抗感冒处方治疗感冒风热证有效性的临床随机对照试验
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摘要
目的评价抗感冒处方汤剂治疗感冒风热证的有效性与安全性。方法选择感冒风热证患者102例进行随机、单盲、安慰剂平行对照的临床试验,其中试验组70例和对照组32例,剔除2例,脱落3例,最终有效病例97例。试验组(66例)给予抗感冒处方每8 h/次,每日3次,每次70 m L口服;对照组(31例)给予安慰剂汤剂每8 h/次,每日3次,每次70 m L口服。治疗3天后,观察患者治疗前(访视1)、治疗第1天(访视2)、疗程结束前(访视3)的临床有效性。结果访视1至访视2期间,试验组和对照组有效率分别为18. 2%(12/66)与6. 4%(2/31);访视1至访视结束后,试验组和对照组有效率分别为71. 2%(47/66)与51. 6%(16/31),两组比较,试验组有效率均高于对照组(P <0. 05,P <0. 01)。与对照组比较,试验组所需的起效时间和解热时间均缩短(P <0. 05);试验组中医症状总积分相对降低,但差异无统计学意义(P> 0. 05);在第2次访视时两组中医症状总积分差异有统计学意义(P <0. 05)。试验组在改善症状体征的身热、咽痛、鼻塞、口渴、体温方面优于对照组(P <0. 05)。临床试验中未发现该药的不良反应。结论抗感冒处方对改善感冒风热证安全有效,可缩短起效与解热时间,对部分中医症状与体征有明显改善作用。
Objective To assess the effectiveness and safety of Treating Cold Prescription for common cold( windheat exterior pattern) in comparison with placebo. Methods A double-blind,double-dummy,randomized controlled trial was conducted. A total of 102 patients( wind-heat exterior pattern) were randomized to 70 cases in the treatment group and32 cases in the control group. There were 2 cases shedding and 3 expulsion cases,and at finally 97 cases including the treatment group( 66 cases,Treating Cold Prescription,70 m L for oral administration,three times per day) and the control group( 31 cases,placebo,70 m L for oral administration,three times per day) were effective. After the therapeutic course of three days,there was to observe the clinical efficacy during the prior treatment( visit 1),the first day of treatment( visit 2) and before the end of the treatment( visit 3). Results From visit 1 to visit 2 the total effective rates of the treatment group and the controlled group were 18. 2%( 12/66) and 6. 4%( 2/31),respectively. From visit 1 to the end of the visit the total effective rates of the treatment group and the controlled group were 71. 2%( 47/66) and 51. 6%( 16/31),compared with two groups,the total effective rate of the treatment group was higher than that of the control group(P < 0. 05,P < 0. 01).There was significant difference between treatment group and the controlled group in onset time and effective time for fever(P< 0. 05). Though the total scores of Chinese medicine( CM) symptoms in the treatment group were decreased compared to the scores in the control group,there was no significant difference(P > 0. 05). During the visit 2 there was significant difference between treatment group and the controlled group on the total scores of CM symptoms(P < 0. 05). About improving symptoms and signs,the treatment group was better than the control group from hot body,pharyngalgia,thirst and temperature(P < 0. 05). No adverse effect was found. Conclusions Treating cold prescription is effective and safe in treating windheat exterior pattern of common cold. It could shorten the onset time and the effective time for fever,and ameliorate some CM symptoms and signs remarkably.
Objective To assess the effectiveness and safety of Treating Cold Prescription for common cold( windheat exterior pattern) in comparison with placebo. Methods A double-blind,double-dummy,randomized controlled trial was conducted. A total of 102 patients( wind-heat exterior pattern) were randomized to 70 cases in the treatment group and32 cases in the control group. There were 2 cases shedding and 3 expulsion cases,and at finally 97 cases including the treatment group( 66 cases,Treating Cold Prescription,70 m L for oral administration,three times per day) and the control group( 31 cases,placebo,70 m L for oral administration,three times per day) were effective. After the therapeutic course of three days,there was to observe the clinical efficacy during the prior treatment( visit 1),the first day of treatment( visit 2) and before the end of the treatment( visit 3). Results From visit 1 to visit 2 the total effective rates of the treatment group and the controlled group were 18. 2%( 12/66) and 6. 4%( 2/31),respectively. From visit 1 to the end of the visit the total effective rates of the treatment group and the controlled group were 71. 2%( 47/66) and 51. 6%( 16/31),compared with two groups,the total effective rate of the treatment group was higher than that of the control group(P < 0. 05,P < 0. 01).There was significant difference between treatment group and the controlled group in onset time and effective time for fever(P< 0. 05). Though the total scores of Chinese medicine( CM) symptoms in the treatment group were decreased compared to the scores in the control group,there was no significant difference(P > 0. 05). During the visit 2 there was significant difference between treatment group and the controlled group on the total scores of CM symptoms(P < 0. 05). About improving symptoms and signs,the treatment group was better than the control group from hot body,pharyngalgia,thirst and temperature(P < 0. 05). No adverse effect was found. Conclusions Treating cold prescription is effective and safe in treating windheat exterior pattern of common cold. It could shorten the onset time and the effective time for fever,and ameliorate some CM symptoms and signs remarkably.
引文
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[2]陈灏珠主编.实用内科学[M].第12版.北京:人民卫生出版社,2001:309-310.
[3]王家良,王吉耀,王觉生,等.临床流行病学-临床科研设计、测量与评价[M].第2版.上海:上海科学技术出版社,2001:138-141.
[4]陆再英主编.内科学[M].第7版.北京:人民卫生出版社,2008:6.
[5]王永炎主编.中医内科学[M].第6版.上海:上海科学技术出版社,1997:27-28.
[6]贾静.双黄连口服液的临床应用评价[J].中国医院用药评价与分析,2013,13(2):110-112.
[7]赵宏杰,郭利平,杨丰文,等.藿香正气方治疗胃肠型感冒有效性和安全性系统评价[J].中国中药杂志,2017,42(8):1495-1499.
[8]牛倩倩,陈愉,刘晔,等.连花清瘟胶囊治疗流行性感冒的有效性及安全性的系统评价[J].中国中药杂志,2017,42(8):1474-1481.
[9]陈亚双,孙世伟.柴胡的化学成分及药理作用研究进展[J].黑龙江医药,2014,27(3):630-633.
[10]付国辉,马香芹.黄芩的化学成分及药理作用研究进展[J].中国当代医药,2015,22(22):18-20.
[11]周灏.石膏清热作用的物质基础及作用机制[J].中医学报,2015,30(6):860-862.