目的 分析復(fù)方芩蘭口服液聯(lián)合奧司他韋治療流行性感冒的多中心隨機(jī)雙盲雙模擬對照研究。方法 采用多中心隨機(jī)、雙盲、雙模擬對照研究，納入3個醫(yī)院門診或住院部在2021年4月—2023年5月收治的240例流行性感冒患兒，按區(qū)組隨機(jī)化方法并根據(jù)1∶1∶1比例原則將所有患者分為3組，即對照1組、對照2組、治療組，每組各80例。對照1組用溫開水沖服磷酸奧司他韋顆粒體，體質(zhì)量≤15 kg，30 mg/次；體質(zhì)量16～23 kg，45 mg/次；體質(zhì)量24～40 kg，60 mg/次；體質(zhì)量＞40 kg，75 mg/次；2次/d；同時服用復(fù)方芩蘭口服液安慰劑，用法用量同對照2組。對照2組口服復(fù)方芩蘭口服液，患兒≤1歲，2.5 mL/次；1歲＜患兒≤3歲，5 mL/次；3歲＜患兒≤7歲，5～10 mL/次；患兒＞7歲，10～20 mL/次；3次/d；同時服用磷酸奧司他韋顆粒安慰劑，其用法用量同對照1組。治療組口服復(fù)方芩蘭口服液和磷酸奧司他韋顆粒，用法用量與對照1組、2組相同。3組連續(xù)治療1周。觀察3組的臨床療效、癥狀緩解時間。比較3組治療前后中醫(yī)癥候評分、炎癥因子、免疫球蛋白、免疫因子水平的變化情況。結(jié)果 治療后，治療組總有效率是97.50%，顯著高于對照1組85.00%、對照2組87.50%（P＜0.05）。治療后，治療組退熱、頭身痛、咽痛、咳嗽流涕緩解時間均顯著短于對照1組、2組（P＜0.05）。治療后，3組發(fā)熱評分、口渴喜飲評分、咽痛評分、咳嗽評分均較治療前顯著降低（P＜0.05）；治療后，治療組中醫(yī)癥候評分均低于對照1組、2組（P＜0.05）。治療后，3組患兒C反應(yīng)蛋白（CRP）、白細(xì)胞介素（IL）-6、干擾素（IFN）-γ水平均較治療前顯著降低（P＜0.05）；且治療后，治療組CRP、IL-6、IFN-γ水平低于對照組（P＜0.05）。治療后，3組患兒免疫球蛋白（Ig）A、IgG、IgM水平均較治療前顯著增加（P＜0.05），且治療后，治療組免疫球蛋白水平顯著高于對照1組、2組（P＜0.05）；治療后，對照2組免疫球蛋白水平高于對照1組（P＜0.05）。治療后，3組患兒誘導(dǎo)蛋白-10（IP-10）、單核細(xì)胞趨化蛋白-1（MCP-1）、巨噬細(xì)胞炎癥蛋白1α（MIP-1α）水平均較同組治療前明顯降低（P＜0.05）；且治療后，治療組免疫因子水平顯著低于對照1組、2組（P＜0.05）；治療后，對照2組免疫因子水平低于對照1組（P＜0.05）。結(jié)論 復(fù)方芩蘭口服液聯(lián)合奧司他韋治療流行性感冒取得較好的臨床效果，臨床癥狀緩解速度快，且能明顯降低患兒血清炎癥因子水平，改善機(jī)體免疫功能，值得臨床應(yīng)用。

Objective To analyze a multicenter randomized double-blind double-simulated controlled study of Compound Qinlan Oral Liquid combined with oseltamivir in treatment of influenza. Methods A multicenter randomized double-blind double-simulated control study was conducted to include 240 children with influenza admitted to outpatient or inpatient departments of 3 hospitals from April 2021 to May 2023. All patients were divided into 3 groups according to the block randomization method and the ratio principle of 1:1:1, namely control group 1, control group 2 and treatment group, with 80 cases in each group. Children in control group 1 were po administered with Oseltamivir Phosphate Granules with warm boiling water, body weight ≤ 15 kg, 30 mg/time; body weight 16 — 23 kg, 45 mg/time; body weight 24 — 40 kg, 60 mg/time; body weight > 40 kg, 75 mg/time; twice daily. And they were po administered with Compound Qinlan Oral Liquid placebo, and the administration and dosage were the same as that of control group 2. Children in control group 2 were po administered with Compound Qinlan Oral Liquid, 0 to 1 year old, 2.5 mL/time; 1 to 3 years old, 5 mL/time; 3 to 7 years old, 5 — 10 mL/ time; over 7 years old, 10 — 20 mL/time; 3 times daily. And they were po administered with Oseltamivir Phosphate Granules placebo, and the administration and dosage were the same as that of control group 1. Children in treatment group were po administered with Oseltamivir Phosphate Granules and Compound Qinlan Oral Liquid, and the administration method was the same as that of control group 1 and control group 2. 3 groups were treated continuously for 1 week. The clinical efficacy and symptom remission time of 3 groups were observed. The changes of TCM symptom score, inflammatory factors, immunoglobulin and immune factors before and after treatment were compared in the 3 groups. Results After treatment, the total effective rate of treatment group was 97.50%, which was significantly higher than that of control group 1 (85.00%) and control group 2 (87.50%) (P < 0.05). After treatment, the relief time of fever, head and body pain, pharyngeal pain, cough and runny nose in treatment group was significantly shorter than that in control group 1 and control group 2 (P < 0.05). After treatment, the scores of fever, thirst and drinkiness, pharyngodynia and cough in 3 groups were significantly lower than before treatment (P < 0.05). After treatment, the scores of TCM symptoms in the treatment group were lower than those in the control group 1 and 2 (P < 0.05). After treatment, the levels of C-reactive protein (CRP), interleukin-6, and interferon (IFN) -γ in 3 groups were significantly decreased compared with those before treatment (P < 0.05). After treatment, CRP, IL-6, and IFN-γ levels in the treatment group were lower than those in the control group (P < 0.05). After treatment, the levels of immunoglobulin (Ig) A, IgG, and IgM in the 3 groups were significantly increased compared with those before treatment (P < 0.05), and the immunoglobulin level in the treatment group was significantly higher than that in the control group 1 and 2 (P < 0.05). After treatment, the immunoglobulin level in control group 2 was higher than that in control group 1 (P < 0.05). After treatment, the levels of induced-protein-10 (IP-10), monocyte chemotactic protein-1 (MCP-1) and macrophage inflammatory protein-1α (MIP-1α) in 3 groups were significantly decreased compared with those before treatment (P< 0.05). After treatment, the immune factor level in treatment group was significantly lower than that in control group 1 and control group 2 (P< 0.05). After treatment, the immune factor level in control group 2 was lower than that in control group 1 (P < 0.05). Conclusion Compound Qinlan Oral Liquid combined with oseltamivir has achieved good clinical effect in treatment of influenza, can quickly relieve clinical symptoms, and can significantly reduce the level of serum inflammatory factors and improve the immune function, which is worthy of clinical application.

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