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目的探讨活菌制剂地衣芽孢杆菌颗粒治疗小儿手足口病(普通型)的临床疗效。方法采用多中心随机、对照研究,将116例患者分为两组,对照组给予利巴韦林喷雾剂6mg/次,每日3次+热毒宁0.5mL/kg,ivgtt,1次/d+对症处理,试验组在基础治疗方案基础上,给予地衣芽孢杆菌颗粒剂(0.25g/袋),每次1袋,3次/d,首次加倍,连续给药5d,比较两组临床效果。结果自治疗2d起,两组患者临床症状比较差异有统计学意义(t=4.134,P<0.05),且至治疗4d时,该差异仍然存在(t=5.356,P<0.05),治疗5d时,两组间比较差异无统计学意义(t=2.124,P>0.05);试验组皮疹开始消退时间、皮疹完全消退时间和开始进食时间均低于对照组,差异具有统计学意义(t=5.456、4.387、7.432,P<0.05);完全退热时间试验组也低于对照组,但差异无统计学意义(P>0.05);治疗后两组患者IgA、IgG均明显改善,且试验组改善程度优于对照组(t=6.372、5.379,P<0.05);IgM、C3、C4治疗前后差异无统计学意义(P>0.05);试验组治疗有效率[93.22%(55/59)]高于对照组[78.95%(45/57)],两组比较差异具有统计学意义(Mann-Whitney=31.368,P<0.05)。结论地衣芽孢杆菌颗粒能够在一定程度上调节患儿免疫功能,减轻临床症状,对小儿手足口病(普通型)具有一定临床价值。
Objective To investigate the clinical efficacy of live bacillus licheniformis granules in the treatment of children with hand, foot and mouth disease (common type). Methods A multicenter, randomized, controlled study was conducted in which 116 patients were divided into two groups. The control group was given ribavirin spray 6mg / time 3 times per day plus luteolin 0.5mL / kg, ivgtt, once / d + Symptomatic treatment, the experimental group based on the basis of treatment programs, given B. licheniformis granules (0.25g / bag), each bag, 3 times / d, for the first time double, continuous administration of 5d, the clinical effect of two groups were compared. Results There were significant differences in clinical symptoms between the two groups (t = 4.134, P <0.05) after 2 days of treatment, and still remained after 4 days of treatment (t = 5.356, P <0.05) . There was no significant difference between the two groups (t = 2.124, P> 0.05). The rash began to subside, the complete eversion time of rash and time to start eating were lower in the experimental group than those in the control group (t = 5.456 , 4.387, 7.432, P <0.05). The complete antipyretic time was also lower in the experimental group than in the control group, but the difference was not statistically significant (P> 0.05). IgA and IgG in the two groups were significantly improved and the experimental group improved (T = 6.372, 5.379, P <0.05). There was no significant difference in IgM, C3, C4 before and after treatment (P> 0.05). The treatment efficiency in the experimental group was 93.22% (55/59) In the control group [78.95% (45/57)], the difference between the two groups was statistically significant (Mann-Whitney = 31.368, P <0.05). Conclusion Bacillus licheniformis granules can regulate immune function and relieve clinical symptoms in children to a certain extent, and has certain clinical value in pediatric hand-foot-mouth disease (common type).