Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial

doi:10.21037/atm-22-4091

	Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial
	Ding, Haiying 3; Song, Yu 3; Wu, Nan 4; Zheng, Xiaowei 3,5; Wei, Qing 4; Sun, Yancai 6; Xie, Ruixiang 1; Zhai, Qing 9; Xu, Silu ; Qi, Yajun 3
刊名	ANNALS OF TRANSLATIONAL MEDICINE
	2022-09-06
关键词	Cancer pain pharmacists pharmaceutical service opioids outpatients
ISSN号	2305-5839
DOI	10.21037/atm-22-4091
通讯作者	Fang, Luo(fangluo@zjcc.org.cn) ; Liu, Yuguo(15553119285@163.com) ; Huang, Ping(huangping1841@zjcc.org.cn)
英文摘要	Background: Managing cancer pain is a growing challenge. Individualized pharmaceutical care is particularly important for opioid-tolerant outpatients due to variation in terms of their knowledge about pain, treatment adherence, and risk of experiencing inadequate analgesia and severe adverse events. This study aimed to determine the influence of individualized pharmaceutical care on outcomes in opioid-tolerant outpatients with cancer pain.Methods: A multicenter, open-label, randomized, controlled study was carried out. Opioid-tolerant outpatients experiencing chronic cancer pain and receiving sustained-release opioids were randomly assigned to the intervention group and the control group with a 1:1 ratio. The intervention group received individualized pharmaceutical care, while the control group received conventional care during 4-week period.The primary endpoint was medication adherence on the intention-to-treat (ITT) population. Secondary outcomes included the patients' knowledge of cancer pain and pain medications, pain score, frequency of breakthrough pain, quality of life (QoL) which were assessed on the ITT population. Adverse events were evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 4.0 on the per-protocol (PP) population.Results: A total of 118 patients were enrolled, and 102 patients (51 in each group) completed the 30-day follow-up from six oncology centers in China. The proportion of patients adhering to opioid medication increased to similar levels in the two groups during the 4 weeks (P=0.149). The intervention group had a significantly lower pain score at 4 weeks compared to the control group (P=0.015), and the proportion of participants without breakthrough pain was significantly higher at 4 weeks than at baseline in the intervention group (P=0.029), but not in the control group (P=0.322). The two groups did not differ significantly in terms of QoL or adverse events. Conclusions: Our results suggest that individualized pharmaceutical care can markedly reduce patient related problems and significantly improve pain control in opioid-tolerant outpatients. These findings validate the recommendations to include clinical pharmacists in the management of cancer pain. Trial Registration: ClinicalTrials.gov NCT03439904.
资助项目	Mundipharma (China) Pharmaceutical
WOS关键词	QUALITY-OF-LIFE ; PHARMACIST INTERVENTIONS ; MANAGEMENT ; SURVIVAL ; PREVALENCE ; ADHERENCE ; UNDERTREATMENT ; BARRIERS ; OUTCOMES ; THERAPY
WOS研究方向	Oncology ; Research & Experimental Medicine
语种	英语
出版者	AME PUBLISHING COMPANY
WOS记录号	WOS:000858964900001
资助机构	Mundipharma (China) Pharmaceutical
内容类型	期刊论文
源URL	[http://ir.hfcas.ac.cn:8080/handle/334002/128978]
专题	中国科学院合肥物质科学研究院
通讯作者	Fang, Luo; Liu, Yuguo; Huang, Ping
作者单位	1.Fujian Med Univ, Fujian Canc Hosp, Dept Pharm, Canc Hosp, Fuzhou, Peoples R China 2.Hangzhou Normal Univ, Sch Publ Hlth, Dept Hlth Policy & Management, Hangzhou, Peoples R China 3.Chinese Acad Sci, Univ Chinese Acad Sci, Zhejiang Canc Hosp, Inst Basic Med & Canc IBMC,Canc Hosp,Dept Pharm, Hangzhou, Peoples R China 4.Nanjing Med Univ, Jiangsu Canc Hosp, Affiliated Canc Hosp, Jiangsu Inst Canc Res,Dept Pharm, Nanjing, Peoples R China 5.Zhejiang Prov Peoples Hosp, Affiliated Peoples Hosp, Hangzhou Med Coll, Ctr Clin Pharm,Canc Ctr,Dept Pharm, Hangzhou, Peoples R China 6.Univ Sci & Technol China, Anhui Prov Canc Hosp, Affiliated Hosp USTC 1, Dept Pharm,Div Life Sci & Med, Hefei, Peoples R China 7.Univ Chinese Acad Sci, Zhejiang Canc Hosp, Dept Clin Trial, Canc Hosp, Hangzhou, Peoples R China 8.Chinese Acad Sci, Univ Chinese Acad Sci, Inst Canc Res & Basic Med Sci, Zhejiang Canc Hosp,Canc Hosp,Dept Anesthesiol, Hangzhou, Peoples R China 9.Fudan Univ, Dept Pharm, Shanghai Canc Ctr, Shanghai, Peoples R China 10.Shandong First Med Univ, Shandong Canc Hosp & Inst, Shandong Acad Med Sci, Dept Pharm, Jinan, Peoples R China
推荐引用方式 GB/T 7714	Ding, Haiying,Song, Yu,Wu, Nan,et al. Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial[J]. ANNALS OF TRANSLATIONAL MEDICINE,2022.
APA	Ding, Haiying.,Song, Yu.,Wu, Nan.,Zheng, Xiaowei.,Wei, Qing.,...&Huang, Ping.(2022).Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial.ANNALS OF TRANSLATIONAL MEDICINE.
MLA	Ding, Haiying,et al."Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial".ANNALS OF TRANSLATIONAL MEDICINE (2022).