Investigator initiated trial （IIT） represents a primary format for clinical research in traditional Chinese medicine （TCM）. As key implementation sites for TCM-based IIT targeting malignant tumors， western medicine institutions often face unique challenges in conducting such studies， which limit their feasibility and standardization. This paper reviews the registration status of TCM-based IIT for malignancies conducted in western medical institutions and analyzes key difficulties， including complex project initiation and management processes， limited TCM knowledge and skills among western medicine physicians， and relatively low patient acceptance of TCM. From a practical perspective， the study proposes several optimization strategies. These include improving the review and management mechanisms of TCM-related IIT within western medical institutions， establishing multidisciplinary clinical research teams that integrate TCM and western medicine， and enhancing investigators' training in TCM theory and clinical skills. Additionally， the study suggests standardizing IIT operational procedures， objectifying the collection of TCM diagnostic information， refining subject recruitment methods， and increasing TCM involvement in patient follow-up and management. These investigator-oriented， TCM-featured， and operable strategies aim to promote the high-quality development of TCM-based IIT in western medicine institutions and enhance the clinical application of TCM.

Objective To investigate the correlation of solute carrier protein 17 family member 1 (SLC17A1) gene single nucleotide polymorphisms (SNPs) and susceptibility to hyperuricemia (HUA) in automotive manufacturing workers. Methods A total of 192 Han male workers diagnosed with HUA were selected as the case group, 192 Han male workers without HUA from the same enterprises were selected as the control group. These workers were determined by the matching factor of age, total length of service, and body mass index by the 1∶1 case-control study method. Peripheral venous blood from the workers was collected for DNA extraction. Two SNPs of SLC17A1 were genotyped by MassArray system. Results The gene frequency distributions of SLC17A1 rs2096386 and rs1183201 of workers in the control group were in consistent with the Hardy-Weinberg equilibrium test (both P>0.05). The allele frequency distribution of rs2096386, and the genotype and allele frequency distribution of rs1183201 were significantly different between workers in the two groups (all P<0.05). There was no significant difference in genotype frequency distribution of rs2096386 between workers in the two groups (P>0.05). The results of conditional logistic regression analysis showed that workers with G allele at rs2096386 increased the risk of HUA [odds ratio (OR)=1.43, 95% confidence interval (CI)=1.01-2.04], workers with T allele at rs1183201 increased the risk of HUA (OR=2.03, 95%CI =1.29-3.19), after adjusting for confounding factors such as serum creatinine, blood urea nitrogen, alanin aminotransferase and aspartate aminotransferase. While workers with TA and TA+AA genotypes at rs1183201 had a lower risk of HUA than those with TT genotype (OR=0.51, 95%CI =0.30-0.85; OR=0.50, 95%CI =0.30-0.83), workers with TA genotype at rs1183201 had a lower risk of HUA than those with TT+AA genotype (OR=0.53, 95%CI =0.32-0.88). Conclusion The polymorphisms at rs2096386 and rs1183201 of SLC17A1 gene may be correlated with HUA susceptibility among automobile manufacturing workers in Guangzhou City.

OBJECTIVE To obtain stronger cytotoxic activity of panaxadiol derivatives. METHODS The 3-amino panaxadiol was prepared by the bioelectronic isosteric principle, and then 18 derivatives of cinnamic acid, NO donor and other types of panaxadiol derivatives were synthesized, among them, 12 compounds had not been reported in the literature, and their structures had been confirmed by 1H-NMR, 13C-NMR and mass spectrometry. These compounds were evaluated for their cytotoxic activity by MTS assay against human leukemia cell line HL-60, liver cancer cell line SMMC-7721, lung cancer cell line A-549, breast cancer cell line MCF-7, and colon cancer cell line SW480. RESULTS These results showed that compounds 6c, 7 as well as 7j exhibited potent inhibitory activities against all five tumor cells, especially the IC50 values of compound 7 against HL-60 and SMMC-7721cells were 3.41 and 4.51 μmol·L−1, respectively. It was significantly superior to panaxadiol in cytotoxicity. CONCLUSION These results show that 7 and 7j can be used as promising lead compounds for further research.

Apical periodontitis (AP) is an inflammatory disease that occurs in the periapical tissue. The treatments of AP mainly include root canal therapy and endodontic surgery which promote the repair of periapical bone tissue by infections clearing and controlling inside or outside the root canal. The evaluation on efficacies of root canal therapy and endodontic surgery is mainly based on clinical and periapical imaging examinations, and the prognosis relates to multiple factors. The systemic factors of patients can directly or indirectly affect the healing of apical periodontitis. The present review summarizes the influence factors, including age, smoking habits, systemic diseases and systemic medication on the prognosis of apical periodontitis treatment, in order to increase the attention of clinicians.

Pulmonary fibrosis is a respiratory system disorder characterized by damage to alveolar epithelial cells,pathological proliferation and transformation of fibroblasts,excessive deposition of extracellular matrix,leading to structural damage and loss of function in lung tissues,with a high mortality rate and limited effective treatment methods.This article was based on the TCM understanding of"lung connecting to large intestine",namely the theory of"lung and the large intestine being interior-exterior related",and set the modern medical understanding of"lung connecting to large intestine",namely the theory of"gut-lung axis"as the key.Combining the TCM pathogenesis of pulmonary fibrosis and the related mechanisms of"gut-lung axis"in pulmonary fibrosis,it preliminarily expounded the connotation of TCM regulating the"gut-lung axis"to treat pulmonary fibrosis,aiming to provide new ideas for clinical treatment of pulmonary fibrosis through the"gut-lung axis".

Objective To investigate the kinesiophobia level in patients after spinal fracture surgery and their correlations with rehabilitation self-efficacy and adherence. Methods A total of 150 patients who underwent spinal fracture surgery were enrolled in this study. General information was collected from all patients. The Tampa Scale for Kinesiophobia, Self-Efficacy for Rehabilitation Outcomes Scale, department-developed Rehabilitation Adherence Scale and postoperative activity pain [assessed using the Visual Analogue Scale (VAS)] were analyzed. Pearson correlation analysis was used to examine the relationships of kinesiophobia level with rehabilitation self-efficacy and adherence. Multiple linear regression analysis was conducted to identify factors influencing kinesiophobia level. Results The total score of postoperative kinesiophobia level in patients with spinal fracture was (57.14±3.12), which was at a high level. The total score of rehabilitation self-efficacy was (35.19±3.45), which was at a low level. The total score of rehabilitation compliance was (16.46±2.32), which was at a low level. Pearson correlation analysis showed that the total score of kinesiophobia level was negatively correlated with the total score of rehabilitation self-efficacy and rehabilitation compliance (P < 0.05). Univariate analysis revealed statistically significant differences in scores of kinesiophobia level among patients with different educational levels, postoperative activity pain and the presence or absence of postoperative complications (P < 0.05). Multiple linear regression analysis identified self-efficacy (B=-0.271, 95%CI, -0.439 to -0.103), adherence (B=-0.168, 95%CI, -0.331 to -0.004), educational level (B=0.190, 95%CI, 0.020 to 0.361), postoperative complications (B=0.403, 95%CI, 0.233 to 0.573) and postoperative activity pain (B=0.162, 95%CI, 0.003 to 0.320) were the influencing factors of postoperative kinesiophobia level in patients with spinal fracture. Conclusion The patients with spinal fracture have a higher level of kinesiophobia. The influencing factors of level of kinesiophobia are rehabilitation self-efficacy, rehabilitation compliance, education level, postoperative complications and postoperative activity pain.

Objective:To evaluate the effect of comprehensive intervention measures on Yunnan unexplained sudden death (YUSD) in Dali Prefecture, Yunnan Province, and to provide scientific basis for improving the prevention and control measures.Methods:Since 2010, Yunnan Province had implemented comprehensive intervention measures in ward areas according to the etiological pattern of YUSD. In July 2019, 47 families with YUSD were selected as case families and 23 families without YUSD were selected as control families in 31 natural villages of Heqing, Xiangyun, Yunlong, Eryuan, Jianchuan, Binchuan and Nanjian counties of Dali Prefecture. A unified questionnaire was used to investigate the basic information, economic status, dietary structure, and health literacy of the families during the two periods of "the first sudden death case" and "the present".Results:The annual household income of the case families at present (median, 20 492.6 yuan) was significantly higher than that of the first sudden death case (3 883.4 yuan), and the difference was statistically significant ( Z = - 5.27, P < 0.001). At present, rice (76.6%, 36/47) was the main diet of the case families; at the time of the first sudden death case, 23.4% (11/47) of the case families could not eat enough, and there was no such situation in the case families at present. Compared with the time of the first sudden death case, the dietary habits of the case families at present were as follows: the proportion of eating Trogia venenata decreased from 19.0% (39/205) to 0 (0/190), the proportion of eating wild fruit decreased from 17.1% (35/205) to 9.5% (18/190), and the proportion of drinking raw water decreased from 55.1% (113/205) to 42.1% (80/190), and the differences were statistically significant (χ 2 = 22.37, 4.90, 6.86, P < 0.05). Lifestyle and health awareness: the proportion of those who washed their hands before meals and after using the toilet increased from 9.8% (20/205) to 41.6% (79/190), those who did not overwork increased from 16.6% (34/205) to 34.2% (65/190), and those who took good protection when spraying pesticides increased from 7.3% (15/205) to 21.6% (41/190), and the differences were statistically significant (χ 2 = 53.17, 33.94, 16.48, P < 0.001). Toilet habits: the proportion of using outdoor toilet decreased from 75.6% (155/205) to 9.5% (18/190), the difference was statistically significant (χ 2 = 175.21, P < 0.001). When the first sudden death case occurred, the proportions of eating Trogia venenata and using outdoor toilet in the case families were higher than those in the control families (χ 2 = 22.37, 23.70, P < 0.001), the proportions of those who washed their hands before meals and after using the toilet and those who did not overwork in the case families were lower than those in the control families (χ 2 = 7.38, 4.93, P < 0.05). Conclusions:The economic conditions, production and living conditions of YUSD areas in Dali Prefecture have been significantly improved, and the health literacy and health prevention awareness of the population have been greatly improved. Economic conditions and living standard, dietary structure and health literacy may be related factors of YUSD.

【Objective】 To conduct a retrospective statistical analysis of the blood discarding situation in Xuzhou Central Blood Station in the past 5 years, so as to explore relevant measures and strategies to reduce blood discarding and save blood resources. 【Methods】 The discarding situation of our station from 2018 to 2022 was systematically sorted out, and Big data analysis base on the two causes, which was unqualified testing and non unqualified testing, was conducted. 【Results】 The total blood discarding rate of our station from 2018 to 2022 was 9.57% (94 273/985 178), and there was a difference in the total discarding rate between different years (P<0.05). Non qualified testing was the main reason for blood discarding, with lipemic blood accounting for the highest proportion[7.27% (71 661/985 178)]. Blood discarding due to unqualified testing: ALT(0.49%, 4 795/985 178)>anti-TP(0.23%, 2 263/985 178)>anti-HCV(0.14%, 1 354/985 178)> HBsAg(0.13%, 1 285/985 178)>anti-HIV (0.12%, 1 140/985 178). The unqualified rate of ALT in males (0.63%, 1 993/317 437) was significantly higher than that in females (0.19%, 388/209 601) (P<0.05). The unqualified rate of ALT at the age of 18-25 accounted for 55% (0.49/0.89) of the total unqualified rate of ALT, and was significantly higher than other age groups (P <0.05). 【Conclusion】 It is suggested to improve the public awareness of voluntary blood donation, strengthen health consultation before blood donation, promote staff training so as to reduce blood discarding rate, as well as ensure sufficient, safe and effective clinical blood use.

Humans ; Nitric Oxide ; Carcinoma, Non-Small-Cell Lung/drug therapy* ; Lung Neoplasms ; Lung ; Nitric Oxide Synthase ; Macrophages, Alveolar ; Pulmonary Alveoli

ObjectiveTo compare the incidence of respiratory and allergic diseases in children in Xuhui District， Shanghai in 2013 and 2020， and to determine the influencing factors. MethodsAnnual average levels of air pollutants including PM_2.5， PM₁₀， O₃， SO₂， and NO₂ were collected and described in Shanghai from 2013 to 2020. A cross-sectional survey was conducted by using a questionnaire among grade 3 to 5 students in a school in Xuhui District， Shanghai， in September 2013 and 2020， respectively. The questionnaire collected variables including living environment， daily habits， family history of respiratory and allergic diseases， and incidence of these diseases in children. Chi-square test was used to determine the difference across respiratory and allergic diseases. Logistic regression was conducted to determine the influencing factors. ResultsA total of 1 398 valid questionnaires were collected （705 in 2013 and 693 in 2020）. Compared with 2013， annual average concentrations of PM_2.5， PM₁₀， O₃， SO₂， and NO₂ in 2020 significantly decreased. The prevalence of bronchial asthma， bronchitis， persistent cough and persistent expectoration in 2013 were significantly higher than those in 2020 （P<0.05） in Xuhui District. Multivariate analysis showed that severe air pollution， boys， parents with asthma or allergy， parents with higher educational levels， and more allergens in household were the risk factors associated with the incidence of bronchial asthma， bronchitis， allergic rhinitis and atopic eczema （P<0.05）. Parents with allergy history， high smoking frequency of family member， and more allergens in household were the risk factors associated with the incidence of persistent cough and persistent expectoration （P<0.05）. ConclusionTo 2013，2020 air pollution in Shanghai has been mitigated and prevalence of bronchial asthma and bronchitis of children has decreased. Childhood respiratory and allergic diseases are associated with indoor and outdoor environment， family medical history， and family daily habits.