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目的:评价中国健康志愿者单次及连续口服仲香胶囊的耐受性。方法:研究分为单次和连续给药两部分。单次给药分为4组,分别给予仲香胶囊2(n=2),4(n=6),6(n=6),9粒(n=4)。连续给药组分为2组,分别给予仲香胶囊6(n=6)和9粒(n=6),qd,用药7 d。观察各组用药后的临床症状和生命体征,并检查心电图、血尿常规、肝肾功能、凝血功能、腹部彩超等。结果:单次给药理化检查有12项指标出现异常,均无临床意义。连续给药有1例受试者检测结果出现异常,但无临床意义,发生1例轻度不良事件,表现为一侧耳鸣(左),与药物无关。结论:建议本品进行II期临床试验的安全剂量范围在9粒以内,进行II期临床试验时注意观察该药物有可能引起的毒性反应,特别是神经系统的症状。
OBJECTIVE: To evaluate the tolerability of single and continuous oral Zhongxiang capsules in Chinese healthy volunteers. Methods: The study was divided into two parts, single and continuous dosing. A single dose was divided into 4 groups and were given Zhongxiang Capsule 2 (n=2), 4 (n=6), 6 (n=6) and 9 (n=4), respectively. The continuous administration of the components was divided into two groups, and the rats were given Zhongxiang Capsule 6 (n=6) and 9 tablets (n=6), qd, respectively for 7 days. Observe the clinical symptoms and vital signs after treatment in each group, and check the electrocardiogram, hematuria, liver and kidney function, coagulation function, and abdominal ultrasound. RESULTS: There were 12 abnormalities in the pharmacological examination for a single time, and there was no clinical significance. One patient in the continuous administration had abnormal test results but no clinical significance. One mild adverse event occurred, one side of tinnitus (left), had nothing to do with the drug. Conclusion: It is recommended that the safety dose of this product in phase II clinical trials should be within 9 capsules. During the phase II clinical trial, observe the toxic reactions that the drug may cause, especially the symptoms of the nervous system.