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Background and aim: Spontaneous rupture of hepatocellular carcinoma (HCC) is a life-threatening complication, and patients who experience it are formally assigned to stage T4 in the TNM system, while many clinicians informally assign them to stage C in the more widely used Barcelona Clinic Liver Cancer (BCLC) system. The present study explored whether these re-staging practices are appropriate for HCC patients who suffer tumor rupture. Methods: We retrospectively reviewed the records of 1952 HCC patients who underwent hepatic resection at our hospital between January 2017 and June 2021. We compared recurrence-free and overall survival between 143 patients who had BCLC stage A or B disease at the time of spontaneous rupture and 449 patients who had BCLC stage C disease without rupture. Results: Overall survival rate was significantly higher among the 143 patients (1, 3, 5-year survival rate was 80.3%, 60.4%, 51.4%) with rupture than among the 449 (1, 3, 5-year survival rate was 69.5%, 41.5%, 32.4%) with BCLC stage C disease (hazard ratio 1.65, 95% confidence interval 1.29 to 2.12). The two groups had similar recurrence-free survival (hazard ratio 1.19, 95% confidence interval 0.92 to 1.53), but most patients with rupture were able to receive interventional and potentially curative treatments after recurrence, whereas most patients in BCLC stage C received interventional or supportive care. Similar results were obtained after propensity score matching. Conclusion: HCC patients who experience spontaneous rupture tumor while in BCLC stage A or B have better prognosis than patients in BCLC stage C without rupture. Our results suggest that HCC patients who suffer rupture in BCLC stage A or B should not be assigned to BCLC stage C.
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Aim To explore the alternative study on rat blood pressure method and HPLC method for vasopressin impurity test of oxytocin injection from biological extraction. Methods The HPLC method for the vasopressin impurity test in vitro was established and validated. The bio-extrac tion oxytocin injection samples and simulated samples were examined for vasopressin impurity by HPLC and rat blood pressure methods respectively. Results Vasopressin and adjacent impurity peaks were successfully separated by the established method. In the range of 210~13 330 IU•L -1the concentration of vasopressin had a good linear relationship with its peak area with r=0.999 9. The results of HPLC method were consistent with the biological examination method-rat blood pressure method in the current standard. Conclusions The method is proved to be specific, sensitive, and accurate, which can be used as a test method for vasopressin impurity to replace the rat blood pressure method in the current standard.
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Aim To establish a batch of endotoxin standard for baeterial endotoxin detection of insoluble samples.Methods Candidate A and candidate B were prepared by freeze -drying bacterial endotoxin without excipient.The two batches of candidates were calibrated by three methods, including 13 laboratories for gel method, 9 laboratories for kinetic-turbidimetric assay and 5 laboratories for kinetic chromogenic assay.Results After statistical analysis, the geometric mean values of gel method, kinetic-turbidimetric assay and kinetic chromogenic assay calibration of candidate A were 680.1 EU, 827.0 EU and 800.8 EU, with RSD of 22.4%, 16.2% and 16.7%, respectively.The P value of variance analysis of calibration results of the three methods was 0.067, showing no significant difference.The weighted mean of potency was 774.0 EU (95% confidence interval 721.0 - 831.0, FL% 7.10).The geometric mean values of the calibration of candidate B by gel method, kinetic-turbidimetric assay and kinetic chromogenic assay method were 1 640.6 EU, 1 828.6 EU and 3 224.8 EU, with RSD of 33.9% , 47.0% and 54.4% , respectively.The P val¬ue of variance analysis of the calibration results of the three methods was 0.030, showing significant differ¬ence.Chi-square test was used to correct the weight of each method , and weighted average of the results of the three methods was used to obtain a corrected weighted average efficiency value of 1 822.7 EU (95% confi¬dence interval 1 548.7 -2 145.2, FL% 16.4).Can¬didate B was eliminated based on the results.Conclu¬sion Candidate A has become the first batch of na¬tional standard bacterial endotoxin (for insoluble sam¬ples only) approved by National Standard Substance Committee of China, and the potency is 700 EU.
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Abstract; Aim To solve the problems in the appliea- tion of egg yolk leeithin endotoxin test method, and and to establish the baeterial endotoxin examination method for egg yolk lecithin (for injeetion). Methods The ethanol solution of Tween 80 ( the volume ratio of tween 80 to anhydrous ethanol was 2. 5 • 2. 7, mixed for 4 min) was used to prepare lecithin solution of egg yolk at 0. 1 kg • L 1 , and 10 test water was added to 1 mL lecithin solution of egg yolk (500 EU • mL 1 standard solution of endotoxin IOjxL was added for pos¬itive control). After diluted 20 times with endotoxin test water, the standard curve range was 10 ~0. 01 EU • mL 1 by kinetic-turbidimetrie assay. Methodology of endotoxin test was studied using limulus lysate from two manufacturers and eight hatches of samples. Results The recoveries of eight hatches of samples all met the requirement of interference test between 50% and 200% stipulated in the pharmacopoeia, which solved the problems of the current endotoxin test method in practical application. Conclusions The bacterial en¬dotoxin test method of egg yolk lecithin with good dura-bility is established to provide the basis for the revision of pharmacopoeia.
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Aim To design and implement the bacteri¬al endotoxin test proficiency testing plan to evaluate the laboratory's ability and level to determine bacterial en¬dotoxin. Methods According to the Chinese Pharma-copoeia (2015 edition, Vol IV) -1143 Bacterial Endo¬toxin Test-Photometric Method ( Method 2 ) , each la¬boratory used any of these methods to determine the endotoxin content of the sample to be tested. The stati- stical software JMP13 was used for statistical analysis of the feedback results of the participating laboratories. The consensus value of the participants, namely the ro¬bust average value of the effective test results of all the participating laboratories, was used as the assigned value X of the endotoxin content of the samples to be tested in the proficiency testing of the round. The re¬sults of participating laboratories were evaluated ac¬cording to the following criteria: (1) the laboratory test results were within 50% to 200% of the assigned value of the sample, which was evaluated satisfactory; ( 2 ) the laboratory test results were not within the 50 -200% range of the assigned value of the sample, which was evaluated dissatisfactory. Results A total of laboratories participated in this capacity verification plan, with 45 in the laboratory with satisfactory re¬sults, with a satisfaction of 91. 8% ; There were 4 la¬boratories that received "dissatisfaction" results, all of which were not within the range of 50% -200% of the assigned value of samples, and the dissatisfaction of 8. 2% . Conclusions Most of the participating labora¬tories can accurately detect the bacterial endotoxin con¬tent in the sample to be tested, indicating that the level of bacterial endotoxin detection in our country is gener¬ally good at present.
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Although ultrafiltration (UF) has been extensively employed for drinking water purification, it is crucial to further develop novel membrane materials to improve the antifouling capacity and satisfy the practical usage. Multi-walled carbon nanotubes (MWCNTs) have characteristics that could potentially improve the membrane antifouling performance. Therefore, in this study, modified cellulose UF membranes were prepared using MWCNTs of various outer diameters ranging from 10 to 20 nm to 40-60 nm. The antifouling properties of the modified membrane and natural organic matter (NOM) removal mechanism were investigated while treating water from a local drinking water source river. Overall, the antifouling ability increased by more than one-fold when the nascent cellulose membrane was coated with MWCNTs (outer diameter of 40-60 nm) at a loading of 17.4 g/m2. The molecular weight distribution profiles of the NOM in the raw water and permeates suggest the superior performance of the modified membranes in removing two major NOM fractions with molecular weights ranging from approximately 5 k-30 k and 500 k-1000 k. Based on its hydrophobicity, the NOM of the raw water was fractionated into the strong hydrophobic (SHPO), the weak hydrophobic, the strong hydrophilic and the moderately hydrophilic (MHPI) fractions. The WHPO fraction caused the highest fouling compared with the other fractions under consistent experimental conditions. Meanwhile, the modified membranes showed a preference for removing the MHPI and SHPO fractions. These results imply that MWCNTs can be employed to improve the antifouling property of cellulose UF membranes and have the potential to selectively remove moderately hydrophilic contaminants from water.
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Aim To investigate the protective effects of the 10 compounds from Clematis filamentosa Dunn, on H
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Purpose@#The aim of this meta-analysis was to evaluate the efficacy and safety of imidafenacin for overactive bladder (OAB) induced by benign prostatic hyperplasia (BPH) in men receiving alpha-blocker monotherapy. @*Methods@#We performed a systematic research of the PubMed, Embase, and Cochrane Library databases, and searched for studies about alpha-blocker with or without imidafenacin treatment for OAB in patients with BPH. We also investigated the original references of the included texts. @*Results@#Four randomized controlled trials including 779 participants with BPH (389 in the alpha-blocker+imidafenacin group and 390 in the alpha-blocker only group) were studied. The main efficacy endpoint was the Overactive Bladder Symptom Score, which showed a mean difference of -1.88 (95% confidence interval, -2.32 to -1.44; P<0.00001), suggesting that alpha-blocker and imidafenacin treatment was effective in treating men with OAB. As other primary efficacy end points, the International Prostate Symptom Score (IPSS) total score (P=0.47), the IPSS storage symptom score (P=0.07), the IPSS voiding symptom score (P=0.60), and the IPSS quality of life score (P=0.18) indicated that 2 methods had no significant differences in treating men with OAB. In terms of safety, which was assessed using postvoid residual volume (P=0.05) and maximum flow rate (P=0.53), the analysis suggested that combination treatment was very well tolerated. @*Conclusions@#This study suggested that imidafenacin plus alpha-blocker was an efficacious and safe treatment for OAB symptoms in BPH patients.
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Purpose@#The aim of this meta-analysis was to evaluate the efficacy and safety of imidafenacin for overactive bladder (OAB) induced by benign prostatic hyperplasia (BPH) in men receiving alpha-blocker monotherapy. @*Methods@#We performed a systematic research of the PubMed, Embase, and Cochrane Library databases, and searched for studies about alpha-blocker with or without imidafenacin treatment for OAB in patients with BPH. We also investigated the original references of the included texts. @*Results@#Four randomized controlled trials including 779 participants with BPH (389 in the alpha-blocker+imidafenacin group and 390 in the alpha-blocker only group) were studied. The main efficacy endpoint was the Overactive Bladder Symptom Score, which showed a mean difference of -1.88 (95% confidence interval, -2.32 to -1.44; P<0.00001), suggesting that alpha-blocker and imidafenacin treatment was effective in treating men with OAB. As other primary efficacy end points, the International Prostate Symptom Score (IPSS) total score (P=0.47), the IPSS storage symptom score (P=0.07), the IPSS voiding symptom score (P=0.60), and the IPSS quality of life score (P=0.18) indicated that 2 methods had no significant differences in treating men with OAB. In terms of safety, which was assessed using postvoid residual volume (P=0.05) and maximum flow rate (P=0.53), the analysis suggested that combination treatment was very well tolerated. @*Conclusions@#This study suggested that imidafenacin plus alpha-blocker was an efficacious and safe treatment for OAB symptoms in BPH patients.
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OBJECTIVE: To summarize and analyze the factors of building the bacterial endotoxin test laboratory. These factors should meet the GPCL quality management concepts. METHODS: Give Some specific methods and experience in five aspects were given, which combine the GPCL quality management concepts with the characteristics of bacterial endotoxin test. RESULTS AND CONCLUSION: Summarizes The applications of GPCL concept for bacterial endotoxin test laboratory is summarized.
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<p><b>BACKGROUND</b>The bacterial endotoxins test (BET) is a method used to detect or quantify endotoxins (lipo-polysaccharide, LPS) and is widely used in the quality control of parenteral medicines/vaccines and clinical dialysis fluid. It is also used in the diagnosis of endotoxemia and in detection of environment air quality control. Although BET has been adopted by most pharmacopoeias, result judgment algorithms (RJAs) of the test for interfering factors in the BET still differ between certain pharmacopoeias. We have evaluated RJAs of the test for interfering factors for the revision of BET described in the Chinese Pharmacopoeia 2010 (CHP2010).</p><p><b>METHODS</b>Original data from 1 748 samples were judged by RJAs of the Chinese Pharmacopoeia 2010, the Japanese Pharmacopoeia 2011 (JP2011), the European Pharmacopoeia 7.0 (EP7.0), the United States Pharmacopoeia 36 (USP36), and the Indian Pharmacopoeia 2010 (IP2010), respectively. A SAS software package was used in the statistical analysis.</p><p><b>RESULTS</b>The results using CHP2010 and USP36, JP2011, EP7.0, and IP2010 had no significant difference (P = 0.7740). The results using CHP2010 of 1 748 samples showed that 132 samples (7.6%) required an additional step; nevertheless there was no such requirement when using the other pharmacopeias. The kappa value of two RJAs (CHP2010 and EP7.0) was 0.6900 (0.6297-0.7504) indicating that the CHP2010 and other pharmacopoeias have good consistency.</p><p><b>CONCLUSIONS</b>The results using CHP2010 and USP36, JP2011, EP7.0, and IP2010 have different characteristics. CHP2010 method shows a good performance in Specificity, mistake diagnostic rate, agreement rate, predictive value for suspicious rate, and predictive value for passed rate. The CHP2010 method only had disadvantages in sensitivity compared with other pharmacopeias. We suggest that the Chinese pharmacopoeia interference test be revised in accordance with the USP36, JP2011, EP7.0, and IP2010 judgment model.</p>
Subject(s)
Adult , Female , Humans , Male , Middle Aged , Algorithms , Asian People , Diskectomy , Endotoxins , Metabolism , Intervertebral Disc Degeneration , General Surgery , Intervertebral Disc Displacement , General Surgery , Low Back Pain , General Surgery , Retrospective StudiesABSTRACT
OBJECTIVES/HYPOTHESIS: Cyclin D1 expression and the rate of apoptosis have been reported to serve as important prognostic indicators in human cancers. The purpose of the present study was to determine the prognostic significance of both initial cyclin D1 expression and the apoptotic index in nasopharyngeal carcinoma. STUDY DESIGN: Cohort study. METHODS: Cyclin D1 protein levels and apoptosis in tumors and their corresponding adjacent, histologically normal tissues were determined at the time of initial diagnosis using immunohistochemical staining, Western blot analysis, and in situ end labeling, respectively, in 64 patients with T1-T4/N0-N2, poorly differentiated squamous cell carcinoma of the nasopharynx. All cases were treated by routine radiation therapy with a total median dose of 70 Gy and followed up for 10 years. RESULTS: High levels of cyclin D1 were found in 35 of 64 tumor specimens (54.7%); no cyclin D1--positive cells were determinable in normal epithelium of the nasopharynx. Rates of early local recurrence (within 5 y) were significantly higher (P <.01) for patients with high levels of cyclin D1 before radiation therapy (24 of 35 patients [68.6%]) as compared with patients with low or no expression (3 of 29 [10.3%]). Furthermore, patients bearing high levels of cyclin D1 had a poorer prognosis concerning 10-year survival than the others (P <.001), whereas overexpression of cyclin D1 did not correlate with the initial TMN classification (P >.05). According to the rate of spontaneous apoptosis in tumors below or above the median, patients were divided into two groups. There was no statistically significant difference for the overall survival between the two groups (P >.05). CONCLUSIONS: The present study demonstrates that cyclin D1 can be used as an indicator of recurrence and subsequent prognosis in nasopharyngeal carcinoma after radiation therapy. At the same time, the apoptotic state before radiation therapy is of no value in predicting the prognosis of patients with nasopharyngeal carcinoma.
Subject(s)
Biomarkers, Tumor/analysis , Carcinoma/pathology , Cyclin D1/analysis , Nasopharyngeal Neoplasms/pathology , Neoplasm Recurrence, Local/pathology , Adult , Aged , Analysis of Variance , Biopsy, Needle , Blotting, Western , Carcinoma/radiotherapy , China , Cohort Studies , Culture Techniques , Female , Humans , Immunohistochemistry , Male , Middle Aged , Nasopharyngeal Neoplasms/radiotherapy , Neoplasm Staging , Probability , Prognosis , Sensitivity and SpecificityABSTRACT
Objective To investigate the effect of electroacupuncture(EA)in improving the reconstruction of synapse after cerebral ischemia.Methods Forty-five Wistar rats were divided into 3 groups:sham-operated group,ischemia group and EA group.The number density(Nv)of synapses and the surface density(Sv)of synaptic joint band were observed 1 hour,1 day,3 days,1 week and 3 weeks after ischemia and EA, respectively.Heat-coagulation-induced occlusion of the middle cerebral artery was performed to establish the model of focal cerebral ischemia.EA group received EA on the acupoints of Baihui and Dazhui.The changes of synaptie structure,Nv and Sv as well as the influence of EA on the above indexes were observed in different time.Results There existed significant decrease of Nv and Sv 1 hour,1 day and 3 days after establishment of models in the isehemia group(P0.05).Conclusion EA can reduce the cerebral ischemic injury by increasing the synaptic amount and area in the cortex of rat model of cerebral isehemia at early stage,promoting the cerebral recovery after ischemia,which will provide substantial morphological basis for the improvement of synaptic reconstruction and recovery from cerebral isehemia by EA at different time after ischemic cerebral injury.
