1.Research on interview outline design and quality control methods based on grounded theory for physician prescribing behavior
Liyuan TAO ; Li WANG ; Xinli XIANG ; Lu YANG ; Songleng DUAN ; Dechun JIANG
China Pharmacy 2025;36(5):524-528
OBJECTIVE To establish a interview outline design process and quality control evaluation method based on grounded theory, providing ideas for qualitative research interview outline design in medical fields. METHODS A literature review was conducted to understand the current research status; a preliminary interview outline was developed around the research content. The triangulation method, group evaluation, expert review and pre-interview were adopted to execute the interview outline and conduct quality control. The evaluation indicators and target values were formulated (an average score for the overall quality evaluation of all indicators ≥4.5, and an average score for individual indicators ≥4.00) to evaluate the effect of the interview outline. Taking the research on the mechanism of physicians’ prescribing behavior under the background of Diagnosis Related Groups (DRGs) payment as an example, the methodological contents of above interview outline were applied in practical research. RESULTS The interview outline included basic information and interview questions. The interview questions were divided into three parts:influencing factors survey, promoting and hindering factors of standardizing physician prescription behavior, and communication, with a total of 12 questions. After being reviewed by members of the research group, experts review and pre- interview, a total of 9 people participated in the quality control evaluation of the interview outline. The overall evaluation score was 4.94 (>4.50), and the average score of each indicator was greater than 4.00, indicating that the quality of the outline met the requirements for the interview and could be used for the formal interview. CONCLUSIONS The established interview outline design and quality control method based on grounded theory provides ideas for the qualitative research interview outline design in the medical field, and lays the foundation for further using grounded theory to study the influencing factors and mechanisms of physician prescription behavior under the DRG background.
2.Study on surface microcirculation sensitization of acupuncture points related to cold coagulation and stasis syndrome in primary dysmenorrhea
Xuxin LI ; Xuesong WANG ; Miao LIN ; Mingjian ZHANG ; Yuanbo GAO ; Xifen ZHANG ; Hao CHEN ; Haiping LI ; Xiaojun ZHENG ; Xisheng FAN ; Jun LIU ; Juncha ZHANG ; Yanfen SHE
Journal of Beijing University of Traditional Chinese Medicine 2025;48(2):253-269
Objective:
To assess the dynamic changes of microcirculation at acupoints in patients with primary dysmenorrhea and cold congelation and blood stasis syndrome using laser speckle blood flow imaging.
Methods:
Patients with primary dysmenorrhea and cold coagulation and blood stasis syndrome (primary dysmenorrhea group, n=53) and healthy female college students(control group, n=57) who met the inclusion and exclusion criteria from October 2020 to July 2022 were enrolled at Hebei University of Chinese Medicine. On the premenstrual and first day of menstruation, a laser speckle blood flow imaging system was used to measure the microcirculation blood flow perfusion on the surface of acupoints related to the conception, thoroughfare, and governor vessels, and stomach, spleen, and bladder meridians in the abdomen and lumbosacral regions. The dynamic changes in microcirculation were calculated based on the difference in average blood flow perfusion at each acupoint before and after menstruation. Receiver operating curve (ROC) analysis was used to analyze the diagnostic efficacy of dynamic changes in microcirculation on the surface of each acupoint. The microcirculation sensitization rate of acupoints was calculated.
Results:
Compared with the control group, the dynamic changes in microcirculation at the following acupoints in the primary dysmenorrhea group were increased (P<0.05): conception vessel (Yinjiao[CV7], Qihai[CV6], Shimen[CV5], Guanyuan[CV4]); left thoroughfare vessel (left Huangshu[KI16], left Zhongzhu[KI15], left Siman[KI14], left Qixue[KI13], left Dahe[KI12], left Henggu[KI11]); left stomach meridian (left Tianshu[ST25], left Wailing[ST26], left Qichong[ST30]); left spleen meridian (left Daheng[SP15], left Fujie[SP14]); right thoroughfare vessel (right Huangshu[KI16], right Zhongzhu[KI15], right Siman[KI14], right Qixue[KI13], right Dahe[KI12], right Henggu[KI11]); right stomach meridian (right Wailing[ST26], right Daju[ST27], right Shuidao[ST28], right Guilai[ST29], right Qichong[ST30]); and right spleen meridian (right Fujie[SP14]). The area under the ROC curve of conception vessel (Yinjiao[CV7], Qihai[CV6], Shimen[CV5], Guanyuan[CV4]), thoroughfare vessel (right Siman[KI14], left Huangshu[KI16], right Qixue[KI13], right Zhongzhu[KI15], right Dahe[KI12], left Zhongzhu[KI15], left Siman[KI14], right Huangshu[KI16], left Qixue[KI13], right Henggu[KI11], left Henggu[KI11], left Dahe[KI12]); stomach meridian (left Tianshu[ST25], right Guilai[ST29], left Wailing[ST26], right Shuidao[ST28], right Daju[ST27], right Wailing[ST26], right Qichong[ST30], left Qichong[ST30]), and spleen meridian (left Daheng[SP15], left Fujie[SP14], right Fujie[SP14]) was 0.610-0.682 (P<0.05). Compared with the control group, the sensitization rate of some acupoints in the primary dysmenorrhea group increased (P<0.05).
Conclusion
With the onset of menstruation, the blood flow perfusion of some acupoints in the abdomen (thoroughfare, and conception vessels, and stomach and spleen meridians) of patients with primary dysmenorrhea and cold blood coagulation and blood stasis syndrome increased, and the status of acupoints changed from a resting state to an active state. These acupoints are sensitive in patients with primary dysmenorrhea and cold blood coagulation and blood stasis syndrome and have a certain diagnostic efficacy, providing a basis for further analyzing the efficacy and mechanism of acupuncture and moxibustion to treat primary dysmenorrhea with cold blood coagulation and blood stasis syndrome.
3.Relationship between serum levels of miR-124,CD146 and Angptl2 and the stability of carotid atherosclerotic plaque in patients with acute cerebral infarction
Xia LI ; Jingmei WANG ; Junhua LI ; Yanyan HU ; Shanshan WANG ; Yajuan MAO ; Yiping WU
International Journal of Laboratory Medicine 2024;45(17):2121-2126,2131
Objective To explore the relationship between serum microRNA-124(miR-124),CD146,angio-poietin-like protein 2(Angptl2)and the stability of carotid atherosclerosis(CAS)plaque in patients with a-cute cerebral infarction(ACI),and to provide reference for early prevention and treatment of patients with ACI.Methods A total of 191 patients with ACI admitted in Handan Central Hospital from January 2020 to February 2023 were selected as ACI group,and another 61 healthy volunteers who were underwent physical examination during the same period were selected as control group.The patients with ACI were divided into unstable plaque group(56 cases),stable plaque group(71 cases),and non plaque group(64 cases)based on carotid color doppler ultrasound results.The serum miR-124 expression levels of all subjects were detected by real time fluorescence quantitative polymerase chain reaction(RT-qPCR),and the serum CD146 and Angptl2 levels were detected by enzyme-linked immunosorbent assay(ELISA).The influencing factors of the instabili-ty of CAS plaque in patients with ACI was analyzed by univariate and multivariate Logistic regression.The predictive value of serum miR-124,CD146 combined with Angptl2 for the instability of CAS plaque in patients with ACI was analyzed by the receiver operating characteristic(ROC)curve.Results The serum CD146 and Angptl2 levels in ACI group were higher than those in control group(P<0.05),and the miR-124 expression level was lower than that in control group(P<0.05).Univariate analysis showed that the stability of CAS plaques in ACI patients was correlated with age,hypertension,hyperlipidemia,fibrinogen(FIB),serum C-reac-tive protein(CRP),serum cystatin C(CyC),CD146,Angptl2 and miR-124(P<0.05).Multivariate Logistic regression analysis showed that the decrease of serum miR-124,the increase of CD146,the increase of Angptl2 and the combination of hyperlipidemia were risk factors for CAS plaque stability in ACI patients(P<0.05).The area under ROC curve(AUC)of serum miR-124,CD146,Angptl2 and the combination of the three indi-cators to predict CAS plaque instability in ACI patients were 0.741,0.719,0.781 and 0.834,respectively.Conclusion The serum miR-124 expression level,CD146 and Angptl2 levels are the influencing factors of CAS plaque instability in ACI patients,which may be involved in the formation and development of CAS plaque in ACI patients.The combined detection of the three factors has a good predictive effect on CAS plaque instability in ACI patients.
4.The predictive value of S100B combined with neuron specific enolase and serum lactate for severe neonatal hypoxic ischemic encephalopathy
Jingmei LI ; Yong ZHOU ; Zhangyan GUO ; Yi WANG
International Journal of Pediatrics 2023;50(12):856-861
Objective:To investigate the predictive value of central nervous system specific protein B (S100B)combined with neuron specific enolase(NSE)and serum lactate for severe neonatal hypoxic ischemic encephalopathy(HIE)induced by perinatal asphyxia.Methods:A retrospective study was conducted.A total of 126 neonates admitted to the Intensive Care Unit of Children′s Hospital Affiliated to Xi ′an Jiaotong University due to perinatal asphyxia from April 2019 to April 2022 were selected as the research subjects.Neonates who were clinically diagnosed with HIE were selected as the observation group(45 cases), and those without HIE were selected as the control group(81 cases). The differences of each parameter between the two groups were compared.Univariate and multivariate Logistic regression were used to analyze the indicators that might cause severe HIE.The risk factors were put into the receiver operating characteristic curve(ROC)to analyze their predictive value for prognosis.Results:There were no significant differences in gestational age, weight and gender between the two groups(all P>0.05). The Apgar scores in the observation group were lower than those in the control group; the rates of cardiopulmonary resuscitation, mechanical ventilation, and prolonged labor were higher than those in the control group.These differences are statistically significant(all P< 0.05). Compared with the control group, the observation group showed significantly higher rates of abnormal brain electroencephalogram and cranial magnetic resonance imaging, as well as increased levels of lactate, S100B( t-values for 8 h and 72 h were 13.10 and 2.00 respectively), and NSE( t-values for 8 h and 72 h were 10.85 and 15.57 respectively), all with statistical significance(all P< 0.05). By conducting binary Logistic regression analysis on indicators that might cause HIE, it was found that Apgar scores at 5 minutes and 10 minutes were negatively correlated with the risk of severe HIE( OR<1 and P<0.05). Prolonged labor, as well as factors such as cardiopulmonary resuscitation, mechanical ventilation, S100B concentration at 8 hours after birth, NSE concentration at 8 hours after birth, and lactate levels were all risk factors for poor prognosis( OR>1 and P<0.05). The predictive threshold values for severe HIE using the biochemical markers S100B, NSE, and lactate were 1.87 μg/L, 19 μg/L, and 4.6 mmol/L respectively.The sensitivity of prediction were 78%, 68%, and 75% respectively; while the specificity were 66%, 71%, and 67%, and all area under the curve(AUC)was greater than 0.5.The sensitivity of the combined prediction by the three factors was 87%, with a specificity of 79% and AUC 0.86( P<0.05). Conclusion:S100B, NSE and serum lactate are independent risk factors for predicting neonatal serve HIE, and the combination of the three indicators can improve the predictive efficiency.
5.Study on Anti-Depression Active Ingredients of Bupleuri Radix Based on UPLC-Q-TOF/MS Integrated with CORT-Induced Poorly Differentiated PC12 Depression Cell Model
Jingbo YU ; Yue HAN ; Ziyang ZHOU ; Qingrui MU ; Jingmei CHEN ; Yuqin OUYANG ; Zhang FEI ; Yuhong WANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(6):2012-2024
Objective To analyze the chemical constituents in the water extract of Bupleuri Radix and investigate the active ingredients of Bupleuri Radix for the treatment of depression.Methods The chemical constituents in the water extract of Bupleuri Radix were identified by Ultra-high-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry(UPLC-Q-TOF/MS).CORT-induced poorly differentiated PC12 depression cell model was launched,and PC12 cells were pretreated with monomeric compounds from Bupleuri Radix for 24 h.The cell viability and LDH release rate were measured by CCK-8 assy kit and LDH assay kit,respectively.Results A total of 53 compounds were identified in the water extract of Bupleuri Radix,mainly including type Ⅰ,type Ⅱ and type Ⅲsaikosaponins.Among them,saikosaponin A,saikosaponin B2,saikosaponin C,saikosaponin E,saikosaponin F and 6″-acetyl saikosaponin A contributed the most to the metabolite profile of Bupleuri Radix,and could improve the viability of CORT-induced PC12 cells(P<0.05,P<0.01).Furthermore,saikosaponin A,saikosaponin B2,saikosaponin C,saikosaponin E and saikosaponin F could decrease the LDH release rate of CORT-induced PC12 cells(P<0.05,P<0.01).Conclusion The major anti-depression active ingredients in Bupleuri Radix may be Saikosaponin A,saikosaponin B2,saikosaponin C,saikosaponin E and saikosaponin F,which lays a foundation for the research of the quality control and pharmacodynamic material basis of Bupleuri Radix.
6.Expression and role of deleted in malignant brain tumor protein 1 in acute respiratory distress syndrome rats induced by sepsis
Chen GE ; Yifan ZHANG ; Hongwei JIA ; Yuquan LUO ; Yiwen ZU ; Zhiwei YANG ; Lijing JIA ; Jingmei WANG ; Quansheng DU
Chinese Critical Care Medicine 2023;35(2):152-157
Objective:To observe the expression of deleted in malignant brain tumor protein 1 (DMBT1) in rat acute respiratory distress syndrome (ARDS) model induced by sepsis and its relationship with ARDS related biomarkers.Methods:Forty-eight healthy male rats were randomly divided into sham operation group (Sham group) and ARDS model group, and the rats in each group were further divided into three subgroups at 6, 12 and 24 hours after operation, with 8 rats in each subgroup. The rats in the Sham group were exposed to the cecum only, and sepsis induced ARDS model was reproduced by cecal ligation and puncture (CLP) in the ARDS model group. The general performance was observed at 6, 12, 24 hours after operation. Abdominal aortic blood of rats was collected, and the levels of DMBT1, surfactant-associated protein D (SP-D), vascular endothelial growth factor (VEGF), interleukins (IL-6, IL-10) in serum were determined by enzyme-linked immunosorbent assay (ELISA). The lung tissues were collected, and the lung wet/dry weight (W/D) ratio was determined. The lung tissue pathological changes were observed under light microscope after hematoxylin-eosin (HE) staining, and the lung tissue injury score was evaluated. The expression of DMBT1 protein in lung tissue was determined by Western blotting. The relationship between the serum DMBT1 and SP-D, VEGF, IL-6, IL-10, lung tissue injury score were analyzed by Pearson correlation analysis.Results:Rats in the ARDS model group showed obvious pathological manifestations after operation. The alveolar structure destruction, inflammatory cell infiltration, and alveolar hemorrhage were observed under microscope. Compared with the Sham group, the lung tissue injury score and the lung W/D ratio at 12 hours after operation in the ARDS model group were significantly increased (lung tissue injury score: 3.35±0.13 vs. 1.16±0.07, lung W/D ratio: 5.36±0.44 vs. 4.38±0.35, both P < 0.05), and pulmonary edema was present, which suggested that the ARDS model caused by CLP was successfully reproduced. The results of ELISA and Western blotting showed that the levels of serum DMBT1, SP-D, VEGF and IL-6 in the ARDS model group increased gradually with time, while the level of IL-10 increased first and then decreased. Compared with the Sham group, the levels of DMBT1 in serum and the expressions of DMBT1 protein in lung tissue in the ARDS model group were significantly increased from 6 hours after operation [serum (ng/L) : 231.96±19.17 vs. 187.44±10.19, lung tissue (DMBT1/β-actin): 2.05±0.19 vs. 0.93±0.25, both P < 0.05], and the levels of SP-D, VEGF, IL-6 and IL-10 in serum were significantly increased from 12 hours after operation [SP-D (ng/L): 73.35±8.05 vs. 43.28±5.77, VEGF (ng/L): 89.85±8.47 vs. 43.19±5.11, IL-6 (ng/L): 36.01±2.48 vs. 17.49±1.77, IL-10 (ng/L): 84.55±8.41 vs. 39.83±5.02, all P < 0.05]. Pearson correlation analysis showed that serum DMBT1 was positively correlated with serum SP-D, VEGF, IL-6, IL-10 and lung injury score at 12 hours and 24 hours in the ARDS model group (12 hours: r values were 0.946, 0.942, 0.931, 0.936, 0.748, respectively; 24 hours: r values were 0.892, 0.945, 0.951, 0.918, 0.973, respectively; all P < 0.05). Conclusion:DMBT1 is a novel early biomarker of ARDS by affecting alveolar epithelial cell, alveolar capillary permeability and inflammatory response.
7.Effect of intrathecal exosomes derived from human amniotic fluid on neuropathic pain in mice
Sha ZHANG ; Jingmei XU ; Ping LI ; Tao ZHONG ; E WANG ; Qulian GUO ; Yong YANG
Chinese Journal of Anesthesiology 2023;43(1):67-71
Objective:To evaluate the effect of intrathecal exosomes derived from human amniotic fluid (hAF exo) on neuropathic pain induced by spared nerve injury (SNI) in mice.Methods:Eighteen clean-grade healthy male Kunming mice, aged 7-8 weeks, weighing 30-35 g, were divided into 3 groups ( n=6 each) using a random number table method: sham operation group (Sham group), SNI group, and SNI+ hAF exo group. Spared nerve injury was produced by exposing the sciatic nerve and its branches and ligation and transection of tibial nerve and common fibular nerve in anesthetized mice. Another three mice were selected to develop the model of neuropathic pain after anesthesia. PKH-26 labeled hAF exo 7 μl was intrathecally injected on days 1, 2 and 3 after developing the model. The mice were sacrificed at 10 h after the end of administration, and the uptake of hAF exo by the dorsal horn of the injured lumbar enlargement of the spinal cord was observed with the fluorescence microscope. On 1, 2 and 3 days after developing the model, 1 μg/μl hAF exo 7 μl was intrathecally injected in SNI+ hAF exo group, and PBS 7 μl was intrathecally injected in Sham group and SNI group. The mechanical paw withdrawal threshold (MPWT) was measured at 1 day before and 1, 3, 5 and 7 days after operation. And then the mice were sacrificed after measurement of the pain threshold at 7 days after developing the model, and the ipsilateral lumbar enlargement of the spinal cord was taken for determination of the expression of CD11b, interleukin-1beta (IL-1β) and IL-10 by Western blot. Results:The dorsal horn of the lumbar enlargement of the spinal cord on the injured side could absorb hAF exo with the fluorescence microscope. Compared with Sham group, the MPWT was significantly decreased at 3-7 days after developing the model, the expression of CD11b and IL-1β was up-regulated ( P<0.05), and no significant change was found in the expression of IL-10 in SNI group ( P>0.05). Compared with SNI group, the MPWT was significantly increased at 3-7 days after developing the model, the expression of CD11b and IL-1β was down-regulated, and the expression of IL-10 was up-regulated in SNI+ hAF exo group ( P<0.05). Conclusions:Intrathecal exosomes derived from human amniotic fluid can alleviate neuropathic pain in mice, and the mechanism may be related to mediation of the polarization of microglia from M1 type to M2 type and attenuation of neuroinflammation.
8.Metabolomic Analysis of Urine in Rat Model with Spleen-stomach Damp-heat Syndrome
Jingbo YU ; Yue HAN ; Xin XIE ; Ziyang ZHOU ; Jingmei CHEN ; Weiyi WANG ; Jingsong QIU ; Yuhong WANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(10):166-173
ObjectiveTaking the rat model of spleen-stomach damp-heat syndrome(SSDHS) as the research object, this study aimed to investigate the potential biomarkers of SSDHS and the related metabolic pathways based on urine metabolomics, and tried to reveal the essence of SSDHS at the level of endogenous small molecular metabolites. MethodSixteen SD rats were randomly divided into normal and model groups. The normal group was fed normal chow and the model group was fed with 200 g·L-1 honey water daily, and lard and Chinese Baijiu alternately on alternate days for 17 days. The SSDHS model rats were exposed to external dampness-heat environment with temperature at 30-34 ℃, relative humidity of 95% for 2 h at the same time every day from the 10th day for 7 d. Then, the model was evaluated by observing the general conditions of the rats, measuring the contents of motilin(MTL) and gastrin(GT) in plasma by enzyme-linked immunosorbent assay(ELISA), and examining the histopathology of gastronitestinal tissues. In additon, the urine metabolomics analysis was performed by ultra-high performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(UPLC-Q-TOF-MS), and the detection conditions was as follows:ACQUITY™ UPLC BEH C18 column(2.1 mm×100 mm, 1.7 μm), mobile phase of 0.1% formic acid aqueous solution(A)-0.1% formic acid acetonitrile solution(B) for gradient elution (0-3 min, 1%-18%B; 3-8 min, 18%-40%B; 8-10 min, 40%-100%B), the flow rate of 0.4 mL·min-1, electrospray ionization(ESI) in positive and negative ion modes, scanning range of m/z 50-1 000. The univariate and multivariate statistical analysis were constructed for screening inter-group differential ions, the element composition was calculated according to the precise relative molecular weight, and ion information was matched with databases such as Human Metabolome Database(HMDB) to identify biomarkers. Kyoto Encyclopedia of Genes and Genomes(KEGG) database was used to obtain the biological information of metabolites, and their associated metabolic pathways were analyzed by MetaboAnalyst 5.0. ResultCompared with the normal group, the rectal temperature of the model group increased significantly(P<0.01), the levels of plasma MTL and GT decreased significantly(P<0.05, P<0.01), and pathological changes such as bleeding, congestion and inflammatory infiltration in the gastric and colonic tissues. A total of 25 differential metabolites such as L-histidine, citric acid and isocitric acid were found to be the potential biomarker of SSDHS by urine metabolomics, 13 of which were phase Ⅱ metabolites of endogenous substances(glucuronic acid conjugates, sulfuric acid conjugates and acetyl conjugates), involving the metabolic pathways of histidine metabolism, tricarboxylic acid cycle, glyoxylate and dicarboxylate metabolism. ConclusionSSDHS primarily causes disorders of histidine metabolism, tricarboxylic acid cycle, glyoxylate and dicarboxylate metabolism, as well as the imbalance of the activation/inactivation of endogenous metabolites, which may involve the immune response, material and energy metabolism, inflammatory response and intestinal flora, and may provide a basis for the establishment and application of SSDHS model.
9.Complications of central venous catheterization and risk factors in Pediatric Intensive Care Unit of Xi 'an Children's Hospital
Jingmei LI ; Feiran GE ; Yi WANG ; Hua ZHANG
Chinese Journal of Primary Medicine and Pharmacy 2023;30(6):824-828
Objective:To analyze the incidence of complications of central venous catheterization and risk factors in the Pediatric Intensive Care Unit of Xi'an Children 's Hospital.Methods:The clinical data of 310 children who underwent central venous catheterization in the Pediatric Intensive Care Unit of Xi 'an Children's Hospital from June 2020 to February 2021 were retrospectively analyzed. The incidence of complications of central venous catheterization and risk factors were analyzed.Results:A total of 334 central venous catheters were used in 310 chidren. Among the 310 children who underwent central venous catheterization, 102 children (30.54%) had complications related to central venous catheterization. The complications related to central venous catheterization included catheter infection (13.17%), catheter malposition (8.38%), exudation at the puncture site (4.79%), catheter occlusion (2.99%), accidental removal (0.60%), and central venous thrombosis (0.60%). Central venous catheters were removed in 82 children (24.55%) because of complications. There was a significant difference in the incidence of central venous thrombosis among three surgical approaches: femoral vein, internal jugular vein, and subclavian vein ( χ2 = 7.06, P = 0.029). Longer time for catheterization resulted in a higher incidence of complications, including catheter-related infection ( χ2 = 7.17, P = 0.028), puncture point exudation and obstruction ( χ2 = 8.59, P = 0.014), central venous thrombosis ( χ2 = 6.78, P = 0.034). Regression analysis showed that suture shedding and bleeding at the insertion sites were the main risk factors for catheter-related complications (suture shedding OR = 4.85, P = 0.001; bleeding at the insertion sites OR = 1.83, P = 0.008). Conclusion:The most common complications of central venous catheterization in the Pediatric Intensive Care Unit of Xi'an Children's Hospital include catheter-related infection, catheter malposition, and puncture site exudation. Risk factors for complications during catheter retention include suture shedding and bleeding at the insertion sites.
10.Efficacy and safety of modified Atkins diet in children with global developmental delay: a multicenter clinical study
Yiwen WANG ; Dengna ZHU ; Na MA ; Zhenjun SU ; Shuming YANG ; Shunyi SONG ; Jingmei FU ; Haitao WANG ; Juan LIU ; Tao ZHANG
Chinese Journal of Applied Clinical Pediatrics 2022;37(12):929-933
Objective:To evaluate the efficacy and safety of modified Atkins diet (MAD) in treating global growth retardation (GDD).Methods:A prospective multicenter clinical controlled study was conducted.The children were included from 8 departments of children′s rehabilitation in Henan Province from July 2017 to October 2017.A total of 154 children who met the inclusion criteria were randomly assigned into the routine treatment group (88 cases) and MAD therapy group (66 cases). A total of 62 children in MAD therapy group and 59 children in routine treatment group completed the study for 15 months.The routine treatment group was provided comprehensive rehabilitation training, and the MAD therapy group was given MAD treatment on the basis of rehabilitation training.Two-way repeated-measures ANOVA was used to compare the differences among datas at different time points. Results:After 3 months, there were significant differences in the scores of the Chinese Version of Urban Infant-Toddler Social and Emotional Assessment (CITSEA)/Achenbach Children′s Behavior Scale (CBCL) between the 2 groups (all P<0.05). Significant improvement was seen in the MAD group.After 6 months, the MAD therapy group had significantly higher scores on the Gesell Developmental Scale for language and social behavior than the routine treatment group (all P<0.05). After 9 months, the scores of the children in the MAD therapy group were better than those in the routine treatment group in the Gesell Developmental Scale adaptive energy area and the infant-junior high school student social life scale (S-M scale), and the differences were statistically significant (all P<0.05). After 15 months, the fine motor in the MAD therapy group was better than that in the routine treatment group ( P<0.05). At the early stage of MAD therapy, 28 patients showed mild adverse reactions that were reversed after symptomatic treatment.No severe adverse reactions were observed. Conclusions:MAD therapy can improve the neuro-development, emotional and social behaviors, and adaptive behaviors with no severe adverse effects.


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