主题:这个外科医疗术值得讨论讨论。 -- 九霄环珮
2004年,
FDA批准蛆疗法
Age-old therapy gets new approval
Sherman R.1: Adv Skin Wound Care. 2005 Jan-Feb;18(1):12-5.
Kathleen A. Greer • Senior Editor • Advances in Skin & Wound
Care • Ambler, PA
Last year, the Food and Drug Administration (FDA) gave
permission to market maggots as the first “live” medical
device. In a recent interview with Advances in Skin &
Wound Care, researcher Ronald Sherman, MD, MSc,
discussed how maggot therapy can help wound healing
and shared his thoughts on the future use of this age-old
therapy. Dr Sherman is Assistant Researcher, University of
California, and Director, BioTherapeutics, Education and
Research Foundation (BTER), both in Irvine, CA.
Q: How do maggots help kill bacteria and stimulate
granulation, as well as debride wounds?
A: In January 2004, the FDA gave clearance to produce and
market medical maggots for “debriding non-healing necrotic
skin and soft tissue wounds, including pressure ulcers,
venous stasis ulcers, neuropathic foot ulcers, and non-healing
traumatic or post surgical wounds.” In July 2004, our laboratory
at the University of California, Irvine, registered with the
FDA as a production site for medical maggots. The FDA has
not considered, nor approved, any claims of disinfection or
growth-promoting properties. Nevertheless, there are both
clinical and scientific studies that address the antibacterial
and growth-promoting properties of maggots.
Debridement results when the maggots release their
potent proteolytic digestive enzymes into the wound bed.
The wound bed is like a dinner table to maggots. These
enzymes gain access to the deeper necrotic tissue through
the mechanical debridement action of the maggots’
“mouth hooks”—2 probing appendages near their toothless
mouth. Mixed with these enzymes—or perhaps
directly as a result of some of these enzymes—many
microorganisms within the wound bed are killed.
Other infectious organisms are ingested by the maggots,
along with the partially digested necrotic tissue, and are
later killed within the maggot’s gut. These secretions have
been shown to stimulate cells in culture and are associated
with the rapid growth of epithelial and granulation tissue in
vivo. Wound healing effects may also be due to the apparent
increase in local perfusion and oxygenation that has
been recorded during maggot therapy.
Q: Are maggots used only in specialized wound centers?
A: Medical maggots are used today in more than 300 sites
around the country, including specialized wound centers
and tertiary care hospitals, specialized and general medical
outpatient clinics, extended care facilities, private practitioners’
offices, and even by visiting nurses who apply the maggot
dressings in patients’ homes.
Q: In appropriate cases, is maggot therapy more costeffective
for patients than traditional surgical procedures?
A: No therapy should ever be selected purely on the basis of
cost. We are discussing maggots today because of their
demonstrated efficacy, not simply their low cost. Nevertheless,
cost-effectiveness is a part of any meaningful discussion of medical care. And the low cost of maggot therapy
has often been touted as one of its major attributes. The
few studies that have addressed the issue of cost indicate
that maggot therapy is, indeed, more cost-effective than
comparable standard surgical or nonsurgical treatments.
We are not in a position to quantify the cost savings, but
we can surmise that it must be substantial, based on 2
observations. In Europe, where national, single-payer
health care is the norm, maggot therapy has become an
increasingly common practice. Approximately 30,000 maggot
treatments are administered annually in Europe. But there
has been less demand in the United States, where insurance
coverage of maggot therapy varies. In fact, the US
demand for medical-grade maggots has been too small to
support a single commercial supplier. Thus, the nonprofit
BTER Foundation is subsidizing the production and patient
care costs through donations.
The cost-effectiveness of maggot therapy is apparent to
many in the United States, however. Some hospitals tell me
they prefer to pay for maggots from their own operating
budgets to cure wounds and discharge patients faster than
to use more conventional, billable treatments. The major
expense associated with maggot therapy is the laborintensive
cost of preparing the perishable maggots. And, it
requires clinical time to secure dressings upon the wound.
Q: Do you believe maggots will be more widely used
for wound treatment in the near future?
A: The use of maggot therapy will soon increase, just as it
has in the rest of the world. In the United States, the
demand for medical maggots has increased by about 20%
per year over the past 10 years. Since the FDA ruling last
year, the demand has already doubled.
Selected References
Graninger M, Grassberger M, Galehr E, et al. Comments, opinions, and brief case reports: biosurgical
debridement facilitates healing of chronic skin ulcers. Arch Intern Med 2002;
162:1906-7.
Jukema GN, Menon AG, Bernards AT, et al. Amputation-sparing treatment by nature: “surgical”
maggots revisited. Clin Infect Dis 2002;35:1566-71.
Sherman RA. Maggot therapy for treating diabetic foot ulcers unresponsive to conventional
therapy. Diabetes Care 2003;26:446-51.
Sherman RA. Maggot vs conservative debridement therapy for the treatment of pressure
ulcers. Wound Repair Regen 2002;10:208-14.
Sherman RA, Shimoda KJ. Presurgical maggot debridement of soft tissue wounds is associated
with decreased rates of postoperative infection. Clin Infect Dis 2004;39:1067-70.
Wollina U, Liebold K, Schmidt WD, et al. Biosurgery supports granulation and debridement in
chronic wounds—clinical data and remittance spectroscopy measurement. Int J Dermatol
2002;41:635-9.
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