• Title/Summary/Keyword: safety standard

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Application of the Pulsatile Cardiopulmonary Bypass in Animal Model (이중 박동성 인공심폐기의 동물 실험)

  • Shin, Hwa-Kyun;Won, Yong-Soon;Lee, Jea-Yook;Her, Keun;Yeum, Yook;Kim, Seung-Chul;Min, Byoung-Goo
    • Journal of Chest Surgery
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    • v.37 no.1
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    • pp.1-10
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    • 2004
  • Background: Currently, the cardiopulmonary machine with non-pulsatile pumps, which are low in internal circuit pressure and cause little damage to blood cells, is widely used. However, a great number of experimental studies shows that pulsatile perfusions are more useful than non-pulsatile counterparts in many areas, such as homodynamic, metabolism, organ functions, and micro-circulation. Yet, many concerns relating to pulsatile cardiopulmonary machines, such as high internal circuit pressure and blood cell damage, have long hindered the development of pulsatile cardiopulmonary machines. Against this backdrop, this study focuses on the safety and effectiveness of the pulsatile cardiopulmonary machines developed by a domestic research lab. Material and Method: The dual-pulsatile cardiopulmonary bypass experiment with total extracorporeal circulation was conducted on six calves, Extracorporeal circulation was provided between superior/inferior vena cava and aorta. The membrane oxygenator, which was placed between the left and right pumps, was used for blood oxygenation. Circulation took four hours. Arterial blood gas analysis and blood tests were also conducted. Plasma hemoglobin levels were calculated, while pulse pressure and internal circuit pressure were carefully observed. Measurement was taken five times; once before the operation of the cardiopulmonary bypass, and after its operation it was taken every hour for four hours. Result: Through the arterial blood gas analysis, PCO2 and pH remained within normal levels. PO2 in arterial blood showed enough oxygenation of over 100 mmHg. The level of plasma hemoglobin, which had total cardiopulmonary circulation, steadily increased to 15.87 $\pm$ 5.63 after four hours passed, but remained below 20 mg/㎗. There was no obvious abnormal findings in blood test. Systolic blood pressure which was at 97.5$\pm$5.7 mmHg during the pre-circulation contraction period, was maintained over 100 mmHg as time passed. Moreover, diastolic blood pressure was 72.2 $\pm$ 7.7 mmHg during the expansion period and well kept at the appropriate level with time passing by. Average blood pressure which was 83$\pm$9.2 mmHg before circulation, increased as time passed, while pump flow was maintained over 3.3 L/min. Blood pressure fluctuation during total extracorporeal circulation showed a similar level of arterial blood pressure of pre-circulation heart. Conclusion: In the experiment mentioned above, pulsatile cardiopulmonary machines using the doual-pulsatile structure provided effective pulsatile blood flow with little damage in blood cells, showing excellence in the aspects of hematology and hemodynamic. Therefore, it is expected that the pulsatile cardiopulmonary machine, if it becomes a standard cardiopulmonary machine in all heart operations, will provide stable blood flow to end-organs.

Use of Undiluted Potassium Solution in Intermittent Antegrade Warm Blood Cardioplegia (IAWBC) (간헐적 전방온혈심정지액에서 희석되지 않은 고농도 포타슘의 사용)

  • 백완기;손국희;김영삼;윤용한;김혜숙;임현경;이춘수;김광호;김정택
    • Journal of Chest Surgery
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    • v.37 no.8
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    • pp.660-664
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    • 2004
  • Background: Dilution of blood cardioplegia is not needed in IAWBC as it is in cold blood cardioplegia because it does not aggregate red blood cells on normal body temperature and does not compromise micro coronary circulation. This study was designed to evaluate the safety and efficacy of undiluted potassium solution in IAWBC. Material and Method: Thirty patients who underwent CABG with IAWBC were grouped into dilutedplegia (n=14) and microplegia (n=16). Potassium was delivered conventionally with 4 : 1 delivery kit in the dilutedplegia group. The undiluted potassium was directly connected on the blood of oxygenator in the microplegia group. Result: There were no differences in sex, age, left ventricular ejection fraction, number of grafts, aortic cross clamping time, and the value of perioperative myocardial enzyme between the two groups. There were no perioperative myocardial infarction and hospital mortality. The amount of crystalloid cardioplegia was 1346$\pm$597 mL in dilutedplegia (mean$\pm$standard deviation, and 28$\pm$9 mL in microplegia (p<0.0001). The hematocrit during cardiopulmonary bypass was 21$\pm$4% in dilutedplegia and 24$\pm$3% in microplegia (p>0.05). 11 patients in dilultedplegia received blood transfusion, but 4 patients in microplegia received blood transfusion (p<0.05). The amount of urine and hemofiltration during the operation were more in dilutedplegia (1250$\pm$810 mL, 1689$\pm$548 mL) than in microplegia (959$\pm$410 mL, 1461$\pm$784 mL; p<0.05). Conclusion: The undiluted potassium of IAWBC in CABG operation is a safe, effective technique for myocardial protection to prevent fluid overload, and blood transfusion. There is no need to use the delivery kit.

Analysis of Octyl-2-Cyanoacrylate as a Dressing Material after Pediatric Urological Procedures (소아비뇨기과 관혈적 수술 시 피부봉합제로 사용된 Octyl-2-Cyanoacrylate (Dermabond$^{TM}$)의 효용성)

  • Lee, Hahn-Ey;Min, Sun Ho;Kim, Kwang Myung
    • Childhood Kidney Diseases
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    • v.16 no.2
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    • pp.115-120
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    • 2012
  • Purpose: We aimed to evaluate the efficacy of Octyl-2-cyanoacrylate (Dermabond$^{TM}$) as a topical skin adhesive for pediatric urologic open surgery. Methods: From August 2010 to August 2011, we retrospectively evaluated pediatric patients who underwent urologic open surgery at our institution. A total of 128 pediatric patients with 210 incisions used Dermabond$^{TM}$ for skin closure. Results: We divided the 128 patients into 3 groups according to type of surgery. Group 1 underwent hydrocelectomy (55 cases, 41.3%), Group 2 underwent orchiopexy (43 cases, 32.3%), Group 3 underwent penoplasty (35 cases, 26.4%). One hundred and twenty eight patients who underwent 133 surgeries in total, with a total of 210 incisions visited our outpatient department postoperatively, and a total of 5 wound complications (2.3%) occurred, but were simple inflammations and no dehiscence was observed. When analyzed according to groups, no wound problems occurred in Group 1 (0/55, 0%), one occurred in Group 2 (1/43, 2.3%) and four cases occurred in Group 3 (4/35, 11.4%) respectively. When re-analyzed according to wound locations, one occurred in an inguinal wound (1/120, 0.83%), none occurred in scrotal wounds (0/55, 0%), and four occurred in penile wounds (4/35, 11.4%). In Group 3, the incidence of penile wounds was significantly increased compared to other groups (P=0.008). All 5 wound problems were inflammatory and healed at an average of 13.8 days (13-15 days) with antibiotic ointment application only. Conclusion: Dermabond$^{TM}$ is feasible and safe topical skin adhesive alternative to standard skin suture in pediatric urologic surgery. However, further research about its efficacy and safety could be valuable in the future.

Performance Measurement of Diagnostic X Ray System (진단용 X선 발생장치의 성능 측정)

  • You, Ingyu;Lim, Cheonghwan;Lee, Sangho;Lee, Mankoo
    • Journal of the Korean Society of Radiology
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    • v.6 no.6
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    • pp.447-454
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    • 2012
  • To examine the performance of a diagnostic X-ray system, we tested a linearity, reproducibility, and Half Value Layer(HVL). The linearity was examined 4 times of irradiation with a given condition, and we recorded a level of radiation. We then calculated the mR/mAs. And the measured value should not be more than 0.1. If the measured value was more than 0.1, we could know that the linearity was decreased. The reproducibility was analyzed 10 times of irradiations at 80kVp, 200mA, 20mAs and 120kVp, 300mA, 8mAs. The values from these analyses were integrated into CV equation, and we could get outputs. The reproducibility was good if the output was lower than 0.05. HVL was measured 3 times of irradiation without a filter, and we inserted additional HLV filters with 0, 1, 2, 4 mm of thickness. We tested the values until we get the measured value less than a half of the value measured without additional filter. We tested the linearity, the reproducibility, and HVL of 5 diagnostic X-ray generators in this facilities. The linearity of No. 1 and No. 5 generator didn't satisfy the standard for radiation safety around 300mA~400mA and 100mA~200mA, respectively. HVL of No.1 generator was not satisfied at 80kVp. The outputs were higher in the three-phase equipment than the single-phase equipment. The old generators need to maintain and exchange of components based on the these results. Then, we could contribute to getting more exact diagnosis increasing a quality of the image and decreasing an expose dose of radiation.

Monitoring of Aflatoxins in Medicinal Herbs (유통 생약재의 아플라톡신 모니터링)

  • Kim, Yong-Hoon;Kang, Han-Saem;Oh, Sun-Woo;Lee, Hwa-Jung;Kim, Mi-Gyeong;Chung, So-Young;Choi, Seon-Hee;Bang, Su-Jin;Han, Kyung-Jin;Lee, Ji-Won;Kim, Young-Seon;Kim, Hee-Yun
    • Korean Journal of Food Science and Technology
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    • v.42 no.1
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    • pp.27-32
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    • 2010
  • This study was conducted to monitor aflatoxins in various medicinal herbs, providing available data for the safety of those products. To monitor aflatoxins in medicinal herbs, a total of 400 samples of 40 different herbs were collected in commercial retailers in Seoul, Daejeon, Gwangju, Daegu, and Busan from March to August, 2008. The samples that passed the sensory evaluation were tested for aflatoxins. Aflatoxins in samples were analyzed by HPLC-florescence coupled with photochemical enhancement. Samples were extracted with 70% methanol and then diluted to the appropriate concentration. A refining process was performed using an immunoaffinity column. The analytical method used in this study was validated. The $R^2$ value for aflatoxin $B_1$ was 0.99946, and the detection range was from 0.25 to 10.0 ng/mL. The accuracy of the analysis was ranged from 83.2% to 101.8%. The relative standard deviation (RSD) in the aflatoxin $B_1$ analysis was 3.4%, demonstrating the precision of this method. In addition, the detection limit and quantitative analysis limit of aflatoxin $B_1$ was $0.53\;{\mu}g/kg$ and $1.76\;{\mu}g/kg$, respectively. These results indicated that the analytical method used in this study was appropriate. The results of HPLC showed that 1% (4 samples) of the samples may contain aflatoxins. The concentration of quantified aflatoxin was $2.3\;{\mu}g/kg$ for both Quisqualis fructus and Remotiflori radix samples. The other samples were below the limit of quantification. Moreover, the concentration of aflatoxin $B_1$ which is made by specific fungi were below the level of regulation. Only 20% of aflatoxin $B_1$ were transferred to hot water. Therefore, the levels of aflatoxins in medicinal herbs were considered to be safe especially considering the aflatoxin transfer ratio.

A study on measures for the mitigation of fire damage in Korea super high-rise building through the improvement of domestic·foreign standards (국·내외 기준개선을 통한 국내 초고층 건축물의 화재피해경감 대책에 관한 연구)

  • Ko, Jaesun
    • Journal of the Society of Disaster Information
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    • v.13 no.2
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    • pp.233-248
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    • 2017
  • Uniform laws and regulations and reasonable design is necessary for the prevention of possible fire in super high-rise building. To this end, this study focused on super high-rise and massive building-related architectural review performance-based design (PBD) evaluation disaster impact assessment (DIA), and provided fire engineering measures for improving fire prevention on the basis of performance-based design by analyzing the buildings subject to these systems and problems in terms of contents. Above all, in the aspect of law and standard improvement, first, with regard to dual parts of two statutes though significant portion of them has the same contents in performance-based design (PBD) evaluation and disaster impact assessment (DIA), it is necessary to operate the systems after making them conform with each other and consolidating or abolishing them. Second, if it is impossible to consolidate or abolish performance-based design (PBD) evaluation and disaster impact assessment (DIA), the areas of contents of performance-based design (PBD) evaluation and disaster impact assessment (DIA) should be precisely classified and established. Next, engineering improvement measures against fire hazard in super high-rise building are as follows. First, it is necessary to revise the provisions of straight-run stairs in special escape stairs. And in case of installing a mechanical smoke exhaust system instead of smoke vent, sandwich pressurization used in the United Stated should be permitted. Second, with regard to smoke control system for special escape stairs, it was shown that there was necessity for revising the standards in order to enable air to be supplied according to section in case of fire, carrying out performance-based design, and the like from the early design stages to the completion stages. In the future, it is expected that an epoch-making contribution will be made to a decrease in casualties and property damage due to fire in case of super high-rise building where the results can be reflected after carrying out a study on maintenance and carrying out an additional study on other considerations of super high-rise building together with reflecting the improvement measures provided in the above-mentioned study.

An Analysis of the Study Tendency on Rheumatoid Arthritis -Focusing on Domestic Theses for a Degree and Journal Since 2004- (류마토이드 관절염의 연구동향에 대한 소고(小考) -2004년 이후의 국내 학위논문 및 학회지 논문을 중심으로-)

  • Choi, Yong-Hun;Yoon, Il-Ji
    • Journal of Korean Medicine Rehabilitation
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    • v.19 no.2
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    • pp.125-156
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    • 2009
  • Objectives : To research the trend of studies related to rheumatoid arthritis and to indicate the hereafter direction for its study in oriental medicine and its treatment. Methods : I reviewed 75 domestic oriental medical journals, and 50 medical journals about rheumatoid arthritis published after 2004, and comparative analysis was made. And these theses were classified by college, year, field of study, subject. Results : The following are the results of this study. 1. Classified by oriental medical college, Dae-jeon college published the most theses, followed by Dong-guk, Kyung-hee, Se-myung and Dong-shin college. Han-yang college published the most theses among college of medicine. 2. Classified by type of thesis, experimental theses(70 pieces, 94%) showed higher rate than that of clinical theses(4 pieces, 5%) in oriental medical studies. However, in medical studies, clinical theses(34 pieces, 68%) showed higher rate than that of experimental theses(15 pieces, 30%). 3. Analyzed by subject, the most dealt subject in oriental medicine was herb medication, followed by herbal acupuncture, single herb, electroacupuncture, sasang & gene, acupuncture & moxibustion, complex accordingly. The most dealt subject in medical clinical journals was standards of diagnosis & prognosis, followed by medication, gene analysis, pathogenesis, clinical pattern, operative treatment and complication accordingly. 4. In theses related to herb medication, most of the subject was to evaluate anti-inflammatory and immunoregulatory effects of herb medication with geopungseup, jibitong, hwalhyeolgeoer function. The tendency of experimental methods was focusing on understanding anti-inflammatory and immunoregulatory mechanisms through molecular biologic methods by analyzing cytokine and gene. 5. Most of theses related to herbal acupuncture were experimental studies verifying ant-inflammatory and immnoregulatory effects through methods observing change of cytokine and immunoregulatory factors. Regarding remedies for herbal acupuncture, Ulmus davidiana Planch was most preferred, followed by bee venom. 6. In theses related to single herb, Boik-yak was most prefered, followed by Geopungseup-yak and Hwalhyeolgeoer-yak. Regarding methods of research, there were tendency of shifting from methods verifying travail, anti-inflammatory and anti-pyretic effects through a test of behavior, morphometry, serology and temperature measurement of the rectum and the skin into verifying anti-inflammatory and immunoregulatory effects through observing inflammatory cytokine in the joint and cells of spleen. 7. In theses related to electroacupuncture, ST36 and adjuvant were most preferred as acupoints and induced factor. The tendency of experimental methods was turning from verifying mechanism of travail effect to analyzing inflammation and pain inducing factors. 8. Diverse medical clinical studies were published. Subjects such as diagnosis and prognosis, medication, gene analysis, clinical pattern, operational treatment, complication and pathogenesis were published. Especially, studies about standards of early diagnosis, and research on possible parallel medications with methotrexate were actively inquired. 9. Most of theses related to medical experimental studies was about mediators and receptors related to inflammatory induction and osteoclasia mechanism. Also, it was presented blockage of them can be effective on rheumatoid arthritis. Conclusions : The oriental medicine studies have merit in its diversity of treatment, but it clinical studies is lacking compared to experimental studies. Also, more diversity of subjects is necessary. Therefore, complementary measures are needed. Hereafter, oriental medicine research about rheumatoid arthritis needs more clinical research verifying the effectiveness and safety in clinical field. Also, we require oriental medical standard of diagnosis and researches on pathological generation which would make early checkup and prognosis possible.

Development and Validation of Analytical Method for Determination of Biphenyl Analysis in Foods (식품 중 비페닐 분석법 개발 및 유효성 검증)

  • Kim, Jung-Bok;Kim, Myung-Chul;Song, Sung-Woan;Shin, Jae-Wook
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.46 no.4
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    • pp.459-464
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    • 2017
  • Biphenyl is used as an intermediate in the production of crop protection products, a solvent in pharmaceutical production, and as a component in the preservation of citrus fruits in many countries. Biphenyl is not authorized for use and also does not have standards or specifications as a food additive in Korea. National and imported food products are likely to contain biphenyl. Therefore, control and management of these products is required. In this study, a simple analytical method was developed and validated using HPLC to determine biphenyl in food. These methods are validated by assessing certain performance parameters: linearity, accuracy, precision, recovery, limit of detection (LOD), and limit of quantitation (LOQ). The calibration curve was obtained from 1.0 to $100.0{\mu}g/mL$ with satisfactory relative standard deviations (RSD) of 0.999 in the representative sample (orange). In the measurement of quality control (QC) samples, accuracy was in the range of 95.8~104.0% within normal values. The inter-day and inter-day precision values were less than 2.4% RSD in the measurement of QC samples. Recoveries of biphenyl from spiked orange samples ranged from 92.7 to 99.4% with RSD between 0.7 and 1.7% at levels of 10, 50, and $100{\mu}g/mL$. The LOD and LOQ were determined to be 0.04 and $0.13{\mu}g/mL$, respectively. These results show that the developed method is appropriate for biphenyl identification and can be used to examine the safety of citrus fruits and surface treatments containing biphenyl residues.

The Evaluation and Development of Head and Neck Radiation Protective Device for Chest Radiography in 10 Years Children (소아(10세) 흉부 방사선촬영에서의 두경부 방사선 방어기구 개발 및 평가)

  • Lee, Jun Ho;Lim, Hyun Soo;Lee, Seung Yeol
    • Journal of Radiation Protection and Research
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    • v.40 no.2
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    • pp.118-123
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    • 2015
  • The frequency of diagnostic radiation examinations in medical institutions has recently increased to 220 million cases in 2011, and the annual exposure dose per capita was 1.4 mSv, 51% and 35% respectively, compared to those in 2007. The number of chest radiography was found to be 27.59% of them, the highest frequency of normal radiography. In this study, we developed a shielding device to minimize radiation exposure by shielding areas of the body which are unnecessary for image interpretation, during the chest radiography. And in order to verify its usefulness, we also measured the difference in entrance surface dose (ESD) and the absorbed dose, before and after using the device, by using an international standard pediatric (10 years) phantom and a glass dosimeter. In addition, we calculated the effective dose by using a Monte Carlo simulation-based program (PCXMC 2.0.1) and evaluated the reduction ratio indirectly by comparing lifetime attributable risk of cancer incidence (LAR). When using the protective device, the ESD decreased by 86.36% on average, nasal cavity $0.55{\mu}Sv$ (74.06%), thyroid $1.43{\mu}Sv$ (95.15%), oesophagus $6.35{\mu}Sv$ (78.42%) respectively, and the depth dose decreased by 72.30% on average, the cervical spine(upper spine) $1.23{\mu}Sv$ (89.73%), salivary gland $0.5{\mu}Sv$ (92.31%), oesophagus $3.85{\mu}Sv$ (59.39%), thyroid $2.02{\mu}Sv$ (73.53%), thoracic vertebrae(middle spine) $5.68{\mu}Sv$ (54.01%) respectively, so that we could verify the usefulness of the shielding mechanism. In addition, the effective dose decreased by 11.76% from $8.33{\mu}Sv$ to $7.35{\mu}Sv$ before and after wearing the device, and in LAR assessment, we found that thyroid cancer decreased to male 0.14 people (95.12%) and female 0.77 people (95.16%) per one million 10-year old children, and general cancers decreased to male 0.14 people (11.70%) and female 0.25 people (11.70%). Although diagnostic radiation examinations are necessary for healthcare such as the treatment of diseases, based on the ALARA concept, we should strive to optimize medical radiation by using this shielding device actively in the areas of the body unnecessary for the diagnosis.

An Exploratory Study about the Importance of Selected Nursing Activities during the Puerperal Period, as Viewed by Women in the Puerperal Period and by Nurses Caring for Them (산모와 간호원이 본 선택된 산욕기 간호활동의 중요도에 관한 탐색적 연구)

  • 박주봉
    • Journal of Korean Academy of Nursing
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    • v.8 no.1
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    • pp.152-162
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    • 1978
  • The desire to maintain health is increasing, consequently the role of nursing which has as one chief aim the solving of man′s basic problems is more and more important. Today, in spite of a growing concern about the nursing activities which nurses provide for individual human having specific needs, clinically in fact, it is questionable that individual′s expectation of nursing activities agrees with nurse′s performance of nursing activities. In this study the importance and agreement of the importance of the nursing activities during the hospitalized puerperal period as viewed by women in the puerperal period and by nurses caring for them, were assessed. The present study was undertaken in an attempt to furnish the basic data for expediting the progress of research activities in this area and further to be helpful in planning maternity nursing practice. The study population defined and selected was nurses (13) caring for women in the puerperal period and doing duty on obstetric & gynecologic ward at Y. hospital, and the women in puerperal period (39) as sum of 3 women selected by each nurse during the period of May 13th-June 4th 1976. The study data was collected by the direct interview method based on the questionnaire which the investigator made out. The study result was analyzed by percentage, t - test. The findings can be summarized as follows: 1. General characteristics of nurses doing duty on puerperal ward: a. Nurses′average age was 24.8 years old. b. 84.6% had educational background of 4 years of college. c. 69.2% had a religion. d. 53.8% were married. e. 53.8% had clinical experience of 1 year -3 years. f, 61.5% did duty on puerperal ward during 1 year -3 years. g. 46.2% desired to do duty on obstetric ? gynecologic ward. 2. General characteristics of the women who were studied during their puerperal period: a. Women′s average age was 26.4 years old. b. 79.5% had educational background above high school. c. 56.4% had a religion. d. 84.6% had living standard above medium. e. 89.7% had no occupation. f, 53,8% had previous hospitalization experience. g. 56.4% had previous delivery experience. 3. Examining the importance of 39 nursing activities during puerperal period selected by investigator, studied group of women considered that the most important nursing activity was "Record precisely about condition, medical treatment and nursing activity results etc". Nurses considered that the most important nursing activity was "Notice whether having pain and care for that". Both groups considered that the least important nursing activity was "Talk with her about topics such as news, hobbies, other interests". 4. Examining the importance of nursing activities in 4 specific categories, studied group of women considered that the most important nursing activity in physical nursing category was "Be sure of safety measure to prevent accidents, injuries", and nurses considered that the most important nursing activity was "Make her sleep and rest sufficiently". Studied group of women considered that the most important nursing activity in psychological category was "Explain about medical treatment and nursing activity ahead of time so she knows what to expect" , and nurses considered that the most important nursing activity was "Explain about puerperal period so she understands". Studied group of women considered that the most important nursing activity in relation to medical care was "Record precisely about condition, medical treatment and nursing activity results etc.", and nurses considered that the most important nursing activity was "Observing, cleaning and protecting the perineum" Studied group of women considered that the most important nursing activity in nursing category in preparation for discharge was "Instruct about personnel hygiene during puerperal period", and nurses considered that the most important nursing activity was "Instruct self-care to protect the perineum". 5. The analysis of this study showed a significant amount of disagreement computed by subtracting the nurse′s score from the patient′s score. Studied group of women put greater importance on physical nursing category, psychological nursing category, nursing in relation to medical care, than the nurses. These results were statistically significant at 0.01 level.

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