健康受试者单次及多次口服痛舒胶囊的人体耐受性和安全性研究

Single-dose and multiple-dose tolerance clinical study of Tong Shu Capsules in healthy volunteers

目的评价健康受试者单次、多次口服痛舒胶囊的耐受性和安全性。方法单中心、随机、双盲、安慰剂对照、剂量增加的多剂量单次、多次给药研究。单次给药7个剂量组共纳入38例受试者,单次口服痛舒胶囊/安慰剂1.2,2.4,3.6,4.8,6.3,7.8和9.9 g,其中试验组共28例,安慰剂共10例,多次给药共纳入30例受试者,分别于1.8,2.7和3.6 g剂量下连续口服痛舒胶囊/安慰剂14 d,每天2次,每组10例。给药前后进行一般情况、实验室检查分析,并记录药物不良反应发生情况。结果 68例全部完成试验,药物不良反应发生情况:单次给药试验组共发生头痛2例,胃痛1例,面部潮红1例,凝血功能检查异常1例;多次给药试验组出现瘙痒症3例及皮疹1例的不良事件,此外还包括谷草转氨酶升高、谷丙转氨酶升高等指标异常。上述不良事件复查后很快恢复正常,无明显剂量相关性。结论痛舒胶囊最大耐受剂量,单次给药为9.9 g;多次给药为每次3.6 g,每日2次,连续给药14 d,是安全且可耐受的。

Objective To evaluate the safety and tolerance in healthy volunteers, who took single and multiple-doses Tong Shu Capsules orally. Methods Using the study of single-center, double-blind, placebo-controlled, randomized, dose escalating, single and multiple-dose. A total of 38 subjects were included in the 7 dose groups with single oral administration of Tong Shu Capsule/placebo 1.2, 2.4, 3.6, 4.8, 6.3, 7.8 and 9.9 g, including 28 subjects in treatment group and 10 subjects in the placebo group. A total of 30 subjects were included in multiple administration, taking Tong Shu Capsule/placebo orally for 14 d, twice a day, respectively in three dose groups of 1.8, 2.7 and 3.6 g, with 10 subjects in each group. Physical examination and laboratory test were performed. Adverse events(AEs) were recorded. Results All 68 subjects completed the study. AEs were as follow, 2 cases of headache, 1 case of stomachache, 1 case of facial flushing and 1 case of abnormal blood clotting in single-dose treatment group study, 3 cases of pruritus and 1 case of rash occurred in multiple-dose treatment group, in addition, laboratory abnormalities included glutamic-oxaloacetic transminase and glutamic-pyruvic transminase level increased, etc. All AEs were recovered in the research, and then supposed without dose correlation. Conclusion Tong Shu Capsules administered up to 9. 9 g in single-dose and 3. 6 g twice a day for 14 d in multiple-dose are safe and tolerable.