龙牡壮骨颗粒治疗小儿汗证肺脾气虚证(维生素D缺乏性佝偻病早期)多中心随机对照临床试验

Multi-center randomized controlled clinical trial of Longmu Zhuanggu Granule in treatment of sweating syndrome with lung and spleen qi deficiency in children(early stage of vitamin D deficiency rickets)

目的:评价龙牡壮骨颗粒治疗小儿汗证肺脾气虚证(维生素D缺乏性佝偻病早期)的临床疗效及安全性。方法:采用随机双盲、阳性药平行对照、多中心设计,将240例患儿以1∶1比例分为试验组和对照组。试验组予龙牡壮骨颗粒+维生素D滴剂模拟剂,对照组予龙牡壮骨颗粒模拟剂+维生素D滴剂,疗程均为8周。比较两组自汗、盗汗总有效率,中医证候疗效,血清钙、磷、碱性磷酸酶、25-(OH)D_(3)、腕部X线复常率和安全性指标。结果:试验组、对照组自汗、盗汗疗效总有效率分别为86.44%(102/118)、75.00%(87/116),试验组优于对照组(P<0.05)。中医证候疗效试验组优于对照组(P<0.05);两组血清钙、磷、碱性磷酸酶、25-(OH)D_(3)、腕部X线复常率比较,差异无统计学意义。两组各发生16例不良事件,无药物不良反应,组间差异无统计学意义。结论:龙牡壮骨颗粒治疗小儿汗证肺脾气虚证(维生素D缺乏性佝偻病早期)疗效确切,且临床应用安全性较好。

Objective:To evaluate the clinical efficacy and safety of Longmu Zhuanggu Granule in the treatment of sweating syndrome with lung and spleen qi deficiency(early stage of vitamin D deficiency rickets).Methods:Randomized,double-blind,positive drug-parallel-controlled,multi-center clinical trial design were used to divide 240 children in a 1∶1 ratio into the experimental group and the control group.The experimental group was given Longmu Zhuanggu Granules and Vitamin D drops simulant while the control group was received Vitamin D drops and Longmu Zhuanggu Granules simulant,and both groups treatment for 8 weeks.The efficiency of spontaneous and night sweating,efficacy of traditional Chinese medicine syndromes,recovery rate of serum calcium,phosphorus,alkaline phosphatase,25-hydroxyvitamin D and wrist X-ray,and safety indicators were compared between the 2 groups.Results:After treatment,the total effective rate of spontaneous and night sweating was 86.44%(102/118)in the experimental group and 75.00%(87/116)in the control group,there was significant difference between the 2 groups(P<0.05).and there was also significant difference between the 2 groups for the effective rate of syndromes of TCM(P<0.05),Two groups did not differ in terms of the recovery rate of serum calcium,serum phosphorus,serum alkaline phosphatase,serum 25-hydroxyvitamin D and wrist X-ray.There were 16 adverse events in each of the two groups and no adverse drug reactions,with no significant difference in the incidence of adverse events and adverse reactions between the 2 groups.Conclusion:Longmu Zhuanggu Granule is effective in the treatment of infant sweating syndrome with lung and spleen qi deficiency in children(early vitamin D deficiency rickets),and has good clinical safety.