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1.
Chinese Journal of Oncology ; (12): 402-409, 2023.
Artigo em Chinês | WPRIM | ID: wpr-984736

RESUMO

Objective: To study the diagnostic value of different detection markers in histological categories of endocervical adenocarcinoma (ECA), and their assessment of patient prognosis. Methods: A retrospective study of 54 patients with ECA in the Cancer Hospital, Chinese Academy of Medical Sciences from 2005-2010 were performed. The cases of ECA were classified into two categories, namely human papillomavirus-associated adenocarcinoma (HPVA) and non-human papillomavirus-associated adenocarcinoma (NHPVA), based on the 2018 international endocervical adenocarcinoma criteria and classification (IECC). To detect HR-HPV DNA and HR-HPV E6/E7 mRNA in all patients, we used whole tissue section PCR (WTS-PCR) and HPV E6/E7 mRNA in situ hybridization (ISH) techniques, respectively. Additionally, we performed Laser microdissection PCR (LCM-PCR) on 15 randomly selected HR-HPV DNA-positive cases to confirm the accuracy of the above two assays in identifying ECA lesions. Receiver operating characteristic (ROC) curves were used to analyze the efficacy of markers to identify HPVA and NHPVA. Univariate and multifactorial Cox proportional risk model regression analyses were performed for factors influencing ECA patients' prognoses. Results: Of the 54 patients with ECA, 30 were HPVA and 24 were NHPVA. A total of 96.7% (29/30) of HPVA patients were positive for HR-HPV DNA and 63.3% (19/30) for HR-HPV E6/E7 mRNA, and 33.3% (8/24) of NHPVA patients were positive for HR-HPV DNA and HR-HPV E6/E7 mRNA was not detected (0/24), and the differences were statistically significant (P<0.001). LCM-PCR showed that five patients were positive for HR-HPV DNA in the area of glandular epithelial lesions and others were negative, which was in good agreement with the E6/E7 mRNA ISH assay (Kappa=0.842, P=0.001). Analysis of the ROC results showed that the AUC of HR-HPV DNA, HR-HPV E6/E7 mRNA, and p16 to identify HPVA and NHPVA were 0.817, 0.817, and 0.692, respectively, with sensitivities of 96.7%, 63.3%, and 80.0% and specificities of 66.7%, 100.0%, and 58.3%, respectively. HR-HPV DNA identified HPVA and NHPVA with higher AUC than p16 (P=0.044). The difference in survival rates between HR-HPV DNA (WTS-PCR assay) positive and negative patients was not statistically significant (P=0.156), while the difference in survival rates between HR-HPV E6/E7 mRNA positive and negative patients, and p16 positive and negative patients were statistically significant (both P<0.05). Multifactorial Cox regression analysis showed that International Federation of Obstetrics and Gynecology (FIGO) staging (HR=19.875, 95% CI: 1.526-258.833) and parametrial involvement (HR=14.032, 95% CI: 1.281-153.761) were independent factors influencing the prognosis of patients with ECA. Conclusions: HR-HPV E6/E7 mRNA is more reflective of HPV infection in ECA tissue. The efficacy of HR-HPV E6/E7 mRNA and HR-HPV DNA (WTS-PCR assay) in identifying HPVA and NHPVA is similar, with higher sensitivity of HR-HPV DNA and higher specificity of HR-HPV E6/E7 mRNA. HR-HPV DNA is more effective than p16 in identifying HPVA and NHPVA. HPV E6/E7 mRNA and p16 positive ECA patients have better survival rates than negative.


Assuntos
Feminino , Humanos , Infecções por Papillomavirus/diagnóstico , Estudos Retrospectivos , Neoplasias do Colo do Útero/patologia , Prognóstico , Proteínas Oncogênicas Virais/genética , Papillomaviridae , Adenocarcinoma/patologia , RNA Mensageiro/genética , Papillomaviridae/genética , RNA Viral/genética
2.
Chinese Journal of Gastrointestinal Surgery ; (12): 448-458, 2023.
Artigo em Chinês | WPRIM | ID: wpr-986813

RESUMO

Objective: Total neoadjuvant therapy has been used to improve tumor responses and prevent distant metastases in patients with locally advanced rectal cancer (LARC). Patients with complete clinical responses (cCR) then have the option of choosing a watch and wait (W&W) strategy and organ preservation. It has recently been shown that hypofractionated radiotherapy has better synergistic effects with PD-1/PD-L1 inhibitors than does conventionally fractionated radiotherapy, increasing the sensitivity of microsatellite stable (MSS) colorectal cancer to immunotherapy. Thus, in this trial we aimed to determine whether total neoadjuvant therapy comprising short-course radiotherapy (SCRT) combined with a PD-1 inhibitor improves the degree of tumor regression in patients with LARC. Methods: TORCH is a prospective, multicenter, randomized, phase II trial (TORCH Registration No. NCT04518280). Patients with LARC (T3-4/N+M0, distance from anus ≤10 cm) are eligible and are randomly assigned to consolidation or induction arms. Those in the consolidation arm receive SCRT (25Gy/5 Fx), followed by six cycles of toripalimab plus capecitabine and oxaliplatin (ToriCAPOX). Those in the induction arm receive two cycles of ToriCAPOX, then undergo SCRT, followed by four cycles of ToriCAPOX. Patients in both groups undergo total mesorectal excision (TME) or can choose a W&W strategy if cCR has been achieved. The primary endpoint is the complete response rate (CR, pathological complete response [pCR] plus continuous cCR for more than 1 year). The secondary endpoints include rates of Grade 3-4 acute adverse effects (AEs) etc. Results: Up to 30 September 2022, 62 patients attending our center were enrolled (Consolidation arm: 34, Induction arm:28). Their median age was 53 (27-69) years. Fifty-nine of them had MSS/pMMR type cancer (95.2%), and only three MSI-H/dMMR. Additionally, 55 patients (88.7%) had Stage III disease. The following important characteristics were distributed as follows: lower location (≤5 cm from anus, 48/62, 77.4%), deeper invasion by primary lesion (cT4 7/62, 11.3%; mesorectal fascia involved 17/62, 27.4%), and high risk of distant metastasis (cN2 26/62, 41.9%; EMVI+ 11/62, 17.7%). All 62 patients completed the SCRT and at least five cycles of ToriCAPOX, 52/62 (83.9%) completing six cycles of ToriCAPOX. Finally, 29 patients achieved cCR (46.8%, 29/62), 18 of whom decided to adopt a W&W strategy. TME was performed on 32 patients. Pathological examination showed 18 had achieved pCR, four TRG 1, and 10 TRG 2-3. The three patients with MSI-H disease all achieved cCR. One of these patients was found to have pCR after surgery whereas the other two adopted a W&W strategy. Thus, the pCR and CR rates were 56.2% (18/32) and 58.1% (36/62), respectively. The TRG 0-1 rate was 68.8% (22/32). The most common non-hematologic AEs were poor appetite (49/60, 81.7%), numbness (49/60, 81.7%), nausea (47/60, 78.3%) and asthenia (43/60, 71.7%); two patients did not complete this survey. The most common hematologic AEs were thrombocytopenia (48/62, 77.4%), anemia (47/62, 75.8%), leukopenia/neutropenia (44/62, 71.0%) and high transaminase (39/62, 62.9%). The main Grade III-IV AE was thrombocytopenia (22/62, 35.5%), with three patients (3/62, 4.8%) having Grade IV thrombocytopenia. No Grade V AEs were noted. Conclusions: SCRT-based total neoadjuvant therapy combined with toripalimab can achieve a surprisingly good CR rate in patients with LARC and thus has the potential to offer new treatment options for organ preservation in patients with MSS and lower-location rectal cancer. Meanwhile, the preliminary findings of a single center show good tolerability, the main Grade III-IV AE being thrombocytopenia. The significant efficacy and long-term prognostic benefit need to be determined by further follow-up.


Assuntos
Humanos , Pessoa de Meia-Idade , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimiorradioterapia , Inibidores de Checkpoint Imunológico/uso terapêutico , Terapia Neoadjuvante , Estudos Prospectivos , Neoplasias Retais/patologia , Trombocitopenia/tratamento farmacológico , Resultado do Tratamento
3.
Asian Journal of Andrology ; (6): 271-276, 2023.
Artigo em Inglês | WPRIM | ID: wpr-971005

RESUMO

Literature regarding the impacts of heavy metal exposure on erectile dysfunction (ED) is scarce. We aimed to evaluate the correlation between 10 urinary metals and ED in a large, nationally representative adult male sample. The dataset was extracted from the National Health and Nutrition Examination Survey (NHANES) during the period of 2001-2002 and 2003-2004. Weighted proportions and multivariable logistic regression analysis adjusted for confounding variables were utilized to determine the relationship between metal exposure and ED. Weighted quantile sum (WQS) regression was utilized to evaluate the impact of a mixture of urinary metals on ED. A total of 1328 participants were included in our study. In multivariable logistic regression analysis, cobalt (Co) and antimony (Sb) were positively associated with ED (odds ratio [OR]: 1.36, 95% confidence interval [CI]: 1.10-1.73, P = 0.020; and OR: 1.41, 95% CI: 1.12-1.77, P = 0.018, respectively) after full adjustment. Men in tertile 4 for Co (OR: 1.49, 95% CI: 1.02-2.41, P for trend = 0.012) and Sb (OR: 1.53, 95% CI: 1.08-2.40, P for trend = 0.041) had significantly higher odds of ED than those in tertile 1. Furthermore, the WQS index was significantly linked with increased odds of ED after full adjustment (OR: 1.31, 95% CI: 1.04-1.72, P < 0.05). Our study expanded on previous literature indicating the possible role of heavy metal exposure in the etiology of ED. The evaluation of heavy metal exposure should be included in the risk assessment of ED.


Assuntos
Adulto , Humanos , Masculino , Estados Unidos , Disfunção Erétil/etiologia , Inquéritos Nutricionais , Metais Pesados , Medição de Risco
4.
Asian Journal of Andrology ; (6): 421-425, 2023.
Artigo em Inglês | WPRIM | ID: wpr-981940

RESUMO

Sleep has attracted extensive attention due to its significance in health. However, its association with erectile dysfunction (ED) is insufficiently investigated. To investigate the potential causal links between sleep traits (insomnia, sleep duration, and chronotype) and ED, this study was performed. The single-nucleotide polymorphisms (SNPs) associated with insomnia, sleep duration, and chronotype were retrieved from previous genome-wide association studies (GWAS). A conventional two-sample Mendelian randomization (MR) was used to estimate the causal links between sleep traits and ED. The summary statistics of ED were from individuals of European ancestry (6175 cases vs 217 630 controls). As shown by the random effect inverse-variance-weighting (IVW) estimator, genetically predicted insomnia was causally associated with a 1.15-fold risk of ED (95% confidence interval: 1.07-1.23, P < 0.001). Sleep duration and morningness were not causally associated with ED, as indicated by the IVW (all P > 0.05). These findings were consistent with the results of sensitivity analyses. Based on genetic data, this study provides causal evidence that genetically predicted insomnia increases the risk of ED, whereas sleep duration and chronotype do not.


Assuntos
Masculino , Humanos , Distúrbios do Início e da Manutenção do Sono/genética , Estudo de Associação Genômica Ampla , Disfunção Erétil/genética , Sono/genética , Fenótipo , Polimorfismo de Nucleotídeo Único
5.
Chinese Journal of Ultrasonography ; (12): 927-932, 2022.
Artigo em Chinês | WPRIM | ID: wpr-992777

RESUMO

Objective:To explore the feasibility and clinical value of artificial intelligence-assisted breast ultrasound in screening breast cancer in Tibet.Methods:Two hundred and eighty-six women who participated in breast cancer screening in Shigatse People′s Hospital from August to September in 2021 were selected. The study included four groups. Group 1, ultrasound screening by senior breast ultrasound doctors from Shanghai; Group 2: local ultrasound doctors used intelligent-assisted ultrasound equipment for screening; Group 3: local ultrasound technicians used intelligent-assisted ultrasound equipment for screening; Group 4: ultrasound screening by local ultrasound doctors. The pathological results of screening positive cases and six-month ultrasound follow-up results of negative cases were set as the gold standard.Results:Twenty-seven lesions of 21 persons were screened positive. Pathology showed that 1 case of invasive ductal carcinoma, 1 case of severe atypical hyperplasia, 6 cases of fibroadenoma, 5 cases of breast disease, 14 cases of breast hyperplasia. Two hundred and sixty-five persons were screened negative, and the results of the six-month ultrasound follow-up were still negative. The accuracy, sensitivity, and specificity of group 2 were 0.966, 1, and 0.964 respectively; The accuracy, sensitivity, and specificity of group 3 were 0.935, 0.769, and 0.943 respectively; The accuracy, sensitivity, and specificity of group 4 were 0.860, 0.308 and 0.885 respectively. The accuracy and area under the curve of groups 2 and 3 were significantly different from that of group 4 (all P<0.001), and there was no significant difference from that of group 1 ( P=0.063, P=0.055). Conclusions:Artificial intelligence-assisted breast ultrasound screening technology can effectively improve the screening efficiency of non-breast ultrasound specialists and technicians. It is very suitable to solve the problems faced by grass-roots screening in Tibet and has great social significance and clinical value.

6.
Chinese Journal of Preventive Medicine ; (12): 165-170, 2022.
Artigo em Chinês | WPRIM | ID: wpr-935266

RESUMO

Objective: To evaluate the performance of point-of-care testing for cervical cancer and precancerous lesions screening. Methods: In September 2020, 197 and 273 women were selected by using simple random sampling method from "self-sampling" cohort and "physician-sampling" cohort established in Xiangyuan county, Shanxi Province, China, respectively. Cervical exfoliated cells were collected by women themselves or gynecologists. All samples were detected by POCT and women with positive result were directly referred for colposcopy. Subsequently, all the samples were detected by careHPV and PCR test. Colposcopy and punch biopsy were performed for women with POCT negative but careHPV or PCR test positive at another visit. Using histopathological diagnosis as the gold standard, we calculated sensitivity, specificity and drew the receiver operating characteristic (ROC) curves. The accuracy of POCT was analyzed and compared to that of careHPV and conventional PCR test in cervical cancer and precancerous lesions screening. Results: The median (Q1 , Q3) age of 470 women was 51 (45, 57) years old. Based on self-sampling, the sensitivity and specificity of POCT for CIN2+ were 100.00% (95%CI: 56.56%-100.00%) and 28.95% (95%CI: 22.97%-35.76%), respectively. Compared with POCT, POCT HPV16/18 test had similar sensitivity and higher specificity of 89.47% (95%CI: 84.30%-93.08%). Self-sampling POCT HPV16/18 test had an AUC of 0.947 (95%CI:0.910-0.985), which was higher than that of careHPV and PCR test. Physician-sampling POCT test had 100.00% sensitivity (95%CI: 64.57%-100.00%) and 55.85% specificity (95%CI: 49.83%-61.70%) for detecting CIN2+. POCT HPV16/18 test had lower sensitivity (71.43%, 95%CI: 35.90%-91.76%) and higher specificity (92.45%, 95%CI: 88.63%-95.06%). POCT HPV16/18 test generally showed similar AUC on both self-collected samples and clinician-collected samples (0.947 vs 0.819, P=0.217). Conclusion: POCT HPV16/18 test is an effective method with relatively high sensitivity and specificity for cervical cancer screening.


Assuntos
Feminino , Humanos , Gravidez , Displasia do Colo do Útero/diagnóstico , Colposcopia , Detecção Precoce de Câncer/métodos , Papillomavirus Humano 16/genética , Papillomavirus Humano 18 , Programas de Rastreamento/métodos , Papillomaviridae , Infecções por Papillomavirus/diagnóstico , Testes Imediatos , Sensibilidade e Especificidade , Neoplasias do Colo do Útero
7.
Chinese Journal of Thoracic and Cardiovascular Surgery ; (12): 96-101, 2022.
Artigo em Chinês | WPRIM | ID: wpr-934222

RESUMO

Objective:To study the effectiveness and safety of programmed cell death receptor 1(PD-1) monoclonal antibody combined with chemotherapy in the preoperative neoadjuvant treatment of stage ⅢA non-small cell lung cancer(NSCLC).Methods:A total of 65 patients with stage ⅢA NSCLC who underwent preoperative neoadjuvant treatment in our hospital from January 2019 to October 2020 were selected. According to the preoperative neoadjuvant treatment plan, they were divided into control group(31 cases) and observation group(34 cases). Patients in the control group were treated with albumin-bound paclitaxel and cisplatin for injection, and the patients in the observation group were treated with immunotherapy(carrelizumab/sintilizumab) on the basis of the control group, all underwent 2 cycles of preoperative neoadjuvant treatment. Compared the clinical efficacy of imaging, T lymphocyte subsets, drug side effects, surgical resection rate, major pathological remission(MPR), complete pathological remission(pCR) and postoperative complications of the two groups of patients, and analyzed the factors those affected MPR.Results:The clinical efficacy of PR and ORR of imaging in the observation group was better than that of the control group( P<0.05). The positive rate of CD3 + cells, the positive rate of CD4 + cells, the positive rate of CD8 + cells and the ratio of CD4 + /CD8 + cells in the observation group after treatment were higher than those in the control group( P<0.05). The drug toxicity of the observation group was higher than that of the control group in RCCEP/rash, abnormal thyroid function, and abnormal myocardial enzymes( P<0.05). Compared among the observation group(carrelizumab group/sintilizumab group), the toxicity of carrelizumab group was higher than that of sintilizumab group in RCCEP/skin rash, bone marrow suppression and abnormal myocardial enzymes( P<0.05). The MPR and pCR of the observation group were higher than those of the control group( P<0.05). There was no significant difference in surgical resection rate, surgical methods and postoperative complications between the two groups( P>0.05). The results of univariate analysis showed that ECOG score, pathological type, neoadjuvant treatment plan were related to MPR( P<0.05). The results of binary logistic regression analysis showed that ECOG score and neoadjuvant treatment plan were independent risk factors affecting MPR( P<0.05). Conclusion:PD-1 monoclonal antibody combined with chemotherapy can enable patients to obtain better MPR and pCR, and can improve the immune function of patients. But the side effects caused by immunotherapy drugs are worthy of attention, and the side effects are different between different immune drugs.

8.
Acta Physiologica Sinica ; (6): 135-144, 2022.
Artigo em Chinês | WPRIM | ID: wpr-927589

RESUMO

Vestibular compensation is an important model for developing the prevention and intervention strategies of vestibular disorders, and investigating the plasticity of the adult central nervous system induced by peripheral injury. Medial vestibular nucleus (MVN) in brainstem is critical center for vestibular compensation. Its neuronal excitability and sensitivity have been implicated in normal function of vestibular system. Previous studies mainly focused on the changes in neuronal excitability of the MVN in lesional side of the rat model of vestibular compensation following the unilateral labyrinthectomy (UL). However, the plasticity of sensitivity of bilateral MVN neurons dynamically responding to input stimuli is still largely unknown. In the present study, by using qPCR, whole-cell patch clamp recording in acute brain slices and behavioral techniques, we observed that 6 h after UL, rats showed a significant deficit in spontaneous locomotion, and a decrease in excitability of type B neurons in the ipsilesional rather than contralesional MVN. By contrast, type B neurons in the contralesional rather than ipsilesional MVN exhibited an increase in response sensitivity to the ramp and step input current stimuli. One week after UL, both the neuronal excitability of the ipsilesional MVN and the neuronal sensitivity of the contralesional MVN recovered to the baseline, accompanied by a compensation of spontaneous locomotion. In addition, the data showed that the small conductance Ca2+-activated K+ (SK) channel involved in the regulation of type B MVN neuronal sensitivity, showed a selective decrease in expression in the contralesional MVN 6 h after UL, and returned to normal level 1 week later. Pharmacological blockage of SK channel in contralateral MVN to inhibit the UL-induced functional plasticity of SK channel significantly delayed the compensation of vestibular motor dysfunction. These results suggest that the changes in plasticity of the ipsilesional MVN neuronal excitability, together with changes in the contralesional MVN neuronal sensitivity, may both contribute to the development of vestibular symptoms as well as vestibular compensation, and SK channel may be an essential ionic mechanism responsible for the dynamic changes of MVN neuronal sensitivity during vestibular compensation.


Assuntos
Animais , Ratos , Locomoção , Neurônios/fisiologia , Técnicas de Patch-Clamp , Núcleos Vestibulares/metabolismo , Vestíbulo do Labirinto
9.
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery ; (12): 417-423, 2022.
Artigo em Inglês | WPRIM | ID: wpr-923434

RESUMO

@#Objective    To evaluate the effect of perioperative nebulization of ipratropium bromide on preoperative pulmonary function and incidence of postoperative pulmonary complications as well as safety in chronic obstructive pulmonary disease (COPD) patients who underwent lung resection in thoracic surgery. Methods    During November 18, 2013 to August 12, 2015, 192 COPD patients with a necessity of selective surgical procedures of lobectomy or right bilobectomy or segmentectomy under general anaesthesia in 10 centers were 1 : 1 randomized to an ipratropium bromide group (96 patients) and a placebo group (96 patients), to compare the effect on preoperative pulmonary function and incidence of postoperative pulmonary complications. The average age of treated patients was 62.90±6.50 years, with 168 male patients and 22 female patients. Results     The demographic and baseline characteristics were well-balanced between the two groups. The adjusted mean increase of forced expiratory volume in one second (FEV1) in the ipratropium bromide group was significantly higher than that in the placebo group (169.90±29.07 mL vs. 15.00±29.35 mL, P<0.05). The perioperative use of ipratropium bromide significantly decreased incidence of postoperative pneumonia (2.6% vs. 14.1%, P<0.05). There was no ipratropium bromide related adverse event (AE) observed in this trial. Conclusion    This trial indicates that perioperative nebulization of ipratropium bromide significantly improves preoperative lung function and reduces postoperative pneumonia in COPD patients undergoing lung resection in thoracic surgery, and has good safety profile.

10.
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery ; (12): 615-622, 2021.
Artigo em Chinês | WPRIM | ID: wpr-881232

RESUMO

@#Objective    To compare the 5-year survival rates between two different follow-up patterns of postoperative stage Ⅰ-ⅢA non-small cell lung cancer (NSCLC) patients. Methods    Pathological stage Ⅰ-ⅢA NSCLC 11 958 patients who underwent surgical resection and received follow-up within 6 months after initial diagnosis through telephone follow-up system were included in nine hospitals from July 2014 to July 2020. The patients were divided into two groups including a proactive follow-up group (n=3 825) and a passive follow-up group (n=8 133) according to the way of following-up. There were 6 939 males and 5 019 females aged 59.8±9.5 years. The Kaplan-Meier and Cox proportional hazards regression model were used. Results    The median follow-up frequency was 8.0 times in the proactive follow-up group and 7.0 times in the passive follow-up group. The median call duration was 3.77 minutes in the proactive follow-up group and 3.58 minutes in the passive follow-up group. The 5-year survival rate was 81.8% and 74.2% (HR=0.60, 95CI 0.53-0.67, P<0.001) in the proactive follow-up group and the passive follow-up group, respectively. Multivariate analysis showed that follow-up pattern, age, gender and operation mode were independent prognostic factors, and the results were consistent in all subgroups stratified by clinical stages. Conclusion    The proactive follow-up leads to better overall survival for resected stage Ⅰ-ⅢA NSCLC patients, especially in the stage ⅢA.

11.
China Journal of Chinese Materia Medica ; (24): 1696-1700, 2021.
Artigo em Chinês | WPRIM | ID: wpr-879081

RESUMO

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.


Assuntos
Humanos , Pesquisa Biomédica , Ensaios Clínicos como Assunto , Consenso , Medicamentos de Ervas Chinesas , Revisão Ética , Medicina Tradicional Chinesa , Estudos Multicêntricos como Assunto , Preparações Farmacêuticas
12.
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery ; (12): 963-971, 2021.
Artigo em Chinês | WPRIM | ID: wpr-886543

RESUMO

@#Objective    To evaluate the efficacy and safety of programmed cell death receptor 1 (PD-1) inhibitor combined with chemotherapy in the preoperative neoadjuvant treatment of stage Ⅲ non-small cell lung cancer (NSCLC). Methods    The clinical data of 68 patients with stage Ⅲ NSCLC who underwent preoperative neoadjuvant treatment in our hospital from June 2019 to October 2020 were analyzed and divided into two groups according to a random number table. There were 34 patients in the control group including 19 males and 15 females with an average age of 59.41±4.77 years. In the observation group, there were 34 patients including 21 males and 13 females with an average age of 61.15±6.24 years. The patients in the control group were treated with albumin-bound paclitaxel and cisplatin for injection, and the patients in the observation group were treated with carrelizumab on the basis of the control group, and both groups received 2 cycles of preoperative neoadjuvant therapy. We compared the clinical efficacy of imaging, T lymphocyte subsets, drug side effects, surgical resection rate, major pathological remission (MPR), complete pathological remission (pCR) and postoperative complications of the two groups of patients, and analyzed the influencing factors for MPR. Results    The objective response rate (ORR) of imaging in the observation group (70.6%) was higher than that in the control group (38.2%, P<0.05). The positive rate of CD3+ cells, the positive rate of CD4+ cells, the positive rate of CD8+ cells and the ratio of CD4+/CD8+ cells in the observation group after treatment were higher than those in the control group (P<0.05). The drug toxicity of the observation group was higher than that of the control group in the reactive cutaneouscapillary endothelial proliferation (RCCEP)/rash, abnormal thyroid function, and abnormal myocardial enzymes (P<0.05). The MPR (66.7%) and pCR (51.9%) of the surgical observation group were higher than those of the surgical control group (MPR: 19.2%, pCR: 7.7%, P<0.05). There was no statistical difference in surgical resection rate and postoperative complications between the two groups (P>0.05). Univariate analysis showed that ECOG score, pathological type, neoadjuvant treatment plan and surgical resection were related to MPR (P<0.05). The results of binary logistic regression analysis showed that Eastern Cooperative Oncology Group (ECOG) score and neoadjuvant treatment plan were independent risk factors for MPR (P<0.05). Conclusion    The clinical efficacy of PD-1 inhibitor combined with chemotherapy in the preoperative neoadjuvant treatment of stage Ⅲ NSCLC patients is definite, and it can significantly improve the patients' MPR, pCR and cellular immune function, but the side effects caused by immunotherapy drugs need to be concerned.

13.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 196-204, 2021.
Artigo em Chinês | WPRIM | ID: wpr-905850

RESUMO

Succus Bambusae, regarded as the holy medicine for the treatment of phlegm by traditional Chinese medicine experts, has the functions of clearing heat and resolving phlegm, resuscitating and relieving convulsions. In clinical practice, it is mainly used to treat phlegm-heat cough, phlegm yellow and shortness of breath, stroke with exuberant phlegm and other syndromes. The research of its processing procedure and quality standard is the key issue to realize the process modernization and quality standardization of this traditional medicine resource. On the basis of literature research, this paper conducted the herbal textual research on Succus Bambusae, sorted out its medicinal history, and compared the advantages and disadvantages of its traditional and modern preparation procedure. Based on the historical records, it is pointed out that there are still many problems in the traditional and modern processing procedure of Succus Bambusae, such as low-yield processing procedure and extensive production technology that cannot meet the requirements of large-scale green manufacturing. At present, there are a lot of literature on the comparative study of the origin, variety and processing procedure of Succus Bambusae, but most of them are limited to the chemical components, and lack of in-depth study on its pharmacodynamic substance basis and mechanism. Meanwhile, the pharmacological effects of Succus Bambusae are mostly limited to antitussive and expectorant, and few other pharmacological effects have been reported. Based on the above analysis, it is suggested that the follow-up research work can be carried out from these five aspects:①Clarifying the original source, enriching and perfecting the medicinal resources. ②Standardizing the processing procedure, establishing relevant quality standards. ③Clarifying the pharmacological mechanism, strengthening the basic research on the pharmacological effect and clinical application. ④Inheriting ancient processing, researching and developing special preparation equipment and standardizing production operation rules. ⑤Comprehensive utilization of the by-products in preparation process.

14.
Chinese Journal of Hospital Administration ; (12): 662-665, 2021.
Artigo em Chinês | WPRIM | ID: wpr-912822

RESUMO

Objective:To investigate the construction and operation of research wards in tertiary medical institutions in Guangzhou, and to put forward suggestions for promoting the construction of research wards.Methods:From May to June 2020, an online questionnaire was distributed to tertiary medical institutions in Guangzhou to investigate the construction of research wards, and the questionnaires were collected for statistical analysis.Results:A total of 58 medical institutions completed the questionnaire survey, and 33 of them obtained GCP qualification. Eighteen medical institutions had established research ward, of which 16 were in operation, with 6-226 beds. The research wards of 14 medical institutions were used for phase I clinical trials of innovative drugs and consistency evaluation of generic drugs; 17 medical institutions were equipped with full-time research teams; 17 medical institutions had two or more basic research platforms.Conclusions:The number of medical institutions that have established research wards in Guangzhou is small, the functional positioning is limited, and the allocation of full-time researchers is insufficient. The supporting and auxiliary conditions need to be strengthened. Promoting research wards still faces some challenges.

15.
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery ; (12): 922-925, 2020.
Artigo em Chinês | WPRIM | ID: wpr-824994

RESUMO

@#Objective    To explore the early outcomes of the surgical treatment for patent ductus arteriosus (PDA) combined with intracardiac abnormities via right vertical infra-axillary thoracotomy (RVIAT). Methods    A total of 7 children with PDA combined with intracardiac defects underwent surgery through RVIAT at the Second Affiliated Hospital of Nanjing Medical University from 2016 to 2018. There were 4 males and 3 females, with an average age of 5.3±4.5 years and weight of 18.0±11.2 kg. Results    In all patients, PDA was ligated before the repair of intracardiac abnormities. No patient died in hospital. All patients were followed up, with a mean follow-up time of 18.0±8.0 months. No other complications such as residual shunts, arrhythmias, hemorrhaging or wound infection occurred after operations or during the follow-up period. Conclusion    RVIAT is an emerging technique used for the surgical repair of PDA combined with intracardiac defects. It yields satisfying cosmetic results, without increasing postoperative complications or mortality.

16.
Journal of Pharmaceutical Practice ; (6): 354-358, 2020.
Artigo em Chinês | WPRIM | ID: wpr-823104

RESUMO

Objective To optimize the process of ultrasonic extraction of polysaccharide in Anoectochilus roxburghii and to investigate the method of protein removal. Methods The extraction rate of polysaccharide was used as the detection index. On the basis of single factor investigation, Box-Behnken experimental design and response surface method were used to optimize the three factors of material-liquid ratio, ultrasonic time and ultrasonic extraction temperature. The five deproteinization methods including Sevage reagent method, TCA method, salt method (NaOH-CaCl2 and NaOH-NaCl) and hydrochloric acid method were investigated with the retention rate of polysaccharide and protein removal rate. Results The optimal extraction conditions of polysaccharide from Anoectochilus roxburghii were as follows: liquid-to-solid ratio was 10∶1, extraction temperature was 48 ℃ and extraction time was 36 min with extraction 2 times, ultrasonic power was 300 W, the extraction rate was 13.13%. NaOH-CaCl2 deproteinized methods∶ the loss rate of polysaccharide was 18.74%, and the removal rate of protein was 95.62%. Conclusion Ultrasonic extraction is easy to operate, and the optimized extraction method can achieve a high extraction rate. NaOH-CaCl2 deproteinization methods can get high protein removal rate and polysaccharide retention rate. This method is suitable for the research and development of the active components of the polysaccharides from Anoectochilus roxburghii.

17.
Journal of Forensic Medicine ; (6): 445-452, 2020.
Artigo em Inglês | WPRIM | ID: wpr-985133

RESUMO

Objective To establish a rapid diagnosis method for the biological toxicity of soil, accurately and rapidly evaluate the toxicity of contaminated sites and identify the dominant pollutants. Methods Take the soil pollution of a galvanized factory as an example, while the metal concentration level was analyzed and detected, a rapid biological toxicity detection method based on the acute toxicity test of luminescent bacteria (Vibrio qinghaiensis sp.-Q67) was established, and the dominant pollutants were identified by stepwise multiple regression. Results The pollutants came from wastewater and metal plating fragments directly discharged from the manufacturing line of the factory. The concentration of those pollutants was correlated with the acute toxicity of Vibrio qinghaiensis sp.-Q67. The dominant pollutants in the study were zinc (Zn), aluminum (Al) and copper (Cu). Conclusion The luminescent bacteria toxicity test method based on Vibrio qinghaiensis sp.-Q67 can conveniently and rapidly assess the degree of toxic damage of polluted soil and identify the dominant pollutants and can be applied to the acute toxicity evaluation of polluted soil.


Assuntos
Luminescência , Vibrio , Águas Residuárias
18.
Chinese Journal of Radiological Medicine and Protection ; (12): 820-825, 2020.
Artigo em Chinês | WPRIM | ID: wpr-868527

RESUMO

Objective:To observe the effect of Chinese herbal compound Siwu decoction (SW) on radiation injury of zebra fish blood system, and to clarify whether zebra fish is a suitable model for this study. Methods:Totally 72 of 4-month-old adult male zebra fish ( Danio Rerio) with body weight ranging from 0.14 to 0.20 g were used in all the experiments, where 36 zebra fish were taken to observe the hemodynamic changes after radiation, and the other 36 zebra fish were used to study the intervention effect of Siwu decoction on the blood injury after radiation. Zebra fish was irradiated with 20 Gy of 60Co gamma-rays at a dose rate of 97.33 cGy/min. For the hemodynamic study, the peripheral blood and whole kidney marrow cells (WKMCs)of irradiated zebra fish and non irradiated control were collected on days 7, 14 and 30 after irradiation, respectively, and the cell number was detected by flow cytometry. For the Siwu decoction treatment, 36 zebra fish were randomly divided into non-irradiation group, irradiation group, SW2 000 group ( Siwu decoction was diluted by 2 000-fold) and SW5 000 group ( Siwu decoction was diluted by 5 000-fold). Siwu decoction was given on the second day after irradiation. Then the peripheral blood and WKM cells of zebra fish were collected at 7 d after irradiation for further analysis. Results:After irradiation, the dynamic of blood development of zebra fish were obviously changed with the most blood cell ablation at 7 d post-irradiation. The total number of peripheral blood cells and WKM cells decreased by 26% and 52%( t=4.535, 28.987, P<0.05), the number of myeloid monocytes, lymphocytes, and red blood cells in the WKM decreased by 46%, 79% and 33%( t=18.457, 66.900, 9.872, P<0.05), and the number of precursor cells decreased by 49% ( P>0.05). The numbers of these blood cells were partly recovered at 14 d after irradiation and returned to the normal level at 30 d after irradiation. In comparison with irradiation alone group, the numbers of WKM cells, myeloid monocytes, progenitor cells, lymphocytes and red blood cells increased by 57%, 125%, 81% and 35%, respectively ( t=12.128, 21.594, 15.473, 4.594, P<0.05), and peripheral red cells did not increase significantly in the SW5 000 group after irradiation. However, SW2 000 had no significant influence on radiation injury of zebra fish blood cells ( P>0.05). Conclusions:Radiation injury of the blood system of zebra fish could be recovered at a month after irradiation, and this radiation damage could be partly intervened by Siwu decoction at a suitable concentration, which provides a reference for the study of blood system regulation of traditional Chinese medicine.

19.
Chinese Journal of Thoracic and Cardiovascular Surgery ; (12): 236-238, 2019.
Artigo em Chinês | WPRIM | ID: wpr-746176

RESUMO

Objective To study l-arginine aerosolized inhalation's protective effect on pulmonary ventilation of the pulmonary-arterial-hypertension patients during the early stage after pulmonary lobectomy,and its preventive effect on reducing postoperative complications.Methods 54 cases of pulmonary lobectomy patients with preoperative plumonary arterial hypertension were divided into two groups randomly-Group A was given L-arginine aerosolized inhalation within 4 h after the operation;Group B was given the same dose of aerosolized inhalation of physiological saline as contrast(other postoperative medication being the same with Group A).Compare the two groups of patients in terms of oxygenation index(PaO2/FiO2),alveolararterial oxygen difference(PA-aO2),nitric oxide(NO) concentration,ultrasonic cardiogram,mechanical ventilation duration,ICU duration,occurances of hemodvnamic disturbance and arrhythmia,and differences in postoperative hospital stay.Results The oxgenation index and the content of NO in plasma of Group A were higher than that of Group B(P <0.001);the alveolar-arterial oxygen difference and the postoperative pulmonary arterial pressure detected by UCG of Group A were lower than that of Group B(P < 0.001);the postoperative mechanical ventilation duration,ICU duration,occurances of hemodynamic disturbance and arrhythmia of Group A were all lower than that of Croup B(P < 0.05).Conclusion The postoperative l-arginine aerosolized inhalation during the early stage after pulmonary lobectomy has positive effect on the lung protection of the pulmonary-arterial-hypertension patients and it can reduce the perioperative complications and postoperative hospital stay of such patients.

20.
Chinese Journal of Internal Medicine ; (12): 278-281, 2019.
Artigo em Chinês | WPRIM | ID: wpr-745743

RESUMO

Objective To analyze the relationship between the level of microRNA-29b in circulation and left ventricular hypertrophy in hypertensive patients.Methods A total of 240 subjects from Henan Province People's Hospital from June 2015 to June 2018 were included in the present study.Among them,160 were hospitalized patients,and were divided into two groups.Patients with simple hypertension and had no left ventricular hypertrophy (80 cases) were in the simple hypertension group (HBP-NLVH),and patients with hypertension combined with left ventricular hypertrophy (80 cases) were in the high blood pressure with left ventricular hypertrophy group (HBP-LVH).Normal control subjects (80 cases) were those with no hypertension and randomly selected from the medical center of Henan Province People's Hospital.Serum microRNA-29b expressions were detected by real time fluorescence quantitative PCR.The thickness of interventricular septum (IVSD) and left ventricular posterior wall thickness (LVPWD) were measured by echocardiography.Results Compared with the normal control group (1.95±0.79),the relative expression of microRNA-29b in the patients both in the HBP-NLVH group (2.67±0.92) and the HBP-LVH group (5.12 ± 1.23) was up-regulated,and the difference between normal control and patients was statistically significant (P<0.05).In patients,the microRNA-29b level in the HBP-LVH group was significantly higher than that in the HBP-NLVH group (P<0.05).The expression level of microRNA-29b was positively correlated with IVSD (r=0.71,P<0.05) and LVPWD (r=0.74,P<0.05),respectively.The sensitivity and specificity of serum microRNA-29b levels in the diagnosis of left ventricular hypertrophy in hypertension patients were 96.8% and 91.3%,respectively.Conclusion Serum microRNA-29b level is elevated in hypertensive patients with left ventricular hypertrophy,and is positively correlated with left ventricular hypertrophy.The circulation microRNA-29b might be a useful biomarker with prognostic value in left ventricular hypertrophy in hypertension patients.

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