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【目的】观察七味白术散加减治疗脾虚湿困型小儿肠系膜淋巴结炎的疗效。【方法】采用多中心随机对照的方法,将150例脾虚湿困型肠系膜淋巴结炎患儿随机分为中药组、西药组和中西医结合组(简称中西医组)各50例。中药组给予口服七味白术散加减治疗,中西医组给予口服七味白术散联合头孢克洛干混悬剂治疗,西药组给予口服头孢克洛干混悬剂治疗。观察3组患儿治疗前及治疗后7 d、1个月及3个月的中医证候变化及腹部肠系膜淋巴结大小变化,比较3组患儿的总有效率及痊愈率,并评价不同治疗方案的安全性。【结果】(1)中药组脱落5例,最终完成观察45例;西药组脱落3例,最终完成观察47例;中西医组脱落7例,最终完成观察43例。(2)中药组和中西医组患儿治疗后7 d、1个月和3个月的总有效率均明显高于西药组(P<0.01),治疗后1个月和3个月的痊愈率也均明显高于西药组(P<0.01);而中药组与中西医组患儿同时期的总有效率和痊愈率比较,差异均无统计学意义(P>0.05)。(3)中药组和中西医组患儿治疗后7 d、1个月和3个月腹部肠系膜淋巴结横径和纵径均明显小于西药组(P<0.05);而中药组与中西医组患儿不同时期的腹部肠系膜淋巴结横径和纵径比较,差异均无统计学意义(P>0.05)。(4)除脱落病例外,其他患儿均完成全部疗程的治疗;且治疗期间,各组患儿均未出现明显不良反应。【结论】七味白术散加减治疗脾虚湿困型肠系膜淋巴结炎的疗效确切。
【Objective】 To observe the therapeutic effect of Qiweibaizhu San on the treatment of children with meningitis due to spleen dampness syndrome. 【Methods】 A total of 150 children with spleen dampness-trapped mesenteric lymphadenitis were randomly divided into TCM group, western medicine group and TCM-WM group (50 cases in each group) by multi-center randomized controlled trial. The traditional Chinese medicine group was treated by oral administration of Qiweibaizhu Powder, while the western medicine group was given oral Shiwei Baizhu Powder combined with cefaclor dry suspension. The western medicine group was given oral Cefaclor dry suspension treatment. The changes of TCM syndromes and the changes of mesenteric lymph node size in the three groups before and after 7 d, 1 month and 3 months after treatment were observed. The total effective rate and cure rate were compared between the three groups, and the different treatment regimens were evaluated Security. 【Results】 (1) The Chinese medicine group shed 5 cases and the final observation 45 cases; the western medicine group 3 cases fall off and the final observation 47 cases; the Chinese and Western medicine group shed 7 cases and the final observation 43 cases. (2) The total effective rate at 7 d, 1 month and 3 months after treatment in the traditional Chinese medicine group and the western medicine group were significantly higher than those in the Western medicine group (P <0.01), 1 month and 3 months after treatment (P <0.01). However, there was no significant difference in the total effective rate and recovery rate between the Chinese medicine group and the Western medicine group in the same period (P> 0.05). (3) The mean diameter and longitudinal diameter of mesenteric lymph nodes of abdominal mellitus in 7 days, 1 month and 3 months after treatment in Chinese medicine group and Western medicine group were significantly less than those in western medicine group (P <0.05) There were no significant differences in the transverse diameter and longitudinal diameter of mesenteric lymph nodes in children between different periods (P> 0.05). (4) In addition to shedding cases, other children completed the whole course of treatment; and during treatment, no significant adverse reactions in each group of children. 【Conclusion】 Qiweibaizhu San addition and subtraction treatment of spleen wet trapped mesenteric lymphadenitis curative effect is exact.