上感颗粒治疗急性上呼吸道感染发热的随机双盲双模拟多中心临床研究

A Randomized,Double-Blind,Double-Dummy and Multi-Center Clinical Study of Shanggan Granules for Acute Upper Respiratory Tract Infection with Fever

目的评价上感颗粒治疗急性上呼吸道感染发热的临床疗效。方法将6家临床研究中心的270例患者随机双盲分为试验组、对照组和安慰剂组各90例。试验组口服上感颗粒加日夜百服咛片剂模拟片,对照组口服日夜百服咛片剂加上感颗粒模拟剂,安慰剂组口服上感颗粒模拟剂加日夜百服咛片剂模拟片,各组均治疗3天。观察患者即刻退热时间、即刻退热疗效、起效时间、解热时间及临床痊愈率。结果试验组、对照组给药后1、2、3、4h体温均较给药前下降(P<0.01);安慰剂组给药后2、3、4h体温较给药前下降(P<0.01)。与安慰剂组比较,试验组、对照组给药后1、2、3、4h各时间点与前一时间点体温下降值差异均有统计学意义(P<0.05或P<0.01)。即刻退热疗效有效率试验组为67.06%,对照组为67.82%,安慰剂组为40.23%,试验组、对照组即刻退热疗效均优于安慰剂组(P<0.01)。对照组、试验组起效时间、解热时间均少于安慰剂组(P<0.05)。急性上呼吸道感染临床痊愈率安慰剂组为51.72%,对照组为70.11%,试验组为84.71%,试验组高于对照组、安慰剂组(P<0.05或P<0.01),对照组高于安慰剂组(P<0.05)。结论上感颗粒对急性上呼吸道感染发热患者有明显降低体温、减少发热时间和改善临床症状的作用。

Objective To objectively evaluate the therapeutic effect of Shanggan Granules [granules for upper respiratory tract infection （URTI）] for acute URTI with fever. Methods A total of 270 patients from 6 clinical research centers were randomized into the trial group, control group and placebo group, with 90 in each. The trial group was given Shanggan Granules and analog Bufferin Cold Tablets orally. The control group was given Bufferin Cold Tablets and analog Shanggan Granules orally. The placebo group was given analog Shanggan Granules and analog Bufferin Cold Tablets orally. The treatment lasted for 3 days. The immediate defervescence time, immediately antipyretic efficacy, onset time, antipyretic time and clinical cure rate was observed. Results The body temperature was significantly decreased in the trial group and control group in the 1st, 2nd, 3rd and 4th hour after administration （P〈0.01）. The body temperature was significantly decreased in the placebo group in the 2nd, 3rd and 4th hour after administration （P〈0.01）. Comparing with the placebo group, the body temperature decrement in the trial group and control group was significantly different at each time point and the previous time point in the 1st, 2nd, 3rd and 4th hour after administration （P〈0.05 or P〈0.01）. The immediately antipyretic efficacy in the trial group, control group and placebo group was 67.06%, 67.82% and 40.23% respectively. The immediately antipyretic efficacy in the trial group and control group was superior to that in the placebo group （P〈0.01）. The onset time and antipyretic time in the trial group and control group was shorter than that in the placebo group （P〈O. 05）. The clinical cure rate in the placebo group, control group and trial group was 51. 72%, 70.11% and 84.71% respectively. The clinical cure rate in the trial group was significantly high er than that in the control group and placebo group （P〈0.05 or P〈0.01）. The clinical cure rate in the control group was significantly higher than that in the placebo group （P〈0.05）. Conclusion Shanggan Granules is effective for acute URTI with fever in lowering the body temperature, reducing the duration of fever and relieving clinical symptoms.