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Objective:To evaluate the clinical efficacy and safety of a skin care ointment containing oligomeric maltose X in the adjuvant treatment of eczema-related pruritus.Methods:A multicenter, randomized, double-blind, vehicle-controlled clinical study was conducted. From March to September 2021, outpatients with mild to moderate eczema were collected from departments of dermatology of 4 hospitals, including Beijing Friendship Hospital, Hebei Traditional Chinese Medical Hospital, the Third People′s Hospital of Hubei Province, and Taizhou Central Hospital in Zhejiang Province. The patients were randomly divided into two groups by using a random number table: observation group topically treated with a skin care ointment containing oligomeric maltose X, and vehicle control group topically treated with an ointment vehicle. The ointments were applied during the attacks of itching for 14 consecutive days. Visits were scheduled before, 7, and 14 days after the start of the adjuvant treatment. The efficacy was evaluated according to the eczema area and severity index (EASI) and visual analog scale (VAS) , and adverse events were recorded. The efficacy and safety analyses were conducted by using chi-square test and t test. Results:Totally, 232 patients with eczema were enrolled, including 90 males and 142 females, with the age being 40.13 ± 13.36 years; 156 patients were in the observation group, and 76 in the vehicle control group. Before the adjuvant treatment, there were no significant differences in EASI (2.07 ± 2.24 points vs. 2.29 ± 2.28 points) or VAS (6.22 ± 1.78 points vs. 6.20 ± 1.79 points) scores between the observation group and vehicle control group ( t = -0.70, 0.06, P = 0.486, 0.955, respectively) . After one-day treatment, the VAS scores significantly decreased compared with the baseline scores in the two groups ( P < 0.001, P = 0.003, respectively) . After 14-day treatment, the VAS score was significantly lower in the observation group (2.67 points) than in the vehicle control group (3.35 points; t = -2.28, P = 0.024) . After 7- and 14-day treatment, the EASI scores significantly decreased compared with the baseline scores in both the two groups (all P < 0.001) , but there were no significant differences between the two groups ( P = 0.853, 0.731) . No adjuvant treatment-related adverse events were recorded in either of the two groups. Conclusion:The skin care ointment containing oligomeric maltose X is safe and effective in the adjuvant treatment of eczema-related pruritus, and can be applied to clinical practice.
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Objective To investigate the optimal thresholds of the passing rate with different gamma measurement criteria (percent dose difference/DTA) based on the Delta 4 three-dimensional dosimetric verification system in the verification of volumetric modulated arc-therapy (VMAT) plan for cervical cancer.Methods Thirty clinically-approved dual-arc VMAT plans using the RapidArcTM (Varian Medical Systems Inc.) for cervical cancer were randomly selected.The gamma analysis and dose-volume histogram (DVH) evaluation were performed using Delta 4.All the plans were classified according to the following two criteria:1.If the absolute percentage dose errors of all specific dosimetry indices on the DVH were less than 5％,the plan was regarded as clinically acceptable.2.If the gamma passing rate was 90％ or 95％ under the criteria of 2％/2 mm and 3％/3 mm,the plan was regarded as acceptable.The sensitivity and specificity analyses were conducted based on the classification results and the receiver operating characteristic (ROC) curve was plotted.By calculating the Youden Index,the optimal thresholds under different Gamma criteria (global and local 2％/2 mm and 3％/3 mm) were investigated.Finally,the ability of distinguishing the plan was clinically acceptable or not between the conventional and optimal thresholds was quantitatively compared according to the sensitivity and specificity analyses.Results The optimal thresholds under the global 3％/3 mm and 2％/2 mm criteria were 98.3％ and 87.05％;and 97.55％ 、86.05％ for the local gamma analysis.Compared with the conventional thresholds,the sensitivity of the optimal thresholds was 0.93 by using the global and local gamma analyses under the 3％/3 mm criterion.Under the 2％/2 mm criterion,the sensitivity of the optimal thresholds was 0.65 and the specificity was 0.49 by using the global gamma analysis.The sensitivity was 0.7 and the specificity was 0.46 by using the local gamma analysis,suggesting that the sensitivity and the specificity were more balanced under the 2％/2 mm criterion.Conclusions Application of the optimal thresholds in the verification of VMAT plans can maintain the balance between the sensitivity and specificity,prevent the harm of clinically unacceptable plans to patients to certain extent and reduce the probability of increasing the daily work load for physicists due to the misjudgement of clinically acceptable plans.
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Objective To investigate the optimal gamma passing rate of intensity-modulated radiotherapy (IMRT) dosimetric verification in the treatment of esophageal cancer using a three-dimensional dose verification system EDoseTM.Methods Twenty five esophageal cancer patients treated by 7-field IMRT were retrospectively reviewed.Measured dose distribution were reconstructed on CT image and evaluated by gamma analysis and DVH metrics using the EDoseTM system.Plans with DVH metrics dose difference ＜ 5％ or with gamma passing ＞ 90％ under 3％/3 mm criteria were accepted.The optimal gamma passing rate for criteria of 5％/3 mm,3％/3 mm,2％/2 mm were investigated by drawing the receiver operating characteristic (ROC) curves and calculating the Youden Index.The sensitivity and specificity of the these optimal thresholds in the plan verification were also analyzed.Results The optimal thresholds for global gamma indices with 5％/3 mm,3％/3 mm,2％/2 mm were 98.66％,94.84％,78.56％,respectively.In the 90％ common threshold,The sensitivity and specificity for common 90％ threshold and optimal threshold under 3％/3 mm criteria were 0.17 vs.0.85 and t 0.84 vs.0.27,respectively.The sensitivity and specificity were 0.89,0.65 and 0.23,0.47 for optimal thresholds under 5％/3 mm and 2％/2 mm criteria,respectively.Conclusions The sensitivity of optimal threshold gamma passing rate improved significantly compared with the common threshold (90％) at 3％/3 mm criteria.,The sensitivity and the specificity were more balanced at the 2％/2 mm criteria compared with those at 3％/3 mm criteria.
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OBJECTIVE@#To compare the dosimetric differences of dosiology between intensity-modulated arc radiotherapy (IMAT) and dynamic intensity-modulated radiation therapy (dIMRT) in nasopharyngeal carcinoma.@*METHODS@#CT data from 25 patients treated in our radiotherapy center were selected randomly for this study. For each patient, the IMAT technique and the fixed beam dIMRT technique were accomplished by the simultaneously integrated boost. Dose volume histogram (DVH) data, isodose distribution, monitor units (MUs) and treatment time were compared in the two techniques.@*RESULTS@#There was no significant difference between the IMAT and the dIMRT in dose received by 95% of target volumes (D(95)) (P>0.05). Overall, the mean dose (D(mean)), maximal dose (D(max)) and volume percentage receiving at least of 107% of the prescribed dose (V(107%)) of planning target volume (PTV) for the IMAT were increased slightly ,compared with the dlMRT (P0.05). Compared with the dlMRI, the D(max) of brain stem for the IMAT was increased slightly (P<0.05). Similar trends was observed for the D(mean) and dose received by 50% of volume (D(50)) of the left and right parotid glands (P<0.05). Healthy tissue (defined as the volume of the body minus PTV,B-P) irradiated from 800 cGy in the IMAT was higher, and that from 1200-4500 cGy was lower compared with the dlMRI (P<0.05).The average number of MUs was reduced by 62.7% per fraction, and the treatment time was on average reduced by 60.1% per fraction in the IMAT compared with the dlMRI.@*CONCLUSION@#There is a slight difference in dosiology between the two radiotherapy techniques investigated, but they both meet the clinical requirement. Compared with the dIMRT, the IMAT delivers less irradiation to healthy tissue, uses fewer MUs and takes less time during radiotherapy for nasopharyngeal carcinoma.
Subject(s)
Female , Humans , Male , Middle Aged , Carcinoma, Squamous Cell , Radiotherapy , Dose Fractionation, Radiation , Nasopharyngeal Neoplasms , Radiotherapy , Radiometry , Radiotherapy Dosage , Radiotherapy Planning, Computer-Assisted , Methods , Radiotherapy, Intensity-Modulated , MethodsABSTRACT
The immune effect of two recombinant protein fragments of spike protein in severe acute respiratory syndrome coronavirus (SARS CoV) was investigated in Balb/c mice. Two partial spike gene fragments S1 (322-1464 bp) and S2 (2170-2814 bp) of SARS coronavirus were amplified by RT-PCR, and cloned into pET-23a prokaryotic expression vector, then transformed into competent Escherichia E.coli BL21 (DE3)(pLysS) respectively. Recombinant proteins were expressed and purified by Ni2+ immobilized metal ion affinity chromatography. The purified proteins mixed with complete Freund adjuvant were injected into Balb/c mice three times at a two-week interval. High titer antibody was detected in the serum of immunized Balb/c mice, and mice immunized with S1 protein produced high titer IgG1, IgG2a, IgG2b and IgG3, while those immunized with S2 protein produced high titer IgG1, IgG2a, but lower titer IgG2b and IgG3. Serum IFN-γ concentration was increased significantly but the concentrations of IL-2, IL-4 and IL-10 had no significant change. And a marked increase was observed in the number of spleen CD8+ T cells. The results showed that recombinant proteins of SARS coronavirns spike protein induced hormonal and cellular immune response in Balb/c mice.
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The immune effect of two recombinant protein fragments of spike protein in severe acute respiratory syndrome coronavirus (SARS CoV) was investigated in Balb/c mice. Two partial spike gene fragments S1 (322 1464 bp) and S2 (2170 2814 bp) of SARS coronavirus were amplified by RT-PCR, and cloned into pET-23a prokaryotic expression vector, then transformed into competent Escherichia E. coli BL21 (DE3)(pLysS) respectively. Recombinant proteins were expressed and purified by Ni2+ immobilized metal ion affinity chromatography. The purified proteins mixed with complete Freund adjuvant were injected into Balb/c mice three times at a two-week interval. High titer antibody was detected in the serum of immunized Balb/c mice, and mice immunized with S1 protein produced high titer IgG1, IgG2a, IgG2b and IgG3, while those immunized with S2 protein produced high titer IgG1, IgG2a, but lower titer IgG2b and IgG3. Serum IFN-concentration was increased significantly but the concentrations of Il-2, IL-4 and IL-10 had no significant change. And a marked increase was observed in the number of spleen CD8+ T cells. The results showed that recombinant proteins of SARS coronavirus spike protein induced hormonal and cellular immune response in Balb/c mice.
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To construct a recombinant plasmid Pet23a-M, the gene encoding severe acute respiratory syndrome (SARS) coronavirus membrane protein was amplified by RT-PCR and cloned into the expression plasmid Pet23a. Results of restriction endonuclease analysis, PCR detection and DNA sequencing analysis revealed that the cloned DNA sequence was the same as that reported. The recombinants were transformed into Escherichia coli (E. Coli) BL21 (DE3) and induced by Isopropyl-beta-D-thiogalactopyranoside (IPTG). The expression of 27 kD (1 kD=0.992 1 ku) protein was detected by SDS-PAGE and pured by metal chelated chromatography. Results of Western-blot showed that this expressed protein could react with antibodies in sera of SARS patients during convalescence. This provided the basis for the further study on SARS virus vaccine and diagnostic agents.
Subject(s)
Cloning, Molecular , Escherichia coli/genetics , Escherichia coli/metabolism , Membrane Proteins/biosynthesis , Membrane Proteins/genetics , Membrane Proteins/isolation & purification , Plasmids/biosynthesis , Plasmids/genetics , Recombinant Proteins/biosynthesis , Recombinant Proteins/genetics , Recombinant Proteins/isolation & purification , Reverse Transcriptase Polymerase Chain Reaction , Severe acute respiratory syndrome-related coronavirus/chemistry , Severe acute respiratory syndrome-related coronavirus/genetics , Viral Vaccines/biosynthesisABSTRACT
To construct a recombinant plasmid Pet23a-M, the gene encoding severe acute respiratory syndrome (SARS) coronavirus membrane protein was amplified by RT-PCR and cloned into the expression plasmid Pet23a. Results of restriction endonuclease analysis, PCR detection and DNA sequencing analysis revealed that the cloned DNA sequence was the same as that reported. The recombinants were transformed into Escherichia coli (E. Coli) BL21 (DE3) and induced by Isopropyl-beta-D-thiogalactopyranoside (IPTG). The expression of 27 kD (1 kD=0.992 1 ku) protein was detected by SDS-PAGE and pured by metal chelated chromatography. Results of Western-blot showed that this expressed protein could react with antibodies in sera of SARS patients during convalescence. This provided the basis for the further study on SARS virus vaccine and diagnostic agents.
Subject(s)
Humans , Cloning, Molecular , Escherichia coli , Genetics , Metabolism , Membrane Proteins , Genetics , Plasmids , Genetics , Recombinant Proteins , Genetics , Reverse Transcriptase Polymerase Chain Reaction , Severe acute respiratory syndrome-related coronavirus , Chemistry , Genetics , Viral VaccinesABSTRACT
Objective To construct a prokaryotic expression system containing the dense granule protein 4(GRA4) of Toxoplasma gondii,purify the expressed protein and detect its immunogenicity.Methods The specific fragment of GRA4 gene was amplified by PCR.After subcloning the prokaryotic expression recombinant pET,GRA4,the expressed product was purified with His?BindTM affinity chromatography and analyzed by Western blot.BALB/c mice were immunized with the GRA4 recombinant protein,and the antibody IgG titer was detected by ELISA.Results The pET,GRA4 prokaryotic expression system was obtained.The MW of the expressed protein was Mr 40 000 and formed in inclusion body.After purification,the recombinant protein could be specifically recognized by the T.gondii infected rabbit serum.Mice immunized with the purified recombinant protein elicited high titer of IgG antibody.Conclusion The pET,GRA4 recombinant protein was successfully expressed and purified,which shows the immunogenicity.