Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain.

BACKGROUND: Combination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective. METHODS: This was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen trometamol (12.5 mg and 25 mg) and tramadol hydrochloride (37.5 mg and 75 mg), given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objective was to evaluate the superior analgesic efficacy and safety of each combination and each single agent versus placebo. The primary outcome was the proportion of patients with at least 50 % max TOTPAR over six hours. RESULTS: 606 patients were randomised and provided at least one post-dose assessment. All combinations were significantly better than placebo. The highest percentage of responders (72%) was achieved in the dexketoprofen trometamol 25 mg plus tramadol hydrochloride 75 mg group (NNT 1.6, 95% confidence interval 1.3 to 2.1). Addition of tramadol to dexketoprofen resulted in greater peak pain relief and greater pain relief over the longer term, particularly at times longer than six hours (median duration of 8.1 h). Adverse events were unremarkable. CONCLUSIONS: Dexketoprofen trometamol 25 mg combined with tramadol hydrochloride 75 mg provided good analgesia with rapid onset and long duration in a model of moderate to severe pain. The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae. TRIAL REGISTRATION: EudraCT (2010-022798-32); Clinicaltrials.gov (NCT01307020).

[Effect of intra-arterial chemotherapy of head and neck tumors on cerebral blood circulation]. / Fej és nyaki tumorok intraarteriális chemotherapiájának hatása az agyi keringésre.

A combination of Cisplatin and Epirubicin was administered through the external carotid artery system according to a standard protocol as preoperative or palliative therapy in 14 oral cancer patients. With the aim of clarifying the subacute side-effects of this chemotherapy on the intracerebral circulation, rCBF SPECT investigations with 99mTc-HMPAO were performed before and after the cytostatic treatment. The interval between SPECT studies was 24 (SD +/- 12) days. In concordance with the neurological condition, visual assessment of the rCBF SPECT reconstructed transversal slices revealed no perfusion abnormalities and no changes on the follow-up. No significant changes were found in the side activity ratios in 22 regions of each hemisphere (unpaired t-test) in the whole group of patients. It was concluded that within the investigated time interval this highly effective combination of cytostatics administered perfectly through the external carotid artery system causes no serious disturbances in the cerebral circulation in oral cancer cases.

[Effectiveness of intra-arterial chemotherapy in the management of intra-oral cancers and their lymphatic metastases]. / Az intraarterialis kemoterápia hatékonysága szájüregi rákok és nyirokcsomó-metasztázisaik komplex kezelése során.

The effect of complex therapy (intra-arterial chemotherapy and radical surgery) on primary tumours and their metastases was studied in 38 oral squamous cell cancer cases. The therapy had different effect on the primary tumours and their lymph node metastases. There was a close correlation between the number of metastatic lymph nodes and survival. The extension and the chemotherapeutic regression rate of metastatic lesions showed a significant correlation with patients' survival.

[Relation of the histological picture of biopsy material and prognosis in cases of squamous cell carcinoma of the oral cavity]. / A próbakimetszés szöveti képe és a prognózis összefüggései szájüregi laphámrákos esetekben.

Biopsy specimens from 42 oral cancer cases were graded by a histological scoring system which was initiated by Bryne et al. This system was based on both the features of the tumor cells and the relationship between tumor cells and connective tissue. The results suggested significant correlation between the histological score values and the survival, the occurrence of recidive tumors and metastatic tumors.

[Experience with Otten's maxillomandibular fixation method]. / Tapasztalataink az Otten-féle mandibulomaxillaris rögzítéssel.

The authors are reporting on a method of mandibulomaxillary fixation worked out in their institute through a modification of those defined in literature. A wire hook is fixed by a screw to the mandibula and maxilla and, by the help of it an intermaxillary fixation is formed. The procedure is simple, quickly accomplishable and cheap. Its application is recommended to be introduced for other institutes, as well.

Intra-arterial preoperative cytostatic treatment versus preoperative irradiation: A prospective, randomized study of lingual and sublingual carcinomas.

BACKGROUND: For several decades, both preoperative intra-arterial chemotherapy and preoperative irradiation have been accepted treatments for patients with tumors of the head and neck. Unfortunately, arguments have often been put forward in favor of one or other of the two methods, but without the performance of an objective, randomized investigation. To resolve this situation, the authors have carried out a multicenter, randomized prospective study of selected patients with a view to deciding which method affords better results in complex tumor therapy from the aspects of survival and postoperative quality of life. METHODS: One hundred thirty-one patients with operable sublingual or lingual squamous cell carcinoma in stages T2NXM0 to T4MXM0 were randomized into 2 groups: 1 group participated in preoperative chemotherapy with cisplatin and epirubicin (total doses: 200 mg cisplatin, 120 mg epirubicin) via the external carotid artery, whereas the other group received preoperative radiation therapy (46 grays). Following subsequent radical surgery, the patients received regular follow-up for 5 years. RESULTS: By the end of the 5 years, 95 of the 131 patients had conformed to the protocol. Of those 95, 47 had received preoperative chemotherapy and 48 preoperative irradiation. After 5 years, 18 of the 47 patients who received chemotherapy and 15 of the 48 patients who received irradiation were still alive and tumor free. A few more patients had died of recurrence or regional metastasis in the chemotherapy group (23 patients) than in the irradiation group (20 patients). Occurrence of a second carcinoma was 3 times as frequent in the irradiation group (9 patients) as in the chemotherapy group (3 patients). Overall, the survival rates were by-and-large the same for the two groups. Regarding postoperative quality of life, the chemotherapy group presented a more favorable picture. CONCLUSIONS: The long term survival results subsequent to preoperative intra-arterial chemotherapy or preoperative radiotherapy were practically the same. Regarding postoperative quality of life, patients who underwent intra-arterial chemotherapy appeared to be in a slightly more favorable situation. The authors consider it important to stress these findings, as they are not aware of a similar randomized study of patients with tumors of the oral cavity.