1.Study on the improvement of quality standard for Psidii Guajavae Folium
Dingding GUO ; Han WANG ; Ran JING ; Cong LIU ; Yuexin WANG ; Shaowei LYU
China Pharmacy 2026;37(15):2009-2015
OBJECTIVE To upgrade and perfect the quality standard of Psidii Guajavae Folium. METHODS A total of 24 batches of Psidii Guajavae Folium samples were adopted in this study. The macroscopic traits and powder microscopic features of the medicinal materials were observed, and thin-layer chromatography (TLC) identification was carried out. In accordance with corresponding methods documented in Volume Ⅳ of the 2025 edition of the Chinese Pharmacopoeia, multiple indexes were determined, including foreign matter, moisture, total ash, acid-insoluble ash, water-soluble extractives, heavy metals (lead, cadmium, copper, arsenic, mercury) as well as residues of 47 prohibited pesticides. A high-performance liquid chromatography (HPLC) method was established to quantify guaijaverin in Psidii Guajavae Folium. Meanwhile, the HPLC fingerprint of the herb was constructed, followed by similarity evaluation and cluster analysis of all samples. RESULTS The macroscopic traits of Psidii Guajavae Folium complied with relevant specifications of quality standards. Distinct microscopic characteristics were observed in medicinal powder, including non-glandular hairs, calcium oxalate crystals, vessels and stomata. TLC results revealed identical fluorescent spots at positions corresponding to the guaijaverin reference substance on chromatograms of test samples. Among the 24 batches of samples, the detection ranges were 0.3%-2.8% for foreign matter, 5.1%-10.7% for moisture, 5.3%-7.2% for total ash, 0.4%-1.8% for acid-insoluble ash, and 11.8%-26.3% for water-soluble extractives. The test results of heavy metals, harmful elements and prohibited pesticide residues all satisfied the Chinese Pharmacopoeia limit criteria. Methodological validation of content determination and fingerprint analysis met relevant validation requirements. The guaijaverin content of the 24 batches ranged from 0.14% to 0.28%. The HPLC fingerprint similarity values of all samples fluctuated between 0.828 and 0.997; fifteen common peaks were calibrated, six of which were chemically identified. The 24 batches were divided into two major clusters, and cluster classification showed high consistency with sample origins. CONCLUSIONS This research optimizes the TLC identification protocol of Psidii Guajavae Folium and supplements new quality control items including quantitative assay and chromatographic fingerprint. Tentative quality limits are proposed as follows: moisture ≤12.0%, total ash ≤8.0%, water-soluble extractives ≥10.0%, and guaijaverin content ≥0.14% (calculated based on dry products).
2.Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection
Shaowei HAN ; Zijie DENG ; Tao LYU ; Nansong WANG ; Jiajing ZENG
China Pharmacy 2024;35(22):2789-2792
OBJECTIVE To evaluate the therapeutic efficacy and safety of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori (Hp) infection. METHODS From March 2022 to August 2023, 198 treatment-naive patients with Hp infection treated at the outpatient service of department of gastroenterology in our hospital were assigned to the vonoprazan- based triple therapy group (VAC group, n=98) and the bismuth-based quadruple therapy group (BQT group, n=100) using the random number table method. Patients in VAC group were given Vonoprazan fumarate tablets (20 mg) + Amoxicillin capsules (1 g) + Clarithromycin tablets (0.5 g), all twice daily. Patients in BQT group were given Esomeprazole magnesium enteric-coated tablets (20 mg, twice daily) + Metronidazole tablets (0.4 g, four times daily) + Tetracycline tablets (0.5 g, three times daily) + Bismuth potassium citrate capsules (0.6 g, twice daily). The treatment course for both groups was 14 days. The Hp eradication rates were compared between the two groups in intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analysis sets, while adverse reaction occurrence and medication compliance of two groups were recorded. RESULTS In the ITT, MITT and PP analyses sets, the Hp eradication rates in VAC group were non-inferior to those in BQT group. The incidences of grades 1-2 nausea, vomiting, and loss of appetite in VAC group were significantly lower than in BQT group, and the proportion of patients with good compliance was significantly higher in VAC group (P<0.05). Regardless of whether the body mass index (BMI) ≤25 kg/m2 or >25 kg/m2, no statistically significant difference was observed in the Hp eradication rates between the two groups (P>0.05). CONCLUSIONS Vonoprazan-based triple therapy is non-inferior to bismuth-based quadruple therapy in the treatment of treatment-naive patients with Hp infection, with higher safety and good patient medication compliance. BMI has no significant impact on the Hp eradication rate.
3.Randomized controlled study of vonoprazan dual therapy and bismuth-containing quadruple therapy with low resistance antibiotics in the treatment of Helicobacter pylori infection
Zijie DENG ; Shaowei HAN ; Mingfeng XU ; Xiaoyu LIU ; Chun NING ; Tao LYU
Chinese Journal of Digestion 2024;44(12):800-805
Objective:To evaluate the efficacy, adverse reactions and compliance of vonoprazan (VPZ) dual therapy and bismuth-containing quadruple therapy with low-resistance antibiotics in the initial treatment of primary Helicobacter pylori ( H. pylori) infection. Methods:From March 7, 2022 to August 25, 2023, a total of 200 patients with H. pylori infection who visited the Department of Gastroenterology and Hepatology of the University of Hong Kong-Shenzhen Hospital were selected. According to the random number table method, the patients were randomly divided into the VPZ combined with amoxicillin treatment group (hereinafter referred as VPZ dual therapy group) and the proton pump inhibitor (PPI), tetracycline, full-dose (1 600 mg/d) metronidazole and bismuth treatment group (hereinafter referred as PPI quadruple therapy group). The patients of VPZ dual therapy group were given VPZ 20 mg (twice a day) combined with amoxicillin 1 000 mg (3 times a day), and the patients of PPI quadruple therapy group were given esomeprazol 20 mg (2 times a day), bismuth 0.6 g (twice a day), metronidazole 400 mg (4 times a day), and tetracycline 500 mg (3 times a day). The patients of both groups were treated for 14 days. The H. pylori infection status was re-examined 4 weeks after drug withdrawal. The results were analyzed by intention-to-treat (ITT) analysis, modified ITT analysis and per-protocol analysis (PPA). One-sided μ test was used for non-inferiority evaluation, and two-sided 95% confidence interval (95% CI) was obtained. Chi-square test was used for statistical analysis. Results:In the ITT analysis, 92.0% (92/100) of patients in the VPZ dual therapy group and 77.0% (77/100) of patients in the PPI quadruple therapy group completed the 14-day treatment, and the difference was statistically significant ( χ2=8.59, P=0.003). In the ITT analysis, the H. pylori eradication rates in the VPZ dual therapy group and the PPI quadruple therapy group were 96.0% (96/100) and 92.0% (92/100), respectively, and the difference was statistically significant (difference=4.0%, 95% CI -2.9% to 11.5%, P<0.001). In the modified ITT analysis, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 97.0% (96/99) and 95.8% (92/96), respectively, and the difference was statistically significant (difference=1.1%, 95% CI -4.9% to 7.6%, P=0.002). In the PPA, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 96.7% (89/92) and 97.4% (75/77), respectively, and the difference was statistically significant (difference=-0.7%, 95% CI -6.9% to 6.1%, P=0.009). In the ITT analysis, the incidence of adverse reaction in the VPZ dual therapy group was lower than that in the PPI quadruple therapy group (39.0%, 39/100 vs. 71.0%, 71/100), and the difference was statistically significant ( χ2=20.69, P<0.001). Conclusion:In initial treatment of H. pylori infection, the eradication rate of VPZ dual therapy is non-inferior to that of PPI quadruple therapy, and VPZ dual therapy demonstrates higher safety.
4.Exploring the feasibility of endoscopic surgery by gastrointestinal surgeons: surgeon′s perspective
Jun LUO ; Bei LI ; Ying YU ; Tingting HUANG ; Lan CHEN ; Meiwen HE ; Shaowei XIONG ; Mingxuan ZHU ; Zhanlong SHEN ; Guoqing LYU
Chinese Journal of Digestive Surgery 2024;23(8):1123-1126
Due to traditional professional divisions, the practice of endoscopy by gastro-intestinal surgeons in China remains controversial. However, with the evolution of treatment philo-sophies, medical technology, and equipment advancements, a trend of integration between tradi-tional surgery and endoscopy is emerging. Gastrointestinal surgeons performing endoscopy can maxi-mize patient benefits, and they naturally possess advantages in conducting endoscopic procedures. It is recommended to further establish entry thresholds for surgeons to perform endoscopy, provide standardized endoscopic training for surgeons, and coordinate efforts at the administrative depart-ment. With the support of artificial intelligence, more patients can receive minimally invasive, indivi-dualized, and precise treatments.
5.Randomized controlled study of vonoprazan dual therapy and bismuth-containing quadruple therapy with low resistance antibiotics in the treatment of Helicobacter pylori infection
Zijie DENG ; Shaowei HAN ; Mingfeng XU ; Xiaoyu LIU ; Chun NING ; Tao LYU
Chinese Journal of Digestion 2024;44(12):800-805
Objective:To evaluate the efficacy, adverse reactions and compliance of vonoprazan (VPZ) dual therapy and bismuth-containing quadruple therapy with low-resistance antibiotics in the initial treatment of primary Helicobacter pylori ( H. pylori) infection. Methods:From March 7, 2022 to August 25, 2023, a total of 200 patients with H. pylori infection who visited the Department of Gastroenterology and Hepatology of the University of Hong Kong-Shenzhen Hospital were selected. According to the random number table method, the patients were randomly divided into the VPZ combined with amoxicillin treatment group (hereinafter referred as VPZ dual therapy group) and the proton pump inhibitor (PPI), tetracycline, full-dose (1 600 mg/d) metronidazole and bismuth treatment group (hereinafter referred as PPI quadruple therapy group). The patients of VPZ dual therapy group were given VPZ 20 mg (twice a day) combined with amoxicillin 1 000 mg (3 times a day), and the patients of PPI quadruple therapy group were given esomeprazol 20 mg (2 times a day), bismuth 0.6 g (twice a day), metronidazole 400 mg (4 times a day), and tetracycline 500 mg (3 times a day). The patients of both groups were treated for 14 days. The H. pylori infection status was re-examined 4 weeks after drug withdrawal. The results were analyzed by intention-to-treat (ITT) analysis, modified ITT analysis and per-protocol analysis (PPA). One-sided μ test was used for non-inferiority evaluation, and two-sided 95% confidence interval (95% CI) was obtained. Chi-square test was used for statistical analysis. Results:In the ITT analysis, 92.0% (92/100) of patients in the VPZ dual therapy group and 77.0% (77/100) of patients in the PPI quadruple therapy group completed the 14-day treatment, and the difference was statistically significant ( χ2=8.59, P=0.003). In the ITT analysis, the H. pylori eradication rates in the VPZ dual therapy group and the PPI quadruple therapy group were 96.0% (96/100) and 92.0% (92/100), respectively, and the difference was statistically significant (difference=4.0%, 95% CI -2.9% to 11.5%, P<0.001). In the modified ITT analysis, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 97.0% (96/99) and 95.8% (92/96), respectively, and the difference was statistically significant (difference=1.1%, 95% CI -4.9% to 7.6%, P=0.002). In the PPA, the H. pylori eradication rates of the VPZ dual therapy group and the PPI quadruple therapy group were 96.7% (89/92) and 97.4% (75/77), respectively, and the difference was statistically significant (difference=-0.7%, 95% CI -6.9% to 6.1%, P=0.009). In the ITT analysis, the incidence of adverse reaction in the VPZ dual therapy group was lower than that in the PPI quadruple therapy group (39.0%, 39/100 vs. 71.0%, 71/100), and the difference was statistically significant ( χ2=20.69, P<0.001). Conclusion:In initial treatment of H. pylori infection, the eradication rate of VPZ dual therapy is non-inferior to that of PPI quadruple therapy, and VPZ dual therapy demonstrates higher safety.
6.Post-stroke anxiety
Xingyu CHEN ; Xiaohan LYU ; Ruina LI ; Shaowei XIE ; Peiyuan LYU
International Journal of Cerebrovascular Diseases 2022;30(2):129-133
Post-stroke anxiety is one of the most common and important complications in patients with stroke, which can seriously affect the rehabilitation, daily life and work of patients with stroke. This article reviews the epidemiology, clinical characteristics, risk factors and predictors, pathophysiological mechanism, prevention and treatment of post-stroke anxiety.
7.Diagnosis and treatment of cerebral small vessel diseases
Ruina LI ; Xingyu CHEN ; Xiaohan LYU ; Shaowei XIE ; Peiyuan LYU
International Journal of Cerebrovascular Diseases 2022;30(11):854-858
Stroke-like symptoms and cognitive impairment caused by cerebral small vessel diseases will bring heavy burden to families and society. Therefore, early diagnosis and treatment of cerebral small vessel diseases are particularly important. This article reviews the diagnosis and treatment of cerebral small vessel diseases.
8.Clinical efficacy of laparoscopic and open distal gastrectomy for gastric cancer in elderly patients: an interim analysis of prospective study
Jun LUO ; Yu ZHU ; Hao LIU ; Hao WANG ; Xinhua CHEN ; Yanfeng HU ; Tian LIN ; Tao CHEN ; Tuanjie LI ; Mingli ZHAO ; Hao CHEN ; Shaowei XIONG ; Meiwen HE ; Guoqing LYU ; Guoxin LI ; Jiang YU
Chinese Journal of Digestive Surgery 2021;20(5):504-511
Objective:To analyze the interim clinical efficacy of laparoscopic and open distal gastrectomy for gastric cancer in elderly patients.Methods:The prospective randomized controlled study was conducted. The clinicopathological data of 102 patients aged ≥65 years who underwent distal gastrectomy for gastric cancer in the Nanfang Hospital of Southern Medical University from September 2014 to May 2018 were collected. After excluding 6 patients, 96 patients were finally included. Based on random number table, patients were allocated into two groups. Patients undergoing laparoscopic distal gastrectomy were allocated into laparoscopic group, and patients undergoing open distal gastrectomy were allocated into open group, respectively. Obser-vation indicators: (1) grouping situations of the enrolled patients; (2) intraoperative situations; (3) postoperative situations; (4) follow-up. Follow-up using outpatient examination and telephone interview was conducted to detect complications in the postoperative 30 days up to July 2018. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was analyzed using the t test. Measurement data with skewed distribution were represented as M( P25, P75) or M(range), and comparison between groups was analyzed using the Mann-Whitney U test. Count data were described as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test. Comparison of ordinal data was analyzed using the non-parameter Mann-Whitney U test. Results:(1) Grouping situations of the enrolled patients: a total of 96 patients were selected for eligibility. There were 66 males and 30 females, aged from 65 to 85 years, with a median age of 69 years. There were 49 of 96 patients in the laparoscopic group and 47 patients in the open group. (2) Intraoperative situations: patients in the two groups underwent distal gastrectomy successfully with D 2 lymphadenectomy, without intra-operative conversion to laparotomy. The volume of intraoperative blood loss and surgical incision length were 50 mL(50 mL,100 mL) and (7.1±1.7)cm for the laparoscopic group, respectively, versus 100 mL(100 mL,200 mL) and (19.1±1.7)cm for the open group, showing significant differences between the two groups ( Z=?3.779, t=?34.880, P<0.05) . (3) Postoperative situations: the number of lymph node dissected, time to postoperative initial out-of-bed activities, time to postoperative first flatus, time to postoperative first liquid food intake, time to postoperative first semi-liquid food intake, time to drainage tube removal, duration of postoperative hospital stay were 49(35,62), 1.9 days(1.3 days,2.9 days), 2.6 days(2.2 days,2.9 days), 3.4 days(2.7days,4.0 days), 5.9 days(4.7 days,7.7 days), 4.9 days(3.5 days,6.8 days), 7.7 days(6.7 days,8.9 days) for the laparoscopic group, respectively, versus 40(27,51), 2.5 days (1.8 days,3.3 days), 2.6 days(2.2 days,2.9 days), 3.9 days(2.9 days,5.7 days), 4.9 days(3.9 days, 5.9 days), 6.3 days(4.7 days,8.9 days), 8.7 days(6.9 days,11.7 days), showing significant differences between the two groups ( Z=?2.354, ?2.210, ?2.743, ?2.474, ?2.906, ?2.503, ?2.359, P<0.05). (4) Follow-up: patients in the two groups received 30 days of follow-up. During the follow-up, 8 patients in the laparoscopic group had postoperative complications, including 1 case with Clavien-Dindo grade Ⅰ complications, 7 cases with Clavien-Dindo grade Ⅱ complications, and no patient with Clavien-Dindo grade Ⅲ complications. Thirteen patients in the open group had postoperative complications, including 2 cases with Clavien-Dindo grade Ⅰ complications, 10 cases with Clavien-Dindo grade Ⅱ complications, and 1 case with Clavien-Dindo grade Ⅲ complications. There was no significant difference in the above indicators between the two groups ( χ2=1.135, 1.973, 1.054, P>0.05). The overall complication rate was 16.3%(8/49) and 27.7%(13/47) for the laparoscopic group and open group, respectively, showing no significant difference between the two groups ( χ2=1.803, 99.7% confidence interval as ?∞ to 2.4%, P>0.05). The upper limit of 99.7% confidence interval was less than non-inferiority level of 15%, interim analysis of which showed that the complication rate of the laparoscopic group was non-inferior to the open group. Conclusion:For elderly patients undergoing laparoscopic or open distal gastrectomy for gastric cancer, laparoscopic surgery does not increase intraoperative or postoperative complications, and has advantages of minimally invasiveness, fine operation, quicker recovery, and shorter hospital stay. Registry: this study was registered at clinicaltrials.gov in United States, with the registry number of NCT02246153.
9.Analysis of prenatal phenotype and pathogenetic variant in a fetus with Papillorenal syndrome.
Jie LI ; Shaowei YIN ; Zeyu YANG ; Meihui LI ; Caixia LIU ; Jesse LI-LING ; Yuan LYU
Chinese Journal of Medical Genetics 2020;37(8):847-850
OBJECTIVE:
To diagnose a fetus with Papillorenal syndrome by prenatal ultrasonography and genetic testing, and to correlate its genotype with phenotype.
METHODS:
Ultrasound finding of the fetus was reviewed. Muscle sample of the abortus was taken, and genetic variant related to the clinical phenotype was screened by whole exome sequencing (WES). Suspected pathogenic variant was verified by Sanger sequencing.
RESULTS:
Prenatal ultrasound revealed severe dysplasia of the fetal kidneys and oligohydramnios. WES revealed that the fetus has carried a c.736G>T (p.Glu246Ter) nonsense variant of the PAX2 gene, which was unreported previously. The result of Sanger sequencing was consistent with that of WES. Both parents of the fetus were of the wild-type, suggesting a de novo origin of the fetal variant.
CONCLUSION
The novel heterozygous c.736G>T (p.Glu246Ter) variant of the PAX2 gene probably underlay the Papillorenal syndrome in the fetus. Above finding has provided a basis for genetic counseling and clinical decision-making.
10.Correlation between cervical elastography parameters and time of the first stage of labor in late pregnancy by transvaginal ultrasound
Miaoqian WANG ; Qingli ZHU ; Zhen′ai LI ; Mingchun ZHI ; Wei LI ; Shaowei WANG ; Qiubo LYU
Chinese Journal of Ultrasonography 2020;29(2):169-174
Objective:To investigate the correlations between the labor process and the elastography parameters, and to explore the correlations among the elastography parameters.Methods:A total of 48 pregnant women in the late periods of pregnancy in Beijing Hospital from November 10, 2018 to January 30, 2019 were recruited prospectively. Elastography was performed to measure several elastographic parameters including the cervical length (CL), elasticity contrast index (ECI), hardness ratio (HR), internal orifice uterus(IOS) and external orifice uterus(EOS). They were followed up to delivery, and were divided into normal group and prolonged group according to the time duration of the first stage of labor. The correlation between the parameters and the time duration of the first stage of labor, as well as the relationships among the parameters were evaluated.Results:Among the 48 pregnant women, 35 cases were delivered by the vagina, 13 by cesarean section, 4 of whom were due to the prolongation of the first stage of labor and the other 9 cases for other reasons. The values of the CL and HR in normal group were significantly lower than that in prolonged group ( P=0.004, 0.02). The ECI in the normal group was significantly higher than that in the prolonged group ( P=0.046). Both the IOS and EOS in the normal group were higher than those in prolonged group without no significant difference( P>0.05). For the 35 women who underwent cervical elasticity assessment before labor and finally delivered vaginally, the duration of the first stage of labor was negatively correlated with cervical ECI ( r=-0.415, P<0.05). The ECI were negatively correlated with CL and HR ( r=-0.528, -0.374; P<0.05), and HR were negatively correlated with IOS and EOS ( r=-0.669, -0.558; P<0.01), whereas HR had no significant correlation with CL( P>0.05). Conclusions:The ECI of cervical tissue measured by cervical elastography can be used to semi-quantitatively evaluate the maturity of the cervix, it has potential value in predicting the labor duration and guiding clinical decision-making.

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