ObjectiveTo explore the changes in volatile components， total polysaccharides， enzyme activity， and chromaticity value of Myristicae Semen Koji（MSK） during the fermentation process， and conduct correlation analysis. MethodsBased on gas chromatography-mass spectrometry（GC-MS）， the changes of volatile components in MSK at different fermentation times were identified. The phenol sulfuric acid method， dinitrosalicylic acid method（DNS）， and carboxymethyl cellulose sodium salt method（CMC-Na） were used to investigate the total polysaccharide content， amylase activity， and cellulase activity during the fermentation process. Visual analysis technology was used to explore the changes in chromaticity values， revealing the fermentation process of MSK and the dynamic changes of various measurement indicators， partial least squares-discriminant analysis（PLS-DA） was used to explore the differential compounds of MSK at different fermentation degrees， and Pearson correlation analysis was used to explore the correlation between volatile components of MSK and total polysaccharides， enzyme activity， and chromaticity values. ResultsA total of 60 volatile compounds were identified from MSK， the relative contents of components such as （+）-α-pinene， β-phellandrene， β-pinene， （+）-limonene， and p-cymene obviously increased， while the relative contents of components such as safrole， methyl isoeugenol， methyleugenol， myristicin， and elemicin significantly decreased. During the fermentation process， the total polysaccharide content showed an upward trend， while the activities of amylase and cellulase showed an initial increase followed by a decrease， and reached their maximum value at 40 h. the overall brightness（L^*） and total color difference（ΔE^*） gradually increased， while the changes in red-green value（a^*） and yellow-blue value（b^*） were not obvious. PLS-DA results showed that MSK could be clearly distinguished at different fermentation times， and 13 differential biomarkers were screened out. Pearson correlation analysis results showed that the contents of α-terpinene， β-phellandrene， methyleugenol， β-cubebene and myristic acid had an obvious correlation with chromaticity values. ConclusionAfter fermentation， the volatile components， total polysaccharides， amylase activity， and cellulase activity of MSK undergo significant changes， and there is a clear correlation between them and chromaticity values， which reveals the dynamic changes in the fermentation process and related indicators of MSK， laying a foundation for the quality control.

Objective To assess the clinical value of a nomogram model constructed by the authors in predicting recurrent laryngeal nerve(RLN)injury after thermal ablation for secondary hyperparathyroidism(SHPT).Methods The clinical data of a total of 102 patients with end-stage renal disease SHPT,who received thermal ablation at the Yulin Municipal First People's Hospital of China from May 2019 to January 2024,were retrospectively analyzed.According to whether RLN injury occurred or not after thermal ablation,the patients were divided into RLN injury group(n=24)and non-RLN injury group(n=78).The clinical data were compared between the two groups.Multivariate logistic regression analysis was used to determine the independent risk factors for RLN injury.R language was used to construct a visualization nomogram according to the variables of the logistic regression model.The receiver operating characteristic(ROC)curve was used to evaluate the discrimination of the nomogram model.Hosmer-Lemeshow test and calibration curve were used to evaluate the goodness of fit and the calibration of the nomogram model.Results Superior gland ablation(OR=8.784,95％ CI:2.056-37.521,P=0.003),total parathyroid gland volume(OR=1.684,95％CI:1.167-2.430,P=0.005),thermal ablation energy(OR=1.132,95％ CI:1.016-1.261,P=0.025)were the independent risk factors for RLN injury after thermal ablation(all P＜0.05).Based on the above 3 risk factors,a nomogram model used for predicting the risk of RLN injury was established.The area under ROC curve(AUC)was 0.868,and the Hosmer-Lemeshow test showed that the degree of fit was good(P=0.769).The calibration curve indicated that the calibration curve basically coincided with the ideal curve.Conclusion Superior gland ablation,total parathyroid gland volume,and thermal ablation energy are the independent risk factors for RLN injury after thermal ablation in patients with end-stage renal disease SHPT.The nomogram model constructed based on the above mentioned three factors can effectively predict RLN injury.

ObjectiveTo evaluate the effect and safety of Jiuxin Pill （救心丸） on exercise tolerance and quality of life in patients with stable angina pectoris （SAP）. MethodsA randomised， double-blind， placebo-controlled， multicentre study design was used to enroll 170 patients of SAP from nine centres， which were divided into 85 patients each in the trial group and control group with 1∶1 ratio. Both groups maintained the original western medicine treatment plan， and added Jiuxin Pill or placebo respectively， 2 pills （0.05 g） each time twicely for 28 days. The main outcomes were total exercise time （TED） in the exercise treadmill test and Seattle Angina Questionnaire （SAQ） scores including physical limitation （PL）， angina stability （AS）， angina frequency （AF）， treatment satisfaction （TS）， and disease perception （DP）. The secondary outcomes were exercise treadmill test indicators including heart rate recovery in 1 min （HRR1）， metabolic equivalents （METs）， maximum magnitude of ST-segment depression， and the Borg rating of perceived exertion scale， the average number of angina attacks per week， withdrawal and reduction rate of nitroglycerin， traditional Chinese medicine syndrome scores， incidence of major adverse cardiovascular events. Safety indicators were evaluated and the occurrence of adverse events during the trial was recorded. Data was collected before treatment， day 28±2 in treatment period， and follow-up at day 56 which is 28±2 days after treatment period finished. ResultsEighty-four and eighty-five patients respectively from trial group and control group were included to the full analysis set （FAS） and safety analysis set （SS）. Compared with the group before treatment and with the control group after treatment， the trial group had higher TED， HRR1， and METs， and lower maximum magnitude of ST-segment depression and Borg rating of perceived exertion scores after treatment （P＜0.01）. Compared with the group before treatment and with the control group after treatment and at follow-up， the total SAQ score and scores of AS， AF， TS and DP of the trial group after treatment and at follow-up elevated， while the average number of angina attacks per week and traditional Chinese medicine syndrome scores reduced （P＜0.01）. There was no statistically significant difference in the withdrawal and reduction rate of nitroglycerin between groups （P＞0.05）. Major adverse cardiovascular events occurred in 1 case （1/84， 1.19%） in the trial group and 1 case （1/85， 1.18%） in the control group， and the difference between groups was not statistically significant （P＞0.05）. A total of 3 cases of adverse events occurred in the trial group （3/84， 3.57%）， and a total of 6 cases of adverse events occurred in the control group （6/85， 7.06%）， and there was no statistically significant difference in the incidence of adverse events between groups （P＞0.05）. ConclusionIn the treatment of SAP， Jiuxin Pill combined with conventional western medicine can further enhance exercise tolerance， improve quality of life， and demonstrate great safety.

Purpose To investigate the risk factors of severe hypocalcemia after ultrasound-guided thermal ablation for secondary hyperparathyroidism.Materials and Methods A retrospective case-control study was used to study 91 patients with uremia complicated with secondary hyperparathyroidism in the First People's Hospital of Yulin from May 2019 to May 2023.All patients underwent ultrasound-guided thermal ablation and were divided into severe hypocalcemia group(SH)and non-SH group according to postoperative blood calcium levels.The difference of clinical data between the two groups was compared,and the independent risk factors of SH were investigated by multivariate Logistic regression analysis.Results A total of 317 glands were ablated in 49 cases of microwave ablation and 42 cases of radiofrequency ablation.SH occurred in 57 cases(62.64%)after ablation.The comparison of clinical data between the two groups showed that there were significant differences in the preoperative intact parathyroid hormone(iPTH),decline rate of iPTH 1 d,preoperative serum alkaline phosphatase,the proportion of parathyroid glands≥4 and the total gland volume between the two groups(all P<0.05).Receiver operating characteristic curve analysis was used to obtain the best cut-off point of iPTH 1 d decline rate,the result was 74.59%,the area under the curve was 0.866(95%CI 0.787-0.945)(P<0.05),the sensitivity was 84.2%,and the specificity was 78.1%.Multivariate Logistic regression analysis showed that preoperative alkaline phosphatase(OR=1.015,95%CI 1.005-1.025,P=0.030)and decline rate of iPTH 1 d≥74.59%(OR=30.423,95%CI 5.938-155.858,P<0.001)and parathyroid glands≥4(OR=4.355,95%CI 1.027-18.469,P=0.046)were independent risk factors for postoperative SH(all P<0.05).Conclusion Preoperative alkaline phosphatase and decline rate of iPTH 1 d≥74.59%and the number of parathyroid glands≥4 are independent risk factors for SH after thermal ablation.

Objective To observe the risk factors of recurrence after ultrasound-guided thermal ablation for treating uremia secondary hyperparathyroidism(SHPT).Methods Totally 59 patients with uremia SHPT who underwent ultrasound-guided thermal ablation were enrolled,including 23 cases with(relapse group)and 36 without SHPT recurrence(non relapsed group).Clinical data were compared between groups,univariate and multivariate logistic regression analysis were performed to screen independent risk factors of SHPT recurrence.Results There were significant differences of serum free thyroxine(FT4),urea,intact parathyroid hormone(iPTH)1 day after ablation,1 day decrease rate of iPTH,the maximum diameter of the largest nodule,ablation time,total ablation energy,energy to volume ratio and the proportion of 1 day decrease rate of iPTH≤90%between groups(all P＜0.05).Higher urea,lower energy to volume ratio and 1 day decrease rate of iPTH≤90%were all independent risk factors of SHPT recurrence(all P＜0.05).Conclusion Higher urea,lower energy to volume ratio and 1 day decrease rate of iPTH≤90%were independent risk factors of recurrence after ultrasound-guided thermal ablation for treating uremia SHPT.

Objective:To investigate the safety and efficacy of total pelvic exenteration (TPE) for treating late complications of radiation-induced pelvic injury.Methods:This was a descriptive case series study. The inclusion criteria were as follows: (1) confirmed radiation-induced pelvic injury after radiotherapy for pelvic malignancies; (2) late complications of radiation-induced pelvic injury, such as bleeding, perforation, fistula, and obstruction, involving multiple pelvic organs; (3) TPE recommended by a multidisciplinary team; (4) patient in good preoperative condition and considered fit enough to tolerate TPE; and (5) patient extremely willing to undergo the procedure and accept the associated risks. The exclusion criteria were as follows: (1) preoperative or intraoperative diagnosis of tumor recurrence or metastasis; (2) had only undergone diversion or bypass surgery after laparoscopic exploration; and (3) incomplete medical records. Clinical and follow-up data of patients who had undergone TPE for late complications of radiation-induced pelvic injury between March 2020 and September 2022 at the Sixth Affiliated Hospital of Sun Yat-sen University were analyzed. Perioperative recovery, postoperative complications, perioperative deaths, and quality of life 1 year postoperatively were recorded.Results:The study cohort comprised 14 women, nine of whom had recto-vagino-vesical fistulas, two vesicovaginal fistulas, one ileo-vesical fistula and rectal necrosis, one ileo-vesical and rectovaginal fistulas, and one rectal ulcer and bilateral ureteral stenosis. The mean duration of surgery was 592.1±167.6 minutes and the median blood loss 550 (100–6000) mL. Ten patients underwent intestinal reconstruction, and four the Hartmann procedure. Ten patients underwent urinary reconstruction using Bricker's procedure and 7 underwent pelvic floor reconstruction. The mean postoperative hospital stay was 23.6±14.9 days. Seven patients (7/14) had serious postoperative complications (Clavien-Dindo IIIa to IVb), including surgical site infections in eight, abdominopelvic abscesses in five, pulmonary infections in five, intestinal obstruction in four, and urinary leakage in two. Empty pelvis syndrome (EPS) was diagnosed in five patients, none of whom had undergone pelvic floor reconstruction. Five of the seven patients who had not undergone pelvic floor reconstruction developed EPS, compared with none of those who had undergone pelvic floor reconstruction. One patient with EPS underwent reoperation because of a pelvic abscess, pelvic hemorrhage, and intestinal obstruction. There were no perioperative deaths. During 18.9±10.1 months of follow-up, three patients died, two of renal failure, which was a preoperative comorbidity, and one of COVID-19. The remaining patients had gradual and significant relief of symptoms during follow-up. QLQ-C30 assessment of postoperative quality of life showed gradual improvement in all functional domains and general health at 1, 3, and 6 months postoperatively (all P<0.05). Conclusions:TPE is a feasible procedure for treating late complications of radiation-induced pelvic injury combined with complex pelvic fistulas. TPE is effective in alleviating symptoms and improving quality of life. However, the indications for this procedure should be strictly controlled and the surgery carried out only by experienced surgeons.

Objective:To investigate the safety and efficacy of total pelvic exenteration (TPE) for treating late complications of radiation-induced pelvic injury.Methods:This was a descriptive case series study. The inclusion criteria were as follows: (1) confirmed radiation-induced pelvic injury after radiotherapy for pelvic malignancies; (2) late complications of radiation-induced pelvic injury, such as bleeding, perforation, fistula, and obstruction, involving multiple pelvic organs; (3) TPE recommended by a multidisciplinary team; (4) patient in good preoperative condition and considered fit enough to tolerate TPE; and (5) patient extremely willing to undergo the procedure and accept the associated risks. The exclusion criteria were as follows: (1) preoperative or intraoperative diagnosis of tumor recurrence or metastasis; (2) had only undergone diversion or bypass surgery after laparoscopic exploration; and (3) incomplete medical records. Clinical and follow-up data of patients who had undergone TPE for late complications of radiation-induced pelvic injury between March 2020 and September 2022 at the Sixth Affiliated Hospital of Sun Yat-sen University were analyzed. Perioperative recovery, postoperative complications, perioperative deaths, and quality of life 1 year postoperatively were recorded.Results:The study cohort comprised 14 women, nine of whom had recto-vagino-vesical fistulas, two vesicovaginal fistulas, one ileo-vesical fistula and rectal necrosis, one ileo-vesical and rectovaginal fistulas, and one rectal ulcer and bilateral ureteral stenosis. The mean duration of surgery was 592.1±167.6 minutes and the median blood loss 550 (100–6000) mL. Ten patients underwent intestinal reconstruction, and four the Hartmann procedure. Ten patients underwent urinary reconstruction using Bricker's procedure and 7 underwent pelvic floor reconstruction. The mean postoperative hospital stay was 23.6±14.9 days. Seven patients (7/14) had serious postoperative complications (Clavien-Dindo IIIa to IVb), including surgical site infections in eight, abdominopelvic abscesses in five, pulmonary infections in five, intestinal obstruction in four, and urinary leakage in two. Empty pelvis syndrome (EPS) was diagnosed in five patients, none of whom had undergone pelvic floor reconstruction. Five of the seven patients who had not undergone pelvic floor reconstruction developed EPS, compared with none of those who had undergone pelvic floor reconstruction. One patient with EPS underwent reoperation because of a pelvic abscess, pelvic hemorrhage, and intestinal obstruction. There were no perioperative deaths. During 18.9±10.1 months of follow-up, three patients died, two of renal failure, which was a preoperative comorbidity, and one of COVID-19. The remaining patients had gradual and significant relief of symptoms during follow-up. QLQ-C30 assessment of postoperative quality of life showed gradual improvement in all functional domains and general health at 1, 3, and 6 months postoperatively (all P<0.05). Conclusions:TPE is a feasible procedure for treating late complications of radiation-induced pelvic injury combined with complex pelvic fistulas. TPE is effective in alleviating symptoms and improving quality of life. However, the indications for this procedure should be strictly controlled and the surgery carried out only by experienced surgeons.

Medicine, Chinese Traditional ; Drugs, Chinese Herbal ; China

Objective:To establish a double antibody sandwich ELISA for detecting the specific antigen of Seoul virus (SEOV) L99 strain and to provide a means for antigen detection in the development, production and verification of vaccine against hemorrhagic fever with renal syndrome (HFRS).Methods:Monoclonal antibodies (McAbs) aganist L99 virus were induced in mice using four hybridoma cell lines and purified by Protein-A affinity chromatography. The purity, titer and specificity of McAbs were determined by SDS-PAGE, indirect ELISA and Western blot, respectively. Four McAbs were paired with each other and the additivity indices of paired McAbs were analyzed. After labeling McAbs with horseradish peroxidase (HRP), the concentrations of the coated and labeled antibodies were optimized by orthogonal test, and then a double antibody sandwich ELISA for virus antigen detection was established. Type Ⅱ HFRS inactivated vaccine standard was used as a quantitative standard to verify the sensitivity, linearity, specificity, accuracy and precision of the developed method. The applicability of the method was verified by testing three batches of vaccine stock solutions.Results:Four McAbs were at titers of greater than 1∶10 6 and their purity was all greater than 98%. The McAbs secreted by 1D5, 3A4 and 5B7 cells could specifically recognize the nucleocapsid protein of SEOV L99. There was cross-reaction between McAb secreted by 1D5 cells and Hantaan virus PS-6. The McAbs secreted by 3A4 and 1D5 were used as coating and labeling antibodies based on the results of antibody pairs. The working concentrations of the coating antibody and the horseradish peroxidase (HRP)-labeled antibody were 20 μg/ml and 1∶4 000, respectively. The minimum detection limit of the established method for the detection of SEOV L99 antigen was 0.078 1 μg/ml, and the linear range was 0.078 1-2.500 0 μg/ml with a R2 value of more than 0.99. There was no cross reaction with other HFRS vaccine. The virus antigen recovery rate was between 95.8% and 108.7%, and the coefficients of variation of precision was less than 10%. Three batches of Type II HFRS inactivated vaccine stocks were detected by this method and the results was dose-dependent. Conclusions:This study successfully established a double antibody sandwich ELISA method for specific detection of SEOV L99 strain antigen in the production of bivalent HFRS vaccines produced from hamster kidney cells.

Objective:To investigate the efficacy of repetitive transcranial magnetic stimulation (rTMS) combined with oral paroxetine in the treatment of older adult patients with severe depression and its effects on the scores of the Hamilton Rating Scale for Depression (HAMD), the Mini-Mental State Examination (MMSE), and Activities of Daily Living (ADL).Methods:A total of 192 older adult patients with severe depression who received treatment in Shaoxing 7 th People's Hospital from January 2018 to December 2019 were included in this study. They were randomly assigned to receive either oral paroxetine (control group, n = 96) or rTMS + oral paroxetine (observation group, n = 96). All patients received 1 month of treatment. Clinical efficacy was compared between the two groups. HAMD, MMSE, and ADL scores pre- and post-treatment and the incidence of adverse events during the treatment were compared between the two groups. Results:Total response rate was significantly higher in the observation group than in the control group [96.88% (93/96) vs. 89.58% (86/96), χ2 = 4.04, P < 0.05]. HAMD scores post-treatment were significantly lower in the observation group than in the control group [(6.43 ± 2.33) points vs. (11.32 ± 2.02) points, t = 15.53, P < 0.05]. MMSE and ADL scores post-treatment in the observation group were (29.13 ± 3.01) points and (71.52 ± 5.32) points, respectively, which were significantly higher than those in the control group [(24.65 ± 2.79) points, (69.65 ± 5.17) points, t = 10.69, 2.47, P < 0.05]. There was no significant difference in the incidence of adverse events between the two groups ( P > 0.05). Conclusion:The combined therapy of rTMS and oral paroxetine is highly effective on severe depression in older adult patients. It can improve cognitive function and the activities of life living.