Cationised gelatin and hyaluronic acid coating enhances polyethylene terephthalate artificial ligament graft osseointegration in porcine bone tunnels

Purpose

The aim of this study was to investigate whether cationised gelatin and hyaluronic acid (CH) coating could induce polyethylene terephthalate (PET) artificial ligament graft osseointegration in the bone tunnel.

Methods

Surface modification of PET artificial ligament graft was performed by layer-by-layer (LBL) self-assembly CH coating. Six pigs underwent anterior cruciate ligament (ACL) reconstruction on the right knees, with three pigs receiving the CH-coated PET grafts and the other three pigs non-CH-coated PET grafts as controls. They were sacrificed at three months after surgery and the graft-bone complexes were acquired for computed tomography (CT) scan and histological examination.

Results

CT scans showed a significant difference at the distal femoral site (p = 0.031) or at the distal tibial site (p = 0.0078), but no significant difference in the bone tunnel areas’ enlargement at other sites (p > 0.05) between the CH group and the control group. Histologically, application of CH coating induced new bone formation between graft and bone at three months compared with the controls at the distal site. The interface width of the CH group was significantly lower than that of the control group at the distal femoral site (p = 0.0327) and at the distal tibial site (p = 0.0047).

Conclusions

The study has shown that CH coating on the PET artificial ligament surface has a positive biological effect in the induction of artificial ligament osseointegration within the bone tunnel at the distal site of the bone tunnel.     

Fairness in cost‐benefit analysis: A methodology for health technology assessment

We evaluate the introduction of various forms of antihypertensive treatments in France with a distribution‐sensitive cost‐benefit analysis. Compared to traditional cost‐benefit analysis, we implement distributional weighting based on equivalent incomes, a new concept of individual well‐being that does respect individual preferences but is not subjectively welfarist. Individual preferences are estimated on the basis of a contingent valuation question, introduced into a representative survey of the French population. Compared to traditional cost‐effectiveness analysis in health technology assessment, we show that it is feasible to go beyond a narrow evaluation of health outcomes while still fully exploiting the sophistication of medical information. Sensitivity analysis illustrates the relevancy of this richer welfare framework, the importance of the distinction between an ex ante and an ex post approach, and the need to consider distributional effects in a broader institutional setting.     

Starch-induced implant periapical lesion: a case report

This paper reports an implant periapical lesion (IPL) with a previously unreported etiology. The presence of an osteolytic area around the apex and around the middle portion of a stable Straumann hollow-screw implant was found on periapical radiographs 3.5 years after implant placement. Case management involved curettage of the soft tissue surrounding the implant apex as well as resection of the nonosseointegrated portion of the implant. Histopathologic examination revealed a connective fibrous tissue containing a dense chronic inflammatory infiltrate with a foreign-body material. Polarized light microscopy and Fourier transform infrared microspectroscopy identified the foreign-body material as starch particles. Etiology of this IPL was thus related to a foreign-body reaction to starch particles. This exogenous contamination probably originated from starch-coated gloves during the surgical procedure. This case report suggests that IPL may successfully be treated by debridement and implant resection instead of implant removal. Peri-implant apical soft tissue should be systematically submitted for histopathologic examination.     

Managing pasireotide-associated hyperglycemia: a randomized,open-label,Phase IV study

Purpose

Pasireotide is an effective treatment for acromegaly and Cushing’s disease, although treatment-emergent hyperglycemia can occur. The objective of this study was to assess incretin-based therapy versus insulin for managing pasireotide-associated hyperglycemia uncontrolled by metformin/other permitted oral antidiabetic drugs.

Methods

Multicenter, randomized, open-label, Phase IV study comprising a core phase (≤?16-week pre-randomization period followed by 16-week randomized treatment period) and optional extension (ClinicalTrials.gov ID: NCT02060383). Adults with acromegaly (n?=?190) or Cushing’s disease (n?=?59) received long-acting (starting 40 mg IM/28 days) or subcutaneous pasireotide (starting 600 µg bid), respectively. Patients with increased fasting plasma glucose (≥?126 mg/dL on three consecutive days) during the 16-week pre-randomization period despite metformin/other oral antidiabetic drugs were randomized 1:1 to open-label incretin-based therapy (sitagliptin followed by liraglutide) or insulin for another 16 weeks. The primary objective was to evaluate the difference in mean change in HbA_1c from randomization to end of core phase between incretin-based therapy and insulin treatment arms.

Results

Eighty-one (32.5%) patients were randomized to incretin-based therapy (n?=?38 received sitagliptin, n?=?28 subsequently switched to liraglutide; n?=?12 received insulin as rescue therapy) or insulin (n?=?43). Adjusted mean change in HbA_1c between treatment arms was – 0.28% (95% CI – 0.63, 0.08) in favor of incretin-based therapy. The most common AE other than hyperglycemia was diarrhea (incretin-based therapy, 28.9%; insulin, 30.2%). Forty-six (18.5%) patients were managed on metformin (n?=?43)/other OAD (n?=?3), 103 (41.4%) patients did not require any oral antidiabetic drugs and 19 patients (7.6%) were receiving insulin at baseline and were not randomized.

Conclusion

Many patients receiving pasireotide do not develop hyperglycemia requiring oral antidiabetic drugs. Metformin is an effective initial treatment, followed by incretin-based therapy if needed.

ClinicalTrials.gov ID: NCT02060383.

     

Concomitant Use of Levothyroxine and Proton Pump Inhibitors in Patients with Primary Hypothyroidism: a Systematic Review

BackgroundThe aim of this study was to assess the effect of concomitant use of levothyroxine (LT4) and proton pump inhibitors (PPIs) on thyroid-stimulating hormone (TSH) levels in patients with primary hypothyroidism.MethodsA systematic review of interventional and observational studies that compared the TSH levels before and after concomitant use of LT4 and PPI was performed. Articles published in English up to September 1, 2019, were included. PubMed, EMBASE, and Cochrane Library databases. Gray literature was also searched in repositories, websites OpenGrey and Google Scholar, and abstracts of major international congresses. Study quality was assessed with the Newcastle–Ottawa quality assessment scale for observational studies and the Risk Of Bias In Non-randomized Studies – of Interventions (ROBINS-I) tool was used.ResultsFive thousand twelve discrete articles were identified. Following assessment and application of eligibility criteria, seven studies were included. There was a considerable heterogeneity among the included studies in design, sample size, inclusion and exclusion criteria, treatment regimen, and baseline demographics. Each of the included studies showed an increase in TSH levels following LT4 and PPI consumption, and in the majority of these, the increase was statistically significant.DiscussionThe concomitant use of LT4 and PPI showed a significant increase in TSH concentration. However, given the small number of studies, further research is needed to clarify the interfering role of PPI on LT4 intestinal absorption.PROSPERO Registration NumberCRD42020047084.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-020-06403-y.KEY WORDS: hypothyroidism, drug interaction, levothyroxine     

Rectal-tube decompression in left colectomy

Summary A series of 392 patients undergoing anterior resection, in each of whom an indwelling rectal tube was used for anastomotic decompression, was reviewed. Anastomotic complications occurred in 3.8 per cent. Five patients (1.3 per cent) died postoperatively, but only one death resulted from anastomotic leak and sepsis. The need for concomitant colostomy was reduced to 3.8 per cent, obviating the morbidity and potential mortality associated with a colostomy and its subsequent closure. Use of a rectal tube facilitated colostomy closure at the time of resection in five of seven patients who had obstruction, making later colostomy closure unnecessary. The low incidence of anastomotic recurrence (1 per cent) and suture line stenosis (0.5 per cent) demonstrates that an indwelling rectal tube does not predispose to these two complications. Anastomotic dehiscence is the primary cause of morbidity and mortality associated with surgical procedures involving the left colon. To minimize anastomotic complications, the surgeon must obtain a water-tight anastomosis, without tension, using healthy bowel with a good vascular supply. The use of an indwelling rectal tube is no substitute for fulfillment of basic surgical requirements, but it assures an adequate lumen, reduces suture-line tension, protects blood supply, and provides a means for local antibiotic irrigation. Read at the meeting of the American Society of Colon and Rectal Surgeons, Orlando, Florida, May 8 to 12, 1977.     

Prevalence, detection, management, and control of hypertension in Ashanti, West Africa

Hypertension and stroke are important threats to the health of adults in sub-Saharan Africa. Nevertheless, detection of hypertension is haphazard and stroke prevention targets are currently unattainable. Prevalence, detection, management, and control of hypertension were assessed in 1013 men (n=385) and women (n=628), both aged 55 [SD 11] years, living in 12 villages in Ashanti, Ghana. Five hundred thirty two lived in semi-urban and 481 in rural villages. The participants underwent measurements of height, weight, and blood pressure (BP) and answered a detailed questionnaire. Hypertension was defined as BP > or =140 and/or > or =90 mm Hg or being on drug therapy. Women were heavier than men. Participants in semi-urban areas were heavier and had higher BP (129/76 [26/14] versus 121/72 [25/13] mm Hg; P<0.001 for both) than in rural areas. Prevalence of hypertension was 28.7% overall and comparable in men and women, but higher in semi-urban villages (32.9% [95% CI 28.9 to 37.1] versus 24.1% [20.4 to 28.2]), and increased with age. Detection rate was lower in men than women (13.9% versus 27.3%; P=0.007). Treatment and control rates were low in both groups (7.8% and 4.4% versus 13.6% and 1.7%). Detection, treatment, and control rates were higher in semi-urban (25.7%, 14.3%, and 3.4%) than in rural villages (16.4%, 6.9%, and 1.7%). Hypertension is common in adults in central Ghana, particularly in urban areas. Detection rates are suboptimal in both men and women, especially in rural areas. Adequate treatment of high BP is at a very low level. There is an urgent need for preventive strategies on hypertension control in Ghana.