Objective To establish the drug use evaluation (DUE) standard of lauromacrogol, evaluate its clinical use, and provide a reference for rational clinical application.
Methods Based on the drug instructions, related relevant guidelines and literature of lauromacrogol, the DUE standard was formulated through the expert consultation method. A retrospective study was conducted to evaluate the drug utilization of lauromacrogol in hospitalized patients in 3 201 Hospital of Xi’an Jiaotong University in Shaanxi province from January 2021 to August 2022.
Results A total of 143 medical records were included, 48 (33.57%) of which fully met the evaluation criteria.Unreasonable use was mainly manifested as inappropriate indications (65.03%) and unsuitable usage and dosage (1.40%). The unreasonable indications are mainly due to the existence of off-label medication.
Conclusion The established DUE standard of lauromacrogol has a certain reference effect on the rational use of lauromacrogol in clinical practice. Irrational usages still exists in the clinical application of lauromacrogol in the hospital, and interventions should be developed to optimize its clinical application and promote the rational drug use.
1.谭建福, 艾婷, 赵云, 等. 介入硬化剂聚桂醇的临床应用及研究进展[J]. 中国全科医学, 2013, 16(29): 3509-3511. [Tan JF, Ai T, Zhao Y, et al. Clinical application and research of lauromacrogol[J]. Chinese General Practice, 2013, 16(29): 3509-3511.] DOI: 10.3969/j.issn.1007-9572.2013.28.071.
2.覃艳丽, 周军. 聚桂醇的临床应用及其不良反应[J].中国介入影像与治疗学, 2020, 17(9): 569-572. [Tan YL, Zhou J. Clinical application and adverse reactions of Lauromacrogol[J]. Chinese Journal of Interventional Imaging and Therapy, 2020, 17(9): 569-572.] DOI: 10.13929/j.issn.1672-8475.2020.09.013.
3.陈新龙. PPH术配合聚桂醇硬化注射术治疗内痔疗效观察[J].实用中医药杂志, 2013, 29(10): 864-864. [Chen XL. Observation on the efficacy of PPH combined with lauromacrogol scleroinjection in the treatment of internal hemorrhoids[J]. Journal of Practical Traditional Chinese Medicine, 2013, 29(10): 864-864.] DOI: 10.3969/j.issn.1004-2814.2013.10.066.
4.黎永滨, 谢婷婷, 钟洁瑜, 等. 聚桂醇在囊肿硬化的临床应用文献综述[J]. 罕少疾病杂志, 2018, 25(4): 73-74. [Li YB, Xie TT, Zhong JY, et al. Review of the literature on the clinical application of lauromacrogol incyst sclerosis[J]. Journal of Rare and Uncommon Diseases, 2018, 25(4): 73-74.] DOI: 10.3969/j.issn.1009-3257.2018.04.028.
5.李素琼, 班立丽. 国内外药物利用评价研究综述[J].中国医院用药评价与分析, 2021, 21(7): 893-896. [Li SQ, Ban LL. Review on drug use evaluation at home and abroad[J]. Evaluation and Analysis of Drug-Use in Hospitals of China, 2021, 21(7): 893-896.] DOI: 10.14009/j.issn.1672-2124.2021.07.028.
6.黄艳芳, 吴柳婷, 罗洁丽, 等. 亚胺培南药物利用评价标准的建立及应用[J].中国药房, 2016, 27(2): 271-273. [Huang YF, Wu LT, Luo JL, et al. Establishment and application of the drug use evaluation criteria on imipenem[J]. China Pharmacy, 2016, 27(2): 271-273.] DOI: CNKI:SUN:ZGYA.0.2016-02-046.
7.袁浩宇, 林勇, 胡明, 等. 药物利用评价标准建立的方法探讨及实践[J]. 中国药房, 2010, 21(22): 2101-2104. [Yuan HY, Lin Y, Hu M, et al. Exploration on the method for establishment of DUE standard and pracyical study[J]. China Pharmacy, 2010, 21(22): 2101-2104.] DOI: CNKI:SUN:ZGYA.0.2010-22-036.
8.中华医学会整形外科分会血管瘤和脉管畸形学组. 血管瘤和脉管畸形的诊断及治疗指南(2019版) [J]. 组织工程与重建外科, 2019, 15(5): 277-317. DOI: 10.3969/j.issn.1673-0364.2019.05.001.
9.杨耀武, 郑家伟, 孙沫逸, 等. 聚桂醇硬化剂治疗口腔颌面部血管瘤和脉管畸形专家共识[J]. 中国口腔颌面外科杂志, 2018, 16(3): 275-278. [Yang YW, Zhen JW, Sun MY, et al. Expert consensus on the treatment of oral and maxillofacial hemangiomas and vascular malformations by lauromacrogol sclerotherapy[J]. China Journal of Oral and Maxillofacial Surgery, 2018, 16(3): 275-278.] DOI: 10.19438/j.cjoms.2018.03.017.
10.中国医师协会介入医师分会妇儿介入专委会. 硬化注射治疗血管瘤专家共识[J]. 中华介入放射学电子杂志, 2021, 9(3): 247-251. DOI: 10.3877/cma. j.issn.2095-5782.2021.03.002.
11.国家放射与治疗临床医学研究中心, 中华医学会超声分会超声介入学组, 中国医师协会介入医师分会超声介入委员会, 等. 卵巢子宫内膜异位囊肿超声引导穿刺硬化治疗专家共识[J]. 中华超声影像学杂志, 2020, 29(12): 1013-1024. DOI: 10.3760/cma.j.cn131148-20200814-00658.
12.中国微循环学会周围血管疾病专业委员会. 聚桂醇注射液治疗下肢静脉曲张微循环专家共识[J]. 血管与腔内血管外科杂志, 2020, 6(5): 377-381. DOI: 10.19418/j.cnki.issn2096-0646.2020.05.001.
13.中华医学会肝病学分会, 中华医学会消化病学分会, 中华医学会消化内镜学分会. 肝硬化门静脉高压食管胃静脉曲张出血的防治指南[J]. 中华内科杂志, 2023, 39(3): 527-538. DOI: 10.3760/cma.j.cn501113-20220824-00436.
14.《结直肠肛门外科》杂志编辑委员会. 聚桂醇内痔硬化注射疗法专家共识(2021版)[J]. 结直肠肛门外科, 2021, 27(3): 183-187. DOI: 10.19668/j.cnki.issn1674-0491.2021.03.001.
15.中国医师协会微无创医学专业委员会, 中国妇幼保健协会放射介入专业委员会. 妇科恶性肿瘤盆腔淋巴结切除术后淋巴囊肿诊治专家共识(2020年版)[J]. 中国实用妇科与产科杂志, 2020, 36(10): 959-964. DOI: 10.19538/j.fk2020100113.
16.王春青, 胡雁. JBI证据预分级及证据推荐级别系统(2014版)[J]. 护士进修杂志, 2015, 30(11): 964-967. [Wang CQ, Hu Y. JBI evidence pre-classification and evidence rank system (2014 Edition)[J]. Journal of Nurses Training, 2015, 30(11): 964-967.] DOI: 10.16821/j.cnki.hsjx.2015.11.002.
17.原国家卫生部. 药品不良反应报告和监测管理办法[S]. 2011.
18.Jie X, Geng X. Curative effect of lauromacrogol and absolute ethyl alcohol injection guided by ultrasound on simplex hepatic cyst[J]. Pak J Pharm Sci, 2015, 28(2 Suppl): 697-700. https://pubmed.ncbi.nlm.nih.gov/25796160/.
19.江攀, 张惠林, 刘海, 等. 超声引导下穿刺硬化治疗肝肾囊肿患者临床疗效研究[J]. 实用肝脏病杂志, 2022, 25(3): 439-442. [Jiang P, Zhang HL, Liu H, et al. Disappearance of liver -kidney cysts by lauromacrogol or anhydrous ethanol sclerotherapy under the guidance of color doppler ultrasound[J]. Journal of Practical Hepatology, 2022, 25(3): 439-442.] DOI: 10.3969/j.issn.1672-5069.2022.03.034.
20.Dong YJ, Zhou JQ, Liu ZH, et al. Efficacy assessment of ultrasound guided lauromacrogol injection for ablation of benign cystic and predominantly cystic thyroid nodules[J]. Front Pharmacol, 2019, 8(10): 478. DOI: 10.3389/fphar.2019.00478.
21.刘云峰, 唐华明, 周赟, 等. 超声引导下聚桂醇硬化术治疗良性乳腺囊肿的疗效及安全性分析[J]. 现代医药卫生, 2021, 37(11): 1896-1898. [Liu YF, Tang HM, Zhou B, et al. Analysis of the efficacy and safety of ultrasound-guided lauromacrogol sclerotherapy in the treatment of benign breast cysts[J]. Journal of Modern Medicine & Health, 2021, 37(11): 1896-1898.] DOI: 10.3969/j.issn.1009-5519.2021.11.028.
22.Khanna R , Sarin SK. Non-cirrhotic portal hypertension-diagnosis and management[J]. J Hepatol, 2014, 60(2): 421-441. DOI: 10.1016/j.jhep.2013.08.013.
23.骆晨, 周军. 聚桂醇硬化治疗的应用现状及研究进展[J]. 巴楚医学, 2020, 3(3): 114-117. [Luo C, Zhou J. Application status and research progress of polylauryl alcohol sclerotherapy[J]. Bachu Medical Journal, 2020, 3(3): 114-117.] DOI: 10.3969/j.issn.2096-6113.2020.03.027.
24.Baeshko A, Shestak N, Korytko S. Results of ultrasound-guided foam sclerotherapy of the great saphenous vein with new parameters of the tTechnique[J]. Vasc Endovascular Surg, 2016, 50(8): 528-533. DOI: 10.1177/1538574416675482.
25.Linghu EQ, Du C, Chai NL, et al. A prospective study on the safety and effectiveness of using lauromacrogol for ablation of pancreatic cystic neoplasms with the aid of EUS[J]. Gastrointest Endosc, 2017, 86(5): 872-880. DOI: 10.1016/j.gie.2017.03.1525.
26.Rathbun S, Norris A, Stoner J. Efficacy and safety of endovenous foam sclerotherapy: meta-analysis for treatment of venous disorders[J]. Phlebology, 2012, 27(3): 105-117. DOI: 10.1258/phleb.2011.011111.