摘要
目的评价风寒方治疗风寒恋肺型感染后咳嗽的临床疗效及安全性。方法将5个研究中心的185例感染后咳嗽风寒恋肺证患者随机分为中药组94例和对照组91例。中药组给予自拟风寒方中药配方颗粒口服,每次17.1g,每日2次;对照组予安慰剂口服。两组均治疗10天,随访7天。随访结束评价临床疗效。治疗前、治疗中(第5天)、治疗后及随访结束时进行两组患者咳嗽症状、数字评价量表(NRS)及中医证候评分。根据咳嗽症状评分评价咳嗽缓解时间和咳嗽复发情况,治疗前后分别测定患者的咳嗽敏感性。并评价药物安全性。结果中药组临床疗效总有效率为92.9%,对照组为73.8%,中药组优于对照组(P<0.01)。两组患者治疗中、治疗后、随访后咳嗽症状、NRS和中医证候评分均较治疗前显著下降(P<0.01);治疗后中药组患者咳嗽症状和中医证候评分均低于对照组(P<0.05);随访后中药组患者咳嗽症状、NRS和中医证候评分均低于对照组(P<0.01)。两组患者咳嗽复发率、咳嗽缓解时间、咳嗽敏感性差异均无统计学意义(P>0.05)。两组患者发生的不良事件严重程度分级均为轻度,不良事件与药物因果关系判断均为可疑或不可能。结论风寒方能有效缓解风寒恋肺型感染后咳嗽患者的咳嗽、咽痒等症状,减轻咳嗽严重程度,缓解率高、复发率低,且安全性好。
Objective To evaluate the efficacy and safety of wind-cold formula for postinfectious cough.Methods Totally185cases of postinfectious cough with wind-cold pattern from 5research centers were randomized into the Chinese medicinal group and control group,with 94and 91in each.The Chinese medicinal group was given wind-cold formula granules 17.1g each time,twice daily.The control group was given placebo.The treatment lasted for 10days and the follow-up lasted for 7days.The efficacy was evaluated after follow-up.The cough,numerical rating scale（NRS）and TCM pattern was scored before treatment,during treatment（on the 5th day of treatment）,after treatment and at the end of follow-up.The remission duration and recurrence of cough was evaluated according to the cough score.The cough sensitivity was measured before and after treatment.The safety was evaluated after treatment.Results The total effective rate of the Chinese medicinal group and control group was 92.9%and 73.8%respectively,with a significant difference between groups（P〈0.01）.The cough score,NRS score and TCM pattern score were significantly decreased in both groups during treatment and after treatment and followup（P〈0.01）,especially cough score and TCM pattern score in the Chinese medicinal group after treatment and follow-up（P〈0.05or P〈0.01）.The remission rate of cough in the Chinese medicinal group was significantly higher than that in the control group（P〈0.01）.There was no significant difference between groups in the recurrence rate,remission time and sensitivity of cough（P〈0.05）.The severity scales of adverse events were mild in both groups.The causal relationship between drug and adverse events in both groups were suspicious or impossible.Conclusion Wind-cold formula can effectively relieve cough and itchy throat in postinfectious cough patients with wind-cold pattern with a high remission rate,low recurrence rate and good safety.
出处
《中医杂志》
CSCD
北大核心
2013年第22期1917-1921,共5页
Journal of Traditional Chinese Medicine
基金
“十一五”国家科技支撑计划资助项目(2007BAI20B086)
