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健康泰国受试者多次口服标准化穿心莲胶囊后的临床参数

Clinical Parameters following Multiple Oral Dose Administration of a Standardized Andrographis paniculata Capsule in Healthy Thai Subjects.

作者信息

Suriyo Tawit, Pholphana Nanthanit, Ungtrakul Teerapat, Rangkadilok Nuchanart, Panomvana Duangchit, Thiantanawat Apinya, Pongpun Wanwisa, Satayavivad Jutamaad

机构信息

Laboratory of Pharmacology, Chulabhorn Research Institute, Bangkok, Thailand.

Center of Excellence on Environmental Health and Toxicology, Office of Higher Education Commission, Ministry of Education, Bangkok, Thailand.

出版信息

Planta Med. 2017 Jun;83(9):778-789. doi: 10.1055/s-0043-104382. Epub 2017 Mar 1.

DOI:10.1055/s-0043-104382
PMID:28249303
Abstract

has been widely used in Scandinavian and Asian counties for the treatment of the common cold, fever, and noninfectious diarrhea. The present study was carried out to investigate the physiological effects of short-term multiple dose administration of a standardized capsule used for treatment of the common cold and uncomplicated upper respiratory tract infections, including blood pressure, electrocardiogram, blood chemistry, hematological profiles, urinalysis, and blood coagulation in healthy Thai subjects. Twenty healthy subjects (10 males and 10 females) received 12 capsules per day orally of 4.2 g of a standardized crude powder (4 capsules of 1.4 g of , 3 times per day, 8 h intervals) for 3 consecutive days. The results showed that all of the measured clinical parameters were found to be within normal ranges for a healthy person. However, modulation of some parameters was observed after the third day of treatment, for example, inductions of white blood cells and absolute neutrophil count in the blood, a reduction of plasma alkaline phosphatase, and an induction of urine pH. A rapid and transient reduction in blood pressure was observed at 30 min after capsule administration, resulting in a significant reduction of mean systolic blood pressure. There were no serious adverse events observed in the subjects during the treatment period. In conclusion, this study suggests that multiple oral dosing of at the normal therapeutic dose for the common cold and uncomplicated upper respiratory tract infections modulates various clinical parameters within normal ranges for a healthy person.

摘要

它已在斯堪的纳维亚和亚洲国家广泛用于治疗普通感冒、发烧和非感染性腹泻。本研究旨在调查用于治疗普通感冒和单纯性上呼吸道感染的标准化胶囊短期多次给药的生理效应,包括对健康泰国受试者的血压、心电图、血液化学、血液学指标、尿液分析和血液凝固的影响。20名健康受试者(10名男性和10名女性)连续3天每天口服12粒胶囊,每粒胶囊含4.2克标准化粗粉(1.4克的4粒胶囊,每天3次,间隔8小时)。结果显示,所有测量的临床参数均在健康人的正常范围内。然而,在治疗第三天后观察到一些参数的调节,例如,血液中白细胞和绝对中性粒细胞计数的增加、血浆碱性磷酸酶的降低以及尿液pH值的升高。给药后30分钟观察到血压迅速短暂下降,导致平均收缩压显著降低。在治疗期间,受试者未观察到严重不良事件。总之,本研究表明,以普通感冒和单纯性上呼吸道感染的正常治疗剂量多次口服,可在健康人的正常范围内调节各种临床参数。

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