利妥昔单抗治疗难治性肺炎支原体肺炎患者的临床研究

Clinical trial of rituximab in the treatment of refractory mycoplasma pneumoniae pneumonia

目的观察利妥昔单抗治疗难治性肺炎支原体肺炎的临床疗效及安全性。方法将102例难治性肺炎支原体肺炎患儿随机分为对照组和试验组,每组51例。对照组给予30 mg·kg^-1·d-1红霉素,qd,连用1周,静脉滴注+10mg·kg^-1·d^-1阿奇霉素,qd,静脉滴注;试验组在对照组治疗的基础上,给予利妥昔单抗每次100 m L,每周1次,静脉滴注。2组患者均治疗2周。比较2组患儿的临床疗效,血清白细胞介素-8(IL-8)、IL-6、肿瘤坏死因子-α(TNF-α)和转化生长因子-β1(TGF-β1)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为82.35%(42例/51例)和60.78%(31例/51例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的IL-8分别为(8.14±1.36)和(13.07±2.16)pg·m L^-1,IL-6分别为(7.23±1.13)和(12.32±1.41)pg·m L^-1,TNF-α分别为(0.82±0.24)和(1.45±0.38)μg·m L^-1,TGF-β1分别为(324.58±43.76)和(368.37±44.65)pg·m L^-1,差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均为胃肠不适和皮疹。试验组和对照组的总药物不良反应发生率分别为9.80%和7.84%,差异无统计学意义(P>0.05)。结论利妥昔单抗治疗难治性肺炎支原体肺炎患儿的临床疗效确切,其能显著降低患儿的血清IL-8、IL-6、TNF-α及TGF-β1水平,且安全性好。

Objective tuximab in the treatment of refractory mycoplasma pneumoniae pneumonia.Methods niae pneumonia were randomly divided into control group and treatment group mg·kg^-1·d^-1 erythromycin,qd for one week,intravenous drip+10 mg·kg^-1·d^-1 azithromycin,qd,intravenous drip.Treatment group was given rituximab 100 m L per time,once a week,intravenous drip,on the basis of control group.Two groups were treated for 2 weeks.The clinical efficacy,the levels of interleukin-8(IL-8),IL-6,tumor necrosis factorα(TNF-α)(TGF-β1),and adverse drug reactions were compared between two groups.Results and control groups were 82.35%(42 cases/51 cases)and 60.78%(31 cases/51 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:IL-8 were(8.14±1.36)and(13.07±2.16)pg·m L^-1,IL-6 were(7.23±1.13)and(12.32±1.41)pg·m L^-1,TNF-αwere(0.82±0.24)and(1.45±0.38)μg·m L^-1,TGF-β1 were(324.58±43.76)and(368.37±44.65)pg·m L^-1,the differences were statistically significant(all P<0.05).The adverse drug reactions of two groups were gastrointestinal discomfort and rash.The total incidences of adverse drug reactions in treatment and control groups were 9.80%and 7.84%without statistically significant difference(P>0.05).Conclusion plasma pneumoniae pneumonia,which can significantly reduce the serum levels of IL-8,IL-6,TNF-αand TGF-β1.