基于潜在类别分析探讨藿香正气口服液治疗风寒湿滞感冒患者的疗效

Latent class analysis of therapeutic effects of Huoxiang Zhengqi Oral Liquid on patients with cold due to wind-cold and dampness stagnation

收集临床诊疗过程使用藿香正气口服液患者的基本信息、药物使用情况、临床症状等资料,运用潜在类别分析(latent class analysis,LCA)探讨患者主症特征,运用双稳健估计分析不同人群服用不同剂量藿香正气口服液的疗效,探索风寒湿滞感冒患者的主症分布及不同证型患者在服用不同剂量藿香正气口服液后的疗效。该研究共纳入11273例患者,其中男性4347例,女性6926例。共纳入15个主症,频率最高的前3个主症为头昏(53.9%)、头重(39.6%)、恶心(39.4%)。根据LCA将人群分为3类,脾虚湿盛证患者最多(5604例,49.71%),其次是风痰上扰证(4955例,43.96%),脾气虚证患者最少(714例,6.33%)。双稳健估计分析表明,与日用剂量20 mL相比,脾气虚证患者在日用剂量为30、40、60 mL的痊愈时间差异无统计学意义;风痰上扰证患者日用剂量为40、60 mL的痊愈时间分别减少16.67(95%CI[5.23,28.12])、15.94 h(95%CI[7.45,24.43]),差异均有统计学意义;脾虚湿盛证患者日用剂量为30、40、60 mL的痊愈时间分别减少4.42(95%CI[1.06,7.77])、13.07(95%CI[1.61,24.54])、13.92 h(95%CI[5.14,22.70]),差异均有统计学意义。结果表明,风寒湿滞感冒患者的主症较多,病位主要集中在头、胃、脾等,临床可根据患者证候适量增加藿香正气口服液的日用剂量,缩短患者痊愈时间。

The demographic characteristics,drug use,clinical symptoms and other data of the patients treated with Huoxiang Zhengqi Oral Liquid were collected.The latent class analysis(LCA)was performed to reveal the distribution of primary symptoms,and then the doubly robust estimation was employed to analyze the efficacy of different doses of Huoxiang Zhengqi Oral Liquid in different populations.A total of 11273 patients were enrolled in this study,including 4347 males and 6926 females.A total of 15 primary symptoms were included,with the top 3 being dizziness(53.9%),head heaviness(39.6%),and nausea(39.4%).According to the LCA,the population was divided into 3 groups of spleen deficiency and dampness exuberance(5604 cases,49.71%),upward harassing of wind-phlegm(4955 cases,43.96%),and spleen Qi deficiency(714 cases,6.33%).Double robust estimation showed that the time to recovery of the patients with spleen Qi deficiency had no significant difference regarding the daily dose.Compared with the daily dose of 20 mL,the daily doses of 40,and 60 mL shortened the time to recovery by 16.67(95%CI[5.23,28.12])and 15.94 h(95%C1[7.45,24.43])in the patients with upward harassingof wind-phlegm,the daily doses of 30,40,and 60 mL shortened the time to recovery by 4.42(95%CI[1.06,7.77]),13.07(95%CI[1.61,24.54]),13.92 h(95%CI[5.14,22.70])in the patients with spleen deficiency and dampness exuberance,respectively.The patients with cold due to wind-cold and dampness stagnation had more primary syndromes,and the disease locations were mainly in the head,stomach,and spleen.In clinical practice,the daily dose of Huoxiang Zhengqi Oral Liquid can be increased according to the symptoms of patients,which can shorten the time to recovery.