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J Acupunct Res > Volume 32(4); 2015 > Article |
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No mortalities or adverse effects were caused by the investigational substance were observed during the study period.
There was no significant difference in body weight caused by the the investigational substance across all groups.
No significant between-group difference was found to be caused by the investigational substance in blood tests and biochemical testing.
No abnormalities were detected by a necropsy examination with the unaided eye at the macro level after treatment with the investigational substance.
Difference in organ weight between groups caused by the investigational substance was not found.
All groups did not exhibit pathological findings caused by the investigational substance in histopathogical examination.
Group | Sex | Animal No.1 | Dose (mg/kg/day) |
---|---|---|---|
G12 | Male | G1-1~G1-10 | 0 |
Female | G1-51~G1-60 | ||
G2 | Male | G2-16~G2-25 | 4.6 |
Female | G2-66~G2-75 | ||
G3 | Male | G3-26~G3-35 | 9.2 |
Female | G3-76~G3-85 | ||
G4 | Male | G4-36~G4-45 | 18.5 |
Female | G4-86~G4-95 |
sex: Male | ||||
---|---|---|---|---|
Hematological | G124(n = 10) | G2 (n = 10) | G3 (n = 10) | G4 (n = 10) |
0 mg/kg | 4.6 mg/kg | 9.2 mg/kg | 18.5 mg/kg | |
wbc1(K/μL) | 8.99±2.42 | 11.04±2.82 | 10.16±2.72 | 9.24±3.26 |
NE2(K/μL) | 0.89±0.24 | 1.37±0.47* | 1.38±0.40* | 1.09±0.23 |
ly3(K/μL) | 7.68±2.15 | 9.27±2.42 | 8.41 ±2.35 | 7.84±2.95 |
mo4(K/μL) | 0.18±0.05 | 0.22±0.08 | 0.18±0.08 | 0.16±0.08 |
eo5(K/μL) | 0.05±0.01 | 0.05±0.02 | 0.05±0.02 | 0.05±0.03 |
BA6(K/μL) | 0.00±0.00 | 0.01 ±0.00 | 0.01 ±0.01 | 0.01±0.01 |
LUC7(K/μL) | 0.19±0.15 | 0.12±0.06 | 0.13±0.10 | 0.10±0.07 |
NEP8(%) | 10.25±2.42 | 12.35±2.75 | 13.77±2.51* | 12.36±2.28 |
LYP9(%) | 85.14±2.94 | 84.04±2.78 | 82.49±2.91 | 84.32±2.41 |
MOP10(%) | 1.95±0.37 | 1.92±0.48 | 1.84±0.71 | 1.68±0.44 |
EOP11(%) | 0.63±0.21 | 0.49±0.31 | 0.53±0.23 | 0.51±0.23 |
BAP12(%) | 0.05±0.05 | 0.08±0.04 | 0.07±0.08 | 0.11±0.12 |
LUP13(%) | 1.97±1.23 | 1.12±0.70 | 1.26±1.22 | 0.99±0.41 |
rbc14(M/μL) | 7.90±0.20 | 8.18±0.32 | 8.12±0.36 | 7.94±0.24 |
Hb15(g/dL) | 17.22±0.47 | 17.86±0.67 | 17.58±0.78 | 17.35±0.62 |
HCT16(%) | 47.30±1.49 | 48.55±2.02 | 48.17±1.57 | 47.72±1.48 |
MCV17(fL) | 59.90±1.64 | 59.43±2.12 | 59.37±1.93 | 60.13±1.65 |
MCH18(pg) | 21.80±0.55 | 21.82±0.60 | 21.69±0.85 | 21.88±0.66 |
MCHC19(g/dL) | 36.38±0.46 | 36.76±0.74 | 36.51±0.67 | 36.35±0.97 |
RDW20(%) | 11.39±0.30 | 11.13±0.30 | 11.37±0.36 | 11.17±0.40 |
PLT21(K/μL) | 1077.90±89.33 | 1154.80±129.89 | 1115.10±218.20 | 1117.50±92.20 |
MPV22(fL) | 6.76±0.36 | 6.48±0.24 | 6.91±0.39 | 6.69±0.54 |
Reti23(%) | 2.61±0.48 | 2.46±0.37 | 2.47±0.48 | 2.65±0.23 |
sex: Female | ||||
---|---|---|---|---|
Hematological | G124(n = 10) | G2 (n = 10) | G3 (n = 10) | G4 (n = 10) |
0 mg/kg | 4.6 mg/kg | 9.2 mg/kg | 18.5 mg/kg | |
wbc1(K/μL) | 7.02±0.88 | 7.72±1.43 | 6.41 ±1.06 | 7.11±2.40 |
ne2(K/μL) | 0.76±0.31 | 1.59±2.36 | 0.69±0.21 | 0.51 ±0.21 |
ly3(K/μL) | 5.91±0.68 | 5.66±1.88 | 5.48±0.94 | 6.35±2.36 |
mo4(K/μL) | 0.15±0.05 | 0.27±0.36 | 0.12±0.03 | 0.11±0.03 |
eo5(K/μL) | 0.07±0.04 | 0.05±0.03 | 0.05±0.01 | 0.05±0.02 |
BA6(K/μL) | 0.01±0.01 | 0.01±0.01 | 0.01±0.00 | 0.01±0.00 |
LUc7(K/μL) | 0.12±0.13 | 0.14±0.14 | 0.08±0.03 | 0.09±0.06 |
NEP8(%) | 10.70±3.80 | 18.09±20.42 | 10.74±2.51 | 8.05±4.43 |
LYP9(%) | 84.46±4.90 | 75.96±22.76 | 85.40±2.54 | 88.31±4.83 |
MOP10(%) | 2.17±0.50 | 3.01±3.12 | 1.85±0.44 | 1.67±0.44 |
EOP11(%) | 0.99±0.56 | 0.71±0.36 | 0.76±0.24 | 0.72±0.26 |
BAP12(%) | 0.09±0.07 | 0.12±0.09 | 0.10±0.04 | 0.09±0.05 |
LUP13(%) | 1.59±1.35 | 2.09±2.29 | 1.15±0.36 | 1.15±0.48 |
rbc14(M/μL) | 7.84±0.34 | 7.76±0.36 | 7.81±0.39 | 7.83±0.37 |
Hb15(g/dL) | 17.26±0.80 | 16.63±0.79 | 16.88±0.83 | 16.93±0.94 |
HCT16(%) | 45.44±2.43 | 44.56±2.23 | 45.68±2.41 | 45.30±2.89 |
MCV17(fL) | 57.92±1.10 | 57.48±2.01 | 58.52±1.70 | 57.86±1.56 |
MCH18(pg) | 22.00±0.38 | 21.45±0.70 | 21.64±0.36 | 21.65±0.53 |
MCHC19(g/dL) | 38.02±0.84 | 37.34±0.45* | 37.00±0.72* | 37.40±0.57 |
RDW20(%) | 10.62±0.98 | 10.51±0.38 | 10.43±0.28 | 10.33±0.24 |
PLT21(K/μL) | 1240.30±147.30 | 1209.30±129.69 | 1165.00±169.52 | 1193.50±88.04 |
MPV22(fL) | 6.63±0.29 | 6.69±0.42 | 6.76±0.28 | 6.66±0.25 |
Reti23(%) | 2.50±1.16 | 2.28±0.45 | 2.22±0.35 | 2.11±0.45 |
sex: Male | ||||
---|---|---|---|---|
Serum | G123(n = 10) | G2 (n = 10) | G3 (n = 10) | G4 (n = 10) |
0 mg/kg | 4.6 mg/kg | 9.2 mg/kg | 18.5 mg/kg | |
AST1 (IU/L) | 133.20±29.70 | 130.10±35.62 | 121.60±28.92 | 121.00±32.86 |
ALT2 (IU/L) | 31.10±4.01 | 37.70±7.39 | 34.60±6.90 | 34.20±6.14 |
ALP3 (IU/L) | 707.80±57.14 | 785.10±137.19 | 681.50±83.95 | 719.70±174.69 |
GGT4 (IU/L) | 0.90±0.30 | 0.80±0.40 | 0.90±0.30 | 1.00±0.00 |
LDH5 (IU/L) | 1288.80±709.57 | 1061.70±915.57 | 847.20±770.71 | 921.40±766.96 |
BUN6 (mg/dL) | 17.69±2.34 | 19.09±2.06 | 17.94±1.33 | 17.50±2.34 |
CRE7 (mg/dL) | 0.52±0.05 | 0.55±0.05 | 0.55±0.05 | 0.51±0.02 |
GLU8 (mg/dL) | 213.80±22.10 | 218.40±27.10 | 203.60±25.80 | 206.30±41.68 |
CHO9 (mg/dL) | 68.40±12.00 | 80.90±10.25 | 72.00±11.94 | 73.50±11.67 |
TP10 (g/dL) | 6.68±0.27 | 6.88±0.26 | 6.79±0.31 | 6.77±0.21 |
CPK11 (U/L) | 843.30±404.87 | 726.90±519.65 | 584.60±392.44 | 648.80±447.59 |
ALB12 (g/dL) | 2.75±0.11 | 2.81±0.13 | 2.78±0.14 | 2.76±0.10 |
T-BIL13 (mg/dL) | 0.04±0.02 | 0.03±0.02 | 0.03±0.20 | 0.04±0.02 |
A/G ratio14 | 0.70±0.04 | 0.69±0.04 | 0.69±0.03 | 0.69±0.03 |
TG15 (mg/dL) | 50.20±22.17 | 51.30±25.41 | 62.90±16.92 | 64.00±26.59 |
UA6 (mg/dL) | 2.63±0.61 | 3.24±0.74 | 3.06±0.59 | 2.88±0.49 |
Ca17 (mg/dL) | 13.13±0.61 | 13.18±0.41 | 13.05±0.47 | 13.35±0.67 |
IP18 (mg/dL) | 12.54±0.97 | 12.72±0.75 | 12.65±0.99 | 12.87±0.75 |
Cl19 (mmol/L) | 105.70±1.42 | 106.10±1.14 | 106.20±1.33 | 106.00±1.41 |
Mg20 (mg/dL) | 3.10±0.26 | 3.36±0.34 | 3.20±0.32 | 3.21±0.28 |
Na21 (mmol/L) | 144.80±1.17 | 144.90±1.45 | 145.40±0.92 | 146.10±1.64 |
K22 (mmol/L) | 5.41 ±0.62 | 5.72±0.28 | 6.06±0.91 | 5.88±0.67 |
sex: Female | ||||
---|---|---|---|---|
Serum | G123(n = 10) | G2 (n = 10) | G3 (n = 10) | G4 (n = 10) |
0 mg/kg | 4.6 mg/kg | 9.2 mg/kg | 18.5 mg/kg | |
AST1 (IU/L) | 163.40±57.47 | 129.60±36.10 | 116.70±18.32 | 139.70±31.07 |
ALT2 (IU/L) | 37.10±13.20 | 34.80±5.74 | 30.10±4.66 | 34.80±7.53 |
ALP3 (IU/L) | 427.60±103.61 | 408.70±116.02 | 460.80±86.69 | 438.10±85.90 |
GGT4 (IU/L) | 0.30±0.46 | 0.30±0.46 | 0.50±0.50 | 0.60±0.49 |
LDH5 (IU/L) | 1316.50±704.54 | 1164.40±941.13 | 835.20±518.99 | 1346.80±716.47 |
BUN6 (mg/dL) | 20.55±2.39 | 20.00±3.35 | 21.51 4.38 | 19.49±1.75 |
CRE7 (mg/dL) | 0.59±0.06 | 0.56±0.05 | 0.61±0.07 | 0.57±0.05 |
GLU8 (mg/dL) | 165.40±40.76 | 167.10±26.18 | 160.90±28.77 | 170.30±31.23 |
CHO9 (mg/dL) | 85.10±13.58 | 96.40±9.33 | 99.00±23.32 | 102.00±17.98 |
TP10 (g/dL) | 7.35±0.37 | 7.11 ±0.41 | 7.18±0.51 | 7.17±0.38 |
CPK11 (U/L) | 807.50±321.17 | 682.90±472.68 | 488.60±217.21 | 731.90±297.78 |
ALB12 (g/dL) | 3.17±0.24 | 3.09±0.23 | 3.12±0.27 | 3.16±0.21 |
T-BIL13 (mg/dL) | 0.06±0.04 | 0.06±0.03 | 0.05±0.02 | 0.05±0.02 |
A/G ratio14 | 0.76±0.10 | 0.77±0.05 | 0.77±0.05 | 0.79±0.06 |
TG15 (mg/dL) | 26.80±11.14 | 29.00±6.32 | 33.40±14.57 | 26.10±11.16 |
UA6 (mg/dL) | 2.67±0.52 | 2.55±0.47 | 2.64±0.45 | 2.96±0.62 |
Ca17 (mg/dL) | 13.10±1.06 | 13.67±2.23 | 13.71±1.62 | 12.90±0.52 |
IP18 (mg/dL) | 11.46±1.27 | 12.09±0.70 | 12.09±0.87 | 11.59±0.83 |
Cl19 (mmol/L) | 106.20±1.99 | 105.30±1.55 | 106.20±1.83 | 106.90±4.18 |
Mg20 (mg/dL) | 3.37±0.17 | 3.38±0.21 | 3.46±0.39 | 3.40±0.47 |
Na21 (mmol/L) | 143.50±1.69 | 141.70±1.55 | 143.40±1.91 | 144.30±5.50 |
K22 (mmol/L) | 5.30±1.00 | 5.90±1.04 | 5.35±0.86 | 5.63±0.91 |
Sex | Organ | Sign | Group (mg/kg) | |||
---|---|---|---|---|---|---|
G11 (n = 10, 0) | G2 (n = 10, 4.6) | G3 (n = 10, 9.2) | G4 (n = 10, 18.5) | |||
Male | All organs | Normal | 10 / 10 | 10 / 10 | 10 / 10 | 10 / 10 |
Female | All organs | Normal | 10 / 10 | 10 / 10 | 10 / 10 | 10 / 10 |
sex: Male (g) | ||||
---|---|---|---|---|
Organ | G11 (n = 10) | G2 (n = 10) | G3 (n = 10) | G4 (n = 10) |
0 mg/kg | 4.6 mg/kg | 9.2 mg/kg | 18.5 mg/kg | |
Body weigh | 362.46±30.55 | 349.16±32.27 | 347.94±33.89 | 356.71±37.30 |
Testis(Lt.) | 1.61±0.08 | 1.69±0.15 | 1.64±0.13 | 1.71±0.11 |
Testis(Rt.) | 1.64±0.09 | 1.68±0.13 | 1.64±0.12 | 1.69±0.12 |
Prostate | 0.58±0.12 | 0.62±0.13 | 0.62±0.10 | 0.66±0.10 |
Spleen | 0.77±0.09 | 0.76±0.06 | 0.69±0.07 | 0.75±0.12 |
Liver | 10.53±1.05 | 10.15±1.15 | 10.42±1.35 | 10.75±1.54 |
Adrenal gland(Lt.) | 0.03±0.00 | 0.14±.34 | 0.03±0.00 | 0.03±0.00 |
Adrenal gland(Rt.) | 0.03±0.01 | 0.03±0.01 | 0.03±0.00 | 0.03±0.00 |
Kidney(Lt.) | 1.26±0.12 | 1.19±0.39 | 1.28±0.10 | 1.33±0.12 |
Kidney(Rt.) | 1.30±0.11 | 1.31±0.09 | 1.33±0.11 | 1.36±0.12 |
Heart | 1.33±0.11 | 1.23±0.10 | 1.28±0.14 | 1.34±0.14 |
Lung | 1.47±0.14 | 1.52±0.14 | 1.45±0.19 | 1.53±0.20 |
Brain | 2.02±0.09 | 2.06±0.10 | 203±0.08 | 204±0.06 |
Pituitary | 0.01±0.00 | 0.01±0.00 | 0.01±0.00 | 0.01±0.00 |
Thymus | 0.51±0.15 | 0.49±0.14 | 0.48±0.09 | 0.46±0.10 |
sex: Female (g) | ||||
---|---|---|---|---|
Organ | G11 (n = 10) | G2 (n = 10) | G3 (n = 10) | G4 (n = 10) |
0 mg/kg | 4.6 mg/kg | 9.2 mg/kg | 18.5 mg/kg | |
Body weigh | 226.01 ±11.21 | 219.97±8.85 | 223.46±9.87 | 220.46±12.84 |
Testis(Lt.) | 0.05±0.01 | 0.05±0.01 | 0.05±0.01 | 0.05±0.00 |
Testis(Rt.) | 0.05±0.01 | 0.05±0.01 | 0.05±0.00 | 0.05±0.00 |
Prostate | 0.38±0.07 | 0.53±0.24 | 0.49±0.10 | 0.51±0.15 |
Spleen | 0.53±0.10 | 0.53±0.11 | 0.52±0.09 | 0.51±0.08 |
Liver | 6.82±0.44 | 6.86±0.37 | 6.97±0.57 | 6.83±0.75 |
Adrenal gland(Lt.) | 0.03±0.00 | 0.03±0.00 | 0.03±0.00 | 0.04±0.00 |
Adrenal gland(Rt.) | 0.03±0.00 | 0.03±0.00 | 0.03±0.01 | 0.04±0.00 |
Kidney(Lt.) | 0.78±0.09 | 0.79±0.06 | 0.83±0.07 | 0.83±0.09 |
Kidney(Rt.) | 0.80±0.07 | 0.83±0.08 | 0.86±0.09 | 0.85±0.08 |
Heart | 0.83±0.08 | 0.88±0.06 | 0.88±0.10 | 0.85±0.07 |
Lung | 1.18±0.11 | 1.19±0.13 | 1.24±0.08 | 1.27±0.22 |
Brain | 1.85±0.06 | 1.88±0.07 | 1.91±0.11 | 1.88±0.06 |
Pituitary | 0.01±0.00 | 0.01 ±0.00 | 0.01±0.00 | 0.01±0.00 |
Thymus | 0.45±0.06 | 0.45±0.06 | 0.46±0.06 | 0.42±0.07 |
Organ / findings (Number of animals) | Male | Female | |||
---|---|---|---|---|---|
G11 (n=10, 0 mg/kg) | G4 (n=10, 18.5mg/kg) | G1 (n=10, 0mg/kg) | G4 (n=10, 18.5mg/kg) | ||
Liver | –Bile duct hyperplasia | ±2 (n=1) | NR3 | NR | NR |
–Cell infiltration, mononuclear, perivascular | ± (n=1) | NR | NR | NR | |
–Cell infiltration, mononuclear, multifocal | ± (n=2) | NR | NR | NR | |
–Cell infiltration, mononuclear, focal | ± (n=1) | ± (n=4) | ± (n=3) | ± (n=3) | |
–Necrosis, focal | NR | NR | ± (n=2) | NR | |
Thyroid | –Ultimobranchial cyst | ± (n=1) | ± (n=1) | NR | NR |
–Ectopic thymus | ± (n=1) | NR | ± (n=1) | NR | |
Lung | –Osseous metaplasia | ± (n=1) | NR | NR | NR |
–Accumulation, alveolarmacrophage, focal | NR | ± (n=1) | NR | NR | |
Heart | –Edema, perivascular | NR | ± (n=1) | NR | NR |
–Cellinfiltration, mononuclear, focal | ± (n=2) | NR | NR | NR | |
Kidney | –Basophilic tubule, with inflammatory cell infiltration, focal, cortex | NR | ± (n=1) | NR | NR |
–Cyst, with inflammatory cell infiltration, cortex | NR | NR | NR | ± (n=1) | |
Pituitary | –Cyst, parsdistalis | NR | ± (n=1) | NR | NR |
There were no remarkable changes in the other organ. |
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