In this paper, near-infrared spectroscopy(NIRS) was employed to analyze 129 batches of commercial products of Reduning Injection. The batch reporting rate was estimated according to the report of Reduning Injection in the direct adverse drug reaction(ADR) reporting system of the drug marketing authorization holder of the Center for Drug Reevaluation of the National Medical Products Administration(National Center for ADR Monitoring) from August 2021 to August 2022. According to the batch reporting rate, the samples of Reduning Injection were classified into those with potential risks and those being safe. No processing, random oversampling(ROS), random undersampling(RUS), and synthetic minority over-sampling technique(SMOTE) were then employed to balance the unbalanced data. After the samples were classified according to appropriate sampling methods, competitive adaptive reweighted sampling(CARS), successive projections algorithm(SPA), uninformative variables elimination(UVE), and genetic algorithm(GA) were respectively adopted to screen the features of spectral data. Then, support vector machine(SVM), logistic regression(LR), k-nearest neighbors(KNN), naive bayes(NB), random forest(RF), and artificial neural network(ANN) were adopted to establish the risk prediction models. The effects of the four feature extraction methods on the accuracy of the models were compared. The optimal method was selected, and bayesian optimization was performned to optimize the model parameters to improve the accuracy and robustness of model prediction. To explore the correlations between potential risks of clinical use and quality test data, TreeNet was employed to identify potential quality parameters affecting the clinical safety of Reduning Injection. The results showed that the models established with the SVM, LR, KNN, NB, RF, and ANN algorithms had the F1 scores of 0.85, 0.85, 0.86, 0.80, 0.88, and 0.85 and the accuracy of 88%, 88%, 88%, 85%, 91%, and 88%, respectively, and the prediction time was less than 5 s. The results indicated that the established models were accurate and efficient. Therefore, near infrared spectroscopy combined with machine learning algorithms can quickly predict the potential risks of clinical use of Reduning Injection in batches. Three key quality parameters that may affect clinical safety were identified by TreeNet, which provided a scientific basis for improving the safety standards of Reduning Injection.
Spectroscopy, Near-Infrared/methods* ; Drugs, Chinese Herbal/administration & dosage* ; Machine Learning ; Algorithms ; Humans ; Quality Control

Following the release of the Technical Requirements on Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules by the National Medical Products Administration in 2021, Chinese Pharmacopoeia Commission has promulgated 296 national drug standards so far, and most provinces have started the work of establishing provincial standards as supplements. The promulgation of standards fostered high-quality development of the industry. Since the implementation of national and provincial standards for more than three years, enterprises have gained deep understanding and hands-on experiences on the characteristics, technical requirements, production process, and quality control of traditional Chinese medicine(TCM) formula granules. Meanwhile, challenges have emerged restricting the high-quality development of this industry, including how to formulate quality control strategies for medicinal materials and decoction pieces, how to reduce manufacturing costs, and how to improve the pass rate and product stability under high standards. Based on the work experiences from standard management and process research, this article analyzed the distribution of sources, processing methods, dry extract rate ranges, process requirements for volatile oil-containing decoction pieces, control measures of safety indices, characteristics and trends of setting characteristic chromatograms or fingerprints, characteristics and trends of setting content ranges, and main differences between national standards and provincial standards. On the one hand, this article aims to present main characteristics for deeply understanding different indicators in standards and provide basic ideas for establishing quality and process control systems. On the other hand, from the perspective of industrial practice, suggestions are put forward on the important aspects that need to be focused on in the quality and process control of TCM formula granules.
Drugs, Chinese Herbal/chemistry* ; Quality Control ; Medicine, Chinese Traditional/standards* ; China ; Drug Industry/standards*

OBJECTIVE: To explore clinical characteristics, lesion sites and correlation differences of different types of diabetic foot gangrene, and to provide evidence-based basis for clinical classification of diabetic foot gangrene. METHODS: A retrospective analysis was conducted on 266 patients with newly diagnosed diabetic foot gangrene who were admitted from January 2018 to December 2018, including 183 males and 83 females, aged from 35 to 92 years old with an average of (69.55±10.84) years old, and they were divided into wet gangrene group and dry gangrene group according to the different natures of gangrene. There were 139 patients in wet gangrene group, including 98 males and 41 females, aged from 35 to 90 years old with an average of (68.95±10.93) years old. There were 127 patients in dry gangrene group, including 85 males and 42 females, aged from 38 to 92 years old with an average of (70.21±10.75) years old. Body mass index (BMI), waist-to-hip ratio (WHR), body temperature, skin temperature difference between the affected and healthy sides of the lower extremities, and Wagner grade between two groups were recorded to evaluate symptoms and signs. The white blood cell count (WBC), neutrophil percentage (NEUT%), and C-reactive protein (C-reactive protein), erythrocyte sedimentation rate (ESR), procalcitonin (PCT), and interleukin-6 (IL-6) in peripheral blood between two groups were detected and compared to evaluate the infection status;the severity of diabetic peripheral neuropathy (DPN) was evaluated by using Toronto Clinical Scoring System (TCSS);the degree of pain in patients with diabetic foot gangrene was evaluated by numerical rating scale (NRS); ankle-brachial index (ABI) and popliteal artery blood flow velocity were used to evaluate the degree of arterial lesions. Spearman correlation analysis was used to analyze the correlations between gangrene TCSS, ABI and age, BMI, WHR, body temperature, calf skin temperature difference, WBC, NEUT%, CRP, ESR, PCT, IL-6, NRS, and Wagner classification indicators. RESULTS: The body temperature, skin temperature difference between the affected and healthy sides of the lower extremities, Wagner grade, WBC, NEUT%, CRP, ESR, PCT, IL-6, TCSS score, ABI, and popliteal artery blood flow velocity in wet gangrene group were higher than those in dry gangrene group (P<0.01), and BMI, WHR, and NRS score in dry gangrene group were higher than those in wet gangrene group;the differences were all statistically significant (P<0.01). The results of Spearman correlation analysis showed TCSS score of gangrene patients was correlated with body temperature (r=0.214), calf skin temperature difference (r=0.364), WBC (r=0.240), NEUT% (r=0.291), CRP (r=0.347), ESR (r=0.167), PCT (r=0.241), IL-6 (r=0.316), and popliteal fossa arterial blood flow velocity (r=0.261) and Wagner grade (r=0.273) were positively correlated, and the differences were statistically significant (P<0.01). ABI was negatively correlated with age (r=-0.183), BMI (r=-0.252), WHR (r=-0.288), and NRS score (r=-0.354), and the differences were statistically significant (P<0.01). CONCLUSION Diabetic foot gangrene is an extremely difficult and critical disease. Wet gangrene has a significant synergic effect with infection and neuropathy, while dry gangrene is closely related to vascular occlusion. The main contradiction of gangrene could be revealed through blood vessels, nerves and infection, providing evidence-based basis for the selection of debridement timing, anti-infection strategies and revascularization, with the aim of reducing the risk of amputation.
Humans ; Male ; Female ; Aged ; Middle Aged ; Diabetic Foot/diagnosis* ; Aged, 80 and over ; Adult ; Retrospective Studies ; Gangrene/physiopathology* ; C-Reactive Protein

PURPOSE: To investigate the incidence and influencing factors of bone loss in patients with spinal cord injury (SCI). METHODS: A retrospective case-control study was conducted. Patients with SCI in our hospital from January 2019 to March 2023 were collected. According to the correlation between bone mineral density (BMD) at different sites, the patients were divided into the lumbar spine group and the hip joint group. According to the BMD value, the patients were divided into the normal bone mass group (t > -1.0 standard deviation) and the osteopenia group (t ≤ -1.0 standard deviation). The influencing factors accumulated as follows: gender, age, height, weight, cause of injury, injury segment, injury degree, time after injury, start time of rehabilitation, motor score, sensory score, spasticity, serum value of alkaline phosphatase, calcium, and phosphorus. The trend chart was drawn and the influencing factors were analyzed. SPSS 26.0 was used for statistical analysis. Correlation analysis was used to test the correlation between the BMD values of the lumbar spine and bilateral hips. Binary logistic regression analysis was used to explore the influencing factors of osteoporosis after SCI. p < 0.05 was considered statistically significant. RESULTS: The incidence of bone loss in patients with SCI was 66.3%. There was a low concordance between bone loss in the lumbar spine and the hip, and the hip was particularly susceptible to bone loss after SCI, with an upward trend in incidence (36% - 82%). In this study, patients with SCI were divided into the lumbar spine group (n = 100) and the hip group (n = 185) according to the BMD values of different sites. Then, the lumbar spine group was divided into the normal bone mass group (n = 53) and the osteopenia group (n = 47); the hip joint group was divided into the normal bone mass group (n = 83) and the osteopenia group (n = 102). Of these, lumbar bone loss after SCI is correlated with gender and weight (p = 0.032 and < 0.001, respectively), and hip bone loss is correlated with gender, height, weight, and time since injury (p < 0.001, p = 0.015, 0.009, and 0.012, respectively). CONCLUSIONS The incidence of bone loss after SCI was high, especially in the hip. The incidence and influencing factors of bone loss in the lumbar spine and hip were different. Patients with SCI who are male, low height, lightweight, and long time after injury were more likely to have bone loss.
Humans ; Spinal Cord Injuries/complications* ; Male ; Female ; Retrospective Studies ; Incidence ; Adult ; Bone Density ; Middle Aged ; Case-Control Studies ; Osteoporosis/etiology* ; Lumbar Vertebrae ; Bone Diseases, Metabolic/etiology* ; Aged ; Risk Factors

Functional dyspepsia (FD), characterized by persistent or recurrent dyspeptic symptoms without identifiable organic, systemic or metabolic causes, is an increasingly recognized global health issue. The objective of this guideline is to equip clinicians and nursing professionals with evidence-based strategies for the management and treatment of adult patients with FD using traditional Chinese medicine (TCM). The Guideline Development Group consulted existing TCM consensus documents on FD and convened a panel of 35 clinicians to generate initial clinical queries. To address these queries, a systematic literature search was conducted across PubMed, EMBASE, the Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Database, China Biology Medicine (SinoMed) Database, Wanfang Database, Traditional Medicine Research Data Expanded (TMRDE), and the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS). The evidence from the literature was critically appraised using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The strength of the recommendations was ascertained through a consensus-building process involving TCM and allopathic medicine experts, methodologists, pharmacologists, nursing specialists, and health economists, leveraging their collective expertise and empirical knowledge. The guideline comprises a total of 43 evidence-informed recommendations that span a range of clinical aspects, including the pathogenesis according to TCM, diagnostic approaches, therapeutic interventions, efficacy assessments, and prognostic considerations. Please cite this article as: Zhang SS, Zhao LQ, Hou XH, Bian ZX, Zheng JH, Tian HH, Yang GH, Hong WS, He YY, Liu L, Shen H, Li YP, Xie S, Shu J, Zeng BF, Li JX, Liu Z, Xiao ZH, Xiao JD, Zheng PY, Huang SG, Chen SL, Fei GJ. International clinical practice guideline on the use of traditional Chinese medicine for functional dyspepsia (2025). J Integr Med. 2025; 23(5):502-518.
Dyspepsia/drug therapy* ; Humans ; Medicine, Chinese Traditional/methods* ; Practice Guidelines as Topic ; Drugs, Chinese Herbal/therapeutic use*

AIM To explore the clinical effects of Jiawei Yanghe Decoction combined with Budesonide and Formoterol Fumarate Powder for Inhalation on patients with mild to moderate bronchial asthma in chronic and persistent period.METHODS One hundred and eighteen patients were randomly assigned into control group(59 cases)for 4-week administration of Budesonide and Formoterol Fumarate Powder for Inhalation,and observation group(59 cases)for 4-week administration of both Jiawei Yanghe Decoction and Budesonide and Formoterol Fumarate Powder for Inhalation.The changes in clinical effects,ACT score,bronchial asthma control rate,pulmonary function indices(FEV1,PEF,FEV1％,PEF％),inflammatory indices(EOS,EOS％,FeNO),TCM syndrome score and incidence of adverse reactions were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P＜0.05).After the treatment,the two groups displayed increased bronchial asthma control rate,ACT score,PEF(P＜0.05),and decreased TCM syndrome score(P＜0.05),especially for the observation group(P＜0.05);the observation group exhibited increased FEV1,FEV1％,PEF％(P＜0.05),among which FEV1,PEF％were higher than those in the control group(P＜0.05);the observation group showed decreased inflammatory indices(P＜0.05),among which FeNO was lower than that in the control group(P＜0.05).No significant difference in incidence of adverse reactions was found between the two groups(P＞0.05).CONCLUSION For the patients with mild to moderate bronchial asthma in chronic and persistent period,Jiawei Yanghe Decoction combined with Budesonide and Formoterol Fumarate Powder for Inhalation can safely and effectively alleviate clinical symptoms,improve pulmonary functions,airway inflammatory reactions,and enhance bronchial asthma control rate.

Objective:To investigate the effect of anterior and posterior selective fusion strategy on evolution of coronal pattern in patients with Lenke 5C adolescent idiopathic scoliosis (AIS) and whether upper end vertebra (UEV)-1 strategy in anterior surgery would have an effect on postoperative coronal balance.Methods:A total of 108 Lenke 5C AIS patients with at least 2 years follow-up who underwent anterior or posterior selective thoracolumbar fusion surgery from January 2005 to December 2020 were enrolled, with 51 patients in the anterior group and 57 patients in the posterior group. The patients were categorized into three groups (type A, C 7PL-CSVL<20 mm; type B, C 7PL-CSVL ≥20 mm with C 7PL toward the concave side of the main curve; and type C, C 7PL-CSVL≥20 mm with C 7PL toward the convex side of the main curve) to investigate the evolution of coronal balance of each preoperative coronal pattern at the anterior and posterior groups. Parameters such as thoracolumbar Cobb angle, rate of coronal imbalance, and SRS-22 score were recorded at preoperative, 1 week postoperatively, and final follow-up in both groups. Results:The differences of basic date between the two groups were not statistically significant except for the fusion level (5.2±0.7 vs. 5.6±0.9, t=2.497, P=0.014). In the anterior group, a total of 27 patients with preoperative type A, 23 patients with preoperative type A maintained type A at the 1 week postoperatively, and 2 of them were converted to type C at the final follow-up. Four patients with preoperative type A converted to type C at the 1 week postoperatively, and all of them returned to type A at the final follow-up. A total of 23 patients with preoperative type C, four patients with preoperative type C maintained type C at the 1 week postoperatively, and one of them maintained type C at the final follow-up. Nineteen patients with preoperative type C converted to type A at the 1 week postoperatively, and all of them maintained type A at the final follow-up. In the posterior group, a total of 26 patients with preoperative type A, 22 patients with preoperative type A maintained type A at the 1 week postoperatively, and only 2 of these patients converted to type C at the final follow-up. Four of the preoperative type A patients converted to type C at the 1 week postoperatively, and all of them returned to type A at the final follow-up. A total of 29 patients with preoperative type C, thirteen patients with preoperative type C maintained type C at the 1 week postoperatively, and 7 of them maintained type C at the last follow-up. Sixteen patients with preoperative type C converted to type A at the 1 week postoperatively, of whom two converted to type C at the final follow-up. For patients with preoperative type C the rate of coronal imbalance was significantly lower in the anterior group than in the posterior group both in the immediate postoperative period (17% vs. 45%, P<0.05) and at the final follow-up (4% vs. 31%, P=0.038). The rate of coronal imbalance at final follow-up was significantly lower in the UEV-1 group than in the UEV group in the posterior approach (3% vs. 38%, P<0.05), and there was no difference between the two groups in the anterior approach. There were no significant differences in radiographic parameters and SRS-22 scores between the two groups, except for the thoracic Cobb angle at the final follow-up, which was greater in the anterior group than in the posterior group at the final follow-up (19.5±7.3 vs.16.4±5.6, t=2.427, P=0.017). Multivariate logistic regression analysis revealed that anterior surgery and Risser were risk factors for postoperative CIB of preoperative type C ( OR=21.138, P=0.030 and OR=0.406, P=0.048 respectively). Conclusion:For patients with preoperative type A, both anterior and posterior procedures lead to a satisfactory reconstruction of coronal balance. In patients with preoperative type C, anterior surgery acquire a better reconstruction of coronal balance. The strategy of proximal UEV-1 was similar to the strategy of UEV in terms of restoring coronary balance in anterior approach and it was unable to lower the rate of postoperative coronal imbalance. In contrast, UEV-1 strategy in posterior surgery was effective in reducing the rate of postoperative coronal imbalance.

Objective:To investigate the impact of correcting rotational subluxation through circumferential fusion and transforaminal lumbar interbody fusion (TLIF) on postoperative coronal plane imbalance in degenerative scoliosis.Methods:A retrospective analysis was conducted on the data of 108 patients with type A degenerative scoliosis in the Nanjing classification who underwent primary multi-segment posterior column osteotomy (PCO) with deformity correction and internal fixation at Nanjing Gulou Hospital from June 2017 to June 2021. Patients were divided into two groups based on the presence of preoperative rotational subluxation: the rotational subluxation group and the non-rotational subluxation group. The rotational subluxation group consisted of 60 patients, with 8 males and 52 females, aged 63.7±5.5 years (range, 56-75 years). The non-rotational subluxation group included 48 patients, with 5 males and 43 females, aged 64.4±5.2 years (range, 53-72 years). Within the rotational subluxation group, depending on whether TLIF was performed on the rotational subluxation segment, they were further categorized into the TLIF group and the PCO group. The TLIF group comprised 28 patients, while the PCO group had 32 patients. Full-spine anteroposterior and lateral X-rays were taken preoperatively, postoperatively, and at the last follow-up to measure coronal balance types and radiographic parameters. The differences in the lumbar Cobb angle, coronal balance distance (CBD), and the Cobb angle of the lumbosacral curve (Cobb-Fra angle) were compared between the rotational subluxation group and the non-rotational subluxation group, as well as between the TLIF group and the PCO group.Results:The average surgery duration ranged from 200 to 310 min, with a mean of 235±47 min. The intraoperative blood loss ranged from 700 to 2,400 ml, with an average of 950±355 ml. The number of fused segments in the rotational subluxation group was 7.6±2.1, ranging from 5 to 11 segments, while in the non-rotational subluxation group, it was 7.4±2.0, ranging from 5 to 10 segments. Postoperatively, 13%(8/60) of patients in the rotational subluxation group developed type C coronal imbalance, significantly higher than the 2%(1/48) in the non-rotational subluxation group. The immediate postoperative and final follow-up lumbar Cobb angles, CBD, and Cobb-Fra angles in the rotational subluxation group were 20.60°±10.73° and 20.33°±10.92°, 22.53±16.45 mm and 18.53±17.31 mm, 13.14°±4.40° and 11.23°±4.92°, respectively, which were higher than those in the non-rotational subluxation group (13.92°±7.02° and 12.92°±6.64°, 18.62±17.44 mm and 8.83±8.95 mm, 11.91°±3.03° and 9.52°±3.30°), with statistical significance ( P<0.05).. Among patients in the rotational subluxation group, the probability of new-onset coronal imbalance postoperatively was 4%(1/28) in the TLIF group, which was lower than the 22%(7/32) in the PCO group, with a statistically significant difference (χ 2=4.330, P=0.037). The immediate postoperative and final follow-up lumbar Cobb angles, CBD, and Cobb-Fra angles in the PCO group were 25.63°±11.00° and 25.13°±11.04°, 27.37±18.95 mm and 25.25±18.67 mm, 15.50°±3.62° and 14.08°±4.77°, respectively, which were significantly higher than those in the TLIF group (14.86°±6.96° and 14.86°±5.37°, 17.08±10.94 mm and 10.86±7.86 mm, 10.14°±3.37° and 8.46°±2.66°), with statistical significance ( P<0.05). Conclusion:For patients with Type A degenerative scoliosis combined with rotational subluxation according to the Nanjing classification, performing a 360-degree circumferential release and interbody fusion at the segment with rotatory subluxation can reduce the risk of developing new postoperative coronal imbalances.

Objective To investigate the effect of intravenous injection of remifentanil on the comfort level of birth-giving women with scarred uterus undergoing cesarean section.Methods A total of 82 birth-giving women with scarred uterus who underwent cesarean section in the Suqian Hospital of Jiangsu Provincial People's Hospital from October 2021 to September 2023 were selected and randomly divided into the observation group and the control group(with 41 cases in each group).Before skin resection of cesarean section,the birth-giving women of the observation group were injected with 0.05 μg·kg-1·min-1 remifentanil intravenously until the end of the operation,and these in the control group was injected with the same amount of normal saline.The vital signs and pain at different time points,traction reaction and occurrence of maternal and infant complications were compared between the two groups.Results The mean arterial pressure(MAP),heart rate(HR),pain visual analogue scale(VAS)score and incidence of traction reactions at abdominal exploration in the observation group were significantly lower than those in the control group(P<0.05).There was no significant difference in the neonatal umbilical vein pH value,umbilical vein blood pulse oximetry saturation(SPO2),Apgar scores 1 minute and 5 minutes after birth of newborn,or nausea,vomiting and respiratory depression of birth-giving women between the two groups(P>0.05).Conclusion For birth-giving women with scar uterus who underwent cesarean section,intravenous injection of 0.05 μg·kg-1·min-1 of reifentanil can reduce the fluctuation of vital signs,significantly relieve the traction reaction at abdominal exploration,with a few maternal and infant complications,which is conducive to improving the comfort level of the birth-giving women.

Objective To assess the blood pressure control and its influencing factors among hypertensive patients in communities in different time periods by 24 h ambulatory blood pressure monitoring(24 h ABPM)and provide reference for optimizing the health management services for hypertension in communities. Methods A total of 765 hypertensive patients registered in the hypertension management project of national essential public health services in Sanxiang Town,Zhongshan City from October 2022 to September 2023 were identified as target subjects.The 24 h ABPM devices were distributed for blood pressure monitoring and a questionnaire survey was conducted to analyze the influencing factors of blood pressure control. Results Of all the participants,16.5% did not monitor blood pressure regularly,and 59.2% monitored blood pressure 1-2 times per week.The patients who were not on night shifts/staying up late had higher mean rates of achieving the target blood pressure and the circadian rhythm of blood pressure during 24 h,nighttime,and early morning than those who were on night shifts/staying up late(all P<0.05).The patients who never drank alcohol had higher rate of achieving the target blood pressure in early morning than those who drank alcohol(P=0.012).The average blood pressure during daytime,nighttime,and 24 h were different by sex(all P<0.05).The average blood pressure during nighttime was different by age and job types(all P<0.05).The average blood pressure during daytime,nighttime,and 24 h were different in patients with different body weight types(all P<0.05).The results of the multivariate logistic regression analysis showed that uncontrolled blood pressure during daytime was more likely to occur in male patients(OR=1.394,95%CI=1.045-1.858,P=0.024),and that during nighttime was more likely to be associated with male patients(OR=1.573,95%CI=1.088-2.275,P=0.016)and night shifts(OR=2.467,95%CI=1.198-5.077,P=0.014).It was difficult to achieve blood pressure control in early morning for the patients who drank alcohol for more than three times per week(OR=4.567,95%CI=1.629-12.807,P=0.004),woke up at night(OR=1.800,95%CI=1.125-2.878,P=0.014),and had night shifts(OR=1.579,95%CI=1.102-2.465,P=0.044).The patients on night shifts were more likely to have abnormal circadian rhythm of blood pressure(OR=1.753,95%CI:1.018-3.018,P=0.043). Conclusions The personal characteristics and lifestyle of hypertensive patients significantly affect the blood pressure control in different time periods(daytime,nighttime,and early morning)and the circadian rhythm of blood pressure.The family doctor team of community healthcare institutions can implement targeted and precise intervention measures for hypertensive patients according to the influencing factors of blood pressure control in different time periods,so as to achieve better management effects.
Humans ; Blood Pressure Monitoring, Ambulatory ; Hypertension/physiopathology* ; Male ; Female ; Middle Aged ; Circadian Rhythm ; Blood Pressure ; Surveys and Questionnaires ; Adult ; Aged ; Time Factors