Genzyme公司推出治疗C型难治型腹泻的药物

一项III期临床试验正在测试tolevamer的安全性和效能，这是一种用于梭状芽胞杆菌属难治性腹泻（CDAD）的探索性多聚体治疗药物。

C型难治性腹泻是由广泛存在于环境中的孢子形成细菌引起的，已知可以在医院环境中与长期监护环境中生存数月。罹患CDAD危险的患者是那些接受抗生素治疗的患者，这些治疗改变了在肠道中定居的正常的保护性细菌。几乎所有的抗生素都有导致CDAD的可能，在最近数年中感染的可能不断增加。

Tolevamer是一种新型不吸收的治疗药物，是获得批准的第一种非抗生素治疗药物。该药被设计用于结合与清除体内由C型难治性梭状芽孢杆菌所释放的毒素。Tolevamer是由Genzyme公司研制开发的。这项III期临床试验正在北美、欧洲和澳大利亚的250多个基地进行，包括了1000多例患者。该项研究将评估Tolevamer与甲硝唑的作用，甲硝唑是用于治疗CDAD最常用的处方药。

Genzyme公司执行副总裁Georges Gemayel指出：“C型难治性腹泻是许多医院和长期监护病房中最显著的危险因素，特别是对许多老年患者而言。我们对已经获得的资料感到欢欣鼓舞，Tolevamer在减少这些患者复发以及多次入院治疗方面十分有价值。”

Therapy for C Difficile Diarrhea
 
A phase III clinical study is testing the safety and efficacy of tolevamer, an investigational polymer therapy for patients with Clostridium difficile-associated diarrhea (CDAD).

C difficile is a spore-forming bacterium that is found widely in the environment and is known to survive for months in hospitals and long-term care facilities. Patients are at risk of developing CDAD when they are treated with antibiotics that alter the normal, protective bacteria that reside in the colon. Virually all antibiotics have been implicated in causing CDAD, and the number of infections has been increasing in recent years.

Tolevamer is a new, nonabsorbed therapy that could be the first non-antibiotic treatment approved for CDAD. It is designed to bind and remove from the body the toxins released by C difficile that damage the intestines. Tolevamer is being developed by Genzyme Corp. (Cambridge, MA, USA). The phase III study will be conducted at more than 250 sites in North America, Europe, and Australia and involve more than 1,000 patients. The study will also evaluate tolevamer against metronidazole, the most commonly prescribed antibiotic treatment for CDAD.

“C difficile represents a significant risk to many hospitals and long-term care patients, especially among the elderly,” noted Georges Gemayel, executive vice-president of Genzyme Corp. “We are encouraged by data that indicate that tolevamer may be particularly valuable in reducing recurrence and repeat hospitalization for these patients.”