复方对乙酰氨基酚胶囊治疗感冒发热、疼痛的疗效和安全性

Effect and safety of compound acetaminophen capsule

目的:评价复方对乙酰氨基酚治疗由感冒引起的发热疼痛的效果及安全性.方法:随机双盲双模拟对照研究.入选139例,完成135例,其中A组(试验组n=68)服用复方对乙酰氨基酚胶囊+模拟片;B组(对照组n=67)服用对乙酰氨基酚片+模拟胶囊.2组按入组顺序服药,每日3次,疗程均为3～5 d.观察2组疗效和不良反应.结果:试验组痊愈率为74%,有效率达96%,对照组痊愈率为69%,有效率达91%(P＞0.05),对发热和头痛的临床症状2组均有改善,试验组68例发热病人中有97%病人恢复正常,62例头痛病人有95%的病人恢复正常;对照组65例发热病人和头痛病人分别有92%和91%恢复正常.试验组不良反应发生率为2%(1/68),对照组为3%(2/67)(P＞0.05).未出现严重及预料之外的不良反应.结论:复方对乙酰氨基酚对治疗感冒具有明显的效果.2药的疗效相仿,无明显不良反应.

AIM: To evaluate the effect and safety of compound acetaminophen capsule in treating symptoms of fever and pain caused by common cold. METHODS: Randomized double blind control clinical trial was used. One hundred and thirty-nine patients were enrolled with 135 of them passing the trial and dividing into A and B groups. A group (trial group n=68) took compound acetaminophen capsule and placebo tablet. B group (control group n=67) took acetaminophen tablet and placebo capsule. Each patient took medicine according to the sequence after joining the group. The medicine was given 3 times every day for 3-5 d. The effect, safety and adverse reactions were observed between the two groups. RESULTS: The effect was analysed. The cured rates and effective rates were 74 % and 96 % for trial group; and 69 % and 91 % for control group, respectively. The effect of trial group was higher than control group(P>0.05). The clinical symptoms of fever and headache were improved including 68 fever patients (97 %) and 62 headache patients (95 %) in trial group; 65 fever(92 %) and 91 % headache patients in control group. The adverse reaction rates were 2 %(1/68) in trial group and 3 %(2/67) in control group (P>0.05). No serious adverse reactions occured. CONCLUSION: Compound acetaminophen capsule in treating common cold is effective. The effect in trial group is higher or similar to control group without any obvious adverse reactions.