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Efficacy and safety of generic paroxetine tablets in centralized drug procurement: a real-world study

Published on Jan. 15, 2023Total Views: 1399 times Total Downloads: 644 times Download Mobile

Author: Fei JIA 1, 2 Yan-Nan ZANG 1, 2 Meng-Xi NIU 1, 2 Shan-Shan LIU 1, 2 Hong-Yan ZHUANG 1, 2 guowe@ccmu.edu.cn Wei GUO 1, 2

Affiliation: 1. Beijing Anding Hospital, Capital Medical University, The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing 100088, China 2. Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing 100069, China

Keywords: Drug centralized procurement Paroxetine Efficacy Safety Real-world study

DOI: 10.19960/j.issn.1005-0698.202301003

Reference: Fei JIA, Yan-Nan ZANG, Meng-Xi NIU, Shan-Shan LIU, Hong-Yan ZHUANG, Wei GUO.Efficacy and safety of generic paroxetine tablets in centralized drug procurement: a real-world study[J].Yaowu Liuxingbingxue Zazhi,2023, 32(1): 18-24.DOI: 10.19960/j.issn.1005-0698.202301003.[Article in Chinese]

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Abstract

Objective  To compare the the efficacy and safety of paroxetine tablet in the treatment of depressive disorder with centralized procurement of generic drug (LeYou®) and branded drug (Seroxat®). To evaluate the effects of drug centralized procurement policy on doctors’ prescribing behavior and patients’ treatment expenses, and to provide a basis for promoting the rational use of the generic drugs.

Methods  To extract the outpatient data of patients who were prescribed paroxetine tablets in the first half year after the implementation of the drug centralized procurement policy and in the same period of the previous year from Hospital Information System (HIS) of a Grade 3A psychiatric hospital. The relevant data were divided into generic drug and branded drug groups and analyzed by Propensity Score Match (PSM). The dosage, blood concentration, abnormal incidence of common adverse reaction, dressing change rate and drug cost of the generic drug and branded drug in clinical use were compared.

Results  There was no signifi-cant difference in drug dosage and blood concentration between the generic drug group and the branded drug group (P>0.05). There was no significant difference in the incidence of adverse drug reactions such as abnormal liver and kidney function, blood glucose increase, dyslipidemia and prolactin elevation between the generic drug group and the branded drug group (P>0.05). In the test period, the replace drug rate of the branded drug to the generic drug was 5.52%, and that of the reference period was 2.87%. In the two periods, about 0.59% and 0.48% of the patients changed to the branded research drug, respectively. The generic drug cost of patients in the test period was 310.38 yuan per time and the total drug cost was 1 052.77 yuan, which were significantly lower than the generic drug cost and the total drug cost in the reference period (P<0.01).

Conclusion  No significant difference was found in safety and efficacy between the generic drug of paroxetine tablet and the branded drug, and the generic drug had great economic advantages.

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References

1.陆林, 主编.沈渔邨精神病学, 第6版[M]. 北京:人民卫生出版社, 2017: 849.

2.李凌江,马辛, 主编.中国抑郁障碍防治指南, 第2版[M].北京:中华医学电子音像出版社, 2015: 49-62.

3.江开达, 主编.精神药理学, 第2版[M]. 北京:人民卫生出版社, 2011: 738.

4.司天梅. 中国强迫症防治指南2016解读:药物治疗[J]. 中华精神科杂志, 2017, 50(4): 249-252. [Si TM. 2016 in-terpretation of guidelines for the prevention and treatment of obsessive-compulsive disorder in China: drug treatment[J]. Chinese Journal of Psychiatry, 2017, 50(4): 249-252.] DOI: 10.3760/cma.j.issn.1006-7884.2017. 04.003.

5.中华医学会, 中华医学会杂志社, 中华医学会全科医学分会, 等. 广泛性焦虑障碍基层诊疗指南(2021年)[J]. 中华全科医师杂志, 2021, 20(12): 1232-1241. DOI: 10.3760/cma.j.cn114798-20211025-00790.

6.国务院办公厅. 国家组织药品集中采购和使用试点方案[EB/OL]. (2019-01-17) [2022-10-12]. http://www.gov.cn/zhengce/content/2019-01/17/content_5358604.htm.

7.谢英, 马骁, 赵艳玲. 恩替卡韦仿制药与原研药治疗慢性乙型肝炎的疗效及安全性研究[J]. 中国医院用药评价与分析, 2021, 21(8): 905-907. [Xie Y, Ma X, Zhao YL. Research on efficacy and safety of generic and original entecavir in the treatment of chronic Hepatitis B[J]. Evaluation and Analysis of Drug-Use in Hospitals of China, 2021, 21(8): 905-907.] DOI: 10.14009/j.issn. 1672-2124.2021.08.002.

8.韩嘉伦, 张翼, 林佰弟, 等. 中标对比原研氯吡格雷用于急性冠脉综合征患者经皮冠状动脉介入术后治疗的临床有效性及安全性研究[J]. 中国医院药学杂志, 2021, 41(6): 601-605. [Han JL, Zhang Y, Lin BD, et al. A comparative study on clinical efficacy and safety of generic versus originalclopidogrel in the treatment of acute cor-onary syndrome patients after percutaneous coronary intervention[J]. Chinese Journal of Hospital Pharmacy, 2021, 41(6): 601-605.] DOI: 10.13286/j.1001-5213.2021.06.08.

9.任衍镇, 劳钊明, 黄彩英, 等. 常见精神障碍发病与气象要素的相关性[J]. 广东医学, 2018, 39(16): 2488-2490. [Ren YZ, Lao ZM, Huang CY, et al. Correlation between common mental disorders and meteorological factors[J]. Guangdong Medical Journal, 2018, 39(16): 2488-2490.] DOI: 10.3969/j.issn.1001-9448.2018. 16.022.

10.李佩佩, 谈博, 黄晓楠, 等. 季节性情感障碍的研究进展[J]. 中华中医药杂志, 2019, 34(7): 3135-3137. [Li PP, Tan B, Huang XN, et al. Research progress of seasonal affective disorder[J]. China Journal of Traditional Chi-nese Medicine and Pharmacy, 2019, 34(7): 3135-3137.] http://www.cnki.com.cn/Article/CJFDTotal-BXYY201907084.htm.

11.Hiemke C, Bergemann N, Clement HW, et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: update 2017[J]. Pharmacopsychiatry, 2018, 51(1-02): e1. DOI: 10.1055/s-0037-1600991.

12.徐子峰. 帕罗西汀治疗抑郁症血药浓度与临床疗效及副作用关系的研究[D]. 昆明: 昆明医科大学, 2016. [Xu ZF. Study on the relationship between serum drug concentration and clinical efficacy and side effects in the treatment of depression in Paroxetine[D]. Kunming: Kunming Medical University, 2016.]

13.中华医学会,中华医学会杂志社,中华医学会消化病学分会,等.药物性肝损伤基层诊疗指南(2019年)[J].中华全科医师杂志, 2020, 19(10): 868-875. DOI: 10.3760/cma.j.cn114798-20200812-00900.

14.中华医学会,中华医学会杂志社,中华医学会全科医学分会,等. 血脂异常基层诊疗指南(2019年)[J].中华全科医师杂志, 2019, 18(5): 406-416. DOI: 10.3760/cma.j.issn.1671-7368.2019.05.003.

15.中国神经科学学会精神病学基础与临床分会精神分裂症临床研究联盟.抗精神病药所致高泌乳素血症干预对策的专家共识[J].中华精神科杂志, 2021, 54(3): 163-169. DOI: 10.3760/cma.j.cn113661-20201219-00514.

16.岳小林,付娜,赵艳玲,等.国家集中带量采购中选药品疗效与安全性的真实世界研究[J].临床药物治疗杂志, 2022, 20(6): 43-48. [Yue XL, Fu N, Zhao YL, et al. Efficacy and safety evaluation of selected drugs in the national volume-based procurement:a real-world study[J]. Clinical Medication Journal, 2022, 20(6): 43-48.] DOI: 10.3969/j.issn.1672-3384.2022.06.008.

17.刘丽娟, 马洁, 张耀东,等.国家药品集中采购政策背景下中选药临床换药率分析[J].今日药学, 2021, 31(3): 219-222, 230. [Liu LJ, Ma J, Zhang YD, et al. Analysis of clinical dressing rate of selected medicine under the background of the national drug centralized procurement policy[J]. Pharmacy Today, 2021, 31(3): 219-222, 230.] DOI: 10.12048 /j.issn.1674-229X.2021.03.016.

18.于娜,吴婷婷,杨林.带量采购政策对我院降压药物利用状况的影响分析[J].药物流行病学杂志, 2021, 30(8): 547-551, 561. [Yu N, Wu TT, Yang L. Analysis of the influence of volume-based drug centralized procurement program on the utilization of anti-hypertension drugs in a tertiary hospital[J]. Chinese Journal of Phar-macoepidemiology, 2021, 30(8): 547-551, 561.] DOI: 10.19960/j.cnki.issn1005-0698.2021.08.010.

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