1.Risk prediction of Reduning Injection batches by near-infrared spectroscopy combined with multiple machine learning algorithms.
Wen-Yu JIA ; Feng TONG ; Heng-Xu LIU ; Shu-Qin JIN ; Yong-Chao ZHANG ; Chen-Feng ZHANG ; Zhen-Zhong WANG ; Xin ZHANG ; Wei XIAO
China Journal of Chinese Materia Medica 2025;50(2):430-438
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
2.Clinical characteristics and outcomes of 11 neonates with venous thrombosis.
Xi-Ge GU ; Li-Ying DAI ; Xiao-Qing SHI ; Wen-Chao ZHANG ; Yong-Li ZHANG
Chinese Journal of Contemporary Pediatrics 2025;27(5):588-594
OBJECTIVES:
To summarize the clinical characteristics, diagnosis, and treatment outcomes of neonatal venous thrombosis.
METHODS:
A retrospective analysis was conducted on the clinical data of 11 neonates with venous thrombosis admitted to the Department of Neonatology of Anhui Children's Hospital from January 2019 to September 2024. The clinical characteristics, diagnostic approaches, treatments, and outcomes were analyzed.
RESULTS:
Among the 11 neonates diagnosed with venous thrombosis, 5 were male, and 6 were preterm infants, with a median gestational age of 35+6 weeks, birth weight of (2 322±1 069) g, and admission temperature of (36.6±0.4)°C. The median age at symptom onset was 6 days. Of the 11 cases, 8 limb venous thromboses and 1 portal vein thrombosis were confirmed by vascular ultrasound, and 2 cases of intracranial venous sinus thrombosis were confirmed by magnetic resonance imaging. Ten cases received low molecular weight heparin for anticoagulation, with a treatment duration of (24±15) days; 2 cases were treated with urokinase thrombolysis, and 4 cases received fresh frozen plasma transfusion. Thrombosis resolved in 7 cases before discharge. Partial resolution occurred in 2 cases before discharge (1 continued outpatient treatment until resolution and 1 resolved during follow-up). One case was transferred to another hospital after 1 day of treatment and was discharged after thrombosis reduction. No adverse reactions such as bleeding were observed. One neonate with cerebral infarction at admission did not receive heparin anticoagulation and was followed up as an outpatient.
CONCLUSIONS
Vascular ultrasound is the most commonly used diagnostic method for neonatal venous thrombosis. Heparin anticoagulation is the recommended treatment. The overall prognosis of neonatal venous thrombosis is favorable.
Humans
;
Male
;
Venous Thrombosis/drug therapy*
;
Infant, Newborn
;
Female
;
Retrospective Studies
3.Exploring urban versus rural disparities in atrial fibrillation: prevalence and management trends among elderly Chinese in a screening study.
Wei ZHANG ; Yi CHEN ; Lei-Xiao HU ; Jia-Hui XIA ; Xiao-Fei YE ; Wen-Yuan-Yue WANG ; Xin-Yu WANG ; Quan-Yong XIANG ; Qin TAN ; Xiao-Long WANG ; Xiao-Min YANG ; De-Chao ZHAO ; Xin CHEN ; Yan LI ; Ji-Guang WANG ; FOR THE IMPRESSION INVESTIGATORS AND COORDINATORS
Journal of Geriatric Cardiology 2025;22(2):246-254
BACKGROUND:
Atrial fibrillation (AF) is a common cardiac arrhythmia in the elderly. This study aimed to evaluate urban-rural disparities in its prevalence and management in elderly Chinese.
METHODS:
Consecutive participants aged ≥ 65 years attending outpatient clinics were enrolled for AF screening using handheld single-lead electrocardiogram (ECG) from April 2017 to December 2022. Each ECG rhythm strip was reviewed from the research team. AF or uninterpretable single-lead ECGs were referred for 12-lead ECG. Primary study outcome comparison was between rural and urban areas for the prevalence of AF. The Student's t-test was used to compare mean values of clinical characteristics between rural and urban participants, while the Pearson's chi-square test was used to compare between-group proportions. Multivariate stepwise logistic regression analysis was performed to estimate the association between AF and various patient characteristics.
RESULTS:
The 29,166 study participants included 13,253 men (45.4%) and had a mean age of 72.2 years. The 7073 rural participants differed significantly (P ≤ 0.02) from the 22,093 urban participants in several major characteristics, such as older age, greater body mass index, and so on. The overall prevalence of AF was 4.6% (n = 1347). AF was more prevalent in 7073 rural participants than 22,093 urban participants (5.6% vs. 4.3%, P < 0.01), before and after adjustment for age, body mass index, blood pressure, pulse rate, cigarette smoking, alcohol consumption and prior medical history. Multivariate logistic regression analysis identified overweight/obesity (OR = 1.35, 95% CI: 1.17-1.54) in urban areas and cigarette smoking (OR = 1.62, 95% CI: 1.20-2.17) and alcohol consumption (OR = 1.42, 95% CI: 1.04-1.93) in rural areas as specific risk factors for prevalent AF. In patients with known AF in urban areas (n = 781) and rural areas (n = 338), 60.6% and 45.9%, respectively, received AF treatment (P < 0.01), and only 22.4% and 17.2%, respectively, received anticoagulation therapy (P = 0.05).
CONCLUSIONS
In China, there are urban-rural disparities in AF in the elderly, with a higher prevalence and worse management in rural areas than urban areas. Our study findings provide insight for health policymakers to consider urban-rural disparity in the prevention and treatment of AF.
4.Multiple biomarkers risk score for accurately predicting the long-term prognosis of patients with acute coronary syndrome.
Zhi-Yong ZHANG ; Xin-Yu WANG ; Cong-Cong HOU ; Hong-Bin LIU ; Lyu LYU ; Mu-Lei CHEN ; Xiao-Rong XU ; Feng JIANG ; Long LI ; Wei-Ming LI ; Kui-Bao LI ; Juan WANG
Journal of Geriatric Cardiology 2025;22(7):656-667
BACKGROUND:
Biomarkers-based prediction of long-term risk of acute coronary syndrome (ACS) is scarce. We aim to develop a risk score integrating clinical routine information (C) and plasma biomarkers (B) for predicting long-term risk of ACS patients.
METHODS:
We included 2729 ACS patients from the OCEA (Observation of cardiovascular events in ACS patients). The earlier admitted 1910 patients were enrolled as development cohort; and the subsequently admitted 819 subjects were treated as validation cohort. We investigated 10-year risk of cardiovascular (CV) death, myocardial infarction (MI) and all cause death in these patients. Potential variables contributing to risk of clinical events were assessed using Cox regression models and a score was derived using main part of these variables.
RESULTS:
During 16,110 person-years of follow-up, there were 238 CV death/MI in the development cohort. The 7 most important predictors including in the final model were NT-proBNP, D-dimer, GDF-15, peripheral artery disease (PAD), Fibrinogen, ST-segment elevated MI (STEMI), left ventricular ejection fraction (LVEF), termed as CB-ACS score. C-index of the score for predication of cardiovascular events was 0.79 (95% CI: 0.76-0.82) in development cohort and 0.77 (95% CI: 0.76-0.78) in the validation cohort (5832 person-years of follow-up), which outperformed GRACE 2.0 and ABC-ACS risk score. The CB-ACS score was also well calibrated in development and validation cohort (Greenwood-Nam-D'Agostino: P = 0.70 and P = 0.07, respectively).
CONCLUSIONS
CB-ACS risk score provides a useful tool for long-term prediction of CV events in patients with ACS. This model outperforms GRACE 2.0 and ABC-ACS ischemic risk score.
5.A double-center randomized controlled study on endoscopic treatment for grade Ⅰ to Ⅲ internal hemorrhoids
Anling HE ; Chao MA ; Yong XIAO ; Ke ZHU ; Shuzhong LIU ; Mingkai CHEN
Chinese Journal of Digestive Endoscopy 2025;42(2):131-136
Objective:To evaluate the efficacy and safety of endoscopic injection sclerotherapy (EIS) and endoscopic rubber band ligation (ERBL) for the treatment of grade Ⅰ-Ⅲ internal hemorrhoids.Methods:A prospective study was conducted on patients with grade Ⅰ-Ⅲ internal hemorrhoids who sought treatment at Renmin Hospital of Wuhan University or the NO.2 People's Hospital of Fuyang City from November 2021 to November 2022. Eligible patients were continuously enrolled based on inclusion and exclusion criteria and randomized into 2 groups using a central randomization system: the EIS group and the ERBL group. The primary outcomes included symptom improvement rate, recurrence rate, incidence of adverse events (bleeding, anal distension, pain, urinary retention, etc.), surgical costs, patient satisfaction, hemorrhoidal disease symptom score (HDSS), European quality of life 5-dimensions (EQ-5D) score, and self-rated health status score.Results:A total of 203 patients were enrolled (86 from Renmin Hospital of Wuhan University and 117 from the NO.2 People's Hospital of Fuyang City), with 103 in the EIS group and 100 in the ERBL group. Both groups successfully completed endoscopic treatment for internal hemorrhoids. The surgical cost in the EIS group was significantly lower than that in the ERBL group (1 044.77±522.77 yuan VS 2 538.44±465.63 yuan, t=-21.660, P<0.001). The incidence of perioperative pain and moderate-to-severe pain in the EIS group was significantly lower than that in the ERBL group [2.91% (3/103) VS 25.00% (25/100), χ2=20.817, P<0.001; 0.97% (1/103) VS 18.00% (18/100), χ2=17.344, P<0.001]. There were no significant differences in the incidence of perioperative bleeding, anal distension, or urinary retention between the two groups [0.97% (1/103) VS 1.00% (1/100), 11.65% (12/103) VS 19.00% (19/100), 0.00% (0/103) VS 2.00% (2/100), P>0.05]. During the 12-week follow-up, 4 patients were lost to follow-up (all from the EIS group). There were no significant differences in symptom improvement rate, recurrence rate, or patient satisfaction rate between the two groups [96.97% (96/99) VS 96.00% (96/100), 3.03% (3/99) VS 5.00% (5/100), 97.98% (97/99) VS 95.00% (95/100), P>0.05]. At 12 weeks postoperatively, the HDSS in the EIS group significantly decreased compared to preoperative levels [0.0 (0.0, 1.0) VS 5.0 (3.0, 7.0), Z=-18.270, P<0.010], the EQ-5D score in the ERBL group significantly increased compared to preoperative levels (1.00±0.01 VS 0.98±0.03, F=27.527, P<0.010), and self-rated health status score in the ERBL group significantly increased compared to preoperative levels (92.31±6.89 VS 82.62±10.98, F=115.025, P<0.010). At 12 weeks postoperatively, the HDSS in the ERBL group significantly decreased compared to preoperative levels [0.0 (0.0, 1.0) VS 5.0 (4.0, 8.0), Z=-16.110, P<0.010], the EQ-5D score in the ERBL group significantly increased compared to preoperative levels (1.00±0.00 VS 0.98±0.05, F=13.718, P<0.010), and self-rated health status score in the ERBL group significantly increased compared to preoperative levels (93.46±6.35 VS 84.15±10.71, F=123.695, P<0.010). Conclusion:Both EIS and ERBL are safe and effective treatments for grade Ⅰ-Ⅲ internal hemorrhoids, with high patient satisfaction. Comparatively, EIS demonstrates lower surgical costs and a reduced incidence and severity of perioperative pain.
6.Preliminary application of human-computer interaction CT imaging AI recognition and positioning technology in the treatment of type C1 distal radius fractures.
Yong-Zhong CHENG ; Xiao-Dong YIN ; Fei LIU ; Xin-Heng DENG ; Chao-Lu WANG ; Shu-Ke CUI ; Yong-Yao LI ; Wei YAN
China Journal of Orthopaedics and Traumatology 2025;38(1):31-40
OBJECTIVE:
To explore the accuracy of human-computer interaction software in identifying and locating type C1 distal radius fractures.
METHODS:
Based on relevant inclusion and exclusion criteria, 14 cases of type C1 distal radius fractures between September 2023 and March 2024 were retrospectively analyzed, comprising 3 males and 11 females(aged from 27 to 82 years). The data were assigned randomized identifiers. A senior orthopedic physician reviewed the films and measured the ulnar deviation angle, radial height, palmar inclination angle, intra-articular step, and intra-articular gap for each case on the hospital's imaging system. Based on the reduction standard for distal radius fractures, cases were divided into reduction group and non-reduction group. Then, the data were sequentially imported into a human-computer interaction intelligent software, where a junior orthopedic physician analyzed the same radiological parameters, categorized cases, and measured fracture details. The categorization results from the software were consistent with manual classifications (6 reduction cases and 8 non-reduction cases). For non-reduction cases, the software performed further analyses, including bone segmentation and fracture recognition, generating 8 diagnostic reports containing fracture recognition information. For the 6 reduction cases, the senior and junior orthopedic physicians independently analyzed the data on the hospital's imaging system and the AI software, respectively. Bone segments requiring reduction were identified, verified by two senior physicians, and measured for displacement and rotation along the X (inward and outward), Z (front and back), and Y (up and down) axes. The AI software generated comprehensive diagnostic reports for these cases, which included all measurements and fracture recognition details.
RESULTS:
Both the manual and AI software methods consistently categorized the 14 cases into 6 reduction and 8 non-reduction groups, with identical data distributions. A paired sample t-test revealed no statistically significant differences (P>0.05) between the manual and software-based measurements for ulnar deviation angle, radial ulnar bone height, palmar inclination angle, intra-articular step, and joint space. In fracture recognition, the AI software correctly identified 10 C-type fractures and 4 B-type fractures. For the 6 reduction cases, a total of 24 bone fragments were analyzed across both methods. After verification, it was found that the bone fragments identified by the two methods were consistent. A paired sample t-tests revealed that the identified bone fragments and measured displacement and rotation angles along the X, Y, and Z axes were consistent between the two methods. No statistically significant differences(P>0.05) were found between manual and software measurements for these parameters.
CONCLUSION
Human-computer interaction software employing AI technology demonstrated comparable accuracy to manual measurement in identifying and locating type C1 distal radius fractures on CT imaging.
Humans
;
Male
;
Female
;
Radius Fractures/surgery*
;
Middle Aged
;
Adult
;
Aged
;
Aged, 80 and over
;
Tomography, X-Ray Computed/methods*
;
Retrospective Studies
;
Software
;
Wrist Fractures
7.The impact of prophylactic cranial irradiation on the prognosis of patients with limited-stage small cell lung cancer
Xiao HU ; Mengyuan CHEN ; Shuohan ZHENG ; Qing WU ; Yue KONG ; Fang PENG ; Qun ZHANG ; Chao ZHENG ; Yong BAO ; Yujin XU ; Ming CHEN
Chinese Journal of Radiation Oncology 2025;34(3):249-255
Objective:To evaluate the impact of prophylactic cranial irradiation (PCI) on the prognosis of patients with limited-stage small cell lung cancer (SCLC) in the era of widespread application of MRI.Methods:Clinical data were collected from an open-lable prospective clinical trial on thoracic radiotherapy target volumes for limited-stage SCLC conducted in Sun Yat-sen University Cancer Center and Zhejiang Cancer Hospital between June 2002 and January 2017. In this study, patients who achieved complete remission (CR) or partial remission (PR) after definitive chemoradiotherapy (CRT) were retrospectively analyzed. Stratified analysis was performed according to different clinical efficacies. Patients were divided into different groups according to whether PCI was conducted or not. Survival analysis of patients was carried out. Survival data were calculated by Kaplan-Meier method, and Cox proportional hazards model was applied for multivariate prognostic analysis.Results:Among 309 patients with limited-stage SCLC who received CRT, 133 patients achieved CR and 140 cases obtained PR. These 273 patients were enrolled in this study. Among 133 patients with CR, 29 of them did not receive PCI, and 89 (85.6%) of the remaining 104 patients receiving PCI underwent brain MRI to exclude brain metastasis (BM) before PCI. With a median follow-up time of 22.1 months, the cumulative BM rates were 18.3% and 37.9% in patients who received or did not receive PCI ( P=0.020). The median overall survival (OS) was 30.2 and 30.5 months, and the 1-, 3- and 5-year OS rates were 93.3%, 41.9%, 27.7% and 82.8%, 44.8%, 40.8%, respectively ( P=0.910). Multivariate analysis indicated that baseline Karnofsky performance status (KPS) = 90 was a favorable independent prognostic factor for OS in CR patients ( HR=0.93, 95% CI: 0.89-0.98, P=0.006). Among 140 patients achieving PR, 52 cases did not receive PCI and 80 (90.9%) of the remaining 88 patients received brain MRI before PCI. With a median follow-up time of 18.9 months, the cumulative BM rates were 10.2% and 44.2% ( P<0.001). The median OS was 26.0 and 18.0 months, and the 1-, 3-, and 5-year OS rates were 86.4%, 37.9%, 32.2% and 75.0%, 17.3%, 10.8%, respectively ( P=0.001). Baseline KPS = 90 ( HR=0.93, 95% CI: 0.89-0.97, P=0.001) and PCI ( HR=0.54, 95% CI: 0.36-0.80, P=0.002) were favorable prognostic factors for OS in PR patients. Conclusions:PCI significantly reduces the incidence of BM and prolongs the OS in patients with limited-stage SCLC who achieve PR after CRT, but it fails to significantly prolong the OS of CR patients.
8.A double-center randomized controlled study on endoscopic treatment for grade Ⅰ to Ⅲ internal hemorrhoids
Anling HE ; Chao MA ; Yong XIAO ; Ke ZHU ; Shuzhong LIU ; Mingkai CHEN
Chinese Journal of Digestive Endoscopy 2025;42(2):131-136
Objective:To evaluate the efficacy and safety of endoscopic injection sclerotherapy (EIS) and endoscopic rubber band ligation (ERBL) for the treatment of grade Ⅰ-Ⅲ internal hemorrhoids.Methods:A prospective study was conducted on patients with grade Ⅰ-Ⅲ internal hemorrhoids who sought treatment at Renmin Hospital of Wuhan University or the NO.2 People's Hospital of Fuyang City from November 2021 to November 2022. Eligible patients were continuously enrolled based on inclusion and exclusion criteria and randomized into 2 groups using a central randomization system: the EIS group and the ERBL group. The primary outcomes included symptom improvement rate, recurrence rate, incidence of adverse events (bleeding, anal distension, pain, urinary retention, etc.), surgical costs, patient satisfaction, hemorrhoidal disease symptom score (HDSS), European quality of life 5-dimensions (EQ-5D) score, and self-rated health status score.Results:A total of 203 patients were enrolled (86 from Renmin Hospital of Wuhan University and 117 from the NO.2 People's Hospital of Fuyang City), with 103 in the EIS group and 100 in the ERBL group. Both groups successfully completed endoscopic treatment for internal hemorrhoids. The surgical cost in the EIS group was significantly lower than that in the ERBL group (1 044.77±522.77 yuan VS 2 538.44±465.63 yuan, t=-21.660, P<0.001). The incidence of perioperative pain and moderate-to-severe pain in the EIS group was significantly lower than that in the ERBL group [2.91% (3/103) VS 25.00% (25/100), χ2=20.817, P<0.001; 0.97% (1/103) VS 18.00% (18/100), χ2=17.344, P<0.001]. There were no significant differences in the incidence of perioperative bleeding, anal distension, or urinary retention between the two groups [0.97% (1/103) VS 1.00% (1/100), 11.65% (12/103) VS 19.00% (19/100), 0.00% (0/103) VS 2.00% (2/100), P>0.05]. During the 12-week follow-up, 4 patients were lost to follow-up (all from the EIS group). There were no significant differences in symptom improvement rate, recurrence rate, or patient satisfaction rate between the two groups [96.97% (96/99) VS 96.00% (96/100), 3.03% (3/99) VS 5.00% (5/100), 97.98% (97/99) VS 95.00% (95/100), P>0.05]. At 12 weeks postoperatively, the HDSS in the EIS group significantly decreased compared to preoperative levels [0.0 (0.0, 1.0) VS 5.0 (3.0, 7.0), Z=-18.270, P<0.010], the EQ-5D score in the ERBL group significantly increased compared to preoperative levels (1.00±0.01 VS 0.98±0.03, F=27.527, P<0.010), and self-rated health status score in the ERBL group significantly increased compared to preoperative levels (92.31±6.89 VS 82.62±10.98, F=115.025, P<0.010). At 12 weeks postoperatively, the HDSS in the ERBL group significantly decreased compared to preoperative levels [0.0 (0.0, 1.0) VS 5.0 (4.0, 8.0), Z=-16.110, P<0.010], the EQ-5D score in the ERBL group significantly increased compared to preoperative levels (1.00±0.00 VS 0.98±0.05, F=13.718, P<0.010), and self-rated health status score in the ERBL group significantly increased compared to preoperative levels (93.46±6.35 VS 84.15±10.71, F=123.695, P<0.010). Conclusion:Both EIS and ERBL are safe and effective treatments for grade Ⅰ-Ⅲ internal hemorrhoids, with high patient satisfaction. Comparatively, EIS demonstrates lower surgical costs and a reduced incidence and severity of perioperative pain.
9.The impact of prophylactic cranial irradiation on the prognosis of patients with limited-stage small cell lung cancer
Xiao HU ; Mengyuan CHEN ; Shuohan ZHENG ; Qing WU ; Yue KONG ; Fang PENG ; Qun ZHANG ; Chao ZHENG ; Yong BAO ; Yujin XU ; Ming CHEN
Chinese Journal of Radiation Oncology 2025;34(3):249-255
Objective:To evaluate the impact of prophylactic cranial irradiation (PCI) on the prognosis of patients with limited-stage small cell lung cancer (SCLC) in the era of widespread application of MRI.Methods:Clinical data were collected from an open-lable prospective clinical trial on thoracic radiotherapy target volumes for limited-stage SCLC conducted in Sun Yat-sen University Cancer Center and Zhejiang Cancer Hospital between June 2002 and January 2017. In this study, patients who achieved complete remission (CR) or partial remission (PR) after definitive chemoradiotherapy (CRT) were retrospectively analyzed. Stratified analysis was performed according to different clinical efficacies. Patients were divided into different groups according to whether PCI was conducted or not. Survival analysis of patients was carried out. Survival data were calculated by Kaplan-Meier method, and Cox proportional hazards model was applied for multivariate prognostic analysis.Results:Among 309 patients with limited-stage SCLC who received CRT, 133 patients achieved CR and 140 cases obtained PR. These 273 patients were enrolled in this study. Among 133 patients with CR, 29 of them did not receive PCI, and 89 (85.6%) of the remaining 104 patients receiving PCI underwent brain MRI to exclude brain metastasis (BM) before PCI. With a median follow-up time of 22.1 months, the cumulative BM rates were 18.3% and 37.9% in patients who received or did not receive PCI ( P=0.020). The median overall survival (OS) was 30.2 and 30.5 months, and the 1-, 3- and 5-year OS rates were 93.3%, 41.9%, 27.7% and 82.8%, 44.8%, 40.8%, respectively ( P=0.910). Multivariate analysis indicated that baseline Karnofsky performance status (KPS) = 90 was a favorable independent prognostic factor for OS in CR patients ( HR=0.93, 95% CI: 0.89-0.98, P=0.006). Among 140 patients achieving PR, 52 cases did not receive PCI and 80 (90.9%) of the remaining 88 patients received brain MRI before PCI. With a median follow-up time of 18.9 months, the cumulative BM rates were 10.2% and 44.2% ( P<0.001). The median OS was 26.0 and 18.0 months, and the 1-, 3-, and 5-year OS rates were 86.4%, 37.9%, 32.2% and 75.0%, 17.3%, 10.8%, respectively ( P=0.001). Baseline KPS = 90 ( HR=0.93, 95% CI: 0.89-0.97, P=0.001) and PCI ( HR=0.54, 95% CI: 0.36-0.80, P=0.002) were favorable prognostic factors for OS in PR patients. Conclusions:PCI significantly reduces the incidence of BM and prolongs the OS in patients with limited-stage SCLC who achieve PR after CRT, but it fails to significantly prolong the OS of CR patients.
10.Patient-Reported Outcomes of Postoperative NSCLC Patients with or without Staged Chinese Herb Medicine Therapy during Adjuvant Chemotherapy (NALLC 2): A Randomized, Double-Blind, Placebo-Controlled Trial.
Yi-Lu ZHANG ; Li-Jing JIAO ; Ya-Bin GONG ; Jian-Fang XU ; Jian NI ; Xiao-Yong SHEN ; Jie ZHANG ; Di ZHOU ; Cheng-Xin QIAN ; Qin WANG ; Jia-Lin YAO ; Wen-Xiao YANG ; Ling-Zi SU ; Li-Yu WANG ; Jia-Qi LI ; Yi-Qin YAO ; Yuan-Hui ZHANG ; Yi-Chao WANG ; Zhi-Wei CHEN ; Ling XU
Chinese journal of integrative medicine 2024;30(11):963-973
OBJECTIVE:
To investigate whether the combination of chemotherapy with staged Chinese herbal medicine (CHM) therapy could enhance health-related quality of life (QoL) in non-small-cell lung cancer (NSCLC) patients and prolong the time before deterioration of lung cancer symptoms, in comparison to chemotherapy alone.
METHODS:
A prospective, double-blind, randomized, controlled trial was conducted from December 14, 2017 to August 28, 2020. A total of 180 patients with stage I B-IIIA NSCLC from 5 hospitals in Shanghai were randomly divided into chemotherapy combined with CHM (chemo+CHM) group (120 cases) or chemotherapy combined with placebo (chemo+placebo) group (60 cases) using stratified blocking randomization. The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life-Core 30 Scale (QLQ-C30) was used to evaluate the patient-reported outcomes (PROs) during postoperative adjuvant chemotherapy in patients with early-stage NSCLC. Adverse events (AEs) were assessed in the safety analysis.
RESULTS:
Out of the total 180 patients, 173 patients (116 in the chemo+CHM group and 57 in the chemo+placebo group) were included in the PRO analyses. The initial mean QLQ-C30 Global Health Status (GHS)/QoL scores at baseline were 57.16 ± 1.64 and 57.67 ± 2.25 for the two respective groups (P>0.05). Compared with baseline, the chemo+CHM group had an improvement in EORTC QLQ-C30 GHS/QoL score at week 18 [least squares mean (LSM) change 17.83, 95% confidence interval (CI) 14.29 to 21.38]. Conversely, the chemo+placebo group had a decrease in the score (LSM change -13.67, 95% CI -22.70 to -4.63). A significant between-group difference in the LSM GHS/QoL score was observed, amounting to 31.63 points (95% CI 25.61 to 37.64, P<0.001). The similar trends were observed in physical functioning, fatigue and appetite loss. At week 18, patients in the chemo+CHM group had a higher proportion of improvement or stabilization in GHS/QoL functional and symptom scores compared to chemo+placebo group (P<0.001). The median time to deterioration was longer in the chemo+CHM group for GHS/QoL score [hazard ratio (HR)=0.33, 95% CI 0.23 to 0.48, P<0.0010], physical functioning (HR=0.43, 95% CI 0.25 to 0.75, P=0.0005), fatigue (HR=0.47, 95% CI 0.30 to 0.72, P<0.0001) and appetite loss (HR=0.65, 95% CI 0.42 to 1.00, P=0.0215). The incidence of AEs was lower in the chemo+CHM group than in the chemo+placebo group (9.83% vs. 15.79%, P=0.52).
CONCLUSION
The staged CHM therapy could help improve the PROs of postoperative patients with early-stage NSCLC during adjuvant chemotherapy, which is worthy of further clinical research. (Registry No. NCT03372694).
Humans
;
Carcinoma, Non-Small-Cell Lung/surgery*
;
Male
;
Middle Aged
;
Female
;
Lung Neoplasms/pathology*
;
Double-Blind Method
;
Drugs, Chinese Herbal/therapeutic use*
;
Chemotherapy, Adjuvant
;
Patient Reported Outcome Measures
;
Quality of Life
;
Aged
;
Postoperative Period
;
Prospective Studies

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