Dialysis & Transplantation最新文献

Azilsartan medoxomil (Edarbi) tablets have been approved by the Food and Drug Administration (FDA) for treating hypertension.1 Compared with olmesartan and valsartan, the 80-mg dose had greater 24-hour blood pressure-lowering effects, in Phase 3 clinical trials.2 It is available in 40-mg and 80-mg tablets. In addition, a new drug application (NDA) was recently filed for a tablet that combines both azilsartan and chlorthalidone. In a clinical trial presented at the American Society of Hypertension's 2010 meeting, the combination of azilsartan/chlorthalidone had better blood pressure-lowering effects than the combination of azilsartan and hydrochlorothiazide (HCTZ).

After all this waiting, belimumab (Benlysta) was finally FDA-approved for treating systemic lupus erythematosus (SLE) in March 2011.3 It is a monoclonal antibody that targets B-lymphocyte stimulator protein, also known as BLyS. It is dosed via an intravenous (IV) infusion of 10 mg/kg every 2 weeks for three doses, followed by every 4-week dosing thereafter. Patients in clinical trials only had modest improvement in symptoms with the agent, but its effectiveness was significantly better than placebo. One-year response rates were 43% for belimumab-treated patients and 32% for placebo-treated patients. The drug should not be administered along with live vaccines. A medication guide will be distributed to all patients who receive this agent to inform them of the treatment risks. The last agent to be FDA-approved to treat SLE was hydroxychloroquine, in 1955.

At a recent guideline committee meeting of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society, the committee recommended that dabigatran be used as an alternative to warfarin in patients with atrial fibrillation who do not have significant heart valve disease, do not have a prosthetic heart valve, and/or do not have advanced hepatic disease, and/or do not have severe renal failure to reduce their clot risk.6 Other similar agents are currently in the FDA pipeline for this and other similar uses.7

The QMS Everolimus Immunoassay was recently FDA-approved as the first test to monitor everolimus blood levels in renal transplant patients.8 Similar blood level tests are already available to monitor transplant patients receiving cyclosporine, tacrolimus, and/or sirolimus. The test is manufactured by Thermo Fisher Scientific (Waltham, Mass.).

Voriconazole tablets were FDA-approved as a generic of Vfend in February of 2011.9 The company has 180 days of market exclusivity before other generics will be available. The liquid and IV versions of the drug are covered under a separate patent.

Calcitonin, recombinant salmon oral, is currently in Phase 3 clinical trials for the treatment of postmenopausal osteoporosis.10 It was compared with synthetic salmon calcitonin nasal s

Put me in, coach! I'm ready to play! Yes, last October I felt like a World Series-bound Texas Ranger player. I really related to the Rangers since, just like their team, I'll be going somewhere I've never been before. You see, I'm 49 years old and I have chronic kidney disease caused by polycystic kidney disease (PKD). Now I'm ready to play the kidney transplant game.

At age 24, I learned that I had PKD when my doctor was investigating my unexplained high blood pressure. (I now know that hypertension is a common sign of kidney problems.) That was in 1986. My doctor reassured me that I wasn't getting a death sentence, and could expect to live a long, fairly normal life. The “but” at the end of that conversation was that some day, my kidneys would probably fail. I was well aware of my family PKD history. My grandfather died at age 51, in the mid-1960 s when dialysis was not readily available. Dialysis was much more common in 1986, but my father died at age 48 from an infection while on peritoneal dialysis. Recognizing that PKD is an inherited condition, my husband and I had a serious talk about whether to have children. A person with autosomal dominant PKD (ADPKD), like me, has a 50% chance of each child inheriting the mutated gene and having ADPKD. With advancing medical technology, my husband and I felt a cure or treatment might be found for our children and so it was worth the risk.

But there's more to this story! In 1995 I discovered there was a PKD Foundation that offered information, a support group, and funded research to find a cure for PKD. Why hadn't I heard about this organization before? Turns out the PKD Foundation, started in 1982, was exactly what I needed. I met people who had PKD or were affected by PKD. I found people I could relate to and who, like me, had a family history of PKD. The support group invited research doctors, nephrologists (CKD, dialysis, and transplant), social workers, transplant recipients, dietitians, transplant surgeons, and even an exercise coach to speak at meetings and share their knowledge for free. I learned how to become my own advocate and what questions I should ask my doctor. The PKD Foundation holds a yearly conference in various cities around the United States. World-renowned doctors share the latest research and knowledge in the fight to end PKD. My husband and I attended a conference in Phoenix where we learned that an angiotensin-converting enzyme (ACE) inhibitor medication for blood pressure control could possibly prolong kidney function in PKD. When I returned, I asked my doctor, who had also heard about the drug's benefits, and he got me started.

Since finding the PKD Foundation in 1995, I've been a sponge absorbing knowledge about PKD, while the cysts in my kidneys have multiplied and grown. My life has been fairly normal, but I know I have a ticking time bomb inside. My kidneys, which should each be the size of my clinched fist, are now at least five times that size. Tho

Chronic kidney disease (CKD) is a major health problem worldwide; in the United States, CKD affects 27 million Americans and is the ninth leading cause of death.1 It is increasingly prevalent in the elderly, estimated to affect 40% of people older than 70.2 The detection and management of CKD in this population presents several challenges due to the reduced accuracy of methods for assessing kidney function and the high prevalence of co-existing conditions that may complicate CKD care. In this article we highlight several issues critical to the effective management of CKD in the elderly: assessment of kidney function, medication management, and hypertension control.

The ideal method for assessment of kidney function in the elderly has yet to be determined but is of vital importance for nephrology clinical care. Glomerular filtration rate (GFR) is currently accepted as the best overall index of kidney function, and as such it assumes central importance in the current National Kidney Foundation KDOQI CKD staging system.

The gold standard measure of GFR, inulin clearance, is not practical in most clinical situations given its cost and time intensiveness. Measurement of creatinine clearance from 24-hour urine collections approximates GFR and may be useful in certain circumstances, but this method is also cumbersome and susceptible to collection errors. Thus, equations that estimate GFR from the serum creatinine concentration have been widely adopted into clinical care. The use of these equations has facilitated greater recognition of CKD, but it has also led to debate as to whether these equations overdiagnose CKD in the elderly. This concern is due to the fact that the two most commonly used equations, the Cockcroft-Gault (CG) equation and the Modification of Diet in Renal Disease (MDRD) Study equation, systematically underestimate measured GFR.3 A related concern is that prognosis for a given level of estimated GFR varies substantially by age.

Recently, a new equation for estimating GFR, the CKD Epidemiology Collaboration (CKD-EPI) equation has been introduced.4 Preliminary reports indicate that the CKD-EPI equation has improved precision and accuracy compared with the MDRD or CG equations.5 Systematic underestimation of GFR appears to be attenuated; when applied to the U.S. population, the mean GFR is shifted upward by approximately 10 mL/min/1.73 m². Of relevance to the elderly, the equation was derived and validated from clinical populations that included approximately 1,500 participants over the age of 65. Thus, use of the CKD-EPI equation may alleviate some, though not all of the concerns associated with GFR estimation in the elderly.

Like the CG equation and MDRD Study equation, the CKD-EPI equation relies on serum creatinine and thus is subject to the limitations of creatinine-based equations, namely, that creatinine production is influenced

We describe the case of a male hypertensive patient with severe hemophilia A. In August 1999 he was admitted to our nephrology department, with hemarthrosis, severe hypertension, dyspnea with minimal efforts, increasing blood urea nitrogen, anemia, uremic symptoms, reduced urine volume, mild edema of the lower limbs, and no hyperkalemia. Imaging confirmed the diagnosis of end-stage renal disease. A Tenckhoff peritoneal dialysis catheter was inserted, and he began continuous ambulatory peritoneal dialysis. In August 2005 he evolved to peritoneal failure (peritoneal equilibration test showing ultrafiltration disorder I) and was transferred to hemodialysis. A permanent catheter was inserted into the right subclavian vein. Hemodialysis sessions lasted 4 hours, three times a week, and gradually resulted in hemodynamic stabilization. In September 2005, an arteriovenous fistula was placed in the right forearm between the cephalic vein and the radial artery. In January 2007 the patient was admitted with abdominal and epigastric pain, double-lumen catheter infection, peritoneal catheter infection, globoid tympanic abdomen, and mild pain on palpation. Preliminary studies showed a large preperitoneal hematoma with bowel compression. Due to the catheter infection, we decided to puncture the fistula using a 17-G needle. Apart from some bleeding during and after the beginning of hemodialysis, there were no other fistula complications. The patient had progressive worsening of clinical symptoms and died in February 2007. In summary, an individualized treatment plan, mainly adequate hemostatic monitoring, care of the dialysis access, and multiprofessional and family involvement, may help in the management of hemophilia patients undergoing dialysis. Dial. Transplant. © 2011 Wiley Periodicals, Inc.

Intradialytic exercise is both safe and beneficial for patients; however, worldwide, despite evidence to support its efficacy, it is underutilized. A pilot project in a large inner city hemodialysis unit demonstrated the benefits of introducing a program to improve physical function among the participants.

In the quest to balance the growing demand for kidneys with a perennially scarce donor supply, some intrepid transplant surgeons are taking another look at individuals the Centers for Disease Control and Prevention (CDC) label “highrisk,” such as sex workers, men who have sex with men, injection drug users, and people with acute kidney injuries. Many transplant centerswould summarily reject organs from these people, due largely to the risk of HIV transmission.

But desperate times call for desperate measures, says Dorry Segev, MD, PhD, associate professor of surgery and epidemiology and director of clinical research at Johns Hopkins Department of Surgery in Baltimore. “There are 90,000 people on the waiting list, and the death rate while on the waiting list is quite high,” says Dr. Segev. “Some people have a greater than 50% chance of dying before they receive their first organ offer.”He believes the donor pool could be expanded considerably if transplant centers increase their willingness to consider “high-risk” organs. “These are still functioning kidneys, and if there are people for whom [the risk of contracting HIV] is lower than the risk of dying while on dialysis, it might be worth it tomake that decision.”

All in all, approximately 10% of donors fall into the high-risk category, says Niraj Desai, MD, surgical director of kidney transplantation at the Johns Hopkins Comprehensive Transplant Center. “Over the last year or two, we've probably done about 100 transplants of organs from donors who have engaged in CDC high-risk behaviors, and we have not had any donor-derived transmission of HIV or hepatitis C.”

People who have suffered an acute kidney injury requiring temporary dialysis represent another potential group of donors who might ordinarily be rejected bymany centers. Usually, these kidneys come from young donors who do not have any kidney pathology, except this acute injury. These are known as high-terminal creatinine kidneys, inwhich the high creatinine levels are associated with the donor's death, not any intrinsic problem with the kidney. “These kidneys do well if you put them in someone who can tolerate the delay in return to graft function, and whose cardiac function can support the allograft through the phase of initial ischemia. Eventually, those organs can turn around,” adds Dr. Desai.

“We have used many kidneys where the terminal creatininewas as high as 4, 5, and even 8 mg/dL,” says Dr. Desai. If the donors are relatively young (usually 40 years old or younger), and if a biopsy can document a lack of chronic changes, the organs may be suitable for some recipients. Acute tubular necrosis is usually the main pathologic finding, but “we don't want to see a lot of scarring in the interstitium, glomerular sclerosis, or arterial vessel thickening, which would indicate that there has been long-term vessel damage, which may impede the kidney's ability to recover from the acute insult,” he adds.

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How do we define “professionalism” in our workplace? Ask this question and you will receive a number of meanings based on the individual's experiences in the workplace. Professionalism in practice has been described as committing to teamwork, adhering to ethical principles and practices, demonstrating sensitivity to diverse patient populations and end-oflife care, and taking personal responsibility for professional growth and development to enhance patient care.

When Centers for Medicare & Medicaid Services (CMS) released a final rule for Medicare conditions for coverage (CfC) in 2008, certification of hemodialysis patient care technicians (PCTs) was mandated. Certification could be obtained by passing a CMS-approved exam and is required in order for a PCT to provide direct patient care in a hemodialysis clinic.1 Beyond the mandate, certification and recertification contributes to professional growth and development though education and the opportunity to network with peers and other professionals for sharing of information. Therefore this certification requirement, along with regular intervals of recertification, can be seen as moving forward the formal recognition of the PCT as a professional member of the nephrology team.

The requirement by CMS for patient care dialysis technicians to be certified can be found at 42 CFR 494.140(e)(4) in the Conditions for Coverage;1 The patient care dialysis technician is to be certified under a state certification program or a national commercially available certification program.

BONENT certification must be maintained with an annual certification fee of $55 (in 2011), or $200 for four years in advance. There is no extra fee for recertification if the annual certification fee is paid.5

See the NNCC website (www.nncc-exam.org) for review of this and additional information concerning PCT recertification.

Further information for attainment of recertification through NNCO can be found at www.nnco.nbccc.net and www.ptcny.com/clients/NNCO.

Several states have implemented a PCT certification and competency-testing program. To meet the requirements of 42 CFR 494.140(e)(4), a PCT certificertification program must be equivalent to the approved commercial national certification programs. CMS requirements include standardized testing reflecting the content listed in the regulation, administered in a proctored environment unrelated to any dialysis facility, and having a process in place for ongoing certification.3 State certification allows a certified PCT to practice in the State in which he or she is employed as a PCT.

One example of a state with provisions or requirements that meet CMS approval is the alternative pathway for California PCTs. Details and guidelines can be found at the websites http://www.californiadialysis.org/res_pct_info.html and www.californiadialysis. org/CHT_Exam_Info.html.

In a 2010 editoria

I have been on hemodialysis for 39 years without interruption. In that time, I have learned a lot about how to live well. One of my favorite mantras is “Dialysis can give you a longer lifespan, but it can't give you a life.” All of us must work at creating our lives, regardless of our health conditions. Living productively and happily with kidney disease means finding the information you need to become involved in your treatment and care. I want to describe here what I have learned from my lifetime with end-stage renal disease (ESRD).

When I was just 2 years old, my grandfather, who was a medical doctor, noticed that my bladder was distended and that my urine had no smell. Doctors discovered Bilateral strictures on my ureters, a defect that was destroying my kidneys. I spent much of my childhood in and out of hospitals, undergoing several surgeries before my kidneys failed in 1971, when I was 13.

In the early days of dialysis, I was one of a fortunate few selected for this life-saving treatment. There were no dialysis centers in my area, so my dad and I went to Miami to train for home hemodialysis. My mother got the house ready by making space for all of the supplies and equipment, including a reverse osmosis water system. From the start, strong family support helped me maintain an active lifestyle. I finished high school on time, went to college, and worked as a respiratory therapist for 14 years. I then earned a master's degree in counseling psychology and worked in that field until I retired. I don't feel as if I've missed a thing. I was just as active as any kid on the block. My parents made sure they didn't treat me any differently from my two brothers and two sisters.

Soon after I began feeling better, my father gave me an ultimatum. I would have to discontinue home dialysis and go to a treatment center if I continued to be dangerously irresponsible. That little talk wasn't magic, but I have never again gotten drunk or overloaded myself with fluids. Later, in the mid-1980 s, I decided to switch to in-center dialysis. I now go to the center three days a week for dialysis. I have not met any other people who have been on dialysis as many years as I have without interruption.

Over the years, I learned how to find the information I needed to play an active role in my own treatment, which gave me the confidence to deal with ESRD and dialysis effectively. I learned a lot just by talking with my doctors. Even now, before my appointments I write down a list of questions. Experience is also a great teacher if you are willing to listen and not try to reinvent the wheel. I have made use of the Internet, including the Dialysis Support e-mail list. I have had a lot of problems with hyperparathyroidism, but I have realized that after 39 years, some problems just don't go away.

In my almost 40 years on dialysis, I have seen big improvements in the quality and quantity of information available to people with kidney disease.