摘要
目的：评价青银注射液通过静滴给药治疗上呼吸道感染风热证的疗效与安全性。方法：采用多中心、随机、双盲方法。符合上呼吸道感染中医风热症的患者467例，其中350例接受青银注射液，117例接受清开灵注射液，给药方案均为30mL加入5％CS250mL中静滴，再予5％GNS250mL静滴，1．5～2h输注完成，qd，连续用药3d。评价发热，咽痛等试验药物适应证候效应指标等级变化与消失率与症状积分，以及血、尿和粪常规、心电图、肝肾功能、PT、APTT等安全性评价。结果：青银注射液治疗该病证的退热效应（即刻退热作用，首诊当天体温下降至正常所需时间，体温恢复正常的时间）与清开灵注射液相同，治疗d3咽痛的消失率明显优于对照药物（P=0．0247）。不良事件的发生率和程度低于对照药物。结论：青银注射液治疗上呼吸道感染风热证是有效、安全的，其退热作用与对照药物相同，对咽痛治疗作用优于对照药物。
Objcetive ： To evaluate the efficacy and safety of Qingyin injection in the treatment of acute infection in upper respiratory tract （ wind heat syndrome ）. Methods ： A multicentral, randomized, double-blind, controlled clinical trial was carried out in 476 patients met the diagnosis. The patients were treated once daily for 3 days with either Qingyin injection （ n = 350） or Qing-kai-ling injection（ n = 117, control）. Both injections （30 mL） were dissolved in 5% GS 250 mL and intravenously infused within 1.5 - 2 h, then followed by 5% GNS 250 mL. Efficacy was assessed by indicators such as the scale of pyrexia and pharyngalgia, its disappearance rate, and the symptom of TCM score ; safety was by indicators such as hemogram, fecal and urine analysis, ECG,liver and renal function, PT and APTT before and after the treatment. Results： The antipyretic effect （ as evaluated by the indexes such as instant decline of body temperature, hours needed treatment day, time needed for body temperature recovery） for the body temperature to return to normal on the 1 st of Qingyin was similar to that of Qing-kai-ling injection; while the disappearance rate of pharyngalgia on the 3rd treatment day was superior in Qingyin group （P = 0. 024 7 ）. Both the incidence and severity of adverse events were lower in Qingyin group than in Qing-kai-ling group. Conclusion： Qingyin injection is effective and safe in treating acute upper respiratory tract infection （wind heat syndrome）. Its antipyretic effect is similar to, while the effect on pharynalgia is superior to, that of Qing-kai-ling injection.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2008年第23期2050-2053,共4页
Chinese Journal of New Drugs
关键词
青银注射液
上呼吸道感染
风热证
Qingyin injection
acute upper respiratory tract infection
wind heat syndrome
