ST LOUIS (MD Consult) - On November 4, 2010, Eli Lilly and Company and the US Food and Drug Administration (FDA) announced that Cymbalta (duloxetine) has been approved for the management of chronic musculoskeletal pain in adults. This medication has been previously approved for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia.

Although the exact mechanism of action of Cymbalta in the reduction of chronic musculoskeletal pain is unknown, it is believed that use of the drug helps lessen pain by enhancing the body's natural pain-suppressing system by increasing the activity of serotonin and norepinephrine in the brain and spinal cord.

The FDA assessed the efficacy of Cymbalta in patients with chronic low back pain and osteoarthritis in 4 double-blind, placebo-controlled, randomized clinical trials. At the end of the study period, patients receiving Cymbalta experienced significantly greater pain reduction compared with patients who received placebo.

More than 29,000 patients have received Cymbalta in clinical trials, and more than 600 patients were studied in the clinical trials involving osteoarthritis and chronic low back pain. The safety evaluation for Cymbalta included review of data from the clinical trials as well as postmarketing data from the previously approved patient populations.

The most common adverse effects reported with the use of Cymbalta include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. Other serious untoward effects include liver damage, allergic reactions, pneumonia, depressed mood, suicide, and suicidal thoughts and behavior. Serious adverse effects occurred in <1% of treated patients.

The recommended dose for Cymbalta is one 60-mg capsule taken once daily without regard to meals. The capsule should be swallowed whole, and not chewed, crushed or opened; the contents should never be sprinkled on food or mixed with liquids.

Cymbalta should not be prescribed for patients who have recently taken monoamine oxidase inhibitors or who are taking Mellaril (thioridazine). In addition, patients with uncontrolled narrow-angle glaucoma should not take Cymbalta.

圣路易斯(MD Consult)——2010年11月4日，礼来公司与美国食品药品管理局(FDA)宣布，欣百达(度洛西汀)已获准用于治疗成人慢性骨骼肌疼痛。先前该药已获准用于治疗重度抑郁症、广泛性焦虑症、糖尿病性周围神经痛和纤维肌痛。

欣百达缓解慢性骨骼肌疼痛的确切作用机制尚不清楚，但其可通过增强脑和脊髓内5-羟色胺和去甲肾上腺素的活性来增强体内天然疼痛抑制系统的功能，进而帮助减轻疼痛。

FDA通过4项双盲、安慰剂对照的随机临床试验评估了欣百达对慢性腰背痛和骨关节炎患者的疗效。在研究结束时，欣百达治疗组患者的疼痛缓解程度显著大于安慰剂对照组。

在临床试验中有逾29,000例患者接受了欣百达治疗，在涉及骨关节炎或慢性腰背痛的临床试验中受试者达600例以上。欣百达的安全性评估包括对临床试验数据以及对先前获准用药的患者群的上市后数据进行审查。

使用欣百达最常见的不良反应包括恶心、口干、失眠、嗜睡、便秘、疲乏和头晕。其他的严重不良反应包括肝损害、过敏反应、肺炎、心情抑郁、自杀以及自杀的意念和行为。在接受欣百达治疗的患者中有不足1%的患者发生了严重的不良反应。

欣百达的推荐剂量为60mg的胶囊、每天1次，无需考虑进食情况。该胶囊应整粒吞服，不得咀嚼、粉碎或打开服用，亦不得将胶囊内容物撒在食物上或与液体混合后服用。

医生不应对近期服用过单胺氧化酶抑制剂或正在服用甲硫哒嗪的患者开处方应用欣百达。此外，窄角型青光眼控制不良的患者禁用欣百达。