Hepatitis B transmission by cell and tissue allografts: How safe is safe enough?

More than 2 million human tissue transplants (bone, tendon, cartilage, skin, cornea, amniotic membrane, stem cells, heart valve, blood vessel, etc.), are performed worldwide every year. Cells and tissues are shared between countries which have different regulations and laboratory equipment and represent a risk of hepatitis B virus (HBV) transmission that has become a global safety concern. While the risk of transfusion-transmitted HBV infection from blood donations has been estimated, the rate of HBV transmission from donors to recipients of allografts is unknown and varies between different tissues. There are various important ways of reducing the transmission risk, but donor screening and donor testing are still the main factors for preventing HBV transmission. HBV detection is included in the routine screening tests for cell and tissue donors. The standard test for preventing transplant-transmitted hepatitis B is the hepatitis B surface antigen. The implementation of methods involving nucleic acid amplification and the new generation of reactives to detect viral antibodies or antigens with an immunoassay, has increased the sensitivity and the specificity of the screening tests. The objective of our research was to review the literature and critically analyse the different steps for avoiding HBV transmission in cell and tissue donors, focusing on the screening tests performed.     

How safe is aggressive statin therapy?

The most recent guidelines of the National Cholesterol Education Program recommend more aggressive low-density lipoprotein cholesterol goals: <100 mg/dL for patients at moderate or high risk of cardiovascular disease, and <70 mg/dL for patients at very high risk. These lower goals are more likely to be achieved using the more powerful statins--atorvastatin, rosuvastatin, and simvastatin. Although statins are widely used, extensively studied, and known to have an excellent safety profile, the perception of many health care providers and patients is that safety concerns about the more efficacious statins, especially at high doses, limit their use. However, clinical data consistently support the view that adverse events are uncommon even when intensive therapy is used to reach aggressive low-density lipoprotein cholesterol goals. Overall, the more potent statins have similar safety profiles. The benefits of aggressive statin treatment in reducing the risk of cardiovascular events appear to far outweigh any potential risks of adverse events.     

Is Hartmann's procedure safe in Crohn's disease?

INTRODUCTION: Crohn's disease-associated colorectal cancer may occur in an area of defunctioning bowel. Some patients with Crohn's colitis undergo subtotal colectomy, ileostomy, and low Hartmann's procedure in an effort to preserve the rectum. This procedure has also been advocated for patients with severe anorectal Crohn's disease, in whom nonhealing of the perineal wound after proctectomy occurs with alarming frequency. The authors present a review of the literature and three cases of cancer developing in the defunctioning rectal stump despite surveillance proctoscopy. METHODS: Twenty-five patients underwent low Hartmann's procedure for severe anorectal Crohn's disease. Surveillance proctoscopy was performed as follow-up. Development of cancer in the rectal remnant or anus or recurrence of symptoms was managed by resection and adjuvant therapy. RESULTS: One patient developed squamous-cell carcinoma of the anal canal, underwent resection and adjuvant therapy, and was disease free at the time of this study. Two patients developed adenocarcinoma of the rectum. Both underwent resection and adjuvant therapy. One patient died and the other developed a recurrence. CONCLUSIONS: The authors recommend interval perineal proctectomy in all patients undergoing low Hartmann's procedure for severe anorectal Crohn's disease in whom rectal preservation is not possible. Regularly scheduled interim surveillance proctoscopy performed every two years, with biopsies of macroscopically normal-appearing and abnormal-appearing rectal mucosa and curetting of fistulous tracts, is also recommended to decrease the possibility of missing occult malignancies.     

Is infliximab safe to use while breastfeeding？

Inflammatory bowel disease （IBD） often affects women around the age of conception and pregnancy. Most drugs used to treat IBD are safe in pregnancy, but physicians must consider the clinical implications of certain treatment regimens in young, fertile females. We report an informative case of a pregnant patient with IBD who underwent treatment with infliximab during her pregnancy and while nursing her infant. Serum and breast milk infliximab levels were monitored throughout this time period. This case report suggests that targeted monoclonal antibodies and other biologic agents can be used with caution in pregnant and breastfeeding patients.