保济口服液治疗感冒160例临床观察

胡冠英 伍柏坚 和海龙 罗燕玉 郑荣波 黄晓丹

【摘 要】 目的：观察保济口服液治疗感冒（风寒夹湿夹滞证）的临床疗效和安全性。方法：采用多中心、随机、对照试验方法，将237例风寒感冒夹湿夹滞证患者随机分为试验组（保济口服液）160例和对照组（藿香正气口服液）77例。结果：两组中医证候疗效比较：试验组愈显率为87.50%，对照组愈显率为70.13%，差异具有统计学意义（P<0.01）;与对照组相比，试验组症状总积分明显降低（P<0.01），尤其是对咽痛症状明显改善（P<0.01）;此外，治疗期间两组均未发现明显不良反应。结论：保济口服液对感冒（风寒夹湿夹滞证）确有较好疗效，症状缓解明显且用药安全，建议临床广泛推广使用。

【关键词】 保济口服液;感冒;风寒夹湿夹滞证;临床研究

【中图分类号】R254.9   【文献标志码】 A    【文章编号】1007-8517（2021）05-0068-05

Clinical Observation on 160 Cases of Common Cold Treated by Baoji Oral Solution

HU Guanying WU Bojian HE Hailong LUO Yanyu ZHENG Rongbo HUANG Xiaodan*

Key laboratory of brand-name and quality Chinese patent medicine enterprise of Guangdong province， Guangzhou wanglaoji pharmaceutical Co.， Ltd. Guangzhou 510450，China

Abstract：Objective To observe the clinical efficacy and safety of Baoji oral liquid in the treatment of common cold with wind-coldwith damp and retention syndrome. Methods Total of 237 patients who were diagnosed common cold of wind-cold with damp and retention syndrome were randomly divided into 160 cases of trial group （treated with Baoji oral solution） and 77 cases of positive control group （treated with Huoxiang Zhengqi oral solution） using a multicenter and randomized controlled trial. Results Comparison of the efficacy of TCM syndrome between the two groups， the markedly effective rate of the trial group and of the control group were 87.50 % and 70.13 %， respectively， which showed a significant difference （P<0.01）. Compared with the  control group， the total score of symptoms was markedly lowered （P<0.01） in the trial group， especially single symptom of pharyngalgia improved significantly （P<0.01）， when compared to that of the control group， respectively. Besides， no obvious adverse reactions were produced in both of two groups during the period of trial. Conclusion Baoji oral solution indeed has good clinical effects on common cold of wind-cold syndrome with damp and retention， the symptom relieved obviously， it therefore is safe and suggested to be used in clinical practice widely.

Keywords：Baoji Oral Solution;Common Cold;Wind-Cold with Damp and Retention;Clinical Research

保濟口服液是源于岭南特色药-保济丸的改剂型品种，由广藿香、化橘红、苍术、厚朴等16味中药组成，具有解表、祛湿、和中功效，在临床上主治外感风寒兼夹湿夹滞证[1]，症见发热头痛、腹痛吐泻、噎食嗳酸、恶心呕吐、肠胃不适、消化不良、舟车晕浪等。既往研究显示，保济口服液对胃肠道疾病（包括秋季腹泻[2-3]、轮状病毒肠炎[4]、急性胃肠炎[5]）有明显的治疗效果，其可能与抑制肠推进、调节胃液分泌和止泻作用有关[6]。然而，国内外至今尚无关于保济口服液治疗感冒（风寒夹湿夹滞证）的临床报道。为此，本研究重点关注保济口服液治疗感冒（风寒夹湿夹滞证）患者的临床疗效和安全性，旨在为其临床安全应用提供科学参考，现报道如下。

1 资料与方法

1.1 一般资料收集 来自广州中医药大学第一附属医院（组长单位）、广州市中医院、广州市第二人民医院和广东省第二中医院四家医院符合感冒（风寒夹湿夹滞证）门诊患者共237例，采用随机对照试验方法，分为对照组77例和试验组160例。……