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Comparison of Ketogenic Diets with and without Ketone Salts versus a Low-Fat Diet: Liver Fat Responses in Overweight Adults.
Crabtree, CD, Kackley, ML, Buga, A, Fell, B, LaFountain, RA, Hyde, PN, Sapper, TN, Kraemer, WJ, Scandling, D, Simonetti, OP, et al
Nutrients. 2021;(3)
Abstract
Ketogenic diets (KDs) often contain high levels of saturated fat, which may increase liver fat, but the lower carbohydrate intake may have the opposite effect. Using a controlled feeding design, we compared liver fat responses to a hypocaloric KD with a placebo (PL) versus an energy-matched low-fat diet (LFD) in overweight adults. We also examined the added effect of a ketone supplement (KS). Overweight adults were randomized to a 6-week KD (KD + PL) or a KD with KS (KD + KS); an LFD group was recruited separately. All diets were estimated to provide 75% of energy expenditure. Weight loss was similar between groups (p > 0.05). Liver fat assessed by magnetic resonance imaging decreased after 6 week (p = 0.004) with no group differences (p > 0.05). A subset with nonalcoholic fatty liver disease (NAFLD) (liver fat > 5%, n = 12) showed a greater reduction in liver fat, but no group differences. In KD participants with NAFLD, 92% of the variability in change in liver fat was explained by baseline liver fat (p < 0.001). A short-term hypocaloric KD high in saturated fat does not adversely impact liver health and is not impacted by exogenous ketones. Hypocaloric low-fat and KDs can both be used in the short-term to significantly reduce liver fat in individuals with NAFLD.
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High absolute lymphocyte counts are associated with longer overall survival in patients with metastatic breast cancer treated with eribulin-but not with treatment of physician's choice-in the EMBRACE study.
Miyoshi, Y, Yoshimura, Y, Saito, K, Muramoto, K, Sugawara, M, Alexis, K, Nomoto, K, Nakamura, S, Saeki, T, Watanabe, J, et al
Breast cancer (Tokyo, Japan). 2020;(4):706-715
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BACKGROUND Eribulin, a nontaxane synthetic inhibitor of microtubule dynamics, is widely used to manage locally advanced or metastatic breast cancer (MBC). Eribulin has demonstrated immunomodulatory activity on the tumour microenvironment. Baseline neutrophil-to-lymphocyte ratio (NLR), a marker of immune status, may predict progression-free survival in eribulin treatment. This post hoc analysis assessed predictors for overall survival (OS). METHODS The phase 3 open-label study (EMBRACE) of eribulin versus treatment of physician's choice (TPC) in patients with MBC provided source data. Baseline absolute lymphocyte counts (ALCs) and NLR were evaluable in 751 and 713 patients, respectively. RESULTS Eribulin prolonged OS versus TPC in patients with baseline ALC ≥ 1500/µl (hazard ratio [HR] 0.586; 95% confidence interval [CI] 0.437-0.784; P < 0.001). There was no significant difference by treatment for ALC < 1500/µl (HR 1.002; 95% CI 0.800-1.253; P = 0.989). Univariate and multivariate analyses were performed and identified baseline ALC as a potential predictor of OS in eribulin-treated patients. Interaction analysis of OS supported 1500/µl as a potentially differential cutoff value. NLR at a cutoff value of 3 was associated with prolonged OS (eribulin group). However, similar results were also observed in the TPC group, without apparent interaction effect, suggesting that NLR may be a general prognostic marker rather than a specific predictor of OS for eribulin. DISCUSSION This hypothesis-generating study speculates that baseline ALC may be an independent predictor for longer OS in eribulin-treated MBC patients and could be clinically impactful because it can be evaluated without the need for additional invasive procedures. TRIAL REGISTRATION www.ClinicalTrials.gov code: NCT00388726.
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PEEK versus metal cages in posterior lumbar interbody fusion: a clinical and radiological comparative study.
Cuzzocrea, F, Ivone, A, Jannelli, E, Fioruzzi, A, Ferranti, E, Vanelli, R, Benazzo, F
Musculoskeletal surgery. 2019;(3):237-241
Abstract
BACKGROUND Low back pain and sciatica represent a common disabling condition with a significant impact on the social, working and economic lives of patients. Transforaminal lumbar interbody fusion (TLIF) is a surgical procedure used in degenerative spine conditions. Several types of cages were used in the TLIF procedure. PURPOSE To determine whether there is a difference in terms of symptomatology improvement, return to daily activities and fusion rate between metal cages and polyetheretherketone (PEEK) cages. METHODS We have retrospectively reviewed 40 patients who have undergone TLIF from October 2015 to May 2016. All patients were clinically evaluated with questionnaires and were assessed with CT scan and standing X-ray films of the full-length spine. RESULTS We found no significant functional differences in the two groups. At 1-year follow-up, osteolysis was present in 50% of cases of the PEEK cages and in 10% cases of the metal cages. The degree of fusion at 1 year was evaluated as complete in 40% cases of the metal cages and 15% cases of the PEEK cages. CONCLUSIONS We have found a better fusion rate and prevalence of fusion in the group treated with metal cages, reflecting the well-known osteoinductive properties of titanium and tantalum.
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Clinical and radiological results comparison of allograft and polyetheretherketone cage for one to two-level anterior cervical discectomy and fusion: A CONSORT-compliant article.
Yang, S, Yu, Y, Liu, X, Zhang, Z, Hou, T, Xu, J, Wu, W, Luo, F
Medicine. 2019;(45):e17935
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BACKGROUND Recently, many kinds of cages for cervical fusion have been developed to avoid the related complications caused by tricortical iliac crest graft. The existing literature has reported the excellent clinical efficacy and superior fusion rate. However, various types of cages have their own disadvantages. Which bone graft material is the best choice for cage with the fewest complications? At present, there is still no conclusion. METHODS By reviewing patients with 1 to 2-level cervical degenerative disease in our hospital with a novel cage made of allograft or polyetheretherketone (PEEK), we evaluated the efficacy and reliability of the new cage in anterior cervical discectomy and fusion (ACDF). From 2015 to 2016, a prospective review of 58 and 49 consecutive cases with spondylotic radiculopathy or myelopathy undergoing ACDF using allograft (group A) and PEEK (group B) cage were performed. The follow-up ranged from 12 to 40 months. Intraoperative index, clinical outcome and complications were recorded. Radiographs evaluated segmental and overall cervical lordosis, the height of the intervertebral space, interbody height ratio (IHR), cage positioning, and fusion state. RESULTS A total of 134 cages were implanted. Compared to preoperatively, the visual analog scale (VAS) and neck disability index (NDI) were reduced postoperatively without any change during the subsequent follow-up in both groups. There was no migration or extrusion of the cages at the latest follow-up. There were 2 and 4 patients suffering dysphagia respectively. In both groups, the intervertebral height, IHR, segmental and overall cervical lordosis were significantly greater than pre-operation (P < .05) and were maintained at the last follow-up, but were not statistically significant (P > .05). The allograft group achieved a fusion rate of 100% (58/58) according to CT scans at 3 months post-operation, while PEEK group was 91.8% (45/49), which reached 95.9% (47/49) at 6 months and 100% at 12 months. In addition, the fusion state was maintained in all patients at the last follow-up. CONCLUSION Our data showed that the new allograft cage is superior to the PEEK cage in providing a high fusion rate and fewer complications after 1-level and 2-level ACDF procedures. It may represent an excellent alternative to other cages.
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Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program.
Jacot, W, Heudel, PE, Fraisse, J, Gourgou, S, Guiu, S, Dalenc, F, Pistilli, B, Campone, M, Levy, C, Debled, M, et al
International journal of cancer. 2019;(12):3359-3369
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Eribulin mesylate (EM) was recently approved for metastatic breast cancer (MBC) chemotherapy (CT) in late lines by the FDA, with debated results in second line. We evaluated outcomes in breast cancer patients receiving EM as second, third and fourth line in a national real-life cohort of 16,703 consecutive MBC patients initiating their first metastatic therapeutic line between 2008 and 2014. Primary and secondary objectives were overall survival (OS) and progression-free survival (PFS). An imbalance was seen for HER2+ tumors and concomitant anti-HER2 targeted therapies use, we thus performed a subanalysis in HER2- patients. PFS and OS were significantly better in EM patients in third and fourth lines, compared to "Other chemotherapies" patients (PFS: 4.14 vs. 3.02 months, p = 0.0010; 3.61 vs. 2.53 months, p = 0.0102, third and fourth-line; OS: 11.27 vs. 7.65 months, p = 0.0001; 10.91 vs. 5.95 months, p < 0.0001, third and fourth-line). No significant difference was reported in second-line (PFS: 5.06 vs. 4.14 months, p = 0.1171; OS: 13.99 vs. 11.66 months, p = 0.151). Among HER2- patients, a significant difference was seen for all lines, including 2nd-line (PFS: 4.57 vs. 3.91 months, p = 0.0379; OS: 14.98 vs. 10.51 months, p = 0.0113). In this large real-world database, HER2-negative MBC patients receiving EM in second or later CT line presented significantly better PFS and OS. This difference disappeared in second line in the overall population, probably because of the imbalance in HER2-targeted treatments use. Our results mirror those of the published randomized trials. The effect of anti-HER2 therapies addition in this setting still needs to be defined.
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The formation of perianchor fluid associated with various suture anchors used in rotator cuff repair: all-suture, polyetheretherketone, and biocomposite anchors.
Kim, SH, Yang, SH, Rhee, SM, Lee, KJ, Kim, HS, Oh, JH
The bone & joint journal. 2019;(12):1506-1511
Abstract
AIMS: The aim of this study was to compare the osseous reactions elicited by all-suture, polyetheretherketone (PEEK), and two different biodegradable anchors used during rotator cuff repair. PATIENTS AND METHODS Transosseous-equivalent rotator cuff repair was performed in 73 patients. The patients were divided into two groups, in both of which two different medial-row anchors were used. In group 1, anchor A comprised 30% β-tricalcium phosphate (TCP) + 70% fast-absorbing poly lactic-co-glycolic acid copolymer (85% polylactic acid enantiomers + 15% polyglycolic acid) and anchor B comprised all-sutures. In group 2, anchor C comprised 23% micro β-TCP + 77% polylactic acid enantiomers and anchor D comprised PEEK polymer. There were 37 patients in group 1 and 36 patients in group 2. The presence and severity of fluid collection around anchors and healing of the rotator cuff were assessed using MRI scans, approximately one year postoperatively. The severity of the collection was graded as 0 (no perianchor fluid signal), 1 (minimal perianchor fluid), 2 (local collection of fluid), 3 (fluid collection around the whole length of the anchor but of a diameter less than twice the anchor diameter), or 4 (fluid collection around the whole length of the anchor and of a diameter greater than twice the anchor diameter). RESULTS A perianchor fluid signal was seen in three patients (8.1%) with anchor A, four (10.8%) with anchor B, 15 (41.7%) with anchor C, and 15 (41.7%) with anchor D. The severity of the collection around anchor was grade 2:1:0:0 for anchor A, grade 2:2:0:0 for anchor B, grade 12:2:0:1 for anchor C, and grade 11:3:0:1 for anchor D (grade 1:2:3:4, respectively). The prevalence and severity of fluid formation was not significantly different between anchors A and B, and anchors C and D. However, on intergroup analysis, there were significant differences for the prevalence and severity of fluid formation between anchors in group 1 and group 2. The prevalence of failure to heal was not significant in group 1 (seven, 18.9%) or group 2 (nine, 25.0%). There was no relationship between the presence of perianchor fluid and each type of anchor, and the integrity of the rotator cuff repair, in either group. CONCLUSION Despite the nonabsorbable nature of all-suture and PEEK anchors, all-suture anchors produced less osseous reaction after rotator cuff repair. In deciding which kind of anchor to use, consideration should be given not only to the strength of the initial fixation, but also to the postoperative biological reaction. Cite this article: Bone Joint J 2019;101-B:1506-1511.
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Comparison between the different types of heterologous materials used in cranioplasty: a systematic review of the literature.
Morselli, C, Zaed, I, Tropeano, MP, Cataletti, G, Iaccarino, C, Rossini, Z, Servadei, F
Journal of neurosurgical sciences. 2019;(6):723-736
Abstract
INTRODUCTION The choice of heterologous materials for cranioplasty after decompressive craniectomy is still difficult. The aim of this study is to examine the association between material of choice and related complications to suggest the best treatment option. EVIDENCE ACQUISITION A systematic review was performed for articles reporting cranioplasty comparing the following heterologous implants: titanium, poli-methyl-methacrylate (PMMA), polyetheretherketone (PEEK) and hydroxyapatite (HA). Extracted data included implant materials and incidence of the most frequent complications. EVIDENCE SYNTHESIS The final selection resulted in 106 papers but according to our rules only 27 studies were included in the final analysis. Among a total of 1688 custom-made prosthesis implanted, 649 were titanium (38.49%), 298 PMMA (17.56%), 233 PEEK (13.82%), and 508 were HA (30.13%). A total of 348 complications were recorded out of 1688 reported patients (20.64%). In the titanium group, 139 complications were recorded (21.42%); in the PMMA group 57 (19.26%), in the PEEK group 49 (21.03%) and in the HA group 103 (20.3%). If we examine a summary of the reported complications clearly related to cranioplasty (postoperative infections, fractures and prosthesis displacement) versus type of material in multicentric and prospective studies we can see how HA group patients have less reported infections and cranioplasty explantation after infections than PMMA, PEEK and titanium. On the contrary HA patients seem to have a higher number of prosthesis displacement again if compared with the other materials. Since these data are not derived from a statistically correct analysis they should be used only to help to differentiate the properties of the various heterologous cranioplasties. CONCLUSIONS The ideal material for all heterologous cranioplasty has not yet been identified. The choice of material should be based on the clinical data of patients, such as the craniectomy size, presence of seizures, possibility of recovery, good long-term outcome associated with a cost analysis.
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Subgroup analysis of patients with HER2-negative metastatic breast cancer in the second-line setting from a phase 3, open-label, randomized study of eribulin mesilate versus capecitabine.
Pivot, X, Im, SA, Guo, M, Marmé, F
Breast cancer (Tokyo, Japan). 2018;(3):370-374
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This post hoc subgroup analysis of a large phase 3 study compared the efficacy and safety of eribulin versus capecitabine in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who received second-line treatment. In the phase 3 study, women with advanced/metastatic breast cancer and ≤ 3 prior chemotherapies were randomized 1:1 to eribulin mesilate 1.4 mg/m2 intravenously on days 1 and 8, or twice-daily oral capecitabine 1.25 g/m2 on days 1-14 (21-day cycles). This analysis included 392 patients. Median overall survival was longer in patients receiving eribulin compared with capecitabine (16.1 vs 13.5 months, respectively; HR 0.77, P = 0.026). Median progression-free survival and response rates were similar between arms. Both treatments had manageable safety profiles.
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Ketone production in children with type 1 diabetes, ages 4-14 years, with and without nocturnal insulin pump suspension.
Wadwa, RP, Chase, HP, Raghinaru, D, Buckingham, BA, Hramiak, I, Maahs, DM, Messer, L, Ly, T, Aye, T, Clinton, P, et al
Pediatric diabetes. 2017;(6):422-427
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OBJECTIVE To compare the frequency of elevated morning blood ketone levels according to age in 4-14 year olds with type 1 diabetes following overnight use of an automated low glucose insulin suspension system, or following control nights when the system was not used. RESEARCH DESIGN AND METHODS For 28 children ages 4-9 years and 54 youth ages 10-14 years, elevation of morning blood ketone levels was assessed using the Precision Xtra Ketone meter following 1155 and 2345 nights, respectively. Repeated measures logistic regression models were used to compare age groups for blood ketone level elevation following control nights (system not activated) and following intervention nights with and without insulin suspension. RESULTS Elevated morning blood ketones (≥0.6 mmol/L) were present following 10% of 580 control nights in the 4-9 year olds compared with 2% of 1162 control nights in 10-14 year olds (P < 0.001). Likewise, the frequency was greater following intervention nights in the younger age group (13% of 575 nights vs 2% of 1183 nights, P < 0.001). A longer duration of pump suspension resulted in a higher percentage of mornings with elevated blood ketones in the younger age group (P = 0.002), but not in the older age group (P = 0.63). The presence of elevated morning ketone levels did not progress to ketoacidosis in any subject. CONCLUSIONS Elevated morning blood ketones are more common in younger children with type 1 diabetes with or without nocturnal insulin suspension. Care providers need to be aware of the differences in ketogenesis in younger age children relative to various clinical situations.
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Comparison of the PEEK cage and an autologous cage made from the lumbar spinous process and laminae in posterior lumbar interbody fusion.
Lin, B, Yu, H, Chen, Z, Huang, Z, Zhang, W
BMC musculoskeletal disorders. 2016;(1):374
Abstract
BACKGROUND A prospective cohort study was performed to evaluate the clinical and radiological outcomes following posterior lumbar interbody fusion (PLIF) in patients treated with a PEEK cage compared to those treated with an autologous cage using the lumbar spinous process and laminae (ACSP). METHODS Sixty-nine consecutive patients with lumbar degenerative disc disease were randomly assigned to either a PEEK cage (group A, n = 34) or an ACSP (group B, n = 35). Monosegmental PLIF was performed in all patients. Mean lumbar lordosis, mean disc height, visual analog scale (VAS) scores, functional outcomes, fusion rates and complication rates were recorded and compared. The patients were followed postoperatively for a minimum of 2 years. RESULTS Successful radiographic fusion was documented in all patients. No flexion-extension hypermobility or pedicle screw loosening or breakage occurred during the follow-up period. No significant difference existed between the 2 groups when comparing the mean lumbar lordosis, mean disc height, visual analog scale (VAS) scores, functional outcomes, fusion rates or complication rates. Overall satisfactory results were achieved in both groups. CONCLUSIONS The results suggest that the ACSP appears to be equally as safe and effective as the PEEK cage. TRIAL REGISTRATION ISRCTN25558534 . Retrospectively registered 16/02/2016.