Taylor D M, Sparshatt A, O'Hagan M, Dzahini O
Maudsley Hospital, Pharmacy Department, Denmark Hill, London SE5 8AZ, UK; Institute of Pharmaceutical Science, King's College, 5th Floor, Franklin-Wilkins Building, 150 Stamford Street, London SE1 9NH, UK.
Maudsley Hospital, Pharmacy Department, Denmark Hill, London SE5 8AZ, UK.
Eur Psychiatry. 2016 Sep;37:43-8. doi: 10.1016/j.eurpsy.2016.04.009. Epub 2016 Jul 20.
Clinical trial outcomes are heavily influenced by the non-naturalistic clinical trial process. Observations of outcomes in clinical practice are a valuable adjunct to clinical trial results.
Our null hypothesis was that clinically indicated switching to paliperidone palmitate had no effect on hospital admissions or hospital bed days.
This was a part-prospective mirror image study examining outcomes 2years before starting paliperidone palmitate and 2years after. Sensitivity analyses examined the effect of different placings of the mirror in the mirror image design.
We prospectively followed-up 225 patients prescribed paliperidone palmitate in clinical practice. At 2years, 41.8% of patients were still receiving paliperidone palmitate. In the primary analysis, the mean number of admissions fell from 1.80 in the two years before starting paliperidone palmitate to 0.81 in two years following the drug's initiation (outpatients) or two years following hospital discharge (inpatients) (P<0.001). More than half of patients were not admitted to hospital during two years follow-up. Mean total bed days was reduced from 79.6 in the two years before to 46.2 in the two years after paliperidone palmitate initiation or discharge (P<0.001). Sensitivity analyses gave broadly similar outcomes. Continuers demonstrated better outcomes than discontinuers in sensitivity analyses but not in the primary analysis.
Paliperidone palmitate initiation is associated with a substantial reduction in hospital admissions and days spent in hospital. The reduction in costs associated with reduced use of health care facilities is likely to exceed the purchase and administration costs of the drug.
临床试验结果受到非自然主义临床试验过程的严重影响。临床实践中对结果的观察是临床试验结果的宝贵补充。
我们的零假设是，临床指示换用棕榈酸帕利哌酮对住院率或住院天数没有影响。
这是一项部分前瞻性镜像研究，观察开始使用棕榈酸帕利哌酮前2年和之后2年的结果。敏感性分析检验了镜像设计中镜子不同放置位置的影响。
我们对临床实践中开具棕榈酸帕利哌酮处方的225例患者进行了前瞻性随访。2年后，41.8%的患者仍在使用棕榈酸帕利哌酮。在初步分析中，开始使用棕榈酸帕利哌酮前两年的平均住院次数从1.80次降至用药后两年（门诊患者）或出院后两年（住院患者）的0.81次（P<0.001）。超过一半的患者在两年随访期间未住院。棕榈酸帕利哌酮开始使用或出院后两年的平均总住院天数从之前的79.6天降至46.2天（P<0.001）。敏感性分析得出的结果大致相似。在敏感性分析中，持续用药者的结果优于停药者，但在初步分析中并非如此。
开始使用棕榈酸帕利哌酮与住院率和住院天数的大幅减少相关。与减少使用医疗保健设施相关的成本降低可能超过该药物的采购和管理成本。
