Meyer G, Besse B, Friard S, Girard P, Corbi P, Azarian R, Monnet I, Alifano M, Chouaid C, Descourt R, Dennewald G, Taillade L, De Luca K, Giraud F, Pichon E, Chatellier G
Hôpital Européen Georges-Pompidou, 75908 Paris, France.
Rev Mal Respir. 2011 May;28(5):654-9. doi: 10.1016/j.rmr.2011.03.015. Epub 2011 Apr 29.
Experimental and clinical findings suggest that low molecular-weight heparins may improve overall survival in patients with cancer. The evidence is still limited and additional studies are needed to confirm these preliminary findings.
Patients with completely resected stage I, II or IIIA (T3N1) histologically confirmed non-small-cell lung cancer will be included in a prospective, controlled, randomized, multicenter open trial. Patients in the control group will receive usual postoperative care including chemotherapy when indicated. Patients in the experimental group will receive tinzaparin given subcutaneously as a daily 100 IU/kg dose for 90 days along with usual postoperative care. Patients will be followed-up for three to eight years. Main end-point is the overall survival. Five hundred and fifty patients are needed to demonstrate a 10% absolute increase in survival in the experimental group.
A 10% absolute increase in the survival rate is expected in the patients receiving tinzaparin.
实验和临床研究结果表明，低分子量肝素可能会提高癌症患者的总生存率。证据仍然有限，需要更多研究来证实这些初步发现。
组织学确诊为I期、II期或IIIA期（T3N1）且已完全切除的非小细胞肺癌患者将被纳入一项前瞻性、对照、随机、多中心开放试验。对照组患者将接受常规术后护理，必要时包括化疗。试验组患者将在接受常规术后护理的同时，皮下注射替扎肝素，每日剂量为100 IU/kg，持续90天。患者将接受三至八年的随访。主要终点是总生存率。需要550名患者才能证明试验组生存率绝对提高10%。
预计接受替扎肝素治疗的患者生存率将绝对提高10%。
