洛之达与辛伐他汀治疗血脂代谢紊乱的疗效
作者:郭小梅 高亚东 杨 菲
单位:(同济医科大学同济医院心脏内科,武汉 430030)
关键词:洛之达;洛伐他汀;辛伐他汀;高脂血症;血脂代谢紊乱
中国新药杂志990215 摘要 目的:比较洛之达(国产洛伐他汀)和辛伐他汀调节血脂代谢紊乱的临床效果。方法:选择原发性血脂代谢紊乱61例,随机分为洛之达(20 mg/d)治疗组(30例)和辛伐他汀(10 mg/d)对照组(31例),均治疗6周。结果:与治疗前比,洛之达治疗6周使TC,LDL-C,Apo B分别极显著性下降35.1%,37.7%和15.6%,辛伐他汀组则分别极显著性下降38.7%,42.7%和16.7%。洛之达调节TC,TG,HDL,(TC-HDL)/HDL代谢紊乱的总有效率为93.3%,66.6%,23.3%,83.3%;辛伐他汀组的总有效率分别为90.3%,83.9%,35.5%,90.3%。两组间上述参数在治疗前、治疗后4周和6周均无明显统计学差异(P>0.05)。结论:洛之达调节血脂代谢紊乱疗效与辛伐他汀疗效基本相当。
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A COMPARATIVE STUDY OF LUOZHIDA AND SIMVASTATIN
IN TREATMENT OF DISLIPIDEMIA
Guo Xiaomei,Gao Yadong,Yang Fei
(Department of Cardiology,Tongji Hospital,Tongji Medical University,Wuhan 430030)
ABSTRACT OBJECTIVE:To compare the efficacy of Luozhida (a kind of domestic lovastatin)and simvastatin in treatment of dislipidemia.METHODS:61 patients with primary dislipidemia were randomly divided to receive Luozhida (n=30) in a dose of 20 mg daily for 6 week,and simvastatin(n=31)in a dose of 10 mg daily for 6 weeks.RESULTS:After treatment,the TC,LDL-C,and Apo B were significantly decreased by 35.1%,37.7%,and 15.6% respectively for Luozhida group and by 38.7%,42.7%,and 16.7% respectively for simvastatin group. The total effective rate for adjustment of TC,TG,HDL,and artherosclerotic index were 93.3%,66.6%,23.3%,and 83.3% respectively for Luozhida group and 90.3%,83.9%,35.5%,and 90.3% respectively for simvastatin group.There is no significant difference between all parameters of the two groups.CONCLUSION: The study showed that the efficacy of Luozhida in treatment of dislipidemia is as effective as those of simvastatin in doses stated above.
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KEY WORDS Luozhida;Lovastatin;Simvastatin;Hyperlipidemia;Dislipidemia
血脂代谢异常致冠状动脉粥样硬化作用已被确认,国外研究证实了他汀类药治疗冠心病血脂代谢紊乱的良好效果[1~3] 。洛之达片为国产洛伐他汀,是一种有效的他汀类调节血脂代谢紊乱药物(简称调脂药)。但国内有关洛之达与辛伐他汀的临床对照研究资料甚少,本文将报道这两种药物对照治疗血脂代谢紊乱的临床效果。
资料与方法
1 病例选择参照“美国成人胆固醇教育规划二”有关标准选择研究病例[4] 。并排除继发性血脂代谢紊乱、肝肾功能不全者、糖尿病、急性心肌梗死、脑血管意外患者。共收集61例病例,随机分为洛之达治疗组(A组)和辛伐他汀对照组(B组)。A组30例,男16例,女14例,平均年龄56.5岁,21例患冠心病,13例患高血压病,6例有2个冠心病危险因子。B组31例,平均年龄58.8岁,男18例,女13例,23例患冠心病,11例合并高血压病,5例有2个冠心病危险因子。
, http://www.100md.com
2 方法
洛之达片(温州市瑞邦大药厂)每日晚餐后20mg一次服用,辛伐他汀(美国默沙东公司)每日晚餐后10 mg一次服用,总疗程6周。观察A、B组患者用药前、用药后4,6周空腹血清TC,TG,LDL-C值,HDL-C,HDL2-C,HDL3-C,Apo A,Apo B含量,并观察服药后的药物不良反应。均采用宁波市慈城生化试剂厂生产药盒测定上述指标,TC,TG,HDL-C,HDL3-C均用酶法测定,其批内和批间RSD分别小于1.5%及2.5%,2.5%及3.5%,1.4%,2.6%,Apo A和Apo B用联合火箭电泳法测定,批内和批间RSD均<5%,LDL-C按Friedewald公式计算。疗效判定标准参照卫生部1988年颁布的心血管药物临床研究指导原则。
3 统计学方法
统计治疗显效率和有效率,组间作u检验。统计计量资料±s,组间采用t检验。
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结果
1 治疗前后血脂、脂蛋白和载脂蛋白水平变化
见表1。
表1 两种药物对患者血脂水平的影响 观察指标
组别
n
治疗前
治疗4周
治疗6周
TC(mmol/L)
A
30
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6.01±1.44
4.28±0.91a
3.90±1.12a
B
31
6.54±2.14
4.55±1.02a
4.01±0.99a
TG(mmol/L)
A
30
, http://www.100md.com
2.58±2.67
1.70±1.69
1.70±1.34
B
31
2.75±2.22
2.30±1.93
1.92±1.33
LDL-C(mmol/L)
A
30
3.29±0.83
, http://www.100md.com
2.29±0.56a
2.05±0.65a
B
31
3.61±1.61
2.43±0.74a
2.07±0.64a
HDL-C(mmol/L)
A
30
1.21±0.37
, http://www.100md.com
1.37±0.30
1.37±0.33
B
31
1.23±0.02
1.31±0.32
1.33±0.35
HDL2-C(mmol/L)
A
30
0.39±0.10
0.43±0.10
, http://www.100md.com
0.42±0.11
B
31
0.44±0.14
0.42±0.10
0.43±0.10
HDL3-C(mmol/L)
A
30
0.82±0.31
0.96±0.28
0.95±0.26
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B
31
0.79±0.27
0.89±0.24
0.90±0.28
Apo A(g/L)
A
30
1.06±0.22
1.13±0.24
1.09±0.25
B
, http://www.100md.com 31
1.11±0.22
1.17±0.30
1.16±0.20
Apo B(g/L)
A
30
0.96±0.26
0.80±0.20a
0.81±0.20a
B
31
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0.97±0.22
0.82±0.26a
0.80±0.21a
治疗后与治疗前比 a:P<0.01; A组各参数与B组比较P均>0.05
2 调节血脂代谢紊乱疗效
洛之达和辛伐他汀治疗血脂代谢紊乱的总疗效见表2。洛之达6周调节代谢紊乱的总有效率与辛伐他汀比较,两组间均无明显统计学差异(P>0.05),说明洛之达调节血脂代谢紊乱的效果与辛伐他汀基本一致。
表2 两种药物调节血脂代谢紊乱的总有效率比较(%) 指标
组别
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n
显效率
有效率
总有效率
TC
A
30
80.0
13.3
93.3
B
31
83.9
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90.3a
TG
A
30
43.3
23.3
66.6
B
31
45.2
19.4
83.9a
, http://www.100md.com
HDL
A
30
12.9
9.7
23.3
B
31
22.6
12.9
35.5a
(TC-HDL)
A
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30
76.7
6.7
83.3
/HDL
B
31
87.1
3.2
90.3a
A组与B组比较a:P>0.05
3 不良反应
在观察期间,洛之达组出现恶心、上腹不适等胃肠道反应3例,ALT轻度升高2例,均无需停药,未见其他不良反应。辛伐他汀组有1例上腹不适,3例ALT轻度升高,坚持服药自行好转,未见其他不良反应。
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讨论
调脂药在冠心病和动脉粥样硬化的一级和二级预防中起着十分重要的作用。预防动脉粥样硬化的理想调脂药首要的是能有效地降低血清TC和LDL-C水平,其次是有效地升高HDL-C水平,降低TG[5~8]。从表1可知,治疗前A、B两组血脂代谢紊乱患者血清各项指标均无统计学差异,两组患者年龄亦无统计学差异,说明本研究单盲随机分组资料具有较强的可比性。本研究中洛之达使用6周后TC,LDL-C,TG分别降低35.1%,37.7%,34.1%,HDL-C升高13.2%,Apo A升高2.8%,Apo B降低15.6%,其调节TC,TG,HDL,(TC-HDL)/HDL代谢紊乱的总有效率分别为93.3%,66.6%,23.3%和83.3%,与国内外资料报告结果[9~11]基本相一致。辛伐他汀是当今较受推崇的HMG-CoA还原酶抑制剂,具有显著降低血清TC、LDL-C作用。从表1可知,辛伐他汀组用药6周后,TC,LDL-C,TG分别降低38.7%,42.7%,30.2%,HDL-C和Apo A分别升高8.1%和4.5%,Apo B降低16.7%,疗效与国外资料报告结果[12,13]基本相一致。观察组与对照组相比,两组间上述参数在治疗前、治疗后均无明显差异,说明20 mg国产洛之达调节血脂代谢紊乱作用和疗效与10 mg辛伐他汀疗效基本一致。该研究表明国产洛之达是一种有效、安全且价格低廉的调节血脂代谢紊乱药。
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参考文献
[1] Blum C. Hyperlipidaemia and cardiovascular disease.Current Opinion in Lipidology,1996,7(2)∶U57
[2] Scandinavian simvastatin survival study group. Randomised trial of cholesterol lowering in 4444 patients with coronary disease.Lancet,1994,344(8934)∶1383
[3] MAAS investigators.Effect of simvastatin on coronary atharoma:the multicenter anti-atheroma study. Lancet,1994,344(8923)∶633
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[4] NIH.Summary of the second report of the national cholesterol edu-cation program.Expert panel on det]ection,evaluation,and treatment of high blood cholesterol in adults. JAMA,1993,269(23)∶3015
[5] Pearson TA,Fuster V. Executive summary.JACC,1996,27(5)∶961
[6] Jones PH,Gotto AM,Dphil. Extending the benefit of lipid-regulating therapy to primary prevention. Am J Cardiol,1995,76(9)∶118C
[7] Holme I. Cholesterol reduction and its impact on coronary artery disease and total mortality. Am J Cardiol,1995,76(9)∶10C
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[8] Grundy SM. Etiologiec and treatment of hyperlipidemia.In:Willerson JT.Treatment of heart disease. New York: Gower Medical Publishing,1992.4.3
[9] 陆宗良,寇文钅 容,徐义枢,等. 乐瓦停治疗原发性和继发性高脂血症的临床观察. 中国循环杂志,1992,7(1)∶30
[10] 迟家敏,孙美珍,曾昭蓍,等.美降之治疗原发性和继发性高脂血症的临床观察.中华内科杂志,1992,31(1)∶32
[11] Furberg CD,Adams AP,Applegate WB,et al.Effect of lovastatin on early carotid atherosclerosis and cardiovascular events(ACAPS).Circulation,1994,90(4)∶1679
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[12] Malini PL,Divitiis OD,Somma SD,et al.A comparative study of simvastatin in patients with primary hypercholesterolaemia.Atherosclerosis,1992,97(Suppl)∶S41
[13] Bredie SJH,Bruin TWA,Demacher PNM,et al.Comparative of gemfibrozil verus simvastatin in familial combined&127;hyperlipidemia and effects on apolipoprotein-B-containing lipoproteins,low-density lipoprotein subfraction profile,and low-density lipoprotein oxidizability.Am J Cardiol,1995,75(5)∶348
(收稿:1998-04-15 修回:1998-10-15)
, 百拇医药
单位:(同济医科大学同济医院心脏内科,武汉 430030)
关键词:洛之达;洛伐他汀;辛伐他汀;高脂血症;血脂代谢紊乱
中国新药杂志990215 摘要 目的:比较洛之达(国产洛伐他汀)和辛伐他汀调节血脂代谢紊乱的临床效果。方法:选择原发性血脂代谢紊乱61例,随机分为洛之达(20 mg/d)治疗组(30例)和辛伐他汀(10 mg/d)对照组(31例),均治疗6周。结果:与治疗前比,洛之达治疗6周使TC,LDL-C,Apo B分别极显著性下降35.1%,37.7%和15.6%,辛伐他汀组则分别极显著性下降38.7%,42.7%和16.7%。洛之达调节TC,TG,HDL,(TC-HDL)/HDL代谢紊乱的总有效率为93.3%,66.6%,23.3%,83.3%;辛伐他汀组的总有效率分别为90.3%,83.9%,35.5%,90.3%。两组间上述参数在治疗前、治疗后4周和6周均无明显统计学差异(P>0.05)。结论:洛之达调节血脂代谢紊乱疗效与辛伐他汀疗效基本相当。
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A COMPARATIVE STUDY OF LUOZHIDA AND SIMVASTATIN
IN TREATMENT OF DISLIPIDEMIA
Guo Xiaomei,Gao Yadong,Yang Fei
(Department of Cardiology,Tongji Hospital,Tongji Medical University,Wuhan 430030)
ABSTRACT OBJECTIVE:To compare the efficacy of Luozhida (a kind of domestic lovastatin)and simvastatin in treatment of dislipidemia.METHODS:61 patients with primary dislipidemia were randomly divided to receive Luozhida (n=30) in a dose of 20 mg daily for 6 week,and simvastatin(n=31)in a dose of 10 mg daily for 6 weeks.RESULTS:After treatment,the TC,LDL-C,and Apo B were significantly decreased by 35.1%,37.7%,and 15.6% respectively for Luozhida group and by 38.7%,42.7%,and 16.7% respectively for simvastatin group. The total effective rate for adjustment of TC,TG,HDL,and artherosclerotic index were 93.3%,66.6%,23.3%,and 83.3% respectively for Luozhida group and 90.3%,83.9%,35.5%,and 90.3% respectively for simvastatin group.There is no significant difference between all parameters of the two groups.CONCLUSION: The study showed that the efficacy of Luozhida in treatment of dislipidemia is as effective as those of simvastatin in doses stated above.
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KEY WORDS Luozhida;Lovastatin;Simvastatin;Hyperlipidemia;Dislipidemia
血脂代谢异常致冠状动脉粥样硬化作用已被确认,国外研究证实了他汀类药治疗冠心病血脂代谢紊乱的良好效果[1~3] 。洛之达片为国产洛伐他汀,是一种有效的他汀类调节血脂代谢紊乱药物(简称调脂药)。但国内有关洛之达与辛伐他汀的临床对照研究资料甚少,本文将报道这两种药物对照治疗血脂代谢紊乱的临床效果。
资料与方法
1 病例选择参照“美国成人胆固醇教育规划二”有关标准选择研究病例[4] 。并排除继发性血脂代谢紊乱、肝肾功能不全者、糖尿病、急性心肌梗死、脑血管意外患者。共收集61例病例,随机分为洛之达治疗组(A组)和辛伐他汀对照组(B组)。A组30例,男16例,女14例,平均年龄56.5岁,21例患冠心病,13例患高血压病,6例有2个冠心病危险因子。B组31例,平均年龄58.8岁,男18例,女13例,23例患冠心病,11例合并高血压病,5例有2个冠心病危险因子。
, http://www.100md.com
2 方法
洛之达片(温州市瑞邦大药厂)每日晚餐后20mg一次服用,辛伐他汀(美国默沙东公司)每日晚餐后10 mg一次服用,总疗程6周。观察A、B组患者用药前、用药后4,6周空腹血清TC,TG,LDL-C值,HDL-C,HDL2-C,HDL3-C,Apo A,Apo B含量,并观察服药后的药物不良反应。均采用宁波市慈城生化试剂厂生产药盒测定上述指标,TC,TG,HDL-C,HDL3-C均用酶法测定,其批内和批间RSD分别小于1.5%及2.5%,2.5%及3.5%,1.4%,2.6%,Apo A和Apo B用联合火箭电泳法测定,批内和批间RSD均<5%,LDL-C按Friedewald公式计算。疗效判定标准参照卫生部1988年颁布的心血管药物临床研究指导原则。
3 统计学方法
统计治疗显效率和有效率,组间作u检验。统计计量资料±s,组间采用t检验。
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结果
1 治疗前后血脂、脂蛋白和载脂蛋白水平变化
见表1。
表1 两种药物对患者血脂水平的影响 观察指标
组别
n
治疗前
治疗4周
治疗6周
TC(mmol/L)
A
30
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6.01±1.44
4.28±0.91a
3.90±1.12a
B
31
6.54±2.14
4.55±1.02a
4.01±0.99a
TG(mmol/L)
A
30
, http://www.100md.com
2.58±2.67
1.70±1.69
1.70±1.34
B
31
2.75±2.22
2.30±1.93
1.92±1.33
LDL-C(mmol/L)
A
30
3.29±0.83
, http://www.100md.com
2.29±0.56a
2.05±0.65a
B
31
3.61±1.61
2.43±0.74a
2.07±0.64a
HDL-C(mmol/L)
A
30
1.21±0.37
, http://www.100md.com
1.37±0.30
1.37±0.33
B
31
1.23±0.02
1.31±0.32
1.33±0.35
HDL2-C(mmol/L)
A
30
0.39±0.10
0.43±0.10
, http://www.100md.com
0.42±0.11
B
31
0.44±0.14
0.42±0.10
0.43±0.10
HDL3-C(mmol/L)
A
30
0.82±0.31
0.96±0.28
0.95±0.26
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B
31
0.79±0.27
0.89±0.24
0.90±0.28
Apo A(g/L)
A
30
1.06±0.22
1.13±0.24
1.09±0.25
B
, http://www.100md.com 31
1.11±0.22
1.17±0.30
1.16±0.20
Apo B(g/L)
A
30
0.96±0.26
0.80±0.20a
0.81±0.20a
B
31
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0.97±0.22
0.82±0.26a
0.80±0.21a
治疗后与治疗前比 a:P<0.01; A组各参数与B组比较P均>0.05
2 调节血脂代谢紊乱疗效
洛之达和辛伐他汀治疗血脂代谢紊乱的总疗效见表2。洛之达6周调节代谢紊乱的总有效率与辛伐他汀比较,两组间均无明显统计学差异(P>0.05),说明洛之达调节血脂代谢紊乱的效果与辛伐他汀基本一致。
表2 两种药物调节血脂代谢紊乱的总有效率比较(%) 指标
组别
, 百拇医药
n
显效率
有效率
总有效率
TC
A
30
80.0
13.3
93.3
B
31
83.9
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90.3a
TG
A
30
43.3
23.3
66.6
B
31
45.2
19.4
83.9a
, http://www.100md.com
HDL
A
30
12.9
9.7
23.3
B
31
22.6
12.9
35.5a
(TC-HDL)
A
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30
76.7
6.7
83.3
/HDL
B
31
87.1
3.2
90.3a
A组与B组比较a:P>0.05
3 不良反应
在观察期间,洛之达组出现恶心、上腹不适等胃肠道反应3例,ALT轻度升高2例,均无需停药,未见其他不良反应。辛伐他汀组有1例上腹不适,3例ALT轻度升高,坚持服药自行好转,未见其他不良反应。
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讨论
调脂药在冠心病和动脉粥样硬化的一级和二级预防中起着十分重要的作用。预防动脉粥样硬化的理想调脂药首要的是能有效地降低血清TC和LDL-C水平,其次是有效地升高HDL-C水平,降低TG[5~8]。从表1可知,治疗前A、B两组血脂代谢紊乱患者血清各项指标均无统计学差异,两组患者年龄亦无统计学差异,说明本研究单盲随机分组资料具有较强的可比性。本研究中洛之达使用6周后TC,LDL-C,TG分别降低35.1%,37.7%,34.1%,HDL-C升高13.2%,Apo A升高2.8%,Apo B降低15.6%,其调节TC,TG,HDL,(TC-HDL)/HDL代谢紊乱的总有效率分别为93.3%,66.6%,23.3%和83.3%,与国内外资料报告结果[9~11]基本相一致。辛伐他汀是当今较受推崇的HMG-CoA还原酶抑制剂,具有显著降低血清TC、LDL-C作用。从表1可知,辛伐他汀组用药6周后,TC,LDL-C,TG分别降低38.7%,42.7%,30.2%,HDL-C和Apo A分别升高8.1%和4.5%,Apo B降低16.7%,疗效与国外资料报告结果[12,13]基本相一致。观察组与对照组相比,两组间上述参数在治疗前、治疗后均无明显差异,说明20 mg国产洛之达调节血脂代谢紊乱作用和疗效与10 mg辛伐他汀疗效基本一致。该研究表明国产洛之达是一种有效、安全且价格低廉的调节血脂代谢紊乱药。
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(收稿:1998-04-15 修回:1998-10-15)
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