PMID: 

Dermatol Online J. 2018 Nov 15 ;24(11). Epub 2018 Nov 15. PMID: 30695972

Abstract Title: 

A systematic review on the use of cryotherapy versus other treatments for basal cell carcinoma.

Abstract: 

BACKGROUND: Cryotherapy is a commonly discussed method for treatment of basal cell carcinoma skin cancer. Some uncertainty remains about its efficacy relative to other modalities.OBJECTIVE: To determine the efficacy and adverse events profile of cryotherapy for the treatment of basal cell carcinoma compared to other therapeutic options or non-intervention.METHODS: We systematically searched PubMed, OVID, Cochrane Library, EMBASE, CINHAL, and CANCERLIT databases for the following terms:"cryotherapy", AND"basal cell carcinoma", OR"cryosurgery"OR"cryoablation"up to April 2018. Two independent reviewers screened the results and extracted the data. Study endpoints included basal cell carcinoma recurrence, cosmetic outcome, and healing time. Study quality was assessed using the Jadad scale.RESULTS: Six clinical studies met our inclusion criteria. The efficacy and safety of cryotherapy alone or with curettage in the treatment of primary superficial and nodular basal cell carcinoma was comparable to photodynamic therapy and surgery, respectively. Cryotherapy was inferior to radiation in terms of recurrence rate. Most patients had better cosmetic outcomes with photodynamic therapy and surgery compared to cryotherapy alone, and cryotherapy with curettage.CONCLUSION: Current available data suggests equivalent efficacy of cryotherapy alone compared to photodynamic therapy or surgery, but inferior to radiotherapy. More studies are necessary to draw definitive conclusions.

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PMID: 

J Natl Compr Canc Netw. 2019 Apr 1 ;17(4):358-364. PMID: 30959472

Abstract Title: 

Efficacy of Oral Cryotherapy During Oxaliplatin Infusion in Preventing Oral Thermal Hyperalgesia: A Randomized Trial.

Abstract: 

BACKGROUND: Chemotherapy-induced oral thermal hyperalgesia (OTH) is a common and debilitating side effect of platinum-based anticancer agents. This study evaluated the efficacy of oral cryotherapy in preventing OTH during oxaliplatin chemotherapy infusion.METHODS: Patients with gastrointestinal cancer treated with biweekly oxaliplatin (85 mg/m2 over 120 minutes) at Abramson Cancer Center at the University of Pennsylvania were randomized to receive oral cryotherapy (ice chips) during oxaliplatin infusion or standard-of-care treatment. All patients completed baseline questionnaires regarding oral and peripheral symptoms and on-treatment questionnaires on day 1 of each subsequent chemotherapy cycle. Those in the treatment arm were asked to document how long they kept the ice chips in their mouths (0,

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PMID: 

Am J Perinatol. 2005 Jul ;22(5):239-43. PMID: 16041632

Abstract Title: 

Neonatal ergot poisoning: a persistent iatrogenic illness.

Abstract: 

Ergot toxicity in the newborn usually manifests itself as respiratory depression, cyanosis, oliguria, and seizures. Death is usually caused by respiratory failure. A limited number of neonatal cases have been reported worldwide, and almost all cases involved confusion of maternal methylergonovine with neonatal vitamin K. Previous case reports provided little information regarding the effectiveness and dosing of antidotal therapy, especially sodium nitroprusside. A full-term male infant was inadvertently given methylergonovine instead of naloxone at birth. Several hours later, he required intubation for respiratory failure. Peripheral perfusion, ventilation, and renal function improved rapidly with nitroprusside infusion, and he was extubated on the third hospital day. Even asymptomatic newborns should be transferred to a neonatal intensive care unit for close observation after methylergonovine administration because toxicity can be life threatening. Rapid recognition of the therapeutic error, ventilatory support, and prompt administration of sodium nitroprusside should lead to a good outcome.

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PMID: 

BMJ. 1994 Apr 2 ;308(6933):908-10. PMID: 8173376

Abstract Title: 

Why we need a clinical trial for vitamin K.

Abstract: 

Vitamin K is given to many babies born in the United Kingdom, but we still do not know if it has substantial hazards. Because the population exposed to vitamin K is very large even quite small hazards would involve many adverse events. It is therefore important to be able to put reasonably close bounds on the potential damage that vitamin K prophylaxis could cause. Past research has not allowed us to do this but a large randomised controlled clinical trial of vitamin K against no vitamin K, enrolling only infants at low risk of haemorrhagic disease, would do so. There is no question that vitamin K is a useful treatment in babies at highest risk of haemorrhagic disease: the question is whether the trend towards use of vitamin K in lower risk babies should be encouraged.

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PMID: 

J Korean Acad Nurs. 2019 Apr ;49(2):149-160. PMID: 31064968

Abstract Title: 

[The Effects of Oral Cryotherapy on Oral Mucositis, Reactive Oxygen Series, Inflammatory Cytokines, and Oral Comfort in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial].

Abstract: 

PURPOSE: The purpose of this study was to examine the effects of oral cryotherapy on oral mucositis, reactive oxygen series, inflammatory cytokines, and oral comfort in patients undergoing chemotherapy for gynecologic cancers.METHODS: Participants were randomly assigned to the experimental group (n=25, receiving oral cryotherapy during chemotherapy) and the control group (n=25, receiving the usual care consisting of 0.9% normal saline gargles three times before meals). Oral mucositis was assessed using the oral assessment guide, while oral comfort was assessed using the oral perception guide. Reactive oxygen series was measured as total oxidant stress, and the level of two inflammatory markers, interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), were examined. The data were analyzed using t-test, chi-square test, Fisher's exact test, Mann-Whitney U-test, and repeated measures analysis of variance.RESULTS: There was a significant difference in the oral mucositis score, reactive oxygen series score, TNF-α level, and oral comfort score between the two groups, and there were significant changes over time and in the group-by-time interactions. There was a significant difference in the IL-6 score between the two groups, but there were no significant changes over time or in the group-by-time interactions.CONCLUSION: The study results revealed that oral cryotherapy was more effective than the usual care regime of normal saline gargles for reducing oral mucositis, reactive oxygen series, and inflammatory cytokines and for improving oral comfort in gynecologic cancer patients undergoing chemotherapy.

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PMID: 

Eur J Pediatr. 2011 May ;170(5):633-7. Epub 2010 Oct 23. PMID: 20972685

Abstract Title: 

An unusual mimicker of a sepsis outbreak: ergot intoxication.

Abstract: 

Methylergonovine (MEV) is a semi-synthetic ergot alkaloid used in the prevention and control of postpartum hemorrhage. This report describes 12 newborns born on the same day in a local country hospital in Turkey and developed sepsis-like symptoms and encephalopathy within the first 6 h of life due to accidental administration of MEV instead of vitamin K in the delivery room. The major features of MEV poisoning were lethargy (41.7%), seizure (75.0%), feeding intolerance (66.6%), hypoventilation (58.3%), irritability (25%), and peripheral circulatory abnormalities (58.3%). As a conclusion, clinical findings of ergot toxicity in newborns cannot be distinguished from infectious disease or neonatal encephalopathy.

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PMID: 

Am J Health Syst Pharm. 2010 Jan 1 ;67(1):49-57. PMID: 20044369

Abstract Title: 

Origins of and solutions for neonatal medication-dispensing errors.

Abstract: 

PURPOSE: Five cases of sound-alike, look-alike, neonatal medication-dispensing errors and their resolution are reviewed.SUMMARY: In 2008, there were five cases in which look-alike or sound-alike neonatal medication-dispensing errors occurred at our institution. A mix-up between neonatal and adult or pediatric products occurred in four of the five cases. Three of the five errors resulted in near misses with the potential to cause harm. The other two errors reached the patients but did not cause harm. The medication mix-ups involved adult and neonatal phytonadione injectable emulsion, sodium citrate injection and vancomycin-heparin combination injection, adult tetanus-diphtheria-acellular pertussis and infant diphtheria-tetanus-acellular pertussis (DTaP) vaccines, Haemophilus B and DTaP vaccines, and cisatracurium and vecuronium. Each error exposed weaknesses in the system of neonatal medication storage, labeling, delivery, knowledge, and administration documentation at our institution. Resolution of system problems was made possible by a collaborative approach and involved reorganizing shelving used to store neonatal medications; using a differently colored labeling scheme for products whose syringes were nearly identical; implementing changes to the infant vaccine ordering, storage, dispensing, and documentation systems; and instituting centralized and decentralized pharmacist review of pharmacy technician automated dispensing cabinet-filling activities.CONCLUSION: An institution providing services to both neonatal and adult patients experienced five cases of medication-dispensing errors with look-alike or sound-alike medications. Multidisciplinary collaboration within the system helped the pharmacy identify, resolve, and prevent errors related to medication storage, labeling, delivery, knowledge, and administration documentation.

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PMID: 

Drug Saf. 1999 Jul ;21(1):1-6. PMID: 10433349

Abstract Title: 

Oral versus intramuscular phytomenadione: safety and efficacy compared.

Abstract: 

Oral and intramuscular phytomenadione (vitamin K1) prophylaxis became an issue following the report of a potential carcinogenic effect of intramuscular but not oral phytomenadione prophylaxis. There is increasing evidence, however, that oral phytomenadione prophylaxis is less effective for the prevention of late vitamin K deficiency bleeding (VKDB) than intramuscular prophylaxis. Following a report of an increased cancer risk after intramuscular phytomenadione, a series of papers on this issue appeared. Although an increased risk for solid tumours could almost certainly be excluded, a potential risk for acute lymphatic leukaemia in childhood could not be ruled out definitively. Almost all cases of late VKDB are preventable with intramuscular phytomenadione prophylaxis administered once at birth, whereas a single oral dose given at birth is much less effective. Repeated oral phytomenadione doses given to breast-fed infants either weekly (1 mg) or daily (25 microg) seem to be as effective as intramuscular phytomenadione prophylaxis. The efficacy of 3 oral 2mg doses with the new mixed micellar preparation ('Konakion MM') remains to be established. Although a number of studies have failed to confirm a cancer risk with phytomenadione, these studies have been unable to rule out a risk definitely because absence of evidence is not evidence of absence. A meta-analysis of the available studies might provide 95% confidence intervals narrow enough to exclude even a small cancer risk with some certainty. Oral prophylaxis will probably be as safe as the intramuscular prophylaxis if given daily (25 microg) or weekly (1 mg).

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PMID: 

Semin Thromb Hemost. 1995 ;21(4):357-63. PMID: 8747698

Abstract Title: 

Observations on vitamin K deficiency in the fetus and newborn: has nature made a mistake?

Abstract: 

The microsomal mixed function oxidase system metabolizes xenobiotics (Phase I) to products that, if not activated and conjugated for excretion (Phase II), are capable of forming conjugates with cellular macromolecules, including DNA, resulting in toxic, mutagenic, or carcinogenic events. Benzo(a)pyrene (BP), a polycyclic aromatic hydrocarbon, is a model carcinogen for this system. Vitamin K1 (phylloquinone) is a regulator of BP metabolism. These studies demonstrate that K1 is capable of increasing Phase I metabolism and decreasing glutathione transferase activity (Phase II) in chick embryo liver; that deprivation of K1 reduces BP/DNA adducts in mouse liver and reduces tumor formation in mice given intraperitoneal BP; and that K1 supplementation increases BP induced tumor formation in mice. However, epidemiologic studies indicate that children of mothers who smoke during pregnancy may not be at increased risk of cancer. It is known that the placentas from these pregnancies exhibit markedly increased levels of arylhydrocarbon hydroxylase induced by the polycyclic aromatic hydrocarbons in tobacco smoke, but there is no corresponding increase in this enzyme activity in the fetus in such pregnancies. We suggest that the low vitamin K level is a secondary protective mechanism for xenobiotics, such as BP, that may escape the primary placental screen. The recently described role of vitamin K-dependent Gla protein as ligands for receptor tyrosine kinases, also establishes K as a link in cell growth and transformation. It is proposed that the small total body pool of K1 in the adult, which is sufficient only to meet continuing needs, and the even smaller pool in the fetus are protective. This protective effect of low K1 levels is particularly important in the presence of the high mitotic rates and rapid cell turnover in the avian embryo and mammalian fetus.

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PMID: 

Ugeskr Laeger. 2001 Sep 24 ;163(39):5365-7. PMID: 11590951

Abstract Title: 

[Risk management by reporting critical incidents. Vitamin K and ephedrine mix-up at a birthing unit].

Abstract: 

INTRODUCTION: Errors of medication are frequent causes of hazards to patients. It has been suggested that containers that look alike constitute a risk of such errors. In this article, we present an example of how reporting incidents of potential risks, can be applied in their clinical management.MATERIAL AND METHODS: As part of a medical technology assessment project on risk management in a delivery department, the staff were encouraged to report incidents that could create a potential risk to patients. The incidents were assessed by a project group as either a general problem to patient safety or a solitary incident. If considered a general problem, procedures should be changed and implemented in the department.RESULTS: Two incidents were reported, where ephedrine and adrenaline were found in a box supposed to contain vitamin K for new-born babies. These were considered a general problem by the project group, and the procedure for storing and managing ephedrine and adrenaline in the delivery department was changed to prevent new cases.DISCUSSION: Near misses occur more often than actual errors, and we argue that, as they are easier to discover, it is important to learn from them and thus prevent further incidents. A forum should be set up to exchange experiences of acknowledged risks, hazards, analytical results and preventive solutions.

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