The rationale for the design of control groups in tuina clinical trial is the foundation for rigorously validating the effectiveness and safety of this therapy. This article reviewed the current state of the design of tuina placebo in control groups of clinical trials， pointed out the necessity of setting up tuina placebo in clinical trials of tuina， analyzed the challenges in implementing blinding of tuina manipulation， and concluded that tuina placebo is still challenged by the placebo effect， the diversification of tuina manipulation but the lack of standardization， and the difficulty of implementing blinding due to the high level of public awareness of tuina. This article also summarized the design of placebo manipulation in three types of clinical trials， including spinal manipulation， acupressure， and paediatric tuina， and proposed four strategies for designing placebo tuina manipulation-controlling placebo effects， developing operational standards for placebo tuina manipulation， ensuring the rigor of blinding implementation， and applying new technologies to enhance the standardization and blinding capacity of placebo tuina methods. So the article is aimed at improving the methodological quality of tuina clinical trial designs， and promoting the standardization and scientificity of tuina clinical trial design.

Objective:Analyze the risk factors of gastrointestinal perforation caused by foreign body and summarize the experience of surgical treatment of foreign bodies.Method:From Jan 2008 to Dec 2023, 89 patients with foreign bodies in the digestive tract were admitted to the Department of Gastrointestinal Surgery, Peking University First Hospital. Relevant data were collected and binary logistic regression was used to analyze the independent risk factors for intestinal perforation, resection and anastomosis of intestine or enterostomy/colostomy.Results:The mean age of 89 patients was (60.1±16.2) years old, 65 patients (73%) had unintentionally ingested foreign bodies. The most common foreign bodies were jujube pits (40 cases). Thirty-nine patients diagnosed with gastrointestinal perforation. Binary Logistic regression analysis showed that the total number of leukocytes ( OR=4.085, 95% CI: 1.214-13.745, P=0.023), sharp foreign body ( OR=26.124, 95% CI: 5.194-131.392, P<0.001), and the location of foreign body ( OR=3.980, 95% CI: 1.178-13.465, P=0.026) were the independent risk factors for gastrointestinal perforation. Thirty-three patients underwent gastrointestinal repair surgery, and 36 patients underwent resection and anastomosis of intestine or enterostomy/colostomy. Binary Logistic regression analysis showed that the foreign body located in the colorectum ( OR=71.928, 95% CI: 4.646-1 113.479, P=0.002) and the length of the foreign body ≤2.5 cm ( OR=5.791, 95% CI: 1.606-20.882, P=0.007) were the independent risk factors for resection and anastomosis of intestine or enterostomy/colostomy. Conclusions:Leukocyte count ≥10×10 9/L, sharp foreign body, and location of foreign body are independent risk factors for gastrointestinal perforation. Foreign body located in the colorectum and foreign body length ≤2.5 cm are risk factors for resection and anastomosis of intestine or enterostomy/colostomy.

Objective:To investigate the short-term efficacy of lenvatinib combined with transcatheter arterial chemoembolization (TACE) and xindilimumab in the treatment of hepatocellular carcinoma.Methods:A prospective, randomized, controlled study was conducted to divide 140 patients with hepatocellular carcinoma admitted to the First Hospital of Putian City from January 2020 to December 2023. The patients were divided into two groups by random number table method, with 70 cases in each group. The control group was treated with lenvatinib after TACE, and the observation group was treated with lenvatinib + xindilimumab after TACE. The patients were followed up for 6 months, and the number of TACE treatment in the two groups was recorded. The clinical efficacy, serum nuclear factor-κB (NF-κB), hypoxia-inducible factor-1α (HIF-1α), alpha-fetoprotein (AFP) levels, tumor blood supply diameter and drug side effects during treatment were compared between the two groups at 4 weeks and 6 months after TACE treatment.Results:There was no statistical significant difference in the number of TACE treatments between the two groups ( P>0.05). At 4 weeks of treatment, compared with the control group, the objective response rate (ORR) and disease control rate (DCR) of the observation group were significantly increased: 74.29% (52/70) vs. 57.14% (40/70), 92.87% (65/70) vs. 81.43% (57/70) ( P<0.05). After 6 months of treatment, compared with the control group, the observation group showed a significant increase in DCR: 85.71% (60/70) vs. 95.71% (67/70) ( P<0.05). Compared with the control group, the levels of serum NF-κ B, HIF-1α and AFP in the observation group were significantly reduced after 4 weeks and 6 months of treatment: (165.34 ± 40.11) ng/L vs. (187.61 ± 40.62) ng/L, (151.67 ± 36.25) ng/L vs. (165.01 ± 37.12) ng/L; (123.69 ± 20.36) μg/L vs. (148.32 ± 20.38) μg/L, (108.84 ± 20.28) μg/L vs. (121.67 ± 19.29) μg/L; (2 117.02 ± 903.36) μg/L vs. (2 469.79 ± 916.27) μg/L, (1 010.32 ± 422.34) μg/L vs. (1 159. 36 ± 412.01) μg/L ( P<0.05). Compared with the control group, the observation group showed a significant reduction in tumor blood supply diameter after 4 weeks and 6 months of treatment: 3.00 (2.00, 4.00) mm vs. 3.00 (3.00, 4.00) mm, 2.00 (1.00, 3.00) mm vs. 3.00 (2.00, 3.00) mm ( P<0.05) There was no statistically significant difference in the incidence of drug toxicity and side effects between the two treatment groups ( P>0.05). Conclusions:The concurrent administration of lenvatinib and xindilimab has been demonstrated to enhance the short-term therapeutic efficacy of TACE in patients with hepatocellular carcinoma. This combination therapy was associated with a significant reduction in serum levels of NF-κB, HIF-1α, and AFP. Additionally, it led to a notable decrease in the diameter of the tumor-feeding arteries. Preliminary safety analysis indicates that this regimen is well-tolerated, with an acceptable safety profile.

Objective:To investigate the effect of left colonic artery (LCA) preservation on rectal cancer patients' short-term postoperative anal function and quality of life.Methods:Two-hundred ninty-two patients with rectal cancer at the Department of Gastrointestinal Surgery of Peking University First Hospital between Jan 2022 and Dec 2023 were enrolled . The patients were divided into two groups according to whether the LCA was preserved during surgery or not. The LARS scale and EORTC QLQ-CR29 quality of life questionnaire were used to assess postoperative anal function and quality of life.Results:There were no significant differences between the two groups in terms of the amount of surgical blood loss and the number of lymph node dissections in the root No. 253 group and the time to postoperative voiding (all P>0.05). However, the LARS scores at 1 and 3 months postoperatively were significantly lower in the preserved LCA group than in the LCA nonpreserved group, especially for gas incontinence, loose stool leakage, and number of bowel movements (all P<0.05). The EORTC QLQ-CR29 scores showed that the LCA preserved group recovered significantly better than the non-preserved group in terms of postoperative voiding dysfunction ( P=0.007), urinary incontinence ( P=0.006), mucus discharge ( P=0.009), and fecal incontinence symptoms ( P<0.001). Male sexual dysfunction recovery was quicker in the preserved LCA group ( P=0.043), but there was no significant difference between the two groups at 3 months postoperatively( P>0.05). Conclusion:Preservation of the left colonic artery in low anterior resection of rectal cancer helps to reduce the incidence of postoperative low anterior resection syndrome, improve genitourinary symptoms, and improve patients' quality of life.

Objective:To investigate the short-term efficacy of lenvatinib combined with transcatheter arterial chemoembolization (TACE) and xindilimumab in the treatment of hepatocellular carcinoma.Methods:A prospective, randomized, controlled study was conducted to divide 140 patients with hepatocellular carcinoma admitted to the First Hospital of Putian City from January 2020 to December 2023. The patients were divided into two groups by random number table method, with 70 cases in each group. The control group was treated with lenvatinib after TACE, and the observation group was treated with lenvatinib + xindilimumab after TACE. The patients were followed up for 6 months, and the number of TACE treatment in the two groups was recorded. The clinical efficacy, serum nuclear factor-κB (NF-κB), hypoxia-inducible factor-1α (HIF-1α), alpha-fetoprotein (AFP) levels, tumor blood supply diameter and drug side effects during treatment were compared between the two groups at 4 weeks and 6 months after TACE treatment.Results:There was no statistical significant difference in the number of TACE treatments between the two groups ( P>0.05). At 4 weeks of treatment, compared with the control group, the objective response rate (ORR) and disease control rate (DCR) of the observation group were significantly increased: 74.29% (52/70) vs. 57.14% (40/70), 92.87% (65/70) vs. 81.43% (57/70) ( P<0.05). After 6 months of treatment, compared with the control group, the observation group showed a significant increase in DCR: 85.71% (60/70) vs. 95.71% (67/70) ( P<0.05). Compared with the control group, the levels of serum NF-κ B, HIF-1α and AFP in the observation group were significantly reduced after 4 weeks and 6 months of treatment: (165.34 ± 40.11) ng/L vs. (187.61 ± 40.62) ng/L, (151.67 ± 36.25) ng/L vs. (165.01 ± 37.12) ng/L; (123.69 ± 20.36) μg/L vs. (148.32 ± 20.38) μg/L, (108.84 ± 20.28) μg/L vs. (121.67 ± 19.29) μg/L; (2 117.02 ± 903.36) μg/L vs. (2 469.79 ± 916.27) μg/L, (1 010.32 ± 422.34) μg/L vs. (1 159. 36 ± 412.01) μg/L ( P<0.05). Compared with the control group, the observation group showed a significant reduction in tumor blood supply diameter after 4 weeks and 6 months of treatment: 3.00 (2.00, 4.00) mm vs. 3.00 (3.00, 4.00) mm, 2.00 (1.00, 3.00) mm vs. 3.00 (2.00, 3.00) mm ( P<0.05) There was no statistically significant difference in the incidence of drug toxicity and side effects between the two treatment groups ( P>0.05). Conclusions:The concurrent administration of lenvatinib and xindilimab has been demonstrated to enhance the short-term therapeutic efficacy of TACE in patients with hepatocellular carcinoma. This combination therapy was associated with a significant reduction in serum levels of NF-κB, HIF-1α, and AFP. Additionally, it led to a notable decrease in the diameter of the tumor-feeding arteries. Preliminary safety analysis indicates that this regimen is well-tolerated, with an acceptable safety profile.

Objective:To investigate the effect of left colonic artery (LCA) preservation on rectal cancer patients' short-term postoperative anal function and quality of life.Methods:Two-hundred ninty-two patients with rectal cancer at the Department of Gastrointestinal Surgery of Peking University First Hospital between Jan 2022 and Dec 2023 were enrolled . The patients were divided into two groups according to whether the LCA was preserved during surgery or not. The LARS scale and EORTC QLQ-CR29 quality of life questionnaire were used to assess postoperative anal function and quality of life.Results:There were no significant differences between the two groups in terms of the amount of surgical blood loss and the number of lymph node dissections in the root No. 253 group and the time to postoperative voiding (all P>0.05). However, the LARS scores at 1 and 3 months postoperatively were significantly lower in the preserved LCA group than in the LCA nonpreserved group, especially for gas incontinence, loose stool leakage, and number of bowel movements (all P<0.05). The EORTC QLQ-CR29 scores showed that the LCA preserved group recovered significantly better than the non-preserved group in terms of postoperative voiding dysfunction ( P=0.007), urinary incontinence ( P=0.006), mucus discharge ( P=0.009), and fecal incontinence symptoms ( P<0.001). Male sexual dysfunction recovery was quicker in the preserved LCA group ( P=0.043), but there was no significant difference between the two groups at 3 months postoperatively( P>0.05). Conclusion:Preservation of the left colonic artery in low anterior resection of rectal cancer helps to reduce the incidence of postoperative low anterior resection syndrome, improve genitourinary symptoms, and improve patients' quality of life.

Objective:Analyze the risk factors of gastrointestinal perforation caused by foreign body and summarize the experience of surgical treatment of foreign bodies.Method:From Jan 2008 to Dec 2023, 89 patients with foreign bodies in the digestive tract were admitted to the Department of Gastrointestinal Surgery, Peking University First Hospital. Relevant data were collected and binary logistic regression was used to analyze the independent risk factors for intestinal perforation, resection and anastomosis of intestine or enterostomy/colostomy.Results:The mean age of 89 patients was (60.1±16.2) years old, 65 patients (73%) had unintentionally ingested foreign bodies. The most common foreign bodies were jujube pits (40 cases). Thirty-nine patients diagnosed with gastrointestinal perforation. Binary Logistic regression analysis showed that the total number of leukocytes ( OR=4.085, 95% CI: 1.214-13.745, P=0.023), sharp foreign body ( OR=26.124, 95% CI: 5.194-131.392, P<0.001), and the location of foreign body ( OR=3.980, 95% CI: 1.178-13.465, P=0.026) were the independent risk factors for gastrointestinal perforation. Thirty-three patients underwent gastrointestinal repair surgery, and 36 patients underwent resection and anastomosis of intestine or enterostomy/colostomy. Binary Logistic regression analysis showed that the foreign body located in the colorectum ( OR=71.928, 95% CI: 4.646-1 113.479, P=0.002) and the length of the foreign body ≤2.5 cm ( OR=5.791, 95% CI: 1.606-20.882, P=0.007) were the independent risk factors for resection and anastomosis of intestine or enterostomy/colostomy. Conclusions:Leukocyte count ≥10×10 9/L, sharp foreign body, and location of foreign body are independent risk factors for gastrointestinal perforation. Foreign body located in the colorectum and foreign body length ≤2.5 cm are risk factors for resection and anastomosis of intestine or enterostomy/colostomy.

ObjectiveMetabolomics was utilized to investigate the preventive effect of notoginseng total saponins（NTS） on aspirin（acetyl salicylic acid， ASA）-induced small bowel injury in rats. MethodFifty male SD rats were randomly divided into normal and model groups， NTS high-dose and low-dose groups（62.5， 31.25 mg·kg^-1）， and positive drug group（omeprazole 2.08 mg·kg^-1+rebamipide 31.25 mg·kg^-1）， with 10 rats in each group. Except for the normal group， rats in other groups were given ASA enteric-coated pellets 10.41 mg·kg^-1 daily to establish a small intestine injury model. On this basis， each medication group was gavaged daily with the corresponding dose of drug， and the normal group and the model group were gavaged with an equal amount of drinking water. Changes in body mass and fecal characteristics of rats were recorded and scored during the period. After 14 weeks of administration， small intestinal tissues of each group were taken for hematoxylin-eosin（HE） staining， scanning electron microscopy to observe the damage， and the apparent damage of small intestine was scored. Serum from rats in the normal group， the model group， and the NTS high-dose group was taken and analyzed for metabolomics by ultra-performance liquid chromatography-quadrupole-electrostatic field orbitrap high-resolution mass spectrometry（UPLC-Q-Exactive Orbitrap MS）， and the data were processed by multivariate statistical analysis， the potential biomarkers were screened by variable importance in the projection（VIP） value≥1.0， fold change（FC）≥1.5 or ≤0.6 and t-test P<0.05， and pathway enrichment analysis of differential metabolites was performed in conjunction with Human Metabolome Database（HMDB） and Kyoto Encyclopedia of Genes and Genomes（KEGG）. ResultAfter 14 weeks of administration， the average body mass gain of the model group was lower than that of the normal group， and the NTS high-dose group was close to that of the normal group. Compared with the normal group， the fecal character score of rats in the model group was significantly increased（P<0.05）， and compared with the model group， the scores of the positive drug group and the NTS high-dose group were reduced， but the difference was not statistically significant. HE staining and scanning electron microscopy results showed that NTS could significantly improve ASA-induced small intestinal injury， compared with the normal group， the small bowel injury score of the model group was significantly increased（P<0.01）， compared with the model group， the small bowel injury scores of the NTS low and high dose groups were significantly reduced（P<0.05， P<0.01）. Serum metabolomics screened a total of 75 differential metabolites between the normal group and the model group， of which 55 were up-regulated and 20 were down-regulated， 76 differential metabolites between the model group and the NTS groups， of which 14 were up-regulated and 62 were down-regulated. NTS could modulate three differential metabolites（salicylic acid， 3-hydroxybenzoic acid and 4-hydroxybenzoic acid）， which were involved in 3 metabolic pathways， namely， the bile secretion， the biosynthesis of folic acid， and the biosynthesis of phenylalanine， tyrosine and tryptophan. ConclusionNTS can prevent ASA-induced small bowel injury， and the underlying mechanism may be related to the regulation of bile secretion and amino acid metabolic pathways in rats.

Objective:To explore application value of combined spinal-epidural anesthesia under the assistant of ultrasound location on lower limb fractures.Methods:A total of 80 patients with lower limb fractures who underwent surgical treatment at the 901th Hospital of the PLA Joint Service Support Force from July 2020 to July 2022 were selected,and they were divided into a control group and an observation group according to the random number table method,with 40 cases in each group.The control group received epidural anesthesia under ultrasound,and the observation group received the combined lumbar-epidural anesthesia under ultrasound.The lidocaine dosage,anesthetic block time,anesthesia onset time and dosage of additional analgesic,as well as the changes in vital signs such as diastolic blood pressure(DBP),systolic blood pressure(SBP)and heart rate(HR),between the two groups of patients were compared.In addition,the thrombelastogram,anesthetic effects and occurrence of adverse reactions also were compared between two groups.Results:The lidocaine dosage,anesthetic block time,anesthesia onset time and dosage of additional analgesic of the observation group were significantly higher than those in the control group,and the differences were statistically significant(t=8.657,23.483,12.785,16.600,P<0.05),respectively.There were no statistically significant differences in DBP,SBP,HR,comprehensive coagulation index(CI),reaction time(R),formation time of blood cell agglutination(K)and incidence of adverse reactions between two groups before anesthesia,at the 30th minute after anesthesia and after the end of anesthesia(P>0.05).Compared with α angle before anesthesia and at the 30th minute after anesthesia,the α angles of the two groups increased significantly after anesthesia(t=6.564,5.783,P<0.05),respectively.The mechanical strength(G)of the blood clot and the maximum amplitude(MA)of chromatogram of the observation group were significantly reduced after completed anesthesia,and the differences of them were statistically significant(t=8.480,4.236,P<0.05),respectively.There were no significant differences between G and MA in the control group(P>0.05).The total effective rate of the observation group was 97.50%,which was significantly higher than 80.00% of the control group,and the difference was statistically significant(x2=4.507,P<0.05).Conclusion:The combined spinal-epidural anesthesia under the assistant of ultrasound location can effectively reduce the amount of anesthetics in patients with lower limb fracture,which has fast block and effect.In addition,it has little influence on circulatory function,and it is less likely to form a hypercoagulable state.It has better clinical anesthesia effect.

ObjectiveTo analyze the traditional Chinese medicine （TCM） patterns in patients with spasmodic torticollis and provide reference for standardized differentiation and clinical treatment. MethodsA cross-sectional study was conducted in the spasmodic torticollis outpatient clinic and dystonia ward of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from June 2022 to December 2023. The general information including gender， age， duration of disease and type， and the TCM four examinations data such as symptoms， tongue manifestation and pulse manifestation of 198 patients with spasmodic torticollis were obtained by means of on-site questionnaires. Descriptive frequency analysis， factor analysis， and cluster analysis were performed， and the distribution of major TCM patterns were summarized based on the clinical information. ResultsA total of 198 patients with spasmodic torticollis were included， of which 89 （44.95%） were male and 109 （55.05%） were female， with an average age of 40.70±0.96 years and an average course of disease of 24.78±2.32 months. A total of 296 symptoms/signs were obtained， with a cumulative frequency of 6756 times， of which 58 symptoms/signs had a frequency ≥20%， and the top three were neck and back stiffness （83.84%）， condition related to emotions （74.75%） and irritability （72.73%）. Factor analysis of 58 symptoms/signs showed that factor rotation converged after 51 iterations， resulting in 20 common factors with a cumulative contribution of 64.03%. The top three syndrome elements related to the location of the disease were liver， channels， tendons and bones， and those related nature of the disease were dominated by qi stagnation， blood stasis and yin deficiency. The cluster analysis of the 20 common factors showed that the main TCM patterns were internal stirring of liver wind syndrome， liver-kidney yin deficiency syndrome， turbid phlegm obstruction syndrome， and pathogen congested in the channels syndrome. Among the 198 patients， 81 were diagnosed with internal stirring of liver wind syndrome， 60 with liver-kidney yin deficiency syndrome， 37 with turbid phlegm obstruction syndrome， and 20 with pathogen congested in the channels syndrome.There was no statistically significant difference in the distribution of TCM patterns among patients of different genders， age groups， and duration of disease （P＞0.05）. ConclusionSpasmodic torticollis is mainly located in the liver， mostly with internal stirring of liver wind syndrome， liver-kidney yin deficiency syndrome， turbid phlegm obstruction syndrome， and pathogen congested in the channels syndrome.