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Objective To study the eye irritation and the pharmacokinetics of tacrolimus-loaded cationic nanoemulsion-based in-situ gel in rabbits. Methods The eye irritation of tacrolimus-loaded cationic nanoemulsion-based in-situ gel in rabbits was observed by histological cross-sections of external ocular tissues stained with HE. The aqueous humor of rabbit eyes was extracted by corneal puncture and analyzed by HPLC-MS for pharmacokinetic study. Results Tacrolimus-loaded cationic nanoemulsion-based in-situ gel had no significant irritation on rabbit eyes. The pharmacokinetic parameter showed that the AUC of tacrolimus-loaded cationic nanoemulsion-based in-situ gel was (128.34±13.09) ng·h/ml, which was 1.13 times of tacrolimus-loaded cationic nanoemulsion (113.61±12.36) ng·h/ml and 1.88 times of Talymus® (68.25±10.82) ng·h /ml. Conclusion Tacrolimus-loaded cationic nanoemulsion-based in-situ gel had the advantages of low irritation, long retention time and high bioavailability in rabbit eyes. It has a good potential for clinical application.
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OBJECTIVE To analyze the compatible stability of commonly used intravenous drugs in the intensive care units （ICU）， and to provide a reference for improving medication safety in clinic. METHODS The commonly used intravenous drugs in the ICU of Hebei General Hospital were investigated and confirmed in April 1-30， 2022， and used as keywords to retrieve the relevant literature about compatible stability from PubMed， CNKI， Wanfang Data and other databases， and manually filtered with Micromedex database at the same time. Then， the compatible stability results of the included literature were analyzed descriptively. RESULTS Totally 32 commonly used intravenous drugs and 39 mixed infusion combinations were collected from ICU of this hospital. A total of 40 studies were included， only 2 studies followed all quality requirements； 18 studies validated their methods to guarantee correct reproducibility； 33 studies evaluated physical stability， including precipitate formation and pH changes； 32 studies evaluated chemical compatibility， mainly content/concentration changes. A total of 666 possible two-drug combinations were obtained from the included literature， of which 254 combinations of stability data were available， including 176 were stable， 68 were unstable， and 10 were contradictory. Totally 412 combinations had no stability results. Among two-drug combinations in ICU of this hospital， 42 combinations were stable， 14 combinations were unstable， and 2 combinations were contradictory. CONCLUSIONS The pH， solvent， excipients and preparation concentration are the factors that affect the stability. There are drug combinations with unstable compatibility of commonly used intravenous drugs in ICU of this hospital. The stability study methods are limited， and the stability data cannot meet the actual clinical needs.
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Objective:To investigate the results of the superficial circumflex iliac artery(SCIA)-based conjoined flap for covering extremely large lower limb defects.Methods:From February 2017 to June 2019, 15 patients were admitted, who suffered from severe degloved injury for the lower limb, including 9 males and 6 females with a median year of 45 (ranged, 36-67 ) years old. All were taken thorough and radical debridement and covered by the VSD device during the emergency operation. The dimension of defects was ranged from 25.0 cm ×8.0 cm to 50.0 cm ×15.0 cm. Using the lower abdominal wall or side chest wall as the donor site, the conjoined flap was dissected when the wound surface became granulating. The perforator match fashions included bilateral SCIA, and ipsilateral SCIA and thoracodorsal artery(TA). The donor sites were primary closure. The follow-up was accomplished by the same surgeon.Results:Fourteen flaps survived completely without significant complications, and distal necrosis was observed in one longitudinal flap, which was healed with the skin graft in the second stage. All flaps were available for a mean follow-up of 18 (ranged 16-24) months. The aesthetic outcomes were achieved on the recipient site without hairy appearance and hyper-pigmentation. A concealed line scare was left on the donor site, without the hernia and limited function. At the last follow-up, 7 cases were excellent and 1 case was good, evaluated with the LEFS criteria. And 6 cases were excellent and 1 case was good, assessed by the AOFAS criteria.Conclusion:The simultaneous reconstruction of extreme lower limb defects and better salvage treatment could be achieved by the SCIA-based conjoined flap. And as a versatile flap, it was blessed with concealed donor site, various design fashions, and larger dissection size in selected cases.
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Objective:To analyze the external quality control assessment results of fluoride in brick tea in the provincial, city (prefecture) and county (city, district)-level endemic fluorosis laboratories in Qinghai Province, and to evaluate the testing capabilities of laboratories at all levels.Methods:The Z-score method was used to analyze and evaluate the results of provincial, city (prefecture) and county (city, district)-level laboratories that participated in the external quality control assessment of fluoride in brick tea in Qinghai Province from 2014 to 2020, and│Z│≤2 was qualified; 2 <│Z│ < 3 was basic qualified; │Z│≥3 was unqualified.Results:From the feedback, the feedback rate of external quality control of fluoride in brick tea in provincial and city (prefecture)-level laboratories in Qinghai Province from 2014 to 2020 was 100.00%; the feedback rate of county (city, district)-level laboratories from 2014 to 2018 was 100.00%, and there were no feedback units in 2019 and 2020. From the assessment of qualification, the qualification rate of provincial, city (prefecture)-level laboratories was 100.00% in all other years except one unit failed in 2017; the qualification rate of county (city, district)-level laboratories was 100.00% in 2014, 2015, 2016 and 2019, and there were 6 unqualified units in other years.Conclusions:From 2014 to 2020, some endemic fluorosis laboratories in Qinghai Province still fail to pass the external quality control assessment of fluoride in brick tea. In the future, it will be the focus of work to strengthen personnel training and improve the detection ability.
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Objective:To analyze the results of serum erythropoietin (EPO) in adults patients with Kaschin-Beck disease (KBD) in Qinghai Province.Methods:According to the "Diagnosis of Kaschin-Beck Disease" (WS/T 207-2010), by using clinical examination and X-ray, adults over 20 years old in KBD areas of Xinghai County and Guide County, Hainan Tibetan Autonomous Prefecture, Qinghai Province, were divided into KBD case group ( n = 109) and internal control group ( n = 95) in July 2019. At the same time, healthy people were selected as external control group ( n = 90) in Xunhua County. Then 2 ml fasting cubital venous blood was collected from the target population to separate serum. The serum EPO level was determined by enzyme-linked immunosorbent assay (ELISA). Results:There was no significant difference in age and sex ratio among the 3 groups ( F = 0.73, P = 0.484; χ 2 = 1.03, P = 0.611). There was significant difference in serum EPO levels among the 3 groups [KBD case, internal and external control groups: (30.74 ± 26.23), (19.73 ± 11.53) and (10.83 ± 4.48) U/L, F = 26.51, P < 0.001]. Multiple comparisons showed that there were statistically significant differences in serum EPO levels between KBD case group and the internal and external control groups ( P < 0.05), but there was no significant difference between the internal and external control groups ( P > 0.05). Conclusions:The serum EPO level in adult KBD patients in Qinghai Province is increased significantly.
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@#Objective: To conduct a comparative study on the brain pharmacokinetics of seven ingredients (i. e. senkyunolide A, ferulic acid, formononetin, calycosin, ononin, calycosin-O-β-D-glucopyranoside, and paeoniflorin), which were the compounds of Buyang Huanwu Decoction (BHD), in normal and cerebral ischemia rats administrated intragastrically with BHD. Methods: The samples of normal and permanent middle cerebral artery occlusion (pMCAO) rats were collected by using brain microdialysis technique. The concentrations of seven ingredients were determined by the HPLC-MS/MS method. After the BHD were administrated intragastrically to the rats for seven consecutive days, brain microdialysis probes were inserted into the hippocampus of rats, and then the brain microdialysates were collected at 20 min time intervals for 5 h. The separation of the seven ingredients and internal standard (IS) was carried out on an ACQUITY UPLC BEH C <inf>18</inf> (2.1 mm × 100 mm, 1.7 μm) chromatographic column, using a mobile phase consisting of acetonitrile (containing 0.1% formic acid) and water (containing 0.1% formic acid) for gradient elution within 13 min. The ionization was conducted using an ESI source in positive ion mode. Multiple reaction monitoring mode was used for quantification of ingredients in BHD. Results: Linearity, accuracy, precision, matrix effect and stability of LC-MS/MS method were all satisfactory, successfully applied to compare the pharmacokinetics of the analytes between normal and model rats after intragastric administration of BHD. Compared with the normal group, the model group after the administration of the BHD showed that T <inf>1/2</inf> of formononetin and ononin were longer, and except for calycosin-O-β-D-glucopyranoside (P < 0.01), there was no significant difference between the normal group and the model group. The C <inf>max</inf> of senkyunolide A and calycosin of model group were increased, while the T <inf>max</inf> of senkyunolide A was decreased, and except for the T <inf>max</inf> of PF, the differences between the two groups were statistically significant (P < 0.01). Conclusion: The LC-MS/MS method combined with microdialysis was successfully applied to the comparative study of brain pharmacokinetics of seven ingredients in BHD. After intragastric administration of BHD, there were differences in the pharmacokinetics of seven ingredients in the brain hippocampus between normal rats and model rats, probably related to the characteristics of the ingredients and the effects of cerebral ischemia on the absorption and distribution of the ingredients.
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Objective:To understand the detection quality and external quality control assessment of fluorine and arsenic laboratories at all levels in Qinghai Province.Methods:Z-ratio scoring method was used to analyze and evaluate the results of provincial, municipal and county-level laboratories participating in the national fluorine and arsenic external quality control assessment from 2014 to 2020 in Qinghai Province, │Z│≤ 2 was qualified, 2 <│Z│ < 3 was basically qualified and│Z│≥ 3 was unqualified. At the same time, the feedback rate and pass rate of the participating laboratories were calculated.Results:From 2014 to 2020, the external quality control assessment results of water arsenic, urinary arsenic and brick tea fluorine in Qinghai Provincial laboratory were all qualified; except for the external quality control assessment of water fluorine in 2018 that was basically qualified, the results of other years were all qualified. Municipal and county-level laboratories did not give feedback the external quality control assessment results of water arsenic and urinary arsenic in 2017, and the feedback rate and pass rate in other years were 100.0%; except for the external quality control feedback rate and pass rate of water fluorine and brick tea fluorine in 2014 that were all 100.0%, there were laboratories that did not give feedback or failed the assessment in other years.Conclusion:The testing ability of provincial laboratory in Qinghai Province meets the standard, and the testing ability of municipal and county-level laboratories still need to be improved continuously.
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Objective:To evaluate the water fluoride detection ability of county (city, district) level (referred to as the county-level) laboratories in Qinghai Province.Methods:During the "13th Five-Year Plan" period (2016 - 2020), 4, 4, 4, 43, 43 county-level laboratories in Qinghai Province were organized to participate in the national water fluoride external quality control assessment, and the assessment results were evaluated by Z-ratio scoring method.Results:The response rate of county-level laboratories was 86.05% (37/43) in 2019, and 100.00% in other years. The qualified rate of county-level laboratories was 100.00% from 2016 to 2018; in 2019 and 2020, the assessment was fully covered, and the qualified rate was 81.40% (35/43) and 95.35% (41/43), respectively. Compared with 2019, the response rate and qualified rate in 2020 increased significantly, and the differences were statistically significant (χ 2 = 6.450, 4.074, P < 0.05). In the past 5 years, two assessment samples│Z│ < 1 in each laboratory were the most common, but with two assessment samples 2≤│Z│ < 3 in some qualified laboratories. Conclusion:The consistency of water fluoride determination in Qinghai Province is not very ideal, and the detection ability of county-level laboratories still needs to be strengthened.
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Objective:To investigate the early evaluation potential of serum levels of apolipoprotein B/apolipoprotein A1 (Apo B/A1), microtubule-associated protein 1-light chain 3 (MAP1-LC3) and intercellular adhesion molecule-1 (ICAM-1) in acute pancreatitis (AP) patients.Methods:A total of 413 AP patients who were treated at the Second Affiliated Hospital of Anhui Medical University between January 2019 and August 2020 were enrolled. Serum samples were collected from AP patients within 24 h of admission. Patients were divided into the non-severe acute pancreatitis (Non-SAP, n=315) and severe acute pancreatitis (SAP, n=98) groups according to the severity of the disease. Sixty healthy controls were recruited. The differences of serum Apo B/A1, MAP1-LC3 and ICAM-1 among the three groups were compared by one-way analysis of variance, and the correlation between Apo B/A1, MAP1-LC3 and ICAM-1 and the severity of AP was analyzed by Pearson correlation analysis. Sensitivity and specificity in assessing AP severity were predicted by receiver operating characteristic curve (ROC). Results:The early levels of Apo B/A1, MAP1-LC3 and ICAM-1 were all significantly higher for AP patients than for healthy controls ( P<0.05), and the levels of Apo B/A1, MAP1-LC3 and ICAM-1 in SAP patients were significantly higher than those in non-SAP patients[Apo B/A1: 2.21±1.40 vs. (0.96±0.34); MAP1-LC3: 0.92±0.29 vs. (0.48±0.24) ng/mL and ICAM-1: (235.57±54.50 ) vs. (120.28±61.69)ng/mL; P<0.05]. Pearson correlation analysis showed that levels of Apo B/A1, MAP1-LC3 and ICAM-1 were positively correlated with the first Ranson score after admission ( P<0.05), and ICAM-1 showed the highest degree of correlation with AP severity ( r=0.519). Areas under the receiver operating characteristic curve (AUROC) were 0.769 for Apo B/A1, 0.811 for MAP1-LC3, 0.828 for ICAM-1, and 0.938 for combined detection. Conclusions:Serum levels of Apo B/A1, MAP1-LC3 and ICAM-1 within 24 h after admission are significantly correlated with the severity of AP, which has clinical significance for early prediction of the severity of AP.
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The ethyl acetate part of the alcoholic extract of Cordia dichotoma fruits was purified by a combination of normal-phase silica gel column chromatography, Sephadex LH-20 gel column chromatography and semi-preparative HPLC, and the structure was identified by modern spectroscopic techniques (UV, IR, MS, NMR). A total of 10 compounds were isolated and identified as cordilide (1), (S)-2-hydroxy-3-(4′-hydroxyphenyl) propanoic acid (2), vanillic acid (3), p-coumaric acid (4), 3-hydroxy-1-(4-hydroxy-3-methoxyphenyl)propan-1-one (5), benzoic acid (6), p-hydroxypropiophenone (7), p-hydroxyacetophenone (8), 5′-methoxyevofolin B (9) and vanillin (10). Among them, compound 1 is a pair of new phenylpropanoid enantiomers, and compounds 3, 6, 8 and 9 were isolated for the first time from the genus.
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OBJECTIVES@#To investigate the current status of unplanned readmission of neonates within 31 days after discharge from the neonatal intensive care unit (NICU) and risk factors for readmission.@*METHODS@#A retrospective analysis was performed on the medical data of 1 561 infants discharged from the NICU, among whom 52 infants who were readmitted within 31 days were enrolled as the case group, and 104 infants who were not readmitted after discharge during the same period of time were enrolled as the control group. Univariate analysis and multivariate logistic regression analysis were performed to identify the risk factors for readmission.@*RESULTS@#Among the 1 561 infants, a total of 63 readmissions occurred in 52 infants, with a readmission rate of 3.33%. hyperbilirubinemia and pneumonia were the main causes for readmission, accounting for 29% (18/63) and 24% (15/63) respectively. The multivariate logistic regression analysis showed that that gestational age <28 weeks, birth weight <1 500 g, multiple pregnancy, mechanical ventilation, and length of hospital stay <7 days were risk factors for readmission (OR=5.645, 5.750, 3.044, 3.331, and 1.718 respectively, P<0.05).@*CONCLUSIONS@#Neonates have a relatively high risk of readmission after discharge from the NICU. The medical staff should pay attention to risk factors for readmission and formulate targeted intervention measures, so as to reduce readmission and improve the quality of medical service.
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Female , Humans , Infant , Infant, Newborn , Pregnancy , Intensive Care Units, Neonatal , Patient Discharge , Patient Readmission , Retrospective Studies , Risk FactorsABSTRACT
OBJECTIVE@#To systematically evaluate the clinical efficacy of arthroscopy and traditional incision in the treatment of tibial avulsion fracture of anterior cruciate ligament (ACL).@*METHODS@#From July 2010 to July 2020, clinical comparative trial about arthroscopy and traditional incision in the treatment of ACL tibial avulsion fracture was conducted by using computer-based databases, including Embase, Pubmed, Central, Cinahl, PQDT, CNKI, Weipu, Wanfang, Cochrane Library, CBM. Literature screening and data extraction were carried out according to the inclusion and exclusion criteria, and the quality of the included literature was evaluated by improved Jadad score and Ottawa Newcastle scale (NOS). The operation time, hospital stay, fracture healing time, knee range of motion, postoperative excellent and good rate, complication rate, Lysholm score, International Knee Documentation Committee (IKDC) score and Tegner score were statistically analyzed by Review Manager 5.3 software.@*RESULTS@#Finally, 16 literatures were included, including 1 randomized controlled trial and 15 non randomized controlled trials, with a total of 822 patients (405 in arthroscopy group and 417 in traditional incision group). Meta analysis showed that the operation time [MD=-9.03, 95% CI(-14.36, -3.70), P<0.001], hospital stay [MD=-5.81, 95%CI(-9.32, -2.31), P=0.001] and fracture healing time [MD=-14.61, 95% CI(-17.93, -11.28), P<0.001] in the arthroscopy group were better than those in the traditional incision group. The incidence of complications in arthroscopy group was lower than that in traditional incision group[OR=0.15, 95%CI(0.07, 0.33), P<0.001]. The postoperative excellent and good rate[OR=4.39, 95%CI (1.96, 9.82), P<0.001], knee mobility[MD=6.78, 95%CI(2.79, 10.77), P<0.001], Lysholm score[MD=11.63, 95%CI(4.91, 18.36), P<0.001], IKDC score[MD=7.83, 95%CI(6.09, 9.57), P<0.001] and Tegner score[MD=0.60, 95%CI(0.31, 0.89), P<0.001] in the arthroscopic group were higher than those in the traditional incision group.@*CONCLUSION@#Compared with the traditional open reduction and internal fixation, arthroscopic surgery in patients with ACL tibial avulsion fracture can shorten the operation time, hospital stay and fracture healing time, reduce the incidence of postoperative complications, and obtain good postoperative knee function. It can be recommended as one of the first choice for patients with ACL tibial avulsion fracture.
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Humans , Anterior Cruciate Ligament/surgery , Anterior Cruciate Ligament Injuries/surgery , Arthroscopy , Fractures, Avulsion/surgery , Randomized Controlled Trials as Topic , Suture TechniquesABSTRACT
Different from other trauma, the scar and pigmentation formed after healing of burn wound not only hinder beauty but also easily lead to a series of sequential psychological problems, such as depression and anxiety. Music therapy, as a supplementary treatment, is widely used in many fields including medical and health care and psychological regulation. However, affected by factors such as medical resources, the awareness and acceptance of music therapy among burn treatment workers in China are still low. Based on the clinical characteristics of burns, this paper matches the applicability of music therapy with it, summarizes the supplementary application of music therapy in the field of burn treatment, expounds this natural science with both science and aesthetics, and puts forward feasible suggestions for its future development.
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Humans , Anxiety , Burns/therapy , Cicatrix , Music Therapy , Wound HealingABSTRACT
This paper summaries the Risk of Bias in Non-randomized Studies-of Environmental Exposure (ROBINS-E), a tool for evaluating risk of bias about non-randomized studies of exposures (NRSE), and introduces the application of ROBINS-E in a published NRSE. According to the characteristics of NRSE, evaluation fields and signaling questions were designed in ROBINS-E to provide essential information about risk of bias for NRSE included in systematic reviews and GRADE. ROBINS-E is the tool in assessment of risk of bias in observational studies and quasi-randomized studies. Although the tool has been used in practice to some extent, but it still needs further improvement. Attention should be paid to its update and progress.
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Humans , Bias , Environmental Exposure , Systematic Reviews as TopicABSTRACT
Objective: To explore the short-term efficacy of fenestrated atrial septal defect (ASD) occulders in the treatment of pulmonary arterial hypertension (PAH). Methods: Thirty-six healthy dogs were divided into the balloon atrial septostomy (BAS)+fenestrated ASD occulders group (n=12), BAS group (n=12) and non-septostomy group (n=12). PAH was induced by intra-atrial injection of dehydrogenized monocrotaline (1.5 mg/kg) in all dogs. Animals in the BAS+fenestrated ASD occulders group underwent atrial septal puncture and fenestrated ASD occulders implantation. Animals in the BAS group underwent balloon atrial septostomy. The non-septostomy group received no surgical intervention. The hemodynamic indexes and blood N-terminal pro-B-type natriuretic peptide (NT-proBNP) of dogs were measured before modeling, 2 months after modeling, 1, 3, and 6 months after surgery, respectively. Echocardiography was performed to observe the patency of the shunt and atrial septostomy of the dogs in the BAS+fenestrated ASD occulders group and BAS group at 1, 3, and 6 months after surgery. Three dogs were sacrificed in each group at 1, 3, and 6 months after surgery, respectively. Atrial septal tissue and fenestrated ASD occulders were removed to observe the patency and endothelialization of the device. Lung tissues were obtained for hematoxylin-eosin (HE) staining to observe the inflammatory cells infiltration and the thickening and narrowing of the pulmonary arterials. Results: Among 36 dogs, 2 dogs died within 24 hours after modeling, and 34 dogs were assigned to BAS+fenestrated ASD occulders group (n=12), BAS group (n=11), and non-septostomy group (n=11). Compared with BAS group, the average right atrial pressure (mRAP) and NT-proBNP of dogs in the BAS+fenestrated ASD occulders group were significantly reduced at 3 months after surgery (P<0.05), and the cardiac output (CO) was significantly increased at 6 months after surgery, arterial oxygen saturation (SaO2) was also significantly reduced (P<0.05). Compared with non-septostomy group, dogs in the BAS+fenestrated ASD occulders group had significantly lower mRAP and NT-proBNP at 1, 3, and 6 months after surgery (P<0.05), and higher CO and lower SaO2 at 6 months after surgery (P<0.05). Compared with the non-septostomy group, the dogs in the BAS group had significantly lower mRAP and NT-proBNP at 1 month after surgery (P<0.05), and there was no significant difference on mRAP and NT-proBNP at 3 and 6 months after surgery (P>0.05). Echocardiography showed that there was a minimal right-to-left shunt in the atrial septum in the BAS group at 1 month after the surgery, and the ostomy was closed in all the dogs in the BAS group at 3 months after the surgery. There was still a clear right-to-left shunt in the dogs of BAS+fenestrated ASD occulders group. The shunt was well formed and satisfactory endothelialization was observed at 1, 3 and 6 months after surgery. The results of HE staining showed that the pulmonary arterials were significantly thickened, stenosis and collapse occurred in the non-septostomy group. Pulmonary microvascular stenosis and inflammatory cell infiltration in the pulmonary arterials were observed in the non-septostomy group. Pulmonary arterial histological results were comparable between BAS+fenestrated ASD occulders group and non-septostomy group at 6 months after surgery . Conclusions: The fenestrated ASD occulder has the advantage of maintaining the open fistula hole for a longer time compared with simple balloon dilation. The fenestrated ASD occulder can improve cardiac function, and it is safe and feasible to treat PAH in this animal model.
Subject(s)
Animals , Dogs , Atrial Septum/surgery , Cardiac Catheterization/methods , Familial Primary Pulmonary Hypertension , Heart Septal Defects, Atrial/surgery , Hypertension, Pulmonary , Pulmonary Arterial HypertensionABSTRACT
Micheliolide is a kind of guaiacane sesquiterpene lactone from natural plants. It distributs in the root bark of Cephalantheropsis gracilis and Michelia compressa . Modern pharmacological studies show that ，micheliolide can play an anti-tumor role by inhibiting the proliferation of tumor cells ，regulating the apoptosis of tumor cells ，inducing autophagy of tumor cells ，and inhibiting invasion and metastasis of tumor cells. It can reduce the expression of inflammatory cytokines by regulating several related signaling pathways ，such as nuclear factor κB and phosphatidylinositol-3-hydroxykinase/protein kinase B ；it can play an immunomodulatory role by restoring the expression of immune-related factors in the body ；it can play a neuroprotective effect by reducing the accumulation of amyloid β-protein and inhibiting microglial activation ；it can play a liver protective role by reducing the inflammatory response and steatosis of hepatocytes ；its nephroprotective mechanism is related to the relief of the inflammatory response by regulating multiple pathways ；the mechanisms of its cardioprotective action include alleviating the inflammatory response and reducing the level of oxidative stress ，etc. In conclusion ，micheliolide is a compound of great development value.
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Objective:According to the new GCP regulations issued by national medical products administration, this paper discusses the management mode of Suspected Unexpected Serious Adverse Reaction (SUSAR) reports during clinical trials.Methods:Combined with GCP regulations and working practice, this paper comprehensively analyzes the issues identified and related reasons for the management of SUSAR reports during clinical trials, and propose possible countermeasures.Results:There are some problems in the management of SUSAR reports among different stakeholders during clinical trials, such as defects in the performance of obligations and responsibilities. It is suggested that investigators should be more carefully to fulfill GCP responsibilities; sponsors should be more accurately implement the reporting procedures; institutional and ethical supervision should also be strengthened to assure better conduct of clinical trials.Conclusions:Multi-party collaboration and management mode play crucial roles in conducting high-quality clinical trials.
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Objective:To propose suggestions on the prevention and treatment measures of drug clinical trial research-related injury from the research center perspective, and improve the protection of the rights of human subjects.Methods:Analyze three representative cases of drug clinical trial research-related injury compensation in a hospital, and put forward suggestions for the project management of the research center.Results:By reviewing informed consent forms and clinical trial liability insurance, actively participating in research-related injury treatment and implementation supervision, paying attention to safety information and risk monitoring, ethics committees, clinical trial institutions and investigators can play more proactive roles in protecting the rights and interests of human subjects.Conclusions:The research center could better control the risks of clinical trials and improve the protection of human subjects by strengthening the prevention and treatment measures for clinical trial research-related injury.
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Data mining technology was adopted to analyze the rules of acupoint selection in treatment of erectile dysfunction with acupuncture and moxibustion. All of the articles for acupuncture and moxibustion in treatment of erectile dysfunction were searched from the databases, i.e. Chinese national knowledge infrastructure (CNKI), Wanfang database, VIP, Chinese biomedical literature database (SinoMed) and PubMed, and the clinical trials on erectile dysfunction treated with acupuncture and moxibustion were screened. The database was set up by using Excel 2019 and input into R 4.0.3, and then, the therapeutic method, use frequency of acupoint, meridian tropism, collection visualization analysis, cluster analysis and association rule analysis were summarized. A total of 240 articles were included, with 516 prescriptions and 145 acupoints involved. The methods for treatment of erectile dysfunction included acupuncture and moxibustion therapy, acupuncture, acupoint injection, electroacupuncture, etc. The acupoints with high use frequency were Guanyuan (CV 4), Shenshu (BL 23), Sanyinjiao (SP 6), Mingmen (GV 4), Zusanli (ST 36), Zhongji (CV 3), Ciliao (BL 32), Qihai (CV 6), Taixi (KI 3) and Taichong (LR 3). The meridians involved with high frequency were the bladder meridian of foot-taiyang, the conception vessel, the spleen meridian of foot-taiyin, etc. The common acupoint combination was Shangliao (BL 31), Zhongliao (BL 33), Ciliao (BL 32), Xialiao (BL 34) and Sanyinjiao (SP 6), Shenshu (BL 23), Guanyuan (CV 4). In association rule analysis (confidence ≥ 90%, support ≥ 20%), there were 27 association rules in total. The acupoint combination with the highest support referred to "Shenshu (BL 23), Sanyinjiao (SP 6)→Guanyuan (CV 4)" (support 46.7%) and the acupoint combination with the highest confidence was "Sanyinjiao (SP 6), Qihai (CV 6)→Guanyuan (CV 4)" (confidence 98.0%). The acupoints could be divided into 5 effective clusters. Acupuncture and moxibustion therapy has a certain of rules of acupoint selection in treatment of erectile dysfunction, which provides the evidences for modern clinical trial and treatment.
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Humans , Male , Acupuncture Points , Acupuncture Therapy , Data Mining , Erectile Dysfunction/therapy , Meridians , Moxibustion , TechnologyABSTRACT
Objective: To investigate the effect and its underlying molecular mechanisms of essential oil from Saussurea costus in esophageal cancer cell line Eca109. Methods: The chemical composition of essential oil from Saussurea costus was investigated by gas chromatography-mass spectrometry (GC-MS). The anti-proliferative, anti-migrative, and apoptotic effects of essential oil from Saussurea costus against Eca109 cells were analyzed. Moreover, the expression of proteins associated with cell cycle, metastasis, and apoptosis was determined. Results: GC-MS analysis showed that essential oil from Saussurea costus was predominantly comprised of sesquiterpenes. Saussurea costus essential oil inhibited the viability of Eca109 cells in a dose-and time-dependent manner with IC 50 values of (24.29±1.49), (19.16±2.27) and (6.97±0.86) μg/mL at 12, 24, and 48 h, respectively. The expression levels of target proteins in the cell cycle (phase G 1 /S), including cyclin D1, p21, and p53, were affected by Saussurea costus essential oil. The essential oil also downregulated the expression of metastasis-related proteins MMP-9 and MMP-2. Moreover, it induced apoptosis of Eca109 cells through the mitochondrial pathway, as well as inhibition of STAT3 phosphorylation. Conclusions: The essential oil from Saussurea costus exhibited anti-proliferative, anti-migrative, and apoptotic effects on Eca109 cells, and could be further explored as a potential anti-esophageal cancer agent.