临床定位是药品在拟定目标适应证中预期的治疗作用,临床定位准确是新药研发成功和上市后临床合理用药的关键.在中药新药临床定位时,需要从研究药物、目标疾病、已有治疗措施和审评要求等维度评估合理性.临床定位的方法与依据包括人用经验、中医药理论、基础研究和临床试验等.以临床价值为导向,选定合理的临床定位,才能真正体现中药的疗效,提高中药新药的研发质量和成功率.

目的 探讨中药临床研究联合用药安全性评价方法,以满足临床安全、有效用药的需求.方法 从中药临床研究入手,分析中药临床研究联合用药安全性存在的问题,并对其关键问题提出适当的建议.结果 中药联合用药安全性评价体系需要建设和完善.结论 中药联合用药的安全性评价需要从研发早期开始,贯穿临床试验至上市后评价的药品全生命周期;重视研究设计和风险-获益评估,搭建研究设计-监测评价-分析预测-风险管理的动态研究模式,建立多学科的综合评估体系.

中药新药研发与临床研究是对科学性与操作性具有较高要求,受到政策法规、疾病研究进展、科学技术创新与发展深度影响的领域,需要“政产学研用”的系统协作.合同研究组织作为药物研究生态链中的一环,在新药研发,特别是临床研究中发挥着重要作用.本文从致力于中医药临床研究的合同研究组织近20年的实践经验出发,对取得成功的经验与案例及遇到的挑战与困难进行讨论,以期能够抛砖引玉,有益于促进中药新药研发与临床研究的健康发展.

目的 探讨尪痹片联合甲氨蝶呤片治疗类风湿关节炎(RA)患者的有效性和经济学.方法 选择病情处于活动期的RA患者360例,随机分为试验组与对照组,每组180例.试验组选用尪痹片联合甲氨蝶呤片,对照组选用甲氨蝶呤片,进行有效性评价,运用药物经济学的成本-效果分析方法对各组进行评价及敏感性分析.结果 试验组较对照组的疾病活动度降低,疾病控制更好,差异有统计学意义(P<0.05).试验组成本为947.54元,对照组成本为142.87元,对照组的各项药品C/E和总成本C/E低于试验组.每增加一个疗效单位,试验组疗效-成本最高的指标是疾病活动度评价(DAS28评分),每提高1分消耗2299.06元,疗效-成本最低的指标为ACR20,每提高1％消耗63.56元.敏感性分析结果与基础分析一致.结论 尪痹片联合甲氨蝶呤片治疗RA可以提高临床疗效,虽然需要增加成本,但是增量成本-效果分析结果表明,增加疗效产生的费用具有成本-效果优势.

Objective:To investigate the safety and effectiveness of Ditong liquid nasal spray in the treat-ment of symptoms of cold and stuffy noses (acute rhinitis). Methods:In a randomized, blinded, parallel con-trolled, multi-center safety/efficacy study, 88 patients with symptoms of cold and stuffy noses were enrolled. The patients were treated by either Ditong liquid nasal spray, 1～2 squirts in each nostril, 3～4 times daily for 5 days (n=66), or rhinitis drop (spray) 1～2 squirts in each nostril, 3～4 times daily for 5 days (control, n=22). Primary outcome measures were based on cold and stuffy noses clinical efficacy criterion; nasal symptoms, total change in symptoms and remission/duration time of stuff noses were observed. Secondary outcome measures were general physical examination, safety assessment (adverse events) and clinical measurements. Results:Of the 88 patients, the full recovery rate, partial recovery rate, effective rate and ineffective rate were 24.24%, 31.82%, 37.88% and 6.06% in Ditong group, and 4.55%, 36.36%, 36.36% and 22.73% in control group, respective-ly. The overall effectiveness of Ditong was significantly better than control (P<0.05). However, the difference in remission time of stuff nose between two groups was not significant as analyzed by rank sum test but was significant by t test (P<0.05). There was no significant difference in temperature,respiration, heart rate, systolic pressure, diastolic pressure between before and after treatment. No obvious adverse effects were found in both groups. Con-clusion:Ditong nasal spray is effective and safe in the treatment of cold and stuff nose (acute rhinitis).