目的 分析小儿热速清糖浆联合对乙酰氨基酚治疗儿童发热的多中心随机双盲双模拟的比较研究。方法 采用多中心随机双盲双模拟的对比试验方法，病例来源于2021年4月—2023年4月牡丹江市第一人民医院、滕州市妇幼保健院、牡丹江妇幼保健院门诊或住院部就诊及招募的外感发热患儿240例，利用SAS统计软件按区组随机化法分为对照1组（80例）、对照2组（80例）、治疗组（80例）。对照1组口服对乙酰氨基酚混悬液，1～3岁，体质量12～15 kg，3 mL/次；4～6岁，体质量16～21 kg，5 mL/次；7～9岁，体质量22～27 kg，8 mL/次；10～12岁，体质量28～32 kg，10 mL/次。若持续发热或疼痛，每隔4～6 h重复用药1次，24 h不可超过4次。同时服用小儿热速清糖浆模拟剂，服用方法同对照2组。对照2组口服小儿热速清糖浆，1～3岁，5～10 mL/次；4～6岁：10～15 mL/次；7～12岁，15～20 mL/次；3～4次/d。同时口服对乙酰氨基酚混悬液模拟剂，其方法同对照1组。治疗组口服对乙酰氨基酚混悬液联合小儿热速清糖浆，服用方法与对照1组、对照2组相同。1个疗程72 h，3组均连续用药1个疗程。观察3组的临床疗效、体温和症状缓解时间。比较3组治疗前后中医证候评分、血清炎性因子、免疫指标的变化情况。观察3组患儿退热反复、高热惊厥发生情况，并计算发生率。结果 治疗后，治疗组总有效率是98.75%，显著高于对照1组88.75%、对照2组90.00%（P＜0.05）。治疗后，治疗组治疗30 min、6 h、24 h、48 h、72 h患儿体温均较治疗前逐渐降低（P＜0.05）；治疗组治疗30 min、6 h、24 h时体温均显著低于对照1组、2组（P＜0.05）。治疗后，治疗组退热起效时间、退热时间、咽痛缓解时间均显著短于对照1组、对照2组（P＜0.05）。治疗后，3组C反应蛋白（CRP）、白细胞介素（IL）-1β、IL-6水平均较同组治疗前显著降低（P＜0.05）；且治疗后，治疗组CRP、IL-6、IL-1β水平均显著低于对照1组、对照2组（P＜0.05）。治疗后，3组患儿CD3⁺、CD4⁺、NK细胞均较同组治疗前显著升高，而CD8⁺显著降低（P＜0.05）；治疗后，治疗组免疫指标改善优于对照1组、对照2组（P＜0.05）。治疗后，3组患儿发热评分、咽痛咽痒评分、鼻塞评分、流涕评分均较同组治疗前显著降低（P＜0.05）；且治疗后，治疗组中医证候评分显著低于对照1组、对照2组（P＜0.05）。治疗组、对照1组均未出现退热反复、高热惊厥情况，对照2组退热反复发生率是10.00%，高热惊厥率是2.50%；治疗组、对照1组退热反复发生率低于对照2组（P＜0.05）。结论 小儿热速清糖浆联合对乙酰氨基酚治疗儿童发热取得较好效果，退热起效快，退热速度快，可显著降低血清炎症因子水平，改善患儿免疫功能，值得临床推广应用。

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