range 18–74) and mean body mass index was 23.6?±?3.3 kg/m2. Reticular veins were observed in 42.1% of patients and 57.9% had telangiectasias. MPPF was prescribed to 905 patients (79%). Sclerotherapy was associated with statistically significant decreases in mean VAS scores for leg heaviness, pain, sensation of swelling, night cramps, and itching. For each symptom, MPFF-treated patients showed a more pronounced improvement than those undergoing sclerotherapy alone: mean VAS pain score with MPFF decreased from 1.90?±?2.30 to 0.30?±?0.62 versus 1.72?±?1.93 to 0.52?±?0.99 with sclerotherapy alone; mean VAS leg heaviness score with MPFF decreased from 2.80?±?2.43 to 0.47?±?1.07 versus 2.38?±?2.23 to 0.76?±?0.85 with sclerotherapy alone. Patient quality-of-life indicators improved with symptom resolution, particularly pain, and for each indicator the observed improvement was greater with MPFF. The outcomes of treatment exceeded patient expectations. Fewer patients experienced sclerotherapy-induced hyperpigmentation with adjunctive MPFF versus sclerotherapy alone (33.9% versus 41.2%, respectively, P?=?0.034). No adverse events related to MPFF were observed.Conclusion
Resolution of venous symptoms post-sclerotherapy was greater in patients treated with MPFF compared with those undergoing sclerotherapy alone, supporting the rationale for use of MPFF in patients undergoing sclerotherapy.Funding
Servier.17.
Background and objectives
The synthetic opioid tilidine is often used in chronic pain treatment. However, the activation via metabolism in patients with concomitant medication and reduced liver or kidney function is not thoroughly investigated. We therefore studied pain treatment efficacy, health-related quality of live and the metabolism of tilidine in patients with chronic pain.Methods and materials
In all, 48 patients, who were on a stable dose of oral prolonged release tilidine for at least 7 days, were included in this observational multicenter study. Liver and kidney function were assessed in routine blood samples, concentrations of tilidine, nortilidine and bisnortilidine were determined using a validated LC/MS/MS method. Comedication was registered and patients experience with regard to quality of life, pain, gastrointestinal symptoms and adverse events was assessed in standardised questionnaires.Results
On average a daily dose of 180?mg tilidine was taken. Dose normalized plasma concentrations of the active metabolite nortilidine ranged between 1.6?ng/ml and 76.5?ng/ml (mean 29.2 ± 25.1?ng/ml). Ratios between tilidine and nortilidine were on average 0.28 (median = 0.13, standard deviation = 0.67). Patients were on 1 to 14 different concomitant medications. About 66% of the patients had sufficient pain treatment. Almost no opioid-induced constipation was observed. Only few patients had decreased kidney or liver function which did not result in elevated nortilidine concentrations.Conclusion
Pain treatment using tilidine resulted in variable nortilidine concentrations which are obviously not strongly influenced by comedication or reduced liver or kidney function. Only a few side effects were observed with almost no opioid-induced constipation.18.
Background
Parental reactions to their child’s pain can comprise cognitive-affective and behavioral responses. Dysfunctional responses like parental catastrophizing may lead to an aggravation of the child’s pain.Objectives
Aims of the online-based study were (1) to psychometrically evaluate existing questionnaires into cognitive-affective (Pain Catastrophizing Scale for Parents; PCS-P) and behavioral responses (Inventar zum schmerzbezogenen Elternverhalten; ISEV-E) within a sample of 105 healthy parents, and (2) to compare their responses to existing (inter)national clinical samples and to the reactions of 80 parents with self-reported chronic pain from the general population.Methods
The assessment of parental pain-related reactions was online-based.Results
While the factor structure of the ISEV-E could not be replicated, the three factors of the PCS-P could be replicated. Parental catastrophizing of the healthy parents was lower compared to clinical samples. Healthy parents did not differ from parents with chronic pain from the general population.Conclusion
The results offer a basis to grade parental catastrophizing, so that risk-groups can be identified.19.
Background
Pain, restriction of mobility and cognitive impairment are often present in old age and intensify each other.Objectives
Is there a relationship between mobility, pain, cognitive capacity, diagnoses and number of prescribed medication for residents of nursing homes?Methods
Subgroup analysis of the baseline data from an intervention study for optimization of the medication safety of 120 nursing home residents.Results
Pain was presumed in 77.8% of the residents. Persons with cognitive impairment were more frequently affected. The results of the observational and self-reported pain assessment in cognitively impaired patients did not agree for two-thirds of the cases. A correlation between prevalence of pain, pain intensity and mobility could only be shown for persons without cognitive impairment. Half of the persons were unable to walk; 80% of the residents with analgesics as a permanent medication were more restricted in their mobility.Conclusions
Cognitive impairment is associated with pain and reduced mobility, whereby self-rated pain did not concur with the observational pain assessment for two-thirds of the residents with cognitive impairment. This illustrates the difficulty of observational pain assessment.20.
Kazuaki Enya Ben T. Saji Takuya Kato Hiroyuki Okamoto Emiko Koumura 《Advances in therapy》2018,35(8):1181-1190