Current Situation and Suggestion of Comprehensive Clinical Evaluation of Medical Products in China in Recent Ten Years / 中医杂志

Through analyzing the current situation of clinical comprehensive evaluation researches of domestic medical products from 2013 to 2023， it is found that there is a phenomenon of “four more， four less”. Specifically， there is a greater emphasis on conducting research on drug clinical comprehensive evaluation， but fewer comprehensive evaluation opinions provided； more research data come from publicly available information， but fewer derived from real world； more options for similar reference drugs， but less pre-defined research on reference drugs； the research process involves more steps， yet there are fewer studies strictly implementing quality control. Based on this， suggestions are proposed in three aspects： improving the quality of clinical comprehensive evaluation of medical products， enhancing the transformation and dissemination of results， and improving the standardization of clinical comprehensive evaluation of medical products. Regarding the current state of clinical comprehensive evaluation research on Chinese patent medicine， reflections are presented on elevating original research evidence and highlighting the characteristics and advantages of Chinese patent medicine， so as to promote better transformation and application of the results of clinical comprehensive evaluation of medical products.

Characteristics and Risk Factors of Functional Dyspepsia Fulfilling the Rome IV Criteria Overlapping With Gastroesophageal Reflux Disease, Irritable Bowel Syndrome, and Functional Constipation in South China

Background/Aims@#Functional dyspepsia (FD) overlapping with other gastrointestinal disorders are quite common. The characteristics of FD overlap in Chinese population with latest Rome IV criteria were unclear. This large-scale outpatient-based study assessed the characteristics of FD overlap in South China. @*Methods@#Consecutive FD patients visited the Gastroenterology Clinic at 2 tertiary medical centers in Hangzhou, China who fulfilled the Rome IV criteria were enrolled. Complete questionnaires related to the gastrointestinal symptoms (Rome IV criteria), Reflux Disease Questionnaire, anxiety and depression, quality of sleep and life, and demographic information were collected. @*Results@#Among the total of 3281 FD patients, 50.69% overlapped with gastroesophageal reflux disease, 21.46% overlapped with irritable bowel syndrome, 6.03% overlapped with functional constipation. FD overlap had higher proportion of single/divorced/widowed rate, high education level, being employed, drinking, night shift, unhealthy dietary habit than FD only (P < 0.05). They had higher frequency of consultation and economic burden, as well as lower scores in quality of life (P < 0.001). Multivariate logistic regression showed that increasing age, female, low body mass index, history of gastroenteritis, anxiety, depression, and poor sleep quality were independent risk factors for FD overlap. @*Conclusions@#FD overlap was quite common in China with high economic burden and poor quality of life, FD patients with history of gastroenteritis, anxiety, depression, and poor sleep quality were more likely to have overlap disorders. Awareness of the physical and psychosocial stressors in overlapping condition would help optimize the management of FD overlap in clinical practice.

A multicenter cross-sectional study on the multidimensional clinical manifestations of irritable bowel syndrome / 中华消化杂志

Objective:To assess the differences in multidimensional clinical manifestations between patients with irritable bowel syndrome (IBS) matching the Rome Ⅲ criteria but not matching Rome Ⅳ and IBS patients matching the Rome Ⅳ criteria, among patients diagnosed with IBS according to Rome Ⅲ criteria.Methods:From November 2016 to October 2017, a total of 472 IBS patients admitted to six hospitals were selected, which included Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology (139 cases), Sir Run Run Shaw Hospital, School of Medicine of Zhejiang University (95 cases), the First Affiliated Hospital of Dalian Medical University (96 cases), the Affiliated Hospital of Guizhou Medical University (90 cases), the People′s Hospital of Guangxi Zhuang Autonomous Region (20 cases), and the Second Affiliated Hospital of Xi′an Jiaotong University (32 cases). The 472 IBS patients were divided into the group that matching the Rome Ⅳ criteria (Rome Ⅳ group), and the group that matching the Rome Ⅲ criteria but not matching the Rome Ⅳ criteria (Rome Ⅲ group). The basic characteristics (IBS course, post-infectious IBS, history of smoking or drinking, etc.), abdominal symptoms, and defecation-related symptoms of two groups were compared and analyzed by face-to-face questionnaires. Multi-dimensional clinical manifestations assessment was completed by questionnaires, which included gastrointestinal symptom rating scale (GSRS), irritable bowel syndrome-severity scoring system (IBS-SSS), irritable bowel syndrome-quality of life (IBS-QOL), and hospital anxiety and depression scale (HADS). Independent sample t-test, rank sum test, and chi-square test were used for statistical analysis. Results:There were 344 patients (72.9%) in Rome Ⅳ group and 128 patients (27.1%) in Rome Ⅲ group. The IBS course of patients in Rome Ⅳ group was longer than that in Rome Ⅲ group (3.0 years (7.0 years) vs. 2.0 years (5.7 years)), and the difference was statistically significant ( Z=-2.73, P=0.006). The GSRS scores of loose stools and abdominal pain of IBS patients in Rome Ⅳ group were higher than those in Rome Ⅲ group, and the GSRS scores of increased exhaust and abdominal distension of IBS patients in Rome Ⅳ group were lower than those in Rome Ⅲ group (3.0(2.0) vs. 2.0(4.0), 3.0(2.0) vs.1.0(2.0), 1.5(3.0) vs. 2.0(3.0), 1.0 (3.0) vs. 2.0(3.0)), and the differences were statistically significant ( Z=-2.48, -9.90, -2.11 and -2.06, P=0.013, <0.001, =0.035 and =0.040). The proportions of fatigue and dizziness of IBS patients in Rome Ⅳ group were higher than those in Rome Ⅲ group (58.4% (201/344) vs. 43.0% (55/128), 30.8% (106/344) vs. 29.7% (38/128)), and the differences were statistically significant ( χ2=8.37 and 12.36, P=0.004 and <0.001). The scores of anxiety and depression subscales of the HADS of IBS patients in Rome Ⅳ group were higher than those in Rome Ⅲ group (6.5 (6.8) vs. 6.0 (6.0), 5.0 (6.0) vs. 3.0 (5.0)), and the differences were statistically significant ( Z=-2.58 and -2.40, P=0.010 and 0.017). The scores of IBS-SSS scale, abdominal pain severity, abdominal pain frequency, and impact on quality of life of IBS patients in Rome Ⅳ group were all higher than those in Rome Ⅲ group (249.5 (108.0) vs. 177.0 (111.8), 50.0 (25.0) vs. 20.0 (30.0), 50.0 (70.0) vs. 10.0 (30.0), 66.0 (42.0) vs. 42.5 (34.0)), and the differences were statistically significant ( Z=-7.79, -9.64, -10.65 and -2.48, P<0.001, <0.001, <0.001 and =0.013). The score of IBS-QOL for behavioral disorder of IBS patients in Rome Ⅳ group was lower than that in Rome Ⅲ group (74.5±21.6 vs. 79.2±17.7), and the difference was statistically significant ( t=-2.22, P=0.027). Conclusion:The clinical symptoms of patients mathching the Rome Ⅳ criteria are more typical and severe, as compared with those of IBS patients matching the Rome Ⅲ criteria but not matching the Rome Ⅳ criteria.

The potential value of ultrasound shear wave elastography in assessing functional defecation disorders / 中华消化杂志

Objective:To preliminary explore the potential application value of ultrasound shear wave elastography (SWE) in assessing functional defecation disorders compared with anorectal manometry and X-ray defecography.Methods:From July 2022 to December 2022, the results of SWE, anorectal manometry and X-ray defecography of 39 patients with functional defecation disorders visited Sir Run Run Shaw Hospital, School of Medicine of Zhejiang University were retrospectively analyzed. Non-parametric tests were used to analyze the changes in elastic modulus values of anorectal muscle groups at different phase.Chi-square test and Bland-Altman plots were used to assess the consistency between SWE, X-ray defecography and anorectal manometry in evaluating spastic pelvic floor syndrome, as well as the changes in the anorectal angle measured by SWE and X-ray defecography (from resting phase to contraction phase, resting phase to strain phase (Valsalval maneuver).Results:The elastic modulus values measured by SWE of the puborectalis muscle, internal anal sphincter, and external anal sphincter of patients with functional defecation disorders during strain phase were 32.4 kPa (19.1 kPa, 60.3 kPa), 25.3 kPa (17.0 kPa, 53.8 kPa), and 28.6 kPa (21.3 kPa, 55.1 kPa), respectively, which had no statistically significant differences compared to elastic modulus values in resting phase (33.5 kPa (22.1 kPa, 44.9 kPa), 28.9 kPa (22.4 kPa, 45.1 kPa), and 32.4 kPa (23.1 kPa, 49.4 kPa), all P>0.05). The consistency between SWE and X-ray defecography in the diagnosis of spastic pelvic floor syndrome was poor (Kappa=0.190). The consistency between SWE and anorectal manometry in the diagnosis of dyssynergic defecation was poor (Kappa=0.160). The differences in the changes of anorectal angle detected by SWE and X-ray defecography were within the 95% consistency limit ( P=0.429 and 0.582). Conclusion:SWE is sensitive in evaluating changes in anorectal angle, and it shows good consistency with defecography in assessing angle changes.

Hyperoside protects mouse spermatocytes GC-2 cells from oxidative damage by activating the Keap1/Nrf2/HO-1 pathway / 南方医科大学学报

OBJECTIVE@#To study the protective effect of hyperoside (Hyp) against ydrogen peroxide (H2O2)- induced oxidative damage in mouse spermatocytes GC-2 cells and explore the role of the Keap1/Nrf2/HO-1 pathway in this protective mechanism.@*METHODS@#GC-2 cells were treated with 2.5 mmol/L azaacetylcysteine (NAC), 50, 100, and 200 μmol/L hyperoside, or the culture medium for 48 h before exposure to H2O2 (150 μmol/L) for 2 h. CCK-8 assay was used to detect the changes in cell viability, and cell apoptosis was analyzed using flow cytometry. Enzyme-linked immunosorbent assay (ELISA) was used to detect the levels of superoxide dismutase (SOD), glutathione peroxidase (GSH-PX), catalase (CAT) activity and malondialdehyde (MDA) in the culture medium. Western blotting and RT-qPCR were used to detect the protein and mRNA expression levels of nuclear factor erythroid 2-related factor2 (Nrf2), Kelch-like ECH-associated protein 1 (Keap1), and heme oxygenase-1 (HO-1); the nuclear translocation of Nrf2 was detected using immunofluorescence assay.@*RESULTS@#Exposure to H2O2 significantly lowered the proliferation rate, reduced the activities of SOD, GSH and CAT, and obviously increased MDA content, cell apoptosis rate, and the expressions of Keap1 and Nrf2 mRNA and Keap1 protein in GC-2 cells (P < 0.05 or 0.01). Treatment of the cells prior to H2O2 exposure with either NAC or 200 μmol/L hyperoside significantly increased the cell proliferation rate, enhanced the activities of SOD, GSH-PX and CAT, and lowered MDA content and cell apoptosis rate (P < 0.05). Treatment with 200 μmol/L hyperoside significantly decreased the mRNA and protein expressions of Keap1 and increased the expressions of HO-1 mRNA and the protein expressions of Nrf2 and HO-1 (P < 0.05 or 0.01). Hyperoside also caused obvious nuclear translocation of Nrf2 in the cells (P < 0.05).@*CONCLUSION@#Hyperoside protects GC-2 cells against H2O2- induced oxidative damage possibly by activation of the Keap1/Nrf2/HO-1 signaling pathway.

Mechanism of transcutaneous electrical acupoint stimulation in improving the symptoms and gastric accommodation in patients with functional dyspepsia / 中华消化杂志

Objective:To investigate the therapeutic efficacy and mechanisms of transcutaneous electrical acupoint stimulation (TEAS) in the treatment of postprandial distress syndrome (PDS) in functional dyspepsia (FD).Methods:A double-blinded, randomized, controlled study was conducted. At Sir Run Run Shaw Hospital, Medical School Zhejiang University 40 patients aged 18-70 years old who met the Rome Ⅳ diagnostic criteria of PDS were prospectively enrolled. After informed consent, the patients were randomly assigned to TEAS group or sham-TEAS group. The patients in the TEAS group received transcutaneous electrical acupoint stimulation at acupoints Zusanli and Neiguan, and those in the sham-TEAS group underwent stimulation at other mimic acupoints for four weeks. The symptoms, gastric accommodation (initial satiety volume (ISV) and maximum tolerable volume (MTV), time of half gastric emptying of solid food ( T1/2) and heart rate variability (high frequency, low frequency and ratio of low frequency to high frequency) were compared between the two groups before and after treatment. The expression levels of inflammatory cytokines in duodenal mucosa were also evaluated by polymerase chain reaction in PDS patients and 24 healthy volunteers. Independent sample t test, Mann-Whitney U test and chi square test were used for statistical analysis. Results:A total of 26 PDS patients were enrolled in the study, 13 cases each in the TEAS group and sham-TEAS group. Between the patients of the two groups, there were no statistically significant differences in gender, age, or score of 36-item short form health survey (SF-36), score of self-rating anxiety scale (SAS), score of self-rating depression scale (SDS), score of dyspeptic symptom severity index (DSSI), ISV, MTV, T1/2 or heart rate variability indexes (high frequency, low frequency and ratio of low frequency to high frequency) before treatment (all P>0.05). After treatment, the DSSI score of TEAS group was lower than that of sham-TEAS group (13.5±5.3 vs. 19.9±9.3), the values of ISV and MTV were both higher than those of sham-TEAS group ((180.0±44.6) mL vs. (121.9±61.0) mL, (480.4±200.7) mL vs. (338.5±108.8) mL), and the differences were all statistically significant ( t=2.18, 2.77 and 2.24, all P<0.05). After treatment there was no statistically significant difference in T1/2 between TEAS group and sham-TEAS group ( P>0.05). There was no statistically significant difference in T1/2 between before and after treatment in patients of TEAS group ( P>0.05). After treatment, the high frequency increased (5.3±1.2 vs. 4.0±0.9) and the ratio of low frequency to high frequency decreased (1.0±0.2 vs. 1.3±0.2), and the differences were statistically significant ( t=-3.31 and 3.73, both P<0.01). The expression levels of interleukin 6 (IL-6) mRNA in mucosa of duodenal bulb and descending duodenum of PDS patients were both higher than that of healthy control group (0.68, 0.11 to 6.74 vs. 0.03, 0.02 to 0.25; 6.46, 1.35 to 12.62 vs. 0.86, 0.32 to 2.90), and the differences were statistically significant ( Z=-2.24 and -2.03, P=0.02 and 0.04). After TEAS treatment for four weeks, the expression of IL-6 mRNA in duodenal bulb mucosa decreased compared with that before treatment in TEAS group (0.04, 0.01 to 0.06 vs. 0.23, 0.09 to 3.66) and the difference was statistically significant ( Z=-2.07, P=0.04). Conclusions:TEAS can improve the gastric accommodation and dyspeptic symptoms in PDS patients. The mechanism may be related with the vagal pathway mediating and regnlating the expression of inflammatory cytokine IL-6 in duodenal bulb mucosa.

Characteristics of colonoscopy in patients aged 75 and above / 中华全科医师杂志

Objective:To analyze the characteristics of colonoscopy in patients aged 75 and above.Methods:The clinical data of 216 elderly patients aged 75 and above undergoing colonoscopy in our hospital from August 2015 to June 2019 were retrospectively analyzed. According to WHO criteria, there were 140 cases in aged group (75 to 89 years old) and 76 cases in the advanced aged group (90 years old and over). Demographic data, colonoscopy completion rate, bowel preparation quality, positive diagnosis rate and adverse events were analyzed and compared between the two groups.Results:More colonoscopies were performed under general anesthesia [7.9% (6/76) vs. 1.4% (2/140), χ 2=5.775, P<0.05] in the advanced aged group compared to the aged group, and the advanced aged group received lower doses of propofol and fentanyl when colonoscopies were administered with moderate sedation [(69.0±37.4) mg vs.(100.8±34.3)mg, t=6.302, P<0.01; (57.5±31.2) μg vs. (84.0±28.6)μg, t=6.297, P<0.01]. Colonoscopy completion was lower in the advanced aged group than that in the aged group[88.2%(67/76) vs. 99.3% (139/140), χ 2=13.815, P<0.01] and bowl preparation quality was worse [31.6%(24/76) vs. 15.0% (21/140), χ 2=8.209, P<0.05]. The proportion of adverse cardiopulmonary events [5.3%(4/76) vs. 0 (0/140), χ 2=7.507, P<0.01] and overall adverse events [9.2% (7/76) vs. 0.7% (1/140), χ 2=9.970, P<0.01] were higher in the advanced aged group than those in the elderly group. Colorectal cancer [14.5% (11/76) vs. 2.1% (3/140), χ 2=12.357, P<0.01] and advanced adenoma [27.6% (21/76) vs. 6.4% (9/140), χ 2=18.516, P<0.01] were more common in the advanced aged group than those in the aged group. Conclusion:Compared with the patients aged 75-89 years, patients aged 90 years and above have lower percentage of colonoscopy completion, lower quality of bowl preparation, and higher incidence of adverse events, and higher percentage of colorectal cancer and advanced adenomas detected.

Clinical characteristics of 326 cases of erosive esophagitis in healthy population undergoing health checkup in Eastern Zhejiang Province / 中华消化杂志

Objective To explore the incidence of asymptomatic erosive esophagitis (AEE) and clinical characteristics of symptoms of erosive esophagitis in healthy population undergoing health check-up.Methods From January 2012 to December 2015,at Ningbo Medical Treatment Center Lihuili Eastern Hospital,a total of 3 052 healthy people receiving routine health checkup and underwent gastroendoscopy were retrospectively analyzed.The demographic characteristics,endoscopic findings,reflux-related symptoms,metabolic syndrome and biochemical parameters were analyzed in AEE and symptomatic erosive esophagitis (SEE) patients.T test and Chi square test were performed for univariate analysis,and multivariate logistic regression analysis was used to compare differences between AEE and SEE patients.Results There were 326 cases of erosive esophagitis,and the incidence rate was 10.7％ (326/3 052).Among them,the incidence rate of AEE was 4.9％ (151/3 052),which accounted for 46.3％ (151/326) of erosive esophagitis;and the incidence rate of SEE was 5.7％ (175/3 052),and accounted for 53.7％ (175/326) of erosive esophagitis.About 98.2％ (320/326)of the patients were diagnosed with mild esophagitis (Los Angeles grade A or B).The results of univariate analysis indicated that,compared with AEE group,there were more smokers (31.8％,48/151 vs.45.7％,80/175) and more drinkers (27.8％,42/151 vs.41.7％,73/175),and higher body mass index (BMI) ((23.95± 2.32) kg/m2 vs.(24.53 ± 2.19) kg/m2) were in SEE group,and the differences were statistically significant (x2 =6.592 and 6.859,t =-2.351;all P ＜ 0.05).There were no significant differences between SEE group and AEE group in age,gender,esophageal hiatal hernia,metabolic syndrome and biochemical indicators (all P ＞ 0.05).The results of multivariate logistic regression analysis indicated that smoking (odds ratio (OR) =1.67,95％ confidence interval (CI) 1.05 to 2.65,P =0.030),alcohol drinking (OR =1.69,95％ CI 1.05 to 2.72,P =0.030) and high BMI (OR =1.11,95％ CI 1.00 to 1.23,P =0.044) were the independent risk factors of gastroesophageal reflux symptoms in patients with erosive esophagitis.Conclusions AEE is common in Chinese population,and the incidence is similar to SEE.Smoking,alcohol drinking and high BMI are the risk factors of reflux symptom in patients with erosive esophagitis.

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia / 中华医学杂志(英文版)

<p><b>Background</b>Functional dyspepsia (FD) is a common upper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome (PDS)-predominant FD.</p><p><b>Methods</b>The study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by <50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared.</p><p><b>Results</b>(1) The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group (38.82% vs. 8.75%, P < 0.001; 69.14% vs. 16.25%, P < 0.001; 77.65% vs. 21.25%, P < 0.001). (2) The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. (3) The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. (4) The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. (5) Qi-Zhi-Wei-Tong granules did not have more adverse effects than the placebo.</p><p><b>Conclusion</b>Qi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo.</p><p><b>Trial Registration</b>https://clinicaltrials.gov/, NCT02460601.</p>

Coralline hydroxyapatite for ridge preservation in the maxillary anterior zone:A cone beam CT analysis / 医学研究生学报

Objective Coralline hydroxyapatite (CHA),in comparison with Bio-Oss bone meal,is a material with extensive resources but no immunogenicity or risk of disease-transmission. The aim of this article was to study the clinical application of CHA in ridge preservation in the maxillary anterior zone. Methods Twenty-six patients underwent extraction of maxillary anterior teeth (n=26) for chronic periodontitis or periapical periodontitis. The patients were randomly assigned into a CHA and a control group of equal number to receive ridge preservation with CHA and Bio-Oss bone meal respectively. Cone beam computed tomography (CBCT) was performed immediately and at 4 months after ridge preservation to compare the vertical and horizontal alterations of the alveolar ridge be-tween the two groups of patients. Results After ridge preservation,both the CHA and control groups showed a reduction in the width ([1.1±0.7] vs [1.3±1.9] mm) and height of the alveolar ridge ([1.3±1.6] vs [1.2±1.4] mm),but with no statistically significant differences between the two groups (P<0.05). Conclusion For ridge preservation in the maxillary anterior zone,CHA has a similar effect to that of Bio-Oss bone meal and therefore is an ideal material for bone graft.

Risk factors of pathological upgrading in gastric mucosa lesions with low-grade intraepithelial neoplasia after endoscopic submucosal dissection / 中华消化杂志

Objective To investigate the risk factors of pathological upgrading in gastric mucosal lesions with low-grade intraepithelial neoplasia (LGIN) after endoscopic submucosal dissection (ESD).Methods From January 2010 to December 2016,the complete clinical data of 326 patients pathologically diagnosed with gastric LGIN lesions before ESD were retrospectively analyzed.Single factor analysis of variance and multiple factor Logistic regression analysis were performed to analyze the risk factors of pathological upgrading after ESD.Results A total of 326 patients with gastric LGIN lesions diagnosed by preoperative biopsy before ESD were enrolled.Among them the postoperative pathological diagnosis of 244 cases (74.85％) were still LGIN,while the postoperative pathological diagnosis of 82 cases (25.15 ％) were upgraded,of which 61 cases (18.71％) were upgraded to high-grade intraepithelial neoplasia and 21 (6.44％) were upgraded to gastric early cancer.The results of single and multiple factor analysis indicated that lesion size≥2.0 cm,deep depressed-type,surface erythema,lesion mucosa with ulceration and lesions with spontaneous bleeding were the risk factors of pathological diagnosis upgrading after ESD (F=5.37,6.44,4.56,7.56 and 7.78,respectively;all P＜0.01),odds ratio (OR) value and 95％ confidence interval (CI) were 4.086 (2.035 to 10.786),7.435 (2.845 to 19.862),3.205 (1.535 to 8.541),8.668 (3.365 to 21.457) and 7.056 (2.732 to 18.355).The age,gender and location of the lesion were not the risk factors.Conclusions Pathological upgrading is common in gastric lesions with LGIN after ESD.The lesions with high risk factors should be alerted and treated more actively.

Risk factors of pathological upgrading in gastric mucosa lesions with low-grade intraepithelial neoplasia after endoscopic submucosal dissection / 中华消化杂志

Objective To investigate the risk factors of pathological upgrading in gastric mucosal lesions with low-grade intraepithelial neoplasia (LGIN) after endoscopic submucosal dissection (ESD).Methods From January 2010 to December 2016,the complete clinical data of 326 patients pathologically diagnosed with gastric LGIN lesions before ESD were retrospectively analyzed.Single factor analysis of variance and multiple factor Logistic regression analysis were performed to analyze the risk factors of pathological upgrading after ESD.Results A total of 326 patients with gastric LGIN lesions diagnosed by preoperative biopsy before ESD were enrolled.Among them the postoperative pathological diagnosis of 244 cases (74.85％) were still LGIN,while the postoperative pathological diagnosis of 82 cases (25.15 ％) were upgraded,of which 61 cases (18.71％) were upgraded to high-grade intraepithelial neoplasia and 21 (6.44％) were upgraded to gastric early cancer.The results of single and multiple factor analysis indicated that lesion size≥2.0 cm,deep depressed-type,surface erythema,lesion mucosa with ulceration and lesions with spontaneous bleeding were the risk factors of pathological diagnosis upgrading after ESD (F=5.37,6.44,4.56,7.56 and 7.78,respectively;all P＜0.01),odds ratio (OR) value and 95％ confidence interval (CI) were 4.086 (2.035 to 10.786),7.435 (2.845 to 19.862),3.205 (1.535 to 8.541),8.668 (3.365 to 21.457) and 7.056 (2.732 to 18.355).The age,gender and location of the lesion were not the risk factors.Conclusions Pathological upgrading is common in gastric lesions with LGIN after ESD.The lesions with high risk factors should be alerted and treated more actively.

Long-term symptom development of functional bowel disease and the effects of lactose-restricted diet on the symptoms / 中华消化杂志

Objective To explore the long-term symptom development in functional bowel disorders (FBD) and the effects of lactose-restricted diet on the symptoms.Methods From January 2008 to December 2010,805 patients with FBD were included.Among them 245 patients who completed lactose hydrogen breath test and the lactose intake exceeded median value (48.75 g/month) were followed up with telephone interview.The changes of gastrointestinal symptoms,lactose intake and anxiety/ depression status of the patients were observed.Chi-square test,t test and inspection rank test were performed for statistically analysis.Binary Logistic regression analysis was used for influence factors analysis.Results Among 805 patients with FBD,there were 432 (53.7％) mild patients and 373 (46.3％) severe patients.The proportions of female patients,patients with gastrointestinal disease history (gastroenteritis,ulcers,chronic diarrhea etc.),anxiety,depression and irritable bowel syndrome (IBS) of severe patients were all higher than those of mild patients (50.4％,188/373 vs 40.3％,174/432;53.6％,200/373 vs 43.5％,188/432;29.5％,110/373 vs 16.9％,73/432;32.2％,120/373 vs 21.5％,93/432;77.2％,288/373 vs 45.1％,195/432),and the differences were statistically significant (x2 =8.60,0.90,18.10,22.10 and 8.20,all P＜0.05).Among 245 FBD patients included in telephone follow-up,144 cases (58.8％) were successfully followed up (follow-up group) and the follow-up duration was five to seven years.Since the first visit,some diseases have been detected including five cases of colonic polyps,three cases of ulcerative colitis (UC),three cases of gallbladder common bile duct stones,two cases of H.pylori-related peptic ulcer,one case of digestive tract hemorrhage and one case of chronic pancreatitis.The frequency scores of abdominal pain,abdominal distension,hard stools and loose stools were all lower than initial status (0 (0 to 1) vs 5 (3 to 6),0 (0 to 1) vs 3 (0 to 5),0 (0 to 0) vs 0 (0 to 1),0 (0 to 2) vs 2 (1 to 3));the general sensation improved compared with that of initial status (2(1 to 2) vs 3(3 to 4)),and the differences were statistically significant (Z=11.23,7.82,2.19,8.42 and 11.49,all P＜0.05).During follow-up,anxiety/depression symptoms of patients in follow-up group were improved (4 (3 to 4) vs 3 (3 to 4),1 (1 to 1) vs 2 (1 to 2));and the differences were statistically significant (Z=-5.81 and 5.06,both P＜0.01).The median value of lactose intake was decreased compared with before in follow-up group (27.0 g/month (3.0 g/month to 99.8 g/month) vs 135.1 g/month (91.6 g/month to 238.6 g/month));and the difference was statistically significant (Z=-0.14,P＜ 0.01).Lactose-restricted diet could improve the gastrointestinal symptoms including abdominal pain,bloating,loose stool and overall feelings of patients,and the differences were statistically significant (x2 =6.09,5.46,10.04 and 6.40,all P＜0.05).Conclusions Over time,there is still possibility that FBD developed into organic diseases.So the patients still needed close follow-up.Lactose-restricted diet could improve the symptoms of FBD.

Bushen Daozhuo Granules for type Ⅲ prostatitis: A multicenter randomized controlled clinical trial / 中华男科学杂志

Objective@#To study the safety and efficacy of Bushen Daozhuo Granules (BDG) in the treatment of type Ⅲ prostatitis.@*METHODS@#This multicenter randomized controlled clinical trial included 478 patients with type Ⅲ prostatitis, 290 in the trial group and 188 as controls, the former treated with BDG at 200 ml bid and the latter with tamsulosin hydrochloride sustainedrelease capsules at 0.2 mg qd, both for 4 weeks. Before treatment, after 4 weeks of medication, and at 4 weeks after drug withdrawal, we obtained the NIH Chronic Prostatitis Symptom Index (NIHCPSI) scores and compared the safety and effectiveness rate between the two groups of patients.@*RESULTS@#Compared with the baseline, the NIHCPSI score was markedly decreased in the control group after 4 weeks of medication (21.42 ± 4.02 vs 15.67 ± 3.65, P 0.05), while the NIHCPSI score in the trial group was remarkably lower than the baseline both after 4 weeks of medication and at 4 weeks after drug withdrawal (10.92 ± 2.06 and 12.91 ± 2.64 vs 21.58 ± 3.67, P < 0.05). The trial group exhibited both a higher rate of total effectiveness and safety than the control (P < 0.05).@*CONCLUSIONS@#BDG is safe and effective for the treatment of type Ⅲ prostatitis.

Effect of human endothelial progenitor cell transplantation treatment on the functional recovery of rats with spinal cord injury / 中国基层医药

Objective To observe the effects of human EP cells (hEPCs)transplantation on the function recovery of rats with spinal cord injury.Methods 24 SD rats (5 ones died in the process of operation)were firstly completed transection of T10 segment of spinal cord by using quick knife slices to complete animal model.19 rats after spinal cord transection were randomly divided into:the experimental group (10 cases)and the control group (9 cases). The experimental group with spinal cord injury was injected 7.5μL suspension of hEPCs (human Endothelial Progeni-tor Cells).Adjacent area of spinal cord injury in control group was injected equal amount DMEM(Dulbecco minimum essential medium.Postoperative intraperitoneal injection of cyclosporine A,an immunosuppressant,was administrated daily.At postoperative 1,2,4,6,8 weeks Basso Beatlie Bresnahan (BBB)score were administrated to record the neural function recovery of lower limbs in SCI rats.The transection spinal cord were removed from rats 8 weeks after operation to detect transplanted survival hEPCs in transection spinal cord of ratsby immunohistochemical and hybridization technique. Results 2 weeks after SCI model established,the BBB scores in the experimental group and the control group showed no statistically significant difference(t =0.61,0.69,all P >0.05).4 weeks postoperatively,the BBB score of the experimental group (1.67 -0.71)points was more than that in the control group (1.11 -0.60),the difference was statistically significant(t =3.16,P <0.05).Untill 8 weeks scores were respectively the (4.00 -1.41)of the experimental group and the (1.44 -0.89)of the control group,the difference was statistically significant(t =5.384,P <0.05). Finally it was concluded that 4,6,8 weeks after SCI,hind limbs function of the experimental group was significantly better than that of the control group,the difference had statistical significance (P <0.05).Hybridization and immuno-histochemical detection showed that the transplanted hEPCs not only live in the host but in partial hEPCs chimeric to SCI in rats of spinal cord and its vascular system.Conclusion After transplantation,hEPCs can survive,differentiate into vascular endothelial cell,and improvement spinal cord function recovery as compared with control group.

Evaluation of test methods for defecation disorders / 中华胃肠外科杂志

Defecation disorders is a common gastrointestinal disease characterized by slow colonic transit and/or paradoxical anal contraction. Gastrointestinal motility test plays an important role in the diagnosis, classification and treatment of defecation disorders. Anorectal manometry (ARM) provides comprehensive information about rectal and anal sphincter function, including resting anal sphincter pressure, squeeze anal sphincter pressure, the rectal and anal sphincter pressure changes during an attempted defecation, rectal sensory testing, rectoanal inhibitory reflex and rectal compliance. However, ARM can not diagnose the defecation disorders without the other tests. It should be combined with defecography and balloon expulsion test. Defecography demonstrates the anatomy and function of the anorectum and pelvic floor. Gastrointestinal transit test assesses regional and whole colon transit time. They are valuable methods in diagnosis of defecation disorders, but these tests have their respective advantages and disadvantages, and combined use should be carried out usually.

Protective effect of Wuziyanzong Pills on rats with experimental oligoasthenospermia and its action mechanism / 中华男科学杂志

<p><b>Objective</b>To investigate the protective effect of Wuziyanzong Pills (WYP) in the rat model of oligoasthenospermia (OAS) and its action mechanism.</p><p><b>METHODS</b>Sixty male SD rats were equally randomized into six groups: normal control, OAS model, Shengjing Capsules (1.6 g per kg of the body weight), low-dose WYP (1 g per kg of the body weight), medium-dose WYP (2 g per kg of the body weight), and high-dose WYP (4 g per kg of the body weight). The OAS model was established by intragastric administration of Tripterygium glucoside at 30 mg per g per d for 6 weeks. From the 3rd week of modeling, the rats of the medication groups were treated intragastrically with corresponding drugs for 4 weeks. Then all the rats were sacrificed for measurement of the testicular and epididymal organ coefficients, examination of epididymal sperm quality and apoptosis, and detection of the openness of the sperm mitochondrial permeability transition pore (MPTP). Histopathological changes in the testis were observed by HE staining and the apoptosis of spermatogenic cells determined by Hochest staining.</p><p><b>RESULTS</b>WYP obviously improved the organ coefficients of the testis and epididymis, increased sperm concentration, motility and viability, decreased the apoptosis of spermatogenic cells, and inhibited the abnormal openness of MPTP in the OAS model rats. HE staining showed that the number and levels of spermatogenic cells were significantly increased while Hochest staining manifested that the apoptosis of spermatogenic cells was remarkably inhibited in the seminiferous tubules of the testis in the WYP-treated rats.</p><p><b>CONCLUSIONS</b>WYP can improve sperm quality and reduce the apoptosis of spermatogenic cells (including sperm) in OAS model rats, which may be related with its inhibitory effect on the abnormal openness of MPTP.</p>

Cloning and expression analysis of MPBQ MT gene in safflower / 中草药

Objective: Safflower (Carthamus tinctorius) is an important natural source of vitamin E. 2-Methy-6-phytyl-1,4- benzoquinone methyltransferase (MPBQ MT) is a key enzyme in vitamin E synthesis pathway. MPBQ MT gene was cloned, bioinformatics was analyzed, and expression was analyzed to provide the foundation for the biosysthesis and regulation mechanism of vitamin E in safflower. Methods: According to the intermediate sequence obtained from the database of the safflower seed,MPBQ MT gene sequence was cloned by RT-PCR and RACE techniques, and the protein characteristics were analyzed using bioinformatics and constructing phylogenetic tree. The expression of MPBQ MT gene in the different development stages was analyzed using real time-PCR. Results: The full cDNA sequence of MPBQ MT gene was 1 392 bp, named CtMPBQ MT, contained an open reading frame (ORF, 1 038 bp), and encoded a protein of 345 amino acids with a predicted molecular mass of 38 900. The conserved structural domain analysis showed that it had the typical functional domains of SAM protein. Sequence alignment and phylogenetic tree analyses showed that the MT MPBQ gene had some homology with other amino acids, and among them CtMPBQ MT had 89% and 86% of consistency with MPBQ MT of Helianthus annuus and Lactuca sativa. The expression of CtMPBQ MT gene in safflower seeds at different development stages was determined by quantitative real-time PCR, it was found that the highest expression level of CtMPBQ MT gene was detected in 50 d after flowering. Conclusion: MPBQ MT gene of safflower is successfully cloned, analyzed, and expressed, meantime a basis for the study on matter in the synthesis and regulation of vitamin E is provided.

A P300 study of cognition in patients with functional constipation / 中华物理医学与康复杂志

Objective To investigate the relationship between cognitive function and emotional status in functional constipation patients.Methods Thirty-five functional constipation patients (the functional constipation group) and 24 healthy controls (the HCs) were enrolled in an event-related potential (ERP),behavior and electroeneephalogram study while performing an oddball auditory task.Response time,accuracy,latency and P300 amplitude were compared between the two groups.The Hamilton depression rating scale (HAMD-17),Hamilton anxiety scale (HAMA),symptom check list-90 (SCL-90) and Eysenck personality questionnaire (EPQ) were administered prior to the oddball task.Results The average HAMD-17,HAM A and SCL-90 (the somatization,obsessive-compulsive disorder,depression,anxiety and psychosis dimensions) scores of the functional constipation group differed significantly from those of the HCs.The intro-extraversion and neurosis dimensions of the EPQ were also significantly different.There was no significant difference in response time or latency between the two groups.The ERP results showed that the P300 amplitudes at the F3 and F7 sites were significantly different between the functional constipation group and the HCs.But there was no significant difference in P300 latencies at F3 or F7 between the two groups.Conclusions The findings suggest that patients with functional constipation are more susceptible to depression and anxiety,as well as somatization,obsessive-compulsive tendencies and other neurotic personality characteristics.Patients may employ psychological defense mechanisms to avoid the depression and anxiety.The ERP results imply there may be the implicit cognitive dysfunction with emotion in patients with functional constipation.

Mutation frequency analysis of mitochondrial ND1 gene associated with Leber hereditary optic neuropathy in Chinese population / 中华实验眼科杂志

Background Leber hereditary optic neuropathy (LHON)is a common inherited eye disease,which generally affects young adults with bilateral loss of central vision.Mutation frequency of Leber hereditary has not been fully clarified. Objective This study was to investigate the mutation frequency of mitochondrial NDI gene associated with LHON in Chinese population. Methods The proposal of the study was approved by Ethic Committee of Wenzhou Medical College.Written informed consent was obtained from each subject initial of this trial.Eight hundred and ninety-four LHON patients and 134 normal subjects were collected.Genomic DNA was extracted from peripheral blood leukocytes of the all participants.Polymerase chain reaction (PCR) was used to amplify and sequence analysis of the mitochondrial ND1 gene was performed and aligned with revised Cambridge Reference Sequence(rCRS) of mitochondrial DNA.Then mutated gene frequency was screened and analyzed. Results Mutational analysis of mitochondrial ND1 gene in 894 LHON patients revealed the presence of G3316A,T3394C,G3460A,C3497T,G3635A,G3733A,and T4216C.11.19％ LHON patients (100/894 ) were found to be associated with the gene mutations mentioned above,and 3.24％ patients (29/894) showed the co-occurrence of three primary mutations.Mutation frequencies in LHON patients were 2.57％,2.23％,1.45％,3.80％,0.67％,0.11％,0.34％,respectively,and G3316A,T3394C,C3497T and T4216C also were detected in 134 normal controls with the mutation frequencies of 4.48％,2.99％,4.48％ and 1.49％,respectively.Mutation frequency analysis showed an insignificant difference in the mutations of G3316A,T3394C,C3497T and T4216C between LHON patients and normal controls (x2 =0.926,P=0.336;x2 =0.052,P=0.820; x2 =0.142,P=0.707;P=0.129).G3376A,G3496T,G3700A,A4136G,T4160C and C4171A were absent in Chinese LHON patients. Conclusions Mitoehondrial ND1 gene in LHON is a mutational hotspot in Chinese population,11.19％ (100/894)associated with LHON was caused by ND1 gene mutation.G3635A,G3733A may be rare pathological mutation in Chinese population.However,G3316A,T3394C,C3497T and T4216C are insufficient to produce the clinical phenotype,but they may play a synergic role for penetrance and phenotypic manifestation in LHON.