1.Randomized controlled trial of recombinant human interferon α2b combined with Baofukang suppository and vaginal Lactobacillus for the treatment of cervical HR-HPV infection in postmenopausal women
Jianyuan CHEN ; Haiquan WU ; Xingwei XIN
Shanghai Journal of Preventive Medicine 2026;38(5):404-408
ObjectiveTo explore the clinical efficacy and safety of a combined therapy by using recombinant human interferon α2b, Baofukang suppository and vaginal lactobacillus for high-risk human papillomavirus (HR-HPV) infection in postmenopausal women, and to provide a reference for the treatment of HR-HPV infection. MethodsThis study was a single-center, prospective, randomized, open-label, and parallel-controlled trial. A total of 210 postmenopausal women with cervical HR-HPV infection who visited the Maternal and Child Health Care and Family Planning Service Center of Deqing County from January 2022 to December 2023 were consecutively selected. They were randomly divided into study group (112 cases) and control group (98 cases) using a random number table. The control group was treated with recombinant human interferon α2b vaginal effervescent capsules and Baofukang suppositories. The study group received vaginal lactobacillus capsules in addition to the treatment given to the control group. The primary outcome measure was the HPV clearance rate at 6 and 12 months after treatment. The secondary outcomes included the rate of cervical cytology improvement, symptom relief rate, vaginal microecological indicators (vaginal pH value, proportion of lactobacillus), and the incidence of adverse reactions. ResultsA total of 196 patients (112 in the study group and 84 in the control group) completed the 12-month follow-up. At 6 months after treatment, there was no significant difference in the negative rate of HR-HPV between the two groups (χ²=3.36, P=0.072). At 12 months after treatment , the negative rate of HPV in the study group (78.57%, 88/112) was higher than that in the control group (52.38%, 44/84) (χ²=3.98, P=0.046). At 6 months after treatment, there was no significant difference in the improvement rate of cervical cytology between the two groups (χ²=0.12, P=0.063). At 12 months after treatment, the improvement rate of cervical cytology in the study group (73.21%, 82/112) was higher than that in the control group (47.62%, 40/84) (χ²=4.26,P=0.039).In terms of vaginal microecology, at 6 months after treatment, the median vaginal pH value of the study group [4.17 (4.03,4.26)] was lower than that of the control group [4.60 (4.31,4.85)] (U=386.52, P=0.004), and the average proportion of lactic acid bacteria [(82.36±5.12)%] was higher than that of the control group [(68.57±6.34)%] (t=7.56, P=0.002). At 12 months after treatment, the median vaginal pH value of the study group [4.04 (3.81,4.12)] was lower than that of the control group [4.06 (3.83,4.19)] (U=352.04, P=0.006), and the average proportion of lactic acid bacteria [(91.25±4.36)%] was higher than that of the control group [(78.63±5.72)%] (t=6.73, P=0.001). At 6 months after treatment, the remission rate of symptoms in the study group (64.29%, 72/112) was higher than that in the control group (40.48%, 34/84) (χ²=10.957, P=0.001). At 12 months after treatment, the remission rate of symptoms in the study group (87.50%, 98/112) was higher than that in the control group (64.29%, 54/84) (χ²=56.81, P<0.001). Regarding side effects, during the treatment period and within one month after the completion of treatment, only three types of mild local side effects, including increased vaginal discharge, vaginal burning sensation, and vulvar pruritus, were observed in both groups. All adverse reactions were alleviated after symptomatic management (such as perineal cleaning and adjusting medication posture). The total incidence of adverse reactions in the study group was 6.25%, compared to 7.14% in the control group, with no statistically significant differences between the two groups (χ²=0.09, P=0.768). ConclusionThe combined treatment of recombinant human interferon α2b vaginal effervescent capsules, Baofukang suppositories, and vaginal lactobacillus capsules in postmenopausal women with cervical HR-HPV infection could effectively increase the HPV clearance rate, improve cervical cytology, restore vaginal microbiota balance, and relieve clinical symptoms.
2.Hybrid decompression-based surgical strategy for treating multilevel thoracic ossification of the ligamentum flavum: a retrospective study
Cong NIE ; Kaiwen CHEN ; Shenyan GU ; Feizhou LYU ; Jianyuan JIANG ; Xinlei XIA ; Chaojun ZHENG
Asian Spine Journal 2025;19(1):74-84
Methods:
Motor-evoked potentials (MEPs) and somatosensory-evoked potentials (SEPs) were recorded in 48 patients with TOLF (hybrid 20 vs. en bloc 28) during surgery. Patients were categorized based on MEP/SEP improvement, deterioration, or no change, and MEP/SEP improvement rates were measured in the improvement group. Furthermore, all patients were assessed using the Ashworth and modified Japanese Orthopedic Association scores.
Results:
The incidences of both MEP/SEP improvement (21.4% vs. 25.0%, p=0.772) and deterioration (21.4% vs. 20.0%, p=0.904) were similar between the en bloc and hybrid laminectomy groups, and no difference in preoperative and postoperative clinical assessments was observed between the two groups (p>0.05). In four patients (4/28, 14.3%) undergoing en bloc laminectomy, MEP amplitudes initially increased after OLF removal but gradually decreased. This delayed MEP reduction did not occur in the hybrid laminectomy group. Furthermore, more patients undergoing en bloc laminectomy had CFL than those undergoing hybrid laminectomy (46.4% vs. 15.0%, p=0.023). In the improvement group, the hybrid laminectomy group exhibited higher MEP improvement rates in the bilateral abductor hallucis than the en bloc laminectomy group (left side: 213.4%±35.9% vs. 152.5%±41.0%, p=0.028; right side: 201.2%±32.0% vs. 145.2%±46.3%, p=0.043).
Conclusions
Compared with en bloc laminectomy, hybrid laminectomy may be a safe and effective method for treating multilevel TOLF, potentially reducing intraoperative spinal cord irritation and CFL and causing relatively better functional recovery.
3.Hybrid decompression-based surgical strategy for treating multilevel thoracic ossification of the ligamentum flavum: a retrospective study
Cong NIE ; Kaiwen CHEN ; Shenyan GU ; Feizhou LYU ; Jianyuan JIANG ; Xinlei XIA ; Chaojun ZHENG
Asian Spine Journal 2025;19(1):74-84
Methods:
Motor-evoked potentials (MEPs) and somatosensory-evoked potentials (SEPs) were recorded in 48 patients with TOLF (hybrid 20 vs. en bloc 28) during surgery. Patients were categorized based on MEP/SEP improvement, deterioration, or no change, and MEP/SEP improvement rates were measured in the improvement group. Furthermore, all patients were assessed using the Ashworth and modified Japanese Orthopedic Association scores.
Results:
The incidences of both MEP/SEP improvement (21.4% vs. 25.0%, p=0.772) and deterioration (21.4% vs. 20.0%, p=0.904) were similar between the en bloc and hybrid laminectomy groups, and no difference in preoperative and postoperative clinical assessments was observed between the two groups (p>0.05). In four patients (4/28, 14.3%) undergoing en bloc laminectomy, MEP amplitudes initially increased after OLF removal but gradually decreased. This delayed MEP reduction did not occur in the hybrid laminectomy group. Furthermore, more patients undergoing en bloc laminectomy had CFL than those undergoing hybrid laminectomy (46.4% vs. 15.0%, p=0.023). In the improvement group, the hybrid laminectomy group exhibited higher MEP improvement rates in the bilateral abductor hallucis than the en bloc laminectomy group (left side: 213.4%±35.9% vs. 152.5%±41.0%, p=0.028; right side: 201.2%±32.0% vs. 145.2%±46.3%, p=0.043).
Conclusions
Compared with en bloc laminectomy, hybrid laminectomy may be a safe and effective method for treating multilevel TOLF, potentially reducing intraoperative spinal cord irritation and CFL and causing relatively better functional recovery.
4.Hybrid decompression-based surgical strategy for treating multilevel thoracic ossification of the ligamentum flavum: a retrospective study
Cong NIE ; Kaiwen CHEN ; Shenyan GU ; Feizhou LYU ; Jianyuan JIANG ; Xinlei XIA ; Chaojun ZHENG
Asian Spine Journal 2025;19(1):74-84
Methods:
Motor-evoked potentials (MEPs) and somatosensory-evoked potentials (SEPs) were recorded in 48 patients with TOLF (hybrid 20 vs. en bloc 28) during surgery. Patients were categorized based on MEP/SEP improvement, deterioration, or no change, and MEP/SEP improvement rates were measured in the improvement group. Furthermore, all patients were assessed using the Ashworth and modified Japanese Orthopedic Association scores.
Results:
The incidences of both MEP/SEP improvement (21.4% vs. 25.0%, p=0.772) and deterioration (21.4% vs. 20.0%, p=0.904) were similar between the en bloc and hybrid laminectomy groups, and no difference in preoperative and postoperative clinical assessments was observed between the two groups (p>0.05). In four patients (4/28, 14.3%) undergoing en bloc laminectomy, MEP amplitudes initially increased after OLF removal but gradually decreased. This delayed MEP reduction did not occur in the hybrid laminectomy group. Furthermore, more patients undergoing en bloc laminectomy had CFL than those undergoing hybrid laminectomy (46.4% vs. 15.0%, p=0.023). In the improvement group, the hybrid laminectomy group exhibited higher MEP improvement rates in the bilateral abductor hallucis than the en bloc laminectomy group (left side: 213.4%±35.9% vs. 152.5%±41.0%, p=0.028; right side: 201.2%±32.0% vs. 145.2%±46.3%, p=0.043).
Conclusions
Compared with en bloc laminectomy, hybrid laminectomy may be a safe and effective method for treating multilevel TOLF, potentially reducing intraoperative spinal cord irritation and CFL and causing relatively better functional recovery.
5.Augmented Central Pain Processing Occurs after Osteoporotic Vertebral Compression Fractures and Is Associated with Residual Back Pain after Percutaneous Vertebroplasty
Kaiwen CHEN ; Tian GAO ; Yu ZHU ; Feizhou LYU ; Jianyuan JIANG ; Chaojun ZHENG
Asian Spine Journal 2024;18(3):380-389
Methods:
Preoperatively, all 160 patients with OVCFs underwent pressure-pain threshold (PPT), temporal summation (TS), conditioned pain modulation (CPM), and imaging assessments. Pain intensity and pain-related disability were evaluated before and after PVP.
Results:
Preoperatively, patients with OVCFs had lower PPTs in both local pain and pain-free areas and lower CPM and higher TS in pain-free areas than healthy participants (p<0.05). Unlike patients with acute fractures, patients with subacute/chronic OVCFs showed higher TS with or without lower CPM in the pain-free area compared with healthy participants (p<0.05). Postoperatively, RBP occurred in 17 of 160 patients (10.6%). All preoperative covariates with significant differences between the RBP and non-RBP groups were subjected to multivariate logistic regression, showing that intravertebral vacuum cleft, posterior fascia edema, numeric rating pain scale scores for low back pain at rest, and TS were independently associated with RBP (p<0.05).
Conclusions
Augmented central pain processing may occur in patients with OVCFs, even in the subacute stage, and this preexisting CS may be associated with RBP. Preoperative assessment of TS in pain-free areas may provide additional information for identifying patients who may be at risk of RBP development, which may be beneficial for preventing this complication.
6.Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults (version 2024)
Qingde WANG ; Yuan HE ; Bohua CHEN ; Tongwei CHU ; Jinpeng DU ; Jian DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Hua GUO ; Yong HAI ; Lijun HE ; Dianming JIANG ; Jianyuan JIANG ; Bin LIN ; Bin LIU ; Baoge LIU ; Chunde LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Hongjian LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Hong XIA ; Guoyong YIN ; Jinglong YAN ; Wen YUAN ; Zhaoming YE ; Jie ZHAO ; Jianguo ZHANG ; Yue ZHU ; Yingjie ZHOU ; Zhongmin ZHANG ; Wei MEI ; Dingjun HAO ; Baorong HE
Chinese Journal of Trauma 2024;40(2):97-106
Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.
7.Future Development Trends and Considerations for Clinical Research of Traditional Chinese Medicine
Zhihan CHEN ; Dan LIANG ; Lina WAN ; Cheng'en LI ; Cui GUO ; Jianyuan TANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):102-109
The advent of digital times promotes the evolution of clinical research from traditional mode to digital mode. Digital technologies, which are introduced to clinical research of traditional Chinese medicine (TCM), can optimize the research design, improve research quality, and save research funds and time. The digital and remote control of clinical research recruitment and screening, disease diagnosis and treatment, informed consent, indicator measurement, and other processes can be realized by computers, networks, sensors, and other technologies. Artificial intelligence (AI) algorithms, wearable monitoring devices, data management tools, blockchain, and virtual clinical trials (VCTs) are key innovation technologies and research design methods. On this basis, this study summarized relevant literature on key digital technologies and research methods such as AI algorithms, wearable monitoring devices, data management tools, blockchain, and VCT, and the following discoveries were obtained: The future development of clinical research of TCM requires to attach importance to the changes in clinical research brought by digital technologies and to promote the utilization of digital technologies in clinical research of TCM. Digital technologies realize the medical ethical ideas of ''putting people first'', promote the decentralization of clinical research, simplify the participation process of participants, reduce the time and cost of clinical research, improve the efficiency of clinical research of TCM, and enhance the objectivity, authenticity, and stability of clinical research of TCM. Deepening the application of digital technologies in clinical research and realizing the interaction and fusion of various digital technologies are inevitable trends of future development of clinical research of TCM. Under the background of digitization, the digital innovation of clinical research of TCM can accelerate the development of clinical research of TCM and promote the internationalization of TCM.
8.Effect of Ursolic Acid on Proliferation and Apoptosis of Colorectal Cancer Cells Based on Akt/FoxO Signaling Pathway
Qiao ZHENG ; Nianzhi CHEN ; Gang ZHANG ; Ziyi ZHAO ; Jianyuan TANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(17):109-115
ObjectiveTo investigate the effects and molecular mechanism of ursolic acid on the proliferation and apoptosis of colorectal cancer cells. MethodThe proliferation inhibition rate of human colorectal cancer RKO cells treated with different concentrations of ursolic acid (0, 5, 10, 15, 20, 25, 30 μmol·L-1) was detected by cell counting kit-8 (CCK-8), and the half maximal inhibitory concentration (IC50) at 24 h and 48 h was calculated. According to the IC50 of RKO cells treated with ursolic acid for 24 h, two concentrations were selected for subsequent experiments. The colony formation assay was used to detect the proliferation ability of the cells and flow cytometry was used to detect the apoptosis rate and cell cycle arrest after treatment of RKO cells with ursolic acid. After treatment of RKO cells with ursolic acid for 24 hours, the expression of B-cell lymphoma 2 (Bcl-2)-associated X protein (Bax) in RKO cells, Bcl-2 in Raji cells, PMA responsive gene in T lymphocyte (Noxa), cyclin-dependent kinase inhibitor 1A (p21), cyclin-dependent kinase inhibitor 1B (p27), cyclin-dependent kinase 4 (CDK4), protein kinase B (Akt), phosphorylated Akt (p-Akt), forkhead transcription factor O3a (FoxO3a), and phosphorylated FoxO3a (p-FoxO3a) was determined by Western blot. ResultCompared with the blank group, the ursolic acid groups could inhibit the viability of RKO cells (P<0.05, P<0.01), and the colony formation rates of RKO cells in the ursolic acid groups were reduced (P<0.05, P<0.01) in a concentration-dependent manner. The cells in the ursolic acid group (20 μmol·L-1) experienced cell cycle arrest, which increased in the early stage of synthesis, ie, the G0/G1 phase (P<0.05) as compared with the results in the blank group. Compared with the blank group, the ursolic acid groups (15 and 20 μmol·L-1) showed increased protein expression of p21 and p27, decreased expression of CDK4 protein (P<0.05, P<0.01), and increased apoptosis rate, and the ursolic acid group (20 μmol·L-1) showed increased protein expression of Bax and Noxa and decreased expression of Bcl-2 (P<0.05, P<0.01). In terms of mechanism, compared with the blank group, the ursolic acid group (20 μmol·L-1) down-regulated the expression of p-Akt protein and up-regulated the expression of p-FoxO3a (P<0.05, P<0.01), and there was no significant change in the total protein of Akt and FoxO3a. ConclusionUrsolic acid can effectively inhibit the proliferation of colorectal cancer RKO cells and promote cell apoptosis, which may be related to the Akt/FoxO pathway.
9.Analysis on the Current Situation and Influencing Factors of Ethical KAP among Clinical Researchers
Lei ZHENG ; Yuxin CHEN ; Jiawei KANG ; Mengwei HU ; Jianyuan WU ; Chunhong WANG ; Jianying HUANG ; Boran LI ; Yuanzhen ZHANG
Chinese Medical Ethics 2023;36(12):1408-1416
【Objective:】 To understand the current situation and influencing factors of ethical knowledge, attitude, and practice (KAP) among clinical researchers, enhance their ethical awareness, and improve the quality of clinical researches. 【Methods:】 A self-designed questionnaire was used to conduct a convenient sampling survey of medical staff who have participated in clinical study. 【Results:】 A total of 6,021 subjects were investigated, with males accounting for 28.46% and females accounting for 71.53%. The average age of them was (37.47±11.46) years old. The total score of ethics and the mean scores of the three dimensions of knowledge, attitude and practice were (70.62±12.99), (59.63±12.50), (79.55±19.62) and (74.92±18.29), respectively. Multiple linear regression analysis showed that researchers with male, tertiary hospitals, doctors, ethics-related part-time jobs, postgraduate education, associate senior title or above, and training experience scored higher (P<0.05). 【Conclusion:】 Ethical attitudes have a significant mediating effect between knowledge and practice, accounting for 62.72% of the total effect. Researchers recognize the importance of ethics, but it is urgent to strengthen their knowledge learning and practical application.
10.Clinical guideline for diagnosis and treatment of adult ankylosing spondylitis combined with thoracolumbar fracture (version 2023)
Jianan ZHANG ; Bohua CHEN ; Tongwei CHU ; Yirui CHEN ; Jian DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Yong HAI ; Lijun HE ; Yuan HE ; Dianming JIANG ; Jianyuan JIANG ; Bin LIN ; Bin LIU ; Baoge LIU ; Dechun LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Wei MEI ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Honghui SUN ; Tiansheng SUN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Yongming XI ; Hong XIA ; Jinglong YAN ; Liang YAN ; Wen YUAN ; Gang ZHAO ; Jie ZHAO ; Jianguo ZHANG ; Xiaozhong ZHOU ; Yue ZHU ; Yingze ZHANG ; Dingjun HAO ; Baorong HE
Chinese Journal of Trauma 2023;39(3):204-213
Ankylosing spondylitis (AS) combined with spinal fractures with thoracic and lumbar fracture as the most common type shows characteristics of unstable fracture, high incidence of nerve injury, high mortality and high disability rate. The diagnosis may be missed because it is mostly caused by low-energy injury, when spinal rigidity and osteoporosis have a great impact on the accuracy of imaging examination. At the same time, the treatment choices are controversial, with no relevant specifications. Non-operative treatments can easily lead to bone nonunion, pseudoarthrosis and delayed nerve injury, while surgeries may be failed due to internal fixation failure. At present, there are no evidence-based guidelines for the diagnosis and treatment of AS combined with thoracic and lumbar fracture. In this context, the Spinal Trauma Academic Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate the Clinical guideline for the diagnosis and treatment of adult ankylosing spondylitis combined with thoracolumbar fracture ( version 2023) by following the principles of evidence-based medicine and systematically review related literatures. Ten recommendations on the diagnosis, imaging evaluation, classification and treatment of AS combined with thoracic and lumbar fracture were put forward, aiming to standardize the clinical diagnosis and treatment of such disorder.

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