一項III期臨床試驗正在測試tolevamer的安全性和效能，這是一種用于梭狀芽胞桿菌屬難治性腹瀉（CDAD）的探索性多聚體治療藥物。

C型難治性腹瀉是由廣泛存在于環(huán)境中的孢子形成細菌引起的，已知可以在醫(yī)院環(huán)境中與長期監(jiān)護環(huán)境中生存數(shù)月。罹患CDAD危險的患者是那些接受抗生素治療的患者，這些治療改變了在腸道中定居的正常的保護性細菌。幾乎所有的抗生素都有導致CDAD的可能，在最近數(shù)年中感染的可能不斷增加。

Tolevamer是一種新型不吸收的治療藥物，是獲得批準的第一種非抗生素治療藥物。該藥被設(shè)計用于結(jié)合與清除體內(nèi)由C型難治性梭狀芽孢桿菌所釋放的毒素。Tolevamer是由Genzyme公司研制開發(fā)的。這項III期臨床試驗正在北美、歐洲和澳大利亞的250多個基地進行，包括了1000多例患者。該項研究將評估Tolevamer與甲硝唑的作用，甲硝唑是用于治療CDAD最常用的處方藥。

Genzyme公司執(zhí)行副總裁Georges Gemayel指出：“C型難治性腹瀉是許多醫(yī)院和長期監(jiān)護病房中最顯著的危險因素，特別是對許多老年患者而言。我們對已經(jīng)獲得的資料感到歡欣鼓舞，Tolevamer在減少這些患者復(fù)發(fā)以及多次入院治療方面十分有價值。”

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.”