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目的:观察扶正健儿膏方对小儿反复呼吸道感染(RRTI)非急性期患者病情的控制作用及对T淋巴细胞亚群、免疫球蛋白和Th1/Th2细胞因子的影响。方法:将160例RRTI非急性期患儿,采用SAS软件生成的数字表法,按就诊先后顺序随机分为对照组和观察组。对照组采用匹多莫德口服溶液,400 mg/次,1次/d;葡萄糖酸锌口服溶液,3~6岁,5 m L/次,2次/d;7~12岁,7.5 m L/次,2次/d;适量补充维生素C和A。观察组采用扶正健儿膏方,3~6岁,5 m L/次,温水冲服,晨起空腹,3次/d;7~12岁,10 m L/次,2次/d。两组疗程均连续服用24周,疗程结束均进行24周的随访。记录48周内呼吸道感染发作次数,每次发作的持续时间,每次发病病种;检测治疗前后血清免疫球蛋白G(Ig G),免疫球蛋白A(Ig A),免疫球蛋白M(Ig M)和T淋巴细胞亚群(CD3~+,CD4~+,CD8~+,CD4~+/CD8~+)水平,检测治疗前后白细胞介素-2(IL-2),干扰素-γ(FN-γ),白细胞介素-4(IL-4),白细胞介素-5(IL-5)水平。结果:观察组临床疗效痊愈率为52.7%高于对照组的32.88%(χ~2=5.898,P<0.05);观察组中医证候疗效总有效率为94.59%,对照组为78.08%,观察组高于对照组(χ~2=8.524,P<0.01);在48周的观察期内,观察组平均发作次数,即反复上呼吸道感染、反复气管支气管炎和反复肺炎的发作次数均少于对照组,平均发病病程也短于对照组(P<0.01);治疗后观察组IgG,IgA,IgM水平高于对照组(P<0.01);治疗后观察组CD3~+,CD4~+和CD4~+/CD8~+均高于对照组,CD8~+低于对照组(P<0.01);治疗后观察组血清IL-2和IFN-γ水平均高于对照组,IL-4和IL-5水平均低于对照组(P<0.01)。结论:扶正健儿膏方治疗反复呼吸道感染患儿,能提高患者的免疫功能,调节Th1/Th2平衡,增加患儿机体免疫能力,从而减少呼吸道感染发生频率,缩短发作病程,提高临床疗效。
OBJECTIVE: To observe the effect of Fuzheng Jianlou Paste on the patients with non-acute respiratory tract infection (RRTI) and the effect on the T lymphocyte subsets, immunoglobulin and Th1 / Th2 cytokines. Methods: 160 cases of non-acute RRTI children, using SAS software generated digital table method, according to the order of treatment were randomly divided into control group and observation group. The control group was treated with Pidotimod oral solution 400 mg / time, once a day; zinc gluconate oral solution 3 to 6 years old, 5 m L / time, 2 times / d; 7 to 12 years old, 7.5 m L / Times, 2 times / d; appropriate amount of vitamin C and A. The observation group was treated with Fuzheng Yaoru Paste, 3 to 6 years old, 5 m L / time, warm water, morning fasting, 3 times / d; 7 to 12 years old, 10 m L / time, 2 times / d. Two groups of treatment were taken continuously for 24 weeks, the end of the course of treatment were followed up for 24 weeks. Record the number of episodes of respiratory infection within 48 weeks, the duration of each episode, each disease types; detection of serum immunoglobulin G (Ig G), immunoglobulin A (Ig A), immunoglobulin M (Ig The levels of CD3 +, CD4 +, CD8 +, CD4 + / CD8 + and T lymphocyte subsets were measured before and after treatment. The levels of interleukin-2 (IL-2), interferon- FN-γ), interleukin-4 (IL-4), interleukin-5 (IL-5) levels. Results: The cure rate of observation group was 52.7% higher than that of the control group (χ ~ 2 = 5.898, P <0.05). The total effective rate of TCM syndrome in observation group was 94.59% and that of control group was 78.08% (Χ ~ 2 = 8.524, P <0.01). In the observation period of 48 weeks, the average number of seizures in the observation group, ie, repeated upper respiratory tract infection, repeated tracheal bronchitis and recurrent pneumonia were fewer than those in the control group The mean duration of disease in the control group was also shorter than that in the control group (P <0.01). After treatment, the levels of IgG, IgA and IgM in the observation group were higher than those in the control group (P <0.01) (P <0.01). After treatment, the levels of serum IL-2 and IFN-γ in the observation group were significantly higher than those in the control group. The levels of IL-4 and IL- 5 levels were lower than the control group (P <0.01). Conclusion: Treatment of recurrent respiratory tract infection with Fuzheng Jianlou Decoction can improve immune function, regulate Th1 / Th2 balance and increase immune capacity in children, thus reducing the frequency of respiratory infection, shortening the course of attack and improving clinical efficacy.