Sirturo(Bedaquiline)双芳基喹啉类抗结核药——是第一种治疗耐多药结核病的药物.
  2012年12月28日，美国食品与药物管理局（FDA）通过加速审批程序批准了强生公司旗下的bedaquiline(商品名为Sirturo 双芳基喹啉类抗结核药）上市，该药为片剂,用于成人耐多药结核病(MDR-TB)的联合治疗,以及使用其他治疗方法无效的患者。Bedaquiline是第一种治疗耐多药结核病的药物。
   Sirturo是自1970年引进利福平以来首个新型抗结核药物。与正常批准过程相比，加速批准属于一种暂行批准，其需要的临床数据较少，强生公司后期提供额外的数据证实它的疗效和安全性。
  据美国疾病控制与预防中心报导，2011年全球有近900万人患结核，其中美国有10528人。耐多药结核病是至少对异烟肼和利福平耐药的结核。Sirturo是首个获准治疗多重耐药TB的药物，且应与其他药物联合治疗TB。该药通过一种新的作用机制——抑制人体内结核杆菌复制和播散所需的酶而发挥作用。
   FDA药物评估与研究中心的爱德华·考克斯博士说：“耐多药结核病对全球健康构成了严重的威胁，对那些没有其它治疗选择的病人来说，Sirturo是一个不错的选择。然而，因为这种药物也有一些重大风险，医生应该确保合理使用它，并且是在病人没有其他治疗选择的时候。”
   Sirturo的说明书和标签中带有加框警示语，他可影响患者的心电活动（QT间期延长），可能会导致心脏节律异常和并可能致命。试验中接受安慰剂治疗的患者中有2例死亡，接受Sirturo治疗的患者中有9例死亡。接受Sirturo治疗的5例死亡患者和接受安慰剂治疗的2例死亡患者似乎与结核相关，但其余4例接受Sirturo治疗的患者死亡原因与上述原因不一致。强生公司将帮助确保该药的正确使用。
   两项2期临床试验
   FDA审批了Sirturo的两项2期临床试验，确定了其安全性和有效性，两项研究共纳入440例患者。
   第一项试验的患者被随机分为接受其他抗结核药物加Sirturo治疗组，或其他抗结核药物加安慰剂治疗组。正在进行的第二项试验中的患者均接受其他抗结核药物加Sirturo治疗。两项试验中均评估患者痰培养结核菌转阴时间长度（SCC）。
   第一项试验显示，Sirturo联合治疗组实现SCC的中位时间为83天，而安慰剂联合治疗组为125天。第二项试验显示，SCC的中位时间为57天，支持了第一项试验的结果。
   临床试验中出现的最常见不良反应包括恶心，关节疼痛和头痛。
   Sirturo推存刘量为：与食物400mg每天1次共2周接着200mg每周3次共22周。与水整吞服SIRTURO片

Sirturo(Bedaquiline Tablets)
SIRTURO Rx
Generic Name and Formulations:
Bedaquiline 100mg; tabs.
Company:
Janssen Therapeutics
Select therapeutic use: Tuberculosis
Indications for SIRTURO:
As part of combination therapy in pulmonary multi-drug resistant tuberculosis (MDR-TB) only when an effective treatment regimen cannot otherwise be provided.
Limitations Of use:
Safety and efficacy for treatment of latent infection, drug-sensitive or extra-pulmonary tuberculosis (eg, CNS), non-tuberculous mycobacterial infections, or use in HIV-infected patients have not been established.
Adult:
Administer by directly observed therapy and in combination with ≥3 other drugs to which the isolate is susceptible. Swallow whole with water. Take with food. ≥18yrs: 400mg once daily for 2 weeks followed by 200mg three times weekly (≥48hrs between doses) for 22 weeks.
Children:
<18yrs: not established.
Warnings/Precautions:
Increased risk of mortality. Increased risk of QT prolongation in patients with history of Torsade de Pointes, congenital long QT syndrome, hypothyroidism, bradyarrhythmias, uncompensated heart failure, electrolyte abnormalities; monitor closely. Obtain ECG prior to therapy, and at least 2, 12, and 24 weeks after starting. Correct any electrolyte abnormalities at baseline and monitor if QT prolongation is detected. Discontinue Sirturo and all other QT prolonging drugs if ventricular arrhythmia or QTcF interval >500ms develops. Monitor ALT/AST, phosphatase, bilirubin at baseline, monthly during treatment, and as needed. Test for viral hepatitis and discontinue other hepatotoxic drugs if serum aminotransferases >3XULN (repeat testing within 48hrs). Discontinue if aminotransferase elevation with total bilirubin >2XULN, aminotransferase elevation >8XULN, or >5XULN that persists >2 weeks. Severe hepatic or severe renal impairment/ESRD. Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions:
Avoid concomitant use with strong CYP3A4 inducers (eg, rifampin, rifapentine, rifabutin). Avoid concomitant use with strong CYP3A4 inhibitors (eg, ketoconazole) for >14 days; monitor. Avoid concomitant moderate CYP3A inducers (eg, efavirenz). Additive QT prolongation with other drugs that prolong the QT interval (eg, fluoroquinolones, macrolides, clofazimine). Avoid alcohol and other hepatotoxic drugs. Sirturo exposure increased with Kaletra (caution).
Pharmacological Class:
Diarylquinoline.
Adverse Reactions:
Nausea, arthralgia, headache, hemoptysis, chest pain, anorexia, increased transaminases; arrhythmias, syncope (obtain ECG), hepatic dysfunction.
How Supplied:
Tabs—188
1）：http://www.sirturo.com/
2）：https://www.medicines.org.uk/emc/medicine/29644
3）：https://www.medicines.org.uk/emc/product/3560/smpc