PURPOSE OF THE STUDY: The primary aim of the study was to identify characteristics predicting the blood loss associated with primary total hip (THA) and knee (TKA) arthroplasty surgery. The other objective was to find out which characteristics were important for peri-operative allogeneic blood transfusion in the same group of patients. MATERIAL AND METHODS: This prospective study comprised 210 consecutive patients who underwent primary THA (n = 115) or primary TKA (n = 95) at our department. In each patient, 21 pre-operative and peri-operative characteristics were recorded. Of them, the following characteristics were selected for statistical evaluation: age, gender, BMI, primary diagnosis, Charlson co-morbidity score, type of prophylaxis for deep-vein thrombosis, type of implant fixation (in THA), pre-operative INR value, haematocrit, haemoglobin (Hb) and platelet levels, amount of autologous blood donated by the patient, ASA score, operative time, use of tourniquet (in TKA), type of anaesthesia used, blood recuperation and patient's smoking habits. Multivariate analysis was used as the statistical method. For hypothesis testing, a statistical significance level of 0.05 was stated and, for enclosing (removing) characteristics to (from) multivariate models, the significance level was set at 0.11. RESULTS: The group included 81 men and 129 women; the mean age at the time of surgery was 65.5 ± 11.97 years (mean±SD) in the THA patients and 68.5 ± 8.52 years in the TKA patients. Primary osteoarthritis was the most frequent surgical diagnosis (THA, 64.35%; TKA, 82.1%). The mean amount of blood loss was 1258 ± 402.6 ml in THA and 1580 ± 475.5 ml in TKA. The mean amount of allogeneic blood required was 130 ± 202 ml when all THA patients were considered, and 371.95 ± 159.3 ml when only those who received it were involved. For the TKA patients, the corresponding values were 160.1 ± 278.8 ml for all patients and 507 ± 264.5 ml for blood recipients only. The characteristics that affected the amount of blood loss in THA included BMI, ASA score, blood recuperation, type of anaesthesia, and smoking habits; in TKA these were BMI, pre-operative platelet count, INR and type of anaesthesia. High pre-operative Hb levels made the probability of allogeneic blood requirement lower in both THA and TKA. Autotransfusion decreased the probability of allogeneic blood requirements only in THA. DISCUSSION That the pre-operative Hb level is the strongest predictor for the probability of allogeneic blood transfusion during both THA and TKA is a logical and well-known fact. What remains to be established is the optimal protocol for pre-operative preparation of the patients with low Hb levels undergoing elective replacement (hip and knee) surgery. This study clearly showed that, in THA patients, pre-operative autologous blood donation decreased the probability of allogeneic blood transfusion. Other results of our multivariate analyses were not clinically unambiguous and therefore further research on a larger patient group is warranted. Such studies will also require the development of a more exact method for the assessment of blood loss at the operating theatre. CONCLUSION: The patients with low pre-operative Hb levels have a high probability that they will require allogeneic blood transfusion during primary THA and TKA. Autologous blood donation can decrease this probability significantly (here proved only for THA patients). The multivariate model of blood loss published here could assist in estimation of peri-operative blood loss and potential risk of blood transfusion requirements.
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- MeSH
- Electroencephalography MeSH
- Genetics, Medical MeSH
- Humans MeSH
- Brain physiology MeSH
- Check Tag
- Humans MeSH
- MeSH
- Child MeSH
- Hypertension etiology complications MeSH
- Adolescent MeSH
- Family MeSH
- Check Tag
- Child MeSH
- Adolescent MeSH
The pharmaceutical industry has to tackle the explosion of high amounts of poorly soluble APIs. This phenomenon leads to numerous sophisticated solutions. These include the use of multifactorial data analysis identifying correlations between the components and dosage form properties, laboratory and production process parameters with respect to the API liberation Example of such API is bicalutamide. Improved liberation is achieved by particle size reduction. Laboratory batches, with different PSD of API, were filled into gelatinous capsules and consequently granulated for tablet compression. Comparative dissolution profiles with Casodex 150 mg (Astra Zeneca) were performed. The component analysis was used for the statistical evaluation of f1 and f2 factors and D(v,0.9) and D[4,3] parameters of PSD to identify optimal PSD values. Suitable PSD limits for API were statistically confirmed in laboratory and in commercial scale with respect to optimized tablet properties. The tablets were bioequivalent with originator (n = 20; 90% CI for ln AUC0-120: 99.8-111.9%; 90% CI for ln cmax: 101.1-112.9%). In conclusion, the micronisation of the API is still an efficient and inexpensive method improving the bioavailability, although there are more complicated and expensive methods available. Statistical multifactorial methods improved the safety and reproducibility of production.
- MeSH
- Anilides chemical synthesis metabolism MeSH
- Biological Availability MeSH
- Chemistry, Pharmaceutical methods MeSH
- Multivariate Analysis MeSH
- Nitriles chemical synthesis metabolism MeSH
- Tablets MeSH
- Therapeutic Equivalency MeSH
- Tosyl Compounds chemical synthesis metabolism MeSH
- Publication type
- Journal Article MeSH
A test-statistic typically employed in the gene set enrichment analysis (GSEA) prevents this method from being genuinely multivariate. In particular, this statistic is insensitive to changes in the correlation structure of the gene sets of interest. The present paper considers the utility of an alternative test-statistic in designing the confirmatory component of the GSEA. This statistic is based on a pertinent distance between joint distributions of expression levels of genes included in the set of interest. The null distribution of the proposed test-statistic, known as the multivariate N-statistic, is obtained by permuting group labels. Our simulation studies and analysis of biological data confirm the conjecture that the N-statistic is a much better choice for multivariate significance testing within the framework of the GSEA. We also discuss some other aspects of the GSEA paradigm and suggest new avenues for future research.
