Q: anticoagulant therapy is an important part of cardiovascular therapy, and every advance in the field of anticoagulation is critical to the clinic. The state food and drug administration changed the general name of kexai ® from "low molecular weight heparin sodium" to "enoxaparin sodium", what is the clinical significance of this name change?
Answer: anticoagulant therapy progress promoted the development of cardiovascular prevention, especially the prompt development and application of low molecular weight heparin anticoagulant therapy into a new era, compared with the ordinary heparin, low molecular weight heparin as a new kind of anticoagulant drugs have stronger anticoagulant effectiveness, less effect on platelet function, small side effects, good subcutaneous injections of absorption, a longer half-life in the body, and many other advantages, is widely used in clinical.
There are more than 10 kinds of low molecular weight heparin used in clinic at home and abroad. In fact, the clinical efficacy and indications of different low molecular weight heparin are also different due to the differences in production process and chemical structure. Therefore, the WHO, FDA and other authoritative agencies pointed out clearly a few years ago that the characteristics of a low molecular weight heparin cannot be generalized randomly
The results of clinical studies on a specific low molecular weight heparin cannot be generalized to other low molecular weight heparin. At the same time, the FDA has classified the low-molecular-weight heparin into different varieties according to the manufacturer and the source.
This time, China's SFDA (state food and drug administration) changed the general name of kexel ® from "low molecular weight heparin sodium" to "enoxaparin sodium" precisely based on the different clinical efficacy and indications of low molecular weight heparin. Despite the low molecular weight heparin is composed of ordinary heparin depolymerization, but different manufacturers have adopted different chemical or enzymatic depolymerization process, in accordance with the norm heparin is after benzyl esterification depolymerization and in alkaline conditions, unique production process makes its chemical structure (the length of the chain, chain sequence, the structure of the fingerprint, etc.), average molecular weight compounds, antithrombin Ⅲ and HC II, resistance to Xa/resistance type IIa than are unique. Due to the unique manufacturing process that determines the efficacy characteristics and non-reproducibility of the safety of enoxaparin sodium, the ACC/AHA guidelines explicitly emphasize that the only recommended low molecular weight heparin is enoxaparin, not low molecular weight heparin in general. At the same time, the name change is also in line with international standards, as "enoxaparin sodium" is used worldwide as the generic name of kesai.
There is no doubt that the renaming of enoxaparin sodium has important clinical significance: it promotes the more accurate and individualized cognition of similar drugs among clinical workers.