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.Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies.
Jun LIU ; Nian WANG ; Hai-Xia DANG ; Bing-Wei CHEN ; Li ZHANG ; Chong ZOU ; Cheng-Liang ZHONG ; Ju-Kai HUANG ; Qiong LIU ; Ya-Nan YU ; Meng JIANG ; Wei-Xiong LIANG ; Qi-Guang CHEN ; Yong-Yan WANG ; Chun-Ti SHEN ; Zhong WANG
Chinese journal of integrative medicine 2021;27(7):483-489
Although there is guidance from different regulatory agencies, there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs. Subsequently, a community standard on CMDMCs (T/CACM 1323-2019) was issued by the China Association of Chinese Medicine on September 12, 2019. This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs, which will further develop the scientific integrity and quality of clinical studies.
3.Comparison on efficacy between fascia-oriented versus vascular-oriented lateral lymph node dissection in patients with rectal cancer.
Zhi Jie WANG ; Zheng LIU ; Jian Wei LIANG ; Ming Guang ZHANG ; Shi Wen MEI ; Hai Yu SHEN ; Jia Nan CHEN ; Juan LI ; Fu Qiang ZHAO ; Fang Ze WEI ; Ti Xian XIAO ; Qian LIU
Chinese Journal of Gastrointestinal Surgery 2021;24(7):611-618
Objective: To compare the postoperative function, the short-term and long-term outcomes between fascia-oriented and vascular-oriented lateral lymph node dissection (LLND) in patients with rectal cancer. Methods: A retrospective cohort study was performed. Clinical data of patients who received total mesorectal excision (TME) with LLND at National Cancer Center, Cancer Hospital of Chinese Academy of Medical Science from January 2014 to December 2019 were retrospectively collected. Inclusion criteria were as follows: (1) rectal cancer was pathologically diagnosed, and the lower margin was below the peritoneal reflection. (2) resectable advanced rectal cancer with suspected lateral lymph node metastasis was evaluated based on rectal MRI assessment. (3) preoperative MRI showed lateral lymph node short diameter ≥5 mm and/or lymph node morphology (spike, blur, irregular) as well as heterogenous signal intensity. Lymph node shrinkage was less than 60% after receiving neoadjuvant therapy based on the reassessment of rectal MRI. (4) TME+LLND surgery was performed synchronously. Exclusion criteria were as follows: (1) previous history of pelvic surgery; (2) preoperative cystitis, urethritis, moderate and severe prostatic hyperplasia and other diseases resulting in abnormal urination function; (3) preoperative sexual dysfunction or loss of function; (4) patients receiving LLND due to lateral recurrence after TME; (5) distant metastasis of the tumor at initial diagnosis; (6) Incomplete collection of clinical data. A total of 73 consecutive patients were enrolled in this study. Based on the surgical approaches in performing LLND, patients were divided into fascia-oriented group (n=30) and vascular-oriented group (n=43). There were no significant differences in baseline data between the two groups (all P>0.05). The main outcome indicators of this study were the incidence of postoperative urinary and male sexual dysfunction, the efficacy, the number of lateral lymph nodes harvested and the detection rate of positive lymph nodes. Overall survival (OS) rates and progression free survival (PFS) rates were calculated by the Kaplan-Meier method and compared by log-rank test. Results: All patients in both groups completed surgery successfully. There were no significant differences in operation time, intraoperative blood loss, postoperative complications, and the length of hospital stay between the two groups (all P>0.05). In the whole group, the incidence of postoperative urinary dysfunction and male sexual dysfunction was 43.8% (32/73) and 62.5% (25/40), respectively. The median number of lateral lymph nodes harvested was 8.0(4.0,11.0) with a positive rate of 20.5%(15/73). Compared to the vascular-oriented group, the fascia-oriented group demonstrated a decreased rate of urinary dysfunction [26.7% (8/30) vs. 55.8% (24/43), χ(2)=6.098, P=0.014], lower rate of sexual dysfunction in males [6/15 vs. 76% (19/25), χ(2)=5.184, P=0.023], more harvested lateral lymph nodes [M (P25, P75): 9.5 (6.8, 15.3) vs. 6.0 (3.0, 9.0), Z=-2.849, P=0.004]. There was no significant difference in the positvie rate of lateral lymph nodes between the two groups [20% (6/30) versus 20.9% (9/43), χ(2)=0.009, P=0.923]. Three(4.1%) patients were lost during a median follow-up of 34 (1-66) months. The 3-year PFS and OS of the whole cohort were 69.5% and 88.3%, respectively. No significant difference in 3-year PFS rates (79.6% vs. 62.0%, P=0.172) and 3-year OS rates (91.2% vs. 85.9%, P=0.333) were observed between the fascia-oriented group and the vascular-oriented group (both P>0.05). Conclusion: Fascia-oriented LLND is associated with lower risk of postoperative urinary and male sexual dysfunction in patients with rectal carcinoma, and harvest of more lymph nodes, but no significant advantage in long-term survival.
Fascia
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Humans
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Lymph Node Excision
;
Lymph Nodes
;
Male
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Neoplasm Recurrence, Local
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Rectal Neoplasms/surgery*
;
Retrospective Studies
;
Treatment Outcome
4.Establishment and application of a clustered management plan for pulmonary care of massive burn casualties
Shujun WANG ; Chunting MA ; Hongyan LU ; Xihe SONG ; Yuezeng NIU ; Guojie CHEN ; Ti ZHOU ; Chuan′an SHEN
Chinese Journal of Burns 2020;36(8):665-670
Objective:To establish a clustered management plan for pulmonary care of massive burn casualties (hereinafter referred to as the clustered management plan for pulmonary care), and to explore its application effects.Methods:(1) A clustered care intervention group was established, including the medical and nursing staff from the Department of Burns and Plastic Surgery, Department of Respiratory Medicine, and Department of Infection Control at the Fourth Medical Center of PLA General Hospital (hereinafter referred to as our hospital). Four major links, including pulmonary care assessment, chest and lung physical therapy, artificial airway management, and specialized infection control were sorted out according to the key points and difficulties in pulmonary care for massive burn casualties. Evidence-based nursing methods were employed to retrieve articles related to the above-mentioned four links from PubMed, Chinese Journal Full- Text Database, VIP Database and Wanfang Data using terms of " mass burn, respiratory management and airway management" and terms of "成批烧伤,肺部护理,集束化管理" , and the clustered management plan for pulmonary care was established based on reading and discussion in combination with clinical practice and experience. (2) In this non-randomized controlled study, the clustered management plan for pulmonary care was applied to 73 massive burn patients (48 males and 25 females, aged 32 (25, 38) years) who were admitted to our hospital from January 2016 to December 2019 and met the inclusion criteria, and they were included into the clustered care group; 43 massive burn patients (25 males and 18 females, aged 35 (17, 45) years) who were admitted to our hospital from January 2013 to December 2015, received routine care and met the inclusion criteria were retrospectively included into routine care group. The pulmonary infection rate and mortality of patients in the two groups were recorded during the hospital stay. Data were statistically analyzed with chi-square test, Mann-Whitney U test, and independent sample t test. Results:(1) The clustered management plan for pulmonary care included a total of 12 specific measures covering four aspects of pulmonary care. The contents in pulmonary care assessment clearly stated to include the previous medical history, history of injury, respiratory status, hoarseness, pulmonary auscultation, etc. Chest and lung physical therapy included how to guide patients to effectively cough and do pursed lip breathing and abdominal breathing exercise, etc. Artificial airway management specified the preparation for the establishment of artificial airway at clinical reception, the observation index and frequency after tracheotomy, the method of humidification, the method and frequency of sputum suction, and the management of mechanical ventilation, etc. Specialized infection control required to strengthen hand hygiene and ventilator management. (2) The pulmonary infection rate and mortality of patients in the clustered care group were 2.74% (2/73) and 4.11% (3/73), respectively, significantly lower than 25.58% (11/43) and 18.60% (8/43) in routine care group ( χ2=11.986, 5.043, P<0.05 or P<0.01). Conclusions:The clustered management plan for pulmonary care developed for massive burn casualties focuses on the major links and key points. The measures are systemic and comprehensive, simple but precise, and highly operable, covering the entire process of massive burn care, hereby reducing the pulmonary infection rate significantly and improving the success rate of treatment.
5.Application of timed, step-by-step and segmented sputum suction in airway management of patients with inhalation injury
Shujun WANG ; Hongyan LU ; Yan ZHANG ; Chunting MA ; Dengfen ZENG ; Ya SI ; Lihua CHEN ; Ti ZHOU ; Chuanan SHEN
Chinese Journal of Modern Nursing 2020;26(30):4171-4175
Objective:To explore the application effect of timed, step-by-step and segmented sputum suction in airway management of patients with inhalation injury.Methods:From January 2017 to December 2019, 104 patients with inhalation injury admitted to the Department of Burns and Plastic Surgery, the Fourth Medical Center of the PLA General Hospital were selected as research objects. A non-randomized controlled study was adopted, and the patients were divided into control group ( n=49) and experimental group ( n=55) according to the single and even day of admission. The control group received the routine sputum suction, and the experimental group received the method of timed, step-by-step and segmented sputum suction. We compared the general information, incidence of lung infection and the number of daily sputum suction of patients between the two groups. Results:There was no statistically significant difference in the general information of patients between the two groups ( P>0.05) . The incidence of lung infection in the experimental group was 29.09% (16/55) , which was lower than 51.02% (25/49) in the control group with a statistically significant difference ( P<0.05) . In the experimental group, the number of daily sputum suction for patients with tracheotomy was 6 (3, 6) times, the number of daily sputum suctions for patients without tracheotomy was 1 (1, 2) times, and the number of daily sputum suctions for patients with severe inhalation injury was (6.56±2.96) times, which were less than 14 (11, 19) , 3 (3, 7) , (15.40±3.75) times respectively in the control group, and the differences were statistically significant ( P<0.01) . Conclusions:The timed, step-by-step and segmented sputum suction can reduce the number of sputum suctions for patients with inhalation injury and the workload of nursing, and effectively decrease the rate of lung infection, which is worthy of clinical promotion.
6.The evaluation of training program "resident team leader in the Department of General Internal Medicine" at Peking Union Medical College Hospital
Yang JIAO ; Min SHEN ; Xiaoming HUANG ; Hongwei FAN ; Xuejun ZENG ; Fengchun ZHANG ; Ti SHEN
Chinese Journal of Internal Medicine 2019;58(6):435-438
Objective To evaluate senior resident training program "resident team leader in the Department of General Internal Medicine" at Peking Union Medical College Hospital.Methods We surveyed the residents or the fellows who had been selected as resident team leaders and received the training from October 2014 to September 2018 on their comments and suggestions.Results Twenty-two rotated senior residents who were selected as team leaders in the Department of General Internal Medicine completed the survey.Almost all(21/22,95.5%) of the respondents reported that they learnt more in general as team leaders by Visual Analog Scale (VAS).The mean VAS scores of clinical skills were 7.23±1.27,7.86± 1.32 in teaching abilities,8.14±0.89 in leadership evaluation.Scales as chief resident assistants were 8.44± 1.26.Sixteen respondents (72.7%)considered that pre-job training by attending doctors was necessary.Another 8 (36.4%)respondents addressed their demands on training of teaching skills.Conclusions The senior resident training program "resident team leader in the Department of General Internal Medicine" improves the competency of rotated senior residents.It is a valuable pilot study on senior resident training and worthy of further application in other departments and hospitals.
7.Effectiveness of infectious source control after transmission control of schistosomiasis in Eryuan County of Yunnan Province
Yun ZHANG ; Chun-Hong DU ; Zong-Ti SHAO ; Ming-Shou WU ; Xi-Guang FENG ; Meng-Tao XIONG ; Mei-Fen SHEN ; Peng HUANG ; Jing SONG ; Yi DONG
Chinese Journal of Schistosomiasis Control 2019;31(3):275-279
Objective To assess the effectiveness of infectious source control at various stages of transmission control of schistosomiasis in Eryuan County of Yunnan Province, so as to provide insights into the further monitoring and management of infectious sources of schistosomiasis. Methods Wenbi Village, a plateau subtype region and Qiandian Village, a mountain subtype region in Eryuan County were selected as the study areas. The species, schistosome infection and transmission capability of infectious sources were investigated in Wenbi and Qiandian villages in 2011 and 2018 and were compared. Results Schistosome infections were detected in human, bovine, horse, dog and mouse in Qiandian Village in 2011, with positive rates of 1.19%, 0.91%, 1.25%, 3.13% and 0.95%, respectively, and human, bovine and dog were found to have schistosome infections, with positive rates of 0.76%, 1.66% and 9.30%, respectively. However, no infections were identified in human, bovine, horse, pig, dog, sheep or mouse in these two villages in 2018. A total of 731 wild feces were collected in both villages in 2011. In Qiandian Village, horse, bovine and dog feces accounted for 34.40%, 29.80% and 20.20% of all fecal samples, and dog and horse feces were found to have schistosome infections (11.94% and 6.90% positive rates, respectively). In Wenbi Village, dog, bovine and human feces accounted for 44.59%, 39.83% and 14.29% of all fecal samples, and dog, human and bovine feces were found to have schistosome infections (16.95%, 9.52% and 2.33% positive rates, respectively). In 2018, a total of 204 wild feces were collected in both villages, and no schistosome infections were identified. Sheep, dog and bovine feces accounted for 36.27%, 33.33% and 27.45% of all fecal samples in Qiandian Village, and dog, bovine and human feces accounted for 72.55%, 11.76% and 10.78% of all fecal samples in Wenbi Village. Conclusions A remarkable achievement has been obtained in the control of infectious sources of schistosomiasis in Eryuan County, and the role of human and bovine as the major infectious sources of schistosomiasis has been effectively controlled. In the future, the integrated strategy with emphasis on the control of infectious sources should be intensified, and the management of reservoir hosts including dog and mouse should be strengthened.
8.Expression of IL-25 and IL-33 and the count of EOS in peripheral blood of children with allergic rhinitis receiving immunotherapy.
Hua FAN ; Tai Jie QIN ; Lin Song YE ; Feng Ti LI ; Gan Sheng LIN ; You Qiong LIANG ; Shen Hong QU
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2018;32(6):443-446
OBJECTIVES:
To investigate the expression of IL-25,IL-33 and EOS in children with allergic rhinitis (AR).
METHODS:
Ninety-four AR children receiving immunotherapy and 23 healthy people were concluded in the study. The serum levels of IL-25 and IL-33 were detected by Enzyme-linked Immunosorbent Assay (ELISA), and a count of EOS were measured.
RESULTS:
The serum levels of IL-25 and IL-33 in the mild group were higher than control group (<0.05). The count of EOS showed no difference between the mild group and the control group (>0.05). The serum levels of IL-25 and IL-33 in the severe group were higher than those in mild group (<0.05). The serum levels of IL-25 and IL-33 in the severe group were higher than control group (<0.05). The count of EOS in the severe group were higher than those in mild group (<0.05). The count of EOS in the severe group were higher than those in control group (<0.05). Spearman test showed the serum levels of IL-25 in the children with AR patients have positive correlation with the serum levels of IL-33 (<0.05, =0.238).
CONCLUSIONS
Expression of IL-25 levels, IL-33 levels and the count of EOS in patients with AR are enhanced, which shows that IL-25, IL-33 and the count of EOS are involved in the AR. If we can understand the mechanism of them, it will profound implications for treatment.
Child
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Enzyme-Linked Immunosorbent Assay
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Eosinophils
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Humans
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Immunotherapy
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Interleukin-17
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metabolism
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Interleukin-33
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metabolism
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Rhinitis, Allergic
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immunology
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therapy
9.An analysis of residents' self-evaluation and faculty-evaluation in internal medicine standardized residency training program using Milestones evaluation system
Yun ZHANG ; Xiaotian CHU ; Xuejun ZENG ; Hang LI ; Fengchun ZHANG ; Shuyang ZHANG ; Ti SHEN
Chinese Journal of Internal Medicine 2018;57(6):440-445
Objective To assess the value of internal medicine residency training program at Peking Union Medical College Hospital (PUMCH),and the feasibility of applying revised Milestones evaluation system.Methods Postgraduate-year-one to four (PGY-1 to PGY-4) residents in PUMCH finished the revised Milestones evaluation scales in September 2017.Residents' self-evaluation and faculty-evaluation scores were calculated.Statistical analysis was conducted on the data.Results A total of 207 residents were enrolled in this cross-sectional study.Both self and faculty scores showed an increasing trend in senior residents.PGY-1 residents were assessed during their first month of residency with scores of 4 points or higher,suggesting that residents have a high starting level.More strikingly,the mean score in PGY-4 was 7 points or higher,proving the career development of residency training program.There was no statistically significant difference between total self-and faculty-evaluation scores.Evaluation scores of learning ability and communication ability were lower in faculty group (t=-2.627,-4.279,all P<0.05).The scores in graduate students were lower than those in standardized training residents.Conclusions The goal of national standardized residency training is to improve the quality of healthcare and residents' career development.The evaluation results would guide curriculum design and emphasize the importance and necessity of multi-level teaching.Self-evaluation contributes to the understanding of training objectives and personal cognition.
10.Shanghai Score: A Prognostic and Adjuvant Treatment-evaluating System Constructed for Chinese Patients with Hepatocellular Carcinoma after Curative Resection
Sun HUI-CHUAN ; Xie LU ; Yang XIN-RONG ; Li WEI ; Yu JIAN ; Zhu XIAO-DONG ; Xia YONG ; Zhang TI ; Xu YANG ; Hu BO ; Du LI-PING ; Zeng LING-YAO ; Ouyang JIAN ; Zhang WEI ; Song TIAN-QIANG ; Li QIANG ; Shi YING-HONG ; Zhou JIAN ; Qiu SHUANG-JIAN ; Liu QIAN ; Li YI-XUE ; Tang ZHAO-YOU ; Shyr YU ; Shen FENG ; Fan JIA
Chinese Medical Journal 2017;130(22):2650-2660
Background:For Chinese patients with hepatocellular carcinoma (HCC),surgical resection is the most important treatment to achieve long-term survival for patients with an early-stage tumor,and yet the prognosis after surgery is diverse.We aimed to construct a scoring system (Shanghai Score) for individualized prognosis estimation and adjuvant treatment evaluation.Methods:A multivariate Cox proportional hazards model was constructed based on 4166 HCC patients undergoing resection during 2001-2008 at Zhongshan Hospital.Age,hepatitis B surface antigen,hepatitis B e antigen,partial thromboplastin time,total bilirubin,alkaline phosphatase,γ-glutamyltransferase,α-fetoprotein,tumor size,cirrhosis,vascular invasion,differentiation,encapsulation,and tumor number were finally retained by a backward step-down selection process with the Akaike information criterion.The Harrell's concordance index (C-index) was used to measure model performance.Shanghai Score is calculated by summing the products of the 14 variable values times each variable's corresponding regression coefficient.Totally 1978 patients from Zhongshan Hospital undergoing resection during 2009-2012,808 patients from Eastern Hepatobiliary Surgery Hospital during 2008-2010,and 244 patients from Tianjin Medical University Cancer Hospital during 2010-2011 were enrolled as external validation cohorts.Shanghai Score was also implied in evaluating adjuvant treatment choices based on propensity score matching analysis.Results:Shanghai Score showed good calibration and discrimination in postsurgical HCC patients.The bootstrap-corrected C-index (confidence interval [CI]) was 0.74 for overall survival (OS) and 0.68 for recurrence-free survival (RFS) in derivation cohort (4166 patients),and in the three independent validation cohorts,the CIs for OS ranged 0.70-0.72 and that for RFS ranged 0.63-0.68.Furthermore,Shanghai Score provided evaluation for adjuvant treatment choices (transcatheter arterial chemoembolization or interferon-α).The identified subset of patients at low risk could be ideal candidates for curative surgery,and subsets of patients at moderate or high risk could be recommended with possible adjuvant therapies after surgery.Finally,a web server with individualized outcome prediction and treatment recommendation was constructed.Conclusions:Based on the largest cohort up to date,we established Shanghai Score-an individualized outcome prediction system specifically designed for Chinese HCC patients after surgery.The Shanghai Score web server provides an easily accessible tool to stratify the prognosis of patients undergoing liver resection for HCC.

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