美国食品和药物管理局（FDA）近日批准无菌注射用凝胶Solesta用于治疗对其他治疗（如饮食改变，纤维素治疗或抗运动药物）失败的大便失禁患者。
大便失禁是一种非随意的肠道控制缺失。引起大便失禁原因有多种，包括神经损伤、与年龄有关的肛门括约肌松弛或直肠肌损伤。据美国国立卫生院称，美国有超过550万人患有大便失禁。
Solesta凝胶注射入肛门内皮下的组织层，这可有助于构建该区域的组织。通过周围组织的生长，肛门口变窄，患者可更好地控制这些肌肉。
FDA器械和辐射健康中心器械评价办公室主任ChristyForeman称，大便失禁的治疗比较困难，该药物的批准为保守治疗无效的大便失禁患者提供了微创治疗的选择。
此次获FDA批准是依据一项纳入206名患者的临床试验。在主要研究中，大部分患者接受了两次治疗，每次包括4次注射，总计8次注射。六个月后，半数以上接受Solesta注射的患者大便失禁发生次数降低了50%。然而，1/3未接受Solesta治疗的患者也有类似的降低。总的来说，接受Solesta治疗的患者得到改善的比例较大，这表明该凝胶对治疗大便失禁有益。
Solesta获批用于18岁以上的患者。禁用于以下情况：活动性肠道炎症、免疫缺陷性疾病、盆腔经放射治疗、显著的直肠脱垂、活动性感染、出血、直肠肛门部肿瘤或畸形、直肠静脉扩张、直肠肛门现有移植物或对含透明质酸产品过敏。
Solesta最常出现的副作用包括注射区疼痛和出血。肛门组织区感染及炎症是较严重的风险，但却不常见。Solesta由新泽西州爱迪生市的OceanaTherapeuticsInc.制造
Generic Name and Formulations:
Dextranomer microspheres 50mg/mL, sodium hyaluronate 15mg/mL; gel for submucosal injection.

Company:
Salix Pharmaceuticals, Inc
Indications for SOLESTA:
Treatment of fecal incontinence in patients who have failed conservative therapy (eg, diet, fiber therapy, antimotility drugs).

Adult:
See literature. Bowel preparation of rectum using enema required prior to injection. Prophylactic antibiotics are recommended. Inject slowly in deep submucosal layer in the proximal part of the high pressure zone of the anal canal about 5mm above the dentate line. Four 1mL injections are to be given in the ­following order: posterior, left lateral, anterior, right lateral. Keep needle in place for 15–30 seconds to minimize leakage. A new needle should be used for each syringe and injection site. Post-treatment: Avoid hot baths and physical activity during first 24 hours, antidiarrheal drugs, sexual intercourse, strenuous physical activity for 1 week, anal manipulation for 1 month. Retreatment: If needed, may repeat with max 4mL no sooner than 4 weeks after first injection. Point of injection should be made in between initial injections, shifted 1/8 of a turn.

Children:
<18yrs: not recommended.

Contraindications:
Active inflammatory bowel disease. Immunodeficiency disorders or ongoing immunosuppressive therapy. Previous radiation treatment to the pelvic area. Significant mucosal or full thickness rectal prolapse. Active anorectal conditions (eg, abscess, fissures, sepsis, bleeding, proctitis, other infections). Anorectal atresia, tumors, stenosis or malformation. Rectocele. Rectal varices. Presence of existing implant in anorectal region.

Warnings/Precautions:
Should only be used by physicians experienced in anorectal procedures who have successfully completed training and a certification program in Solesta injection procedure. Do not inject intravascularly; may cause vascular occlusion. Avoid injecting in midline of anterior wall of rectum in men with enlarged prostate. Complete external sphincter disruption. Significant chronic anorectal pain. Previous anorectal procedures. Bleeding diathesis. Pregnancy. Nursing mothers.

Interactions:
Concomitant anticoagulants, antiplatelets: increased risk of bleeding at injection site.

Pharmacological Class:
Tissue bulking agent.

Adverse Reactions:
Anal hemorrhage, anorectal discomfort, chills, diarrhea, injection site hemorrhage, pain.

How Supplied:
Syringe (1mL)—4 (w. needles)