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Tuesday, August 20, 2013
EMPOWER Phase III ALS drug trial of
dexpramipexole has failed to meet its
primary endpoint.
Dexpramipexole, a treatment for amyotrophic
lateral sclerosis (ALS), did not meet its
primary endpoint of a joint rank analysis of
function and survival, and no efficacy was
seen in individual components of function or
survival, the drug company announced today.
... The trial also failed to show efficacy in its
key secondary endpoints. As such, Biogen
Idec has said it will abandon development of
dexpramipexole in ALS.
Biogen Idec Research and Development
executive vice president Dr Douglas Williams
said; "We share the disappointment of
members of the ALS community, who had
hoped that dexpramipexole would offer a
meaningful new treatment option.
"Nevertheless, the EMPOWER trial represents
a significant contribution to ALS research,
and Biogen Idec is committed to advancing
ALS science. We continue to work with
researchers around the world to understand
the causes of ALS and find potential
treatments for people with ALS."
The EMPOWER trial was a randomised,
double-blind placebo-controlled Phase III
trial of 943 people with ALS in 81 sites,
covering 11 countries. Patients were
randomised on a one-to-one basis to receive
either dexpramipexole or placebo.
Biogen Idec Neurodegeneration Clinical
Research director Dr Douglas Kerr said; "As
a physician who has treated people with ALS,
I hoped with all my heart for a different
outcome. While these results were not what
we expected, we hope these data will provide
a foundation for future ALS research."
The company intends to present detailed
results at a future medical conference.
Sunday, January 27, 2013
Suture production
All Sewn Up: Postcesarean Skin Staples vs. Subcuticular Sutures Subcuticular closure was associated with lower risk for wound complications.
As the cesarean delivery rate climbs, we are increasingly obliged to determine best practices for the procedure. In particular, averting wound-related complications would lower postcesarean morbidity considerably. Whether skin staples are better than subcuticular suture closure is not known; thus, investigators in Alabama conducted a randomized, controlled trial of the two methods in 393 women undergoing scheduled or unscheduled cesarean deliveries.
Regardless of maternal body-mass index (BMI; mean, 36 kg/m 2 ), women in the staple group were more likely than those in the suture group to suffer wound disruption or infection by 4 to 6 weeks postpartum (14.5% vs. 5.9%; relative risk, 2.5). Most complications consisted of wound disruption (RR, 3.8), and much of the difference in outcomes occurred before hospital discharge. Use of subcuticular closure added 10 minutes to median operating time (from 48 to 58 minutes; P <0.001). Patient-centered measures such as pain, cosmesis, and satisfaction did not differ between groups.
Comment: As we scrutinize the quality of care that we provide for its impact on patient safety and satisfaction, trials such as this are especially valuable. Although the study population was enriched for factors associated with wound complications (e.g., high body-mass index), the benefits of subcuticular closure persisted even in low-risk women (BMI <30, primary cesarean, no preceding chorioamnionitis). As the authors note, the costs associated with longer operative times are probably rivaled by costs associated with wound morbidity, the surgical stapler itself, and the time required to remove staples. This trial adds to the mounting evidence that subcuticular suturing is the best method for postcesarean skin closure.
Sunday, January 6, 2013
DISCUSSION ON RADIOISOTOPE & RADIOPHARMACEUTICAL: IT’S USES
Radiopharmaceuticals are drugs containing a radionuclide and are used routinely in nuclear medicine for the diagnosis and therapy of various diseases. Depending upon their medical applications radiopharmaceuticals are divided into two classes’ viz. diagnostic radiopharmaceuticals and therapeutic radiopharmaceuticals. They are briefly discussed below.
Diagnostic radiopharmaceuticals are molecules which are tagged with a gamma ray emitting radioisotope. Such agents when administered into the body localize in certain organs or tissue, for which they are designed for, and the radiation emitted by the associated radionuclide could be detected from outside with the help of suitable instrument like gamma camera. The analysis of the resultant images obtained from the gamma camera could reveal useful information regarding the disease condition of the patient.
Therapeutic Radiopharmaceuticals are very similar much to the diagnostic radiopharmaceuticals but the only difference being the use of a therapeutic radionuclide instead of a diagnostic radionuclide. In this case the primary aim is not to get diagnostic information but to deliver therapeutic doses of ionizing radiations to specific diseased sites. Further discussion on therapeutic radiopharmaceuticals is beyond the scope of present work. The various isotope used as therapeutic, diagnostic or research work are listed below in table-1 [6]
ISOTOPE
|
t1/2
|
APPLICATION
|
198Au
|
2.7 d
|
Therapeutic
Diagnostic
|
14C
|
5700 Y
|
Research
|
45Ca
|
165 d
|
Diagnostic
|
47Ca
|
4.5 d
|
Diagnostic
|
57Co
|
270 d
|
Diagnostic
|
58Co
|
71 d
|
Diagnostic
|
60Co
|
5.27 y
|
Therapeutic
Diagnostic
|
51Cr
|
27.8 d
|
Diagnostic
|
121Cs
|
9.7 d
|
Diagnostic
|
137Cs
|
30 y
|
Research
|
18F
|
1.7 H
|
Diagnostic
|
3H
|
12.3 y
|
Diagnostic
Research
|
59Fe
|
45 d
|
Diagnostic
|
197Hg
|
2.7 d
|
Diagnostic
|
203Hg
|
46.9 d
|
Diagnostic
|
125I
|
60 d
|
Diagnostic
Therapeutic
|
131I
|
8.08 d
|
Diagnostic
Therapeutic
Research
|
113In
|
1.66 h
|
Diagnostic
|
192Ir
|
74.4 d
|
Therapeutic
|
42K
|
12.4 h
|
Research
|
99Mo
|
2.8 d
|
Source of 99mTc
|
22Na
|
2.6 y
|
Diagnostic
|
24Na
|
15 h
|
Diagnostic
|
32P
|
14.3 d
|
Diagnostic
Therapeutic
Research
|
226Ra
|
1620 y
|
Therapeutic
|
86Rb
|
18.8 d
|
Diagnostic
|
222Rn
|
3.8 d
|
Therapeutic
|
35S
|
88 d
|
Research
|
75Se
|
120 d
|
Diagnostic
|
85Sr
|
64 d
|
Diagnostic
|
90Sr
|
28 y
|
Therapeutic
|
182Ta
|
115 d
|
Therapeutic
|
99mTc
|
6.0 h
|
Diagnostic
|
90Y
|
2.6 d
|
Diagnostic
Therapeutic
|
169Yb
|
32 d
|
Diagnostic
|
65Zn
|
245 d
|
Research
|
There are many practical applications to the use of radioactivity/radiation. Radioactive sources are used to study living organisms, to diagnose and treat diseases, to sterilize medical instruments and food, to produce energy for heat and electric power, and to monitor various steps in all types of industrial processes.
Tracersare a common application of radioisotopes. A tracer is a radioactive element whose pathway through which a chemical reaction can be followed. Tracers are commonly used in the medical field and in the study of plants and animals. Radioactive Iodine-131 can be used to study the function of the thyroid gland assisting in detecting disease.
Nuclear reactorsare devices that control fission reactions producing new substances from the fission product and energy. Recall our discussion earlier about the fission process in the making of a radioisotope. Nuclear power stations use uranium in fission reactions as a fuel to produce energy. Steam is generated by the heat released during the fission process. It is this steam that turns a turbine to produce electric energy.
Sterilization of medical instruments and food is another common application of radiation. By subjecting the instruments and food to concentrated beams of radiation, we can kill microorganisms that cause contamination and disease. Because this is done with high energy radiation sources using electromagnetic energy, there is no fear of residual radiation. Also, the instruments and food may be handled without fear of radiation poisoning.
Radiation sources are extremely important to the manufacturing industries throughout the world. They are commonly employed by nondestructive testing personnel to monitor materials and processes in the making of the products we see and use every day. Trained technicians use radiography to image materials and products much like a dentist uses radiation to x-ray your teeth for cavities. There are many industrial applications that rely on radioactivity to assist in determining if the material or product is internally sound and fit for its application. Radioactive isotopes have many useful applications. In medicine, for example, cobalt-60 is extensively employed as a radiation source to arrest the development of cancer. Other radioactive isotopes are utilized as tracers for diagnostic purposes, as well as in research on metabolic processes. When a radioactive isotope is added in small amounts to comparatively large quantities of the stable element, it behaves exactly the same as the ordinary isotope chemically; it can, however, be traced with a Geiger counter or other detection device. Iodine-131 has proved effective in locating brain tumours, measuring cardiac output, and determining liver and thyroid activity. Another medically important radioactive isotope is carbon-14, which is useful in studying abnormalities of metabolism that underlie diabetes, gout, anemia, and acromegaly. In industry, radioactive isotopes of various kinds are used for measuring the thickness of metal or plastic sheets; their precise thickness is indicated by the strength of the radiations that penetrate the material being inspected. They also may be employed in place of large X-ray machines to examine manufactured metal parts for structural defects. Other significant applications include the use of radioactive isotopes as compact sources of electrical power—e.g., plutonium-238 in cardiac pacemakers and spacecraft. In such cases, the heat produced in the decay of the radioactive isotope is converted into electricity by means of thermoelectric junction circuits or related devices