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ObjectiveDepression is common in patients with primary biliary cholangitis （PBC）， but the role of depression in disease progression remains unclear. This study aims to investigate the association between depression and treatment response and the impact of depression on liver cirrhosis in PBC patients. MethodsA retrospective analysis was performed for the clinical data of 141 patients with PBC who attended the outpatient service of autoimmune liver diseases in General Hospital of Tianjin Medical University from January 2018 to December 2020 and received standard ursodeoxycholic acid （UDCA） monotherapy for 1 year， and 170 healthy controls， matched for age and sex， who underwent physical examination in Physical Examination Center were enrolled as healthy control group. Patient Health Questionnaire-9 （PHQ-9） was used to evaluate depressive state in the patients with PBC and the healthy controls. The independent-samples t test was used for comparison of normally distributed continuous data between two groups， and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups； the chi-square test was used for comparison of categorical data between two groups. The binary logistic regression model and the decision tree model were used to analyze the influencing factors for liver cirrhosis in patients with PBC， as well as the influence of depression and the HLA-DRB1 gene on liver cirrhosis. The receiver operating characteristic （ROC） curve， the area under the ROC curve （AUC）， and goodness of fit were used to evaluate model performance. All 13 variables were used to establish a classification and regression tree （CART） model， i.e.， age， sex， PHQ-9 score， the DRB1*03∶01 gene， and the serum levels of alanine aminotransferase， aspartate aminotransferase， alkaline phosphatase （ALP）， gamma-glutamyl transpeptidase （GGT）， total bilirubin， immunoglobulin G， immunoglobulin M （IgM）， C3， and C4. The indications including AUC， sensitivity， and specificity were used to evaluate the performance of CART model in the model cohort. ResultsCompared with the normal control group， the PBC group had a significantly higher proportion of the patients with depression （53.9% vs 15.3%， χ2=57.836， P<0.001）. Compared with the PBC patients without depression， the PBC patients with depression had a significantly poorer response to UDCA treatment （χ2=7.549， P=0.006） and significant increases in the serum levels of ALP （Z=-2.157， P=0.031）， GGT （Z=-2.180， P=0.029）， and IgM （Z=-2.000， P=0.046）. Compared with the PBC patients without depression， the PBC patients carrying the HLA-DRB1*03∶01 allele had a significant increase in the risk of liver cirrhosis （P<0.001）. The binary logistic regression model analysis showed that PHQ-9 score （OR=1.148， 95%CI： 1.050 — 1.255， P=0.002）， the HLA-DRB1*03∶01 gene （OR=5.150， 95%CI： 1.362 — 19.478， P=0.016）， age （OR=1.057， 95%CI： 1.009 — 1.106， P=0.018）， and serum ALP level （OR=1.009， 95%CI： 1.001 — 1.017， P=0.020） were independent risk factors for liver cirrhosis in patients with PBC. The decision tree analysis showed that PHQ-9 score ≥3.5 was also a risk factor for liver cirrhosis in PBC patients. ConclusionDepression is associated with poor treatment response in patients with PBC， and it is an independent risk factor for liver cirrhosis in patients with PBC. This study highlights the important clinical significance of the identification and early management of depressive state in patients with PBC.
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OBJECTIVE： To establish the method for content determination of ligustilide and to optimize the extraction technology of volatile oil and inclusion technology in Quhan zhufeng granules. METHODS： HPLC method was adopted. The determination was performed on Waters C18 column with mobile phase consisted of methanol-water （70 ∶ 30， V/V） at the flow rate of 1 mL/min. The detection wavelength was set at 327 nm， and the column temperature was 30 ℃. The sample size was 10 μL. Using yield of volatile oil and the content of ligustilide as index， with soaking time， the amount of adding water and extraction time as factors， the extraction technology was optimized by orthogonal test. Using inclusion rate， the yield of inclusion compound and yield of volatile oil as index， with ratio of volatile oil to β-cyclodextrin， inclusion temperature and inclusion time as factors， the inclusion technology of volatile oil was optimized by orthogonal test. RESULTS： The linear range of ligustilide was 0.4-4 μg（r＝0.999 9）； RSDs of precision， stability and reproducibility tests were all lower than 2％ （n＝6）. The recoveries were 96.75％-102.03％（RSD＝2.06％，n＝6）. The optimal extraction technology of volatile oil included 10-fold water （mL/g）， soaking for 15 min， extracting for 8 h. Average yield of volatile oil was 0.310 7％， and average content of ligustilide was 0.418 0 mg/g. The optimal inclusion technology of volatile oil included ratio of β-cyclodextrin and volatile oil was 1 ∶ 8 （mL/g）； inclusion temperature was 50 ℃； inclusion time was 3 h. Average inclusion rate was 69.43％， and the yield of inclusion compound was 58.89％； the yield of volatile oil was 14.15％. CONCLUSIONS： Established determination method is simple， accurate and stable. The optimal extraction technology of volatile oil and inclusion technology are stable and feasible.
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Objective To establish the quality standard of flavone extracts in licorice residue; To provide the methods and basis for the quality control of total flavonoids extracted from licorice residue.Methods TLC was applied to compare the extracts with liquiritin and licorice; UV-spectrophotometry was used to measure the content of total flavones; EDTA-2Na titration was used to determine the content of calciumion.Results In the chromatogram of the test product, the spots of the same color were displayed on the corresponding position of the control medicinal material, and the fluorescent spots of the same color were displayed on the corresponding position of the control product. UV-spectrophotometry showed glycyrrhizin had a good linear relationship in the range of 3.32–9.96 μg/mL (r=0.9997), the absorbance between 0.3 and 0.7. The average recovery rate was 102.41% (RSD=3.22%), and the average content of total flavonoids in three batches of flavonoids extract was 8.82%. The average content of calciumion was 0.107% (RSD=3.61%).Conclusion This method has good repeatability, high sensitivity and accurate results, and can be used for the quality control of flavonoids in licorice residue.
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OBJECTIVE:To optimize the purification process of the extract from Yiqi guben granules. METHODS:The purifi-cation effect of the process was investigated with transfer rate of polysaccharide,calycosin glucoside and dry paste as evaluation in-dexes,using ZTC1+1 type Ⅱ,and shell poly sugar and 95% ethanol as clarifying agents. The purification process of the extract from Yiqi guben granules was optimized by orthogonal test using the ratio of material to liquid,the amount of clarifying agent and standing time as factor. The validation test was conducted. RESULTS:Selecting ZTC1+1 type Ⅱ as a clarifying agent,the best trans-fer rate of effective component had been obtained;optimal purification process was as follows as the ratio of material to liquid 1:2, the ratio of ZTC1+1 type Ⅱ A liquid 5%,the ratio of B liquid 10%,standing time of 5 h. The results of verification test showed transfer rates of dry paste in 3 tests were 71.54%,70.98%,69.21%,respectively;those of polysaccharide were 82.55%, 81.78%,82.15%,respectively;those of calycosin glucoside were 91.92%,92.34%,91.58%,respectively (all RSD≤1.72%, n=3). CONCLUSIONS:The optimized purification process is effective,stable and practical,and can be used for the purification of the extract from Yiqi guben granules.
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Objective To optimize the prescription of flaxseed lignans sustained release tables by central composite design-response surface methodology.MethodsWith HPMC, EC and starch dosage as factors, and flaxseed lignans in 2, 6 and 12 h of cumulative release as evaluation indexes, central composite design-response surface optimization method was used to conduct prescription optimization experiments, and optimized prescription analysis was carried out.Results The optimal prescription of flaxseed lignans sustained release tables was as following: HPMC dosage was 43%; EC was 26%; starch content was 17%. Optimized index forecast values were very close to the observed values. In vitro release test of three selected optimal formulations indicated that there existed high approximation between the observed and estimated values.Conclusion It shows that the established model is suitable for flaxseed lignans sustained release tables, which can be used in the optimization of the prescription of flaxseed lignans sustained release tables.
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Objective To develop an HPLC method for determination of paeoniflorin in Fufang Chishao Granula. Methods The separation was performed on a Waters C18 column (250 mm× 4.6 mm, 5μm) with acetonitrile-water (30∶70) as the mobile phase at the flow rate of 1.0 mL/min. The detection wavelength was set at 230 nm. Results Paeoniflorin showed good linearity (r=0.999 9) in the range of 0.266-5.32 μg, and the average recovery was 98.00%, RSD=2.22%. Conclusion The method is convenient, sensitive, accurate and repeatable. It can be applied to determination of paeoniflorin in Fufang Chishao Granula and control the quality of the preparation.
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Objective To investigate the efficacy of treatment on malignant intracranial gliomas with the chemotherapy of intracerebral implantation of 5-Fu biodegradable polymers combined with radiotherapy of interstitial implantation of 125Ⅰ after microsurgery resection. Methods Sixty-five patients with malignant intracranial gliomas who had underwent craniotomy microsurgical resection were intraoperatively implanted in the tumor bed around with 5-Fu biodegradable polymers and 125Ⅰ seeds. After first implantation (3 months to 1 year), stereotactic guided implantation was carried out 1 or 2 times again. The patients were followed up for 6-36 months to observe the efficacy, edema and adverse reactions, compared with follow-up of 40 patients with malignant intracranial gliomas treated by conventional radiotherapy and chemotherapy after microsurgical total resection. Results Within 1 week after the implantation the patients had headache significantly, WBC of cerebrospinal fluid was increased to some degrees, and edema was obvious compared with surgery alone. All patients were treated and discharged. Forty-four patients were completely followed-up and the survival period was significantly longer. Within 6 months, 1 year, 2 years and 3 years, there were 4 cases (9.1 %) of recurrence and no case of death, 14 cases (31.8 %) of recurrence and no case of death, 20 cases (45.5 %) of recurrence and 12 cases (27.6 %) of death and 29 cases (65.9 %) of recurrence and 20 cases(45.5 %) of death, respectively. No obviously adverse reactions were found and the quality of life was significantly improved. Conclusion Microsurgical total resection is the key of the treatment. It is an alternative treatment of human malignant gliomas in the safe and effective way that the local chemotherapy of intracerebral implantation of 5-Fu biodegradable polymers combined with local sensitivity radiotherapy of interstitial implantation of 125Ⅰ after microsurgical resection.
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Objective To establish the determination of luteolin and 1,7-dihydroxy-3,8-dimethoxyxanthone in Herbal Gentianopsis paludosa. Method The RP-HPLC with ZORBAX SB-C18 (250 mm?4.6 mm, 5 ?m) comlum was used. Mobile phase was methanol (A)-0.4% H3PO4 (B) Gradient elution was used, 0～15 min, A∶B=50∶50, 15～60 min, A∶B=55∶45. Detection wavelengh was 260 nm. Flow rate was 1.0 mL/min. Temperature of column was 30 ℃. Result The linear relationship of 1,7-dihydroxy-3,8-dimethoxyxanthone and luteolin were showed at the range of 0.084～0.84 ?g and 0.184～1.84 ?g (r=0.999 4 and r =0.999 7). The average recovery rate of 1,7-dihydroxy-3,8-dimethoxyxanthone and luteolin were 96.82% and 97.19%, RSD