Efficacy of Aortic Valve Replacement through Full Sternotomy and Minimal Invasion (Ministernotomy).

Background: new minimally invasive sternotomy (mini-sternotomy) procedures have improved the treatment outcome and reduced the incidence of perioperative complications leading to improved patient satisfaction and a reduced cost of aortic valve replacement in comparison to the conventional median sternotomy (full sternotomy). The aim of this study is to compare and gain new insights into operative and early postoperative outcomes, long-term postoperative results, and 5-year survival rates after aortic valve replacement through a ministernotomy and full sternotomy. Methods: This is a retrospective study of patients who underwent an isolated replacement of the aortic valve via a full sternotomy or ministernotomy from 2011 to 2016. From 2011 to 2016, 426 cardiac interventions were performed, 70 of which (16.4%) were of the ministernotomy and 356 (83.6%) of the full sternotomy. Through propensity score matching, 70 patients who underwent the ministernotomy (ministernotomy group) were compared with 70 patients who underwent the full sternotomy (control group). Results: in the propensity matching cohort, no statistical difference in operative time was noted (p = 0.856). The ministernotomy had longer cross clamp (88.7 ± 20.7 vs. 80.3 ± 24.6 min, p = 0.007) and bypass (144.0 ± 29.9 vs. 132.9 ± 44.9 min, p = 0.049) times, less ventilation time (9.7 ± 1.7 vs. 11.7 ± 1.4 h, p < 0.001), shorter hospital stay (18.3 ± 1.9 vs. 21.9 ± 1.9 days, p = 0.012), less 24-h chest tube drainage (256.2 ± 28.6 vs. 407.3 ± 40.37 mL, p < 0.001), fewer corrections of coagulopathy (p < 0.001), fewer patients receiving catecholamine (5.71 vs. 30.0%, p < 0.001) and better cosmetic results (p < 0.001). Moreover, the number of patients without complaints at 1 year after the operation was significantly greater in the ministernotomy group (p = 0.002), and no significant differences in the 5-year survival between the groups were observed. In the overall cohort, the ministernotomy had longer cross clamp times (88.7 ± 20.7 vs. 79.9 ± 24.8 min, p < 0.001), longer operative times (263.5 ± 62.0 vs. 246.7 ± 74.2 min, p = 0.037) and bypass times (144.0 ± 29.9 vs. 132.7 ± 44.5 min, p = 0.026), lower incidence of 30-day mortality (1(1.4) vs. 13(3.7), p = 0.022), shorter hospital stays post-surgery p = 0.025, less 24-h chest tube drainage, p < 0.001, and fewer corrections of coagulopathy (p < 0.001). Conclusions: the ministernotomy has a number of advantages compared with the full sternotomy and thus could be a better approach for aortic valve replacement.

Stem cell intervention ameliorates epigallocatechin-3-gallate/lipopolysaccharide-induced hepatotoxicity in mice.

Stem cells are identified as a novel cell therapy for regenerative medicine because of their ability to differentiate into many functional cell types. We have shown earlier a new model of hepatotoxicity in mice by administering (1500 mg/kg) epigallocatechin-3-gallate (EGCG) intragastric (IG) for 5 days after a single intraperitoneal dose (6 mg/kg) of lipopolysaccharide (LPS). In this study, we aimed to study the effect of intrahepatic (IH) injection of mouse embryonic stem cells (MESCs) on the hepatotoxicity induced by EGCG/LPS in mice. Mice were administered EGCG/LPS and rested for 3 days. MESCs were obtained from American Type Culture Collection and cultured in vitro for 4 days. Stem cells were injected IH. Seven days later, a single dose of LPS (6 mg/kg) followed by daily doses of IG administration of EGCG were re-administered for 5 days. At the end of the experiment, blood samples were collected for analysis of biochemical parameters associated with liver. Results showed that the group of mice that were administered MESCs prior to EGCG/LPS showed lower levels of alanine amino transferase, alkaline phosphatase, and bilirubin, higher albumin/globulin ratio, and less remarkable histopathological lesions. Also, that group of mice showed less expression of oxidative stress biomarkers (oxidized low-density lipoprotein Ox.LDL and chemokine CXCL16), less expression of nuclear protein receptors (retinoic acid receptor and retinoid X receptor), and less expression of inflammatory biomarkers (tumor necrosis factor α and transforming growth factor ß1) compared with other groups of mice that were not given MESCs. In conclusion, MESCs can ameliorate EGCG/LPS-induced hepatotoxicity in mice.

Process analytical technology: non-destructive assessment of anastrozole entrapment within PLGA microparticles by near infrared spectroscopy and chemical imaging.

The objective of this study was to evaluate near-infrared (NIR) spectroscopy and imaging as approaches to assess anastrozole entrapment within PLGA microparticles. By varying the polymer concentration, three batches containing the same amount of the drug were prepared. The spectral features that allow NIR drug quantitation were evaluated and compared with a best fit line algorithm. Actual entrapment efficiencies (EEF) determined via a destructive method were used for construction of calibration models using partial least square regression (PLS) or the algorithm. On the other hand, a chemical imaging system based on array detector technology was used to rapidly collect high contrast NIR images of the formulated microparticles. A quantitative measure of anastrozole entrapped was determined by calculating the percentage standard deviation of the distribution of pixel intensities in the PLS score images and histograms. Concerning conventional NIR analysis, both methods were equivalent for the prediction of EEF over the range of polymer levels studied. Correlation coefficients of more than 0.992 were obtained for either the calibration or prediction of EEF by the two methods; 0.392% and 0.374% were the standard errors of calibration and prediction (SEC and SEP) obtained for the prediction of EEF using the fit line, respectively, whereas the prediction of the EEF by the partial least square regression showed a SEC of 0.195% and SEP of 0.179%. As a result, the spectral best fit algorithm method compared favourably to the multivariate PLS method, but was easier to develop. In contrast, NIR spectral imaging was capable of clearly differentiating the three batches, both qualitatively and quantitatively. The percentage standard deviation increased progressively by increasing the ratio of drug-to-polymer concentrations. In conclusion, both NIR approaches were capable of accurate assessment of drug entrapment within microparticles. In addition, the NIR spectral imaging system provides a rapid approach for acquiring spatial and spectral information on microparticles.

Correlation between somatic sensation inventory scores and hyperarousal scale scores.

Somatization mechanisms are poorly understood. The authors tested whether somatization might involve altered central nervous system information processing. They measured somatization using the Somatization Sensation Inventory (SSI) and information processing style using the Hyperarousal Scale, scores of which correlate with electroencephalogram(EEG) measures of cortical electrical responsiveness. SSI scores correlated highly with Hyperarousal scores. On logistic regression, two SSI items and two Hyperarousal items accounted for most of this correlation. These specific hyperarousal items had previously been found to covary with EEG activity and cortical evoked potential amplitudes. The authors concluded that somatization may involve altered CNS processing of somatic stimuli.

Solubility and stability of lorazepam in bile salt/soya phosphatidylcholine-mixed micelles.

In the present study, the solubility and stability of the drug lorazepam, which was solubilized in bile salt/soya phosphatidylcholine-mixed micelles (BS/SPC-MMs), were investigated. The solubility of lorazepam could be enhanced substantially in different bile salts and also in sugar ether, whereas the solubility in Pluronic F68 (Pl.F68) was of lower order. Moreover, the addition of SPC to different BS solutions greatly enhanced their solubilizing capacities toward lorazepam; this could be correlated with the ability of the formed MM to reduce the surface tension. The stability study showed that lorazepam degradation followed apparent first-order degradation kinetics in phosphate buffer, as well as in the BS/SPC-MM, with highly enhanced stability in the latter system. The stabilizing effect of BS/SPC-MM was higher in the case of trihydroxy BS than for dihydroxy BS. From an Arrhenius plot with degradation constants in a temperature range from 30 degrees C to 60 degrees C, a shelf stability of about 10 months could be calculated for BS/SPC-MM at 5 degrees C. The solubility studies in BS/SPC-MM showed a recrystallization and a polymorphic transition from modification II to I.

Solubility and stability of tetrazepam in mixed micelles.

The solubility and stability of the chemically unstable drug tetrazepam which has poor water solubility have been studied in bile salts-phosphatidylcholine-mixed micelles (BS-PC-MM). The solubilization potential of BS-PC-MM was much higher than that of BS alone. The use of soya-PC (SPC) instead of egg-PC (EPC) increased the solubilization capacity of MM. The results of the stability studies indicated first order degradation kinetics in most cases under aerobic conditions. An Arrhenius plot could be constructed in a temperature range from 30 to 60 degrees C in sodium deoxycholate-SPC-MM (SDC-SPC-MM) as well as in phosphate buffer at pH 7.4. Sodium glycocholate-SPC-MM (SGC-SPC-MM) interfered with the degradation kinetics and displayed better stabilizing effects under both aerobic and anaerobic conditions. The addition of ascorbic acid (AA) protected tetrazepam to some extent, whereas Na2SO3 or Na2S2O5 were incompatible with it. Formulating tetrazepam in SGC-SPC-MM containing 0.1% AA resulted in a shelf stability of more than 1 year under anaerobic conditions.

Increasing drug solubility by means of bile salt-phosphatidylcholine-based mixed micelles.

Study of the solubilization of commercial grades of soya phosphatidylcholine (SPC) with different purities by bile salts (BS) indicated that only highly pure grades of SPC are suitable for the preparation of clear solutions of BS/SPC-mixed micelles (BS/SPC-MM). The solubilizing capacity of different BS towards SPC increased in the following order; Sodium cholate (SC) < sodium deoxycholate (SDC) < sodium glycocholate (SGC). Moreover, egg phosphatidylcholine (EPC) was solubilized to a higher extent than SPC. Furthermore, the solubility study of different drugs in the prepared MM showed substantial enhancement of solubility, the extent of which is essentially affected by the chemical nature of the drug and the composition of MM. Benzodiazepine drugs such as clonazepam, tetrazepam, diazepam, and lorazepam displayed higher affinity for MM compared with BS alone, whereas steroidal drugs, such as estradiol, prednisolone and progesterone, compared with benzodiazepines, displayed relatively higher affinity for BS alone. The solubilizing capacity of MM for the different drugs was increased to different degrees by the addition of benzyl alcohol which was comparable to the solubility of the drug in pure benzyl alcohol. The interaction between benzyl alcohol and the drug in MM could be proved by NMR.

Chronic pelvic pain in Lippes IUD users. Laparoscopic and venographic evaluation.

PIP: 39 women using the Lippes loop C, and complaining of chronic pelvic pain dating from after insertion of the IUD, were investigated by laparoscopy and transuterine pelvic venography in the premenstrual period of the cycle. Patients complaining only of cramp-like pain similar to spasmodic dysmenorrhea were not included. Other types of pain noticed were dull aching low abdomen, deep seated pelvic pain with associated dyspareunia, and low backache mainly on the sacrum. Pain was attributed to the presence of pelvic variocele diagnosed by laparoscopy (52%), and venography (95%), chronic pelvic inflammatory disease (28%), and pelvic adhesions (8%). The sites of maximum pain correlated well with the sites of maximum varicosities and/or venous stasis. Menorrhagia was associated with pain in one-third of the cases and was explained on the basis of increased pelvic vascularity, chronic pelvic inflammatory disease, and cystic changes in the ovaries. The possible factors predisposing to uterine perforation during venography in 3 cases are discussed.^ieng