丁桂油软胶囊Ⅰ期临床耐受性研究

Tolerability of Dingguiyou capsula mollis in a phase I study

目的:评价健康人体对丁桂油软胶囊的耐受性和安全性。方法:健康受试者32名随机分入单次和连续给药组。单次给药组分别单次口服丁桂油软胶囊4,8,13,21和27粒;连续给药组每次口服3粒,tid,连续7 d。观察临床症状、体征,包括体温、脉搏、呼吸频率、血压等指标;实验室指标包括心电图、血常规、尿常规、肝功能、肾功能等。结果:单次给药在D组(21粒)出现一过性白细胞降低,但无剂量相关关系;单次给药在C组(13粒)和E组(27粒)各有1例出现轻度腹胀,E组(27粒)有1例出现嗝气。连续给药组仅2例在服药首d出现一过性口干,试验结束复查未发现有临床意义的实验室检查和心电图检查异常。结论:在观察剂量内,受试者对丁桂油软胶囊的安全性和耐受性好,建议临床采用每次3粒,tid的给药方案。

Objective： To assess the safety and tolerance of Dingguiyou capsula mollis in a phase Ⅰ study. Methods： Thirty-two healthy volunteers were randomly divided to either single-dose or multipledoses group. In the single-dose group, subjects received oral dose of 4, 8, 13, 21 or 27 capsules ; while in the multiple-doses group, subjects received 3 capsules, three times per day, for 7 days. The safety profiles and tolerability were evaluated by observing the symptoms, vital sign, laboratory tests and electro- cardiogram. Results： Serious adverse effects were not observed in all the volunteers. Transient reduction in leukocyte count that was not dose-related occurred in volunteers with single dose of 21 capsules; one case of mild abdominal distention was found in volunteers with single dose of 13 or 27 capsules; one case of hiccup was found in volunteers with single dose of 27 capsules. Two cases of transient dry mouth were found in volunteers with multiple doses. No clinically significant changes in laboratory tests and electrocardiogram were found in the follow-up after the trial. Conclusion： Dingguiyou capsula mollis is safe and well-tolerated at the doses observed. The recommended optimal dose regimen is 3 capsules for one time and three times per day.