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Background: Osteopathy is present in a large number of hospitals in Italy, firstly in pediatric departments. It is mainly deals with musculo-skeletal imbalances, but osteopathy states to have a role in improving general health. Few studies about safety and efficacy of osteopathic manipulative treatment (OMT) in Obstetrics have been produced. Objectives: Our long-term study, of which this report is a preliminary communication, is aimed at investigating the effects of OMT during the third trimester of pregnancy on labour and delivery and on the peri-partum parameters of fetal well-being and it is aimed at verifying the prognostic value of a diagnostic dynamic test. Methods: From July 2015, our cross-sectional and analytical controlled study enrolled women, with low-risk singleton pregnancy, referring to the hospitals of the Second District of Liguria (Savona and Pietra Ligure - Italy). The OMT and the diagnostic test were performed at the obstetrics-osteopathic practice of the hospitals, approved by the local Healthcare Director. Nulliparous patients who agreed to submit to OMT were treated at the beginning, mid and late (36-38 weeks) third trimester of pregnancy; patients who were not interested in OMT entered the control group. The values of the transverse diameter of the Michaelis' sacral rhomboid area (PSIS) in changing three different positions (1- vertical kneeling position; 2- hand-to-knee position; 3- kneeling squat position) and their differences were the diagnostic predictive tool. Results: Obstetrical outcomes considered for this study are: normal deliveries (ND), operative deliveries (OD: kiwi and/or >3 Kristeller manouvres), cesarean sections (CS), pharmacological inductions of labour for pregnancy beyond the term, demands for analgesia, use of oxytocin in the first stage of labour, episiotomy rate, presence of meconium-stained fluid, neonatal APGAR score, PROM. Statistical analysis of clinical outcomes: chi-square test and risk ratio (RR) with 95% confidence interval (95%CI). Apgar score was analyzed by Mann-Whitney U test. T-test and area under the ROC curve (θ value) for the transverse sacral diameter were done. Significance from p= 0.05. The low-risk nulliparae in labour were in total 327: 166 for the OMT group and 161 for the control group. The deliveries were between October 2015 and December 2016. It was shown to be significant (OMT vs control): an overall lower rate of dystocia (CS+OD: 19/166 - 11.4% vs 47/161 - 29.1%: p=0.00006; RR 0.39 and 95%CI 0.24-0.63), a lower CS rate during labour (7.8% vs 13.1%: p = 0.05; RR 0.52 and 95%CI 0.27-1.003), a lower OD rate (3.6% vs 16.1%: p=0.00006, RR 0.21 and 95%CI 0.08-0.49) and a lower use of episiotomy (9.8% vs 22.8%: p=0.002; RR 0.42 and 95%CI 0.24- 0.75). Amniotic fluid was less frequently meconium-stained (13.2% vs 23.6%: p = 0.01; RR 0.56 and 95%CI 0.34-0.91). The rate of pregnancy beyond the term, treated with pharmacological induction, was not significantly different (13.2% vs. 19.2%: p = 0.1) but in the OMT group CS+OD was less effective frequency (18.1% vs 54.8%: p = 0.008; RR 0.33 and 95%CI 0.12-0.85). The transverse diameter of Michaelis' losanga adapts in changing positions: 364 triplets of data (ND= 283; CS+OP: 81) are summarized as follow. ND PSIS1: mm. 125,5±13,8 and CS+OD PSIS1: mm. 127,7±16,9 (t-test and ROC: not significant - ns). ND PSIS2: mm. 133,1±14,1 and CS+OD PSIS2: mm. 130,1±17,6 (t-test and ROC: ns). ND PSIS3: mm. 132,9±15,1 and CS+OD PSIS3: mm. 127,7±18,1 (t-test and ROC: ns). ND PSIS2-1: mm. 8,3±3,8 and CS+OD PSIS2-1: mm. 2,5±2,1 (t-test p 0,000 ; ROC θ value: 0, and 95%CI 0,92-0,97). ND PSIS3-1: mm. 7,3±5,9; CS+OD PSIS3-1: mm. 1,1±4,3 (t-test p 0,000 ; ROC θ value: 0,81 and 95%CI 0,76-0,86 ). ND PSIS2-3: mm. 1,1±4,8; CS+OD PSIS2-3: mm. 1,4±3,7 (t-test and ROC: ns). A PSIS2-1 (difference between hand-to-knee position and vertical position) cut-off value of 3,0 mm. shows a True Positive Rate: 0,98; a True Negative Rate: 0,81; False Positive Rate 0,18; False Negative Rate: 0,01. Conclusion: Preliminary data from our experience confirm that osteopathic treatment during the third trimester of pregnancy is safe for both mother and baby, OMT seems to be able to support birth physiology and reduce dystocia. These outcomes potentially result in fewer days of hospitalization and a reduction in risk factors for maternal and neonatal disease. Osteopathy seems also to support midwives and obstetricians in the diagnosis of dystocia by its dynamic approach to external pelvimetry. WHO recommends collaboration and integration between traditional and conventional approaches in medicine. Midwives and osteopaths together could improve the quality of childbirth and delivery, thus affecting the well-being of the infants in the short and long term as well as women's health. [ABSTRACT FROM AUTHOR]

Objectives: The response rate to treatment of chronic hepatitis C virus-genotype 1 and 4 infections was recently found to be strongly influenced by many polymorphisms. The aim of our study was to carry out an integrated analysis of the effects of polymorphisms and ribavirin (RBV) plasma exposure on outcome., Methods: The retrospective analysis included 174 patients. IL28B, CYP27B1, SLC29A1, SLC28A3, and SLC28A2 polymorphisms were genotyped and tested for association with sustained virological response. The impact of RBV plasma exposure during the first 3 months of therapy on outcome was also investigated., Results: Considering patients infected by hepatitis C virus-1/4, 3 polymorphisms (IL28B rs8099917TT, CYP27B1 rs4646536TT, and CNT2 rs11854484TT) were associated with sustained virological response. The number of negative variant allele and low RBV exposure were correlated to percentage increasing to therapy failure, suggesting some degree of cumulative effect of the 4 factors. A cutoff of 2.5 μg/mL of RBV was found to be associated with outcome (area under ROC [AUROC] curve = 0.64, sensitivity = 55.0%, and specificity = 71.2%, P = 0.020). In multivariate logistic regression analyses, each variant allele and RBV plasma exposure cutoff were independently associated with outcome., Conclusions: In this study, we found that additional polymorphisms and RBV plasma exposure are also able to influence the achievement of response. Regardless of the magnitude of RBV pharmacokinetic exposure, the negative predictive value of the polymorphisms here investigated is much stronger than the positive one.

Introduction: Raltegravir (RAL) is the first in class integrase inhibitor and is licensed for administration at 400 mg twice daily. RAL pharmacokinetics are characterized by high interpatient variability and recently RAL plasma exposure has been correlated with efficacy. RAL is primarily metabolized by glucuronidation via uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) and UGT1A1*28 considered to be the main genetic variant associated with decreased UGT1A1 expression. This study investigated variability in RAL trough plasma concentrations (Ctrough) in the clinical setting, the effect of UGT1A1*28 and concomitant antiretrovirals., Methods: A total of 86 patients, from Turin, Italy, and Madrid, Spain, were included in the analysis. Blood samples were obtained 10-14 hours postdose. Genotyping for UGT1A1*28 was conducted by sequencing., Results: High interpatient and intrapatient variabilities were observed; 13 patients had ≥3 samples available, and the median coefficient of variation was 128 (64-265). Coadministration of RAL with atazanavir (ATV, n = 9) resulted in higher raltegravir Ctrough, 517 (307-2706) ng/mL when compared with patients not receiving ATV (n = 77) 223 (95-552; P = 0.02). UGT1A1*28 did not influence RAL plasma exposure., Discussion: We have documented large intersubject and intrasubject variabilities in RAL plasma concentrations and confirmed the interaction with ATV. Further studies are required to better understand the mechanisms that influence the pharmacokinetics of RAL.