GLP-1类似物及DPP-4抑制剂国内上市情况分析
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摘要
目的总结肠促胰素类药物胰高血糖素样肽1(GLP-1)受体激动剂和二肽基肽酶4(DDP-4)抑制剂在我国的上市情况,为2型糖尿病的临床应用提供参考。方法检索原国家食品药品监督管理总局(CFDA)网站中GLP-1和DDP-4获准上市药品的相关信息,分类统计其上市药品数、上市时间、生产企业、剂型、规格等信息,并根据药品说明书对各药品的药理作用、CFDA批准的适应证、用法用量及不良反应等信息进行定性分析。结果与结论我国先后有4种GLP-1类似物和5种DPP-4抑制剂上市,上市品种数、上市时间及批准适应证等均与美国有所不同。随着两类药物在我国临床的逐渐推广,各种药品的有效性、安全性和经济性会进一步得到验证,国内上市情况及用药指南等均有可能发生变化;其次,同类药品的临床疗效差异也会逐渐明显。
Objective To summarize the status of glucagon-like peptide-1( GLP-1) receptor agonists and dipeptidyl peptidase-4( DDP-4) inhibitors of intestinal tryptotropic drugs listed in China, and to provide a reference for its clinical application in type 2diabetes mellitus( T2DM). Methods The relevant information of GLP-1 and DDP-4 approved and listed drugs on the website of the former China Food and Drug Administration( CFDA) was retrieved,and the information of listed varieties,the time of listing,manufacturers,dosage forms and specifications were classified and analyzed. According to the drug instructions, the pharmacological effects, indications approved by CFDA,usage and dosage,adverse reactions of the drugs were analyzed qualitatively. Results and Conclusion Four GLP-1 analogues and five DPP-4 inhibitors have been listed in China successively. The number of listed varieties,time of listing and the indications for approval are different from those in the United States. With the gradual promotion of the two kinds of drugs in clinical practice in China, the effectiveness, safety and economy of various drugs will be further verified, the listed situation and medication guidelines in China may change,and the difference in the clinical efficacy of similar drugs will gradually be obvious.
Objective To summarize the status of glucagon-like peptide-1( GLP-1) receptor agonists and dipeptidyl peptidase-4( DDP-4) inhibitors of intestinal tryptotropic drugs listed in China, and to provide a reference for its clinical application in type 2diabetes mellitus( T2DM). Methods The relevant information of GLP-1 and DDP-4 approved and listed drugs on the website of the former China Food and Drug Administration( CFDA) was retrieved,and the information of listed varieties,the time of listing,manufacturers,dosage forms and specifications were classified and analyzed. According to the drug instructions, the pharmacological effects, indications approved by CFDA,usage and dosage,adverse reactions of the drugs were analyzed qualitatively. Results and Conclusion Four GLP-1 analogues and five DPP-4 inhibitors have been listed in China successively. The number of listed varieties,time of listing and the indications for approval are different from those in the United States. With the gradual promotion of the two kinds of drugs in clinical practice in China, the effectiveness, safety and economy of various drugs will be further verified, the listed situation and medication guidelines in China may change,and the difference in the clinical efficacy of similar drugs will gradually be obvious.
引文
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[2] NOOR S,KHAN RU,AHMAD J. Understanding diabetic foot infection and its management[J]. Diabetes Metab Syndr,2017,11(2):149-156.
[3] DE MORAES G,LAYTON CJ. Therapeutic targeting of diabetic retinal neuropathy as a strategy in preventing diabetic retinopathy[J]. Clin Exp Ophthalmol,2016,44(9):838-852.
[4] HASSLACHER C,BORGHOLTE G,RITZ E,et al. Impact of hypertension on prognosis in IDDM[J]. Diabete Metab,1989,15(5 Pt 2):338-342.