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.Optimization of extraction process for Shenxiong Huanglian Jiedu Granules based on AHP-CRITIC hybrid weighting method, grey correlation analysis, and BP-ANN.
Zi-An LI ; De-Wen LIU ; Xin-Jian LI ; Bing-Yu WU ; Qun LAN ; Meng-Jia GUO ; Jia-Hui SUN ; Nan-Yang LIU ; Hui PEI ; Hao LI ; Hong YI ; Jin-Yu WANG ; Liang-Mian CHEN
China Journal of Chinese Materia Medica 2025;50(10):2674-2683
By employing the analytic hierarchy process(AHP), the CRITIC method(a weight determination method based on indicator correlations), and the AHP-CRITIC hybrid weighting method, the weight coefficients of evaluation indicators were determined, followed by a comprehensive score comparison. The grey correlation analysis was then performed to analyze the results calculated using the hybrid weighting method. Subsequently, a backpropagation-artificial neural network(BP-ANN) model was constructed to predict the extraction process parameters and optimize the extraction process for Shenxiong Huanglian Jiedu Granules(SHJG). In the extraction process, an L_9(3~4) orthogonal experiment was designed to optimize three factors at three levels, including extraction frequency, water addition amount, and extraction time. The evaluation indicators included geniposide, berberine, ginsenoside Rg_1 + Re, ginsenoside Rb_1, ferulic acid, and extract yield. Finally, the optimal extraction results obtained by the orthogonal experiment, grey correlation analysis, and BP-ANN method were compared, and validation experiments were conducted. The results showed that the optimal extraction process involved two rounds of aqueous extraction, each lasting one hour; the first extraction used ten times the amount of added water, while the second extraction used eight times the amount. In the validation experiments, the average content of each indicator component was higher than the average content obtained in the orthogonal experiment, with a higher comprehensive score. The optimized extraction process parameters were reliable and stable, making them suitable for subsequent preparation process research.
Drugs, Chinese Herbal/analysis*
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Neural Networks, Computer
3.Thermal Ablation of Pulmonary Nodules by Electromagnetic Navigation Bronchoscopy Combined With Real-Time CT-Based 3D Fusion Navigation:Report of One Case.
Yuan XU ; Qun LIU ; Chao GUO ; Yi-Bo WANG ; Xiao-Fang WU ; Chen-Xi MA ; Gui-Ge WANG ; Qian-Shu LIU ; Nai-Xin LIANG ; Shan-Qing LI
Acta Academiae Medicinae Sinicae 2025;47(1):137-141
A nodule in the right middle lobe of the lung was treated by a combination of cone-beam CT,three-dimensional registration for fusion imaging,and electromagnetic navigation bronchoscopy-guided thermal ablation.The procedure lasted for 90 min,with no significant bleeding observed under the bronchoscope.The total radiation dose during the operation was 384 mGy.The patient recovered well postoperatively,with only a small amount of blood in the sputum and no pneumothorax or other complications.A follow-up chest CT on the first day post operation showed that the ablation area completely covered the lesion,and the patient was discharged successfully.
Humans
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Bronchoscopy/methods*
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Catheter Ablation/methods*
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Cone-Beam Computed Tomography
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Electromagnetic Phenomena
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Imaging, Three-Dimensional
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Lung Neoplasms/diagnostic imaging*
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Tomography, X-Ray Computed
4.CT examination big data based on the Ningbo City Medical Imaging Cloud Platform
ZHANG Qun ; ZHANG Dandan ; WANG Yong ; ZHANG Liang ; ZOU Yuanjie ; LU Beibei ; TANG Sheng
Journal of Preventive Medicine 2025;37(12):1257-1260,1265
Objective:
To evaluate the radiation dose, operational standardization, and image quality of computed tomography (CT) Ningbo City Medical Imaging Cloud Platform, so as to provide references for optimizing the quality of CT examinations.
Methods:
Six CT devices were randomly selected from the Ningbo City Medical Imaging Cloud Platform. Digital Imaging and Communication in Medicine (DICOM) image data from CT examinations of the head, neck, chest, and abdomen in males aged 36 to 60 years were collected from January 2023 to December 2024. The radiation dose levels were evaluated using the volume CT dose index (CTDIvol) and dose length product (DLP). The coefficient of variation (CV) of CTDIvol and scan length were calculated to assess scan stability. Operational standardization was evaluated using the redundancy rate of scan length and protocol matching degree. Imaging quality was assessed using the signal to noise ratio (SNR) and contrast to noise ratio (CNR).
Results:
A total of 28 897 DICOM images were collected, including 6 730 axial scans of the skull, 2 778 plain scans of the neck, 15 496 plain scans of the chest, and 3 893 plain scans of the abdomen. The typical values of CTDIvol and DLP radiation doses for the head, neck, and chest were all lower than the diagnostic reference levels. The maximum typical values of CTDIvol and DLP for the abdomen were 22.49 mGy and 941.45 mGy·cm, respectively, which were higher than the diagnostic reference levels. The CV values of CTDIvol and scan length ranged from 14.59% to 37.88% and from 8.27% to 44.96%, respectively. The scan stability of head CT was relatively poor, with CV values ranging from 21.74% to 37.88% and from 12.66% to 44.96%, respectively. The redundancy rate of scan length ranged from 6.02% to 74.40%, and the protocol matching degree ranged from 79.80% to 100.00%. The operational standardization of neck CT was relatively poor, with redundancy rates ranging from 45.70% to 74.40% and protocol matching degrees ranging from 79.80% to 95.36%. The mean SNR and mean CNR of the pulmonary arteries in the chest were relatively high, ranging from 15.81 to 17.65 and from 6.33 to 7.41, respectively.
Conclusions
The radiation doses from abdominal CT examinations on some CT devices exceed the diagnostic reference levels. The scan stability of head CT examinations and the operational standardization of neck CT examinations represent weak points in quality control. It is recommended to carry out targeted quality control training to enhance the overall quality level of CT examinations.
5.Integrated Chinese and Western Medicine Prognosis Model of Complications in Patients with Influenza A/B or COVID-19
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(19):144-153
ObjectiveBased on real-world clinical data of traditional Chinese medicine (TCM), a Cox proportional hazards model was built to predict the risk factors of complications in patients with Corona Virus Disease 2019 (COVID-19) or influenza A/B, and the cumulative occurrence function graph was used to present the prediction output. MethodThe medical records of the patients with respiratory infectious diseases, including COVID-19 and influenza A/B, treated in the First Affiliated Hospital of Heilongjiang University of Chinese Medicine from November 2022 to October 2023 were collected. The data from the electronic medical record system were integrated into a data warehouse. The information of the patients with respiratory diseases caused by influenza A and B viruses and SARS-CoV-2 from November 2022 to October 2023 was retrospectively collected. The information involved age, gender, disease course, past medical history, laboratory test results, tongue manifestation, pulse manifestation, TCM syndrome, and main therapeutic drugs. The outcome indicators of whether complications occurred were obtained by telephone follow-up and review of readmission records. The data was divided into a training set and a validation set in a ratio of 70% and 30%, respectively. In the training set, the Cox proportional hazards model was used to identify the key factors affecting patient complications. Then, the combination of variables was optimized by stepwise elimination method, and an efficient complication risk assessment model was constructed, which was visualized in the form of histogram. The C-index, receiver operating characteristic (ROC) curve, calibration error graph, and decision curve analysis were employed to comprehensively measure the prediction performance of the model. ResultThe history of chronic lung diseases [hazard ratio (HR) 4.46, 95% confidence interval (95%CI) 1.79-11.12], Qi deficiency (HR 5.74, 95%CI 2.14-15.39), thready and weak pulse (HR 4.45, 95%CI 1.88-10.50), hormone use history (HR 4.57, 95%CI 2.04-10.23), procalcitonin (PCT>10 μg·L-1) (HR 1.23, 95%CI 0.06-0.86), serum amyloid A (SAA)>100 mg·L-1 (HR 9.80, 95%CI 7.24-59.75), and platelet (PLT)>303×109 /L (HR 5.66, 95%CI 2.01-16.00) were the risk factors for complications. Chinese medicine intervention (HR 0.20, 95%CI 0.06-0.70) was the protective factor for complications. Based on the above risk factors, the prediction model was constructed. In the training set, the C-index was estimated to be 0.765, and the CI was within the range of 0.667 to 0.859. In the validation set, the C-index was 0.804, and the CI varied within the range of 0.773 to 0.855. The temporal variation graph of C-index was then described. The area under the ROC curve (AUC) at 5, 10, 15 months was 0.61, 0.72, and 0.79 in the training set and 0.60, 0.67, and 0.62 in the validation set, respectively. In addition, calibration and decision curves were drawn for 5, 10, 15 months for both training and validation sets, which showed that the model had good calibration performance and was effective in clinical practice. ConclusionThe history of chronic lung diseases, Qi deficiency, thready and weak pulse, hormone use history, PCT>10 μg·L-1, SAA>100 mg·L-1, and PLT>303×109 /L were risk factors for complications in patients with COVID-19 or influenza A/B, while Chinese medicine intervention was a protective factor. The prediction model was established based on the indicators above. The model showcased excellent distinguishing performance, calibration performance, and clinical practicability, providing scientific support for the prevention and control of complications caused by respiratory viral infections.
6. Effect of naringenin regulating RIP1-RIP3-MLKL signaling pathway on apoptosis of ovarian granulosa cells in rats with polycystic ovary syndrome
Xiang-Yang LYU ; Liang ZHANG ; Ji-Qun XU ; Xiao-Shuang REN
Chinese Pharmacological Bulletin 2024;40(3):483-489
Aim Based on the apoptotic pathway mediated by receptor interacting protein kinase(RIP)1-RIP3-mixed spectrum kinase domain like protein(MLKL), to explore the effects of naringenin on ovarian granulosa cell apoptosis in rats with polycystic ovary syndrome(PCOS). Methods SD rats were randomly assigned into normal control group, model group, naringenin group, RIP1 inhibitor(Nec-1)group, RIP1-RIP3-MLKL necrosis signal activator(Z-VAD-fmk)group, naringenin+Z-VAD-fmk group, 15 rats per group. ELISA method was performed to measure the levels of IL-1β and TNF-α in ovarian tissue. HE method was performed to observe the shape of the ovary. Granular cells were isolated from ovarian tissue, and flow cytometry was performed to measure apoptosis rate and necrosis rate. Immunohistochemistry was performed to measure the positive expression of p-RIP1 in ovarian tissue. Western blot was employed to detect the expression of RIP1-RIP3-MLKL pathway. Results RIP1 specific inhibitor Nec-1 and naringenin could block the phosphorylation and activation of RIP1, inhibit the RIP1-RIP3-MLKL signaling pathway, reduce the inflammation level in PCOS rats, and alleviate the necrosis and apoptosis of ovarian granulosa cells(P<0.05). Z-VAD-fmk could promote the activation of RIP1-RIP3-MLKL pathway, aggravate the apoptosis of ovarian granulosa cells, and partially weaken the anti-apoptosis effect of naringenin(P<0.05). Conclusions Naringenin may inhibit the apoptosis of ovarian granulosa cells in PCOS rats by blocking the activation of the necrotic apoptotic pathway mediated by RIP1-RIP3-MLKL.
7.Autologous platelet-rich plasma treatment for infected deep second-degree burn wounds: a case report
Hao HUANG ; Jun HUANG ; Qun LIANG ; Jian LIU ; Ting LI ; Yang ZHAO
Chinese Journal of Blood Transfusion 2024;37(1):95-100
【Objective】 To explore the feasibility of using autologous platelet-rich plasma (PRP) in the treatment of deep second-degree burns complicated with wound infection. 【Methods】 A retrospective analysis was conducted on the treatment process of a patient with deep second-degree burns and bacterial infection on the wound using autologous PRP. Clinical treatment highlights and outpatient follow-up were combined to discuss the feasibility and clinical effects of using autologous PRP in the treatment of burn wounds complicated with infection. 【Results】 The patient had a deep second-degree burn with a coagulase-negative Staphylococcus infection on the left lower limb. After one week of conventional wound dressing and antibiotic treatment, the patient's body temperature returned to normal. However, wound healing was slow and yellow secretion persisted. Subsequently, the burn wound was treated combined with topical autologous PRP. The wound pain score gradually decreased from 8 to 1. After 2 weeks, the bacterial culture of the wound secretion was negative, and the wound healed completely after 18 days. The wound scar score decreased from 5 to 2 at 1, 3 and 6 months after PRP treatment, and no obvious scar formation was observed. In the course of PRP treatment, there were no adverse reactions such as increased wound inflammation, abnormal blood routine and liver and kidney function test results. 【Conclusion】 For deep second-degree burn patients with localized wound bacterial infections who either refuse surgery or are not suitable for surgery, autologous PRP is a safer alternative that can effectively promote tissue regeneration and wound healing. The patient in this case achieved a curative effect in a short period of time.
8.Advances in the internal fixation surgical approach for sacroiliac joint dislocation caused by posterior pelvic ring injury
Bo SUN ; Yuan-Kai GU ; Xiang-Qun YANG ; Liang-Yu ZHAO
Journal of Regional Anatomy and Operative Surgery 2024;33(1):89-93
Injury of the posterior pelvic ring can easily be caused by high-energy impact,and sacroiliac joint dislocation is the most common.The sacroiliac joint,as the hub of load transfer between the trunk and lower extremities,is essential to maintain the stability of the posterior pelvic ring,and once dislocation occurs,restoring the stability of the posterior pelvic ring by timely surgery is necessary.The current surgical approaches for the internal fixation of sacroiliac joint are mainly divided into anterior approach and posterior approach.The choice of the surgical approach directly affects the exposure of the surgical field,the stability of internal fixation and the prognosis of patients;therefore,it is particularly important to select the appropriate surgical approach and fixation method.In this paper,we briefly review the selection of sacroiliac joint fixation points,surgical approaches and postoperative complications.
9.Establishment of abdominal aortocaval fistula in adenine-induced renal failure rats
Yifei ZHANG ; Liming LIANG ; Xianglei KONG ; Shuqi XU ; Qun WANG ; Zunsong WANG ; Dongmei XU
Chinese Journal of Nephrology 2024;40(2):131-136
Objective:To explore the construction of abdominal aortocaval fistula (ACF) model in adenine-induced renal failure rats, and to provide a suitable animal model for subsequent mechanism and intervention researches.Methods:Adult female Sprague-Dawley rats (250-300 g) were fed with 0.75% adenine diet (renal failure group, n=60) and the same diet without adenine (control group, n=10) for 4 weeks, and the rats were randomly grouped by block randomization method with a ratio of 6∶1. Thirty rats in the renal failure group were randomly selected by block randomization method at a ratio of 1∶1 to undergo laparotomies to establish ACF models (renal failure+ACF group). The serum creatinine, blood urea nitrogen detection and Masson staining were used to evaluate the establishment of renal failure model. Small animal ultrasound imaging system was applied to verify the successful construction of the ACF model. After 6 weeks of ACF observation, blood samples were collected from the heart of rats, and ACF-vascular tissues were collected for pathological study (HE staining). Results:At 4 weeks of feeding, compared with the control group, serum creatinine [(63.8±23.5) μmol/L vs. (33.0±3.8) μmol/L, Z=3.651, P<0.001] and blood urea nitrogen [(13.1±6.9) mmol/L vs. (5.3±0.6) mmol/L, Z=3.254, P=0.001] in the renal failure group were both higher. Masson staining showed renal tubulointerstitial inflammatory cell infiltration, renal tubular epithelial cell atrophy, interstitial fibrosis and vascular injury. Five rats sacrificed after ACF surgeries, and the survival rate was 83.3%. Doppler ultrasound showed turbulent blood flow of arterial to venous shunt at the anastomosis of open ACF (23/25) in the renal failure+ACF group. HE staining showed typical eccentric neointimal hyperplasia in the outflow tract of ACF vein in the renal failure+ACF group. Conclusions:The adenine-induced ACF rat model is successfully constructed, and ACF shows typical eccentric neointimal hyperplasia. The ACF construction would provide a reliable animal model to study the mechanism and intervention of neointimal hyperplasia for autologous arteriovenous fistula.
10.Post-operative healthcare-associated infection influencing factors and me-diating effect of diagnosis-intervention packet payment differentials in colorectal cancer patients
Yu RONG ; Qian-Qian HUANG ; Jia-Yi OU ; Shu-Liang YU ; Ye-Ying SONG ; Wei-Qun LU ; Li-Ming REN ; Yao FU ; Jian-Hui LU
Chinese Journal of Infection Control 2024;23(11):1421-1429
Objective To explore the potential influencing factors of post-operative healthcare-associated infection(HAI)in colorectal cancer patients,as well as the mediating effect relationship between the influencing factors and the diagnosis-intervention packet(DIP)payment differentials.Methods Medical data of patients who underwent colorectal cancer surgery in a tertiary first-class cancer hospital in Guangzhou were retrospectively analyzed.According to HAI status,patients were divided into infection group and non-infection group.Baseline demographic information and differences in DIP payment differentials between two groups of patients were compared by rank sum test or chi-square test.The influence of each potential factor on the occurrence of HAI was analyzed by logistic re-gression.Mediating analysis was preformed by bootstrap method,and mediating effect of HAI and total hospitaliza-tion days on DIP payment differentials was evaluated.Results A total of 350 patients were included in analysis,50 were in the infection group and 300 in the non-infection group.The incidence of HAI was 14.29%.Logistic regres-sion analysis result showed that risk of HAI in patients with central venous catheterization ≥10.00 days was 13.558 times higher than that<10.00 days(P<0.001);risk of HAI in patients with urinary catheterization ≥3.00 days was 2.388 times higher than that<3.00 days(P=0.022).There were all statistically significant differences in DIP payment differentials among patients with different ages,prognostic nutritional index(PNI),HAI status,total length of hospitalization stay,duration of surgery,central venous catheterization days,and catheterization days(all P<0.05).The mediating analysis results showed that the occurrence of HAI resulted a change in DIP payment di-fferentials by affecting the total number of hospitalization days.The mediating effect value of total hospitalization days was 0.038,accounting for 35.68%of the total effect.Conclusion Medical institutions should pay attention to HAI resulting from prolonged central venous and urinary catheterization in patients underwent surgery for colorectal cancer,reducing the total length of hospital stay,thus reducing the overruns associated with the increased DIP pay-ment differentials.


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