No influence of Hirudoid and Hirudoid forte on systemic blood coagulation

喜疗妥和特强喜疗妥软膏对凝血系统无影响

 

After topical application of Hirudoid and Hirudoid forte plasma levels of MPS are Iow and no influence on blood coagulation can be determined.

外用喜疗妥和特强喜疗妥软膏后，MPS血浆水平很低并且不影响凝血系统。

 

Darragh et al. reported that in healthy volunteers all hematological and clinico-chemicai parameters remained unchanged during a 7-day treatment with Hirudoid forte.

Darragh等人报道健康志愿者在连续应用特强喜疗妥软膏的7天期间，所有的血液生化参数均无改变。

 

 

Investigations with non-human primates, rabbits and rats had also shown that the cutaneous application of MPS does not influence the systemic coagulation (Chasseaud et al., Fianu et al., Hoppensteadt et al.).

受试对象为兔和大鼠的研究同样显示，连续应用MPS后对凝血系统无影响(Chasseaud 等人, Fianu 等人, Hoppensteadt 等人)。

 

Excellent tolerability in clinical use

卓越的临床耐受性

Hirudoid and Hirudoicl forte have been used over decades worldwide in an extensive number of patients. All reports about adverse drug reactions are registered in national post-marketing surveillance systems. Additionally, a great number of studies, investigating efficacy and safety of the product, is available.

喜疗妥和特强喜疗妥软膏已经数十年在全世界范围广泛应用于大量患者。所有有关药物副反应的报告均被记录于上市后的监控系统。另外，还有大量有关药物疗效和安全性的研究。

 

Summarizing the post-marketing experience and safety data from clinical trials, it can be stated that only local adverse reactions were observed in isolated cases. Transient local skin irritation or contact allergies may occur. Up to now, no systemic adverse reactions were reported.

总结上市后的经验和临床试验的安全性数据，仅在个别病例观察到局部的副反应，表现为短暂的局部皮肤刺激或接触性过敏反应。到目前为止，未发现有全身副作用。

 

Positive benefit-risk evaluation

利益/风险评估

Regarding the efficacy of the Hirudoid and Hirudoid forte preparations, proven in many studies, and the excellent tolerability there is no doubt, that the benefit-risk ratio of the product is positive.

关于喜疗妥和特强喜疗妥制剂，大量的研究证实其毫无疑问具有极好的耐受性，利益/风险评估是积极的。