1.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
2.Effects of obesity on alveolar bone resorption and gut microbiota in periodontitis mice
Lichun ZHENG ; Rixin CHEN ; Nannan WANG ; Min WANG ; Jun QIAN ; Lili LI ; Fuhua YAN
Chinese Journal of Stomatology 2025;60(5):482-491
Objective:To study the effects of obesity on alveolar bone loss and gut microbiota in mice with periodontitis.Methods:Twenty-four seven-week-old female C57BL/6J mice were randomly divided into four groups based on table of random numbers ( n=6 in each group): normal-fat diet group (NFD group), high-fat diet group (HFD group), normal-fat diet and periodontitis group (NFD_PD group) and high-fat diet and periodontitis group (HFD_PD group). NFD and HFD groups were fed with normal or high-fat diet for twelve weeks respectively; NFD_PD and HFD_PD groups were induced to periodontitis by ligating the bilateral maxillary second molars with 5-0 silk thread at the fourth week after feeding with normal or high-fat diet respectively. The body weight was measured weekly. The mice were euthanized for collecting the samples at the end of the 12th week. Liver, kidneys, perirenal and retroperitoneal fat were weighed. Serum was collected to detect the level of serum lipids and inflammatory factors. The right maxilla bones were scanned by micro-CT. HE staining was performed to observe the periodontal tissue. The cecum contents were collected for gut microbiota 16S rRNA gene sequencing. Spearman correlation analysis was performed to analyze the correlation between the abundance of gut microbiota and serum inflammatory level and CT value. Results:After 12 weeks of high-fat diet fed, the body weight of HFD group [(26.52±1.96) g] was significantly higher than that of NFD group [(20.95±0.63) g] ( t=6.63, P<0.001). The body weight of HFD_PD group [(23.82±1.12) g] was significantly higher than that of NFD_PD group [(20.73±0.47) g] ( t=6.23, P=0.001). The serum levels of total cholesterol, triglyceride and low density lipoprotein in HFD group and HFD_PD group were significantly higher than those in NFD group and NFD_PD group ( P<0.01). The distance from the cemento-enamel junction to the alveolar bone crest (CEJ-ABC) on the mesial site of maxillary second molar in HFD_PD group [(647.46±47.46) μm] was significantly higher than that in NFD_PD group [(440.48±68.08) μm] ( t=5.58, P<0.001). HE staining showed that the maxillary second molar attachment loss, collagen fiber destruction and inflammatory cell infiltration were more significant serious in HFD_PD group compared with NFD_PD group. The levels of interleukin (IL)-1β, IL-6 and monocyte chemotactic protein-1 (MCP-1) of serum in HFD_PD group [(17.11±1.92), (31.61±3.20) and (204.42±35.96) ng/L, respectively] were significantly higher than those in NFD_PD group [(10.44±1.65), (19.96±2.09) and (147.36±10.76) ng/L, respectively] ( P<0.001, P<0.001, P=0.004). The 16S rRNA gene analysis revealed that the Bacteroides/Firmicutes ratio in HFD_PD group (4.00±3.30) was significantly higher than that in NFD_PD group (0.62±0.19) ( t=2.50, P=0.030). The abundance of Oscillospira in HFD_PD group [(12.25±0.05) %] was significantly higher than that in NFD_PD group [(2.80±0.01) %] ( t=4.64, P<0.001). The abundance of Parabacteroides in HFD_PD group [(0.25±0.27)% ] was significantly lower than that in NFD_PD group [(2.04±0.02)%] ( t=2.32, P=0.043). The β-diversity analysis of gut microbiota based on Bray-Curtis distance showed that samples of HFD_PD group and NFD_PD group were obviously grouped. Correlation analysis showed that the abundance of Oscillospira was positively correlated with IL-1β, IL-6, MCP-1 concentration and CEJ-ABC value in serum significantly ( r values were 0.80, 0.79, 0.80, 0.89, P<0.05). The abundance of Parabacteroides was negatively correlated with IL-1β, IL-6 concentration and CEJ-ABC value in serum significantly ( r values were -0.71, -0.71, -0.86, -0.95, P<0.05). Conclusions:Obesity promotes alveolar bone resorption in periodontitis mice and changes the gut microbiota. Oscillospira and Parabacteroides may play a key role.
3.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
4.Effects of obesity on alveolar bone resorption and gut microbiota in periodontitis mice
Lichun ZHENG ; Rixin CHEN ; Nannan WANG ; Min WANG ; Jun QIAN ; Lili LI ; Fuhua YAN
Chinese Journal of Stomatology 2025;60(5):482-491
Objective:To study the effects of obesity on alveolar bone loss and gut microbiota in mice with periodontitis.Methods:Twenty-four seven-week-old female C57BL/6J mice were randomly divided into four groups based on table of random numbers ( n=6 in each group): normal-fat diet group (NFD group), high-fat diet group (HFD group), normal-fat diet and periodontitis group (NFD_PD group) and high-fat diet and periodontitis group (HFD_PD group). NFD and HFD groups were fed with normal or high-fat diet for twelve weeks respectively; NFD_PD and HFD_PD groups were induced to periodontitis by ligating the bilateral maxillary second molars with 5-0 silk thread at the fourth week after feeding with normal or high-fat diet respectively. The body weight was measured weekly. The mice were euthanized for collecting the samples at the end of the 12th week. Liver, kidneys, perirenal and retroperitoneal fat were weighed. Serum was collected to detect the level of serum lipids and inflammatory factors. The right maxilla bones were scanned by micro-CT. HE staining was performed to observe the periodontal tissue. The cecum contents were collected for gut microbiota 16S rRNA gene sequencing. Spearman correlation analysis was performed to analyze the correlation between the abundance of gut microbiota and serum inflammatory level and CT value. Results:After 12 weeks of high-fat diet fed, the body weight of HFD group [(26.52±1.96) g] was significantly higher than that of NFD group [(20.95±0.63) g] ( t=6.63, P<0.001). The body weight of HFD_PD group [(23.82±1.12) g] was significantly higher than that of NFD_PD group [(20.73±0.47) g] ( t=6.23, P=0.001). The serum levels of total cholesterol, triglyceride and low density lipoprotein in HFD group and HFD_PD group were significantly higher than those in NFD group and NFD_PD group ( P<0.01). The distance from the cemento-enamel junction to the alveolar bone crest (CEJ-ABC) on the mesial site of maxillary second molar in HFD_PD group [(647.46±47.46) μm] was significantly higher than that in NFD_PD group [(440.48±68.08) μm] ( t=5.58, P<0.001). HE staining showed that the maxillary second molar attachment loss, collagen fiber destruction and inflammatory cell infiltration were more significant serious in HFD_PD group compared with NFD_PD group. The levels of interleukin (IL)-1β, IL-6 and monocyte chemotactic protein-1 (MCP-1) of serum in HFD_PD group [(17.11±1.92), (31.61±3.20) and (204.42±35.96) ng/L, respectively] were significantly higher than those in NFD_PD group [(10.44±1.65), (19.96±2.09) and (147.36±10.76) ng/L, respectively] ( P<0.001, P<0.001, P=0.004). The 16S rRNA gene analysis revealed that the Bacteroides/Firmicutes ratio in HFD_PD group (4.00±3.30) was significantly higher than that in NFD_PD group (0.62±0.19) ( t=2.50, P=0.030). The abundance of Oscillospira in HFD_PD group [(12.25±0.05) %] was significantly higher than that in NFD_PD group [(2.80±0.01) %] ( t=4.64, P<0.001). The abundance of Parabacteroides in HFD_PD group [(0.25±0.27)% ] was significantly lower than that in NFD_PD group [(2.04±0.02)%] ( t=2.32, P=0.043). The β-diversity analysis of gut microbiota based on Bray-Curtis distance showed that samples of HFD_PD group and NFD_PD group were obviously grouped. Correlation analysis showed that the abundance of Oscillospira was positively correlated with IL-1β, IL-6, MCP-1 concentration and CEJ-ABC value in serum significantly ( r values were 0.80, 0.79, 0.80, 0.89, P<0.05). The abundance of Parabacteroides was negatively correlated with IL-1β, IL-6 concentration and CEJ-ABC value in serum significantly ( r values were -0.71, -0.71, -0.86, -0.95, P<0.05). Conclusions:Obesity promotes alveolar bone resorption in periodontitis mice and changes the gut microbiota. Oscillospira and Parabacteroides may play a key role.
5.Multi-criteria decision model in treatment of adolescent scoliosis with three-dimensional printed scoliosis orthosis
Hongsheng ZHANG ; Hanwei HUANG ; Jinwu WANG ; Junwei ZHENG ; Rixin LIU ; Zijie LIAO ; Peng WANG ; Yuanjing XU ; Zanbo WANG ; Keming WAN
Chinese Journal of Tissue Engineering Research 2024;28(30):4806-4811
BACKGROUND:Traditional scoliosis orthosis has some disadvantages,such as complex manufacturing process,long processing cycle,poor fit and so on.Three-dimensional printed scoliosis orthosis has the advantages of high manufacturing precision and personalization. OBJECTIVE:To evaluate the efficacy of three-dimensional printed scoliosis orthosis for scoliosis based on multi-criteria decision model. METHODS:Clinical data of 72 patients with scoliosis admitted to Chen Xinghai Hospital of Integrated Traditional Chinese and Western Medicine from January 2019 to October 2022 were retrospectively collected and divided into two groups according to the treatment of orthosis.Study group(n=23)received three-dimensional printed scoliosis orthosis.Traditional group(n=49)received the traditional polypropylene spine brace treatment.The clinical efficacy and complications were compared between the two groups.A multi-criteria decision model for the treatment of scoliosis with three-dimensional printed scoliosis orthosis was established,and the stability of the benefit value,risk value and decision model of the two groups were evaluated. RESULTS AND CONCLUSION:(1)Compared with the traditional group,there were significant differences in the top vertebral offset distance,Cobb angle,top vertebral rotation,Functional Movement Screen score,visual analog scale score and total effective rate in the study group at 6 months after surgery(P<0.05).(2)Among the benefit indexes,Cobb angle had the greatest impact on the condition of patients,while the risk indexes had the greatest impact on dyspnea.(3)The benefit values of the study group and the traditional group for scoliosis were 79 and 64,and the risk values were 74 and 57,respectively.The combined benefit and risk values found that the benefit-risk value of the study group was 16 higher than that of the traditional group.(4)In the range of 0-100%relative risk weight,the benefit-risk value of the study group was always higher than that of the traditional group,which proved that the multi-criteria decision-making model had good stability.(5)It is indicated that three-dimensional printed scoliosis orthosis can better restore the physiological curvature of scoliosis and improve the efficiency of treatment.
6.Exploring Efficacy and Mechanism of Saffron Floral Bio-residues for Treatment of Hyperuricemia Combined with Gouty Arthritis Based on Compound Compatibility Environment
Jiping WU ; Qingqing LI ; Lan WANG ; Xiaojie YIN ; Shuyi FENG ; Zhihao WANG ; Rixin LIANG ; Bin YANG ; Zhiyong LI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(23):129-140
ObjectiveTo investigate the efficacy and mechanism of saffron floral bio-residues(SFB) in the treatment of hyperuricemia(HUA) combined with gouty arthritis(GA) in a compound compatibility setting. MethodScreening candidate control Chinese medicines for compound and SFB based on network target distance calculation and data analysis. After adaptive feeding of 80 SD rats for 7 days, 10 rats were randomly selected as the blank group, while the remaining 70 rats were intraperitoneally injected with 3% potassium oxonate and orally administered with 1% adenine for 14 consecutive days. On the 13th day, rats were injected with 2.5% sodium urate solution into the right ankle joint cavity to induce swelling of the joint capsule on the opposite side, inducing a HUA combined with GA model. At the same time, the modeling rats were randomly divided into 7 groups, including the model group, benzbromarone group(positive drug, 0.02 g·kg-1), Tongfengshu tablets group(9 g·kg-1), Tongfengshu granules group(9 g·kg-1), SFB granules group(3.6 g·kg-1), Plantaginis Semen granules group(3.6 g·kg-1), and new formula group(SFB replacing Plantaginis Semen in Tongfengshu granules, 9 g·kg-1), with 10 rats in each group. Each treatment group was orally administered with the corresponding drugs according to body weight, while the control and model groups were given equal volume of distilled water by gavage once a day for 14 consecutive days. After 14 days of synchronous administration and modeling, changes in gait, ankle joint swelling and mechanical pain threshold in rats were observed, and serum uric acid, creatinine, urea nitrogen and xanthine oxidase(XOD) were measured. Enzyme-linked immunosorbent assay(ELSIA) was used to detect the levels of tumor necrosis factor(TNF)-α, interleukin(IL)-1β and IL-6 in rat serum, hematoxylin-eosin(HE) staining was used to observe the pathological changes in the liver, kidney and ankle joints of rats, Western blot was used to detect the expression levels of uric acid transporter 1(URAT1), glucose transporter 9 (GLUT9), organic anion transporter 1(OAT1), adenosine triphosphate(ATP) binding cassette transporter G2(ABCG2), and liver XOD proteins. ResultThrough network pharmacology analysis, Plantaginis Semen was selected as a candidate control herb, and Tongfengshu tablets was used as a compound compatibility environment to explore the efficacy of SFB in reducing blood uric acid levels and treating GA. Animal experiments showed that compared with the blank group, the gait score and joint swelling degree of the model group were significantly increased, and the mechanical pain threshold was significantly decreased(P<0.01). Compared with the model group, the gait score, joint swelling degree and mechanical pain threshold of rats in each medication group were improved to varying degrees. Biochemical indicators showed that compared with the blank group, the serum uric acid, creatinine, urea nitrogen and XOD levels of the model group were significantly increased(P<0.01). Compared with the model group, the serum uric acid and XOD levels of rats in each treatment group were significantly decreased(P<0.01). ELISA results showed that compared with the blank group, the levels of serum TNF-α, IL-1β and IL-6 in the model group were significantly increased(P<0.01). Compared with the model group, the levels of TNF-α, IL-1β and IL-6 in the benzbromarone group, Tongfengshu tablets group, Tongfengshu granules group and new formula group were significantly reduced(P<0.05,P<0.01). Western blot results showed that compared with the blank group, the expression levels of URAT1 and GLUT9 proteins in renal tissue and OXD protein in liver tissue of the model group were significantly increased, while the expression levels of renal OAT1 and ABCG2 were significantly decreased(P<0.01). Compared with the model group, the expression levels of renal URAT1 and GLUT9 in the SFB granules group, Tongfengshu granules group and new formula group were significantly decreased, while the expression levels of renal OAT1 and ABCG2 were significantly increased, and the expression of XOD protein in liver tissue was significantly decreased(P<0.05, P<0.01). Pathological analysis showed that focal infiltration of neutrophils, cell necrosis and nuclear fragmentation were observed in the liver tissue of the model group, sodium urate deposition crystals and tubular dilation appeared in renal tissue, synovial hyperplasia and inflammatory cell infiltration appeared in ankle joint. Compared with the model group, the abnormal degrees of liver, kidney and ankle joint tissue of rats in each treatment group were alleviated. ConclusionThe new formula of SFB replacing Plantaginis Semen has the same effect in the treatment of HUA combined with GA. This study proposes a new strategy to investigate the efficacy of new resources of Chinese medicine in a compound compatibility environment, which can provide a new demonstration for the research and development of new resources of Chinese medicine.
7.Infection and treatment of surgical site infection after inguinal hernia repair for obesity patients
Kai LI ; Yong WANG ; Xin DUAN ; Ling ZHU ; Zhi ZHENG ; Rixin ZHANG
Chinese Journal of Endocrine Surgery 2017;11(3):233-235
Objective To evaluate the effect of obesity on the incidence of surgical site infection (SSI) in patients with inguinal hernia after tensionless repair and its treatment.Methods Clinical data of 628 cases with inguinal hernia undergoing tensionless repair from Sep.2008 to May.2016 were retrospectively analyzed.The 628 patients were divided into obesity group (n=150) and non-obesity group (n=478),or SSI group (n=9) and non-SSI group(n=619).The effect of obesity on SSI after inguinal hernia and its treatment was analyzed.Re sults Among the 628 patients,SSC happened to 9 patients and the incidence was 1.43%.The rate of SSI in obesity group and non-obesity group was 4.00% (6/150) and 0.63% (3/478),respectively (x=6.960,P=0.002).BMI was 30.92±3.03 and 26.24±3.79 respectively in SSI group and non-SSI group (t=3.686,P=0.000).The difference has statistical significance.Factors such as diabetes,age,sex,albumin levels,American society of anesthesiology (ASA),type of hernia,method and duration of operation had no significant difference between SSI group and non-SSI group (P>0.05).Conclusion By analyzing the risk factors of SSI after tensionless hernia repair,we find that patients with obesity are more likely to have SSI.Strengthening prevention and early treatment is a key measure to prevent postoperative infection in these patients.
8.Evaluation on Transdermal Absorption Properties and Efficacy of Huoxue Zhitong ;Cataplasm
Yao YAO ; Weihong FENG ; Lan WANG ; Hong YI ; Rixin LIANG ; Aiping HE ; Xiaojie YIN ; Maobo DU ; Shuzhi LIU
Chinese Journal of Information on Traditional Chinese Medicine 2017;24(2):70-75
Objective To study the effects of microemulsion/ethosomes on transdermal absorption properties and efficacy of Huoxue Zhitong Cataplasm. Methods The improved Franz diffusion cells were used for the in-vitro permeation experiment with rat skins as the barriers, which was used to evaluate the transdermal absorption properties. In the erxeriment, the contents of paeonol, eugenol and methyl salicylate were used as markers, and detected by ultra performance liquid chromatography to evaluate the transdermal absorption effects. The anti-inflammatory and analgesia activity were evaluated through the writhing plate experiments. Results The cumulative release rate of paeonol in Huoxue Zhitong Cataplasm, Microemulsion Huoxue Zhitong Cataplasm and Ethosomes Huoxue Zhitong Cataplasm were, in order, 65.30%, 61.30%and 60.20%in 24 h;eugenol were, in order, 51.08%, 54.71% and 55.66% in 24 h; methyl salicylate were, in order, 49.20%, 65.17% and 72.15% in 24 h. Furthermore, Microemulsion Huoxue Zhitong Cataplasm high-dose group and Ethosomes Huoxue Zhitong Cataplasm medium-dose group had good effects on reducing the inflammatory exudate of peritoneal capillary and capillary permeability (P<0.05) in animal models. Conclusion Huoxue Zhitong Cataplasm based on microemulsion/ethosomesnano-technology has good transdermal absorption properties and efficacy.
9.Correlation study between ratio of aldosterone to renin and heart rate variability, QT interval in patients with essential hypertension
Min DENG ; Daxin WANG ; Yong XIE ; Shenghu HE ; Xiujue ZHANG ; Qingyong ZHU ; Yong CHENG ; Rixin XU
Journal of Clinical Medicine in Practice 2017;21(19):6-9,13
Objective To study the correlation between aldosterone/renin ratio (ARR) and heart rate variability (HRV),QT interval in patients with essential hypertension.Methods A total of 179 people were divided into two groups according to median number of ARR,and 24 h Holter,24 h ambulatory blood pressure,ECG,serum potassium,serum sodium were monitored,then HRV and QT interval index were compared between the two groups.Results There were significant differences between the two groups in SDNN,SDNN index,SDANN index,RMSSD,QTc,blood potassium,sodium (P < 0.05),while gender,age,diabetes,smoking,BMI,average heart rate,heart rate standard deviation showed no significant difference.At the same time,correction factors showed that ARR was still negatively correlated with SDNN,SDNN Index,SDANN Index,RMSSD,serum potassium (r =-0.444,-0.677,-0.381,-0.623,-0.432,P < 0.05),andwaspositivelycorrelated with QTc,serum sodium (r =0.391,0.379,P < 0.05).Multivariate logistic regression analysis showed that SDNN,SDNN Index,SDANN Index were the independent factors related to ARR (P <0.05).Conclusion High aldosterone is closely related to heart rate variability reduction.
10.Correlation study between ratio of aldosterone to renin and heart rate variability, QT interval in patients with essential hypertension
Min DENG ; Daxin WANG ; Yong XIE ; Shenghu HE ; Xiujue ZHANG ; Qingyong ZHU ; Yong CHENG ; Rixin XU
Journal of Clinical Medicine in Practice 2017;21(19):6-9,13
Objective To study the correlation between aldosterone/renin ratio (ARR) and heart rate variability (HRV),QT interval in patients with essential hypertension.Methods A total of 179 people were divided into two groups according to median number of ARR,and 24 h Holter,24 h ambulatory blood pressure,ECG,serum potassium,serum sodium were monitored,then HRV and QT interval index were compared between the two groups.Results There were significant differences between the two groups in SDNN,SDNN index,SDANN index,RMSSD,QTc,blood potassium,sodium (P < 0.05),while gender,age,diabetes,smoking,BMI,average heart rate,heart rate standard deviation showed no significant difference.At the same time,correction factors showed that ARR was still negatively correlated with SDNN,SDNN Index,SDANN Index,RMSSD,serum potassium (r =-0.444,-0.677,-0.381,-0.623,-0.432,P < 0.05),andwaspositivelycorrelated with QTc,serum sodium (r =0.391,0.379,P < 0.05).Multivariate logistic regression analysis showed that SDNN,SDNN Index,SDANN Index were the independent factors related to ARR (P <0.05).Conclusion High aldosterone is closely related to heart rate variability reduction.

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