临床试验团队应对方案执行中的每一细节力求按计划 偏离及违反方案的 进行,如发生方案偏倚或违背时,要及时发现并积极处理, 情况及发生率尽管 尽可能令方案始终按预定的基线进行。另外,试验进行中首 不可避免,但是要 先考虑的是患者的安全性,一切以患者为中心。 尽一切努力,并采 取积极措施,减少 会议连线 其发生,因为严重 的违反方案会直接影响试验数据的质量, P28 进而影响试验的结果,甚至左右该新药能 健康中国,掀起 “心”革命 否通过政府药政主管机构的核决。 ——第21届长城国际心脏病学会议报道 心血管疾病已成为全世界的“头号杀手”,并仍 时评 持续增长,其中大约有一半的病例发生在亚太 P12 地区。而且与西方国家相比,亚洲地区的心血管疾病患者更趋年轻化。因此,对心血管的 减肥药开发成“烫手山芋” 防治战线必须前移。 对待如此庞大的减肥药市场,为何许多 心血管专版 企业望而却步?是新药开发的难度大? P32 是药物审批过于严格?还是上市后因药 物副作用而导致的官司及巨额损失?这RAS,联合控制心肾损害的靶标 个问题值得玩味! 心脏和肾脏各自独立,却又紧密相联。多种危 险因素可同时作用于心肾,造成两者联合损 害。肾素-血管紧张素系统(RAS)是两器官联 系的“纽带”,其激活是心血管疾病发生发展 的关键。因此,抑制RAS,是心血管疾病防治 的“重头戏”。 P38 ACEI,阻断RAS系统的领跑者 自第一个肾素血管紧张素转化酶抑制剂(ACEI)问世以来,ACEI便以卓越的疗效活跃于 P26 降压药物的舞台,拥有大量的循证医学证据,其适应证也在不断扩展。即便在RAS系统抑 对超说明书用药 制剂的其他成员的挑战下,其光环依旧,王者地位尚不可动摇。 多种意义上的完善思考 JCPD·CSCO临床肿瘤专版 缺乏医院批准和行政许可的临床试验和 P50 实验性临床医疗程序而所采取的“超说 氨磷汀在血液系统疾病中的应用 明书用药”,本身既不科学,也不合 细胞保护剂已成为抗肿瘤药物研究与开发领域的“新星”,氨磷汀就是其中的一名佼佼 法。“科学性”、“社会性”、“为患 者,在抗肿瘤、逆转耐药和保护正常细胞方面具有潜在的应用价值,目前已被广泛用于 者好”必须建立在符合法律程序之上才 临床多种血液系统疾病。 具有正当性。 Journal of China Prescription Drug 2010.10 No.103 5 英文摘要英文摘要 SummarySummary Journal of China Prescription Drug 2010.10 VOL.103 Column kidney simultaneously, causing combined damage H o w t o C o n d u c t C l i n i c a l Tr i a l s i n to heart and kidney. The renin-angiotensin system Special Report China? (II) (RAS) is a hormone system that regulates blood Off-label Drug Use, Pros and Cons pressure and ﬂ uid balance, and the activation of The implementation of clinical trial protocol is from the View of Regulation and RAS is the key of pathogenesis and development particularly important, which is related to whether Science? of cardiovascular disease. Therefore, inhibition of the whole clinical trial can succeed or not. Clinical Off-label use is the practice of prescribing trial team should ensure that any detail in the RAS is the key to the prevention and treatment of pharmaceuticals for an unapproved protocol should be implemented according to the cardiovascular disease. indication; off-label use may include plan, if any bias or violation to the original portal ACEI, the Primary Blocker of RAS irrational use and evidence-based occurs, the protocol should be implemented treatments required by the patients’ Since the marketing of the first angiotensin- according to the planned baseline as strict as conditions. The former one is due to the converting enzyme inhibitor (ACEI), ACEIs have possible. In addition, safety of the participating irresponsibility of physicians, and the latter been used primarily in treatment of hypertension patients should be the priority to be considered one is needed by the patients’ conditions. and congestive heart failure with the excellent in clinical trial, and patients should be focused as Although the latter condition may be the center. efficacies that are supported by lots of clinical supported by clinical evidence, off-label evidences, and the indications have been use implicates that both the physicians Insight expanded. Even challenged by other RAS and patients will face more extra risks. inhibitors, the efficacies of ACIEs remain to be Development of Diet Pills Becomes a The phenomenon of off-label will continue Hot Potato excellent, and the preferred position cannot be to exist, how to regulate and avoid the shaken. possible risk should be considered the most Faced with the huge market of diet pills, why importantly. some many pharmaceutical manufacturers stay away? Is it due to difﬁ culty in drug development, JCPD•CSCO Clinical H o w t o R e g u l a t e O f f - l a b e l strict drug approval, or lawsuit and huge losses Oncology D r u g U s e , a M u l t i - p e r s p e c t i v e due to post-marketing adverse effects? The Amifostine in the Treatment of Blood Exploration paradox is worth pondering! System Diseases Without hospital approval and administrative licensing, any off-label use in the name Conferences Cell protective agents have become a new star of clinical trial and experimental clinical in R&D of antineoplastic agents, and amifostine Healthy Hear t Revolution in Healthy procedure is neither rational nor legal. Only China is one of the leaders with potential antineoplastic, rationality, sociality, and benefits to the tolerance-reversing, and normal cell protecting —Report from the 21st Great Wall International patients that comply with legal proceedings values, which has been widely used in a variety of Congress of Cardiology (GW-ICC) are legitimate. blood system diseases in clinical practices. Cardiovascular disease has become the world's No. 1 killer, and still growing, with about half of Fan Dachao the cases occurred in the Asia Paciﬁ c region. And Analysis of Bias or Violation in compared with the western countries, the patients Clinical Trials with cardiovascular diseases in Asia tend to be younger. Therefore, the front for the prevention Although bias and violation to the clinical trial and treatment of cardiovascular diseases in Asia protocol cannot be avoided, any effort should be should be moved forward. exerted and positive measures should be taken to reduce its occurrence, because serious violation Cardiovascular Disease of the clinical trial protocol can directly affect the RAS:the Target for Combined Control data quality of clinical trial, thereby affecting the trial of Heart and Kidney Impairment result, and even can inﬂ uence the veriﬁ cation and approval of a new drug by the regulators. Heart and kidney are independent, but closely linked. Multiple rick factors may act on heart and (Editor Yao Lixin) 2010.10 No.103 72 中国处方药