巴戟天寡糖胶囊在中国健康志愿者中的耐受性研究

Tolerance of Bajitian oligosaccharide capsule in Chinese healthy volunteers

目的：观察健康志愿者对巴戟天寡糖胶囊的耐受性，为Ⅱ期临床研究提供安全有效的给药剂量及方案.方法：根据改良Black well法，起始剂量为50mg。共入选健康受试者42例，其中单剂量组的32例受试者分别接受了6个剂量组（50mg组2例、150mg组4例、300mg组6例、600mg组6例、800mg组8例和1000mg组6例）的单剂量巴戟天寡糖胶囊治疗；连续给药剂量组的10例受试者接受800mg·d^-1，qd，连续服药7d的巴戟天寡糖胶囊治疗。分别比较了单次给药和连续给药前后受试者的生命体征、心电图和实验室检查结果的变化，单次服药和连续服药后观察到的不良事件和受试者报告的不良反应。结果：42例受试者全部完成研究，且未出现具有临床意义异常的生命体征、心电图和实验室检查结果，主要的不良反应为口干、疲乏、困倦，与剂量相关，程度轻微。结论：本研究中的中国健康受试者对50～1000mg·d^-1的巴戟天寡糖胶囊具有良好的耐量性。

Objective： To assess the tolerance of Bajitian oligosaccharide capsule in Chinese healthy volunteers. Methods： On the basis of modified Black well method, the initial dose was 50 mg. Healthy volunteers （n = 42） were recruited. Of the volunteers, 32 volunteers were randomly divided into six groups （2, 4, 6, 6, 8 and 6 volunteers in each group in the turn of dose escalation） for the single dose tolerance test. The volunteers in each group received a single dose of Bajitian oligosaccharide capsule at 50, 150, 300, 600, 800 and 1 000 mg, respectively, once in the morning. The other 10 volunteers received a multiple dose of 800 mg once a day for 7 days consecutively. The electrocardiograph, vital signs and laboratory tests were respectively monitored before and after drug administration in the single and multiple dose groups. The adverse effects both observed and spontaneously reported by the subjects were recorded. Results： All the 42 healthy volunteers completed the tolerance test. No significant abnormality in vital sign, ECG and laboratory tests was found in all of volunteers. The most common adverse effects were mild and dose-dependent dry mouth, fatigue and drowsiness. Conclusion： Bajitian oligosaccharide capsule can be well tolerated in the Chinese healthy volunteers.