目的 分析小兒熱速清糖漿聯(lián)合對乙酰氨基酚治療兒童發(fā)熱的多中心隨機雙盲雙模擬的比較研究。方法 采用多中心隨機雙盲雙模擬的對比試驗方法，病例來源于2021年4月—2023年4月牡丹江市第一人民醫(yī)院、滕州市婦幼保健院、牡丹江婦幼保健院門診或住院部就診及招募的外感發(fā)熱患兒240例，利用SAS統(tǒng)計軟件按區(qū)組隨機化法分為對照1組（80例）、對照2組（80例）、治療組（80例）。對照1組口服對乙酰氨基酚混懸液，1～3歲，體質(zhì)量12～15 kg，3 mL/次；4～6歲，體質(zhì)量16～21 kg，5 mL/次；7～9歲，體質(zhì)量22～27 kg，8 mL/次；10～12歲，體質(zhì)量28～32 kg，10 mL/次。若持續(xù)發(fā)熱或疼痛，每隔4～6 h重復(fù)用藥1次，24 h不可超過4次。同時服用小兒熱速清糖漿模擬劑，服用方法同對照2組。對照2組口服小兒熱速清糖漿，1～3歲，5～10 mL/次；4～6歲：10～15 mL/次；7～12歲，15～20 mL/次；3～4次/d。同時口服對乙酰氨基酚混懸液模擬劑，其方法同對照1組。治療組口服對乙酰氨基酚混懸液聯(lián)合小兒熱速清糖漿，服用方法與對照1組、對照2組相同。1個療程72 h，3組均連續(xù)用藥1個療程。觀察3組的臨床療效、體溫和癥狀緩解時間。比較3組治療前后中醫(yī)證候評分、血清炎性因子、免疫指標(biāo)的變化情況。觀察3組患兒退熱反復(fù)、高熱驚厥發(fā)生情況，并計算發(fā)生率。結(jié)果 治療后，治療組總有效率是98.75%，顯著高于對照1組88.75%、對照2組90.00%（P＜0.05）。治療后，治療組治療30 min、6 h、24 h、48 h、72 h患兒體溫均較治療前逐漸降低（P＜0.05）；治療組治療30 min、6 h、24 h時體溫均顯著低于對照1組、2組（P＜0.05）。治療后，治療組退熱起效時間、退熱時間、咽痛緩解時間均顯著短于對照1組、對照2組（P＜0.05）。治療后，3組C反應(yīng)蛋白（CRP）、白細(xì)胞介素（IL）-1β、IL-6水平均較同組治療前顯著降低（P＜0.05）；且治療后，治療組CRP、IL-6、IL-1β水平均顯著低于對照1組、對照2組（P＜0.05）。治療后，3組患兒CD3⁺、CD4⁺、NK細(xì)胞均較同組治療前顯著升高，而CD8⁺顯著降低（P＜0.05）；治療后，治療組免疫指標(biāo)改善優(yōu)于對照1組、對照2組（P＜0.05）。治療后，3組患兒發(fā)熱評分、咽痛咽癢評分、鼻塞評分、流涕評分均較同組治療前顯著降低（P＜0.05）；且治療后，治療組中醫(yī)證候評分顯著低于對照1組、對照2組（P＜0.05）。治療組、對照1組均未出現(xiàn)退熱反復(fù)、高熱驚厥情況，對照2組退熱反復(fù)發(fā)生率是10.00%，高熱驚厥率是2.50%；治療組、對照1組退熱反復(fù)發(fā)生率低于對照2組（P＜0.05）。結(jié)論 小兒熱速清糖漿聯(lián)合對乙酰氨基酚治療兒童發(fā)熱取得較好效果，退熱起效快，退熱速度快，可顯著降低血清炎癥因子水平，改善患兒免疫功能，值得臨床推廣應(yīng)用。

Objective To analyze a multicenter randomized double-blind double-simulation study of Xiaoer Resuqing Syrup combined with paracetamol in treatment of fever in children. Methods A multicenter randomized double-blind double-simulation comparative trial method was used to study 240 children with external fever who were recruited from the outpatient or inpatient department of Mudanjiang First People’s Hospital, Tengzhou Maternal and Child Health Care Hospital and Mudanjiang Maternal and Child Health Care Hospital from April 2021 to April 2023. Using SAS statistical software, they were divided into control group 1 (80 cases), control group 2 (80 cases) and treatment group (80 cases) by block randomization method. Children in control group 1 were po administered with Paracetamol Oral Suspension, 1 — 3 years old, body weight 12 — 15 kg, 3 mL/time; 4 — 6 years old, body weight 16 — 21 kg, 5 mL/time; 7 — 9 years old, body weight 22 — 27 kg, 8 mL/time; 10 — 12 years old, body weight 28 — 32 kg, 10 mL/time. If the fever or pain persists, repeat the drug once every 4 — 6 hours, and not more than 4 times in 24 hours. At the same time, they were po administered with Xiaoer Resuqing Syrup simulant, and the method of administration was the same as that of control group 2. Children in control group 2 were po administered with Xiaoer Resuqing Syrup, 1 — 3 years old, 5 — 10 mL/time; 4 — 6 years old, 10 — 15 mL/time; 7 — 12 years old, 15 — 20 mL/time; 3 — 4 times daily. At the same time, they were po administered with Paracetamol Oral Suspension simulant, and the method of administration was the same as that of control group 1. Children in treatment group were po administered with Paracetamol Oral Suspension and Xiaoer Resuqing Syrup, and the administration method was the same as that of control group 1 and control group 2. A course of treatment lasted 72 h, and all the 3 groups were given continuous medication for 1 course. The clinical efficacy, body temperature and symptom remission time of the 3 groups were observed. The changes of TCM syndrome scores, serum inflammatory factors and immune indexes before and after treatment were compared between the three groups. The recurrence of febrile degeneration and hyperfebrile convulsion were observed in the 3 groups, and the incidence was calculated. Result After treatment, the total effective rate of treatment group was 98.75%, which was significantly higher than that of control group 1 88.75% and control group 2 90.00% (P < 0.05). After treatment, the body temperature in the treatment group decreased gradually after 30 min, 6 h, 24 h, 48 h and 72 h compared with that before treatment (P < 0.05). The body temperature of the treatment group at 30 min, 6 h and 24 h was significantly lower than that of the control group 1 and 2 (P < 0.05). After treatment, the onset time of fever, fever and pain relief time of pharynx in the treatment group were significantly shorter than those in control group 1 and control group 2 (P < 0.05). After treatment, the levels of C-reactive protein (CRP), interleukin-1β and IL-6 in 3 groups were significantly decreased compared with those before treatment (P < 0.05). After treatment, the levels of CRP, IL-6 and IL-1β in treatment group were significantly lower than those in control group 1 and control group 2 (P< 0.05). After treatment, CD3⁺, CD4⁺ and NK cells in 3 groups were significantly higher than before treatment, while CD8⁺ was significantly lower (P < 0.05). After treatment, the improvement of immune indexes in treatment group was better than that in control group 1 and control group 2 (P < 0.05). After treatment, fever score, pharyngeal pain score, nasal congestion score and runny nose score in 3 groups were significantly lower than before treatment (P < 0.05). After treatment, the TCM syndrome score of the treatment group was significantly lower than that of control group 1 and control group 2 (P< 0.05). Neither the treatment group nor the control group had recurrent fever and hyperpyretic convulsion. The incidence of recurrent fever and hyperpyretic convulsion was 10.00% and 2.50% in the control group. The recurrence rate of fever in treatment group and control group 1 was lower than that in control group 2 (P < 0.05). Conclusion Xiaoer Resuqing Syrup combined with paracetamol has good effect in treatment of fever in children, and the antipyretic effect is fast, the antipyretic speed is fast, and can significantly reduce the level of serum inflammatory factors, improve the immune function of children, which is worthy of clinical application.

R974