药理分类：
大环内酯类抗生素

活性成分（S）：
Fidaxomicin 200毫克;片。

指示（S）：
对于艰难梭菌相关性腹泻的治疗。

药理：
Fidaxomicin是一种发酵产品从放线菌Dactylosporangium aurantiacum获得。正是在C.体外，抑制RNA的RNA聚合酶合成艰难的杀菌。

临床试验：
在两项随机，双盲试验，非劣效设计用来展示fidaxomicin疗效（200毫克每天两次10天）相比，万古霉素与艰难梭菌相关性腹泻的成年人（125mg四次10天每天） （CDAD）。参加试验的患者接受了万古霉素或甲硝唑的预处理不超过24小时。 CDAD被定义为> 3未成形的排便（或> 200毫升的未成形粪便收集装置因直肠科）在随机化之前的24小时，任艰难梭菌毒素存在一个或在48小时的随机大便B。登记患者要么没有事先CDAD历史或只有一个事先在过去三个月CDAD插曲。与life-threatening/fulminant感染的主题，低血压，感染性休克，腹膜的迹象，显着的脱水，或中毒性巨结肠被排除在外。

主要疗效终点是在治疗结束临床反应率，在改善腹泻或这样，在研究者的判断，进一步CDAD治疗是没有必要的其他症状。一个额外的疗效终点是持续25天之后，治疗结束临床反应。持续反应只计算谁的病人均在治疗结束临床成功。持续反应定义为临床反应在治疗结束，并没有证实或怀疑超出了通过25天的治疗结束CDAD复发生存。

对在治疗结束在这两个试验的临床反应结果表明，fidaxomicin是不劣于万古霉素（试行1：88％对万古霉素fidaxomicin 86％;试验2：fidaxomicin 88与万古霉素87％）。在随访期间结束了持续的临床反应结果表明，fidaxomicin优于万古霉素在此端点（试行1：70％对万古霉素fidaxomicin 57％;试验2：72％对万古霉素fidaxomicin 57％）。由于在治疗率和死亡率的临床成功结束了在治疗武器（每组约6％）相似，在持续的临床反应的差异是由于经证实或怀疑在fidaxomicin患者在随访期间CDAD率较低。

限制性内切酶分析是用来识别梭状在BI组基线分离，分离率和严重程度的增加在未来的CDAD在美国之前，相关的临床试验。类似的临床反应率在治疗和证实或怀疑在随访期间CDAD年底被发现与一BI隔离感染fidaxomicin处理和万古霉素治疗的患者。然而，fidaxomicin并没有表现出优势，在持续的临床反应，与万古霉素相比。

法律分类：
接收

成人：
≥18岁：200毫克每天两次，连续10天。

儿童：
<18岁：不推荐。

警告/注意事项：
不治疗（最小的全身吸收）全身性感染。妊娠（部件B）。护理母亲。

不良反应（S）：
恶心，呕吐，腹痛，消化道出血，贫血，中性粒细胞减少。

如何提供：
标签- 20，60，100（10 × 10吸塑卡）

最后更新：
二○一一年六月三十〇日

Dificid（fidaxomicin）获批用于梭菌感染治疗

近日，FDA批准Dificid（fidaxomicin）用于治疗艰难梭菌（难辨梭状芽孢杆菌）相关性腹泻(CDAD)。

艰难梭菌（难辨梭状芽孢杆菌）为引起痢疾的细菌，并可引发结肠炎、其他严重的肠道疾病，甚至死亡。艰难梭菌（难辨梭状芽孢杆菌）会出现在感染者的粪便中，他人接触到沾染细菌或菌孢的物品后接触口部的也会引起感染。

通过对564名成年患者、两项临床试验对Dificid的安全性及有效性进行评估，艰难梭菌（难辨梭状芽孢杆菌）感染者分别使用Dificid或普通CDAD抗菌药万古霉素。使用选择的两组样本临床反应类似，并有CDAD复发患者。在治疗结束3周后Dificid组较万古霉素组有明显的持续治愈效果

FDA药品评价及研究中心，抗菌药办公室负责人EdwardCox博士表示：近年来，艰难梭菌（难辨梭状芽孢杆菌）感染的流行度有所升高，Dificid能有效治疗并为艰难梭菌（难辨梭状芽孢杆菌）相关性腹泻患者提供了新的选择。

Dificid为大环内酯抗菌药，每日两次，用药10天，佐餐使用或空腹均可。其常见不良反应有：恶心、呕吐、头疼、胃痛及痢疾等。易感染该病菌的人群有老年人、住院患者、疗养群居人员及服用抗生素治疗其他感染的患者等，预防CDAD的有效方法是用肥皂及热水洗手。

Manufacturer:
Optimer Pharmaceuticals

Pharmacological Class:
Macrolide antibiotic

Active Ingredient(s):
Fidaxomicin 200mg; tablets.

Indication(s):
For the treatment of Clostridium difficile-associated diarrhea.

Pharmacology:
Fidaxomicin is a fermentation product obtained from the Actinomycete Dactylosporangium aurantiacum. It is bactericidal against C. difficile in vitro, inhibiting RNA synthesis by RNA polymerases.

Clinical Trials:
In two randomized, double-blinded trials, a non-inferiority design was utilized to demonstrate the efficacy of fidaxomicin (200mg twice daily for 10 days) compared to vancomycin (125mg four times daily for 10 days) in adults with Clostridium difficile-associated diarrhea (CDAD). Enrolled patients received no more than 24 hours of pretreatment with vancomycin or metronidazole. CDAD was defined by >3 unformed bowel movements (or >200mL of unformed stool for subjects having rectal collection devices) in the 24 hours before randomization, and presence of either C. difficile toxin A or B in the stool within 48 hours of randomization. Enrolled patients had either no prior CDAD history or only one prior CDAD episode in the past three months. Subjects with life-threatening/fulminant infection, hypotension, septic shock, peritoneal signs, significant dehydration, or toxic megacolon were excluded.

The primary efficacy endpoint was the ­clinical response rate at the end of therapy, based upon improvement in diarrhea or other symptoms such that, in the investigator’s judgment, further CDAD treatment was not needed. An additional efficacy endpoint was sustained clinical response 25 days after the end of treatment. Sustained response was evaluated only for patients who were clinical successes at the end of treatment. Sustained response was defined as clinical response at the end of treatment, and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment.

The results for clinical response at the end of treatment in both trials indicate that fidaxomicin is noninferior to vancomycin (Trial 1: fidaxomicin 88% vs. vancomycin 86%; Trial 2: fidaxomicin 88% vs. vancomycin 87%). The results for sustained clinical response at the end of the follow-up period indicate that fidaxomicin is superior to vancomycin on this endpoint (Trial 1: fidaxomicin 70% vs vancomycin 57%; Trial 2: fidaxomicin 72% vs. vancomycin 57%). Since clinical success at the end of treatment and mortality rates were similar across treatment arms (approximately 6% in each group), differences in sustained clinical response were due to lower rates of proven or suspected CDAD during the follow-up period in fidaxomicin patients.

Restriction Endonuclease Analysis was used to identify C. difficile baseline isolates in the BI group, isolates associated with increasing rates and severity of CDAD in the U.S. in the years prior to the clinical trials. Similar rates of clinical response at the end of treatment and proven or suspected CDAD during the follow-up period were seen in fidaxomicin-treated and vancomycin-treated patients infected with a BI isolate. However, fidaxomicin did not demonstrate superiority in sustained clinical response when compared with vancomycin.

Legal Classification:
Rx

Adults:
≥18 years: 200mg twice daily for 10 days.

Children:
<18 years: not recommended.

Warnings/Precautions:
Not for treating systemic infections (minimal systemic absorption). Pregnancy (Cat. B). Nursing mothers.
Adverse Reaction(s):
Nausea, vomiting, abdominal pain, GI hemorrhage, anemia, neutropenia.

How Supplied:
Tabs—20, 60, 100 (10 x 10 blister cards)