英文药名: Qutenza(Capsaicin Patch)

中文药名: 辣椒素透皮贴剂

药品介绍

美国食品药品管理局（FDA）近日已批准德国Lohmann Therapie-Systems公司的Qutenza（辣椒碱）8%贴剂上市。这种外用皮肤贴剂可用于缓解疱疹后神经痛（PHN）—一种带状疱疹发病后的常见严重并发症。

带状疱疹会使患者皮肤上出现大量红疹或水疱。与水痘相同，带状疱疹也是由水痘-带状疱疹病毒引起的。这种病毒可能会在初次感染的数年后再次活化，因此曾患水痘的人群更易出现带状疱疹症状。PHN会对神经纤维和皮肤产生影响，从而引起长达数周、数月甚至数年的剧烈疼痛。大约10%～15%的带状疱疹患者都曾遭受过PHN，这种并发症在老年患者中尤为常见。

临床研究已显示，疼痛部位贴上Qutenza仅1h后PHN疼痛即可减少，效力能持续达12周。可以使用达4贴，并可根据疼痛区域的大小和形状对贴片进行相应的剪切。Qutenza贴剂治疗可以每3个月或3个月以上重复一次，这视疼痛的复发时间而定。

在临床试验中，Qutenza最常见的不良反应为用药部位发红、疼痛、发痒以及丘疹。其中大多数不良反应呈暂时性和自限性。在接受

Qutenza治疗的患者中，有1%因不良反应而提前终止治疗。严重的不良反应包括用药部位疼痛和血压升高。血压升高发生于应用Qutenza过程中或接触此贴剂后不久。某些患者的血压出现较大幅度的上升，但平均变化值为60;10 mmHg。在去除贴剂后血压变化持续约2 h。

Qutenza中含有辣椒碱（一种存在于辣椒中的成分）。虽然目前市场上已有含低浓度辣椒碱的OTC产品用于治疗PHN，但Qutenza是首个经FDA批准的，含有高浓度合成纯辣椒碱的处方药。

Neurogesx公司拟于2010年上半年将Qutenza推向美国市场。

NeurogesX先前曾与Astellas Pharma Europe Ltd.签订配销, 行销与授权协议，有关NeurogesX的Qutenza贴片，这是在皮肤上的贴片，里面含有强度辣椒素(Capsaicin)。

NeurogesX的Qutenza是一种vanilloid VR1受体拮抗剂辣椒素的透皮制剂，该药去年在美国和欧盟获得不同适应症的批文。欧洲该产品在5月获批，用于非糖尿病患者外周神经痛的治疗，可单独或与其他止痛药物合用。在美国该药被批准用于神经痛联合疱疹神经痛的疼痛管理。Qutenza作用于发生疼痛的皮肤区域的确定神经。这种透皮制剂可以提供长达12周的缓解疼痛功效。该药将于2010年在欧洲上市，由Astellas公司销售。在美国该药具有罕见病治疗药物的身份。尽管在几个国家已经有基于辣椒素的止痛产品，但这是第一个长效透皮制剂。

QUTENZA

Generic Name for QUTENZA

Capsaicin 8% (179mg); patch.

Legal Classification:

Rx

Pharmacological Class for QUTENZA

TRPV1 channel agonist.

Manufacturer of QUTENZA

NeurogesX, Inc.

Indications for QUTENZA

Management of neuropathic pain associated with post-herpetic neuralgia.

Adult dose for QUTENZA

Identify treatment area and mark the skin; may cut patches to match size and shape of area. Pretreat with topical anesthetic to reduce discomfort, once anesthetized, remove anesthetic and wash the treatment area. Apply to dry, intact skin within 2 hours of opening patch. Apply patch (up to 4 may be used) for 60 minutes, repeat every 3 months or as warranted by the return of pain (not more frequently than every 3 months). May use a dressing to ensure patch remains in contact with treatment area. After removal of patch, apply Cleansing Gel to area and leave on for at least one minute. Remove Cleansing Gel with dry wipe; wash and dry the area. Treat acute pain during and following the procedure with local cooling and/or analgesics. Use nitrile gloves when handling patch and cleaning capsaicin residue from skin. Immediately dispose of patches.

Children's dosing for QUTENZA

<18yrs: not recommended.

Warnings/Precautions for QUTENZA

Should only be administered by a physician or healthcare professional. Aerosolization of capsaicin may occur with rapid removal of patches, remove patches slowly by rolling the adhesive side inward. Avoid exposure to eyes, mucous membranes. Evaluate for recent history of cardio- and cerebrovascular disease. Monitor BP periodically during treatment. Pregnancy (Cat.B). Nursing mothers; do not breastfeed after treatment on the day of treatment.

Adverse Reactions for QUTENZA

Application site reactions (eg, erythema, pain, pruritus, papules); increased blood pressure.

How is QUTENZA supplied?

Patch—1, 2 (both with 50g tube of Cleansing Gel)

Related Disease:

Postherpetic neuralgia~topical analgesics/anesthetics

包装规格：8%  1贴剂(Astellas Pharma生产)