鱼油制剂对人体降脂作用的研究
发布时间：2018-07-13 09:44
【摘要】：目的通过对成年血脂异常人群进行鱼油制剂的干预试验,以验证二种鱼油制剂在调节血脂方面的功能有效性,并尝试探讨不同EPA(20碳五烯酸)和DHA(22碳六烯酸)配比的鱼油制剂在血脂调节方面的可能差异,从而为血脂调节及其相关心血管疾病的防治提供理论依据和实践指南。方法采用随机、平行、组间对照的试验设计,在上海某两社区内,各入选血清总胆固醇(TC)和/或血清甘油三脂(TG)异常升高的受试者120名,其中60名为试验组,另60名入选空白对照组。两项试验各评价60名受试者服用1000mg规格鱼油胶囊I(EPA 175mg和DHA 70mg DHA)每天4粒和1500mg鱼油胶囊II(EPA 197mg和DHA 131mg),每天3粒,连续服用45天,观察其对血脂的作用。主要评价指标为鱼油胶囊组较空白对照组TC下降10%以上且TG下降15%以上受试者的比例。其它评价指标包括受试者干预后TC或TG下降达到分别上述标准的比例和TC及TG服用后改变的平均百分率。用卡方检验分析鱼油胶囊组和空白对照组有效率差异的显著性,按照连续变量的分布特性,选择组间t检验或Wilcoxon秩和检验分析鱼油胶囊组和空白对照组干预后血脂改变的差异；最后采用荟萃分析(Meta-Analysis)综合2种不同配比鱼油胶囊对血脂的作用。结果试验结束时,由于受试者未完成实验而造成脱失率为20%,故得到有效数据的样本量各组均为50例。两项试验所有受试者基线TC 5.2 mmol/L和TG1.65mmol/L,鱼油胶囊服用45天后,两试验组分别有20名(40%)和16名(32%)受试者TC下降10%且TG下降15%,相应地,两试验空白对照组仅分别有4名(8%)和0名受试者达到该标准；两鱼油胶囊组与空白对照组比较,总有效率增加均为32%,p值分别为0.0002和0.0001。每天服用4粒鱼油胶囊I 45天,受试者TC由5.74±0.452 mmol/L下降至5.07±0.663 mmol/L,中位数改变百分率为-11.54%；相应对照组由基线5.70+0.475mmol/L改变至5.64±0.830mmol/L,中位数改变百分率为-0.50%,即服用鱼油胶囊I后,试验组受试者TC较对照组显著下降,Hodges-Lehmann方法估计差异为-11.7%,Wilcoxon秩和检验p0.0001。类似地,在试验2中,服用鱼油胶囊II每天3粒可使受试者TC由基线水平平均改变-10.4+13.85%,而空白对照组平均改变为0.6±8.08%,即试验组TC与空白对照组改变的差异为-11.0%(p0.0001)。试验结果揭示,连续服用鱼油胶囊I或鱼油胶囊1145天,与空白对照相比较,TC由基线水平下降10%的受试者比例更高,分别较对照组增加48%(p0.0001)和42%(p0.0001)。服用鱼油胶囊145天后,受试者TG由基线水平2.58±1.099 mmol/L下降至1.89±0.797mmol/L,中位数平均变化-21.19%,相应对照组基线TG水平为2.41±0.864mmol/L,试验后为2.43±1.130 mmol/L,平均改变3.09%,鱼油胶囊I引起TG百分改变与对照组相比,其差异有统计学显著性,平均约为-24.3%(p=0.0006)。服用鱼油胶囊1145天后,受试者TG由试验前2.47±1.151 mmol/L下降至1.97±1.259 mmol/L,中位变化百分率-29.55%；对照组基线TG为2.50±1.085mmol/L,45天后为2.46±0.956mmol/L,中位改变百分率-0.11%；Hodges-Lehmann估计试验组对应于对照组TG改变百分率为-29.01%(p=0.0003)。采用鱼油胶囊Ⅰ和鱼油胶囊Ⅱ干预,分别有31名(62.0%)和33名(66%)受试者TG较基线下降15%以上,而空白对照组相应分别为15名(30%)和11名(22%)。比较鱼油胶囊组与空白对照组TG较基线下降15%以上的受试者比例,鱼油胶囊I和鱼油胶囊11分别较对照组高32%(p=0.0013)和44%(p0.0001)。服用鱼油胶囊145天后,HDL-C中位数由1.425mmol/L改变至1.455 mmol/L变化中位数为0.025mmol/L;对照组基线时HDL-C中位浓度为1.46 mmol/L,45天时为1.355mmol/L,中位改变-0.065 mmol/L;Hodges-Lehmann估计两组之间的服用前后HDL-C改变的差异为0.0650mmol/L (p=0.0581);鱼油胶囊II服用45天,受试者HDL-C由服用前1.45±0.310 mmol/L改变至1.40±0.341 mmol/L,对照组由1.37±0.226改变至1.34±0.255 mmol/L,变化值分别为-0.050+0.2669mmol/L和-0.035±0.1889 mmol/L,两组相差-0.0154 mmol/L (p=0.7399)。鱼油胶囊I和鱼油胶囊II试验组与对照组之间均未见显著性差异。合并分析两项试验结果,无证据说明2种EPA和DHA配比鱼油胶囊的效果存在差异。两项试验中均未见不良事件发生。结论本研究通过两项试验证明鱼油胶囊可有效改善受试者的血脂代谢,显著降低血清TC和TG水平,但不改变正常水平的HDL-C;亦未见证据支持2种不同EPA和DHA配比的鱼油胶囊在降脂疗效上存在差异。因此,在成人血脂异常的防治措施中,增加鱼油制剂,n-3不饱和脂肪酸的摄入可能是一项保护因素,进而有助降低心血管疾病风险。
[Abstract]:Objective to verify the functional effectiveness of the two fish oil preparations in regulating blood lipids, and to try to explore the possible difference between the different EPA (20 carbon five enoic acid) and the DHA (22 carbon six enoic acid) in the regulation of lipid regulation by the intervention test of fish oil preparation in adult dyslipidemia population, and the possible difference in the prescription of lipid regulation with different ratio of 20 carbon five enoic acid and 22 carbon six enoic acid was tried to provide the regulation of blood lipid and related heart blood. To provide theoretical basis and practical guide for prevention and control of disease, a randomized, parallel, and inter group controlled trial was designed. In a two community of Shanghai, 120 subjects were selected for the abnormal increase of serum total cholesterol (TC) and / or serum glycerin three fat (TG), of which 60 were in the experimental group and 60 in the blank control group. Two tests were assessed at 60. The subjects took 1000mg specification fish oil capsule I (EPA 175mg and DHA 70mg DHA) and 1500mg fish oil capsule II (EPA 197mg and DHA) every day, 3 tablets a day for 45 days, and observed its effect on blood lipid. The main evaluation index was that the fish oil capsule group decreased more than 10% compared with the blank control group and dropped more than 15% subjects. The evaluation index included the ratio of TC or TG to the above standards after the subjects' intervention and the average percentage of the changes after TC and TG. The significant difference in efficiency difference between the fish oil capsule group and the blank control group was analyzed by chi square test. According to the distribution characteristics of the continuous variables, the t test or the Wilcoxon rank sum test were selected to analyze the fish oil glue. The difference of blood lipid changes in the capsule group and the blank control group. Finally, the effect of 2 different fish oil capsules on the blood lipid was combined with the meta-analysis (Meta-Analysis). Results the loss rate of the subjects was 20% due to the unfinished experiment. All the samples of the effective data were all 50 cases. All the two tests were received. At baseline TC 5.2 mmol/L and TG1.65mmol/L, 45 days after taking fish oil capsules, 20 (40%) and 16 (32%) subjects in the two test group decreased 10% and TG decreased by 15%. Accordingly, two test blank control groups were only 4 (8%) and 0 subjects reached the standard, and the total efficiency of the fish oil capsule group was higher than that of the blank control group. For 32%, P values of 0.0002 and 0.0001. were taken respectively for 45 days of 4 fish oil capsule I, and the participants' TC decreased from 5.74 + 0.452 mmol/L to 5.07 + 0.663 mmol/L, the median change percentage was -11.54%; the corresponding control group changed from baseline 5.70+0.475mmol/L to 5.64 + 0.830mmol/L, the median change percentage was -0.50%, that is, after taking fish oil capsule I. The test group TC was significantly lower than the control group. The difference between the Hodges-Lehmann method was -11.7%, the Wilcoxon rank and the test p0.0001. were similar. In Experiment 2, 3 tablets of fish oil capsule II could change the TC from the baseline level to -10.4+13.85%, while the blank control group changed to 0.6 + 8.08%, that is, the experimental group TC and the blank control group. The difference was -11.0% (P0.0001). The test results revealed that the continuous use of fish oil capsule I or fish oil capsule for 1145 days, compared with the blank, the proportion of TC from the baseline level dropped by 10% was higher, 48% (P0.0001) and 42% (P0.0001), respectively, compared with the control group. After 145 days of fish oil capsule, the subjects TG was 2.58 + 1.099 mmol at baseline. The average change of /L was 1.89 + 0.797mmol/L, the median change was -21.19%, and the baseline TG level in the corresponding control group was 2.41 + 0.864mmol/L. The average change was 2.43 + 1.130 mmol/L, the average change was 3.09%. The difference of TG percent caused by fish oil capsule I was statistically significant compared with the control group, the average was about -24.3% (p=0.0006). After taking fish oil capsules for 1145 days, The subjects' TG decreased to 1.97 + 1.259 mmol/L from 2.47 + 1.151 mmol/L before the test, and the median change percentage was -29.55%; the baseline TG of the control group was 2.50 + 1.085mmol/L, 2.46 + 0.956mmol/L, the median change percentage -0.11%, and the Hodges-Lehmann estimated test group was corresponding to the control group TG modification percentage -29.01% (p=0.0003). Fish oil glue was used. The TG of 31 (62%) and 33 (66%) subjects decreased more than 15%, while the blank control group was 15 (30%) and 11 (22%) respectively. The ratio of fish oil capsule group and blank control group TG to the baseline decreased more than 15%, fish oil capsule I and fish oil capsule 11 higher than the control group 32% (p= 0.0013) and 44% (P0.0001). The median of HDL-C median change from 1.425mmol/L to 1.455 mmol/L was 0.025mmol/L after taking fish oil capsules for 145 days. The median HDL-C level of the control group was 1.46 mmol/L, 45 days was 1.355mmol/L, and the median of -0.065 mmol/L was changed; Hodges-Lehmann estimated the difference of HDL-C changes between the two groups before and after taking. 0.0650mmol/L (p=0.0581); the HDL-C of fish oil capsule II was changed to 1.40 + 0.341 mmol/L before taking 1.45 + 0.310 mmol/L, the control group changed from 1.37 + 0.226 to 1.34 + 0.255 mmol/L, the change value was -0.050+0.2669mmol/L and -0.035 + 0.1889 mmol/L, and the two phase difference -0.0154 mmol/L (fish oil capsule) and fish oil glue No significant difference was found between the II test group and the control group. The results of the combined analysis of two tests showed no evidence of the difference in the effect of the 2 kinds of fish oil capsules with the ratio of EPA and DHA. There was no adverse event in the two tests. Conclusion this study proved that fish oil capsules could effectively improve the metabolism of blood lipids in the subjects by two tests. Low serum TC and TG levels, but do not change the normal level of HDL-C; there is no evidence to support the difference in the effect of 2 different EPA and DHA ratio fish oil capsules. Therefore, the increase of fish oil preparation and the intake of n-3 unsaturated fatty acids may be a protective factor in the prevention and treatment of dyslipidemia in adults. Disease risk.
【学位授予单位】：复旦大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：R151;R589.2
本文编号：2118950
[Abstract]:Objective to verify the functional effectiveness of the two fish oil preparations in regulating blood lipids, and to try to explore the possible difference between the different EPA (20 carbon five enoic acid) and the DHA (22 carbon six enoic acid) in the regulation of lipid regulation by the intervention test of fish oil preparation in adult dyslipidemia population, and the possible difference in the prescription of lipid regulation with different ratio of 20 carbon five enoic acid and 22 carbon six enoic acid was tried to provide the regulation of blood lipid and related heart blood. To provide theoretical basis and practical guide for prevention and control of disease, a randomized, parallel, and inter group controlled trial was designed. In a two community of Shanghai, 120 subjects were selected for the abnormal increase of serum total cholesterol (TC) and / or serum glycerin three fat (TG), of which 60 were in the experimental group and 60 in the blank control group. Two tests were assessed at 60. The subjects took 1000mg specification fish oil capsule I (EPA 175mg and DHA 70mg DHA) and 1500mg fish oil capsule II (EPA 197mg and DHA) every day, 3 tablets a day for 45 days, and observed its effect on blood lipid. The main evaluation index was that the fish oil capsule group decreased more than 10% compared with the blank control group and dropped more than 15% subjects. The evaluation index included the ratio of TC or TG to the above standards after the subjects' intervention and the average percentage of the changes after TC and TG. The significant difference in efficiency difference between the fish oil capsule group and the blank control group was analyzed by chi square test. According to the distribution characteristics of the continuous variables, the t test or the Wilcoxon rank sum test were selected to analyze the fish oil glue. The difference of blood lipid changes in the capsule group and the blank control group. Finally, the effect of 2 different fish oil capsules on the blood lipid was combined with the meta-analysis (Meta-Analysis). Results the loss rate of the subjects was 20% due to the unfinished experiment. All the samples of the effective data were all 50 cases. All the two tests were received. At baseline TC 5.2 mmol/L and TG1.65mmol/L, 45 days after taking fish oil capsules, 20 (40%) and 16 (32%) subjects in the two test group decreased 10% and TG decreased by 15%. Accordingly, two test blank control groups were only 4 (8%) and 0 subjects reached the standard, and the total efficiency of the fish oil capsule group was higher than that of the blank control group. For 32%, P values of 0.0002 and 0.0001. were taken respectively for 45 days of 4 fish oil capsule I, and the participants' TC decreased from 5.74 + 0.452 mmol/L to 5.07 + 0.663 mmol/L, the median change percentage was -11.54%; the corresponding control group changed from baseline 5.70+0.475mmol/L to 5.64 + 0.830mmol/L, the median change percentage was -0.50%, that is, after taking fish oil capsule I. The test group TC was significantly lower than the control group. The difference between the Hodges-Lehmann method was -11.7%, the Wilcoxon rank and the test p0.0001. were similar. In Experiment 2, 3 tablets of fish oil capsule II could change the TC from the baseline level to -10.4+13.85%, while the blank control group changed to 0.6 + 8.08%, that is, the experimental group TC and the blank control group. The difference was -11.0% (P0.0001). The test results revealed that the continuous use of fish oil capsule I or fish oil capsule for 1145 days, compared with the blank, the proportion of TC from the baseline level dropped by 10% was higher, 48% (P0.0001) and 42% (P0.0001), respectively, compared with the control group. After 145 days of fish oil capsule, the subjects TG was 2.58 + 1.099 mmol at baseline. The average change of /L was 1.89 + 0.797mmol/L, the median change was -21.19%, and the baseline TG level in the corresponding control group was 2.41 + 0.864mmol/L. The average change was 2.43 + 1.130 mmol/L, the average change was 3.09%. The difference of TG percent caused by fish oil capsule I was statistically significant compared with the control group, the average was about -24.3% (p=0.0006). After taking fish oil capsules for 1145 days, The subjects' TG decreased to 1.97 + 1.259 mmol/L from 2.47 + 1.151 mmol/L before the test, and the median change percentage was -29.55%; the baseline TG of the control group was 2.50 + 1.085mmol/L, 2.46 + 0.956mmol/L, the median change percentage -0.11%, and the Hodges-Lehmann estimated test group was corresponding to the control group TG modification percentage -29.01% (p=0.0003). Fish oil glue was used. The TG of 31 (62%) and 33 (66%) subjects decreased more than 15%, while the blank control group was 15 (30%) and 11 (22%) respectively. The ratio of fish oil capsule group and blank control group TG to the baseline decreased more than 15%, fish oil capsule I and fish oil capsule 11 higher than the control group 32% (p= 0.0013) and 44% (P0.0001). The median of HDL-C median change from 1.425mmol/L to 1.455 mmol/L was 0.025mmol/L after taking fish oil capsules for 145 days. The median HDL-C level of the control group was 1.46 mmol/L, 45 days was 1.355mmol/L, and the median of -0.065 mmol/L was changed; Hodges-Lehmann estimated the difference of HDL-C changes between the two groups before and after taking. 0.0650mmol/L (p=0.0581); the HDL-C of fish oil capsule II was changed to 1.40 + 0.341 mmol/L before taking 1.45 + 0.310 mmol/L, the control group changed from 1.37 + 0.226 to 1.34 + 0.255 mmol/L, the change value was -0.050+0.2669mmol/L and -0.035 + 0.1889 mmol/L, and the two phase difference -0.0154 mmol/L (fish oil capsule) and fish oil glue No significant difference was found between the II test group and the control group. The results of the combined analysis of two tests showed no evidence of the difference in the effect of the 2 kinds of fish oil capsules with the ratio of EPA and DHA. There was no adverse event in the two tests. Conclusion this study proved that fish oil capsules could effectively improve the metabolism of blood lipids in the subjects by two tests. Low serum TC and TG levels, but do not change the normal level of HDL-C; there is no evidence to support the difference in the effect of 2 different EPA and DHA ratio fish oil capsules. Therefore, the increase of fish oil preparation and the intake of n-3 unsaturated fatty acids may be a protective factor in the prevention and treatment of dyslipidemia in adults. Disease risk.
【学位授予单位】：复旦大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：R151;R589.2
【参考文献】
相关期刊论文 前2条
1 夏树华;姜元荣;张余权;牛付欢;;鱼油在食品领域中的应用技术综述[J];食品科学;2012年11期
2 胡春生;胡余明;张莹莹;;鱼油对儿童记忆功能的影响研究[J];实用预防医学;2008年01期
，本文编号：2118950
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