目的:观察中西医结合治疗新生儿硬肿症的临床疗效。方法:84例患儿随机分为治疗组47例和对照组37例。两组均采用综合治疗,包括复温,能量液体供给,控制感染,纠正器官功能紊乱及抗DIC等治疗;治疗组中加用复方丹参和654-2注射液交替静滴和口服或鼻饲中药方剂及硬肿局部外用红花油。结果:治疗组痊愈39例,显效6例,无效2例,总有效率为95.74%(95%CI=85.05%～99.45%);对照组痊愈15例,显效12例,无效10例,总有效率为72.97%(95%CI=55.85%～86.20%);两组综合疗效比较,有显著差异(u=3.5070,P=0.0008)。结论:中西医结合治疗新生儿硬肿症综合疗效优于单纯西医疗法,其收益OR=0.12(95%CI=0.02～0.59),NNT=4(95%CI=3.69～12.99)。 Objective: To observe the clinical efficacy of integrated traditional Chinese and western medicine treatment of neonatal sclerema. Methods: Eighty-four children were randomly divided into treatment group (n = 47) and control group (n = 37). The two groups were treated with comprehensive treatment, including rewarming, energy liquid supply, infection control, organ dysfunction correction and anti-DIC treatment; the treatment group plus compound Salvia and 654-2 injection alternately intravenous and nasal feeding Chinese medicine prescription And hard swelling topical safflower oil. Results: The treatment group cured 39 cases, 6 cases markedly effective, 2 cases ineffective, the total effective rate was 95.74% (95% CI = 85.05% ~ 99.45%); control group cured 15 cases, markedly effective in 12 cases, ineffective in 10 cases, The effective rate was 72.97% (95% CI = 55.85% ~ 86.20%). There was significant difference between the two groups (u = 3.5070, P = 0.0008). Conclusion: The integrated treatment of neonatal pediatric sclerogesis with traditional Chinese and western medicine is better than that of western medicine alone. The benefit is 0.12 (95% CI = 0.02-0.59) and NNT = 4 (95% CI = 3.69-12.99).