1.Clinical application effects of the pedicled anterior intercostal artery perforator flap in breast reconstruction after breast-conserving surgery for breast cancer
Ansi YIN ; Bin WU ; Yi QUAN ; Hua FU ; Huaiquan ZUO ; Mingquan HUANG ; Yixian LI ; Jianzhe CHEN ; Dajiang SONG ; Zan LI ; Guangrui PAN
Chinese Journal of Burns 2025;41(7):680-687
Objective:To investigate the clinical application effects of the pedicled anterior intercostal artery perforator flap in breast reconstruction after breast-conserving surgery for breast cancer.Methods:This study was a retrospective observational study. From January to December 2023, 16 female breast cancer patients who met the inclusion criteria were hospitalized in the Department of Breast Surgery of the Affiliated Hospital of Southwest Medical University, with the age of (48±8) years. The pedicled anterior intercostal artery perforator flap was used for breast reconstruction of patients after breast-conserving surgery. After complete resection of tumor tissue, a "crescent-shaped" incision was designed at the inframammary fold. The pedicled anterior intercostal artery perforator flap was harvested based on the tumor location and the defect area after tumor removal. The flap was de-epithelialized, coapted, and rotated anterogradely or retrogradely to fill the defect. The donor site wound was closed with layered sutures. The following parameters were recorded: breast tissue loss volume during surgery, surgical duration, retention duration of the drainage tube, positive proportion of tumors in the breast incision margin tissue, breast loss ratio, flap survival, and incidence ratio of complications after operation. Patients were followed up for local recurrence or distant metastasis of tumor. At the last follow-up, the Ueda score was used to evaluate cosmetic outcomes of reconstructed breasts after breast-conserving surgery, and the Breast-Q scale version 2.0 was applied to assess patients' satisfaction and quality of life with breast reconstruction after breast-conserving surgery.Results:The breast tissue loss volume during surgery in this group of patients was 20-128 (59±34) cm3, the surgical duration was 105-200 (143±27) min, the retention duration of the drainage tube was 3-7 (4.6±1.0) d, and the positive proportion of tumors in the breast incision margin tissue was 1/16, with breast loss ratio of 0. After the surgery, the patient's transplanted flaps all survived. One patient had postoperative fat liquefaction in the surgical area, and the incidence ratio of postoperative complications was 1/16. The patients were followed up for 3-12 (11±4) months, and no local breast cancer recurrence or distant metastasis occurred. At the last follow-up, the cosmetic score of breast reconstruction after breast-conserving surgery were excellent in 6 cases, good in 8 cases, and fair in 2 cases, with an excellent and good ratio of 14/16. At the last follow-up, the highest score in the evaluation of patients' satisfaction with breast reconstruction and quality of life after breast-conserving surgery was the satisfaction with the surgeons, with a score of 59-100 (91±13), followed respectively by physiological health of the chest with a score of 60-100 (77±14), psychological health with a score of 35-100 (74±20), breast satisfaction with a score of 55-100 (73±13), satisfaction with information acquisition with a score of 53-100 (70±14), and sexual health with a score of 34-100 (70±23).Conclusions:The pedicled anterior intercostal artery perforator flap is safe and reliable for breast reconstruction after breast-conserving surgery for breast cancer, and can achieve high cosmetic effects and patient satisfaction. This flap is simple in design, easy to operate and highly reproducible, and is worthy of clinical promotion and application.
2.Efficacy and safety of esophageal variceal ligation combined with gastric variceal intensive ligation in non-emergency settings
Jiaxin LI ; Shanshan XU ; Runzhao QUAN ; Hao ZHANG ; Manman LU ; Zhenjuan LI ; Sai MA ; Jun MI ; Hui DING ; Huimin ZHANG ; Lin FU ; Xiuling LI
Chinese Journal of Digestive Endoscopy 2025;42(1):34-41
Objective:To evaluate the efficacy and safety of endoscopic variceal ligation (EVL) of esophageal varices combined with endoscopic variceal intensive ligation (EVIL) of gastric varices for gastroesophageal variceal bleeding with liver cirrhosis under non-emergency settings.Methods:Data of 643 consecutive patients with gastroesophageal variceal bleeding due to liver cirrhosis admitted to the Department of Gastroenterology, Henan Provincial People's Hospital from January 2017 to March 2023 were included in the retrospective study. A total of 192 patients were included after excluding 451 patients. One hundred and forty-nine patients who underwent EVL of esophageal varices combined with EVIL of gastric varices were enrolled into the EVIL group, while 43 patients who underwent EVL of esophageal varices combined with endoscopic tissue adhesive injection (ETAI) of gastric varices were enrolled into the ETAI group. The endoscopic treatment success rate, esophageal variceal ligations number, operation time of endoscopic treatment, hospitalization time, rebleeding rate, mortality and the incidence of adverse events were compared between the two groups.Results:Compared with the ETAI group, the EVIL group exhibited significantly higher endoscopic treatment success rate [100.0% (149/149) VS 95.3% (41/43), P=0.049], slightly greater esophageal variceal ligations number [8 (6, 11) rings VS 7 (6, 9) rings, Z=-1.29, P=0.196], shorter operation time of endoscopic treatment [27.0 (20.5, 34.0) min VS 36.0 (21.0, 51.0) min, Z=-2.30, P=0.021], and significantly shorter hospitalization time [10 (7, 13) d VS 13 (9, 15) d, Z=-3.02, P=0.003]. The rebleeding rate within 24, 72, 120 hours after the operation, early, delayed and total rebleeding in the EVIL group were 0.0% (0/149), 0.0% (0/149), 0.7% (1/149), 2.0% (3/149), 12.8% (19/149) and 14.8% (22/149) respectively, and 4.7% (2/43) ( P=0.049), 9.3% (4/43) ( P=0.002), 9.3% (4/43) ( χ2=6.69, P=0.010), 4.7% (2/43) ( χ2=0.17, P=0.679), 30.2% (13/43) ( χ2=7.34, P=0.007) and 44.2% (19/43) ( χ2=17.20, P<0.001) in the ETAI group, respectively. No death related to rebleeding occurred within 6 weeks after the operation in 2 groups. The mortality related to rebleeding within 1 year after the operation and during the follow-up period in the EVIL group were 1.3% (2/149) and 3.4% (5/149) respectively, and 0.0% (0/43) ( P=1.000) and 2.3% (1/43) ( χ2=0.02, P=0.876) in the ETAI group, respectively. The incidences of fever, chest pain, nausea or vomiting in the EVIL group were 12.1% (18/149), 14.1% (21/149) and 13.4% (20/149) respectively, and 11.6% (5/43) ( χ2=0.01, P=0.936), 16.3% (7/43) ( χ2=0.13, P=0.721) and 18.6% (8/43) ( χ2=0.72, P=0.396) in the ETAI group, respectively. Two patients (1.3%) in the EVIL group had gastric variceal ring loss. Ectopic embolism occurred in 1 patient (2.3%) in the ETAI group. Conclusion:For patients with gastroesophageal variceal bleeding due to liver cirrhosis who are suitable for non-emergency endoscopic treatment, EVL of esophageal varices combined with EVIL of gastric varices is also safe, and more effective than EVL of esophageal varices combined with ETAI of gastric varices. This approach offers improved treatment success rate, reduced operation and hospitalization time, lower rebleeding rates, and decreased rebleeding-related mortality.
3.Evaluation value of urinary 8-oxo-7, 8-dihydroguanosine in the short-term prognosis of sepsis in frail elderly patients
Jie CHANG ; Wei WEN ; Jinhua QUAN ; Dahai HUANG ; Chunyi FU ; Fan WANG ; Jianping CAI ; Yaqing MA ; Yamin DANG ; Chaojie CHEN
Chinese Journal of Geriatrics 2025;44(2):162-166
Objective:To investigate the significance of urinary 8-oxo-7, 8-dihydroguanosine(8-oxoGuo)in assessing the short-term prognosis of sepsis in frail elderly patients.Methods:We conducted a cross-sectional study involving 62 frail elderly patients diagnosed with sepsis who were admitted to the Emergency Intensive Care Unit(EICU)at Beijing Hospital between March 2021 and March 2022.Based on their 28-day prognosis, the patients were categorized into two groups: those who died and those who survived.Upon admission, we collected urine samples and clinical data from both groups.We employed isotope dilution high-performance liquid chromatography-mass spectrometry to measure the levels of the RNA oxidation marker 8-oxoGuo in the urine.Results:A total of 62 frail elderly patients[aged(85.1±6.3)years]diagnosed with sepsis were included in the study, comprising 36 patients in the 28-day mortality group and 26 patients in the survival group.Univariate analysis revealed that the survival group had significantly lower body temperature, blood calcitonin(PCT)levels, sequential organ failure assessment(SOFA)scores, and urinary 8-oxoGuo levels compared to the mortality group.Additionally, the survival group exhibited a higher mean arterial pressure(MAP)than the mortality group, with all differences reaching statistical significance(all P<0.05).Spearman correlation analysis indicated that urinary 8-oxoGuo levels were positively correlated with both PCT and SOFA scores in frail elderly sepsis patients( r=0.426, 0.768, both P<0.05).Furthermore, logistic regression analysis identified urinary 8-oxoGuo and SOFA as independent risk factors for 28-day mortality in this population( OR=1.936, 1.427; P=0.006, 0.002).The area under the receiver operating characteristic curve(AUC)for urinary 8-oxoGuo and SOFA in predicting the 28-day prognosis of frail elderly sepsis patients was 0.761 and 0.741, respectively, both demonstrating statistical significance(both P<0.001). Conclusions:Our findings suggest that urinary 8-oxoGuo possesses strong predictive value for the short-term prognosis of sepsis in this vulnerable population.
4.OBE-based Design of Biochemistry Teaching:Taking the Teaching of"Classification and Specificity of Enzymes"as an Example
Hua HAI ; Li-Yan NA ; Ming-Lei HE ; Hong-Ze YANG ; Li-Ming JIN ; Chun-Bin LI ; Hua JIN ; Quan ZHOU ; De-Fu ZHI
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):903-913
Biochemistry,as a fundamental course for science and engineering majors related to biology and chemistry,holds a significant position in the curriculum.The course team at Dalian Minzu University is committed to teaching innovation,adopting the outcome-based education(OBE)concept for teaching de-sign and incorporating ideological and political elements,in order to achieve the dual goals of knowledge transmission and value guidance.The team has established a three-dimensional teaching goal of"knowl-edge,morality,and ability",covering"consolidating core knowledge,cultivating moral sentiment,and enhancing innovation ability".Through a multi-dimensional integrated teaching method of"three integra-tions and five combinations",multiple rounds of teaching practice have been carried out in the applied chemistry major using"classification and specificity of enzyme"as an example.The output of teaching re-sults and survey questionnaires show that students highly recognize the teaching design and its"process-based learning"evaluation method,fully reflecting the student-centered teaching idea.Research has shown that OBE design combined with ideological and political elements can effectively promote students' knowl-edge acquisition,moral growth,and innovation ability improvement in the course of Biochemistry.This teaching design not only helps students construct correct worldviews,outlooks on life,and values,but also significantly enhances their innovative thinking and practical abilities.This teaching design can not only ef-fectively improve the teaching quality of the course,but also provide new perspectives and ideas for the teaching design of Biochemistry,realizing the organic integration of professional knowledge imparting and i-deological and political education,and has certain innovation and practical significance.
5.Expert Consensus on the Ethical Requirements for Generative AI-Assisted Academic Writing
You-Quan BU ; Yong-Fu CAO ; Zeng-Yi CHANG ; Hong-Yu CHEN ; Xiao-Wei CHEN ; Yuan-Yuan CHEN ; Zhu-Cheng CHEN ; Rui DENG ; Jie DING ; Zhong-Kai FAN ; Guo-Quan GAO ; Xu GAO ; Lan HU ; Xiao-Qing HU ; Hong-Ti JIA ; Ying KONG ; En-Min LI ; Ling LI ; Yu-Hua LI ; Jun-Rong LIU ; Zhi-Qiang LIU ; Ya-Ping LUO ; Xue-Mei LV ; Yan-Xi PEI ; Xiao-Zhong PENG ; Qi-Qun TANG ; You WAN ; Yong WANG ; Ming-Xu WANG ; Xian WANG ; Guang-Kuan XIE ; Jun XIE ; Xiao-Hua YAN ; Mei YIN ; Zhong-Shan YU ; Chun-Yan ZHOU ; Rui-Fang ZHU
Chinese Journal of Biochemistry and Molecular Biology 2025;41(6):826-832
With the rapid development of generative artificial intelligence(GAI)technologies,their widespread application in academic research and writing is continuously expanding the boundaries of sci-entific inquiry.However,this trend has also raised a series of ethical and regulatory challenges,inclu-ding issues related to authorship,content authenticity,citation accuracy,and accountability.In light of the growing involvement of AI in generating academic content,establishing an open,controllable,and trustworthy ethical governance framework has become a key task for safeguarding research integrity and maintaining trust within the academic community.This expert consensus outlines ethical requirements across key stages of AI-assisted academic writing-including topic selection,data management,citation practices,and authorship attribution.It aims to clarify the boundaries and ethical obligations surrounding AI use in academic writing,ensuring that technological tools enhance efficiency without compromising in-tegrity.The goal is to provide guidance and institutional support for building a responsible and sustainable research ecosystem.
6.Brucea javanica Seed Oil Emulsion and Shengmai Injections Improve Peripheral Microcirculation in Treatment of Gastric Cancer.
Li QUAN ; Wen-Hao NIU ; Fu-Peng YANG ; Yan-da ZHANG ; Ru DING ; Zhi-Qing HE ; Zhan-Hui WANG ; Chang-Zhen REN ; Chun LIANG
Chinese journal of integrative medicine 2025;31(4):299-310
OBJECTIVE:
To explore and verify the effect and potential mechanism of Brucea javanica Seed Oil Emulsion Injection (YDZI) and Shengmai Injection (SMI) on peripheral microcirculation dysfunction in treatment of gastric cancer (GC).
METHODS:
The potential mechanisms of YDZI and SMI were explored through network pharmacology and verified by cellular and clinical experiments. Human microvascular endothelial cells (HMECs) were cultured for quantitative real-time polymerase chain reaction, Western blot analysis, and human umbilical vein endothelial cells (HUVECs) were cultured for tube formation assay. Twenty healthy volunteers and 97 patients with GC were enrolled. Patients were divided into surgical resection, surgical resection with chemotherapy, and surgical resection with chemotherapy combining YDZI and SMI groups. Forearm skin blood perfusion was measured and recorded by laser speckle contrast imaging coupled with post-occlusive reactive hyperemia. Cutaneous vascular conductance and microvascular reactivity parameters were calculated and compared across the groups.
RESULTS:
After network pharmacology analysis, 4 ingredients, 82 active compounds, and 92 related genes in YDZI and SMI were screened out. β-Sitosterol, an active ingredient and intersection compound of YDZI and SMI, upregulated the expression of vascular endothelial growth factor A (VEGFA) and prostaglandin-endoperoxide synthase 2 (PTGS2, P<0.01), downregulated the expression of caspase 9 (CASP9) and estrogen receptor 1 (ESR1, P<0.01) in HMECs under oxaliplatin stimulation, and promoted tube formation through VEGFA. Chemotherapy significantly impaired the microvascular reactivity in GC patients, whereas YDZI and SMI ameliorated this injury (P<0.05 or P<0.01).
CONCLUSIONS
YDZI and SMI ameliorated peripheral microvascular reactivity in GC patients. β-Sitosterol may improve peripheral microcirculation by regulating VEGFA, PTGS2, ESR1, and CASP9.
Humans
;
Microcirculation/drug effects*
;
Drugs, Chinese Herbal/administration & dosage*
;
Stomach Neoplasms/physiopathology*
;
Emulsions
;
Male
;
Plant Oils/administration & dosage*
;
Brucea/chemistry*
;
Middle Aged
;
Female
;
Drug Combinations
;
Human Umbilical Vein Endothelial Cells/metabolism*
;
Seeds/chemistry*
;
Injections
;
Vascular Endothelial Growth Factor A/metabolism*
;
Aged
;
Network Pharmacology
7.MAMMAL-SPECIFIC GENOMIC FEATURES CAN PREDICT HIGH ADAPTABILITY TO THE WEST NILE VIRUS
Yu-Rong CAI ; Dan-Dan ZENG ; Sen ZHANG ; Jing LI ; Quan FU
Acta Parasitologica et Medica Entomologica Sinica 2025;32(2):84-92
Objective West Nile virus(WNV)is one of the most common mosquito-borne zoonotic viruses worldwide,with unique transmission dynamics and varied hosts.Lots of ecological and host factors have been reported to influence the host adaptation and transmission of WNVs,however,general genomic features of WNVs are less focused,except for some exact host-specific genotypes at molecular level.Artificial intelligence that analyzes genome composition characteristics currently shows significant advantages in identifying and predicting viral host adaptability.This research aimed to establish a convolutional neural network(CNN)model to predict the host adaptability of WNVs based on general genomic features.Methods Presently available WNV gene sequences were embedded for their genomic features with an embedding approach of dinucleotide composition representation(DCR).And DCR-based distribution difference of WNV samples among various hosts was performed with unsupervised learning methods.Then a classification model was built with a convolutional neural network(CNN)framework based on genomic DCR to evaluate the adaptation of the WNVs from birds,mammals and mosquitos.Additionally,host-specific amino acids in WNV proteins were inferred via Bayes method.Results DCR features could effectively distinguish host-specific WNVs.The trained CNN model predicted accurately mammalian susceptible WNVs from avian susceptible WNVs,however,much less accurately for mosquito/mammalian WNVs.Such predicted host adaptation was interpreted as host specified significance of biased amino acid distribution on the bayes-inferred sites in WNV proteins,implying a possible high significance of these sites for WNV adaptive phenotypes.Conclusions Genomic compositional features of WNVs are host-specific,and such genomic bias facilitates predicting the adaptation of WNVs to avian or mammalian hosts via deep learning methods.DCR-based decomposition is helpful to recognize the high risk of infecting mammals of WNVs.The present study provides a general knowledge of genomic features contributing to host adaptation to WNVs.
8.Therapeutic efficacy of Roujin formula in managing fibromyalgia patients with liver depression and spleen deficiency syndrome: A single-blinded randomized controlled trial
Jingsi FU ; Shiya WU ; Quan JIANG ; Juan JIAO
Science of Traditional Chinese Medicine 2025;3(1):62-68
Objective: Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by central sensitivity to pain, and it is universally acknowledged as a recalcitrant disease. A single-blind randomized controlled trial was conducted to assess the effectiveness and safety of the Roujin formula in treating FMS patients with liver depression and spleen deficiency syndrome, aiming to provide more scientific and effective treatment options. Methods: Forty-eight eligible participants were enrolled and randomly assigned to either the Roujin formula group (n = 24) or the placebo group (n = 24). The Roujin formula group received 150 mL of the Roujin formula twice daily, whereas the placebo group was given a tenth of the Roujin formula dosage, twice daily. The treatment lasted for 8 weeks, with a follow-up extending to 12 weeks. The primary outcome was the improvement in the pain Visual Analogue Scale (VAS) score, whereas secondary outcomes included enhancements in the Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory-II (BDI-II), Revised Fibromyalgia Impact Questionnaire (FIQR), and 36-item Short-Form Health Survey (SF-36) scores. These measures were assessed at baseline and after 4, 8, and 12 weeks. The Patients’ Global Impression of Change (PGIC) was collected at week 12. Safety assessments were based on routine blood tests, urine tests, and liver and kidney function evaluations. Results: The improvement in the pain VAS score was significantly greater in the Roujin formula group than that in the placebo group at the 4-, 8-, and 12-week follow-ups (p < 0.05). At the 8-week treatment and the 12-week follow-up, improvements in PSQI and FIQR scores were also superior in the Roujin formula group compared with the placebo group (p < 0.05). There were no differences between the 2 groups in the improvement of BDI-II scores, SF-36 physical component summary, and mental component summary scores at any observation time points. At the 12-week follow-up, PGIC ratings were significantly better in the Roujin formula group (p < 0.05). There were 4 adverse events, all of which occurred in the Roujin formula group, including 3 cases of diarrhea and 1 case of stomach pain; no serious adverse events were reported during the study. Conclusion: The Roujin formula can effectively enhance the overall condition of FMS patients, relieve pain, improve sleep quality, and elevate physical and mental well-being. Only mild gastrointestinal reactions were observed. The Roujin formula may be a viable candidate for clinical implementation.
9.Therapeutic efficacy of Roujin formula in managing fibromyalgia patients with liver depression and spleen deficiency syndrome: A single-blinded randomized controlled trial
Jingsi FU ; Shiya WU ; Quan JIANG ; Juan JIAO
Science of Traditional Chinese Medicine 2025;3(1):62-68
Objective: Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by central sensitivity to pain, and it is universally acknowledged as a recalcitrant disease. A single-blind randomized controlled trial was conducted to assess the effectiveness and safety of the Roujin formula in treating FMS patients with liver depression and spleen deficiency syndrome, aiming to provide more scientific and effective treatment options. Methods: Forty-eight eligible participants were enrolled and randomly assigned to either the Roujin formula group (n = 24) or the placebo group (n = 24). The Roujin formula group received 150 mL of the Roujin formula twice daily, whereas the placebo group was given a tenth of the Roujin formula dosage, twice daily. The treatment lasted for 8 weeks, with a follow-up extending to 12 weeks. The primary outcome was the improvement in the pain Visual Analogue Scale (VAS) score, whereas secondary outcomes included enhancements in the Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory-II (BDI-II), Revised Fibromyalgia Impact Questionnaire (FIQR), and 36-item Short-Form Health Survey (SF-36) scores. These measures were assessed at baseline and after 4, 8, and 12 weeks. The Patients’ Global Impression of Change (PGIC) was collected at week 12. Safety assessments were based on routine blood tests, urine tests, and liver and kidney function evaluations. Results: The improvement in the pain VAS score was significantly greater in the Roujin formula group than that in the placebo group at the 4-, 8-, and 12-week follow-ups (p < 0.05). At the 8-week treatment and the 12-week follow-up, improvements in PSQI and FIQR scores were also superior in the Roujin formula group compared with the placebo group (p < 0.05). There were no differences between the 2 groups in the improvement of BDI-II scores, SF-36 physical component summary, and mental component summary scores at any observation time points. At the 12-week follow-up, PGIC ratings were significantly better in the Roujin formula group (p < 0.05). There were 4 adverse events, all of which occurred in the Roujin formula group, including 3 cases of diarrhea and 1 case of stomach pain; no serious adverse events were reported during the study. Conclusion: The Roujin formula can effectively enhance the overall condition of FMS patients, relieve pain, improve sleep quality, and elevate physical and mental well-being. Only mild gastrointestinal reactions were observed. The Roujin formula may be a viable candidate for clinical implementation.
10.Therapeutic efficacy of Roujin formula in managing fibromyalgia patients with liver depression and spleen deficiency syndrome: A single-blinded randomized controlled trial
Jingsi FU ; Shiya WU ; Quan JIANG ; Juan JIAO
Science of Traditional Chinese Medicine 2025;3(1):62-68
Objective: Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by central sensitivity to pain, and it is universally acknowledged as a recalcitrant disease. A single-blind randomized controlled trial was conducted to assess the effectiveness and safety of the Roujin formula in treating FMS patients with liver depression and spleen deficiency syndrome, aiming to provide more scientific and effective treatment options. Methods: Forty-eight eligible participants were enrolled and randomly assigned to either the Roujin formula group (n = 24) or the placebo group (n = 24). The Roujin formula group received 150 mL of the Roujin formula twice daily, whereas the placebo group was given a tenth of the Roujin formula dosage, twice daily. The treatment lasted for 8 weeks, with a follow-up extending to 12 weeks. The primary outcome was the improvement in the pain Visual Analogue Scale (VAS) score, whereas secondary outcomes included enhancements in the Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory-II (BDI-II), Revised Fibromyalgia Impact Questionnaire (FIQR), and 36-item Short-Form Health Survey (SF-36) scores. These measures were assessed at baseline and after 4, 8, and 12 weeks. The Patients’ Global Impression of Change (PGIC) was collected at week 12. Safety assessments were based on routine blood tests, urine tests, and liver and kidney function evaluations. Results: The improvement in the pain VAS score was significantly greater in the Roujin formula group than that in the placebo group at the 4-, 8-, and 12-week follow-ups (p < 0.05). At the 8-week treatment and the 12-week follow-up, improvements in PSQI and FIQR scores were also superior in the Roujin formula group compared with the placebo group (p < 0.05). There were no differences between the 2 groups in the improvement of BDI-II scores, SF-36 physical component summary, and mental component summary scores at any observation time points. At the 12-week follow-up, PGIC ratings were significantly better in the Roujin formula group (p < 0.05). There were 4 adverse events, all of which occurred in the Roujin formula group, including 3 cases of diarrhea and 1 case of stomach pain; no serious adverse events were reported during the study. Conclusion: The Roujin formula can effectively enhance the overall condition of FMS patients, relieve pain, improve sleep quality, and elevate physical and mental well-being. Only mild gastrointestinal reactions were observed. The Roujin formula may be a viable candidate for clinical implementation.

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