中国中西医结合杂志2024，Vol.44Issue(9)：1036-1043,8.DOI:10.7661/j.cjim.20240809.054
双清合剂治疗卫气同病证流行性感冒有效性和安全性多中心随机对照非劣效性试验
Efficacy and Safety of Shuangqing Mixture in the Treatment of Both Defense and Qi Syndrome of Influenza:A Multicenter,Randomized,Controlled,Non-inferiority Trial
林江涛 1王光恩 2马晓斌 3黄滔 4郭安 5张常喜 6赵小兵 7孙绪武 8江柏华 9甄会 10陈红平 11孙增涛 12丁俊平 13封继宏 14吴建华 15陆光兵 16郭瑞斌 17麻晓 18李月荣 19申云红20
作者信息
- 1. 中日友好医院呼吸与危重症医学科(北京 100029)
- 2. 邯郸市中医院呼吸科(河北 056001)
- 3. 山东省立医院呼吸与危重症医学科(济南 250000)
- 4. 眉山市人民医院发热门诊(四川 620000)
- 5. 天津中医药大学研究生院(天津 300250)
- 6. 宁夏回族自治区中医医院肺病科(银川 750000)
- 7. 枣庄妇幼保健院呼吸科(山东 277000)
- 8. 牡丹江市中医医院呼吸科(黑龙江 157000)
- 9. 黑龙江省中医医院肺病科(哈尔滨 150036)
- 10. 中国中药协会呼吸病药物研究专业委员会(北京 100061)
- 11. 北京药海宁康医药科技有限公司(北京 100101)
- 12. 天津中医药大学热病与呼吸疾病研究所(天津 300250)
- 13. 哈尔滨康赛思医药科技开发有限公司(哈尔滨 150001)
- 14. 天津中医药大学第二附属医院呼吸与危重症医学科(天津 300250)
- 15. 山西省汾阳医院呼吸与危重症医学科(山西 032200)
- 16. 眉山市中医医院呼吸与危重症医学科(四川 620000)
- 17. 阳煤集团总医院呼吸与危重症医学科(山西 045000)
- 18. 漯河市中医院急诊科(河南 462000)
- 19. 济南市章丘区人民医院感染性疾病科(济南 250200)
- 20. 长治市第二人民医院感染疾病科(山西 046000)
- 折叠
摘要
Abstract
Objective To observe the effectiveness and safety of Shuangqing Mixture(SQM)in treating pattern of both defense and qi syndrome of influenza.Methods A multicenter,randomized,double-blind,double-dummy,parallel controlled,non-inferiority trial design was used.Totally 240 patients with influenza of pattern of both defense and qi syndrome were randomly assigned to the experimental group and the control group using SAS software in a 1∶1 ratio,120 in each group.The experimental group received SQM and Oseltamivir Capsules simulant,while the control group received Oseltamivir Capsules and SQM simulant.The therapeutic course for all 5 days.The main clinical symptom relief time,complete fever resolution time,fever onset time,usage of acetaminophen,Chinese medicine(CM)syndrome scores,efficacy of CM syndrome treatment,important clinical symptom relief time,incidence of severe/critical influenza,and safety were observed before treatment,and on the 3rd and 5th days of treatment.Results The trentment course,16 patients dropped out(8 in the experimental group and 8 in the control group),224 patients were finally include in analyses,with 112 individuals in each group.Compared with the control group,the experimental group showed a shorter time for headache relief[28.00(17.75,42.99)h vs.41.00(18.75,59.00)h]and reduced muscle or joint pain relief time[37.83(12.88,52.77)h vs.38.07(13.50,69.25)h](P＜0.05).There was no statistically significant difference in the main clinical symptom relief time,complete fever resolution time,usage rate and amount of acetaminophen,and the rate of marked improvement in CM syndrome efficacy(P＞0.05).The incidence of adverse reactions in the experimental group was 4.17％,and 1.67％in the control group,showing no significant difference(x2=1.36,P＞0.05).Conclusions The clinical efficacy of SQM in the treatment of headache and muscle or joint pain in patients with influenza of both defense and qi syndrome was better than use of Oseltamivir Capsules.In terms of improving fever,cough,hyperhidrosis,flushed face,productive cough of yellow sputum,reducing acetaminophen usage,and lowering CM syndrome scores,its efficacy is comparable to Oseltamivir Capsules.Its safety profile is also equivalent to that of Oseltamivir Capsules(China Clinical Trials Registry,No.ChiCTR2400087831).关键词
流行性感冒/卫气同病/双清合剂/随机对照试验/中西医结合Key words
influenza/syndrome of both defense and qi/Shuangqing Mixture/randomized controlled trial/integrative medicine引用本文复制引用
林江涛,王光恩,马晓斌,黄滔,郭安,张常喜,赵小兵,孙绪武,江柏华,甄会,陈红平,孙增涛,丁俊平,封继宏,吴建华,陆光兵,郭瑞斌,麻晓,李月荣,申云红..双清合剂治疗卫气同病证流行性感冒有效性和安全性多中心随机对照非劣效性试验[J].中国中西医结合杂志,2024,44(9):1036-1043,8.
