1.A double-blind randomised controlled clinical trial of Shenling Baizhu Granules in treating low anterior resection syndrome in rectal cancer
Shuo FENG ; Hui YE ; Yingchao WU ; Guowei CHEN ; Tao WU ; Yong JIANG ; Tao LIU ; Shuai ZUO ; Xuezhi ZHANG ; Junling ZHANG ; Xin WANG
Journal of Beijing University of Traditional Chinese Medicine 2024;47(7):953-960
Objective This study aimed to assess the clinical efficacy of Shenling Baizhu Granules in treating low anterior resection syndrome(LARS)in rectal cancer.Methods The study employed a randomized,double-blind,placebo-parallel controlled,single-center,validity-tested clinical trial design.December 2019 to June 2022,the Department of Gastrointestinal Surgery and Integrated Traditional Chinese and Western Medicine of Peking University First Hospital recruited 110 patients who had undergone low anterior resection(LAR)for rectal cancer and subsequently developed LARS.These patients,meeting the enrollment criteria,were randomly assigned into the treatment group(55)and the control group(55)using the double-blind method principle.The randomization table was generated by SAS 9.2 software employing the double-blind method.The treatment group received oral Shenling Baizhu Granules,while the control group received oral placebo granules.Both groups commenced treatment on the 10th day after-surgery for 30 consecutive days.Patients were evaluated using LARS score,traditional Chinese medicine(TCM)symptom grading,and XU Zhongfa score before treatment,on the 15th day of treatment,and on the 1st day after treatment cessation.Results Out of 110 patients,107 were included in the full analysis set for efficacy analysis:55 patients in the treatment group and 55 patients in the control group.One case in the treatment group was excluded(against protocol),and two cases in the control group were excluded(one lost to follow-up,one against protocol).Baseline data between the two groups were consistent,with no statistically significant difference.Before treatment,LARS scores for the treatment and control groups were 33.0(31.0,36.0)and 34.0(32.0,37.0)respectively.Patients with TCM symptom scores of grades 2 to 3 accounted for 92.73%and 90.57%in the treatment and control groups,respectively,with no statistically significant difference.After 30 days of treatment,LARS scores for the treatment and control groups were 21.0(19.8,23.0)and 26.0(22.0,28.0)respectively.The percentage of patients with TCM symptom scores of grades 2 to 3 decreased to 33.33%in the treatment group and 66.04%in the control group,with a statistically significant difference.Shenling Baizhu Granules showed rapid improvement in watery or loose stools in post-operative rectal cancer patients.After 30 days of treatment,Shenling Baizhu Granules significantly improved appetite,stool consistency,abdominal distension,abdominal pain,and eructation symptoms in postoperative rectal cancer patients.Before treatment,the XU Zhongfa scores for the treatment and control groups were 3.0(2.0,4.3)and 4.0(2.0,4.0)respectively,with no statistically significant difference.After 30 days of treatment,the XU Zhongfa scores for the treatment and control groups were 7.0(6.0,8.0)and 6.0(5.0,7.0)respectively,with the treatment group significantly higher than the control group(P<0.01).Conclusion Shenling Baizhu Granules can effectively improve LARS symptoms in patients following LAR of rectal cancer within a short period of time.
2.Efficacy and safety of Jiuhua hemorrhoid suppository plus diosmin for the treatment of hemorrhoid hemorrhage: a multicenter, randomized, and controlled trial
RONG Xinqi ; WU Mingsheng ; XIN  ; Xuezhi ; ZHANG  ; Bo ; LIU  ; Dianwen ; XIAO  ; Huirong ; WANG  ; Zhenyi ; CUI  ; Junhui ; WANG  ; Jianping ; WANG Zhongcheng ; FAN Xiaohua ; HU  ; Ying ; RONG  ; Yisheng ; LI  ; Ying
Digital Chinese Medicine 2023;6(4):467-476
Objective:
To compare the efficacy and safety of combining diosmin with Jiuhua hemorrhoid suppository versus diosmin alone for the treatment of hemorrhoid hemorrhage.
Methods:
The Jiuhua hemorrhoid suppository study was conducted in 10 medical centers across China from April 1, 2019 to June 30, 2020. Patients with hemorrhoid bleeding were randomized in a ratio of 1 : 1 to either receive Jiuhua hemorrhoid suppository and diosmin tablets (the study group) or diosmin tablets alone (the control group). The suppository was used once a day after defecation or at bedtime after rinsing the anus with warm water. Diosmin tablets were administered only once a day (0.9 g). The primary endpoint of the study was the assessment of hemorrhoid bleeding relief 7 ± 2 days after treatment, classified as “very effective” “effective” and “ineffective”. The secondary endpoint included the evaluation of pain alleviation using the visual analogue scale (VAS, with scores ranging from 0 to 10) and edema (with scores ranging from 0 to 3). The safety of the two treatment regimens was evaluated 14 ±
2 days after drug administration.
Results:
The full analysis set (FAS) comprised 107 participants in the study group and 111 in the control group, while the per-protocol set (PPS) included 106 participants in the study group and 111 in the control group. In terms of hemorrhoid bleeding, the proportion of very effective and effective cases in the study group were significantly higher than that in the control group [106 (99.06%) vs. 91 (81.98%), P < 0.0001] in the FAS, and the PPS results [105 (99.06%) vs. 91 (81.98%), P < 0.0001] were comparable to the FAS results. The pain VAS scores at day 7 after treatment were comparable between the two groups (0.80 ± 1.17 vs. 0.80 ± 1.20, P = 0.2177). The majority of the participants in both groups had an edema score of 0 at day 7 after treatment [96 (89.72%) vs. 99 (91.67%), P = 0.370 5]. Adverse events (AEs) occurred in 9 patients (8.4%) in the study group and 3 patients (2.7%) in the control group. In addition, 5 AEs in the study group and 1 AE in the control group were possibly in association with the study drug.
Conclusion
Compared with the administration of diosmin oral tablets alone, the addition of Jiuhua hemorrhoid suppository to the tablets demonstrates enhanced efficacy in addressing hemorrhoid bleeding, with satisfactory patient adherence and acceptable safety.
3.Computational fluid dynamics study on the effects of morphology of prostatic urethra in mid-voiding after minimally invasive surgery with BPH
Bin ZHANG ; Shuang LIU ; Xuhui ZHANG ; Xuezhi LIANG ; Bo WU ; Rong LIU ; Xiaoming CAO ; Dongwen WANG
Chinese Journal of Urology 2021;42(3):226-228
It is important to investigate the mechanical effects of morphology of prostatic urethra (PU) for benign prostatic hyperplasia (BPH). PU and bladder neck transverse diameter ratio (RPU-1), which related to vortex, and their influence on urine flow were observed by CFD. The results showed that vortexes appeared and expanded with increasing RPU on both sides of PU when RPU-1>0.79, and velocity of external urethral orifice decreased gradually. CFD is an available method for urodynamics research. The quantitative simulation of the relationship between RPU-1 and vortex was proposed for the first time, providing a new idea for advancing theory of PU lumen repair in BPH.
4.Analysis on the current situation of pediatric nurses′ professional autonomy and its influencing factors
Yunyun WANG ; Li WU ; Jihong FANG ; Hongqing WANG ; Yuxia TANG ; Bing XU ; Haixia XU ; Hui ZHANG ; Yuping HU ; Changyu WANG ; Meiyun ZHU ; Lili DAI ; Li ZHAO ; Ping ZHONG ; Min WEI ; Xuezhi SHI
Chinese Journal of Practical Nursing 2021;37(17):1333-1339
Objective:To understand the degree of professional autonomy of nurses in Pediatric Nursing Alliance and the status of pediatric nursing practice environment, which providing guidance for the development of a series of specialized training in the alliance.Methods:Stratified random sampling method was used to conduct a questionnaire survey on nursing staff of different professional levels in Pediatric Nursing Alliance, which through the questionnaire star by using the questionnaire general information and training demand questionnaire, nurses practice professional autonomy scale, pediatric nursing staff structural empowerment questionnaire and nursing practice influencing factors questionnaire through the questionnaire star.Results:The total score for professional autonomy of nurses in the pediatric alliance was 192.66±18.63, the structural empowerment ( OR=1.137, 95% CI=1.084-1.194), lack of caring team ( OR=2.763, 95% CI=1.443-5.292) and performance evaluation ( OR=0.498, 95% CI= 0.274-0.908), specialized education and professional experience ( OR=0.548, 95% CI= 0.334-0.871) were affecting the clinical nursing practice. Conclusion:The degree of professional autonomy of nurses in the Pediatric Nursing Alliance is in the middle and high level. Key factors affecting nursing practice including insufficient structural empowerment, lack of opportunities to continue learning, lack of nursing teams, lack of effectiveness evaluation and the lack of specialized education and work experience, which guiding the pediatric nursing alliance to continuously deepen the connotation of pediatric nursing professional and innovative team collaboration new model, utilize the advantages of resources to actively cultivate specialized nursing research personnel, carry out multi-disciplinary and cross-disciplinary cooperation, improve the nursing quality evaluation index system, so as to enhance the professional nursing service capacity and value.
5. Antibacterial effectiveness of calcium silicate-based root canal sealer against Enterococcus faecalis biofilms in infected dentinal tubules in vitro
Tianfeng DU ; Laidi WU ; Xuezhi TANG ; Qi SHI ; Kang GAN ; Juanfang ZHU ; Yingguang CAO
Chinese Journal of Stomatology 2019;54(10):656-661
Objective:
To evaluate the antiseptic effect of combined using of 5% sodium hypochlorite and calcium silicate-based root canal sealer against
6.Antibacterial effectiveness of calcium silicate?based root canal sealer against Enterococcus faecalis biofilms in infected dentinal tubules in vitro
Tianfeng DU ; Laidi WU ; Xuezhi TANG ; Qi SHI ; Kang GAN ; Juanfang ZHU ; Yingguang CAO
Chinese Journal of Stomatology 2019;54(10):656-661
To evaluate the antiseptic effect of combined using of 5% sodium hypochlorite and calcium silicate?based root canal sealer against Enterococcus faecalis (Ef) biofilms in infected dentinal tubules in vitro . Methods Cells of Ef were inoculated into the dentinal tubules of single?rooted teeth (without caries, periapical lesions and malformations extracted due to periodontal disease or orthodontic reasons; collected from Department of Maxillofacial Surgery, The First Affiliated Hospital of Zhengzhou University) with centrifugation and incubated in brain?heart infusion (BHI) to form 3?week?old biofilms. The infected samples were subjected to sodium hypochlorite or sterile water bathing for 10 minutes followed by calcium silicate?based root canal sealer (iRoot SP) (calcium silicate?based group), Gutta?percha group and sterile water group placed on the root canal wall for 1, 4 and 12 weeks. There were two samples in each treatment at each point. The antiseptic effectiveness of combined use of sodium hypochlorite and calcium silicate?based root canal sealer was analyzed by laser scanning confocal microscope (LSCM), ANOVA and LSD?t test. Results After treatment with 5% sodium hypochlorite,in calcium silicate?based group for 4 and 12 weeks more Ef biofilm cells [(75.3 ± 3.5)% and (74.8 ± 3.8)% ] were killed than in Gutta?percha group [(65.9±4.1)% and (63.0±3.7)%] and sterile water group [(63.9±4.0)% and (64.2±3.5)%] (P<0.05). After being treated with sterile water, the proportion of dead bacterial cells in calcium silicate?based group for 1, 4 and 12 weeks [(27.5±4.6)%, (43.0±4.4)% and (40.3±6.1)%] were more than those in Gutta?percha group and sterile water group (P<0.05). After being treated with 5% sodium hypochlorite or sterile water, more biofilm bacteria were killed in calcium silicate?based group for 4 and 12 weeks than in calcium silicate?based group for 1 week (P<0.05). Conclusions The combined use of sodium hypochlorite and calcium silicate?based root canal sealer kills more biofilm cells in infected dentinal tubules.
7.Preparation and Characterization of Lurasidone Hydrochloride Solid Dispersion and Study on the in vitro Dissolution Behavior
Haitao ZHAO ; Guangxi SONG ; Xuezhi YIN ; Chen WU ; Bing WANG
China Pharmacy 2017;28(34):4876-4878
OBJECTIVE:To prepare the lurasidone hydrochloride solid dispersion,and improve its dissolution rate. METH-ODS:Taking povidone K30 as the carrier,solvent method was used to prepare the lurasidone hydrochloride solid dispersion with different drug-load ratios(1:0.5,1:1,1:2). The in vitro dissolution rates of 3 kinds of lurasidone hydrochloride solid dispersion with physical mixture (lurasidone hydrochloride-povidone K30) and original preparation were compared. X-ray powder diffraction method was adopted to analyze the crystal structures of raw material of lurasidone hydrochloride,povidone K30 and accessories, physical mixture (1:2) and accessories,and lurasidone hydrochloride solid dispersion (1:2) and accessories. RESULTS:Com-pared with physical mixture,the dissolution rate of lurasidone hydrochloride solid dispersion with drug-load ratios of 1:0.5,1:1, 1:2 was significantly improved,and the dissolution rate of solid dispersion was increased as the increase of the carrier ratio. The in vitro dissolution rates of lurasidone hydrochloride solid dispersion with drug-load ratio of 1:2 and original preparation were respec-tively 101.2%and 100.2%in 20 min. X-ray powder diffraction showed,there were characteristic absorption peaks of lurasidone hy-drochloride and accessories in physical mixture;the characteristic absorption peak of lurasidone hydrochloride in solid dispersion disappeared basically,and the characteristic absorption peak of accessories still existed. CONCLUSIONS:The in vitro dissolution of lurasidone hydrochloride solid dispersion with drug-load ratio of 1:2 is similar to original preparation,and lurasidone hydrochlo-ride exists in the solid dispersion as amorphous form.
8.Regulating Sub-health Along Meridians And Viscera
Yanjing WU ; Tingli NIU ; Yu LU ; Tianyu CHEN ; Lujiao GAO ; Yujin ZHANG ; Yang YANG ; Liangxiao MA ; Xuezhi YANG ; Xin NIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2017;19(10):1675-1679
This study was aimed to observe the clinical effect of low frequency negative pressure meridian viscera regulating sub-health.According to the diagnostic criteria,34 cases of sub healthy subjects were randomly selected.The low frequency negative pressure meridian viscera regulating method was used.By analyzing the cupping spot color feedback conditioning information of the sub healthy subjects and conditioning before and after the synthesis of the four diagnostic methods of digital and quantitative,its effect was evaluated.After 4 weeks of continuous adjustment,34 cases of sub healthy subjects,compared with preconditioning,cupping spot color of the subjects was shallow or disappeared (P < 0.01);after adjusting,the proportion of light red tongue and thin white tongue coating increased obviously (P < 0.05),the proportion of ecchymosis tongue was decreased compared to precoditioning (P < 0.05);after adjustment,core symptoms such as back pain,neck pain,anxiety and irritability,were alleviated or disappeared;after adjustment,the pulse string tightness decreased significantly (P < 0.01).It was concluded that the low frequency negative pressure meridian viscera regulation can significantly improve discomfort symptoms of sub healthy subjects and promote therecovery of tongue,pulse and cupping spot color in sub healthy subjects.This method is worth popularizing and further exploring.
9.Relationship between atherosclerotic renal artery stenosis and cerebral blood supply artery stenosis in patients with cerebral infarction
Qiang YE ; Xuezhi YANG ; Zusen YE ; Weiyong YIN ; Jianhua CHENG ; Lianghao FAN ; Xiaoyang WU
Chinese Journal of Postgraduates of Medicine 2016;39(3):254-257
Objective To investigate the incidence of atherosclerotic renal artery stenosis (ARAS), the relationship between ARAS and cerebral artery stenosis, and the risk of ARAS in patients with brain infarction. Methods The clinical data of 1 650 brain infarction patients were analyzed, which were carried out digital subtraction angiography(DSA) of cerebral and renal artery.The incidence of ARAS was counted out, and the relationship was analyzed between the different degree and number of cerebral artery stenosis and the rate of RAS. The demographic characteristics and the common risk factors of atherosclerosis were recorded, and the risk factors of ARAS were analyzed. Results The rate of ARAS in moderate stenosis group and severe stenosis and occlusion group of cerebral artery were all significantly higher than that in mild stenosis group and no stenosis group (all P < 0.01). The rates of ARAS in severe stenosis and occlusion group were significantly significantly higher than those in moderate stenosis group (P < 0.01). The rates of ARAS in 2 branch stenosis group and ≥3 branch stenosis group were both significantly higher than those in no stenosis group and 1 branch stenosis group (P < 0.01). The rates of ARAS of ≥3 branch stenosis group were significantly higher than those in 2 branch stenosis group (P<0.05). The rate of ARAS of 1 branch stenosis group were significantly higher than those in no stenosis group (P < 0.05). Age, hypertension, moderate or more artery stenosis or occlusion, and≥2 branch stenosis was independent risk factor of ARAS. Conclusions The incidence of ARAS increasesd with the increase of the degree of cerebral artery stenosis and the number of branch involved.Older age, hypertension, moderate or more artery stenosis or occlusion, and≥2 branch stenosis is risk factor for ARAS.
10.Interaction between folate and the expression of human papillomavirus 16 E6/E7 mRNA in the progression of cervix carcinogenesis
Jing NAN ; Ling DING ; Xuezhi LIU ; Juan LI ; Tingting WU ; Xiao CHEN ; Jintao WANG
Chinese Journal of Epidemiology 2016;37(6):852-857
Objective To explore the interaction between folate and the expression of HPV16 E6/E7 mRNA in the progression of cervix carcinogenesis.Methods Subjects were selected from the participants who were diagnosed pathologically,including 64 patients with cervical squamous cell carcinoma (SCC),55 patients with low-grade cervical intraepithelial neoplasm (CIN1),55 patients with high-grade cervical intraepithelial neoplasm (CIN2 +) and 80 with normal cervix (NC).The levels of serum folate and RBC folate were detected by microbiological assay,and the expression levels of HPV16 E6/E7 mRNA were measured,using the real-time polymerase chain reaction (real-time PCR).Data was analyzed by methods as chi-square test,analysis of variance (ANOVA),Welch test,Kruskal-Wallis H test and ordinal logistic regression.Spearman correlation was tested using the SPSS statistical software (version 16.0) while the interaction effects were evaluated by additive model.Results There was a positive correlation seen between the serum folate and RBC folate (r=0.41,P<0.001).The levels of serum folate and RBC folate decreased gradually along with the severity of cervical lesions (x2=32.71,P<0.001;x2=16.32,P<0.001).The expression levels of HPV 16 E6/E7 mRNA increased gradually with the severity of cervical lesions (x2 =30.11,P< 0.001;x2 =38.99,P<0.001).There was a negative correlation between the levels of RBC folate,expression levels of HPV16 E6 (E6:r=-0.14,P=0.009) and HPV16 E7 mRNA (E7:r=-0.21,P=0.001),respectively.Both RBC folate deficiency and HPV16 E6/E7 mRNA high expression showed additive interaction in CIN 1,CIN2 + and SCC.Conclusion Folate deficiency and high expression of HPV16 E6/E7 mRNA might increase the risk of cervical cancer and cervix precancerous lesions,and having a synergistic action in the progression of cervix carcinogenesis.

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