Home storage of biological medications administered to patients with rheumatic diseases.

BACKGROUND: The inadequate storage of biopharmaceuticals may result in an ineffective therapeutic response since poor conservation can lead to the emergence of protein aggregates and cause immunogenicity in patients, which can increase the risk of adverse events by inducing the production of anti-drug antibodies. This can also lead to significant economic losses for public health, given the high cost of these medicines. The aim of this study was to verify whether the home storage of biopharmaceuticals dispensed by the Unified Public System was in accordance with the manufacturers' specified standards and whether external variables interfered with the correct home storage. METHODS: This was a prospective observational study. Patients with a confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis who were using a biologic exclusively dispensed by Unified Public System were included. Storage temperature was measured by digital thermometer inserted into the refrigerator of the participant's home. Fisher's exact test was performed to cross-reference the temperature data and the qualitative variables obtained using an epidemiologic questionnaire. Mean, minimum, maximum values and standard deviation were described in the quantitative data. Mann-Whitney non-parametric test was performed to the association between temperature excursion and the number of people in the house. RESULTS: A total of 81 participants were included and 67 (82.71%) did not maintain home storage correctly. The maximum temperature observed among all patients was 15.5 °C, the minimum was - 4.4 °C and the average was 5.6 °C (standard deviation 2.8); 10 (12.3%) had at least one negative temperature measured. The average time for participants who had an inadequate temperature record was 8 h and 31 min. Nine participants (90%) who stored the medication into the shelf/drawer below the freezer had a temperature excursion (p = 0.011). Most of the participants (88.5%) who stored their biopharmaceutical near the back side, close to the wall of the refrigerator had a negative temperature record (p < 0.001). CONCLUSION: Most of the study participants (82.71%) did not maintain adequate home storage conditions for their biopharmaceutical. Intrinsic factors of household refrigerators may be involved in temperature deviations.

Randomized, blinded, controlled trial on effectiveness of photobiomodulation therapy and exercise training in the fibromyalgia treatment.

This study evaluated the role of the phototherapy and exercise training (EXT) as well as the combined treatment in general symptoms, pain, and quality of life in women suffering from fibromyalgia (FM). A total of 160 women were enrolled and measures were carried out in two sets: it was sought to identify the acute effect for a single phototherapy and EXT session (Set 1); long-term effect (10 weeks) of the interventions (Set 2). Phototherapy irradiation was performed at 11 locations in their bodies, employing a cluster with nine diodes (one super-pulsed infrared 905 nm, four light-emitting diodes [LEDs] of 640 nm, and four LEDs of 875 nm, 39.3 J per location). Algometry and VAS instrument were applied to evaluate pain. The FM symptoms were evaluated with Fibromyalgia Impact Questionnaire (FIQ) and Research Diagnostic Criteria (RDC) instruments. Quality of life was assessed through SF-36 survey. Set 1: pain threshold was improved with the phototherapy, and EXT improved the pain threshold for temporomandibular joint (right and left body side) and occipital site (right body side). Set 2: there was improved pain threshold in several tender points with the phototherapy and EXT. There was an overlap of therapies to reduce the tender point numbers, anxiety, depression, fatigue, sleep, and difficulty sleeping on FIQ/RDC scores. Moreover, quality of life was improved with both therapies. The phototherapy and EXT improved the pain threshold in FM women. A more substantial effect was noticed for the combined therapy, in which pain relief was accomplished by improving VAS and FIQ scores as well as quality of life.

Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial.

BACKGROUND: Fibromyalgia (FM) is a syndrome most prevalent in women, in whom it is characterized mainly by chronic pain. An important issue is that many patients with FM are reported to have temporomandibular dysfunction (TMD), and the coexistence of these pathologies generates a clinical outcome of high complexity. The literature is unclear regarding an effective therapy for reducing pain in patients with both comorbidities. Exercise training and phototherapy (low-level laser therapy with light-emitting diode) are two of the approaches used to treat pain. Thus, the aim of this study is to assess the potential role of exercise training plus phototherapy in reducing chronic pain in women with FM and TMD. A further aim is to determine whether the interventions can improve quality of life and modulate endogenous serotonin. METHODS/DESIGN: A randomized controlled clinical trial will be conducted. It will involve 60 women ≥ 35 years of age with a diagnosis of FM and TMD. After recruitment, patients will be randomly allocated to one of four groups: a control group (no intervention), a group that will receive a phototherapy intervention (PHO), a group that will be prescribed muscle-stretching, aerobic, and facial exercises (EXT), or a group that will receive phototherapy plus exercise interventions (PHO + EXT). The trial will last 10 weeks, and the following outcomes will be evaluated on two separate occasions (baseline and within 24 h after the last day of the protocol). Pain intensity will be analyzed using a visual analogue scale and the McGill Pain Questionnaire, and pain thresholds will be punctuated using a digital algometer. FM symptoms will be assessed using the Fibromyalgia Impact Questionnaire, and quality of life will be determined with the 36-item Short Form Health Survey. Serotonin levels will be evaluated in salivary samples using a competitive enzyme-linked immunosorbent assay. DISCUSSION: This is the first randomized controlled trial in which the role of phototherapy, exercise training, and a combination of these interventions will be evaluated for chronic pain in patients with FM and TMD. The results will offer valuable clinical evidence for objective assessment of the potential benefits and risks of procedures. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02279225. Registered 27 October 2014.