Suhaj A, Manu M K, Unnikrishnan M K, Vijayanarayana K, Mallikarjuna Rao C
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India.
Department of Pulmonary Medicine, Kasturba Medical College Hospital, Manipal University, Manipal, India.
J Clin Pharm Ther. 2016 Feb;41(1):78-83. doi: 10.1111/jcpt.12353. Epub 2016 Jan 18.
Chronic obstructive pulmonary disease (COPD), a preventable and treatable disease, has been described as '10% medication and 90% education'. Extreme physician scarcity limits the implementation of quality healthcare delivery in India. We conducted this study to evaluate the effectiveness of clinical pharmacist intervention on health-related quality of life (HRQoL) in patients with COPD in an Indian tertiary care hospital.
An open-labelled randomized controlled study was conducted over a 3-year period, at Kasturba Medical College Hospital, Manipal, India, after obtaining institutional ethics clearance (IEC 88/2012). The study was registered with the Indian clinical trial registry (CTRI/2014/08/004848). Patients were randomly assigned to two groups (intervention group [IG] and control group [CG]) by envelope method. St. George's Respiratory Questionnaire (SGRQ) was used to assess the HRQoL. The pharmacist intervention laid emphasis on (i) importance of medication compliance, (ii) need for smoking cessation, (iii) simple exercise, (iv) proper use of inhaler devices and (v) need for timely follow-up by pulmonary medicine department. SGRQ assessment was repeated at 6, 12, 18 and 24 months.
Of 328 patients with COPD screened during the study period (March 2012 to June 2013), 260 (79%) were recruited. Of these, 202 (78%) patients completed follow-up (98 in CG and 104 in IG). Both groups were matched for baseline, sociodemographics and clinical characteristics. SGRQ scores and its subscales (symptoms, activity and impact) improved significantly after the pharmacist intervention in IG at follow-up (P < 0·001).
Our randomized controlled study shows that pharmacist intervention improved the HRQoL of patients with COPD in India. The generalizability of our results requires exploration even within other settings in India. Nonetheless, our results provide support for a greater involvement of pharmacists in the care of patients with COPD.
慢性阻塞性肺疾病（COPD）是一种可预防和可治疗的疾病，有“10%靠药物治疗，90%靠教育”的说法。在印度，医生极度短缺限制了优质医疗服务的实施。我们开展这项研究，以评估在印度一家三级护理医院中，临床药师干预对COPD患者健康相关生活质量（HRQoL）的有效性。
在获得机构伦理批准（IEC 88/2012）后，于印度马尼帕尔卡斯图巴医学院医院进行了一项为期3年的开放标签随机对照研究。该研究已在印度临床试验注册中心注册（CTRI/2014/08/004848）。采用信封法将患者随机分为两组（干预组[IG]和对照组[CG]）。使用圣乔治呼吸问卷（SGRQ）评估HRQoL。药师干预重点关注：（i）药物依从性的重要性；（ii）戒烟的必要性；（iii）简单运动；（iv）吸入装置的正确使用；（v）呼吸内科及时随访的必要性。在6、12、18和24个月时重复进行SGRQ评估。
在研究期间（2012年3月至2013年6月）筛查的328例COPD患者中，260例（79%）被纳入研究。其中，202例（78%）患者完成了随访（CG组98例，IG组104例）。两组在基线、社会人口统计学和临床特征方面相匹配。随访时，IG组在药师干预后，SGRQ评分及其子量表（症状、活动和影响）显著改善（P<0.001）。
我们的随机对照研究表明，药师干预改善了印度COPD患者的HRQoL。即使在印度的其他环境中，我们结果的普遍性也需要探索。尽管如此，我们的结果为药师更多地参与COPD患者的护理提供了支持。
