Multicenter Randomized Controlled Clinical Trial of Longmu Zhuanggu Granule in Treatment of Children Recurrent Respiratory Infection with Lung-Spleen Qi Deficiency Syndrome
10.13422/j.cnki.syfjx.20212392
- VernacularTitle:龙牡壮骨颗粒治疗小儿反复呼吸道感染肺脾气虚证多中心随机对照临床观察
- Author:
Xin-lu ZHU
1
;
Si-yuan HU
1
;
Cheng-liang ZHONG
1
;
Hong-fang LUO
2
;
Yun-feng ZHANG
3
;
Yue-xia ZHANG
4
;
Mo-li GAO
5
;
Hai-jun FENG
6
;
Juan WU
7
;
Ying DING
8
;
Niu-an MENG
9
;
Yu-hua BAI
10
;
Wen-long YI
11
Author Information
1. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine（TCM），National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion，Tianjin 300193，China
2. The Second Affiliated Hospital of Guizhou Medical University，Kaili 556000，China
3. The Second Hospital of Jilin University，Changchun 130041，China
4. Luoyang Second Hospital of TCM，Luoyang 471003，China
5. Qian 'an Hospital of TCM，Tangshan 064499，China
6. Daqing People's Hospital，Daqing 163711，China
7. Qiandongnan Miao and Dong Autonomous Prefecture Hospital of TCM，Kaili 556000，China
8. The First Affiliated Hospital of Henan University of Chinese Medcine，Zhengzhou 450099，China
9. Anyang Hospital of TCM，Anyang 455001，China
10. Inner Mongolia International Mongolian Hospital，Hohhot 010020，China
11. Tianyou Hospital Affiliated to Wuhan University of Science&Technology，Wuhan 430070，China
- Publication Type:Research Article
- Keywords:
Longmu Zhuanggu granule;
recurrent respiratory infection;
children;
randomized controlled trial
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2021;27(23):111-117
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the clinical efficacy and safety of Longmu Zhuanggu granule for the treatment of children recurrent respiratory infection due to lung-spleen Qi deficiency. Method:This multicenter stratified， block-randomized， double-blind， double-dummy， positive drug （pidotimod granule） parallel controlled， and non-inferiority trail intended to included 240 children patients and divided them into the experimental group （n=120） and the control group （n=120） at the ratio of 1∶1. Patients in both groups were treated for eight successive weeks and followed up for 12 months. The cure rates， numbers of respiratory infections， average courses of disease， curative effects of traditional Chinese medicine （TCM） syndrome， curative effects of individual symptoms， curative effects of immune indexes， and safety indexes between the two groups were observed and compared. Result:A total of 237 subjects were collected from 10 research centers， including 119 cases in the control group and 118 in the experimental group. There were 236 cases enrolled into the full analysis set （FAS）， 210 into the per-protocol set （PPS）， and 236 into the safety set （SS）. The baseline data of the two groups were not significantly different from each other， indicating that they were comparable. The cure rates of the experimental group and control group were 75.21% （88/117） and 73.95%（88/119）， respectively， with the 95% confidence interval （CI） of difference between the two groups being 1.26% （-9.85%，12.37%） for FAS and 3.81% （-6.28%，13.90%） for PPS. The 95% CI fell within the 10% non-inferiority margin， implying that non-infertility test of the cure rate in the treatment of endpoint disease was valid， and the conclusions of FAS and PPS analysis were consistent. There was no significant difference in the number or course of upper respiratory infection， bronchitis， and pneumonia. The difference in curative effects of TCM syndrome between the two groups after four weeks of treatment was not remarkable. After eight weeks of treatment， the total effective rate of the experimental group was 84.62%（99/117）， statistically higher than 78.15%（93/119） of the control group（χ2=-3.26，P<0.05）. There were no significant differences in the disappearance rates of individual symptoms between the two groups after four weeks of treatment. After eight weeks of treatment， the experimental group and control group exhibited the disappearance rates of 67.50%（54/80） and 47.37%（36/76） for shortness of breath and laziness to speak， 75.00%（54/72） and 53.33%（40/75） for poor appetite， 54.55%（60/110） and 37.84%（42/111） for hyperhidrosis， respectively， with obviously better outcomes observed in the experimental group （P<0.05，P<0.01）. The inter-group comparison revealed significant differences in immune indexes after eight weeks of treatment. As demonstrated by comparison with the situations before treatment， IgA， IgG， IgM， and CD4 did not change significantly after treatment. Except for CD8 in the experimental group (P<0.05), there was no significant difference in other immune indexes before and after treatment There was no significant difference in the incidence of adverse reactions. Conclusion:Longmu Zhuanggu granule is not inferior to pidomod granule in the treatment of children recurrent respiratory infection due to lung-spleen Qi deficiency， and it exhibits good safety， implying its promising clinical application value.
