Off-label Drug Use of Alprostadil Injection among Inpatients in Guangdong General Hospital in 2012: A Status-quo Survey_Chinese Journal of Evidence-Based Medicine

Authors：

 LINLu ^1,2 , ZENGYing-tong ¹ , LIUXiao-qi ¹ , LUNYu-ning ¹ , LIYou-ping ³ , YANGMin ^1,4 ,  LAOHai-yan ¹

1. Department of Pharmacy, Guangdong General Hospital(Guangdong Academy of Medical Sciences), Guangzhou 510080, China;
2. School of Pharmaceutical Sciences, SUN YAT-SEN University, Guangzhou 510006, China;
3. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;
4. Guangdong Provincial Cardiovascular Research Institute, Guangzhou 510080, China;

Corresponding author：

LAOHai-yan, Email: laohaiyan1208@vip.sina.com

Keywords：

Alprostadil injection; Off-label drug use; Inpatient; Guangdong General Hospital; Cross-sectional survey

DOI：

10.7507/1672-2531.20140171

Video：

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Objective Based on the off-label drug use (OLDU) record application of alprostadil injection (Lipo-PGE₁) which was the only one rejected in the Guangdong General Hospital in 2013, we retrospectively investigated all the background information of inpatients' OLDU of Lipo-PGE₁ in 2012, so as to provide references for intervention of OLDU and effect evaluation. Methods According to OLDU in dose record application of clinical departments, we summarized medical orders about inpatients' use of Lipo-PGE₁ during hospitalization in 2012 and analyzed OLDU situation according to drug labels. Then, we summarized situation of drug use in all departments, analyzed OLDU incidence in dose, calculated prescribed daily dose (PDD) and drug use density (DUD) in each department to evaluate the degree of OLDU in dose. Results a) A total of 106 576 medical orders involving 8 620 case-times were analyzed. According to the data of cases, medical orders and drug use amount, the OLDU incidences were 34.43%, 25.16% and 41.37%, respectively. Lipo-PGE₁ was used in every clinical department in this hospital and OLDU occurred in 69.44% departments (25/36). b) According to the number of medical orders, there were 6 departments with the OLDU incidence in dose > 50% and 5 departments with the OLDU incidence in dose during 50% to 20%. c) The average of PDD of the whole hospital was 12.77 μg. A total of 25 departments' PDDs were off-label, and 10 departments' PDDs were above the average level of the whole hospital. The ICU's PDD was the highest, with 2.35 times more than label dose. d) The PDD in each department was not directly proportional to DUD, which indicated the degree of OLDU in dose was not directly proportional to use intensity. This may be caused by different disease burdens in departments. Conclusion Lipo-PGE₁ is widely used in the Guangdong General Hospital where OLDU in dose occurs commonly. Since PDD and DUD reflect different contents, the two indicators should be combined to monitor OLDU.

Citation： LINLu, ZENGYing-tong, LIUXiao-qi, LUNYu-ning, LIYou-ping, YANGMin, LAOHai-yan. Off-label Drug Use of Alprostadil Injection among Inpatients in Guangdong General Hospital in 2012: A Status-quo Survey. Chinese Journal of Evidence-Based Medicine, 2014, 14(9): 1038-1043. doi: 10.7507/1672-2531.20140171 Copy

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2.	许统俭, 陈剑群.前列腺素E1脂微球载体制剂治疗肝硬化腹水临床疗效评价.中华现代内科学杂志, 2005, 2(4):347-349.
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4.	吕芳芳, 陈雪凤, 徐小微, 等.不同剂量脂质体前列腺素E1治疗早期慢性重型肝炎临床疗效观察.浙江医学, 2002, 24(9):566-567.
5.	周华坚, 李韶光, 杨小云, 等.前列腺素E1脂微球载体制剂治疗病毒性肝炎高胆红素血症的疗效和安全性.中国新药杂志, 2005, 14(7):909-911.
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8.	昝立新.前列地尔治疗47例短暂性脑缺血发作的临床疗效观察.中国实用医药, 2011, 6(6):150-151.
9.	何文贞, 欧利民, 郑俊忠.前列地尔改善脑梗死后眩晕症状的效应.中国临床康复, 2013, 7(3):424-426.
10.	钟伟强, 刘冠贤, 杨永铭, 等.前列腺素E1脂微球载体制剂治疗慢性肾小球肾炎的临床研究.中国危重病急救医学, 2004, 16(5):292-294.
11.	李铁岭, 赵秀梅, 蔡力力, 等.脂微球化前列腺素E1干预老年动脉硬化闭塞症患者的下肢功能:不同量化标准的评估.中国临床康复, 2005, 9(15):40-41.
12.	孙勇, 李强, 王建安.前列腺素E1对急性冠脉综合征介入治疗围术期纤溶系统的影响.中华急诊医学杂志, 2003, 12(10):699-700.
13.	孙勇, 王建安.前列腺素E1对急性冠脉综合征早期部分炎症因子的影响.中华急诊医学杂志, 2003, 12(10):405-407.
14.	冯玉欣, 逄力男, 张奕.脂化前列腺素E1治疗糖尿病足疗效观察.中华糖尿病杂志, 2004, 12(5):317-320.
15.	邱有波, 杨拯, 呙金海, 等.凯时注射液治疗糖尿病肾病的系统评价.中国循证医学杂志, 2010, 10(7):832-837.
16.	张伶俐, 李幼平, 曾力楠, 等. 15国超说明书用药政策的循证评价.中国循证医学杂志, 2012, 12(4):426-435.
17.	张伶俐, 李幼平, 胡蝶, 等.四川大学华西第二医院2010年儿科住院患儿超说明书用药情况调查.中国循证医学杂志, 2012, 12(2):161-167.
18.	张伶俐, 李幼平, 梁毅.全球住院儿童超说明书用药现状的系统评价.中国循证医学杂志, 2012, 12(2):176-187.
19.	Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med, 2006, 166(9):1021-1026.
20.	李延敏, 杨悦. "药品说明书之外的用法"相关问题研究.中国药房, 2010, 21(37):3469-3471.

1. 余翠琴.凯时的制剂特点.中国医院药学杂志, 2002, 22(11):691-692.
2. 许统俭, 陈剑群.前列腺素E1脂微球载体制剂治疗肝硬化腹水临床疗效评价.中华现代内科学杂志, 2005, 2(4):347-349.
3. 谢玉桃, 蒋孝华, 谭德明, 等. Lipo PGE₁治疗肝肾综合征的临床研究.中日友好医院学报, 2003, 17(1):29-31.
4. 吕芳芳, 陈雪凤, 徐小微, 等.不同剂量脂质体前列腺素E1治疗早期慢性重型肝炎临床疗效观察.浙江医学, 2002, 24(9):566-567.
5. 周华坚, 李韶光, 杨小云, 等.前列腺素E1脂微球载体制剂治疗病毒性肝炎高胆红素血症的疗效和安全性.中国新药杂志, 2005, 14(7):909-911.
6. 邓洪波, 李友元, 刘丹. Lipo PGE₁注射液对老年人颈动脉斑块及血小板聚集的影响.实用医药杂志, 2005, 22(8):685-686.
7. 韩朝, 林国经.前列地尔治疗突发性聋的效果观察.临床耳鼻咽喉科杂志, 2004, 18(4):245.
8. 昝立新.前列地尔治疗47例短暂性脑缺血发作的临床疗效观察.中国实用医药, 2011, 6(6):150-151.
9. 何文贞, 欧利民, 郑俊忠.前列地尔改善脑梗死后眩晕症状的效应.中国临床康复, 2013, 7(3):424-426.
10. 钟伟强, 刘冠贤, 杨永铭, 等.前列腺素E1脂微球载体制剂治疗慢性肾小球肾炎的临床研究.中国危重病急救医学, 2004, 16(5):292-294.
11. 李铁岭, 赵秀梅, 蔡力力, 等.脂微球化前列腺素E1干预老年动脉硬化闭塞症患者的下肢功能:不同量化标准的评估.中国临床康复, 2005, 9(15):40-41.
12. 孙勇, 李强, 王建安.前列腺素E1对急性冠脉综合征介入治疗围术期纤溶系统的影响.中华急诊医学杂志, 2003, 12(10):699-700.
13. 孙勇, 王建安.前列腺素E1对急性冠脉综合征早期部分炎症因子的影响.中华急诊医学杂志, 2003, 12(10):405-407.
14. 冯玉欣, 逄力男, 张奕.脂化前列腺素E1治疗糖尿病足疗效观察.中华糖尿病杂志, 2004, 12(5):317-320.
15. 邱有波, 杨拯, 呙金海, 等.凯时注射液治疗糖尿病肾病的系统评价.中国循证医学杂志, 2010, 10(7):832-837.
16. 张伶俐, 李幼平, 曾力楠, 等. 15国超说明书用药政策的循证评价.中国循证医学杂志, 2012, 12(4):426-435.
17. 张伶俐, 李幼平, 胡蝶, 等.四川大学华西第二医院2010年儿科住院患儿超说明书用药情况调查.中国循证医学杂志, 2012, 12(2):161-167.
18. 张伶俐, 李幼平, 梁毅.全球住院儿童超说明书用药现状的系统评价.中国循证医学杂志, 2012, 12(2):176-187.
19. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med, 2006, 166(9):1021-1026.
20. 李延敏, 杨悦. "药品说明书之外的用法"相关问题研究.中国药房, 2010, 21(37):3469-3471.

Chinese Journal of Evidence-Based Medicine

Off-label Drug Use of Alprostadil Injection among Inpatients in Guangdong General Hospital in 2012: A Status-quo Survey

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