2010年6月22日，基因泰克宣布，美国食品药品管理局(FDA)已批准Lucentis(兰尼单抗)用于治疗可继发于视网膜静脉阻塞(RVO)的黄斑水肿。Lucentis是一种血管内皮生长因子(VEGF)抑制剂，于2006年首次获准用于治疗新生血管性老年黄斑变性。

Lucentis新适应症 获准治疗黄斑水肿

这一适应症获准的重要依据是两项临床试验数据：其中一项名为BRAVO，受试者人数397人；另外一项名为CRUISE，受试人数392人。在CRUISE试验中，Lucentis受试组达到上述效果的人数比例达到48%，而对照组仅为17%。

在美国，深受RVO困扰的人超过100万，是由于视网膜血管病而导致视力丧失的第二大原因，RVO有可能长期发展而成，也有可能突然发病。当视网膜血管血流阻塞时，可导致水肿及出血。

此类患者尽管经过长时间的发展最终才会导致视力丧失，但突发性的视力模糊和视力丧失普遍存在。这种眼疾好发于50岁以上人群，老龄化、高血压、糖尿病和动脉硬化症则是其中的危险因素。

Lucentis可结合并抑制VEGF-A，VEGF-A被认为是一种在血管新生过程及血管高渗性中起关键作用的蛋白。在RVO中，血管新生和高渗性可导致黄斑水肿，而黄斑是形成精细的中央视力的部位。据基因泰克公司全球发展执行副主席兼首席医学官Hal Barron博士称，“在有关Lucentis 的RVO临床试验中，接受每月1次Lucentis治疗者中6个月研究期内视力获得持续改善的患者例数明显增加，早在7天即可显效。”
 
Lucentis 经眼内注射用药。Lucentis治疗一直与视网膜剥脱及严重眼部感染有关，不宜用于眼内或眼周存在感染的患者。注射后1 h内可观察到眼压增加。眼部和非眼部相关的动脉血栓事件尽管不多见，但也可能会发生。严重不良反应包括眼内炎症，在极少数情况下，还可发生与注射过程相关的不良反应(如白内障)。

与使用Lucentis有关的最常见的非眼部不良反应包括鼻咽部感染、头痛以及呼吸道和泌尿道感染。最常见的眼部不良反应为眼部异物感 和泪液分泌过多。应指导患者在使用Lucentis治疗后出现发红、光敏感、视力改变或眼部疼痛时立即前去眼科就诊。

LUCENTIS

Lucentis Information

The generic (professional) medical term for Lucentis is Ranibizumab; this product is known to belong to the class of antivascular endothelial growth factors. It is important for you to seek detailed information about the ingredients of Lucentis; your pharmacist should be able to provide you with such information.

Lucentis Indications

This medical remedy is widely employed in the therapy course of age-related macular degeneration (a medical disorder in which the blood vessels that are found behind the patient's retina leak fluid and / or blood). The presence of this medical condition leads to the development of macular damage, which leads to vision loss. The use of Lucentis is able to slow down the degenerative processes as it stops the growth of the damaged blood vessels and diminishes the leakage of new blood vessels in the patient's eye. If you think that you may benefit from the use of Lucentis you should discuss with your personal ophthalmologist the possibility to start a treatment course with Lucentis.

Lucentis Warnings

Although this medical product is widely prescribed to patients from all over the world, not everyone is allowed to start using this medication. Several clinical precautions have been associated with the use of Lucentis; for example, patients who are suffering from an allergy to any of the ingredients of this product must not be permitted to start using this eye clinical remedy. Furthermore, individuals who have an infectious condition that affects the eye or any surrounding region or patients who present redness and / or pain inside the eye should be prescribed an alternative therapy for their condition, as the use of Lucentis would be more than risky in their case.

Studies have shown that pregnant females and nursing mothers should employ extra precautions during their treatment trial with this eye medication. Such patients should refer to their personal gynecologist and discuss with him or her the risks and benefits that may be associated with a treatment trial with Lucentis. No studies have been performed concerning the safety of use of this eye remedy in the case of adolescents or children. Consult with a well trained pediatrician in order to gain the needed information concerning this matter.

Lucentis Intake Guidelines

This medical remedy is generally administered through an injection into the patient's eye. This procedure should be performed by a professional medical ophthalmologist after the individual is applied a local anesthetic. During your therapy course with Lucentis you may have to employ a special antibiotic, preferably in the form of eye-drops. This clinical remedy must be kept at a low temperature, in the refrigerator. However, it is forbidden to allow Lucentis to freeze. The product's professional leaflet should also include certain information that is linked to this aspect of your therapy with this eye medication. Read it with great care and then refer to your medical prescriber if you have any further questions.

Lucentis Dosage

Most patients are administered 0.5 mg of Lucentis as a dose of this medication. They require a single dose of this product per month. If it is not possible to administer the patient a monthly dose of this product, the individual's physician generally prescribes the patient a therapy course that involves the administration of a larger dose of Lucentis every 3 months. Only your medical provider is allowed to make changes to your current dosing routine with this eye product.

Lucentis Overdose

As this clinical remedy is generally administered by an eye doctor, over-dosage with this medication is highly unlikely to occur. For this reason, we have no information concerning the main medical symptoms that may arise in case of over-exposure to Lucentis. If you are interested in acquiring details concerning this matter you should refer to your main medical prescriber.

Lucentis Missed Dose

It is very important to be administered all of your prescribed doses of Lucentis at their due time. In case you are unable to go to one of your appointments with your PD you should contact him or her as soon as possible and reschedule.

Lucentis Side Effects

Numerous clinical remedies are responsible for the development of adverse manifestations. These symptoms can be severe or mild, and they can disappear in time or be of a permanent nature. If you have any concerns about the side effects that you experience or that you may experience during your therapy course with Lucentis you should refer to your prescribing professional. During your treatment trial with this eye clinical remedy you may develop one or more of the following adverse symptoms: diarrhea, back pain, eye discharge, eye dryness, headache, flu-like symptoms, increased production of tears, increased blood pressure, vision changes, blurred vision (in most cases, this symptom is only temporary), and so on. Only your main medical prescriber can help you manage the unpleasant side effects of Lucentis in a safe and effective way. Contact him or her whenever you experience a symptom that becomes excessively bothersome.

Lucentis Drug Reactions

Like most other medical products, the patient's therapy course with Lucentis can be affected by the use of other medical products, especially with that of other eye remedies. The best way in which you can avoid becoming affected by such a pharmaceutical interaction (and avoid the unpleasant consequences that may arise from such a condition) is to discuss with your PD before starting any new therapy course.

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