魚油制劑對(duì)人體降脂作用的研究
發(fā)布時(shí)間：2018-07-13 09:44
【摘要】：目的通過(guò)對(duì)成年血脂異常人群進(jìn)行魚油制劑的干預(yù)試驗(yàn),以驗(yàn)證二種魚油制劑在調(diào)節(jié)血脂方面的功能有效性,并嘗試探討不同EPA(20碳五烯酸)和DHA(22碳六烯酸)配比的魚油制劑在血脂調(diào)節(jié)方面的可能差異,從而為血脂調(diào)節(jié)及其相關(guān)心血管疾病的防治提供理論依據(jù)和實(shí)踐指南。方法采用隨機(jī)、平行、組間對(duì)照的試驗(yàn)設(shè)計(jì),在上海某兩社區(qū)內(nèi),各入選血清總膽固醇(TC)和/或血清甘油三脂(TG)異常升高的受試者120名,其中60名為試驗(yàn)組,另60名入選空白對(duì)照組。兩項(xiàng)試驗(yàn)各評(píng)價(jià)60名受試者服用1000mg規(guī)格魚油膠囊I(EPA 175mg和DHA 70mg DHA)每天4粒和1500mg魚油膠囊II(EPA 197mg和DHA 131mg),每天3粒,連續(xù)服用45天,觀察其對(duì)血脂的作用。主要評(píng)價(jià)指標(biāo)為魚油膠囊組較空白對(duì)照組TC下降10%以上且TG下降15%以上受試者的比例。其它評(píng)價(jià)指標(biāo)包括受試者干預(yù)后TC或TG下降達(dá)到分別上述標(biāo)準(zhǔn)的比例和TC及TG服用后改變的平均百分率。用卡方檢驗(yàn)分析魚油膠囊組和空白對(duì)照組有效率差異的顯著性,按照連續(xù)變量的分布特性,選擇組間t檢驗(yàn)或Wilcoxon秩和檢驗(yàn)分析魚油膠囊組和空白對(duì)照組干預(yù)后血脂改變的差異；最后采用薈萃分析(Meta-Analysis)綜合2種不同配比魚油膠囊對(duì)血脂的作用。結(jié)果試驗(yàn)結(jié)束時(shí),由于受試者未完成實(shí)驗(yàn)而造成脫失率為20%,故得到有效數(shù)據(jù)的樣本量各組均為50例。兩項(xiàng)試驗(yàn)所有受試者基線TC 5.2 mmol/L和TG1.65mmol/L,魚油膠囊服用45天后,兩試驗(yàn)組分別有20名(40%)和16名(32%)受試者TC下降10%且TG下降15%,相應(yīng)地,兩試驗(yàn)空白對(duì)照組僅分別有4名(8%)和0名受試者達(dá)到該標(biāo)準(zhǔn)；兩魚油膠囊組與空白對(duì)照組比較,總有效率增加均為32%,p值分別為0.0002和0.0001。每天服用4粒魚油膠囊I 45天,受試者TC由5.74±0.452 mmol/L下降至5.07±0.663 mmol/L,中位數(shù)改變百分率為-11.54%；相應(yīng)對(duì)照組由基線5.70+0.475mmol/L改變至5.64±0.830mmol/L,中位數(shù)改變百分率為-0.50%,即服用魚油膠囊I后,試驗(yàn)組受試者TC較對(duì)照組顯著下降,Hodges-Lehmann方法估計(jì)差異為-11.7%,Wilcoxon秩和檢驗(yàn)p0.0001。類似地,在試驗(yàn)2中,服用魚油膠囊II每天3�？墒故茉囌逿C由基線水平平均改變-10.4+13.85%,而空白對(duì)照組平均改變?yōu)?.6±8.08%,即試驗(yàn)組TC與空白對(duì)照組改變的差異為-11.0%(p0.0001)。試驗(yàn)結(jié)果揭示,連續(xù)服用魚油膠囊I或魚油膠囊1145天,與空白對(duì)照相比較,TC由基線水平下降10%的受試者比例更高,分別較對(duì)照組增加48%(p0.0001)和42%(p0.0001)。服用魚油膠囊145天后,受試者TG由基線水平2.58±1.099 mmol/L下降至1.89±0.797mmol/L,中位數(shù)平均變化-21.19%,相應(yīng)對(duì)照組基線TG水平為2.41±0.864mmol/L,試驗(yàn)后為2.43±1.130 mmol/L,平均改變3.09%,魚油膠囊I引起TG百分改變與對(duì)照組相比,其差異有統(tǒng)計(jì)學(xué)顯著性,平均約為-24.3%(p=0.0006)。服用魚油膠囊1145天后,受試者TG由試驗(yàn)前2.47±1.151 mmol/L下降至1.97±1.259 mmol/L,中位變化百分率-29.55%；對(duì)照組基線TG為2.50±1.085mmol/L,45天后為2.46±0.956mmol/L,中位改變百分率-0.11%；Hodges-Lehmann估計(jì)試驗(yàn)組對(duì)應(yīng)于對(duì)照組TG改變百分率為-29.01%(p=0.0003)。采用魚油膠囊Ⅰ和魚油膠囊Ⅱ干預(yù),分別有31名(62.0%)和33名(66%)受試者TG較基線下降15%以上,而空白對(duì)照組相應(yīng)分別為15名(30%)和11名(22%)。比較魚油膠囊組與空白對(duì)照組TG較基線下降15%以上的受試者比例,魚油膠囊I和魚油膠囊11分別較對(duì)照組高32%(p=0.0013)和44%(p0.0001)。服用魚油膠囊145天后,HDL-C中位數(shù)由1.425mmol/L改變至1.455 mmol/L變化中位數(shù)為0.025mmol/L;對(duì)照組基線時(shí)HDL-C中位濃度為1.46 mmol/L,45天時(shí)為1.355mmol/L,中位改變-0.065 mmol/L;Hodges-Lehmann估計(jì)兩組之間的服用前后HDL-C改變的差異為0.0650mmol/L (p=0.0581);魚油膠囊II服用45天,受試者HDL-C由服用前1.45±0.310 mmol/L改變至1.40±0.341 mmol/L,對(duì)照組由1.37±0.226改變至1.34±0.255 mmol/L,變化值分別為-0.050+0.2669mmol/L和-0.035±0.1889 mmol/L,兩組相差-0.0154 mmol/L (p=0.7399)。魚油膠囊I和魚油膠囊II試驗(yàn)組與對(duì)照組之間均未見(jiàn)顯著性差異。合并分析兩項(xiàng)試驗(yàn)結(jié)果,無(wú)證據(jù)說(shuō)明2種EPA和DHA配比魚油膠囊的效果存在差異。兩項(xiàng)試驗(yàn)中均未見(jiàn)不良事件發(fā)生。結(jié)論本研究通過(guò)兩項(xiàng)試驗(yàn)證明魚油膠囊可有效改善受試者的血脂代謝,顯著降低血清TC和TG水平,但不改變正常水平的HDL-C;亦未見(jiàn)證據(jù)支持2種不同EPA和DHA配比的魚油膠囊在降脂療效上存在差異。因此,在成人血脂異常的防治措施中,增加魚油制劑,n-3不飽和脂肪酸的攝入可能是一項(xiàng)保護(hù)因素,進(jìn)而有助降低心血管疾病風(fēng)險(xiǎn)。
[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.
【學(xué)位授予單位】：復(fù)旦大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2013
【分類號(hào)】：R151;R589.2
本文編號(hào)：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.
【學(xué)位授予單位】：復(fù)旦大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2013
【分類號(hào)】：R151;R589.2
【參考文獻(xiàn)】
相關(guān)期刊論文 前2條
1 夏樹(shù)華;姜元榮;張余權(quán);牛付歡;;魚油在食品領(lǐng)域中的應(yīng)用技術(shù)綜述[J];食品科學(xué);2012年11期
2 胡春生;胡余明;張瑩瑩;;魚油對(duì)兒童記憶功能的影響研究[J];實(shí)用預(yù)防醫(yī)學(xué);2008年01期
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