Wu Jennifer Y F, Leung Wilson Y S, Chang Sophie, Lee Benjamin, Zee Benny, Tong Peter C Y, Chan Juliana C N
Department of Medicine and Therapeutics, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong SAR.
BMJ. 2006 Sep 9;333(7567):522. doi: 10.1136/bmj.38905.447118.2F. Epub 2006 Aug 17.
To investigate the effects of compliance and periodic telephone counselling by a pharmacist on mortality in patients receiving polypharmacy.
Two year randomised controlled trial.
Hospital medical clinic.
502 of 1011 patients receiving five or more drugs for chronic disease found to be non-compliant at the screening visit were invited for randomisation to either the telephone counselling group (n = 219) or control group (n = 223) at enrollment 12-16 weeks later.
Primary outcome was all cause mortality in randomised patients. Associations between compliance and mortality in the entire cohort of 1011 patients were also examined. Patients were defined as compliant with a drug if they took 80-120% of the prescribed daily dose. To calculate a compliance score for the whole treatment regimen, the number of drugs that the patient was fully compliant with was divided by the total number of prescribed drugs and expressed as a percentage. Only patients who complied with all recommended drugs were considered compliant (100% score).
60 of the 502 eligible patients defaulted and only 442 patients were randomised. After two years, 31 (52%) of the defaulters had died, 38 (17%) of the control group had died, and 25 (11%) of the intervention group had died. After adjustment for confounders, telephone counselling was associated with a 41% reduction in the risk of death (relative risk 0.59, 95% confidence interval 0.35 to 0.97; P = 0.039). The number needed to treat to prevent one death at two years was 16. Other predictors included old age, living alone, rate of admission to hospital, compliance score, number of drugs for chronic disease, and non-treatment with lipid lowering drugs at screening visit. In the cohort of 1011 patients, the adjusted relative risk for death was 1.61 (1.05 to 2.48; P = 0.029) and 2.87 (1.80 to 2.57; P < 0.001) in patients with compliance scores of 34-66% and 0-33%, respectively, compared with those who had a compliance score of 67% or more.
In patients receiving polypharmacy, poor compliance was associated with increased mortality. Periodic telephone counselling by a pharmacist improved compliance and reduced mortality.
International Standard Randomised Controlled Trial Number Register: SRCTN48076318.
研究药师的依从性干预及定期电话咨询对接受多种药物治疗患者死亡率的影响。
为期两年的随机对照试验。
医院内科门诊。
1011例接受五种或更多药物治疗慢性病的患者中，502例在筛查就诊时被发现存在不依从情况，在12 - 16周后入组时被邀请随机分为电话咨询组（n = 219）或对照组（n = 223）。
主要结局是随机分组患者的全因死亡率。同时也对1011例患者整个队列中依从性与死亡率之间的关联进行了研究。如果患者服用规定日剂量的80% - 120%，则定义为对某种药物依从。为计算整个治疗方案的依从性得分，将患者完全依从的药物数量除以规定药物总数并以百分比表示。仅将依从所有推荐药物的患者视为依从（得分为100%）。
502例符合条件的患者中有60例失访，仅442例患者被随机分组。两年后，60例失访者中有31例（52%）死亡，对照组中有38例（17%）死亡，干预组中有25例（11%）死亡。在对混杂因素进行调整后，电话咨询与死亡风险降低41%相关（相对风险0.59，95%置信区间0.35至0.97；P = 0.039）。两年内预防一例死亡所需治疗人数为16。其他预测因素包括老年、独居、住院率、依从性得分、慢性病用药数量以及筛查就诊时未使用降脂药物。在1011例患者队列中，依从性得分分别为34% - 66%和0% - 33%的患者与依从性得分67%及以上的患者相比，调整后的死亡相对风险分别为1.61（1.05至2.48；P = 0.029）和2.87（1.80至2.57；P < 0.001）。
在接受多种药物治疗的患者中，依从性差与死亡率增加相关。药师定期电话咨询可提高依从性并降低死亡率。
国际标准随机对照试验编号注册库：SRCTN48076318
