浏览全部资源
扫码关注微信
- Journal Information
- Archive
- Submission
- For Reviewers
- Statement and Policies
Comparison of efficacy， safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia
- ZHONGGUO YAOFANG Vol. 34, Issue 2, Pages: 200-204(2023)
- 作者机构：
1.连云港市第一人民医院药学部，江苏 连云港 222023
2.南京医科大学康达学院第一附属医院药学部，江苏 连云港 222023
3.连云港市第一人民医院呼吸与危重症医学科，江苏 连云港 222023
4.连云港市第二人民医院药学部，江苏 连云港 222023
- 作者简介：
- 基金信息：
DOI：10.6039/j.issn.1001-0408.2023.02.14
CLC： R978.1;R563.1Published：30 January 2023，
Received：27 May 2022，
Revised：31 December 2022，
扫 描 看 全 文
庞婕,吴晓雯,李春华等.中标与原研盐酸莫西沙星片治疗门诊社区获得性肺炎的有效性、安全性与经济性比较 Δ[J].中国药房,2023,34(02):200-204.
PANG Jie,WU Xiaowen,LI Chunhua,et al.Comparison of efficacy， safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia[J].ZHONGGUO YAOFANG,2023,34(02):200-204.
庞婕,吴晓雯,李春华等.中标与原研盐酸莫西沙星片治疗门诊社区获得性肺炎的有效性、安全性与经济性比较 Δ[J].中国药房,2023,34(02):200-204. DOI： 10.6039/j.issn.1001-0408.2023.02.14.
PANG Jie,WU Xiaowen,LI Chunhua,et al.Comparison of efficacy， safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia[J].ZHONGGUO YAOFANG,2023,34(02):200-204. DOI： 10.6039/j.issn.1001-0408.2023.02.14.
摘要
目的
2
比较中标和原研盐酸莫西沙星片治疗门诊社区获得性肺炎（CAP）的有效性、安全性和经济性。
方法
2
采用回顾性队列研究，筛选并纳入2021年1－12月在江苏省连云港市第一人民医院门诊治疗的CAP患者，根据其所用药品来源分为原研药组（1 058例）和中标药组（1 121例）。2组患者分别口服原研盐酸莫西沙星片和中标盐酸莫西沙星片，每次0.4 g，每天1次。比较2组患者的有效性指标（临床治疗有效率、缓解时间、用药疗程、再次就诊率）和安全性指标（变态反应、神经系统反应等不良反应发生情况），并采用多因素修正Poisson回归模型分析临床治疗失败的影响因素；比较2种药物的经济性指标[使用数量、销售金额、用药频度（DDDs）、日均费用（DDDc）、价格比、中标药替代率]。
结果
2
2组患者的临床治疗有效率、用药疗程、再次就诊率和神经系统反应、Q-T间期延长的发生率比较差异均无统计学意义（
P
＞0.05）；原研药组患者的缓解时间显著短于中标药组，其总药品不良反应、变态反应、消化系统反应和血糖异常的发生率均显著低于中标药组（
P
＜0.05）。多因素Poisson回归分析显示，使用中标药不会增加门诊CAP患者临床治疗失败风险[风险比＝1.132，95%置信区间（0.883，1.542），
P
＝0.327]，但有抗菌药物暴露史、临床表现异常项目或辅助检查异常项目≥2项均会增加临床治疗失败风险（
P
＜0.05）。与实施集中带量采购政策前比较，实施集中带量采购政策后，盐酸莫西沙星片的使用数量和DDDs明显增加，销售金额明显下降；中标药的DDDc明显下降，与原研药的价格比降至0.117，替代率升至69.44%。
结论
2
与原研药物相比，中标盐酸莫西沙星片治疗门诊CAP的临床疗效可靠，且具有明显的价格优势，但不良反应发生率较高。
Abstract
OBJECTIVE
2
To compare the efficacy， safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia （CAP）.
METHODS
2
A retrospective cohort study was conducted to screen and include CAP outpatients during the period of January to December 2021 in Lianyungang First People’s Hospital. They were divided into generic drug group （1 058 cases） and bid-winning drug group （1 121 cases） according to the drug source. Two groups were respectively given original and bid-winning Moxifloxacin hydrochloride tablets， 0.4 g each time， once a day. The efficacy indexes （clinical effective rate， remission time， treatment course， revisiting rate） and safety indexes （allergy， nervous system symptoms， etc.） were compared between the two groups； and the influence factors of clinical treatment failure were analyzed with multi-factor modified Poisson regression model. The economic indicators of the two drugs [quantity， consumption sum， defined daily doses （DDDs）， defined daily dose cost （DDDc）， price ratio， replacement rate] were compared.
RESULTS
2
There were no significant differences in the clinical effective rate， treatment course， revisiting rate， the incidence of nervous system symptoms and Q-T interval prolongation between the two groups （
P
＞0.05）. The remission time of original drug group was significantly shorter than that of bid-winning drug group， and the incidence of total adverse drug reaction， allergy reaction， gastrointestinal symptom reaction and hyperglycemia were significantly lower than those in bid-winning drug group（
P
＜0.05）. Multivariate Poisson regression analysis showed that bid-winning drug did not increase the risk of clinical treatment failure in CAP outpatients [RR＝1.132， 95%CI （0.883， 1.542），
P
＝0.327]. However， antibiotic exposure history， more than 2 items of abnormal clinical manifestations and auxiliary examination all increased the risk of clinical treatment failure （
P
＜0.05）. Compared with before the implementation of centralized volume-based procurement policy， the quantity and DDDs of Moxifloxacin hydrochloride tablets increased significantly， while the consumption sum decreased significantly， DDDc of bid-winning drug decreased significantly， the price ratio of it to original drug decreased to 0.117， and the replacement rate increased to 69.44% after the implementation of centralized volume-based procurement policy.
CONCLUSIONS
2
Compared with original drug， bid-winning Moxifloxacin hydrochloride tablet shows reliable efficacy and obvious price advantage in the treatment of outpatient CAP， but the incidence of adverse drug reactions is higher.
关键词
社区获得性肺炎门诊盐酸莫西沙星片仿制药原研药药品集中带量采购
Keywords
outpatientmoxifloxacin hydrochloridegeneric drugoriginal drugcentralized volume-based procurement
references
WANG X X，ZHANG H H，ZHANG T，et al. Etiology of community-acquired pneumonia requiring hospital admission in adults with and without cancers：a single-center re-trospective study in China[J]. Infect Drug Resist，2020，13：1607-1617.
GCKD Collaboration. Global，regional，and national burden of chronic kidney disease，1990-2017：a systematic analysis for the Global Burden of Disease Study 2017[J]. Lancet，2020，395（10225）：709-733.
中华医学会呼吸病学分会.中国成人社区获得性肺炎诊断和治疗指南：2016年版[J]. 中华结核和呼吸杂志，2016，39（4）：253-279.
METLAY J P，WATERER G W，LONG A C，et al. Diagnosis and treatment of adults with community-acquired pneumonia an official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America[J]. Am J Respir Crit Care Med，2019，200（7）：e45-e67.
胡付品，郭燕，朱德妹，等. 2020年CHINET中国细菌耐药监测[J]. 中国感染与化疗杂志，2021，21（4）：377-387.
OLSON G，DAVIS A M. Diagnosis and treatment of adults with community-acquired pneumonia[J]. JAMA，2020，323（9）：885-886.
国务院办公厅. 国务院办公厅关于印发国家组织药品集中采购和使用试点方案的通知：国办发〔2019〕2号[J]. 中国制药信息，2019（3）：7-10.
ITO Y，HARA K，KOBAYASHI Y. The effect of inertia on brand-name versus generic drug choices[J]. J Econ Behav Organ，2020，172：364-379.
WHO Collaborating Centre for Drug Statistics Methodo-logy. Purpose of the ATC/DDD system[EB/OL].（2018-02-07）[2021-01-23]. https：//www.whocc.no/atc_ddd_me-thodology/purpose_of_the_atc_ddd_systemhttps://www.whocc.no/atc_ddd_me-thodology/purpose_of_the_atc_ddd_system.
邹国盛，赵家强，梅清华，等. “4+7城市”药品集中采购实施后广东省第二人民医院原研药与仿制药使用情况分析[J]. 中国医院用药评价与分析，2020，20（7）：854-858.
LIM W S，VAN DER EERDEN M M，LAING R，et al. Defining community acquired pneumonia severity on presentation to hospital：an international derivation and validation study[J]. Thorax，2003，58（5）：377-382.
KUZMAN I，BEZLEPKO A，KONDOVA TOPUZOVSKA I，et al. Efficacy and safety of moxifloxacin in community acquired pneumonia：a prospective，multicenter，observational study （CAPRIVI）[J]. BMC Pulm Med，2014，14：105.
LI Y，ZHU D M，PENG Y Q，et al. A randomized，controlled，multicenter clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus moxifloxacin in adult patients with community-acquired pneumonia[J]. Curr Med Res Opin，2021，37（4）：693-701.
DU X W，HAN Y，JIAN Y F，et al. Clinical benefits and cost-effectiveness of moxifloxacin as initial treatment for community-acquired pneumonia：a meta-analysis and economic evaluation[J]. Clin Ther，2021，43（11）：1894-1909.
RAHMEL T，ASMUSSEN S，KARLIK J，et al. Moxifloxacin monotherapy versus combination therapy in patients with severe community-acquired pneumonia evoked ARDS[J]. BMC Anesthesiol，2017，17（1）：78.
陈文静，欧阳冬生，黄洁，等. 盐酸莫西沙星片在中国健康受试者体内的生物等效性研究[J]. 中国临床药理学杂志，2021，37（14）：1771-1775.
张亮，侯文洁，周秋云，等. 原研与仿制莫西沙星注射液在治疗社区获得性肺炎中的成本-效果分析[J]. 中国医院药学杂志，2021，41（3）：246-250.
李秀梅. 初始治疗失败的成人社区获得性肺炎的多中心临床研究[D]. 青岛：青岛大学，2019.
尤晓敏，吕旭峰，杨悦. 我国公立医院药品带量采购制度实施状况研究[J]. 中国药房，2017，28（31）：4345-4349.
0
Views
5
下载量
0
CSCD
- L-PDFDownload
- WORDDownload
- Meta-XMLDownload
- BibTeXDownload
- EndnoteDownload
- RefMan Download
- NoteExpressDownload
- NoteFirstDownload
Publicity Resources
Related Articles
Related Author
Related Institution
- Address：8/F,129 Daping Main Street,Yuzhong District,Chongqing 400042,P.R.China
- Technical support is provided by Beijing Founder Electronics co., LTD 渝ICP备15012710号
公网安备50010302001817 - It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
- Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.