1.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.
2.Practice and effect of construction of rational drug use mode of PIVAS by the activities of quality control circle
Yun LU ; Gao WU ; Peng FU ; Yisheng FAN ; Ting YANG ; Shanshan LIU
Journal of Pharmaceutical Practice 2023;41(9):566-571
Objective To establish a rational drug use model of PIVAS and promote the rational drug use in clinical practices by enhancing the quality of prescription review by pharmacists. Methods The PIVAS physician orders received from 2014 to 2021 were extracted through the hospital information management (HIS) system. The types of irrational physician orders were statistically analyzed, the improvements were made by the method of quality control circle (QCC). Results The model of PIVAS rational drug use formed a standardized process. The proficiency of physician order review was improved. From 2014 to 2021, the number and proportion of unreasonable physician orders in PIVAS decreased year by year. Every type of unreasonable physician orders was improved year by year. Conclusion The professional and technical levels of pharmacist for physician order review at our hospital were improved by the model of PIVAS rational drug use. The quality of pharmaceutical service was significantly improved which ensured the safety of patients' medication.
3.A Non-inferiority Randomized Controlled Trial of Topical Bisaitong (鼻塞通) in Treatment of Moderate to Severe Allergic Rhinitis
Jintao PANG ; Feiting FAN ; Jingmin XIAO ; Bing HE ; Lei WU ; Yisheng XU ; Fuping XU ; Zhongwen WANG ; Yuanbin CHEN
Journal of Traditional Chinese Medicine 2023;64(19):1995-2002
ObjectiveTo evaluate the efficacy and safety of topical Bisaitong (鼻塞通) in treating moderate-to-severe allergic rhinitis (AR). MethodsA randomized, positive-controlled, non-inferiority clinical trial design was adopted. Totally, 108 cases of moderate-to-severe AR were randomly divided into Bisaitong group and mometasone furoate group,with 54 cases in each group. The Bisaitong group was treated with Bisaitong smeared at the nasal cavity twice a day, and the mometasone furoate group received inhalation of mometasone furoate nasal spray 100 μg in each nostril, once a day. Both groups were treated for 4 weeks and followed up after additional 4 weeks. Both groups were compared on the rhinoconjunctivitis quality of life questionnaire (RQLQ), rhinoconjunctivitis total symptom score (RTSS), visual analogue score (VAS) of sneezing, runny nose, nasal itching, nasal congestion degree, days of AR episodes at enrollment, after 2- and 4-week, and at follow-up. The peripheral blood eosinophil (EOS) count and percentage (EOS%), serum eosinophil cationic protein (ECP), serum dust mite, dermatophagoides farinae, and cockroach allergen-specific IgE (sIgE) levels were compared between groups at enrollment and after 4-week treatment. Drug overuse rate was calculated, and the safety was evaluated. The analysis of all efficacy outcomes was based on both full analysis set (FAS) and per-protocol set (PPS). ResultsThe lower limit of the 95% confidence interval for the differences in RQLQ scores were greater than -0.6 measured after 2- and 4-week treatment and at follow-up compared to that measured at the enrollment in both groups, indicating of the Bisaitong group being non-inferior to the mometasone furoate group. There was no statistically significant difference between groups on RTSS score, VAS scores of sneezing, runny nose, nasal itching, nasal congestion degree and days of episodes at all timepoints (P>0.05), but each outcome changed significantly over time in both groups (P<0.01). The differences between groups in EOS count, EOS%, ECP levels, serum dust mite, dermatophagoides farinae, cockroach sIgE levels, and drug overuse rate were not statistically significant at enrollment and after 4-week treatment (P>0.05). Adverse events occurred in eight cases (15.10%) in the Bisaitong group and five cases (9.30%) in the mometasone furoate group, showing no significant difference between groups (P>0.05). ConclusionTopical Bisaitong is non-inferior to mometasone furoate nasal spray in the treatment of moderate to severe AR in terms of clinical symptom relief,reduction in the episodes, improvement of quality of life, and sound safety.
4.Efficacy and safety of CalliSpheres microsphere versus conventional transcatheter arterial chemoembolization in treatment of hepatocellular carcinoma: A Meta-analysis
Yisheng PENG ; Pan HE ; Gang ZHU ; Xinkai LI ; Shunde TAN ; Jianfei CHEN ; Jun FAN ; Bin LUO ; Song SU ; Bo LI ; Xiaoli YANG
Journal of Clinical Hepatology 2021;37(8):1841-1847.
ObjectiveTo investigate the efficacy and safety of CalliSpheres microsphere-transcatheter arterial chemoembolization (CSM-TACE) versus conventional transcatheter arterial chemoembolization (cTACE) in the treatment of hepatocellular carcinoma (HCC) through a meta-analysis. MethodsPubMed, Web of Science, Cochrane Library, CNKI, Wanfang Data, and VIP were searched for all Chinese and English articles on the application of CSM-TACE and cTACE in HCC published up to the end of October, 2020. After quality assessment was performed for the articles included, RevMan 5.3 software provided by Cochrane Library was used for analysis. ResultsA total of 15 studies were included, with 1535 patients in total. This meta-analysis showed that compared with the patients receiving cTACE, the patients receiving CSM-TACE had significantly higher 1-year overall survival rate (odds ratio [OR]=2.26, 95% confidence interval [CI]: 1.63-3.13, P<0.000 01), 2-year overall survival rate (OR=1.73, 95%CI: 1.20-2.50, P=0.003), and 2-year progression-free survival rate (OR=1.60, 95%CI: 1.05-2.43, P=0.03). In terms of safety, compared with the patients receiving cTACE, the patients receiving CSM-TACE had significantly lower incidence rates of postoperative vomiting (OR=0.65, 95%CI: 0.46-0.92, P=0.01), bone marrow suppression (OR=0.17, 95%CI: 0.05-0.54, P=0.003), and neutropenia (OR=0.18, 95%CI: 0.07-045, P=0.000 3), while there were no significant differences between the two groups of patients in postoperative pyrexia, abdominal pain, and ascites (all P>0.05). ConclusionCSM-TACE has significant advantages in improving 1- and 2-year overall survival rates and 2-year progression-free survival rates and can significantly reduce the incidence rates of postoperative vomiting, bone marrow suppression, and neutropenia. Therefore, CSM-TACE is a safe and effective treatment method.
5.The key role of gut-liver axis in pyrrolizidine alkaloid-induced hepatotoxicity and enterotoxicity.
Yisheng HE ; Jiang MA ; Xiaoyu FAN ; Liang DING ; Xinxin DING ; Qing-Yu ZHANG ; Ge LIN
Acta Pharmaceutica Sinica B 2021;11(12):3820-3835
Pyrrolizidine alkaloids (PAs) are the most common phytotoxins with documented human hepatotoxicity. PAs require metabolic activation by cytochromes P450 to generate toxic intermediates which bind to proteins and form protein adducts, thereby causing cytotoxicity. This study investigated the role of the gut-liver axis in PA intoxication and the underlying mechanisms. We exposed mice to retrorsine (RTS), a representative PA, and for the first time found RTS-induced intestinal epithelium damage and disruption to intestinal barrier function. Using mice with tissue-selective ablation of P450 activity, we found that hepatic P450s, but not intestinal P450s, were essential for PA bioactivation. Besides, in RTS-exposed, bile duct-cannulated rats, we found the liver-derived reactive PA metabolites were transported by bile into the intestine to exert enterotoxicity. The impact of gut-derived pathogenic factors in RTS-induced hepatotoxicity was further studied in mice with dextran sulfate sodium (DSS)-induced chronic colitis. DSS treatment increased the hepatic endotoxin level and depleted hepatic reduced glutathione, thereby suppressing the PA detoxification pathway. Compared to RTS-exposed normal mice, the colitic mice displayed more severe RTS-induced hepatic vasculature damage, fibrosis, and steatosis. Overall, our findings provide the first mode-of-action evidence of PA-induced enterotoxicity and highlight the importance of gut barrier function in PA-induced liver injury.
6.Study on the HPLC Fingerprint of Gynecological Lotion
Liu YANG ; Ting LI ; Yanbo FAN ; Zheren LIN ; Yisheng ZHANG
China Pharmacist 2017;20(3):463-465
Objective:To establish the HPLC fingerprint detection method for gynecological lotion. Methods:Wondasil C18 (250 mm × 4. 6 mm,5 μm)was selected as the analytical column. The mobile phase was composed of acetonitrile-0. 3% phosphric acid and 0. 3% diethylamine solution with gradient elution at a flow rate of 1. 0 ml·min-1 . The detection wavelength was set at 284 nm and the column temperature was 30℃. Ten batches of gynecological lotion were detected by the HPLC fingerprint and evaluated by Chromato-graphic Fingerprint Evaluation System of Chinese Medicine (2004 edition). Results: The separated peaks were clear and 15 common peaks were identified in the fingerprint of 10 batches of gynecological lotion. Conclusion: The HPLC fingerprint is with good repeat-ability and stability, which can provide evidence for the quality control of gynecological lotion.
7.Study on the Quality Standard for Tiandijing Pills
Wei WANG ; Yisheng ZHANG ; Yanbo FAN ; Zhijie LI
China Pharmacist 2016;19(10):1954-1956
Objective:To establish the quality standard for Tiandijing pills. Methods:A microscopic method was used to identify the crush herbs. TLC was performed to identify Rhizoma Polygonati and Fructus Ligustri Lucidi. HPLC was used to determine the con-tent of gastrodine. Results:The microscopy could identify earthworm and Acorus tatarinowii. The identification characteristics by TLC were distinct and highly specific. Gastrodine could be determined in HPLC. The linearity of gastrodine was good within the range of 19. 80-158. 40 μg·ml-1(r=1. 000 0). The average recovery of gastrodine was 98. 33% (RSD=0. 45%, n=6). Conclusion:The methods of identification and quantification are simple and reproducible, which can be used for the quality control of Tiandijing pills.
8.Study on Extraction Technology for Water Extract of Tangganjian Concentrated Pills
Ying WU ; Yisheng ZHANG ; Yanbo FAN
China Pharmacist 2016;19(7):1236-1238
Objective:To optimize the extraction parameters for the water extract of Tangganjian concentrated pills .Methods:U-sing the content of paeoniflorin and extraction yield as the evaluation indices .An HPLC was used to determine the content of peoniflorin in the extract, and the chromatographic conditions were as follows: a WondaSil C18 chromatographic column (250 mm ×4.6 mm, 5μm), the mobile phase was acetonitrile-0.1%phosphoric acid solution (16∶84) with a flow rate of 1 ml· min-1, the column tem-perature was 30℃and the detection wavelength was 230 nm.The amount of water , extraction time and extraction times were regarded as the influencing factors ,an orthogonal design was adopted to develop the analysis of variance for extraction parameters for water ex -tract.Results:The optimal extraction process was as follows:adding 12-fold amount of water and extracting 3 times with 1 h for each time.Conclusion:The optimum extraction process is reasonable , stable and feasible, which provides experimental basis for the extrac-tion process of Tangganjian concentrated pills .
9.Rapid Determination of CaSO4 ·2H2 O in Gypsum by Raman Spectra
Mingyang YUAN ; Xiaojing SUN ; Long CHEN ; Yisheng ZHANG ; Yanbo FAN ; Liu YANG
China Pharmacist 2015;(1):73-76
Objective:To develop a method for the rapid determination of CaSO4 ·2H2 O in gypsum by Raman spectra. Methods:Totally 40 batches of gypsum from different origins were used as the training set, compared with the results by ENTA titration, and OPUS software was used to establish a quantitative analysis model of CaSO4 ·2H2 O in gypsum by Raman spectra. Results:The estab-lished quantitative analysis model could provide a good prediction result rapidly when the content was between 97. 93% and 99. 81%. Conclusion:The method is accurate, fast and simple, which can be developed as an analysis method for CaSO4 ·2H2 O in gypsum.
10.Analysis on Characteristic Peaks of Gypsum Fibrosum from Authentic Product Area Hubei Yingcheng by X-ray Diffraction
Yanbo FAN ; Weijun LIANG ; Yisheng ZHANG
China Pharmacist 2015;(5):775-777
Objective:To analyze the characteristic peaks of gypsum fibrosum from authentic product area Hubei Yingcheng via X-ray diffraction. Methods:The fingerprint and common peaks of gypsum fibrosum from different areas were analyzed via X-ray diffrac-tion, and the characteristic peaks of gypsum fibrosum from authentic product area Hubei Yingcheng were identified Results:The finger-prints of X-ray diffraction of gypsum fibrosum from different areas were obtalned. Sixteen common peaks were determined, and two characteristic peaks of gypsum fibrosum from authentic product area Yingcheng were determined via X-ray diffraction with interplanar spacing of 1. 68 and 1. 51, respectively. Conclusion:The determination of two characteristic peaks of gypsum fibrosum from authentic product area Hubei Yingcheng can distinguish gypsum fibrosum from the other areas and provide basis for the quality evaluation of gyp-sum fibrosum.

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