OBJECTIVE: To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension. METHODS: This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups. RESULTS: A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period. CONCLUSIONS Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans ; Amlodipine/adverse effects* ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Hypertension/complications* ; Middle Aged ; Treatment Outcome ; Drug Therapy, Combination ; Adult ; Blood Pressure/drug effects* ; Double-Blind Method ; Aged ; Antihypertensive Agents/adverse effects*

OBJECTIVE: To investigate the accuracy and safety of pedicle screw placement using 3D-printed auxiliary guides in scoliosis correction surgery for adolescents. METHODS: A retrospective analysis was conducted on the clinical data of 51 patients who underwent posterior scoliosis correction surgery from January 2020 to March 2023. Among them, there were 35 cases of adolescent idiopathic scoliosis and 16 cases of congenital scoliosis. The patients were divided into two groups based on the auxiliary tool used:the 3D-printed auxiliary guide screw placement group (3D printing group) and the free-hand screw placement group (free-hand group, without auxiliary tools). The 3D printing group included 32 patients (12 males and 20 females) with an average age of (12.59±2.60) years;the free-hand group included 19 patients (7 males and 12 females) with an average age of (14.58±3.53) years. The two groups were compared in terms of screw placement accuracy and safety, spinal correction rate, intraoperative blood loss, number of intraoperative fluoroscopies, operation time, hospital stay, and preoperative and last follow-up scores of the Scoliosis Research Society-22 (SRS-22) questionnaire. RESULTS: A total of 707 pedicle screws were placed in the two groups, with 441 screws in the 3D printing group and 266 screws in the free-hand group. All patients in both groups successfully completed the surgery. There was a statistically significant difference in operation time between the two groups (P<0.05). The screw placement accuracy rate of the 3D printing group was 95.46% (421/441), among which the Grade A placement rate was 89.34% (394/441);the screw placement accuracy rate of the free-hand group was 86.47% (230/266), with a Grade A placement rate of 73.31% (195/266). There were statistically significant differences in the accuracy of Grade A, B, and C screw placements between the two groups (P<0.05), while no statistically significant differences were observed in intraoperative blood loss, number of fluoroscopies, correction rate, or hospital stay (P>0.05). In the SRS-22 questionnaire scores, the scores of functional status and activity ability, self-image, mental status, and pain of patients in each group at the last follow-up were significantly improved compared with those before surgery (P<0.05), but there were no statistically significant differences in all scores between the two groups (P>0.05). CONCLUSION In scoliosis correction surgery, compared with traditional free-hand screw placement, the use of 3D-printed auxiliary guides for screw placement significantly improves the accuracy and safety of screw placement and shortens the operation time.
Humans ; Male ; Scoliosis/surgery* ; Female ; Adolescent ; Printing, Three-Dimensional ; Retrospective Studies ; Pedicle Screws ; Child

Objective:To explore the efficacy and safety of sivelestat sodium in patients with acute respiratory distress syndrome (ARDS) in the intensive care unit (ICU).Methods:Sixty patients with ARDS admitted to the ICU of the Fuyang Hospital Affiliated to Anhui Medical University from August 1, 2023 to November 1, 2024 were selected and divided into the control group (conventional treatment, 30 cases) and the sivelestat sodium group (treated with sivelestat sodium in addition to conventional treatment, 30 cases) by the random number table method. The clinical data such as inflammatory factors, blood gas analysis indicators, Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score and Sequential Organ Failure Assessment (SOFA) score of the two groups of patients before treatment and 3 days after treatment were compared. The prognostic indicators such as mechanical ventilation time, ICU stay time, total hospital stay time, 28-day mortality rate and clinical efficacy of the two groups of patients were compared.Results:Before treatment, there were no statistically significant differences in inflammatory factors, blood gas analysis indicators, APACHE Ⅱ score and SOFA score between the two groups of patients (all P>0.05). After 3 days of treatment, the improvement degrees of APACHE Ⅱ score, SOFA score, arterial partial pressure of oxygen (PaO 2), oxygenation index (PaO 2/FiO 2), procalcitonin (PCT), interleukin-6 (IL-6), and C-reactive protein (CRP) in the sivelestat sodium group were all greater than those in the control group. The differences were all statistically significant (all P<0.05); The mechanical ventilation time [(5.31±4.12) d vs (7.17±2.32)d] and ICU stay [(6.31±3.42)d vs (8.93±5.26)d] of patients in the sivelestat sodium group were significantly shorter than those in the control group, and the differences were statistically significant (all P<0.05). There was no statistically significant difference in the 28-day mortality rate between the sivelestat sodium group [20.00%(6/30)] and the control group [43.33%(13/30)] ( P>0.05). The total effective rate of treatment in the sivelestat sodium group was significantly higher than that in the control group [80.00%(24/30) vs 56.67%(17/30)], and the difference was statistically significant (χ 2=4.167, P=0.041). Conclusions:Sivelestat sodium is helpful in improving the physiological parameters of patients with ARDS, effectively reducing the levels of inflammatory factors in the body, shortening the duration of mechanical ventilation and ICU stay, but has no significant effect on the 28-day mortality rate.

Objective:To explore the efficacy and safety of sivelestat sodium in patients with acute respiratory distress syndrome (ARDS) in the intensive care unit (ICU).Methods:Sixty patients with ARDS admitted to the ICU of the Fuyang Hospital Affiliated to Anhui Medical University from August 1, 2023 to November 1, 2024 were selected and divided into the control group (conventional treatment, 30 cases) and the sivelestat sodium group (treated with sivelestat sodium in addition to conventional treatment, 30 cases) by the random number table method. The clinical data such as inflammatory factors, blood gas analysis indicators, Acute Physiology and Chronic Health Evaluation (APACHE) Ⅱ score and Sequential Organ Failure Assessment (SOFA) score of the two groups of patients before treatment and 3 days after treatment were compared. The prognostic indicators such as mechanical ventilation time, ICU stay time, total hospital stay time, 28-day mortality rate and clinical efficacy of the two groups of patients were compared.Results:Before treatment, there were no statistically significant differences in inflammatory factors, blood gas analysis indicators, APACHE Ⅱ score and SOFA score between the two groups of patients (all P>0.05). After 3 days of treatment, the improvement degrees of APACHE Ⅱ score, SOFA score, arterial partial pressure of oxygen (PaO 2), oxygenation index (PaO 2/FiO 2), procalcitonin (PCT), interleukin-6 (IL-6), and C-reactive protein (CRP) in the sivelestat sodium group were all greater than those in the control group. The differences were all statistically significant (all P<0.05); The mechanical ventilation time [(5.31±4.12) d vs (7.17±2.32)d] and ICU stay [(6.31±3.42)d vs (8.93±5.26)d] of patients in the sivelestat sodium group were significantly shorter than those in the control group, and the differences were statistically significant (all P<0.05). There was no statistically significant difference in the 28-day mortality rate between the sivelestat sodium group [20.00%(6/30)] and the control group [43.33%(13/30)] ( P>0.05). The total effective rate of treatment in the sivelestat sodium group was significantly higher than that in the control group [80.00%(24/30) vs 56.67%(17/30)], and the difference was statistically significant (χ 2=4.167, P=0.041). Conclusions:Sivelestat sodium is helpful in improving the physiological parameters of patients with ARDS, effectively reducing the levels of inflammatory factors in the body, shortening the duration of mechanical ventilation and ICU stay, but has no significant effect on the 28-day mortality rate.

Air Pollution/analysis* ; Environmental Exposure/analysis* ; China/epidemiology* ; Air Pollutants/analysis* ; Particulate Matter/analysis* ; Environmental Monitoring

Objective To observe the application effect of montelukast sodium combined with terbutaline on cough variant asthma(CVA)in children and its influence on airway remodeling and peripheral blood inflammatory indicators.Methods The children with CVA were randomly classified into control group and treatment group.The control group was given aerosol inhalation of terbutaline(5 mg each time,twice a day),and on the basis of the control group,the treatment group was combined with oral administration of montelukast sodium granules(4 mg each time,once a day,taking before going to bed),and both groups were continuously treated for 3 months.The clinical efficacy,airway cross-section area(AO),airway lumen area(AI),airway wall thickness(T),airway wall area(WA),serum interleukin-5(IL-5),eosinophilic chemotactic factor(Eotaxin),macrophage inflammatory protein-1α(MIP-1α)and T lymphocyte subgroups CD4+,CD8+and CD4+/CD8+were compared between the two groups of children,and the medication safety was assessed.Results Fifty-three cases in control group and 53 cases in treatment group were included.After treatment,the total effective rates in treatment group and control group were 96.23％(51 cases/53 cases)and 83.02％(44 cases/53 cases),respectively(P＜0.05).The AO values in treatment group and control group were(39.42±3.67)and(45.69±4.92)mm2;AI values were(22.36±2.85)and(27.06±3.18)mm2;T values were(1.12±0.28)and(1.44±0.33)mm;WA values were(53.82±4.17)and(60.13±4.66)mm2;serum IL-5 levels were(25.46±5.83)and(41.46±7.64)ng·L-1;Eotaxin levels were(181.24±30.05)and(238.21±39.42)ng·L-1;MIP-1a levels were(15.24±3.67)and(22.43±4.05)ng·L-1;CD4+levels were(37.18±4.06)％and(33.57±3.82)％;CD8+levels were(24.08±3.15)％and(27.31±3.07)％;and CD4+/CD8+levels were 1.54±0.33 and 1.24±0.28,respectively(all P＜0.05).The total incidences of adverse drug reactions in treatment group and control group were 9.43％(5 cases/53 cases)and 3.77％(2 cases/53 cases),respectively(P＞0.05).Conclusion Montelukast sodium combined with terbutaline has an exact efficacy in the treatment of CVA in children,and it can effectively reverse airway remodeling,reduce inflammation level and enhance immune function,and it has good safety.

Objective To investigate the curative effect of suture anchor(SA)repair combined with open reduction and internal fixation(ORIF)on patients with ankle joint fracture(AF)combined with deltoid ligament injury(DLI).Methods A total of 138 patients with AF combined with DLI admitted to our hospital from January 2020 to September 2022 were selected and divided into the control group(69 cases)and the observation group(69 cases)according to the random number table method.Patients in the control group were treated with ORIF,while patients in the observation group were treated with SA repair on the basis of the control group.The clinical efficacy,American Orthopedic Foot and Ankle Society(AOFAS)score,visual analogue scale(VAS)score,talus inclination angle,medial malleolar space of affected side,bone metabolic indexes[serum bone gla protein(BGP),β-collagen degradation product(β-CTX)]levels and the incidence of complications before and 3 months after treatment were compared between the two groups.Results The total effective rate in the observation group was higher than that in the control group,and the difference was statistically significant(P<0.05).Compared with before treatment,the talus inclination angle,medial malleolar space of affected side,VAS score,β-CTX level 3 months after treatment of patients in the two groups were reduced,while the AOFAS score and BGP level were increased,and the differences were statistically significant(P<0.05).After treatment,the AOFAS score and BGP level in the observation group were higher than those in the control group,while the talus inclination angle and medial malleolar space of affected side were smaller than those in the control group,and the VAS score and β-CTX level were lower than those in the control group,with statistically significant differences(P<0.05).The total incidence of complications in the observation group was lower than that in the control group,and the difference was statistically significant(P<0.05).Conclusion SA repair has a definite therapeutic effect on AF combined with DLI,which can improve patients' symptoms and promote the recovery of ankle joint function and bone metabolism.

Objective: To investigate the impact of molecular classification and key oncogenes on the oncologic outcomes in patients with endometrial carcinoma (EC) and atypical endometrial hyperplasia (AEH) receiving fertility-preserving treatment. Methods: Patients with EC and AEH undergoing progestin-based fertility-preserving treatment and receiving molecular classification as well as key oncogenes test at Obstetrics and Gynecology Hospital, Fudan University from January 2021 to March 2023 were reviewed. Hysteroscopic lesion resection and endometrial biopsy were performed before initiating hormone therapy and every 3 months during the treatment to evaluate the efficacy. The risk factors which had impact on the treatment outcomes in EC and AEH patients were further analyzed. Results: Of the 171 patients analyzed, the median age was 32 years, including 86 patients with EC and 85 patients with AEH. The distribution of molecular classification was as follows: 157 cases (91.8%) were classified as having no specific molecular profile (NSMP); 9 cases (5.3%), mismatch repair deficient (MMR-d); 3 cases (1.8%), POLE-mutated; 2 cases (1.2%), p53 abnormal. No difference was found in the cumulative 40-week complete response (CR) rate between the patients having NSMP or MMR-d (61.6% vs 60.0%; P=0.593), while the patients having MMR-d had increased risk than those having NSMP to have recurrence after CR (50.0% vs 14.4%; P=0.005). Multi-variant analysis showed PTEN gene multi-loci mutation (HR=0.413, 95%CI: 0.259-0.658; P<0.001) and PIK3CA gene mutation (HR=0.499, 95%CI: 0.310-0.804; P=0.004) were associated with a lower cumulative 40-week CR rate, and progestin-insensitivity (HR=3.825, 95%CI: 1.570-9.317; P=0.003) and MMR-d (HR=9.014, 95%CI: 1.734-46.873; P=0.009) were independent risk factors of recurrence in EC and AEH patients. Conclusions: No difference in cumulative 40-week CR rate is found in the patients having NSMP or MMR-d who received progestin-based fertility-preserving treatment, where the use of hysteroscopy during the treatment might be the reason, while those having MMR-d have a higher risk of recurrence after CR. Oncogene mutation of PTEN or PIK3CA gene might be associated with a lower response to progestin treatment. The molecular profiles help predict the fertility-preserving treatment outcomes in EC and AEH patients.
Pregnancy ; Female ; Humans ; Adult ; Hyperplasia ; Progestins ; Fertility Preservation ; Endometrial Neoplasms/pathology* ; Endometrial Hyperplasia/surgery* ; Treatment Outcome ; Precancerous Conditions ; Fertility ; Class I Phosphatidylinositol 3-Kinases ; Retrospective Studies

Objective To understand the characteristics and developmental differences between cerebral organoids in vitro and normal cerebral cortices in vivo. Methods 1. Grouping: cerebral cortices in vivo group and cultured cerebral organoids in vitro group. 2. Sample collection: cortical tissues were collected from Kunming mouse embryos at embryonic day 7.5(E7.5), E9.5, E11.5, E14.5, and postnatal day 3 (P3) or P7. Three specimens were taken from each group. Meanwhile, cerebral organoids were cultured with mouse induced pluripotent stem cells (iPSCs), and samples at different culture time point were collected, and more than 3 samples were collected at each time point. 3. Detection method: the distribution of different types of cells in each group of specimens was analyzed by immunofluorescent staining. Results While relative similarities between in vivo cerebral cortical development and the cerebral organoids in vitro were observed, including the histogenesis, and the morphological differentiation of nerve cells and glial cells, the lamellar architecture of cerebral cortex in mouse brain was not observed in cerebral organoids. Conclusion The development of cerebral organoids in vitro has some similarity with body's cortical development. Therefore, cerebral organoids can be used to a substitution of cortex and diseases' models, but improvement of the existing technologies is necessary.