1.CHINA PH ARMACY Volume 33,Number 6,March 30,2022 Semimonthly Table of Contents Guideline for the evaluation of medicine list in Chinese med ical instituti ons
Hui CHEN ; Guangquan SU ; Xiao LIU ; Fangyuan TIAN ; Yingyun GUAN ; Ngting Ti CHEN ; Yingnan ZHAO ; Linlin LIU ; Xiaolan BIAN ; Ting XU ; Xiaoyu LI ; Ong Aiz SHEN ; Lihong LIU
China Pharmacy 2022;33(6):641-652
In order to improve the management level of medicine list of medical institutions in China ,and help medical institutions build a medicine list of medical institutions with reasonable drug use structure ,standardized adjustment procedures , convenient operation and application and scientific evaluation methods ,so as to meet the needs of clinical rational drug use to the greatest extent ,with the support of the Pharmaceutical Care Professional Committee of the Chinese Pharmaceutical Association , China-Japan Friendship Hospital and the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital )jointly initiate and complete Guideline for the Evaluation of Medicine List in Chinese Medical Institutions jointly with a number of medical institutions. In strict accordance with the methodological requirements of World Health Organization standard guidelines ,based on the Delphi method ,the guideline formulation working group has constructed the quality evaluation index system and quantitative scoring table of medicine list management in medical institutions from the 5 dimensions of organization and management ,structure,adjustment,application and e valuation of the list. It is used to help medical institutions evaluate the quality of their medicine list management ,so asto play a positive role in the fine management of medicine list in medical institutions.
2.Preliminary analysis of the promotion effect of laparoscopic standardized surgical treatment for gastric cancer in regional medical centers in Shanghai.
Xiao Dong SHEN ; Ming XU ; Chang SU ; Min YE ; Wei LI ; Zhen Xi YANG ; Jiang HAN ; Zhi Qi ZHANG ; Hong Gang XIANG ; Lin Hai YU ; Peng SUN ; Wen Hai HUANG ; Bo Wen XIE ; Ying Xin GUAN ; Zeng Hao CAI ; Wenpeng ZHANG ; Lu ZANG
Chinese Journal of Gastrointestinal Surgery 2022;25(8):708-715
Objective: To explore the promotion effect of laparoscopic standardized surgery for gastric cancer observational in some regional medical centers in Shanghai. Methods: A retrospective cohort study was carried out. Eleven regional medical centers in Shanghai received the promotion program of laparoscopic standardized surgery for gastric cancer, which was led by Ruijin Hospital, Shanghai Jiaotong University School of Medicine (Shanghai Minimally Invasive Surgery Center) from January to December 2020. Clinicopathological data of gastric cancer patients treated at these 11 regional medical centers before and after the promotion program were collected. Inclusion criteria were as follows: patients undergoing laparoscopic distal gastrectomy or total gastrectomy; gastric cancer confirmed by pathology; without distant metastasis or peritoneal metastasis. Patients who did not undergo laparoscopic D2 radical resection, or received neoadjuvant chemotherapy before surgery, or without complete clinical data were excluded. Patients undergoing laparoscopic surgery from January to December 2019 were included in the pre-promotion group (46 cases). Patients undergoing laparoscopic surgery from January to December 2021 were included in the post-promotion group (102 cases). In addition, patients undergoing laparoscopic surgery at Ruijin Hospital from January 2021 to December were included in the control group (138 cases). The baseline data, perioperative measurements postoperative complications, and pathological results of the three groups were analyzed and compared. Results: There were no significant differences in baseline characteristics among the three groups (all P>0.05). Compared with the pre-promotion group, the operation time in post-promotion group was significantly shorter [(207.3±36.0) minutes vs. (254.2±47.1) minutes, t=7.038,P<0.001], and the number of harvested lymph node was significantly more (24.4±12.2 vs. 18.9±5.5, t=2.900, P=0.004). However, there were no significant differences in the extent of resection, time to fluid intake, and postoperative hospital stay between the two groups (all P>0.05). Compared with the control group, the operation time [(207.3±36.0) minutes vs (172.6±26.0) minutes, t=8.281, P<0.001], time to fluid intake [(6.3±3.2) days than (5.5±3.0) days, t=2.029, P=0.044], and the postoperative hospital stay [(14.3±5.6) days vs. (10.1±4.8) days, t=6.036, P<0.001] in the post- promotion group were still longer. Total gastrectomy was less common in the post-promotion group compared with the control group [18 cases (17.6%) vs. 41 cases (29.7%), χ2=7.380, P=0.007]. However, there was no significant difference in the number of harvested lymph node between the two groups (P>0.05). The morbidity of postoperative complication in the post-promotion group (9.8%, 10/102) was significantly lower than that in the pre-promotion group (23.9%, 11/46) (χ2=5.183, P=0.023), while above morbidity was not significantly different between the post-promotion group and the control group [9.8% vs. 6.5% (9/138), χ2=0.867, P=0.352]. Conclusion: After the promotion of laparoscopic standardized surgery for gastric cancer in regional medical centers, the standardization degree of surgery has been improved, and the morbidity of postoperative complication decreases. Laparoscopic standardized surgery for gastric cancer can be promoted to more regional medical centers.
China
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Gastrectomy/methods*
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Hospitals
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Humans
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Laparoscopy
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Lymph Node Excision/methods*
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Postoperative Complications/etiology*
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Retrospective Studies
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Stomach Neoplasms/pathology*
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Treatment Outcome
3.Expert consensus on the diagnosis and treatment of severe and critical coronavirus disease 2019.
You SHANG ; Jianfeng WU ; Jinglun LIU ; Yun LONG ; Jianfeng XIE ; Dong ZHANG ; Bo HU ; Yuan ZONG ; Xuelian LIAO ; Xiuling SHANG ; Renyu DING ; Kai KANG ; Jiao LIU ; Aijun PAN ; Yonghao XU ; Changsong WANG ; Qianghong XU ; Xijing ZHANG ; Jicheng ZHANG ; Ling LIU ; Jiancheng ZHANG ; Yi YANG ; Kaijiang YU ; Xiangdong GUAN ; Dechang CHEN
Chinese Medical Journal 2022;135(16):1913-1916
Humans
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COVID-19
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Consensus
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SARS-CoV-2
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China
4.Clinical Recommendations for Perioperative Immunotherapy-induced Adverse Events in Patients with Non-small Cell Lung Cancer.
Jun NI ; Miao HUANG ; Li ZHANG ; Nan WU ; Chunxue BAI ; Liang'an CHEN ; Jun LIANG ; Qian LIU ; Jie WANG ; Yilong WU ; Fengchun ZHANG ; Shuyang ZHANG ; Chun CHEN ; Jun CHEN ; Wentao FANG ; Shugeng GAO ; Jian HU ; Tao JIANG ; Shanqing LI ; Hecheng LI ; Yongde LIAO ; Yang LIU ; Deruo LIU ; Hongxu LIU ; Jianyang LIU ; Lunxu LIU ; Mengzhao WANG ; Changli WANG ; Fan YANG ; Yue YANG ; Lanjun ZHANG ; Xiuyi ZHI ; Wenzhao ZHONG ; Yuzhou GUAN ; Xiaoxiao GUO ; Chunxia HE ; Shaolei LI ; Yue LI ; Naixin LIANG ; Fangliang LU ; Chao LV ; Wei LV ; Xiaoyan SI ; Fengwei TAN ; Hanping WANG ; Jiangshan WANG ; Shi YAN ; Huaxia YANG ; Huijuan ZHU ; Junling ZHUANG ; Minglei ZHUO
Chinese Journal of Lung Cancer 2021;24(3):141-160
BACKGROUND:
Perioperative treatment has become an increasingly important aspect of the management of patients with non-small cell lung cancer (NSCLC). Small-scale clinical studies performed in recent years have shown improvements in the major pathological remission rate after neoadjuvant therapy, suggesting that it will soon become an important part of NSCLC treatment. Nevertheless, neoadjuvant immunotherapy may be accompanied by serious adverse reactions that lead to delay or cancelation of surgery, additional illness, and even death, and have therefore attracted much attention. The purpose of the clinical recommendations is to form a diagnosis and treatment plan suitable for the current domestic medical situation for the immune-related adverse event (irAE).
METHODS:
This recommendation is composed of experts in thoracic surgery, oncologists, thoracic medicine and irAE related departments (gastroenterology, respirology, cardiology, infectious medicine, hematology, endocrinology, rheumatology, neurology, dermatology, emergency section) to jointly complete the formulation. Experts make full reference to the irAE guidelines, large-scale clinical research data published by thoracic surgery, and the clinical experience of domestic doctors and publicly published cases, and repeated discussions in multiple disciplines to form this recommendation for perioperative irAE.
RESULTS:
This clinical recommendation covers the whole process of prevention, evaluation, examination, treatment and monitoring related to irAE, so as to guide the clinical work comprehensively and effectively.
CONCLUSIONS
Perioperative irAE management is an important part of immune perioperative treatment of lung cancer. With the continuous development of immune perioperative treatment, more research is needed in the future to optimize the diagnosis and treatment of perioperative irAE.
5. The preliminary report of a registration clinical trial of proton and heavy ion irradiation
Jiade LU ; Ming YE ; Xiaomao GUO ; Shen FU ; F. Michael MOYERS ; Qing ZHANG ; Jingfang MAO ; Lin KONG ; Wen Chien HSI ; Kambiz SHAHNAZI ; Jingfang ZHAO ; Zhen ZHANG ; Xiumei MA ; Songtao LAI ; Xiaomeng ZHANG ; Ningyi MA ; Yunsheng GAO ; Xin CAI ; Xiyin GUAN ; Junhua ZHANG ; Bin WU ; Jingyi CHENG ; Yin-xiang-zi SHENG ; Wei REN ; Jun ZHAO ; Lining SUN ; Guoliang JIANG
Chinese Journal of Oncology 2018;40(1):52-56
Objective:
To verify the safety and efficacy of IONTRIS particle therapy system (IONTRIS) in clinical implementation.
Methods:
Between 6.2014 and 8.2014, a total of 35 patients were enrolled into this trial: 31 males and 4 females with a median age of 69 yrs (range 39-80). Ten patients had locally recurrent head and neck tumors after surgery, 4 cases with thoracic malignancies, 1 case with hepatocellular carcinoma, 1 case with retroperitoneal sarcoma, and 19 cases with non-metastatic prostate carcinomas. Phantom dose verification was mandatory for each field before the start of radiation.
Results:
Twenty-two patients received carbon ion and 13 had proton irradiation. With a median follow-up time of 1 year, all patients were alive. Among the 16 patients with head and neck, thoracic, and abdominal/pelvic tumors, 2, 1, 12, and 1 cases developed complete response, partial response, stable disease, or disease progression, respectively. Progression-free survival rate was 93.8% (15/16). Among the 19 patients with prostate cancer, biological-recurrence free survival was 100%. Particle therapy was well tolerated in all 35 patients. Twenty-five patients (71.4%) experienced 33 grade 1 acute adverse effects, which subsided at 1 year follow-up. Six (17.1%) patients developed grade 1 late adverse effects. No significant change in ECOG or body weight was observed.
Conclusions
IONTRIS is safe and effective for clinical use. However, long term follow-up is needed to observe the late toxicity and long term result.
6.Exploration of the Method of Developing Core Data Sets for Post-marketing Clinical Safety Evaluation of Chinese Proprietary Medicine
Ruijin QIU ; Min LI ; Jiayuan HU ; Ya HUANG ; Tianmai HE ; Songjie HAN ; Rui ZHENG ; Xiaoyu ZHANG ; Manke GUAN ; Jing CHEN ; Hongcai SHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(10):1723-1728
The insufficient reporting of adverse reactions of Chinese proprietary medicines is common. In addition, there is a lack of safety information in the specifications of Chinese proprietary medicines, which led to less evidence for clinical safety of Chinese proprietary medicines in clinical practice. It is urgent to carry out post-marketing clinical safety re-evaluation of Chinese proprietary medicine. Developing a clinical safety evaluation data set for Chinese proprietary medicine may reduce the insufficient reporting of safety information and the inconsistency of data reporting in similar studies, as well as include more studies in systematic reviews, so that they can provide higher-level evidence for clinical safety of Chinese proprietary medicine. This paper proposes a method for developing core data set of clinical safety evaluation of Chinese proprietary medicine: firstly, the application scope of core data set for clinical safety evaluation was determined according to the characteristics of diseases, population, research objectives, administration methods, evaluation methods, etc. Systematic reviews and semi-structured interviews should be conducted to develop the list of original items for clinical safety evaluation. Based on the list, Delphi surveys can be developed in different stakeholders. Then the final core data set can be developed via consensus meetings.
7.Influence factor analysis of 656 cases with AMI undergoing emergency PCI
Lirong LIN ; Ruijin GUAN ; Zhiyong WU ; Lihong LU ; Hui JIANG
Chinese Journal of cardiovascular Rehabilitation Medicine 2016;25(1):58-61
Objective:To analyze influence factors in patients with acute myocardial infarction (AMI) undergoing e‐mergency percutaneous coronary intervention (PCI ) .Methods:Clinical data of 656 patients ,who received emer‐gency PCI because of AMI in our hospital from Jan 2005 to Jan 2015 ,were retrospectively analyzed .Short -term prognosis ,including incidence rates of heart failure (HF) ,cardiogenic shock (CS) ,arrhythmias and mortality , were compared and analyzed among these patients from onset related factors ,coronary disease and vascular reope‐ning time etc .Results:Mean onset age of men was significantly younger than that of women (P<0.05) .Incidence rate of AMI in winter and spring was significantly higher than those in summer and autumn (χ2 = 6.244 , P=0.012) .According to complicated with hypertension ,DM ,dyslipidemia and smoking or not ,patients were divided into corresponding disease group and normal group ;only incidence rates of CS (37.78% vs .29.62% ) and arrhyth‐mia (47.78% vs .38.24% ) in DM group were significantly higher than those of non -DM group ,mortality rate of dyslipidemia group was significantly lower than that of normal blood lipid group (0.73% vs .3.69% ) , P<0.05 or< 0.01 ,there were no significant difference in incidence rates of other events between normal group and disease group (P>0.05 all) .Incidence rate of arrhythmia in RCA group was significantly higher than those of LAD group , LCX group and multi -vessel group (56.36% vs .31.55% ,37.50% ,34.38% ) ,mortality of LM group was signifi‐cantly higher than those of LAD group ,RCA group and LCX group (25.00% vs .1.79% ,0.91% ,0% ) , P<0.05 or <0.01. Incidence rate of HF in 10~12h group was significantly higher than those of 0~3h ,4~6h and 7~9h group (79.46% vs .61.70% ,66.81% ,64.78% ) ,incidence rate of arrhythmia was significantly lower than those of 0~3h ,4~6h and 7~9h group (32.14% vs .55.32% ,43.81% ,44.65% ) ,and incidence rate of CS was significant‐ly higher than that of 0~3h group (35.27% vs .21.28% ) , P<0.05 or <0.01. Conclusion:Onset age ,season and DM ,coronary disease extent ,vascular reopening time are risk factors influencing short‐term prognosis of AMI .
8.Inhibition of Ubiquitin-specific Peptidase 8 Suppresses Adrenocorticotropic Hormone Production and Tumorous Corticotroph Cell Growth in AtT20 Cells.
Fang-Fang JIAN ; Yun-Feng LI ; Yu-Fan CHEN ; Hong JIANG ; Xiao CHEN ; Li-Li ZHENG ; Yao ZHAO ; Wei-Qing WANG ; Guang NING ; Liu-Guan BIAN ; Qing-Fang SUN
Chinese Medical Journal 2016;129(17):2102-2108
BACKGROUNDTwo recent whole-exome sequencing researches identifying somatic mutations in the ubiquitin-specific protease 8 (USP8) gene in pituitary corticotroph adenomas provide exciting advances in this field. These mutations drive increased epidermal growth factor receptor (EGFR) signaling and promote adrenocorticotropic hormone (ACTH) production. This study was to investigate whether the inhibition of USP8 activity could be a strategy for the treatment of Cushing's disease (CD).
METHODSThe anticancer effect of USP8 inhibitor was determined by testing cell viability, colony formation, apoptosis, and ACTH secretion. The immunoblotting and quantitative reverse transcription polymerase chain reaction were conducted to explore the signaling pathway by USP8 inhibition.
RESULTSInhibition of USP8-induced degradation of receptor tyrosine kinases including EGFR, EGFR-2 (ERBB2), and Met leading to a suppression of AtT20 cell growth and ACTH secretion. Moreover, treatment with USP8 inhibitor markedly induced AtT20 cells apoptosis.
CONCLUSIONSInhibition of USP8 activity could be an effective strategy for CD. It might provide a novel pharmacological approach for the treatment of CD.
Adrenocorticotropic Hormone ; metabolism ; Animals ; Apoptosis ; drug effects ; Cell Proliferation ; drug effects ; physiology ; Cell Survival ; drug effects ; physiology ; Endopeptidases ; metabolism ; Endosomal Sorting Complexes Required for Transport ; antagonists & inhibitors ; metabolism ; Enzyme Inhibitors ; pharmacology ; Humans ; Indenes ; pharmacology ; Mice ; Pyrazines ; pharmacology ; Receptor, Epidermal Growth Factor ; metabolism ; Ubiquitin Thiolesterase ; antagonists & inhibitors ; metabolism
9.Analysis for influence of coronary artery lesions position and degree in 224 patients with acute ST eleva-tion myocardial infarction
Mingguang CHEN ; Ruijin GUAN ; Zhiyong WU ; Fenghui LIN
Chinese Journal of cardiovascular Rehabilitation Medicine 2015;24(5):550-553
Objective:To explore influence of position of myocardial infarction and coronary artery lesions in patients with acute ST elevation myocardial infarction (STEMI) ,and the relationship among heart failure ,arrhythmia and severity of coronary artery lesion .Methods :Clinical data of 224 patients ,who hospitalized in our hospital because of STEMI and received coronary angiography from Jan 2009 to Jun 2011 ,were retrospectively analyzed .General data of patients were collected ,and SYNTAX score was used to reflect severity of coronary artery lesion ,and the rela‐tionship among heart failure ,arrhythmia and SYNTAX scores were analyzed .Results:Incidence rate of heart fail‐ure in patients with infarction relate artery left anterior descending artery (LAD) AND/or left main coronary artery (LM) was significantly higher than that of patients with right coronary artery (RCA) (57.0% vs .39.7% , P=0.017) ,incidence rate of arrhythmia in patients with RCA was significantly higher than that of patients with left circumflex artery (LCX) (37.0% vs .6.3% , P=0.016);incidence rates of arrhythmia (48.4% ) ,shock (54.8% ) were highest in patients with inferior wall/right ventricle than those of other position , P<0.05 or <0.01.SYNTAX scores in patients with heart failure and arrhythmia were significantly higher than those of patients without heart failure and arrhythmia respectively [ (18.7 ± 9.1) scores vs .(15.4 ± 8.6) scores ,(19.7 ± 9.0) scores vs .(16.1 ± 8.8) scores , P<0.01 both] .Conclusion:Incidence rates of heart failure ,cardiogenic shock and arrhythmia are related to coronary artery lesions position and degree and myocardial infarction position in STEMI patients .
10.Overactive bladder symptom score to evaluate efficacy of solifenacin for the treatment of overactive bladder symptoms.
Ming LIU ; Jianye WANG ; Yong YANG ; Ruihua AN ; Jianguo WEN ; Zhichen GUAN ; Shaobin ZHENG ; Dongwen WANG ; Bo SONG ; Limin LIAO ; Hongqian GUO ; Jiaquan XIAO ; Yinghao SUN ; Zhoujun SHEN ; Chuize KONG ; Dalin HE ; Yiran HUANG ; Xiaofeng WANG ; Xu ZHANG ; Hanzhong LI ; Jian HUANG ; Xiaokun ZHAO ; Puqing ZENG ; Xishuang SONG ; Zhangqun YE
Chinese Medical Journal 2014;127(2):261-265
BACKGROUNDOveractive bladder (OAB) is a series of symptoms with high prevalence in elderly people. This study was conducted using the overactive bladder symptom score (OABSS) to evaluate the efficacy of solifenacin succinate for the treatment of OAB.
METHODSThis was a prospective, multicenter, single-arm, 12-week study that enrolled 241 OAB patients. The patients received 5-10 mg/day solifenacin. Changes in OABSS, symptoms from voiding diary, perception of bladder condition (PPBC) score, international prostate symptom score (IPSS) and quality of life (QOL) were evaluated at weeks 0, 4, and 12. The relationship between OABSS and PPBC score or parameters of voiding diary was also evaluated.
RESULTSAt baseline, the mean OABSS for all patients was 9.41 ± 2.40, and was reduced significantly at week 12 (-3.76 points; 61.21%, P < 0.0001). The OABSS subscore, PPBC score, IPSS, and QOL were also significantly reduced during the study (P < 0.0001). The overall incidence of adverse events was 19.91% (44 cases). The gastrointestinal system was the most commonly affected (11.31%). Around 5.88% of the cases had adverse events related to the genitourinary system. There was a strong correlation between OABSS and urinary symptoms that was recorded in the 3-day voiding dairy.
CONCLUSIONSWe showed that solifenacin was clinically effective for relieving OAB symptoms, considering the balance between efficacy, patients' well-being, and tolerability. OABSS integrates four OAB symptoms into a single score and can be a useful tool for research and clinical practice.
Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Muscarinic Antagonists ; therapeutic use ; Prospective Studies ; Quality of Life ; Quinuclidines ; therapeutic use ; Solifenacin Succinate ; Tetrahydroisoquinolines ; therapeutic use ; Treatment Outcome ; Urinary Bladder, Overactive ; drug therapy

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