部份中文TauroSept资料（仅供参考）
【中文品名】牛磺罗定
【药效类别】抗菌药>其它
【通用药名】TAUROLIDINE
【别 名】滔罗定, Drainasept, Tauroflex, Taurolin, Taurolin ringers
【化学名称】 2H-1,2,4-Thiadiazine, 4,4'-methylenebis[tetrahydro-, 1,1,1',1'-tetraoxide
【CA登记号】[19388-87-5]
【结 构 式】
【分 子 式】CHNOPS·
【分 子 量】
【收录药典】
【开发单位】Geistlich
【首次上市】1981年，瑞士
【性 状】
【用 途】用于腹膜炎（包括厌氧菌的扩散性、脓性腹膜炎）和胸膜腔积脓。
Taurolidine is a broad spectrum antibiotic that was derived from the aminosulfoacid Taurine. Shown to be effective against aerobic, anaerobic, gram-negative and gram-positive bacteria as well as fungi and mycobacterium. Found to exhibit antitumor activity with low toxicity, antiangiogenic effects, antiendotoxin activity, and to induce apoptosis of tumor cells; thereby decreasing proliferation of the tumor cells (both in vitro and in vivo). Has been used in studies of alternative chemotherapeutics, and is shown to work synergistically with rhTRAIL doubling the effects of Taurolidine alone. The synergistic response of Taurolidine and TRAIL may outline a new therapeutic strategy in oncology therapy.
Taurolidine 2% as an antimicrobial lock solution for prevention of recurrent catheter-related bloodstream infections[Read More…]
Clinical Trial With Catheter Locking TauroSept® (Taurolidine 2%) or Saline Solution 0,9%
TauroSept®
Ages Eligible for Study:18 years to 80 years
Genders Eligible for Study:Both
Industry
Geistlich Pharma AG
Other
Geert Wanten
Inclusion Criteria
- Benign underlying disease leading to long-term intestinal failure who will receive HPN and/or fluids (saline and/or glucose) at least 2 times /week over a subcutaneously tunnelled single-lumen Central Venous Catheter (CVC) (Hickman/Broviac or subcutaneous port) for at least one year
1. Patient receives a new single lumen central vascular access device for HPN (new patient starting HPN or patient already on HPN) allocation to Group I = new catheter group] or
2. Patient is already on HPN for ≥1 year prior to trial inclusion and has a CRBSI rate (bacterial and/or yeast infections) of >0.3/year and a catheter that has
been in place for ≥6 months (allocation to Group II = high risk group).
(Previous salvage of this catheter by line-lock antibiotics or other therapeutic interventions is not an exclusion criterion as long as this has been performed
at least two months before enrolment in the trial)
- Estimated life expectancy ≥1 year
- Male or female patient aged 18 - 80 years
- Patient is fully able to understand the nature of the proposed intervention and gives written informed consent before entering the trial.
Exclusion Criteria
- cannot be expected to comply with the trial plan (substance abuse, mental condition)
- has significant cardiovascular disease such as unstable angina, acute myocardial infarction or recent cerebral vascular accident (within 6 weeks); a cardiac rhythm which in the investigators judgment may result in significanthemodynamic effects
- has a known hypersensitivity/allergy to taurolidine 2% or saline solution 0.9% and/or their excipients.
- is pregnant, lactating, or nursing.
- has a current bloodstream infection
- has any clinically significant abnormalities in blood coagulation requiring intervention
- has received thrombolytic therapy in the 6 weeks prior to insertion (aspirin 80-325 mg daily is acceptable).
- has received an investigational drug within 30 days of trial entry
- has an antibiotic coated, silver impregnated or antimicrobial cuff catheter
- has received a Taurolidine lock previously
- has compromised skin integrity, including any infection at the insertion site
- has received parenteral or oral antibiotic therapy
Detailed Description
The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient than saline solution 0.9% as a catheter lock solution in preventing catheter related blood stream infections in patients with home parenteral nutrition.