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OCR for page 103
APPENDIX E
CASE-FILE DATA ON E=EWOOD SUBJECTS.
SUMMARY OF VOLUMES TESTING ~TH GB (M )
A total of 246 subjects was tested with GB under gracious
conditions. Twenty-five subjects were selected for review,
representing approximately lOX of the test ~group. Selections were
based upon she f allowing cri teria:
No Treatment ~ 9 subjects)
_
Route: Intravenous (3~0 ~ 4.0 p8/kg) 9 subjects
No symptoms
Treatment ( PAMCL) ( 9 sub jec ts )
Dizziness, frontal headache, blurred vision lethargy,
nausea, stomach pain, voiding.
Route: 1~ ~g/kg) (P2S) 2 sub jects
Intravenous (3.0 - 4.0 ~g/kg) (TMB4) 3 subjects
Whole-body exposure to vapor (Atropine) 1 subject
Whole-body exposure to vapor (Pyrbenzamine) 1 subject
Rhinorrhea ~ chest tightness, wheezing.
SUMMARY OF YOLU~EER TEST ING ~TH VX ( A2 )
A total of 740 subjects was tested under various conditions with
VX. Seventy-five sub jec ts were selected for review, representing
lOX of the test group. Selections were based upon the following
cri teria:
Hen ~
Route: Oral (single dose~kg) 1 subjec t
Percutaneous (single dose; 5 - 45 ~g/kg) 22 subjects
Oral (multiple dose) 29 subjects
Treatment ~ 23 sub jects 2-P - , Atropine, Regitine
Route: Intravenous (1. 2 - 2.0 ,ug/kg) 7 subjects
Intramuscular 3 sub jects
Oral (4.25 - 4.5,ug/kg) 3 sub feces
Percutaneous (5.0 - 45 ug/kg) lO subjects
The vast mad ority of these sub jects reportedly experienced
little or no effect from the drug. ~ s
(RBC) level was less that 20Z of normal in subjects
multiple doses, but in each case the toeing was stopped and the
cholinestera~e levels returned to normal limits within 6-7 days post
exposure. No visible effects of the Snug were observed in any of
these subjects. One subject (A2(BN)) received 30 ug/kg,
pare utaneou~ly, ~
normal, nervous) and was treated with multiple doses of atropine ant
2-PAM. Sub ject recovered and RBC~E was 97Z of
di scharget ~
Another subject (A2(BA) ) received 1~5 ~ug/kg in~cra~renously,
developed twitching (fasciculation?) of leg muscles, perspiration of
palms ant soles of feet IS min after injection when RBC ChE was 87%
*This represents selection of high-lose subjects. A second set of
records of equal number was also procured, on the basis of random
selection.
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Representative terms from entire chapter:
volunteer testing
of coronal (bopping tO 17% at lie). By 30 min. handa and feet were
cold and the eyes felt "heavy." A third subject (42(BS)), who
received 3.2 ,ug/ltg intra'~uacularly, wee dizzy, nauseated, and very
drowsy after 2h. During the next 10 hour e, the subject lacked
conceneration and stared vacantly into space. Slight dizziness and
blurred vision persisted at 26h when he wee treated with 2-PAM and
rec-o~rered.
Some others reportedly experienced dlzzinesa, light-headednesa,
nausea, voollting, "stiff Jaw," headache, and ptocia lasting for at
least 24h af ter exposure .
SUMMARY OF VOLUNTEER TESTING WITH GA (43 )
A total of 26 aubJeces vea tested under various conditions with
GA. Thirteen (13) subjects were selected for review, representing
50Z of the teat group. Selections were based upon the following
cri tart a:
Treatment ( 10 subjec ts)
Route: Intravenous (2.0 - 3.o~ugJkg)+(PAMcl. Pretreat Bent) 3
subjects
Intravenous (~.0 0 2.0 ug~kg)+(PAMCI, Post Treatment) 2
subjects
Intravenous (3 . O ~g/kg)+
experienced. They also developed persistent vomiting and nausea to
a point. of dehydration. One subject was referred to Walter Reed
Hospital for psychiatric observation ant diagnosed for anxiety
reaction, acute agitation ant hysterical reaction; he was later
released for duty.
SUMMARY OF VOLUNTEER TESTING WITH DFP
A total of I] subjects was tested with DFP under various test
conditions. Fire (5) subjects were selected for review,
representing approximately 45% of the test group. Selections were
based upon the following cri teria:
No Treatment ~ ~ sub jec t ~
Route: Intramuscular (16.0 ~g/kg) ~ subject
'treatment ( 4 subject s )
Route: Intramuscular (40 - 55,ug/kg) (PAMC1) 3 subjects
Intramuscular (65 ~g/kg) (PAMCl + Atropine) 1 sub ject
(Weak, shaky knees, dizziness, nausea, blurred vision,
per sp iration) .
SUMMARY OF VOLUNTEER TESTING WITH EA 3148 (Al )
A total of 32 subjects was tested under various conditions with EA
3148. Sixteen (16) subjects were selected for review, representing
50: of the test group. Selections were based upon the following
cri teria:
No Treatment ( 13 subjects)
.
Route: Intravenous (O. 7 - 1.15 ~g/kg) 13 subjects
lE~
Route: Intr~)
Intravenous ( 1.15 ug/kg
~ PAMCl ~ ~ sub jec t
_ ~ ~ Scopolamine) 2 sub jects
Sub jects wi th large doses experienced a rapid, severe
depre ssion of RBC ChE following agent administration. For example,
volunteer #3799 (case fI385), who received 1.15 ug/kg EA 314B,
showed 22: of normal R8C ChE values at 15 min after tio8ing and 0%
af ter 4Sh; this recovered to t3 63: of normal at 72d post-exposure.
Of the subjects that
~ `" pua~-~:^pu~u~e
_ received no additional treatment, two
sub jec ~ s who had received the highest dose ~ ~ .15 ,ug/kg) showed toxic
signs with 5 to ~ minutes post-exposure. These sub jects fell dizzy,
weak, tired, sweating, with hands and feet very moist. Within 2
hours po~-exposure, these sub jects reportedly were resting, eating
well ant feeling fine. Anorexia, poor sleep, fatigue, unusual
dreams, dizziness, euphoria, blurred vision, increased calibration,
restlessness are rec orded in an Army report summarizing the
expert ence with EA 3148 (CRDL. Tech. Memo 2-3-~) . The report also
notes one individual whose schizoid personality seemed to be
exaggerated by the drug. Four individuals had decrements on the
tes ~ of numerical facility .
Subjects treated with PAMC] or Scopolamine did not have any
severe drop in ChE, and there were no long lasting effects of the
rug o bserved .
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SUMMARY OF VOLUNTEER TESTING WITH T" (A9), Tacrine
total of 15 subjects was tested under various conditions with
~A. Five (5) subjects were selected for review, representing
approximately 33X of the test group. Selections were based upon the
following criteria:
Route: Intravenous (2~EU) 1 sub ject
Oral (250 ma, total) 1 sub jece
Treatment ( 3 sub ject e )
Route: Oral (192-200 ma, total) (Atropine) 2 subjects
Oral ( 250 ma, total ) ( PAMCl+Atroplne ) 1 sub jec ~
The subjects' blood cholinesterase levels were monitored
continuously, along with BEG, EKG, respiratory rate and volume with
pneumotact, and blood pressure. There were no significant changes
in the parameters measured. Untreated subjects were aeg~pto~atic at
the tose levels given, ant even though there wee some drop in ChE
(28% of nomal) in pla - ~, the RBC ChE was unaffected. Subjects
treated with atropine alone, or with PAMC1, responded well to relief
of severe parasympa thomimetic ~actions. No residual effects of the
drug reportedly were obeer~red in any of the subjects tested.
SUMMARY OF VOLUNTEER TESTING W~ PHY~STIG=" (MO)
A total of 138 sub Jects was tested Erich phy~ostigeine and 22
were selected for review, representing approximately 16: of the tese
group. The criteria for selection was based upon the following:
Dose, Route, Frequency ant Treatment.
No Treatment ( 6 subjects)
Route: Intramuscular he (TWO ,ug/kg) 2 sub jects
Intramuscular, multiple dose (15-30 ~g/kg) 4 subjects
~
Route: PhysoatlgoIine in Single (45 ~g/kg) and mulelple doses over
1 to 2 days was administered intramuscularly in subjects
that had beers previously dosed with a variety of drugs
such as:
BZ (7.4 - 14.5 ug/kg) aerosol inhalation, 2 subjects
3834 (2.0 me) percutaneous, 1 sub ject
Atropine ( 125 ,ug/l~g ) intramuscular ~ 3 sub jects
Prolixin (15.0 - 23.0 ~g/kg) intramuscular, 6 subjects
302668 (lO.O,ug/kg) intravenous, 1 subject
302196 (75. 6 .ug/kg) oral, ~ sub ject
TAB (90 mg total) intramuscular, 1 subject
Pretreatmen~c with methyl scopola - ice (~.C
On 19. 2 sub jects (~03) and (AlOK) who received
ma) 1 sub ject
doses of BZ and
were subsequently treated with physostigo~ne, showed any prolonged
central effects (hallucinations, disorientation, confusion) lasting
4 to 6 days post~exposure. Both sub jects were as~pto~atic and
appeared normal when discharged from test. One subject (~0-0) was
exposed to Prolixin (23.0 ~g/kg) and then treated with multiple
doses (~.0 mg x 7 doses) over a 2-day period, intramuscularly: At
27 hours post-exposure, the sub ject complained of blurred Piston,
and facial expression was mask-~ike, tongue "thick" and jaws open.
By 28 hours post-exposure, subject was having an oculo~gyric crisis,
mouth to one side, and left f Got tremulous and turned inward .
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-
SubJect was further treated with Cogentin, Intravenously (l.O fig ant
1.3 fig), in two doses. Within 30 minutes poet-treatment, Subject
was relaxed and dozing ant , by 31 hours post-exposure, the sub jec
appeared normal. At SO hours post-exposure, the sub ject was
asymptomatic and was discharged at 73 hours post-exposure with no
complaint s .
SUMMARY OF VOLONTEER TESTING WITH PROSTIGlIINE (All)
A total of 27 subjects was rested with proatig~ine as a part of
the esophageal motility studies. Seven ~7) subjects were selected
for review, representing approximately 26Z of the test group.
Selections were based upon the following criteria:
No Treatment ~ ~ sub iect ~
.
Route: Intramuscular (0.5 ma) 1 subject
Treatment (6 subiecto)
Route: Intramuscular (1.5 mg3 (A~cropine/PAMCI) 6 subjects
The esophageal motility studies (EPP) were performed by the
subjects before ant after administration of the bug. ChE levels
were also determined in many of the subjects. One subject developed
severe cramps in the abdomen, necessitating termination of the study
(ARAB) . Al1 o ther subjects reportedly tolerated all procedures very
well.
SUMMARY OF VOLUNTEER TESTING WITH HEXAFl UORENTUM (!lylaxinR) (Ai2)
.
A total of 11 subjects was testes with Mylaxin an a part of an
esophageal test. 11 Subjects were selected for review, representing
100% of the test group. Selections were based upon the following
cri teria.
No Treatment (11 subjects)
Route: Intravenous (0.4 ~7~ subjects
The ma jort ty of subjects tested expert enced a sensation of
"warmness" in the stomach and nausea very shortly (2-10 minutes)
after receiving the drug, foil-owed by vomiting within 5-15 minutes.
The plasma ChE levels in all subjects were depresses while RBC ChE
Petrels were not significantly affected. Esophageal motility studies
disclosed marked spasm of the lower 2/3 during deglutltion. This
coincided with depression of the plasma ChE. There were no
prolonged or long-lasting effects reported in any of these subjects
as a result of this drug. All sub jects reportedly had recovered
within 24 hours post-exposure.
SUMMARY OF VOLUNTEER TESTING WITH MALATHION (A14)
A total of lO sub Jects was tested witch l.~% malathion powder
dusted over the entire body for up to lO days. Fire (5) subjects
were selected for review, representing 50: of the test group. All
of these sub Sects report edly were asymptomatic and developed no
signs of intoxication. One subject (Al44), showed low R8CChE which
could not be ascribed to laboratory error; however, there were no
o ther significant drops in this subject 's ChE levels. All other
subjects showed no significant decreases in choline~terase.
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Sl~iMARY OF VOLUNTEER TESTING WITH CHOLINE
A total of 9 subjects was tested with otecholyl alone or with EA
1729. Several of these subjects also received other drugs such as
neostigmine, urecholine, PANC1, epinephrine by various routes.
Three (3) subjects were selected for review, representing 33X of the
test group.
Although these subjects were tested or treated with several of
these drugs, as well as mecholyl, their vital signs reportedly
returned to normal and they were all in good condition by the end of
the testing period. There were no prolonged or delayed effects from
thi s drug re port ed in these subjects .
SIXTY OF VOLUNTEER TESTING WITH U~CHOLI~_ (A21)
_
A total of 15 subjects was tested with urecholine under various
conditions, under the (E~P) . Five (5) subjects were selected for
review, representing 33% of the test group. Selections were based
upon the following criteria:
No Treatment (2 subjects)
Route: Subcutaneous (5.0 Ogle dose) ~ subject
Subcutaneous ~ 5.0 ma) (multiple dose) ~ subject
Treatment of Multiple Compounds (3 subjects)
Route: Subcutaneous (5.0 ma) (PAMCl+Prostigmine) 1 subject
Subcutaneous (5~0 ma) (Prostigmine+Curare+PAMCl) 1 subject
Su he utaneous ( 5 . O rag ~ ~ Tu bocura re+Pr 0 st igmi ne+At rapine
1 subject
EPP were performed before and after administration of the
drug. ChE was also monitored in sore cases. All subjects tolerated
these procedures very well, and there were reportedly no untoward
effects of the drugs ire "ny of the subjects tested.
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