新药介绍
Introduction of New Medicine
最近，一个治疗纤维性肌痛的新药Savella在美国上市。美国FDA在今年年初批准了这个药物可用于临床治疗纤维性肌痛。其疗效已被3期临床试验所证实。2084例患者参加了这个试验，其中1460例患者服用Savella，624例服用安慰剂。Savella组每天服用100mg或200mg，显著降低疼痛，缓解30%以上，增强身体功能状态以及病人的自我满意度。
Savella的详细作用机制还不十分清楚。但它能抑制5-羟色胺或去甲肾上腺素的再摄取，对去甲肾上腺素更具选择性，从而缓解疼痛。
服用Sevella要从小剂量开始，缓慢加量，停药亦要缓慢。
具体用法是：第一天每天一次，每次12.5毫克，第二，三天每天二次，每次12.5毫克；然后第四到第八天每天二次，每次25毫克；如果病人能耐受，再加量到50毫克Bid；最大用量200毫克/天。
肝功能不良者要酌情减量。
常见的副作用包括：恶心，呕吐，头痛，便秘，心慌，失眠，血压增高等。
毒性作用包括：加重抑郁症，自杀倾向，过敏反应，5-羟色胺综合症，高血压，心律失常，肝肾毒性等。
A new medicine for fibromyalgia, Savella, was launched recently in the U.S. market. The U.S. Food and Drug Administration approved earlier this year the marketing of this agent indicated for the treatment of fibromyalgia. The clinical efficacy was confirmed by phase 3 trials. In the reported test of 2084 cases, 1460 cases took Savella, and 624 took placebo. When given daily dosage from 100mg to 200mg, Savella can provide significant reduction of pain in more than 30% cases, at the same time improved physical functioning and self-reported satisfaction.
Slow titration at the beginning and gradual tapering during termination are suggested when dosing Savella. Typical titration schedule is as the following:
Day 1: 12.5 mg QD
Day 2-3: 12.5 mg BID
Day 4-8: 25 mg BID
If tolerated, the dosage may be increased to 50 mg BID, up to the maximum daily dose of 200 mg.
Dose should be reduced for patients with impaired liver function.
Frequently seen adverse effects include: nausea, vomiting, headache, constipation, palpitation, insomnia, blood pressure elevation, etc.
Severe adverse effects include: worsening of depression, suicidality, allergic reaction, serotonin syndrome, hypertension, cardiac arrhythmia, and hepatorenal toxicity.
