This study explores methodological issues in the design， evaluation， and reporting of randomized controlled trials （RCTs） under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design， the screening of research participants， the standardization of syndrome differentiation， the balance between intervention individualization and standardization， the integration of multi-dimensional outcome measures， and the limitations of existing evaluation and reporting tools when applied to this type of research， along with corresponding recommendations and future perspectives. Regarding research design， it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs， in order to innovate the design format of RCTs. Meanwhile， criteria for participant screening， TCM syndrome differentiation， and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization， and a multidimensional assessment system encompassing TCM syndromes， disease-specific outcomes， and patient-reported outcomes should be established. For risk of bias assessment and research reporting， it is recommended，to develop specialized assessment and reporting tools based on existing instruments， in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design， risk-of-bias assessment， and reporting quality assessment of RCTs based on the "syndrome dominating disease" model， with a particular focus on methodological optimization， data integration， and enhancement of research quality.

This study explores methodological issues in the design， evaluation， and reporting of randomized controlled trials （RCTs） under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design， the screening of research participants， the standardization of syndrome differentiation， the balance between intervention individualization and standardization， the integration of multi-dimensional outcome measures， and the limitations of existing evaluation and reporting tools when applied to this type of research， along with corresponding recommendations and future perspectives. Regarding research design， it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs， in order to innovate the design format of RCTs. Meanwhile， criteria for participant screening， TCM syndrome differentiation， and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization， and a multidimensional assessment system encompassing TCM syndromes， disease-specific outcomes， and patient-reported outcomes should be established. For risk of bias assessment and research reporting， it is recommended，to develop specialized assessment and reporting tools based on existing instruments， in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design， risk-of-bias assessment， and reporting quality assessment of RCTs based on the "syndrome dominating disease" model， with a particular focus on methodological optimization， data integration， and enhancement of research quality.

Objective To investigate the safety and clinical efficacy of the Laennec membrane left side hepatic parenchymal transection-first approach combined with APR triangle in laparoscopic anatomical central hepatectomy.Methods 24 patients underwent laparoscopic anatomical central hepatectomy via Laennec membrane left side hepatic parenchymal transection-first approach combined with APR triangle from January 2023 to June 2024 were selected.Statistical analysis of patients with operation time,intraoperative blood loss,postoperative complications,and postoperative hospital stay.Results All the 24 patients underwent laparoscopic anatomical central hepatectomy without perioperative death.The operation time was(210.2±75.6)minutes(range:95～295 min),and the intraoperative blood loss was(358.9±118.4)mL(range:150～1 100 mL).There was no intraoperative blood transfusion and no conversion to open surgery.The abdominal drainage tube was removed on the average of(5.5±0.5)d(range:4～10 d)after operation,and the average postoperative hospital stay was(7.5±1.5)d(range:5～16 d).There were 5 cases of Clavien-Dindo grade Ⅰ and Ⅱ complications,including 4 cases of abdominal effusion and 1 case of pleural effusion.Postoperative pathology:all patients were hepatocellular carcinoma.Patients with liver malignant tumor were followed up for 1 month to 1.5 years.All the patients survived during the follow-up period,and 2 patients had tumor recurrence.Conclusion For central hepatic segment tumors,laparoscopic anatomical central hepatectomy can be performed using the left hepatic parenchyma via Laennec membrane priority approach combined with APR triangle method,which is safe and feasible.

Objective:To evaluate the effect of acupuncture on postoperative delirium (POD) in diabetic patients undergoing surgery under general anesthesia.Methods:In this randomized controlled trial, 92 diabetic patients of either sex, aged 30-80 yr, with a body mass index of 18-28 kg/m 2, of American Society of Anesthesiologists Physical Status classification Ⅱ or Ⅲ, scheduled for elective surgery under general anesthesia, were divided into 2 groups ( n=46 each) using a table of random numbers: control group (group C) and acupuncture group (group A). Group A received acupuncture at the Baihui (GV20), Shenting (GV24) and Sishencong (EX-HN1) acupoints before anesthesia. The needles were retained for 30 min, with manual stimulation applied every 10 min for 10 s each time. After 4 stimulations, routine anesthesia was carried out. Group C received routine anesthesia only. Regional cerebral oxygen saturation was recorded on admission to the operating room (T 0), after anesthesia induction (T 1), at the start of surgery (T 2), at the end of surgery (T 3), and immediately after tracheal extubation (T 4). The POD developed within 3 days after surgery was assessed. The occurrence of needle-related adverse effects such as fainting, subcutaneous bleeding, and local paresthesia was recorded. Results:Compared with group C, the incidence of POD was significantly reduced, and the regional cerebral oxygen saturation was increased at T 1, 4 in group A ( P<0.05). Conclusions:Acupuncture can decrease the development of POD in diabetic patients undergoing surgery under general anesthesia, which is related to an increase in regional cerebral oxygen saturation.

Objective:To study the feasibility and safety of left semiprone position in 3D laparoscopic liver resection for tumor in segment Ⅶ.Methods:Clinical data of 60 patients with liver tumors treated at Jinhua Central Hospita from January 2018 to September 2022 were retrospectively collected, including 40 males and 20 females, aged (51.5±4.5) years. Perioperative data on operative time, intraoperative blood loss, postoperative time of ambulation, postoperative time to flatulate, duration of hospital stay, pathological type, complications (bile leakage, pleural effusion, etc.) were analyzed. Postoperative follow-ups were conducted through telephone reviews, outpatient visits.Results:Of 57 patients (95.0%) successfully underwent the surgery, while three cases (5.0%) were converted to open surgery due to excessive intraoperative bleeding. The operative time was (210.5±20.5) min. The intraoperative blood loss was (220.5±50.5) ml. The postoperative time of ambulation was (1.5±0.5) d, and the postoperative time to flatulate was (2.0±0.8) d. The postoperative hospital stay was (7.2±1.5) d. Bile leakage occurred in four cases (6.7%) after surgery, which was managed by conservative treatment, and pleural effusion occurred in eight cases (13.3%), which recovered after puncture and drainage. Postoperative pathology included 40 cases (66.7%) of hepatocellular carcinoma, three cases (5.0%) of intrahepatic cholangiocarcinoma, five cases (8.3%) of liver metastases, seven cases (11.7%) of hepatic hemangioma, two case (3.3%) of angiomyolipoma, and three case (5.0%) of focal hepatic nodular hyperplasia. No tumor recurrence was observed during follow-up (median 26 months; range 18-40 months).Conclusion:The application of left semiprone position in 3D laparoscopic liver resection for tumor in segment Ⅶ is safe and feasible.

Objective:To evaluate the effect of acupuncture on postoperative delirium (POD) in diabetic patients undergoing surgery under general anesthesia.Methods:In this randomized controlled trial, 92 diabetic patients of either sex, aged 30-80 yr, with a body mass index of 18-28 kg/m 2, of American Society of Anesthesiologists Physical Status classification Ⅱ or Ⅲ, scheduled for elective surgery under general anesthesia, were divided into 2 groups ( n=46 each) using a table of random numbers: control group (group C) and acupuncture group (group A). Group A received acupuncture at the Baihui (GV20), Shenting (GV24) and Sishencong (EX-HN1) acupoints before anesthesia. The needles were retained for 30 min, with manual stimulation applied every 10 min for 10 s each time. After 4 stimulations, routine anesthesia was carried out. Group C received routine anesthesia only. Regional cerebral oxygen saturation was recorded on admission to the operating room (T 0), after anesthesia induction (T 1), at the start of surgery (T 2), at the end of surgery (T 3), and immediately after tracheal extubation (T 4). The POD developed within 3 days after surgery was assessed. The occurrence of needle-related adverse effects such as fainting, subcutaneous bleeding, and local paresthesia was recorded. Results:Compared with group C, the incidence of POD was significantly reduced, and the regional cerebral oxygen saturation was increased at T 1, 4 in group A ( P<0.05). Conclusions:Acupuncture can decrease the development of POD in diabetic patients undergoing surgery under general anesthesia, which is related to an increase in regional cerebral oxygen saturation.

Objective To investigate the safety and clinical efficacy of the Laennec membrane left side hepatic parenchymal transection-first approach combined with APR triangle in laparoscopic anatomical central hepatectomy.Methods 24 patients underwent laparoscopic anatomical central hepatectomy via Laennec membrane left side hepatic parenchymal transection-first approach combined with APR triangle from January 2023 to June 2024 were selected.Statistical analysis of patients with operation time,intraoperative blood loss,postoperative complications,and postoperative hospital stay.Results All the 24 patients underwent laparoscopic anatomical central hepatectomy without perioperative death.The operation time was(210.2±75.6)minutes(range:95～295 min),and the intraoperative blood loss was(358.9±118.4)mL(range:150～1 100 mL).There was no intraoperative blood transfusion and no conversion to open surgery.The abdominal drainage tube was removed on the average of(5.5±0.5)d(range:4～10 d)after operation,and the average postoperative hospital stay was(7.5±1.5)d(range:5～16 d).There were 5 cases of Clavien-Dindo grade Ⅰ and Ⅱ complications,including 4 cases of abdominal effusion and 1 case of pleural effusion.Postoperative pathology:all patients were hepatocellular carcinoma.Patients with liver malignant tumor were followed up for 1 month to 1.5 years.All the patients survived during the follow-up period,and 2 patients had tumor recurrence.Conclusion For central hepatic segment tumors,laparoscopic anatomical central hepatectomy can be performed using the left hepatic parenchyma via Laennec membrane priority approach combined with APR triangle method,which is safe and feasible.

Objective:To study the feasibility and safety of left semiprone position in 3D laparoscopic liver resection for tumor in segment Ⅶ.Methods:Clinical data of 60 patients with liver tumors treated at Jinhua Central Hospita from January 2018 to September 2022 were retrospectively collected, including 40 males and 20 females, aged (51.5±4.5) years. Perioperative data on operative time, intraoperative blood loss, postoperative time of ambulation, postoperative time to flatulate, duration of hospital stay, pathological type, complications (bile leakage, pleural effusion, etc.) were analyzed. Postoperative follow-ups were conducted through telephone reviews, outpatient visits.Results:Of 57 patients (95.0%) successfully underwent the surgery, while three cases (5.0%) were converted to open surgery due to excessive intraoperative bleeding. The operative time was (210.5±20.5) min. The intraoperative blood loss was (220.5±50.5) ml. The postoperative time of ambulation was (1.5±0.5) d, and the postoperative time to flatulate was (2.0±0.8) d. The postoperative hospital stay was (7.2±1.5) d. Bile leakage occurred in four cases (6.7%) after surgery, which was managed by conservative treatment, and pleural effusion occurred in eight cases (13.3%), which recovered after puncture and drainage. Postoperative pathology included 40 cases (66.7%) of hepatocellular carcinoma, three cases (5.0%) of intrahepatic cholangiocarcinoma, five cases (8.3%) of liver metastases, seven cases (11.7%) of hepatic hemangioma, two case (3.3%) of angiomyolipoma, and three case (5.0%) of focal hepatic nodular hyperplasia. No tumor recurrence was observed during follow-up (median 26 months; range 18-40 months).Conclusion:The application of left semiprone position in 3D laparoscopic liver resection for tumor in segment Ⅶ is safe and feasible.

Objective To investigate the safety and clinical efficacy of the combined gallbladder plate approach using Laennec membrane based on APR triangle in laparoscopic anaphylactic right lobe hepatectomy.Methods Clinical data of 27 patients underwent laparoscopic anaphylactic of right lobe hepatectomy based on the APR triangle combined with the gallbladder plate approach using Laennec membrane were collected from January 2021 to December 2023.The relevant data of patients were statistically analyzed,including operation time,intraoperative blood loss,postoperative complications,and postoperative hospital stay.Results All the 27 patients underwent laparoscopic anatomic hepatectomy,and no perioperative death occurred.Among them,segment Ⅴ was resected in 4 cases,segment Ⅵ in 3 cases,segment Ⅴ+Ⅷ in 6 cases,segment Ⅴ+Ⅵ in 4 cases,segment Ⅵ+Ⅶin 5 cases,segment Ⅴ+Ⅵ+Ⅶ in 3 cases,and segment Ⅴ+Ⅵ+Ⅷ in 2 cases.All cases belonged to the China Liver Cancer(CNLC)clinical staging,stage Ⅰa in 15 cases,stage Ⅰb in 8 cases and stage Ⅱa in 4 cases.The operative time was(258.3±62.3)min,the intraoperative blood loss was(168.8±48.1)mL,and there was no transfusion.The patients were given liquid diet on the first day after surgery,and were active in bed on the second day after surgery.The mean postoperative length of hospital stay was(6.5±1.7)d after removal of abdominal drainage tube.There were 5 cases of Clavien-Dindo Ⅰ and Ⅱ complications(3 cases of abdominal effusion,1 case of pleural effusion,1 case of pulmonary infection),and no complications such as bile leakage and abdominal hemorrhage occurred.Postoperative pathology:21 cases of hepatocellular carcinoma,4 cases of hepatociliary duct carcinoma,2 cases of liver metastasis.Patients with liver malignant tumor were followed up for 2 months to 2 years,and all patients survived during the follow-up period without tumor recurrence.Conclusion The gallbladder plate approach based on APR triangle combined with Laennec membrane is a safe and effective surgical method for laparoscopic anaphylactic right lobe hepatectomy,which is worthy of clinical application.

Objective To evaluate the effect of mild hypothermia on the renal ischemia-reperfusion injury (IRI), and the expression profile of RNA-binding motif protein 3(RBM3) and its downstream effector molecules during this process. Methods Eighteen healthy SD male rats were randomly divided into the normal control (NC) group, IRI group and mild hypothermia pretreat (MHP) group, with 6 rats in each group. Serum creatinine level was measured to evaluate the renal function. Hematoxylin-eosin (HE) staining was performed to assess the renal tissue injury. Western blot was used to determine the relative expression levels of RBM3, Yes-associated protein 1(YAP1), nuclear factor E2-related factor 2(Nrf2), B cell-lymphoma-2(Bcl-2) and Bcl-2-associated X protein (Bax) in the kidney tissues. Immunohistochemical staining was employed to further detect the expression levels of RBM3 and YAP1 proteins. Terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) assay was adopted to detect the cell apoptosis of kidney tissues. Malondialdehyde (MDA) content and superoxide dismutase (SOD) activity were evaluated to determine the oxidative stress level of kidney tissues. Results Compared with the NC group, the serum creatinine level, the pathological injury score of kidney tissues and the expression levels of RBM3, YAP1 and Nrf2 proteins were significantly up-regulated, the Bcl-2/Bax ratio was considerably lower, the apoptosis rate was remarkably elevated, the MDA content was significantly increased and the SOD activity was dramatically reduced in the IRI and MHP groups (all P < 0.05). Compared with the IRI group, the serum creatinine level and the pathological injury score of kidney tissues were significantly decreased, the expression levels of RBM3, YAP1 and Nrf2 proteins were significantly up-regulated, the Bcl-2/Bax ratio was considerably higher, the apoptosis rate was significantly decreased, the MDA content was significantly decreased and the SOD activity was considerably elevated in the MHP group (all P < 0.05). Conclusions Mild hypothermia may exert protective effect upon renal IRI and it could alleviate cell apoptosis and oxidative stress injury induced by IRI, probably by up-regulating the expression level of RBM3 and its downstream effector molecules of YAP1 and Nrf2.