Treatment trend

TRFATMENTTRENDS Electrostimulation Helping Stroke Patients Each year, 500,000 persons suffer a stroke in the United States. Electrostimulation significantly aids recovery of muscle strength following stroke, according to a recent study conducted by Dr. William Stason and colleagues from the Harvard School of Public Health. Muscle strength enables muscles to efficiently contract, allowing movement and improved function. However, muscle strength is only one aspect of neurological deficit that occurs with stroke-induced upper motor neuron injury. Functional electrostimulation (FES) is a technique that applies short, programmed bursts of electrical current to the neuromuscular region affected by the stroke, either to the partially paralyzed muscles directly or to the associated peripheral nerves. Four studies were reviewed involving middle-aged men and w o m e n who had suffered stroke 1.5 months to 2.5 years earlier and were treated with FES for 3 to 4 weeks to achieve extension of the wrist or knee or bending of the ankle. Although the results did not necessarily confirm sustained improvement in muscle strength or actual functioning improvement, they nonetheless provide promising support for the use of FES. The researchers point out that FES treatment units are relatively inexpensive (mean price, $1250), extremely durable and reliable, and can be used by the patient or a family member without the ongoing assistance of a professional. Research Activities, October 1996

FDA Approves Skin Burn Product An FDA panel in November recommended that a skin product made from living h u m a n cells be approved as a treatment for severe burns. This approval will allow the company, Advanced Tissue Sciences, Inc., to launch its first therapeutic prod-

uct, called Dermagraft TC, which will be produced in San Diego. The human skin cells are grown in plastic containers designed to keep out contaminants until a surgeon opens the lid to graft the patch onto a patient. Both Dermagraft and cadaver skin are temporary coverings that must be replaced by grafts of the patient's own skin. The FDA panel voted 5-3 to recommend approval, but they included a requirement for postapproval studies to examine infection rates. The company also may apply for permission to market this product for use in patients with diabetes w h o have chronic foot ulcers. Estimates of the potential market for Dermagraft range from between $15 million and $65 million a year for burn patients, compared with as much as $1 billion for diabetic patients with chronic foot ulcers.

Radiation with Angioplasty Improves Success At the annual Scientific Sessions of the American Heart Association in November, heart researchers gave the first indication that radiation can significantly improve the success rate of one of the most common procedures used to treat coronary heart disease. Although more than 400,000 U.S. heart patients undergo balloon angioplasty each year, more than 25% need a second procedure as their arteries narrow again within 6 months. New research by Dr. Paul Tierstein and colleagues at Scripps Clinic and Research Foundation in La Jolla, California, found that delivering a low dose of radiation to the site of the obstruction during treatment reduced the failure rate by nearly 75% in a group of hard-to-treat patients. The randomized study involved 55 patients, all of whom were treated with balloon angioplasty and then implanted with metal stents used to prop open coronary arteries. All the patients had undergone at least one previous procedure that had failed. After I year, Tier-

stein noted that 11.5% of patients treated with radiation needed an additional procedure, compared with 44.8% among those treated with placebos. The findings raised hopes that several competing experiments now underway using radiation also will show success.

New Cervical Cancer Test May Replace PAP Smear On November 6, the FDA gave a small Massachusetts company, Cytyc Corp., the go-ahead to claim that its new method of examining cervical cells is "significantly more effective" than the traditional PAP smear. Developed approximately 50 years ago, the PAP smear has saved the lives of countless women but has a troubling predisposition to inaccuracy that has sometimes resulted in misdiagnosis, undetected cancers, and avoidable deaths. The PAP smear involves removing a small sample of cells from the cervix and placing them directly onto a slide for microscopic examination. In the Cytyc method, cells instead are immersed in a vial of liquid to prevent them from drying out. Later in the laboratory, the cells are agitated to randomly mix them in the event cancer cells are dustered together in a w a y that might evade careless microscopic detection. They then are filtered to remove blood and debris before they are put on the slide. In data submitted to the FDA, Cytyc said its tests accurately identified 65% more abnormal cell samples than the conventional PAP smear in a study of 4000 women. A spokesperson for the National Cancer Institute noted this was the biggest advance in 50 years in preparation of PAP smear-type examination. The test is expected to add about $20 to the typical PAP smear cost of about $10 to $40, but so far insurers are paying the cost. More than 50 million PAP smears are performed each year in the United States for early detection of cervical cancer. [~

March/April1997

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