1.Comparison of sleep EEG power spectral density between depressive episode patients and schizophrenia patients with suicidal behavior
Jingwen LIU ; Yunfei ZHOU ; Jingchu HU ; Jiaoyan ZHOU ; Junwei YANG ; Jie LIANG ; Hong XU ; Yu CANG ; Shimeng MA
Sichuan Mental Health 2026;39(1):50-57
BackgroundPatients with depressive episode and schizophrenia have a high risk of suicide. The sleep electroencephalogram power spectral density characteristics of patients with depressive episode accompanied by suicidal behavior and those with schizophrenia may be different, but there is currently a lack of direct comparative studies on these two groups of patients. ObjectiveTo compare the sleep electroencephalogram power spectral density between depressive episode and schizophrenic patients with suicidal behavior, in order to provide references for exploring predictive indicators of suicidal behavior. MethodsFrom June 2018 to December 2020, 20 patients with depressive episode and 20 patients with schizophrenia who had committed suicide within the past month and were treated at the outpatient department of Shenzhen Kangning Hospital were selected. All of them met the diagnostic criteria for depressive episode or schizophrenia as defined in the International Classification of Diseases, tenth edition (ICD-10). Using a random sampling method, 20 volunteers with matching gender and age to the patient groups were selected from the Cuiping community in Shenzhen as the control group. The subjective sleep of the patients was evaluated using the Insomnia Severity Index (ISI), the Dysfunctional Belief and Attitude about Sleep (DBAS), the Disturbing Dreams and Nightmare Severity Index (DDNSI), and the Epworth Somnolence Scale (ESS). The objective sleep of the patients was assessed using polysomnography. The sleep electroencephalogram was filtered and the power spectral density of the brain wave was analyzed and processed for all the subjects. The subjective and objective sleep conditions of the two patient groups were compared, and the sleep electroencephalogram power spectral density of the patient groups and the control group were also compared. ResultsA comparison of subjective and objective sleep conditions between patients with depressive episode accompanied by suicidal behavior and patients with schizophrenia accompanied by suicidal behavior showed no statistically significant differences (P>0.05). Comparisons of sleep electroencephalogram power spectral density in the W stage (average power of α wave, total power of δ wave, average power of δ wave, average power of θ wave), N1 stage (average power of β wave, total power of α wave, total power of δ wave), N2 stage (total power of α wave, average power of α wave, total power of δ wave, average power of δ wave), N3 stage (average power of α wave, average power of δ wave), and R stage (total power of α wave, average power of α wave, total power of δ wave, average power of δ wave) between patients with depressive episode accompanied by suicidal behavior, patients with schizophrenia accompanied by suicidal behavior, and the control group showed statistically significant differences (P<0.05 or 0.01). The total power of δ wave in the W stage and the average power of β wave and δ wave in the N1 stage were higher in two patient groups were higher than those of the control group. The total power of α wave and the average power of α wave in the N2 stage were lower than those of the control group, while the average power of δ wave was higher than that of the control group. The average power of α wave in the N3 stage of both patient groups were lower than that of the control group, while the average power of δ wave was higher than that of the control group. The total power and average power of α wave in the R stage were lower than those of the control group, while the total power and average power of δ wave were higher than those of the control group. All the differences were statistically significant. Patients with depressive episode accompanied by suicidal behavior had higher average powers of α wave, δ wave, and θ wave in the W stage compared with the control group, while the total power of α wave in the N1 stage was lower in the former group. All these differences were statistically significant (P<0.05). ConclusionThe depressive episode patients accompanied by suicidal behavior have highly overlapping sleep electroencephalogram abnormal patterns with those of schizophrenia patients, mainly manifested as a general decrease in α wave power (N2, N3, R stage) and a general increase in δ wave power (W, N1, N2, N3, R stage) as well as β wave power in N1 stage. At the same time, patients with depressive episode accompanied by suicidal behavior also show specific changes, including an increase in the average power of α and θ waves during the wakefulness period (W stage), and a decrease in the total power of α wave in N1 stage. [Funded by Guangdong Province High-level Clinical Key Specialty (with supporting funds from Shenzhen City) (number, SZGSP013); Shenzhen Key Medical Discipline (number, SZXK041); Shenzhen Clinical Medicine Research Center Project (number, 20210617155253001)]
2.Coupling of an Au@AgPt nanozyme array with an micrococcal nuclease-specific responsiveness strategy for colorimetric/SERS sensing of Staphylococcus aureus in patients with sepsis
Xueqin HUANG ; Yingqi YANG ; Hanlin ZHOU ; Liping HU ; Annan YANG ; Hua JIN ; Biying ZHENG ; Jiang PI ; Jun XU ; Pinghua SUN ; Huai-Hong CAI ; Xujing LIANG ; Bin PAN ; Junxia ZHENG ; Haibo ZHOU
Journal of Pharmaceutical Analysis 2025;15(2):389-400
Rapid and ultrasensitive detection of pathogen-associated biomarkers is vital for the early diagnosis and therapy of bacterial infections.Herein,we developed a close-packed and ordered Au@AgPt array coupled with a cascade triggering strategy for surface-enhanced Raman scattering(SERS)and colorimetric identification of the Staphylococcus aureus biomarker micrococcal nuclease(MNase)in serum samples.The trimetallic Au@AgPt nanozymes can catalyze the oxidation of 3,3',5,5'-tetramethylbenzidine(TMB)molecules to SERS-enhanced oxidized TMB(oxTMB),accompanied by the color change from colorless to blue.In the presence of S.aureus,the secreted MNase preferentially cut the nucleobase AT-rich regions of DNA sequences on magnetic beads(MBs)to release alkaline phosphatase(ALP),which subsequently mediated the oxTMB reduction for inducing the colorimetric/SERS signal fade away.Using this"on-to-off"triggering strategy,the target S.aureus can be recorded in a wide linear range with a limit of detection of 38 CFU/mL in the colorimetric mode and 6 CFU/mL in the SERS mode.Meanwhile,the MNase-mediated strategy characterized by high specificity and sensitivity successfully discriminated between patients with sepsis(n=7)and healthy participants(n=3),as well as monitored the prog-nostic progression of the disease(n=2).Overall,benefiting from highly active and dense"hot spot"substrate,MNase-mediated cascade response strategy,and colorimetric/SERS dual-signal output,this methodology will offer a promising avenue for the early diagnosis of S.aureus infection.
3.Optimization of the Extraction Process of Changyan Heji Ⅱ Based on UPLC-Q-TOF-MS/MS Combined with Response Surface Method and Principal Component Analysis
Shulin WANG ; Jing SHANG ; Wenjun LIU ; Zerong CAI ; Mengyu QIAN ; Xiaoxin HU ; Liang CAO ; Zhenz-hong WANG ; Wei XIAO
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(4):501-512
OBJECTIVE To establish a extraction process of Changyan Heji Ⅱ(CYHJ-Ⅱ)based on UPLC-Q-TOF-MS/MS technology combined with response surface analysis,and to optimize the extraction process.METHODS The chemical components in CYHJ-Ⅱ were qualitatively analyzed by UPLC-Q-TOF-MS/MS technology,and the chemical components with good linear relation-ship in mass spectrometry response were selected as process investigation indicators;the extraction process parameters(water addition amount,extraction time and soaking time)were investigated by Box-Behnken design;the comprehensive score was obtained by princi-pal component analysis(PCA),and the optimal process was determined by the comprehensive score combined with response surface a-nalysis.RESULTS Through qualitative analysis,110 components were inferred and identified from CYHJ-Ⅱ,including 2 organic acids,82 flavonoids,13 terpenoids,and 13 alkaloids.Based on the results of qualitative analysis,48 index components with good lin-ear relationships were derived by UPLC-Q-TOF-MS/MS combined with Masshunter mass spectrometry data analysis software.PCA was performed and the comprehensive score was calculated.Response surface analysis was performed with the comprehensive score as an indicator.The optimal extraction process obtained by combining the response surface prediction results and actual production was:soaking for 45 min,8 times the amount of solvent,2 extractions,each time for 120 min.CONCLUSION This study provides a new idea for the investigation of the extraction process of traditional Chinese medicine compound prescriptions and expands a new method for the development of traditional Chinese medicine compound prescriptions.
4.Optimization of the Extraction Process of Changyan Heji Ⅱ Based on UPLC-Q-TOF-MS/MS Combined with Response Surface Method and Principal Component Analysis
Shulin WANG ; Jing SHANG ; Wenjun LIU ; Zerong CAI ; Mengyu QIAN ; Xiaoxin HU ; Liang CAO ; Zhenz-hong WANG ; Wei XIAO
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(4):501-512
OBJECTIVE To establish a extraction process of Changyan Heji Ⅱ(CYHJ-Ⅱ)based on UPLC-Q-TOF-MS/MS technology combined with response surface analysis,and to optimize the extraction process.METHODS The chemical components in CYHJ-Ⅱ were qualitatively analyzed by UPLC-Q-TOF-MS/MS technology,and the chemical components with good linear relation-ship in mass spectrometry response were selected as process investigation indicators;the extraction process parameters(water addition amount,extraction time and soaking time)were investigated by Box-Behnken design;the comprehensive score was obtained by princi-pal component analysis(PCA),and the optimal process was determined by the comprehensive score combined with response surface a-nalysis.RESULTS Through qualitative analysis,110 components were inferred and identified from CYHJ-Ⅱ,including 2 organic acids,82 flavonoids,13 terpenoids,and 13 alkaloids.Based on the results of qualitative analysis,48 index components with good lin-ear relationships were derived by UPLC-Q-TOF-MS/MS combined with Masshunter mass spectrometry data analysis software.PCA was performed and the comprehensive score was calculated.Response surface analysis was performed with the comprehensive score as an indicator.The optimal extraction process obtained by combining the response surface prediction results and actual production was:soaking for 45 min,8 times the amount of solvent,2 extractions,each time for 120 min.CONCLUSION This study provides a new idea for the investigation of the extraction process of traditional Chinese medicine compound prescriptions and expands a new method for the development of traditional Chinese medicine compound prescriptions.
5.Efficacy and Safety of Blinatumomab in Adult Patients with B-Cell Acute Lymphoblastic Leukemia
Ya-Lei HU ; Yong-Feng SU ; Yang LI ; Xuan ZHENG ; An WANG ; Yi-Zhi WANG ; Lei XU ; Chun-Ji GAO ; Liang-Ding HU ; Dai-Hong LIU ; Xiao-Ning GAO
Journal of Experimental Hematology 2025;33(6):1571-1576
Objective:To evaluate the efficacy and safety of blinatumomab in adult patients with relapsed/refractory(R/R)or measurable residual disease(MRD)positive B-cell acute lymphoblastic leukemia(B-ALL)in the real world.Methods:The clinical data of 30 B-ALL patients received at least 1 course of blinatumomab therapy in the Chinese PLA General Hospital from January 1st,2021 to December 31st,2023 were retrospectively analyzed,including pre-treatment baseline clinical feature,post-treatment complete response(CR),CR with partial hematologic recovery(CRh),CR with incomplete hematologic recovery(CRi),complete MRD response rate,MRD response rate(MRD<10-4),overall survival(OS),and disease-free survival(DFS),as well as drug-related adverse reactions.Results:Among 5 patients who were not assessed 4 were MRD negative and 1 did not receive bone marrow biopsy.In the R/R B-ALL group(13 cases),11 patients achieved CR/CRh/CRi and 10 patients achieved complete MRD response.In MRD+group(12 cases),9 patients achieved overall MRD response and 7 patients achieved complete MRD response.The median follow-up time was 8.4(95%CI:6.3-10.4)months.The median OS was 15.5(95%CI:0.7-30.3)months in the R/R group,while not reached in the MRD+group.The median DFS of the two groups were not reached.Drug-related adverse reactions occurred in 22 patients,and pyrexia was the most common(13 cases).Grade ≥3 adverse reactions occurred in 15 patients,and neutropenia was the most common(9 cases).Cytokine release syndrome occurred in 6 patients,including 5 cases with grade 1 and 1 case with grade 3.No patients interrupted therapy or died due to drug-related adverse reactions.Conclusion:Blinatumomab is effective in the treatment of R/R or continuous MRD+B-ALL with acceptable adverse reactions.
6.Mechanism of Myocardial Protection by Electroacupuncture at PC6 Attenuates TRPV1 Pathway-Mediated Dorsal Root Ganglion Sympathetic Sprouting on Myocardial Ischemia-Reperfusion Injury in Rats
Liyuan YANG ; Jinqun HU ; Jian XIONG ; Xiao LI ; Yu LIU ; Ying WEI ; Qianhua ZHENG ; Wenchuan QI ; Fanrong LIANG ; Hong ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1616-1627
Objective To explore the mechanism of electroacupuncture improving myocardial ischemia-reperfusion injury(MIRI),electroacupuncture PC6 Attenuates TRPV1 pathway in spinal cord C5-T6 dorsal root ganglion(DRG)on MIRI rats was observed.Methods After one week of experimental feeding,30 SD rats with normal electrocardiogram were randomly divided into sham-operated group and model group,PC6 group,non-meridian and non-acupuncture group,and PC6+capsaicin(TRPV1 receptor agonist)group,with 6 rats in each group.The MIRI model was prepared by ligation of the left anterior descending(LAD)coronary artery in the other groups.The next day after modeling,electroacupuncture of the"PC6"point in the EA group,electroacupuncture of the caudal"non-meridian non-points"in the the non-meridian non-acupuncture point group,and electroacupuncture of the"PC6"point after intraperitoneal injection of capsaicin in the PC6+capsaicin group,20 min/d for 7 days.ECG was used to record the changes of ST level and LF/HF ratio in rats.Evans blue-TTC double staining and HE staining was used to observe the myocardial infarction area and the changes of myocardial tissue morphology.ELISA was used to detect the levels of serum CK-MB and cTnI.Immunofluorescence staining was used to the phenomenon of sympathetic-sensory coupling with TH-CGRP positive labeling in the DRG of rats.qPCR was to detect the mRNA expression of TRPV1,TH,CGRP,SP,ERK and AKT in rat DRG.Results Compared with the sham-operated group,rats in the model group showed significant higher ST level and LF/HF ratio(both P<0.001),and IA/AAR ratio increased significantly(P<0.0001).Massive inflammatory cell infiltration,serum CK-MB,cTnI levels up-regulated significantly(both P<0.0001).The formation of TH-CGRP-labeled sympathetic budding phenomenon in the DRG and the TRPV1,TH,CGRP in the DRG,SP,ERK,and AKT mRNA expression levels increased significantly(both P<0.01).Compared with the model group,the ECG of the endograft group was significantly improved(both P<0.001).The IA/AAR ratio decreased significantly in PC6 group(P<0.001).The myocardial infarction area reduced significantly(P<0.0001).The levels of serum CK-MB and cTnI down-regulated significantly(both P<0.0001),and the phenomenon of sympathetic sprouting within DRG was not evident,and the DRG of the 6 corresponding mRNA expression decreased significantly(both P<0.01).Compared with the PC6 group,the effect of treatment was not obvious in the non-meridian and non-acupuncture group and PC6+capsaicin group,and the electrocardiogram,IA/AAR ratio,myocardial infarcted area,and serum CK-MB,and cTnI levels did not improve(both P<0.01),and a large number of sympathetic budding phenomena were seen in the DRG.The expression of the mRNA corresponding to the phase of 6 increased significantly(both P<0.01).Conculsion Electroacupuncture PC6 may reduce myocardial injury by inhibiting TRPV1 pathway-mediated sympatheticsprouting in dorsal root ganglia.
7.Efficacy and Safety of Blinatumomab in Adult Patients with B-Cell Acute Lymphoblastic Leukemia
Ya-Lei HU ; Yong-Feng SU ; Yang LI ; Xuan ZHENG ; An WANG ; Yi-Zhi WANG ; Lei XU ; Chun-Ji GAO ; Liang-Ding HU ; Dai-Hong LIU ; Xiao-Ning GAO
Journal of Experimental Hematology 2025;33(6):1571-1576
Objective:To evaluate the efficacy and safety of blinatumomab in adult patients with relapsed/refractory(R/R)or measurable residual disease(MRD)positive B-cell acute lymphoblastic leukemia(B-ALL)in the real world.Methods:The clinical data of 30 B-ALL patients received at least 1 course of blinatumomab therapy in the Chinese PLA General Hospital from January 1st,2021 to December 31st,2023 were retrospectively analyzed,including pre-treatment baseline clinical feature,post-treatment complete response(CR),CR with partial hematologic recovery(CRh),CR with incomplete hematologic recovery(CRi),complete MRD response rate,MRD response rate(MRD<10-4),overall survival(OS),and disease-free survival(DFS),as well as drug-related adverse reactions.Results:Among 5 patients who were not assessed 4 were MRD negative and 1 did not receive bone marrow biopsy.In the R/R B-ALL group(13 cases),11 patients achieved CR/CRh/CRi and 10 patients achieved complete MRD response.In MRD+group(12 cases),9 patients achieved overall MRD response and 7 patients achieved complete MRD response.The median follow-up time was 8.4(95%CI:6.3-10.4)months.The median OS was 15.5(95%CI:0.7-30.3)months in the R/R group,while not reached in the MRD+group.The median DFS of the two groups were not reached.Drug-related adverse reactions occurred in 22 patients,and pyrexia was the most common(13 cases).Grade ≥3 adverse reactions occurred in 15 patients,and neutropenia was the most common(9 cases).Cytokine release syndrome occurred in 6 patients,including 5 cases with grade 1 and 1 case with grade 3.No patients interrupted therapy or died due to drug-related adverse reactions.Conclusion:Blinatumomab is effective in the treatment of R/R or continuous MRD+B-ALL with acceptable adverse reactions.
8.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
9.Clinical analysis of Haemophilus influenzae meningitis in children
Zhenzhen DOU ; Hong LI ; Qiang YE ; Wenbin LIU ; Lingyun GUO ; Bing HU ; Tianming CHEN ; Huili HU ; Xin GUO ; Heying CHEN ; Liang ZHU ; Haijuan XIAO ; Gang LIU
Chinese Journal of Pediatrics 2025;63(3):288-292
Objective:To analyze the clinical characteristics and outcomes of Haemophilus influenzae (Hi) meningitis in children. Methods:This is a retrospective case series study. This study included 34 Hi meningitis patients who admitted to Beijing Children′s Hospital, Capital Medical University, from January 1, 2010, to December 31, 2023. Data on clinical presentations, laboratory tests, hearing assessment and outcomes at discharge were collected. Patients were divided into 2 groups according to the outcome at discharge: favorable outcome group and unfavorable outcome group. Mann-Whitney U test and Fisher exact test was used to estimate the risk factors for an unfavorable outcome at discharge. Results:Thirty-four patients were enrolled. There were 16 males and 18 females. The age at onset ranged from 3 months to 12 years. Fever (34 patients (100%)), convulsions (17 patients (50%)), and coma (21 patients (62%)) were the common clinical presentations. Twenty-four patients (71%) developed complications. There were 15 patients (44%) needed treatment in the intensive care unit, 5 patients (15%) received intubation, and 4 patients (12%) had developed shock. The favorable outcome group included 23 patients, and the unfavorable outcome group included 11 patients. Female, patients with limb movement disability, dystonia, ventriculomegaly or hydrocephalus, and a concentration of glucose in the initial cerebrospinal fluid lower than 1 mmol/L were risk factors of unfavorable outcome at discharge (all P<0.05). Among the 23 patients (68%) in favorable outcomes group, 13 patients (57%) had data available on their long-term follow-up results, including 12 patients with favorable long-term outcomes and 1 patient with unfavorable long-term outcome. Among the 11 patients (32%) in unfavorable outcomegroup, 1 patient died, the other 10 patients (91%) had data available on their long-term outcomes. Eight patients had unfavorable long-term outcomes and 2 patients with favorable long-term outcomes. Patients who had unfavorable outcomes at discharge were at a greater risk of experiencing unfavorable long-term outcomes ( P=0.001). Conclusions:It is common for patients with Hi meningitis to have intracranial complications or develop into critical conditions. Patients who have limb movement disability, dystonia, ventriculomegaly or hydrocephalus, and who exhibit a concentration of glucose in the initial cerebrospinal fluid lower than 1 mmol/L tend to have unfavorable outcomes; they need to be assessed for sequelae.
10.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome

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