1.Shufeng Jiedu Granule against mild COVID-19: Protocol of the randomized, double-blind, placebo-controlled, multi-center heal-COVID phase III study.
Li YANG ; Thomas FRIEDEMANN ; Jun PAN ; Xiangyu LI ; Fuxiang WANG ; Yuanlong LIN ; Qiang ZHU ; Sven SCHRÖDER ; Qingsong LIU ; Hongzhou LU
Chinese Herbal Medicines 2025;17(3):601-608
OBJECTIVE:
Since Omicron will likely persist, this trial evaluates the safety and efficacy of Shufeng Jiedu Granule (SFJDG) for mild Omicron infection, aims at finding new therapies especially for home-treated patients.
METHODS:
This randomized, double-blind, placebo-controlled, multi-center phase III trial involves 844 patients, divided into a treatment group (422) and control group (422). Participants will receive SFJDG or placebo for 7 d (1.2 g/bag, 2 bags, 3 times/d). Hospital evaluations will be done on days 1 and 8, with telephone assessments on days 3 and 5. Follow-up continues on days 10 and 14. Diary cards will track symptom scores and safety data. The primary outcome is the time to sustained clinical recovery from corona virus disease 2019 (COVID-19) symptoms. An interim analysis will occur after 70 % of patients complete follow-up, with Type I error correction (α1 = 0.015) at interim analysis based on O'Brien-Fleming-type cumulative error spending function.
RESULTS:
This phase III trial evaluates the efficacy and safety of SFJDG for mild COVID-19, focusing on real-world applicability for home-managed patients. The study's randomized, double-blind, placebo-controlled design ensures methodological rigor, while its comprehensive outcome measures address both symptom recovery and treatment safety. By emphasizing symptom resolution and recovery time, the trial aligns with the clinical priorities for managing mild cases of COVID-19. The findings could offer valuable insights into SFJDG's role in improving patient outcomes and addressing gaps left by existing antiviral therapies, particularly in symptom management.
CONCLUSION
The global risk assessment remains high due to the ongoing virulence of SARS-CoV-2 Omicron sub-lineages. This Phase III study adopts a robust methodology to investigate SFJDG as a treatment for mild COVID-19 as well as it's effectiveness and safety. Furthermore, this study aim to provide sufficient scientific evidence for the market registration of SFJDG especially for home-treated patients. If successful, SFJDG could be a meaningful addition to therapeutic options for mild infections, supporting public health strategies in managing the ongoing impact of SARS-CoV-2.
2.Isolation,identification and pathogenicity of Histophilus somni from goats in Chi-na
Fuxiang LI ; Huafeng GAO ; Wenhua ZHAO
Chinese Journal of Veterinary Science 2025;45(5):971-977,986
To identify the bacterial pathogens in a case of goat respiratory disease in Yunnan prov-ince,three Gram-negative,rod-shaped bacteria strains,YN240861,YN240862 and YN240863,were isolated from lung samples of three diseased goats with respiratory disease,and the identifications of the biochemical and the sequence similarity and phylogeny of 16S rDNA gene,and the analyses of the pathogenicity and antimicrobial susceptibility were studied.The results of the bacterial iden-tification indicated that the most biochemical characteristics of the three isolates were identical with those of the Histophilus somni(H.somni)type stain ATCC 43625T and the other reference strains of H.somni.The three strains had the 16S rDNA sequence similarity of 97.7%with H.som-ni type strain ATCC 43625T,and shared the 16S rDNA sequence similatiies of 99.4%-99.9%with the other H.somni reference strains.The three strains formed the same branch with all the H.som-ni reference strains in the 16S rDNA gene sequence phylogenetic tree.Based on these identification results,the three strains were identified as H.somni.The mouse pathogenicity test showed that each of the three strains had the median lethal dose(LD50)≤7.6×10 5 CFU in mice,which indica-ted that the three stains have higher pathogenicity to mice.The results of the antimicrobial suscep-tibility test indicated that the three strains were sensitive to ampicillin of penicillins,cefazolin and ceftriaxone of cephalosporins,chloramphenicol and florfenicol of chloramphenicols,kanamycin and gentamicin of aminoglycosides,and ofloxacin of quinolones.The strain YN240862 was resistant to sulfamethoxazole of sulfonamides.To our knowledge,this is the first isolation of Hi.somni in Chi-na,and confirmed the presence of H.somni infection in goats in China,which provides the basic da-ta for the prevention and treatment of H.somni infection in goats in China.
3.Effect of preoperative continuous fascia iliaca compartment block on perioperative opioids dosage and quality of postoperative recovery in elderly patients with frail
Changsheng GAO ; Fuxiang HUANG ; Yinqiang OU ; Minling XU ; Zhichao CHEN ; Yongle LI
Chinese Journal of Postgraduates of Medicine 2025;48(7):597-602
Objective:To investigate the effect of preoperative continuous fascia iliaca compartment block (FICB) on perioperative opioids dosage and quality of postoperative recovery in elderly patients with frail.Methods:A prospective study method was used. Sixty elderly frail patients underwent selective unilateral femoral head replacement surgery from November 2022 to October 2024 in Sihui People′s Hospital were selected. The patients were divided into control group and FICB group by random digits table method with 30 cases each. The patients in control group did not receive continuous FICB before surgery, and the patients in FICB group received continuous FICB 1 d before surgery. The perioperative use of opioids and analgesic effect, operative time, intraoperative blood loss, postoperative hospital stay, quality of recovery-40 (QoR-40) score at discharge and postoperative complications were compared between the two groups.Results:A total of 57 patients completed the study, with 29 cases in the FICB group and 28 cases in the control group. There were no statistical differences in operative time, intraoperative blood loss and postoperative hospital stay between the two groups ( P>0.05). The sufentanil dosage of patient-controlled analgesia (PCA), perioperative nalbuphine dosage, frequency of perioperative visual analog score (VAS)>4 scores, rate of preoperative rescue analgesia, rate of postoperative rescue analgesia and pressing frequency of PCA in FICB group were significantly lower than those in control group: (94.1 ± 5.4) μg vs. (102.1 ± 6.1) μg, 0 (0, 0) mg vs. 10.0 (0, 20.0) mg, 3.0 (2.0, 5.0) times vs. 5.0 (4.0, 6.0) times, 3.4% (1/29) vs. 32.1% (9/28), 13.8% (4/29) vs. 39.3% (11/28) and 2.0 (1.0, 3.0) times vs. 4.0 (3.0, 5.0) times, and there were statistical differences ( P<0.01 or <0.05). The total QoR-40 score and physical comfort, pain scores in FICB group were significantly higher than those in control group: 156(153, 161) scores vs. 153 (148, 159) scores, 47 (45, 50) scores vs. 45 (43, 47) scores and 30 (29, 31) scores vs. 28 (25, 30) scores, and there were statistical differences ( P<0.05 or <0.01); there were no statistical differences in emotional state, physical independence and psychological support scores between the two groups ( P>0.05). The incidences of dizziness and nausea vomiting in FICB group were significantly lower than those in control group: 13.8% (4/29) vs. 42.9% (12/28) and 10.3% (3/29) vs. 35.7% (10/28), and there were statistical differences ( P<0.05); there were no statistical difference in the incidences of delirium, pulmonary infection and deep vein thrombosis in the lower extremities between the two groups ( P>0.05). Conclusions:Preoperative continuous FICB can reduce perioperative opioids dosage in elderly patients with frail, and improve early stage postoperative recovery quality.
4.Isolation,identification and pathogenicity of Histophilus somni from goats in Chi-na
Fuxiang LI ; Huafeng GAO ; Wenhua ZHAO
Chinese Journal of Veterinary Science 2025;45(5):971-977,986
To identify the bacterial pathogens in a case of goat respiratory disease in Yunnan prov-ince,three Gram-negative,rod-shaped bacteria strains,YN240861,YN240862 and YN240863,were isolated from lung samples of three diseased goats with respiratory disease,and the identifications of the biochemical and the sequence similarity and phylogeny of 16S rDNA gene,and the analyses of the pathogenicity and antimicrobial susceptibility were studied.The results of the bacterial iden-tification indicated that the most biochemical characteristics of the three isolates were identical with those of the Histophilus somni(H.somni)type stain ATCC 43625T and the other reference strains of H.somni.The three strains had the 16S rDNA sequence similarity of 97.7%with H.som-ni type strain ATCC 43625T,and shared the 16S rDNA sequence similatiies of 99.4%-99.9%with the other H.somni reference strains.The three strains formed the same branch with all the H.som-ni reference strains in the 16S rDNA gene sequence phylogenetic tree.Based on these identification results,the three strains were identified as H.somni.The mouse pathogenicity test showed that each of the three strains had the median lethal dose(LD50)≤7.6×10 5 CFU in mice,which indica-ted that the three stains have higher pathogenicity to mice.The results of the antimicrobial suscep-tibility test indicated that the three strains were sensitive to ampicillin of penicillins,cefazolin and ceftriaxone of cephalosporins,chloramphenicol and florfenicol of chloramphenicols,kanamycin and gentamicin of aminoglycosides,and ofloxacin of quinolones.The strain YN240862 was resistant to sulfamethoxazole of sulfonamides.To our knowledge,this is the first isolation of Hi.somni in Chi-na,and confirmed the presence of H.somni infection in goats in China,which provides the basic da-ta for the prevention and treatment of H.somni infection in goats in China.
5.Effect of preoperative continuous fascia iliaca compartment block on perioperative opioids dosage and quality of postoperative recovery in elderly patients with frail
Changsheng GAO ; Fuxiang HUANG ; Yinqiang OU ; Minling XU ; Zhichao CHEN ; Yongle LI
Chinese Journal of Postgraduates of Medicine 2025;48(7):597-602
Objective:To investigate the effect of preoperative continuous fascia iliaca compartment block (FICB) on perioperative opioids dosage and quality of postoperative recovery in elderly patients with frail.Methods:A prospective study method was used. Sixty elderly frail patients underwent selective unilateral femoral head replacement surgery from November 2022 to October 2024 in Sihui People′s Hospital were selected. The patients were divided into control group and FICB group by random digits table method with 30 cases each. The patients in control group did not receive continuous FICB before surgery, and the patients in FICB group received continuous FICB 1 d before surgery. The perioperative use of opioids and analgesic effect, operative time, intraoperative blood loss, postoperative hospital stay, quality of recovery-40 (QoR-40) score at discharge and postoperative complications were compared between the two groups.Results:A total of 57 patients completed the study, with 29 cases in the FICB group and 28 cases in the control group. There were no statistical differences in operative time, intraoperative blood loss and postoperative hospital stay between the two groups ( P>0.05). The sufentanil dosage of patient-controlled analgesia (PCA), perioperative nalbuphine dosage, frequency of perioperative visual analog score (VAS)>4 scores, rate of preoperative rescue analgesia, rate of postoperative rescue analgesia and pressing frequency of PCA in FICB group were significantly lower than those in control group: (94.1 ± 5.4) μg vs. (102.1 ± 6.1) μg, 0 (0, 0) mg vs. 10.0 (0, 20.0) mg, 3.0 (2.0, 5.0) times vs. 5.0 (4.0, 6.0) times, 3.4% (1/29) vs. 32.1% (9/28), 13.8% (4/29) vs. 39.3% (11/28) and 2.0 (1.0, 3.0) times vs. 4.0 (3.0, 5.0) times, and there were statistical differences ( P<0.01 or <0.05). The total QoR-40 score and physical comfort, pain scores in FICB group were significantly higher than those in control group: 156(153, 161) scores vs. 153 (148, 159) scores, 47 (45, 50) scores vs. 45 (43, 47) scores and 30 (29, 31) scores vs. 28 (25, 30) scores, and there were statistical differences ( P<0.05 or <0.01); there were no statistical differences in emotional state, physical independence and psychological support scores between the two groups ( P>0.05). The incidences of dizziness and nausea vomiting in FICB group were significantly lower than those in control group: 13.8% (4/29) vs. 42.9% (12/28) and 10.3% (3/29) vs. 35.7% (10/28), and there were statistical differences ( P<0.05); there were no statistical difference in the incidences of delirium, pulmonary infection and deep vein thrombosis in the lower extremities between the two groups ( P>0.05). Conclusions:Preoperative continuous FICB can reduce perioperative opioids dosage in elderly patients with frail, and improve early stage postoperative recovery quality.
6.Inhibitory Effect of Sophora alopecuroides Total Alkaloids and Two Monomer Alkaloids on PC12 Cell Activity
Li GAO ; Fuxiang LUO ; Mahemuti ANAER ; Jingying LUO ; Ming YAN
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(17):126-133
ObjectiveTo compare the effects of total alkaloids, matrine, and sophoridine extracted from Sophora alopecuroides on the activity of pheochromocytoma cells (PC12 cells). MethodThe effect of S. alopecuroides total alkaloids, matrine, and sophoridine at concentrations of 2, 1, 0.5, 0.25, 0.125, and 0.062 5 g·L-1 on the proliferation of PC12 cells was evaluated using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) assay. The lactate dehydrogenase (LDH) leakage rate was measured by enzyme-linked immunosorbent assay (ELISA). Flow cytometry was used to assess cell apoptosis rate, cell cycle distribution, and intracellular Ca2+ levels. Real-time quantitative polymerase chain reaction (Real-time PCR) was performed to determine the mRNA transcription levels of B-cell lymphoma-2 (Bcl-2) and Bcl-2-associated X protein (Bax). Protein expression levels of apoptosis-related proteins Caspase-3, Caspase-8, Bcl-2, and Bax were detected by Western blot. ResultCompared to the control group, S. alopecuroides total alkaloids, matrine, and sophoridine inhibited the proliferation of PC12 cells, increased LDH leakage rate, enhanced intracellular Ca2+ fluorescence intensity, and induced cell apoptosis in concentration-dependent manner (P<0.05, P<0.01). Among them, S. alopecuroides total alkaloids had the strongest inhibitory effect on cell proliferation and induction of apoptosis in PC12 cells (P<0.01). After treatment with S. alopecuroides total alkaloids, matrine, and sophoridine, the cell cycle progression of PC12 cells was arrested at G1/G0 in the S. alopecuroides total alkaloids group, and at G1/S in the matrine and sophoridine groups. The expression levels of Bax mRNA were significantly increased (P<0.05, P<0.01), while the expression levels of Bcl-2 mRNA were significantly decreased (P<0.05, P<0.01). All treatments significantly downregulated the expression of the anti-apoptotic protein Bcl-2 (P<0.05, P<0.01) and upregulated the expression of the pro-apoptotic proteins Bax, Caspase-3, and Caspase-8 (P<0.05, P<0.01), with the most significant protein expression changes observed in the S. alopecuroides total alkaloids group. ConclusionAmong the S. alopecuroides total alkaloids, matrine, and sophoridine, S. alopecuroides total alkaloids exhibit the strongest inhibitory effect on the activity of PC12 cells, and its mechanism of action may be related to the inhibition of anti-apoptotic protein expression, upregulation of pro-apoptotic protein expression, and activation of the mitochondrial Caspase-8 apoptotic pathway.
7.Hyperuricemic Nephropathy in Traditional Chinese Medicine and Integrated Traditional Chinese and Western Medicine: A Review
Jia LUO ; Tongyu LI ; Fuxiang NONG ; Wencong XU ; Jingyan LIANG ; Yan ZHOU ; Yiming SUN ; Guodong HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(10):274-282
Hyperuricemic nephropathy (HN), a secondary renal damage common in clinical practice, is characterized by early concealing and continuous progression. The understanding of HN in traditional Chinese medicine (TCM) is from a macroscopic perspective. According to the TCM theory, HN is caused by the combination of external pathogens and internal injuries, with the main pathogenesis being root deficiency combined with superficial excess and deficiency-excess in complexity. In western medicine, the understanding of HN is from the microscopic perspective, which holds that the occurrence of HN is the result of inflammation, oxidative stress, renin-angiotensin-aldosterone system (RAAS) activation, and metabolic abnormalities. The TCM syndromes of HN include internal dampness and heat, obstruction in dampness and turbidity, deficiency of spleen and kidney, and deficiency of kidney yin. Accordingly, the prescriptions should clear heat and dampness, remove dampness and turbidity, tonify spleen and kidney, and nourish kidney yin, respectively. In addition to TCM prescriptions, single herbal medicines and their extracts, Chinese patent medicines, and external applications of Chinese medicines have played a significant role in the treatment of HN, promoting the application of TCM in the treatment of HN. Moreover, the integrated traditional Chinese and western medicine has also played a role in the treatment of HN, enriching the treatment schemes of HN. Different from common kidney diseases such as acute and chronic glomerulonephritis and nephrotic syndrome, HN with particularity should be carefully differentiated in clinical practice. This article systematically summarizes the research progress in the treatment of traditional Chinese medicine and integrated traditional Chinese and western medicine on hyperuricemic nephropathy with TCM and integrated traditional Chinese and western medicine, aiming to enrich the system and theory of HN treatment and further guide the clinical practice.
8.Practice and benefit of national standardized management of type 2 diabetes in Yulin City
Jie HU ; Feng ZHANG ; Xingmei LI ; Yanni WANG ; Fuxiang SHI ; Shaojuan FENG ; Puliufang HE ; Xiumei ZHANG ; Hui ZHAO ; Qiaofen YANG ; Rui SONG ; Xiuxiu FENG ; Jiansheng NIU
Journal of Xi'an Jiaotong University(Medical Sciences) 2023;44(5):836-840
【Objective】 To investigate the practice and benefit of national standardized management of type 2 diabetes in Yulin City. 【Methods】 We recruited the adult type 2 diabetes patients who sought medical help at our hospital from May 2020 to October 2022 as subjects. We collected their basic information (sex and age); measured height, weight, waist and hip circumference, and blood pressure; calculated body mass index (BMI); and detected blood glucose, c-peptide, HbA1c, biomarkers, urinary microalbumin, sensory nerve conduction velocity of lower limbs, ABI, and subcutaneous and visceral fat at the time of MMC recruited and the end of six months. T test and Mann-Whitney U rank sum test were used for measurement data and χ2 test or Fisher’s exact probability method for counting data to analyze the data. 【Results】 After 6 months, the levels of fasting blood glucose, postprandial blood glucose, HbA1c, and visceral and subcutaneous fat in all the patients decreased, but the level of fasting c-peptide increased compared with the baseline (all P<0.05). Secondly, compared with the baseline, the control rate of HbA1c (35.21% vs. 13.71% ) and the comprehensive control rate (13.97% vs. 7.26% ) were both significantly increased at six months (P<0.05). Thirdly, after 6 months, the levels of fasting blood glucose, postprandial blood glucose, HbA1c, TG, TC, and UA were decreased more, while the fasting c-peptide and postprandial c-peptide were increased more in the patients of the HbA1c standard group (HbA1c<7% ) than those of the non-standard group. 【Conclusion】 The multiple benefits of blood glucose, blood lipid, uric acid and islet function can be achieved by taking type 2 diabetes patients into MMC. Meanwhile, the rates of HbA1c control and comprehensively reaching the standard are significantly increased. Therefore, MMC can explore a new way for the management of type 2 diabetic patients in this area.
9.Mouse nerve growth factor combined with rehabilitation in the treatment of global developmental delay: a prospective multicenter clinical randomized controlled trial
Jiulai TANG ; Xiaojie LI ; De WU ; Wei PANG ; Hujie SONG ; Yan HUANG ; Jin GUO ; Ling LI ; Li YANG ; Ran HUA ; Fuxiang SONG ; Yutang LIU ; Mingda ZHANG ; Yang LYU
Chinese Journal of Applied Clinical Pediatrics 2023;38(11):857-862
Objective:To observe the clinical efficacy of mouse nerve growth factor (mNGF) combined with rehabilitation on children with global developmental delay(GDD).Methods:It was a prospective multicenter clinical randomized controlled trial (RCT) involving 120 children with GDD admitted to 5 hospitals in China from May 2020 to January 2022.They were randomly divided into mNGF group and conventional rehabilitation group using block randomization method.All children were managed by standardized rehabilitation after recruitment, and those in the mNGF group were additionally given mNGF injections.All subjects were surveyed using the Gesell Development Diagnosis Schedules(GDDS) at baseline, 90 days and 120 days after treatment, and their developmental quotient (DQ) was recorded.Clinical efficacy was analyzed by the paired t-test, rank sum test and Chi- squared test. Results:After 90 days of treatment and the continuous follow-up to 120 days, the increases in the DQ of gross motor (7.520±13.900 vs.0.450±11.459), fine motor (7.800±15.346 vs.1.250±11.581), adaptive behavior (7.730±13.428 vs.2.100±12.022) and personal-social behavior (6.780±11.651 vs.1.780±10.120) than baseline were significantly higher in mNGF group than those of conventional rehabilitation group (all P<0.05). Serious adverse events and important drug-related medical events were not reported. Conclusions:mNGF combined with rehabilitation effectively enhances the development levels of gross motor, fine motor, adaptive behavior and personal-social behavior, and continuously improves the condition of GDD in children with a high safety.
10.Application of traditional Chinese medicine Qingkailing to extend platelet storage in vitro: the metabolism and morphology study
Xuerui ZHANG ; Jie LI ; Yan XIAO ; Qiqing LI ; Liang LIANG ; Fuxiang LUO ; Xueyan ZHONG ; Jiongcai LAN
Chinese Journal of Blood Transfusion 2021;34(12):1299-1304
【Objective】 To study the metabolism and morphology changes of platelets in vitro using traditional Chinese medicine named Qingkailing injection as the additive solution, and to explore the viability of Qingkailing in the extension of platelet storage. 【Methods】 Apheresis platelets, adding 1% final concentration of Qingkailing injection, were taken as experiment groups, and sampled on 1, 3, 5, 8, 10 and 14 days(6 time points)of storage. Apheresis platelets without adding Qingkailing injection were taken as the control, and sampled on 1, 3 and 5 days(3 time points)of storage. The platelet count, morphology scores, biochemical parameters, pH and response rate of hypotonic shock during agitated storage(22 ℃) were tested. 【Results】 1) No significant change in platelet count was noticed in both experimental group(within 14 days) and the control(within 5 days)(P>0.05). The MPV and PDW of both groups increased at any sampling time within 5 days(P<0.05). 2) The morphology score of experimental groups and the control all decreased within the storage period(P<0.05), but its decrease of the control was greater than that of the experimental groups, especially on day 8(P<0.05). 3)Glucose, lactate dehydrogenase, lactate, Na+, and K+ values increased or decreased in varying degrees(P<0.05), while Cl- value stayed almost the same during 14 days(P>0.05). Glucose, lactate dehydrogenase, lactate and Na+ value changed significantly in the control within 5 days(P<0.05), while K+ and Cl- value did not(P>0.05). Within 5-day storage, the glucose consumption, lactate dehydrogenase and lactate generation in the control were significantly greater than those in experimental groups(P<0.05), but the added value of Na+, K+ and Cl- showed no significant difference(P>0.05). 4) pH value, relative to the baseline of day 1, decreased in both groups within 5 days, and its decreasing trend was significant in the control (P<0.05), but not in the experimental group(P>0.05). No significant difference was noticed in the response rate of hypotonic shock in experimental groups within 8 days, while significant decrease was noticed in the control within 5days(P<0.05). The response rate of hypotonic shock in experimental groups were significantly higher than that in the control on day 3 and day 5(P<0.05). 【Conclusion】 The comparison of apheresis platelets, stored in vitro, in terms of platelet count, morphology scores, biochemical parameters, pH and response rate of hypotonic shock showed that platelets, adding 1% final concentration of Qingkailing injection, could prolong the platelet storage to at least 10 days in vitro.

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