Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty.

BACKGROUND: The aim was to evaluate the analgesic efficacy and safety of the dexketoprofen/tramadol 25 mg/75 mg fixed-dose combination vs dexketoprofen (25 mg) and tramadol (100 mg) in moderate-to-severe acute pain after total hip arthroplasty. METHODS: This was a randomized, double-blind, parallel-group study in patients experiencing pain of at least moderate intensity on the day after surgery, compared with placebo at first administration to validate the pain model. The study drug was administered orally every 8 h throughout a 5 day period. Rescue medication, metamizole 500 mg, was available during the treatment period. The evaluation of efficacy was based on patient assessments of pain intensity and pain relief. The primary end point was the mean sum of the pain intensity difference values throughout the first 8 h (SPID8). RESULTS: Overall, 641 patients, mean age 62 (range 29-80) yr, were analysed; mean (sd) values of SPID8 were 247 (157) for dexketoprofen/tramadol, 209 (155) for dexketoprofen, 205 (146) for tramadol, and 151 (159) for placebo. The primary analysis confirmed the superiority of the combination over dexketoprofen 25 mg (P=0.019; 95% confidence interval 6.4-73) and tramadol 100 mg (P=0.012; 95% confidence interval 9.5-76). The single components were superior to placebo (P<0.05), confirming model sensitivity. Most secondary analyses supported the superiority of the combination. The incidence of adverse drug reactions was low and similar among active treatment groups. CONCLUSION: The efficacy results confirmed the superiority of dexketoprofen/tramadol over its single components, even at higher doses (tramadol), with a safety profile fully in line with that previously known for these agents in monotherapy. CLINICAL TRIAL REGISTRATION: EudraCT 2012-004548-31 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004548-31);ClinicalTrials.gov NCT01902134 (https://www.clinicaltrials.gov/ct2/show/NCT01902134?term=NCT01902134&rank=1).

[A new treatment possibility for osteoporosis with osteochin (ipriflavone) tablets]. / Az osteoporosis kezelésének új lehetösége osteochin (ipriflavone) tablettával.

It was found as a result of preclinical experimental examinations, performed in Hungary and Japan that Ipriflavone stimulates calcitonin secretion through increasing the oestrogene effect. Its effect of hindering bone resorption works presumably also this way. Authors report on experiences and results gained in 408 treatment years of 114 primary and secondary osteoporotic patients. The results of clinical experiments in Hungary, Japan and Italy are similar. The treatment with Osteochin and calcium is an effective therapy of osteoporosis. The progression of the loss of bone mass can be hindered, the number of bone fracture is diminished in proportion of time and the method proved to be effective in 79 per cent of the patients. Out of the gastric complaints, found in 5.5 per cent of the cases no side effect was observed.

Revision arthroplasty of the hip with extensive bone loss. Preliminary study.

In this preliminary study, authors describe their experiences with revision of the cup and with that of the femoral stem. Former has been performed by them since 1993 39 times on 37 patients, the latter 3 times on 3 patients. The method was successful in most of the cases; the anatomical integrity was preserved and stability was satisfactory.

Efficacy and tolerability of oral chondroitin sulfate as a symptomatic slow-acting drug for osteoarthritis (SYSADOA) in the treatment of knee osteoarthritis.

Patients with osteoarthritis (OA) of the knee were treated with chondroitin sulfate (CS, Condrosulf, IBSA, Lugano, CH) in a randomized, double-blind, placebo-controlled study, performed in two centres. The efficacy and tolerability of oral CS capsules 2 x 400 mg/day vs placebo was assessed in a 6-month study period. Patients with idiopathic or clinically symptomatic knee OA, with Kellgren and Lawrence radiological scores I-III, were included in this trial. Clinical controls were performed at months 0, 1, 3 and 6. Eighty patients completed the 6-month treatment period. Lequesne's Index and spontaneous joint pain (VAS) decreased constantly in the CS group; on the contrary, slight variations of the scores were reported in the placebo group. The walking time, defined as the minimum time to perform a 20-meter walk, showed a statistically significant constant reduction only in the CS group. ANOVA with repeated measures showed a statistically significant difference in favor of the CS group for these three parameters. During the study, patients belonging to the placebo group reported a higher paracetamol consumption, but this consumption was not statistically different between the two treatment groups. Efficacy judgements were significant in favor of the CS group. Both treatments were very well tolerated. All these results strongly suggest that chondroitin sulfate acts as a symptomatic slow-acting drug in knee OA.

[Callus luxurians in osteogenesis imperfecta]. / Callus luxurians esete osteogenesis imperfectában.

A case is introduced with osteogenesis imperfecta, suffered from left femoral fracture and a consecutive hypertrophic callus formation, with extreme swelling on the thigh. Concerning the laboratory tests the only significant difference was the elevation in alkaline phosphatase activity and a moderate elevation in ESR. The case is reported because of it's accidental appearance.

[Comparative study of the in vitro effects of calcitonin, NaF and ipriflavone in cell culture]. / Calcitonin, NaF és Ipriflavon in vitro hatásának összehasonlító vizsgálata sejttenyészeten.

The aim of these in vitro series of experiments was to state whether the medicaments used in the treatment of loss of bone density the Calcitonin, NaF and Ipriflavon do have a direct effect on the preosteoblast cells. The results show that both the Calcitonin and Fluorid stimulated the development of the fibroblast colonies and the NaF had a role in the increase of the alkaline phosphatase too. In the concentration of Ipriflavon applied no effect could be demonstrated in any parameter.

[Ultrastructural and histological studies on type I osteogenesis imperfecta]. / Ultrastrukturális és hisztológiai vizsgálatok I-es típusú osteogenesis imperfectában.

The results of 3 bone biopsies in patients with Sillence I. type of osteogenesis imperfecta are described. The biopsy material was examined with light microscope histomorphometric and various electron microscopic methods. Histomorphometry showed that the osteoid rim (OS%) and the steroid surface covered by osteoblasts (OB%) was significantly greater, in the same time the relative quantity of osteoid (Vvos%) was significantly less, compared with the normal bone. Electron microscopy showed the broadening and unevenness of the mineralization front. The diameters of the collagen fibers were quite unstable compared with the control. The structure of the newly developed apatit crystals was not different, although their measure was less than of the control. The microanalytical examinations of Ca/P relation of the crystal phase did not show any difference.

Posterolateral lumbar spine fusions: private v. NHS. Comparative, preliminary study.

In the present study comparative evaluation has been carried out between the groups of patients (31 in each group, private and National Health Service) treated by posterolateral lumbar spine fusion for mechanical lower back pain. The same surgical team was involved in the treatment. The patients were evaluated independently at an average follow-up of more than three years in each group. The acceptable clinical results (good and fair) showed a remarkable difference between the two groups, with the private group enjoying the better outcome. The difference of final outcome was analyzed by looking at the waiting time for surgery, the social classification of the patients and the provision of state benefit for disability.

[The Oswestry peduncular screw system used in 108 patients. Oswestry experiences]. / Az Oswestry peduncularis csavar-rendszerröl 108 beteg kapcsán. Oswestry-tapasztalatok.

Authors report on the control examinations of 108 patients on a peduncular system, known since 1986 and applied successfully in the operative treatment of various diseases of the lumbosacral spine. The results of healing of 69 patients in whom the fusion of the lumbosacral spine was performed because of long standing low-back pains are analysed. They describe also other possibilities given by the peduncular system, among others the correction and stabilization of the lumbar kyphosis in Becterew's disease, the postlaminectomy kyphosis and the lumbar scoliosis of adults. Cases of trauma and tumor in which this method of stabilization was also successfully used are also mentioned.

[Experiences with surgical fusion of the lumbar spine]. / Az ágyéki gerinc fúziós mütétjei során szerzett tapasztalataink.

Authors report on the results of the operative fusion of the lumbar spine performed by them between 1 March 1987 through 31 December 1990. Based on the assessment of 243 cases they call attention to the importance of the correct indication and operative technique and of the close supervision. It is stated that the use of the internal fixation improves the results of the operative fusions.

[Treatment of osteoarthritis of the knee joint. Efficacy and tolerance to acemetacin slow release in comparison to celecoxib]. / Behandlung der Gonarthrose. Wirksamkeit und Verträglichkeit von retardiertem Acemetacin im Vergleich zu Celecoxib.

OBJECTIVE: The aim of this trial was to compare acemetacin (ACE) with celecoxib (CEL) in terms of tolerability and efficacy in the treatment of osteoarthritis of the knee joint. METHODS: A total of 105 patients (26-64 years old) suffering from primary osteoarthritis (OA) of the knee were enrolled in this international, multicenter, randomized, double blind controlled trial. Fifty three patients were given ACE and 52 CEL. They were treated with either 90 mg bid of slow release ACE or 200 mg bid of CEL for 6 weeks. Additional gastroprotective therapy was not provided. Tolerability was assessed by physical examination, laboratory tests, vital signs and reports of side effects, as well as by patient and physician global assessments. Efficacy parameters comprised pain assessment by visual analogue scale (VAS) and ordinal scale, WOMAC, SF-36 and patient and physician global impressions of efficacy. In addition, acetaminophen consumption was recorded. RESULTS: In 21 ACE (39.6%) and 19 CEL patients (36.5%), the number of side effects totaled 56 (ACE n=29; CEL n=27) (ns). Mean pain reduction at week 6 was highly significant ( P<0.0001) in both groups and amounted to 38.7 mm (+/-20.3) in the ACE group and to 35.1 mm (+/-18.7) in the CEL group (ns). Very similar results were seen with respect to the other efficacy parameters. CONCLUSION: ACE is not inferior to CEL for the short-term treatment of knee OA in terms of tolerability and efficacy.