Comparison of 0.125% bupivacaine and 0.2% ropivacaine in obstetric analgesia

This comparative study of low doses of ropivacaine was conducted in order to identify the most effective form of analgesia during labour with the aid of supplementary low doses of fentanyl and clonidine. 60 ASA I and II parturient primipares who had asked for epidural analgesia were randomly assigned to two groups. Group R was given 5-7 ml 0.2% ropivacaine and Group B 0.125% bupivacaine with both groups receiving 75 ng clonidine and 50 ng fentanyl with their first bolus of local anaesthetic. The parameters measured included the speed and spread of the sensory blockade and the scale of any motor blockade. The material haemodynamics and VAS pain relief scores were also measured at 30-minute intervals during labour and all side-effects (nausea, vomiting, localised or generalised itching, headache etc) were also monitored. Apgar anaesthetics and other drugs was decided on the basis of the VAS score (a further dose was given to women with a VAS of > 3-4). The study was completed by a telephone interview 6 months after delivery and the data were analysed using the Student's t-test and the chi 2 test. The analgesic effect was satisfactory in both groups and no statistically significant differences were found between the two groups under most of the headings analysed, apart from the top-up doses needed to maintain adequate analgesia. The average time between the first VAS to parturition was 292 mns in Group B and 267 mns in Groups R. Top-up doses of local anaesthetic (2.35 vs 5.05) came on average to 15.8 ml in Group B compared to 24.1 ml in Group R. There were 20% Caesarian sections in Group R and 13.8% in Group B. Optimum analgesia was achieved in Group R, the level of analgesia was insufficient or barely sufficient in 3.3% of cases. There was no Apgar score < 7 in either group. It was therefore concluded that both bupivacaine and ropivacaine offer excellent analgesia during labour and have no significant side effects on mothers or babies.     

Lack of association between ENAM gene polymorphism and dental caries in primary and permanent teeth in Czech children

Clinical Oral Investigations - The enamelin gene (ENAM) polymorphism (rs12640848) was recently associated with dental caries in primary teeth in Polish children. The aims of the present study were...     

Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride.

AIM: To compare the efficacy and safety of two analog insulins as starting regimens in insulin-na?ve Type 2 diabetes patients. METHODS: In this randomized, open-label parallel study, twice-daily biphasic insulin aspart 30 (30% soluble and 70% protaminated insulin aspart; BIAsp 30) plus metformin (met) was compared with once-daily insulin glargine (glarg) plus glimepiride (glim) in 255 insulin-na?ve patients (131 male; mean+/-SD age, 61.2+/-9.1 years). Mean baseline HbA (1c) (+/-SD) was 9.2+/-1.4% and 8.9+/-1.3% for BIAsp 30 plus met ( N=128) and glarg plus glim ( N=127), respectively ( P=0.0747). Primary endpoint was the difference in absolute change in HbA (1c) between groups after 26 weeks of treatment. RESULTS: HbA (1c) change was significantly greater in the BIAsp 30 plus met group than the glarg plus glim group (between-group difference: -0.5% (95% CI: -0.8; -0.2); P=0.0002). Mean prandial plasma glucose increment was significantly lower for BIAsp 30 plus met compared with glarg plus glim: 1.4+/-1.4 mmol/l vs. 2.2+/-1.8 mmol/l; P=0.0002. During the maintenance phase (weeks 6-26), one major hypoglycemic episode occurred in each group; 20.3% and 9% of patients experienced minor hypoglycemic episodes in the BIAsp 30 plus met and glarg plus glim groups, respectively ( P=0.0124). At end-of-trial, mean daily insulin doses were 0.40 U/kg BIAsp 30 and 0.39 U/kg glarg. Glarg plus glim-treated patients experienced significant weight gain of 1.5 kg (95% CI: 0.84; 2.19; P<0.0001). Weight change with BIAsp 30 plus met of +0.7 kg was not statistically significant (95% CI: -0.07; 1.42; P=0.0762). CONCLUSIONS: Starting insulin in Type 2 diabetes patients with twice-daily BIAsp 30 plus met can reduce HbA (1c) and mean prandial plasma glucose increment to a greater extent than once-daily glarg plus glim.     

Novel Illumina-based next generation sequencing approach with one-round amplification provides early and reliable detection of BCR-ABL1 kinase domain mutations in chronic myeloid leukemia

The occurrence of mutations in the BCR-ABL1 kinase domain (KD) can lead to treatment resistance in chronic myeloid leukaemia patients. Nowadays, next-generation sequencing (NGS) is an alternative method for the detection of kinase domain mutations, compared to routinely used Sanger sequencing, providing a higher sensitivity of mutation detection. However, in the protocols established so far multiple rounds of amplification limit reliable mutation detection to approximately 5% variant allele frequency. Here, we present a simplified, one-round amplification NGS protocol for the Illumina platform, which offers a robust early detection of BCR-ABL1 KD mutations with a reliable detection limit of 3% variant allele frequency.     

Incidence of second malignancies during treatment of chronic myeloid leukemia with tyrosine kinase inhibitors in the Czech Republic and Slovakia

Tyrosine kinase inhibitors (TKI) have completely changed the prognosis of patients with Ph+ chronic myeloid leukemia (CML). The occurrence of a second malignancy (SM) in CML patients successfully treated with TKI may significantly affect their prognosis. In a retrospective study of 1,038 patients with CML treated at 10 centers in the Czech Republic and Slovakia between 2000 and 2009, SM was detected in 35 (3.37%) patients after TKI therapy was initiated. The median intervals from the diagnosis of CML and from the start of TKI therapy to the diagnosis of SM were 58 months (range 2 - 214) and 32 months (range 1 - 102), respectively. The observed age-standardized incidence of SM after the start of TKI therapy was 8.95 / 1,000 person-years. Comparison of the incidence of SM in CML patients with population data was performed only for patients from the Czech Republic. The age-standardized incidence rate of all malignant tumors except non-melanoma skin cancers was 6.76 (95% CI: 6.74; 6.78) / 1,000 person-years in 2000 - 2007 while the incidence rate of SM in 708 CML patients from the Czech Republic treated with TKI was 9.84 (95% CI: 6.20; 13.48) / 1,000 person-years, i.e. 1.5-fold higher, although the difference was statistically insignificant. The distribution of SM types in CML patients treated with TKI was similar to that in the age-standardized general Czech population. The median overall survival (OS) of patients treated with TKI who also developed SM (57 months) was shorter than the OS of patients treated with TKI but not suffering from SM (median OS not reached, log rank test p < 0.001. Prospective long-term population-based studies in CML patients treated with TKI as first-line therapy are needed to determine the relationship of SM to KTI therapy.     

No clinical evidence for performing trough plasma and intracellular imatinib concentrations monitoring in patients with chronic myelogenous leukaemia

This multicentre study focused on monitoring imatinib mesylate (IMA) trough plasma (C_trough) and intracellular (IMA C_intrac) concentrations in 228 chronic myelogenous leukaemia patients. The median of measured IMA C_trough in our patient group was 905.8 ng ml (range: 27.7–4628.1 ng/ml). We found a correlation between IMA C_trough and alpha 1‐acid glycoprotein plasma concentrations (rS = 0.42; p < 0.001). All other analysed parameters revealed only weak (gender, dose of IMA per kg) or not significant (age, albumin, creatinine plasma concentration or body mass index) impact on measured IMA C_trough. The IMA C_trough decreased during the first 6 months and significantly increased later during treatment. The IMA C_trough at the first month of therapy did not differ between patients with and without an optimal response at the 12th (p = 0.724) and 18th month (p = 0.135) of therapy. There were no significant differences in medians of IMA C_trough between both groups measured during the first year of treatment. The IMA C_intrac during the first month were not different between patients with and without an optimal response at the 6th (p = 0.273) and the 12th month (p = 0.193) of therapy. Our data obtained from real life clinical practice did not find a benefit of routine and regular IMA C_trough nor IMA C_intrac therapeutic drug monitoring in chronic myelogenous leukaemia patients or for subsequent adjustments of the IMA dose based on these results. Moreover, actual alpha 1‐acid glycoprotein plasma concentration should be used for proper interpretation of IMA C_trough results. Copyright © 2013 John Wiley & Sons, Ltd.