1.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
2.Manual reduction combined with 3D printed small splint in treating humeral shaft fractures.
Qiang WANG ; Yan-Kui LENG ; Bo ZHAI ; Jia-Yi XU ; Geng-Sheng JI
China Journal of Orthopaedics and Traumatology 2025;38(4):364-370
OBJECTIVE:
To analyze the clinical efficacy of manual reduction combined with 3D printing small splint external fixation and synchronous manual reduction combined with traditional small splint external fixation in the treatment of humeral shaft.
METHODS:
Between January 2021 and December 2022, 40 patients with humeral shaft fractures were treated with 3D printing small splints and traditional small splints. They were divided into 3D group and traditional group according to different fixation methods. Among them, there were 15 males and 5 females in the 3D group, aged from 20 to 52 years old with an average of (36.3±15.6) years old. In the traditional group there were 17 males and 3 females, aged from16 to 51 years old with an average of (32.9±17.2) years old. The occurrence of complications, duration of fracture healing, rate of fracture healing, subjective evaluation scores for brace comfort at 1 week and 4 weeks, as well as the Constant-Murley shoulder function score and Mayo elbow function score at 8 weeks and 16 weeks were compared between the two groups.
RESULTS:
All patients were followed up for 16 weeks. The 3D group did not experience any complications, while there were two cases of complications in the traditional group. However, this difference was not found to be statistically significant (χ2=2.105, P=0.146). The fracture healing time of the 3D group (90.1±4.5) days was significantly shorter compared to that of the traditional group (93.3±3.8) days (P<0.05). The subjective evaluation scores for brace comfort in the 3D group (53.7±2.3) points and (62.8±1.1) points were significantly higher than those in the traditional group (45.6±2.4) points and (52.3±1.4) points at 1 and 4 weeks after reduction (P<0.05). After 8 weeks of reduction, the Constant-Murley shoulder function score in the 3D group was(68.1±5.3) points, which demonstrated a statistically significant improvement compared to the traditional group(54.3±4.9) points (P<0.05). However, at 16 weeks post-reduction, there were no significant differences observed between the two groups (P>0.05). The Mayo elbow function score of the 3D group (84.1±7.5) points was significantly superior to that of the traditional group (79.5±6.8) points at 8 weeks post-reduction (P<0.05). However, there was no statistically significant difference between the two groups at 16 weeks post-reduction (P>0.05).
CONCLUSION
For humeral shaft fractures with conservative treatment indications, manual reduction combined with 3D printed small splints is a good choice for treatment. The patient's comfort level is higher, which can not only reduce the occurrence of complications, but also improve the fracture healing rate and joint function to a certain extent, and improve the patient's quality of life.
Humans
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Female
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Male
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Adult
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Middle Aged
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Humeral Fractures/physiopathology*
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Printing, Three-Dimensional
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Splints
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Adolescent
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Young Adult
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Fracture Healing
3.Application status and research progress of tranexamic acid in the perioperative period of joint replacement and arthroscopic surgery
Bao-Hua YUAN ; Hai-Ping LIU ; Xing-Yong LI ; Xiao-Ting LIU ; Ji-Hai MA ; Xu-Sheng ZHANG ; Hao-Fei YANG ; Jin-Sheng LI ; Sheng-Long HAN
The Chinese Journal of Clinical Pharmacology 2024;40(7):1080-1084
Tranexamic acid is widely used in joint orthopedic surgery.At the same time,it has high safety and few adverse drug reactions.It can effectively improve intraoperative bleeding and promote early functional recovery of patients.This article reviews the mode of administration,safe dose,administration time and adverse drug reactions of tranexamic acid in the perioperative period of joint replacement and arthroscopic surgery,in order to provide reference for the clinical application of tranexamic acid.
4.Molecular Mechanism and Therapeutic Exploration of CD36 in Breast Cancer
Shengqiao FU ; Qian JI ; Xinyu SUN ; Xi PU ; Yuting WU ; Haowei TANG ; Wanying SHENG ; Xu WANG
Cancer Research on Prevention and Treatment 2024;51(5):380-385
Breast cancer is the most diagnosed cancer in women worldwide and the leading cause of most cancer-related deaths,posing a serious threat to women′s health worldwide.At present,although the prognosis of some patients with breast cancer has improved,the emergence of drug resistance and the metastasis and recurrence of breast cancer are still the main reasons for poor prognosis.CD36 is a multiligand transmembrane glycoprotein expressed on various cell types.In recent years,studies have confirmed that CD36 can reshape the lipid metabolism of cancer cells;promote the differentiation of tumor-related macrophages into M2 type and recruitment into tumor tissues;regulate the function of Treg cells,CD8+T cells,DCs,and other immune cells,and thus promote tumor development.In addition,CD36 is also associated with breast cancer stem cells,metastasis-initiating cells,and breast drug resistant cells.Therefore,CD36 could be an important potential therapeutic target for breast cancer.
5.Design, synthesis, and antifungal mechanism of carbaline fluorescent probes
Xiao-qing WANG ; Ji YANG ; Qiao SHI ; Dong-jian XU ; Na LIU ; Chun-quan SHENG
Acta Pharmaceutica Sinica 2024;59(3):643-650
Three carboline fluorescent probes F1-F3 were designed and synthesized, based on lead compound JYJ-19, an antifungal compound discovered previously by our group. The antifungal activity
6.Design,numerical simulation and experimental study of novel oxygenator
Ming-Hao YUE ; Shi-Yao ZHANG ; Ji-Nian LI ; Hui-Chao LIU ; Zi-Hua SU ; Ya-Wei WANG ; Zeng-Sheng CHEN ; Shi-Hang LIN ; Jin-Yu LI ; Ya-Ke CHENG ; Yong-Fei HU ; Cun-Ding JIA ; Ming-Zhou XU
Chinese Medical Equipment Journal 2024;45(3):23-28
Objective To design a novel oxygenator to solve the existing problems of extracorporeal membrane oxygenation(ECMO)machine in high transmembrane pressure difference,low efficiency of blood oxygen exchange and susceptibility to thrombosis.Methods The main body of the oxygenator vascular access flow field was gifted with a flat cylindrical shape.The topology of the vascular access was modeled in three dimensions,and the whole flow field was cut into a blood inlet section,an inlet buffer,a heat exchange zone,a blood oxygen exchange zone,an outlet buffer and a blood outlet section.The oxygenator was compared with Quadrox oxygenator by means of ANSYS FLUENT-based simulation and prototype experiments.Results Simulation calculations showed the oxygenator designed was comparable to the clinically used ones in general,and gained advantages in transmembrane pressure difference,blood oxygen exchange and flow uniformity.Experimental results indicated that the oxygenator behaved better than Quadrox oxygenator in transmembrane pressure difference and blood oxygen exchange.Conclusion The oxygenator has advantages in transmem-brane pressure difference,temperature change,blood oxygen ex-change and low probability of thrombosis.[Chinese Medical Equipment Journal,2024,45(3):23-28]
7.Clinical Characteristics of CD4-CD56+Blastic Plasmacytoid Dendritic Cell Neoplasm
He-Sheng HE ; Yuan-Feng WEI ; Xin-Yue JI ; You-Hai XU ; Yu-Qiong YANG ; Xiao-Ke JIN
Journal of Experimental Hematology 2024;32(2):588-594
Objective:To explore the clinical manifestations,pathological features,immunophenotype,as well as diagnosis,treatment and prognosis of patients with CD4-CD56+blastic plasmacytoid dendritic cell neoplasm(BPDCN),in order to further understand the rare disease.Methods:The clinical data,laboratory examinations and treatment regimens of two patients with CD4-CD56+BPDCN in the First Affiliated Hospital of Wannan Medical College were retrospectively analyzed.Results:The two patients were both elderly males with tumor involved in skin,bone marrow,lymph nodes,etc.Immunohistochemical results of skin lesions showed that both CD56 and CD123 were positive,while CD4,CD34,TdT,CD3,CD20,MPO and EBER were negative.Flow cytometry of bone marrow demonstrated that CD56,CD123,and CD304 were all positive,while specific immune markers of myeloid and lymphoid were negative.Two patients were initially very sensitive to acute lymphoblastic leukemia or lymphomatoid chemotherapy regimens,but prone to rapid relapse.The overall survival of both patients was 36 months and 4 months,respectively.Conclusion:CD4-CD56+BPDCN is very rare and easily misdiagnosed as other hematological tumors with poor prognosis.Acute lymphoblastic leukemia or lymphomatoid therapy should be used first to improve the poor prognosis.
8.Exploration of the Effect and Mechanism of Tiaoqi Zhike Prescription on Airway Inflammation in Rats with Cough Variant Asthma Based on MAPK/NF-κB Signalling Pathway
Chunying LI ; Yanyan YIN ; Mengyao JI ; Xiyu ZHANG ; Chen XU ; Sheng WANG
Traditional Chinese Drug Research & Clinical Pharmacology 2024;35(7):1008-1015
Objective To investigate the effects and mechanisms of Tiaoqi Zhike Prescription(Ephedrae Herba,Armeniacae Semen Amarum,Fritillariae Thunbergii Bulbus,Scutellariae Radix,Trichosanthis Semen,etc.)on airway inflammation in cough variant asthma rats based on the MAPK/NF-κB signaling pathway.Methods Cough variant asthma rat model was established by ovalbumin sensitization.SD rats were randomly divided into blank group,model group,Dexamethasone group(0.5 mg·kg-1),Montelukast group(1.0 mg·kg-1)and Tiaoqi Zhike Prescription low-,medium-and high-dose groups(9.6,19.2,38.4 g·kg-1),with 10 rats in each group.Intragastric administration was given once a day for 14 consecutive days.The general condition of rats was observed and the number of coughs in rats within two minutes after atomization was recorded.HE staining and Masson staining were used to observe the pathological changes of lung tissue in rats.The levels of serum interleukin-1β(IL-1β),IL-6 and tumor necrosis factor-α(TNF-α)were detected by ELISA.The protein expression levels of p38 MAPK,p-p38,NF-κB p65 and p-p65 in lung tissue were detected by Western Blot.The mRNA expression levels of p38 MAPK and NF-κB p65 in lung tissue were detected by RT-qPCR.Results Compared with the blank group,the times of coughs in the model group was significantly increased(P<0.01),and the pathological score of lung injury and the area ratio of collagen fibers were significantly increased(P<0.01).The levels of serum IL-1β,IL-6 and TNF-α were significantly increased(P<0.01).The protein expressions of p-p38,p-p65,p-p38/p38 and p-p65/p65 in lung tissue were significantly up-regulated(P<0.01),and the mRNA expressions of p38 MAPK and NF-κB p65 were significantly up-regulated(P<0.01).Compared with the model group,the cough frequency of rats in each administration group was significantly decreased(P<0.01),the pathological score of lung injury and the area ratio of collagen fibers were significantly decreased(P<0.01),the levels of serum IL-1β,IL-6 and TNF-α were significantly decreased(P<0.01),and the protein expressions of p-p38 and p-p65 and the mRNA expressions of p38 MAPK and NF-κB p65 in lung tissue were significantly down-regulated(P<0.05,P<0.01).The protein expression ratios of p-p3/p38 and p-p65/p65 in the lung tissue of rats in the high-dose group of Tiaoqi Zhike Prescription were significantly down-regulated(P<0.01).Compared with the Dexamethasone group and the Montelukast group,the number of coughs in the high-dose group of Tiaoqi Zhike Prescription was significantly reduced(P<0.05).Compared with the Dexamethasone group,the serum levels of IL-1β,IL-6 and TNF-α in the high-dose group of Tiaoqi Zhike Prescription were significantly decreased(P<0.01).Compared with the Montelukast group,the levels of serum IL-1β and TNF-α in the high-dose group of Tiaoqi Zhike Prescription were significantly decreased(P<0.05,P<0.01).Conclusion Tiaoqi Zhike Prescription can improve the cough symptoms of ovalbumin-induced cough variant asthma model rats,reduce airway inflammatory cell infiltration and airway remodeling,and reduce the levels of inflammatory cytokines IL-1β,IL-6 and TNF-α.The mechanism may be related to the regulation of MAPK/NF-κB signaling pathway.
9.Letter 2 regarding “Assessing the performance of ChatGPT in answering questions regarding cirrhosis and hepatocellular carcinoma”
Yiwen ZHANG ; Liwei WU ; Zepeng MU ; Linlin REN ; Ying CHEN ; Hanyun LIU ; Lili XU ; Yangang WANG ; Yaxing WANG ; Susan CHENG ; Yih Chung THAM ; Bin SHENG ; Tien Yin WONG ; Hongwei JI
Clinical and Molecular Hepatology 2024;30(1):113-117
10.Deep neck space infections: a retrospective cohort study of surgical risk factors.
Chun Ge ZHENG ; Yan JIANG ; Long Gang YU ; Xu Dong YAN ; Li Wei JIANG ; Ji Sheng ZHANG ; Lin WANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(1):59-63
Objective: To explore risk factors affecting treatment for deep neck space infections (DNSIs) so as to provide guidance for appropriate early managements. Methods: A retrospective cohort study was conducted on inpatients with DNSIs admitted to the Department of Otolaryngology, Head and Neck Surgery, Affiliated Hospital of Qingdao University from March 2013 to February 2021. Patients were divided into surgical and non-surgical groups based on whether they had surgery or not. Information collected included demographic data, disease-related signs and symptoms, treatment history, systemic comorbidities, imaging data and laboratory indicators. Hypothesis testing, univariate Logistic regression and multivariate Logistic regression were used for data processing. Resuts A total of 61 patients were included, including 37 males and 24 females, aged 6-96 years. There were 35 cases (57.4%) in the surgical group and 26 cases (42.6%) in the non-surgical group. Multivariate analysis showed that risk factors for surgery as followings: neck dyskinesia (OR=0.03, 95%CI: 0.00-0.24), dysphagia (OR=0.10, 95%CI: 0.02-0.72), serum white blood cell count≥16.74×109/L (OR=1.18, 95%CI: 1.01-1.39) and interspace gas (OR=0.03, 95%CI: 0.00-0.30). Conclusion: Clinicians should be alert to these risk factors for surgery in the course of treatment and timely surgical treatment for patients who meet the conditions.
Male
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Female
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Humans
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Retrospective Studies
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Neck/surgery*
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Risk Factors
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Deglutition Disorders

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