Lindholm L H, Ekbom T, Dash C, Isacsson A, Scherstén B
Lund University, Department of Community Health Sciences, Sweden.
J Intern Med. 1996 Jul;240(1):13-22. doi: 10.1046/j.1365-2796.1996.492831000.x.
The objectives of the Cost Effectiveness of Lipid Lowering (CELL) study were twofold: (i) to evaluate the effect on overall cardiovascular risk of two types of health care advice ("usual' and "intensive') given in primary care, with or without pharmacological medication, with the target being to attain a moderate decrease in cholesterol; (ii) to evaluate the ritual of daily medication on compliance with the health care advice.
A prospective, double-blind, randomized, controlled trial of 18 months' duration.
The study was carried out in 32 health centres (out of a total of approximately 850) in Sweden.
In all, 681 subjects, aged 30-59 years, were randomized. They had at least two cardiovascular risk factors in addition to moderate primary hyperlipidaemia (total cholesterol of at least 6.50 mmol L-1 on three occasions measured by Reflotron triglycerides less than 4.0 mmol L-1 and an LDL:HDL cholesterol ratio of more than 4.0). Most (87%) of the subjects were males; 626 subjects (92%) completed the 18-month follow-up.
Half the subjects were randomized to 'intensive advice' given in group sessions led by doctors and nurses in primary care. The other half received 'usual advice'. In each of the two advice groups, one-third received an active lipid-lowering drug (pravastatin), one-third placebo, and one-third no drug at all. The tablets were titrated to achieve a 15% reduction in cholesterol.
Changes in the overall Framingham risk score, and the development of adverse events in each group.
The change in Framingham risk score was significantly reduced only in subjects taking lipid-lowering medication (together with intensive advice -0.13; 95% CI-0.20, -0.06, and together with usual advice -0.16; 95% CI -0.23, -0.09). The other subjects receiving intensive advice tended to fare better than those on usual advice. Lifestyle was not influenced significantly over the study period. The ritual of daily medication did not affect the outcome.
As expected, lipid-lowering medication reduced serum cholesterol as well as overall cardiovascular risk in subjects with several risk factors for cardiovascular disease. There was no additive effect of intensive advice to these subjects. However, there was a meagre but significant effect of intensive advice in subjects not receiving active lipid-lowering drugs. One explanation for this difference may be that those on active lipid-lowering medication who had substantial drops in cholesterol might have felt less inclined to change their lifestyle compared with those on other treatment regimens who had less successful drops in cholesterol. There was no benefit from the ritual of taking daily medication.
降脂成本效益（CELL）研究有两个目标：（i）评估在初级保健中给予两种类型的医疗建议（“常规”和“强化”）对总体心血管风险的影响，无论有无药物治疗，目标是使胆固醇适度降低；（ii）评估每日用药规律对遵循医疗建议的影响。
一项为期18个月的前瞻性、双盲、随机对照试验。
该研究在瑞典的32个健康中心（总共约850个）进行。
总共681名年龄在30至59岁之间的受试者被随机分组。除中度原发性高脂血症外，他们至少有两个心血管危险因素（用反射仪三次测量总胆固醇至少为6.50 mmol/L，甘油三酯低于4.0 mmol/L，低密度脂蛋白：高密度脂蛋白胆固醇比率超过4.0）。大多数（87%）受试者为男性；626名受试者（92%）完成了18个月的随访。
一半受试者被随机分配接受由初级保健医生和护士在小组会议上给予的“强化建议”。另一半接受“常规建议”。在两个建议组中，每组三分之一的受试者接受一种活性降脂药物（普伐他汀），三分之一接受安慰剂，三分之一根本不接受药物治疗。片剂进行滴定以实现胆固醇降低15%。
总体弗雷明汉风险评分的变化以及每组不良事件的发生情况。
仅在服用降脂药物的受试者中，弗雷明汉风险评分的变化显著降低（强化建议联合用药时降低0.13；95%可信区间为-0.20，-0.06，常规建议联合用药时降低0.16；95%可信区间为-0.23，-0.09）。其他接受强化建议的受试者往往比接受常规建议的受试者情况更好。在研究期间，生活方式没有受到显著影响。每日用药规律对结果没有影响。
正如预期的那样，降脂药物降低了患有多种心血管疾病危险因素的受试者的血清胆固醇以及总体心血管风险。对这些受试者强化建议没有附加效果。然而，在未接受活性降脂药物治疗的受试者中，强化建议有微弱但显著的效果。这种差异的一个解释可能是，与其他治疗方案中胆固醇降低不太成功的受试者相比，服用活性降脂药物且胆固醇大幅下降的受试者可能不太愿意改变他们的生活方式。每日服药规律没有益处。
