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Objective@#To investigate the diagnosis and treatment for enterocutaneous fistula (ECF) in China, and to explore the prognostic factors of ECF.@*Methods@#A multi-center cross-sectional study was conducted based on the Registration System of Chinese Gastrointestinal Fistula and Intra-Abdominal Infections to collect the clinical data of ECF patients from 54 medical centers in 22 provinces/municipalities from January 1, 2018 to December 31, 2018. The clinical data included patient gender, age, length of hospital stay, intensive care unit (ICU) admission, underlying diseases, primary diseases, direct causes of ECF, location and type of ECF, complications, treatment and outcomes. All medical records were carefully filled in by the attending physicians, and then re-examined by more than two specialists. The diagnosis of ECF was based on the clinical manifestations, laboratory/imaging findings and intraoperative exploration.@*Results@#A total of 1521 patients with ECF were enrolled, including 1099 males and 422 females, with a median age of 55 years. The top three primary diseases of ECF were malignant tumors in 626 cases (41.2%, including 540 gastrointestinal tumors, accounting for 86.3% of malignant tumors), gastrointestinal ulcers and perforations in 202 cases (13.3%), and trauma in 157 cases (10.3%). The direct causes of ECF were mainly surgical operation in 1194 cases (78.5%), followed by trauma in 156 (10.3%), spontaneous fistula due to Crohn′s disease in 92 (6.0%), radiation intestinal injury in 41 (2.7%), severe pancreatitis in 20 (1.3%), endoscopic treatment in 13 (0.9%) and 5 cases (0.3%) of unknown reasons. All the patients were divided into three groups: 1350 cases (88.7%) with simple ECF, 150 (9.9%) with multiple ECF, and 21 (1.4%) with combined internal fistula. Among the patients with simple ECF, 438 cases (28.8%) were jejuno-ileal fistula, 313 (20.6%) colon fistula, 170 (11.2%) rectal fistula, 111 (7.3%) duodenal fistula, 76 (5.0%) ileocecal fistula, 65 (4.3%) ileocolic anastomotic fistula, 55 (3.6%) duodenal stump fistula, 36 (2.4%) gastrointestinal anastomotic fistula, 36 (2.4%) esophagogastric/esophagojejunal anastomotic fistula, 29 (1.9%) gastric fistula and 21 (1.4%) cholangiopancreatiointestinal. Among all the simple ECF patients, 991 were tubular fistula and 359 were labial fistula. A total of 1146 patients finished the treatment, of whom 1061 (92.6%) were healed (586 by surgery and 475 self-healing) and 85 (7.4%) died. A total of 1043 patients (91.0%) received nutritional support therapy, and 77 (6.7%) received fistuloclysis. Infectious source control procedures were applied to 1042 patients, including 711 (62.0%) with active lavage and drainage and 331 (28.9%) with passive drainage. Among them, 841 patients (73.4%) underwent minimally invasive procedures of infectious source control (replacement of drainage tube through sinus tract, puncture drainage, etc.), 201 (17.5%) underwent laparotomy drainage, while 104 (9.1%) did not undergo any drainage measures. A total of 610 patients (53.2%) received definitive operation, 24 patients died within postoperative 30-day with mortality of 3.9% (24/610), 69 (11.3%) developed surgical site infection (SSI), and 24 (3.9%) had a relapse of fistula. The highest cure rate was achieved in ileocecal fistula (100%), followed by rectal fistula (96.2%, 128/133) and duodenal stump fistula (95.7%,44/46). The highest mortality was found in combined internal fistula (3/12) and no death in ileocecal fistula. Univariate prognostic analysis showed that primary diseases as Crohn′s disease (χ2=6.570, P=0.010) and appendicitis/appendiceal abscess (P=0.012), intestinal fistula combining with internal fistula (χ2=5.460, P=0.019), multiple ECF (χ2=7.135, P=0.008), esophagogastric / esophagojejunal anastomotic fistula (χ2=9.501, P=0.002), ECF at ileocecal junction (P=0.012), non-drainage/passive drainage before the diagnosis of intestinal fistula (χ2=9.688, P=0.008), non-drainage/passive drainage after the diagnosis of intestinal fistula (χ2=9.711, P=0.008), complicating with multiple organ dysfunction syndrome (MODS) (χ2=179.699, P<0.001), sepsis (χ2=211.851, P<0.001), hemorrhage (χ2=85.300, P<0.001), pulmonary infection (χ2=60.096, P<0.001), catheter-associated infection (χ2=10.617, P=0.001) and malnutrition (χ2=21.199, P<0.001) were associated with mortality. Multivariate prognostic analysis cofirmed that sepsis (OR=7.103, 95%CI:3.694-13.657, P<0.001), complicating with MODS (OR=5.018, 95%CI:2.170-11.604, P<0.001), and hemorrhage (OR=4.703, 95%CI: 2.300-9.618, P<0.001) were independent risk factors of the death for ECF patients. Meanwhile, active lavage and drainage after the definite ECF diagnosis was the protective factor (OR=0.223, 95%CI: 0.067-0.745, P=0.015).@*Conclusions@#The overall mortality of ECF is still high. Surgical operation is the most common cause of ECF. Complications e.g. sepsis, MODS, hemorrhage, and catheter-associated infection, are the main causes of death. Active lavage and drainage is important to improve the prognosis of ECF.
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OBJECTIVE： To provide reference for constructing ADR damage relief system in China. METHODS： Questionnaire survey was conducted among 217 pharmaceutical manufacturers in Shaanxi province by census method. Fisher’s exact test， Pearson χ2 test and multivariate Logistic regression analysis were used to analyze the factors effecting construction of ADR damage relief systerm unter marketing authorization holder （MAH） system， and the interaction among various factors. RESULTS： A total of 217 drug manufacturers were investigated in this study （217 questionnaires were sent out）. 209 questionnaires were collected and 204 valid questionnaires were screened out with recovery rate of 94.01％. Totally 9 independent influential factors screened by Fisher’s exact test and Pearson χ2 test had a significant impact on the attitude of building ADR damage relief system under MAH system， i.e. the last year’s earnings of enterprises， the proportion of pharmaceutical technicians， whether to set up R&D departments， whether to obtain new drugs/generic drugs in recent 3 years， whether to actively carry out post-marketing safety evaluation of drugs， whether ADR commissioners are familiar with ADR-related policies in MAH system， cognition about whether MAH system promotes the development of pharmaceutical industry， the development direction of enterprises after the full implementation of MAH， cognition about the lack of legal basis for ADR damage relief （P＜0.05）. Multivariate Logistic regression analysis showed that whether the ADR specialist was familiar with the ADR-related policies in MAH system was the main influential factor for constructing ADR damage relief system under the MAH system （P＝0.044）. It was positively correlated with the attitude of approving the construction of ADR damage relief system under MAH system （B＝1.697）. CONCLUSIONS： The pharmaceutical manufacturers， in which ADR specialists who are familiar with the ADR-related policies in the MAH system， are more inclined to agree to constructing ADR damage relief system under MAH system.
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Objective:To optimize the flash extraction process of Isatidis Radix by Box-Behnken experimental design. Methods:A flash extraction method was used with the extraction voltage, material-liquid ratio and extraction time as the independent variables. A Hassan’s method was used to calculate the normalized value(OD) of comprehensive evaluation of the dry extract yield and the epi-goitrin extraction rate in order to establish the mathematical relationship between the comprehensive evaluation OD and the independent variables, and the response surface method was used to predict the best process conditions. Results:The optimum process conditions were as follows:voltage of 88 V, material-liquid ratio of 19. 62, and extraction time of 2. 03 min. The rate of dry extract and epigoitrin extraction was 37. 902% and 0. 1887%, respectively. Conclusion:The measured value is close to the predicted one,which indicates the comprehensive flash extraction parameters optimized by Box-Behnken experimental design can be used for the extraction for Isatidis Radix.
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OBJECTIVE:To investigate the cognition,evaluation and demands of medical staff to the clinical pharmacy work in the secondary and tertiary medical and health institutions in Xi’an city,and provide reference for further promoting the develop-ment of the local clinical pharmacy work. METHODS:20 secondary and tertiary medical and health institutions in Xi’an city were randomly selected to conduct a random sampling questionnaire for physicians,nurses (senior nurses),pharmacists (non-clinical pharmacist)and other medical technicians. And the results were statistically analyzed. RESULTS:Totally 1 020 questionnaires were sent out,851 were effectively received with effective recovery of 83.4%. 45.9% respondents knew clinical pharmacy,and“Col-league”was the main channel;34.3% thought clinical pharmacy“only maintained normal operation. 74.7% surveyed medical staff,92.6% surveyed pharmacists and 70.6% surveyed physicians thought clinical pharmacists“should”take round with the doc-tors and nurses;44.3% respondents showed“dissatisfaction”and“general satisfaction”with the clinical pharmacy work in their hospitals. 48.5% respondents would take the initiative to consult the clinical pharmacist for medication;45.5% respondents partial-ly accepted the drug information provided by clinical pharmacists. There were significant differences in the investigation results in aspects of respondents’understanding level and channel for clinical pharmacy,cognition for development situation of clinical phar-macy,evaluation for clinical pharmacists participating round,demand for consulting the medication,acceptance for drug informa-tion provided by clinical pharmacists,and other items(P<0.05). CONCLUSIONS:The cognition and effect of clinical pharmacy work on medical staff need to be further strengthened,clinical pharmacists should also have solid clinical knowledge and the knowl-edge of medicine to meet the demand of medical staff in different positions,the acceptance of medical staff to the pharmaceutical care needs to be further improved. Clinical pharmacists should earnestly fulfill their job functions through various efforts to promote rational drug use.
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Objective:To evaluate the knowledge, attitudes and practices ( KAP) on National Essential Medi-cine System among pharmacists from secondary public hospitals in Shaanxi province. Methods: The quantitative re-search of KAP questionnaire is used, and the content of questionnaire includes personal information, knowledge, atti-tudes and practices. Results: A total of 520 copies of questionnaires were distributed and 82. 3% were effective. Respondents’ overall knowledge and attitudes are at the middle level;the main way to obtain knowledge is via training and meeting;respondents’ education level and frequency of participating in training have a significant impact on their level of knowledge;the degree of attention paid by hospitals has yet to be strengthened; and respondents are mostly concerned about the supply and distribution of essential drugs. Conclusion: In order to improve the awareness and recognition levels of pharmacists on the implementation of National Essential Medicine System in secondary public hospitals, the government should take the relevant measures, including introducing the high educated persons into secondary public hospitals, organizing related training programs and standardizing the daily monitoring of essential drugs in secondary public hospitals, etc.
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OBJECTIVE:To understand the present situation of ADR reporting entities in Shaanxi and Sichuan province,and provide evidence for the improvement of ADR monitoring. METHODS:Getting the overview of ADR monitoring at home and abroad by reading a lot of literature,the ADR monitoring entities(drug manufacturers,drug distributors and medical institutions) in Shaanxi and Sichuan province were selected as subject for cluster sampling,questionnaires were sent out and descriptive statis-tics analysis was adopted to processing and analyze the results. RESULTS:Totally 198 questionnaires were received,100 for Shaanxi province and 98 for Sichuan province. In Shaanxi and Sichuan province,there are 61 and 63 investigated subjects had es-tablished ADR monitoring departments,98.0% and 100% had had personnel for the ADR work;ADR monitoring work mostly be-longed to the quality control department in drug manufacturers and drug distributors,and belonged to pharmacy department in medi-cal institutions;most of them were equipped with computer,printer and other basic office equipment;however,the major duty of most was not clearly;13 and 23 subjects had special budget for ADR monitoring;87 and 89 subjects had communication with lo-cal ADR monitoring center,however,the information feedback was not very ideal;training the workers accounted for 80.0% and 83.0%,respectively;in terms of system construction,the standard operation procedure was relatively good,and the other related was not ideal;reporting quickly when finding ADR was 89.0% and 96.9%,88.0% and 96.9% of which had backup records for ADR reporting,it was mainly network report;Shaanxi province was better than Sichuan province about the satisfaction evaluation of ADR work. CONCLUSIONS:According to the results,it is suggested to adjust the structure of workers,buy related software re-source,improve the responsibilities and strengthen the financial support to promote the implementation of ADR monitoring.
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OBJECTIVE:To investigate the situation of ADR reporting entities in Henan province and Hebei province to pro-vide reference for the improvement of ADR monitoring. METHODS:Literatures were consulted to investigate the ADR monitoring at home and abroad. With the subject of ADR reporting entities(pharmaceutical manufacturers,drug distributors and medical insti-tutions)in Henan and Hebei province,questionnaires and descriptive statistical analysis were conducted to analyze the results. RE-SULTS:186 valid questionnaires were received. There were respectively 58 and 62 ADR reporting entities with ADR monitoring de-partment in Henan and Hebei province,all of them had personnel who were responsible for ADR;ADR monitoring mostly belonged to quality control department in pharmaceutical manufacturers and drug distributors,and pharmacy department in medical institu-tions;most were equipped with computer,printer,phone and other basic office equipments;most were not clearly for major duty;there were respectively 24 and 2 entities with special budget for ADR monitoring;95.7% and 96.8% had communication with the local ADR monitoring centers,however,the information feedback was not ideal;86.7%and 98.9%had training for the stuff;stan-dard operation procedure was relatively good in Hebei province;96.7% and 98.9% would report ADR immediately after finding ADR,92.3% and 97.8% would record and backup the reported ADR;the form mainly by network report;the average degree of satisfaction evaluation in Henan province was higher than Hebei. CONCLUSIONS:According to the results,it is suggested to pro-mote the implementation of ADR monitoring by optimizing the work conditions,ensuring work fund and strengthening work feed-back.
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OBJECTIVE:To investigate the present situation of adverse drug reaction(ADR)reporting entities in Jiangsu prov-ince and Guangdong province,and provide reference for the improvement of ADR monitoring. METHODS:With the overview of ADR monitoring at home and abroad by reading literatures,the ADR reporting entities(drug manufacturers,drug distributors and medical institutions) in Jiangsu province and Guangdong province were selected as objects for cluster sampling by questionnaires, and descriptive statistical analysis and other methods were adopted to process and analyze the results. RESULTS:There were totally 205 effective questionnaires. In Jiangsu province and Guangdong province,67 and 60 of the surveyed ADR reporting entities had specialized ADR monitoring departments,98.1% and 99.0% had equipped with specialized personnel for ADR work;ADR moni-toring mostly belonged to quality management department in drug manufacturers and distributors,and pharmacy department in medi-cal institutions;most entities were equipped with computers,printers,copiers and other basic office equipments;but most entities’ responsibilities were not clear enough;27 and 15 entities had specialized budget for ADR monitoring;97.2% and 96.9% had com-munication with ADR ,monitoring center,but the feedback information was unsatisfactory;85.0% and 86.7% had related training for personnel;establishing standard operating procedures of the system construction was relatively good,the other related system construction was still not ideal;91.6% and 90.8% would report ADR immediately after discovery,92.5% and 97.9% would back-up recording the ADR,mainly by internet reporting;the average scores in terms of job satisfaction in Jiangsu province were higher than Guangdong province. CONCLUSIONS:According to the results,it is suggested to improve the system construction of ADR monitoring,optimize working conditions,ensure financial support of ADR monitoring,and strengthen work communication and system construction and other measures to promote conduct of ADR monitoring.
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Objective:To conduct a systematic review on the implementation effects of National Essential Medi-cine System ( NEMS) since the new health care reform and provide some suggestions to further improve the NEMS. Methods:Databases and relevant international organization reports were searched to collect studies related to the im-plementation of NEMS in China. The database search occurred from January 2009 to December 2014. Results:A to-tal of 1 292 studies were finally included, encompassing 1,277 Chinese papers, 12 English papers, and 3 WHO/HAI reports. A lot of researches have been done on NEMS, but the techniques of NEMS evaluation are not perfect. The sample representativeness is poor, and the longitudinal follow-up studies of the microscopic view is insufficient. . Evi-dence-based evaluation research using big data has just started. Conclusions: The research on NEMS should be strengthened. The NEMS evaluation should not only be based on national conditions, but it should also be in combi-nation with an international, multidimensional evaluation framework in terms of availability, affordability and rational drug use, so as to provide evidences to perfect the NEMS.
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Objective:To compare drug policies in Brazil, Russia, India, China, and South Africa (BRICs), sum-marize the experiences from the process of implementation and provide some suggestions to further improve the national drug policy in China. Methods:National drug polices of BRICs and experiences in the implementation of essential medicine policy were summed up systematically by means of systematic review. Results:Essential medicine policy and popular phar-macy are implemented in Brazil;Pharmaceutical separation system is established in Russia;the mode of essential medicine policy in Delhi is typical in India;Government of South African focuses on procurement and distribution of drugs. Although drug policies of BRICs have their own characteristics, the objective is to increase the public access to low-cost, high-quality drugs. Conclusions:Despite the BRICs have attained some achievements, they still face serious challenges in deep-ening the health care reform. Hence, they need to explore the measures continuingly consisting with their national condi-tions, and learn from the experiences of developed countries to further consolidate and improve the national drug policies.
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Objective: To analyze the essential medicines supply of medical institutions at county-level in Shaanxi Province and to provide empirical evidences and suggestions to improve relevant policies. Methods:A strati-fied cluster random sampling method was used to choose the institution samples. A survey was conducted to study the supply of essential medicines in 2012. Indicators include the variety and amount of essential medicines procured, the medicine shortage condition, and the rate of winning the bid for essential medicine. Results:Essential medicines ac-counted for 69 . 1% of all medicines;and procurement of essential medicines accounted for 42 . 4% of all procurement spending on medicines. Of the top 25 chemical products of essential medicines, provincial supplementary medicines accounted for 33. 9%;and among the top 25 traditional Chinese medicines of essential medicines, the provincial sup-plementary medicines accounted for 51. 9%. All 27 medical institutions faced a shortage of medicines. There were 47 kinds of essential drugs in urgent need were out of bid. Conclusion:Essential medicine supply of medical institutions at county-level is in good condition;however, more attention needs to be paid to medicine shortage. We should take measurements to standardize the process of bidding for essential medicines and strengthen the management of medi-cine shortage in order to better meet patients’ needs.
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Objective To evaluate the implementation of the national essential medicine system in Shaanxi Province.Methods Using a standardized methodology (2008 Edition) developed by the World Health Organization(WHO) and Health Action International(HAD,data on the prices and availability of 38 essential medicines were collected from 120 primary,secondary and tertiary public hospitals in ten cities of Shaanxi Province from March to May 2012.Results The availability of essential medicines is generally low at public hospitals in Shaanxi province,as the average availability of originator brands is but 5.9％,and that of generics of the lowest prices is but 23.9％,while this availability at tertiary hospitals is higher than hospitals of lower levels.The procurement prices of originator drugs within essential medicines are distinctly higher than the international reference prices for the originator brands,and slightly higher for the lowest priced generics.The procurement prices at primary care hospitals are slightly lower than that of other hospitals.Retail prices of essential medicine are not significantly different among regions of different income levels.Affordability of originator brands is poor,while that of their generic equivalents is good.Conclusion The government is recommended to adjust the national essential medicine list,expand the variety of essential medicine moderately,improve the medicine pricing mechanism,and deepen public hospitals reform.
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To construct a cDNA library of gerbil′s cochlea, the mRNA was separated from the cochlea of gerbil and the first strand cDNA was synthesized through reverse transcription by a modified oligo(dt) primer. The double strand cDNA was amplified by Ld pcR. After cDNA size fractionation , the ds cDNA was ligated in the ? TripIEx2 vector . The cDNA library was identified with special primers of prestin genes of cochlea by PCR .The results showed that the titer of library was 1.8?10 6 pfu and the percentage of recombinant clones was 80% . Prestin gene was contained in the library , the size of the fragment was 863bp . The results suggest that the established cDNA library has a high titer, recombinant percentage and large insert fragments of genes . The study lays the foundation of molecular biological study of the cochlea.
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OBJECTIVE: To provide reference for the further implementation of national essential drug system in China. METHODS: The establishment of national essential drug system in China was reviewed to find out the problem in the implementation process. Related solutions were proposed. RESULTS & CONCLUSION: The implementation of essential drugs in China demand clarifying the legal status of essential drugs, strengthening popularity of essential drugs, improving awareness of medical staff and the public about essential drugs. Moreover, patients can be benefited in the medical institutions where essential drug system has been carried out to improving the dependence of the public to essential medicines.
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OBJECTIVE:To improve the research level of hospital pharmaceutical management in China in order to pro-mote the pharmaceutical care in hospital.METHODS:298published articles on pharmaceutical management between2002and2003were collected and analyzed.The differences were compared between Chinese and American research papers.RESULTS&CONCLUSION:Chinese articles mainly dealt with drug management,including drug use,preparation management and drug purchase,and the research methods used in these articles were less scientific,while the research methodology in U.S studies is worthy of learning.
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OBJECTIVE:To construct retail chain pharmacy service quality evaluation model suitable for our country.ME_ THODS:SERVQUAL service quality evaluation method was adopted.RESULTS:Based on the practical condition of domestic retail chain pharmacy,24influencing indexes of which were presented and a service quality evaluation model was estab-lished.CONCLUSION:This evaluation model serves as guidance for the improvement of service level of retail chain pharmacy.
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OBJECTIVE:To discuss the necessities and countermeasures of pharmaceutical care in the rural areas of China.METHODS:The existing difficulties of pharmaceutical care in the rural areas of China were analyzed realistically.RESULTS&CONCLUSION:In order to successfully carry out pharmaceutical care,firstly the state food and drug adminis-tration must strengthen the supervision,construct the supply network of drugs and ensure the quality of medication;secondly the pharmacists'ability must be enhanced and pharmacists'quantity increased through various of training and education;thirdly the consultation service should be carried out by specially assigned persons.Only in this way can we improve the quality of pharmaceutical care and ensure the secure,efficient and economic drug use.
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OBJECTIVE:To study the current situation of development in personnel resources of licensed pharmacists of drug supply enterprises in China and the ways of development.METHODS:The existing problems in the development of per-sonnel resources of licensed pharmacists were analyzed through the ways of questionnaires and interviews.RESULTS&CONCLUSIONS:The drug supply enterprises lacked collocation and application rules of pharmacists and there lacked a system for employing,training,assessing and encouraging the licensed pharmacists.Furthermore,because of the inefficient policy,the supply-demand market of licensed pharmacists was unsatisfactory and the functions of the pharmacists were incomplete.Therefore,the practicing environment for the licensed pharmacists must be optimized.It is recommended that a perfect system of employment and assessment should be established;the full-time practice and the part-time practice should be allowed to coexist;the information network platform for supply-demand of the licensed pharmacists should be set up to improve the management as well as self-discipline function of licensed pharmacist association,better the further education system,and therefore promote the development of personnel resoures.
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OBJECTIVE:To provide some suggestions for reference in establishment of clinical pharmacist institution in China.METHODS:Through analysing the present policy,mechanism,education,social psychology and law,the difficulties confronting us in establishment of clinical pharmacist institution were discussed.RESULTS&CONCLUSION:It needs to improve the mechanism in many aspects and to intensify the reform continuously in the process of establishing clinical phar-macist institution.
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OBJECTIVE:To discuss the risk in clinical pharmacy service in order to provide reference for Chinese hospitals in both guarding against and reducing risk.METHODS:This study adopted a classified method to set forth the tactics on re?ducing risk of both organization and individual person in clinical pharmacy practice after analyzing the risk factors.RESULTS&CONCLUSION:It is important for the working personnel who engage in clinical pharmacy work to heighten their con?sciousness of risk and to strengthen managing it.