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脂肪组织来源口服制剂 V-6 Immunitor(V-6)的安全性和疗效试验:开放标签、为期两个月的随访研究结果。

Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6): results of open-label, two-month, follow-up study.

机构信息

Immunitor USA Inc, College Park, MD 20740, USA.

出版信息

Lipids Health Dis. 2010 Feb 2;9:14. doi: 10.1186/1476-511X-9-14.

DOI:10.1186/1476-511X-9-14
PMID:20122177
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2823747/
Abstract

BACKGROUND

Chronic inflammations, atherosclerosis and obesity, are major risk factors for cardiovascular diseases. Immune modulation of the inflammatory response has shown promise in animal models of atherogenesis and metabolic disease. Tableted dietary supplement, V-6, containing pooled antigens derived from pig adipose tissue has been administered daily to 12 volunteers for 2 months.

RESULTS

No significant changes were observed in liver ALT and AST enzymes, i.e., 28 vs 23.8 IU and 22.6 vs 24.8 IU, with p=0.07 and p=0.49, respectively. Creatinine decreased; 0.88 vs 0.84 mg/dL (p=0.05) while BUN moved upward; 14.5 vs 17.5 mg/dL (p=0.01), but both values remained within normal range. Blood glucose remained within normal range; 96.1 vs 101.1 mg/dL (p=0.04). Complete blood cell analysis has not revealed any change except slight increase in hemoglobin; 13.13 to 13.96 g/dL (p=0.0002); hematocrit and red blood cells count 40.3 to 42.3% (p=0.02) and 5.15 to 5.35x10(6) cells/mm3 (p=0.03) respectively. Blood pressure systolic and diastolic values were not affected, i.e., 116.1 vs 116.3 (p=0.12) and 76.8 vs 76.6 (p=0.99). Body weight and body mass index (BMI) remained same; 66.4 vs 66.3 kg (p=0.47) and 25.7 vs 25.6 kg/m2 (p=0.2). Body fat deposit indices, such as abdomen; mid-arm; and thigh circumferences declined by 3.5 cm (p=0.008); 1.2 cm (p=0.004); and 3.0 cm (p=0.0007) respectively. The total cholesterol and LDL levels did not change; 195.5 vs 195.1 (-0.2%; p=0.8) and 113.4 vs 120.3 (6.1%; p=0.08) respectively. Triglycerides have been reduced but not statistically significant; 168.1 vs 118 mg/dL (-29.8%; p=0.2). In contrast, HDL content had risen by 29.7% from 39.4 to 51.1 mg/dL in all 12 patients (p=0.000003). TG/HDL ratio--a marker of insulin resistance--was reduced from 4.78 to 2.56 (-46.5%; p=0.04).

CONCLUSIONS

These results demonstrate that V-6 is safe and has a potential as an anti-atherogenic and overweight/obesity immune intervention.

摘要

背景

慢性炎症、动脉粥样硬化和肥胖是心血管疾病的主要危险因素。在动脉粥样硬化和代谢疾病的动物模型中,免疫调节炎症反应显示出了一定的前景。一种名为 V-6 的片剂膳食补充剂,含有源自猪脂肪组织的混合抗原,已被 12 名志愿者每天服用 2 个月。

结果

未观察到肝 ALT 和 AST 酶的显著变化,即 28 与 23.8 IU 和 22.6 与 24.8 IU,p 值分别为 0.07 和 0.49。肌酐降低,0.88 与 0.84 mg/dL(p=0.05),而 BUN 升高,14.5 与 17.5 mg/dL(p=0.01),但均在正常范围内。血糖仍在正常范围内,96.1 与 101.1 mg/dL(p=0.04)。全血细胞分析除血红蛋白略有增加外,无其他变化,13.13 至 13.96 g/dL(p=0.0002);红细胞压积和红细胞计数分别为 40.3 至 42.3%(p=0.02)和 5.15 至 5.35x10(6) cells/mm3(p=0.03)。血压收缩压和舒张压不受影响,即 116.1 与 116.3(p=0.12)和 76.8 与 76.6(p=0.99)。体重和体重指数(BMI)保持不变,66.4 与 66.3 kg(p=0.47)和 25.7 与 25.6 kg/m2(p=0.2)。腹部、上臂和大腿周长等体脂肪沉积指数分别下降 3.5 cm(p=0.008)、1.2 cm(p=0.004)和 3.0 cm(p=0.0007)。总胆固醇和 LDL 水平没有变化,195.5 与 195.1(-0.2%;p=0.8)和 113.4 与 120.3(6.1%;p=0.08)。甘油三酯虽有所降低,但无统计学意义,168.1 与 118 mg/dL(-29.8%;p=0.2)。相反,HDL 含量从 39.4 上升至 51.1 mg/dL,在所有 12 名患者中均上升了 29.7%(p=0.000003)。TG/HDL 比值——胰岛素抵抗的标志物——从 4.78 降至 2.56(-46.5%;p=0.04)。

结论

这些结果表明,V-6 是安全的,并具有作为抗动脉粥样硬化和超重/肥胖免疫干预的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2db8/2823747/b8e0dcfc4aa4/1476-511X-9-14-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2db8/2823747/0a7c1fa02dc4/1476-511X-9-14-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2db8/2823747/b8e0dcfc4aa4/1476-511X-9-14-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2db8/2823747/0a7c1fa02dc4/1476-511X-9-14-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2db8/2823747/b8e0dcfc4aa4/1476-511X-9-14-2.jpg

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