SOLESTA 50-15MG/ML SYR 4/PAC (DEXTRANOMER/SODIUM HYALURONATE) 注射填充剂为大便失禁患者带来了一种重要的新选择，其可以作为保守疗法（如饮食控制）和更侵袭性干预疗法（如手术）之间的过渡治疗手段。 注射肛管填充剂获准用于治疗大便失禁 Oceana Therapeutics公司宣布，FDA已批准Solesta用于治疗对较保守的疗法（如纤维疗法）无效的成人大便失禁。Solesta是一种具有生物相容性的组织填充剂，由聚糖酐微球和稳定剂透明质酸钠构成。 Solesta是一种凝胶制剂，其注射部位是肛管近端黏膜下深层，可在门诊用药，无需麻醉。其确切的作用机制尚不明了，但据推测，使用Solesta可引起肛管缩窄，从而优化括约肌的控制功能。 支持FDA批准Solesta的主体临床证据是一项涉及206例患者的多中心、前瞻性、随机、安慰剂对照研究。该研究包括一个6个月的双盲期以及之后的一个开放性治疗期，在开放性治疗期，研究者对原先被随机分入安慰剂对照组的患者提供Solesta治疗与使用Solesta有关的最常见的不良反应包括注射区疼痛和出血。肛门组织感染和炎症的风险较大，但不常见。 适应证 Solesta用于治疗未能通过保守治疗(例如，饮食、纤维治疗、抗运动药物)的18岁及以上患者的大便失禁。 剂量和管理 石灰石注射在肛管高压区近端的深层粘膜下层，大约在齿线以上5毫米。每次治疗期间总共进行4次粘膜下注射1mL Solesta。 如何供应 Solesta是在一个玻璃注射器与标准卢尔锁配件包含1毫升凝胶。每个注射器最终都是湿热的消毒袋。四个袋子，每个袋子包含一个注射器，连同四个无菌Ject∈针(21Gx4英寸，0.80mm x 120 mm)、患者记录标签和包装插入物一起装在纸箱中。这些针是用伽玛射线消毒的。 保管部 贮存温度可达25℃（77°F），防止阳光照射和冰冻。 SOLESTA 50-15MG/ML SYR 4/PAC  DEXTRANOMER/SODIUM HYALURONATE  VALEANT PHARMACEUTICALS KENCO  NDC：89114-0850-03 Solesta(dextranomer microspheres and stabilized sodium hyaluronate, in phosphate-buffered sodium chloride solution) SOLESTA Rx Generic Name and Formulations: Dextranomer microspheres 50mg/mL, sodium hyaluronate 15mg/mL; gel for submucosal injection. Company: Bausch Health Companies 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. Pharmacological Class: Tissue bulking agent. Interactions: Concomitant anticoagulants, antiplatelets: increased risk of bleeding at injection site. Adverse Reactions: Anal hemorrhage, anorectal discomfort, chills, diarrhea, injection site hemorrhage, pain. How Supplied: Syringe (1mL)—4 (w. needles)