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The Characteristic of Research Regulation in Recent Japanese Medical World (최근 일본의 의학계 연구규율의 특색)

  • Song, Young-mi
    • The Korean Society of Law and Medicine
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    • 제20권2호
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    • pp.173-206
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    • 2019
  • This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as 「dynamic guideline」) and ethics guideline on clinical research(here after, referred to as 「clinical guideline」) to ethics guideline on medical research aimed at human(here after, referred to as 「integrated guideline」), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of 「invasiveness」, a preliminary consideration of evaluation. 「Evaluation issue of risk and profit」, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define 「invasiveness」 concept, a preliminary consideration of risk evaluation for human subjects. This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of 「invasiveness」 concept, a preliminary of risk evaluation to protect human subjects.

A Study on Protection Performance of Radiation Protective Aprons classified by Manufacturers and Lead Equivalent using Over Tube Type Fluoroscopy (Over Tube Type의 투시촬영장치를 이용한 제조사별, 납당량별 엑스선방어 앞치마의 Protection 성능 평가에 관한 연구)

  • Song, Jong-Nam;Seol, Gwang-Wook;Hong, Seong-Il;Choi, Jeong-Gu
    • Journal of the Korean Society of Radiology
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    • 제5권3호
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    • pp.135-141
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    • 2011
  • If protective performance of apron cannot be good, radiation exposure of an guardian or a patient, a person engaged in radiation related industry cannot rise. Therefore, It will be evaluated protection performance to radiation protection aprons by manufacturers and lead equivalent more than 0.25mm lead equivalent. And, will show in the direction of application to clinic. The new aprons by manufacturers(H, X, I, J company) and lead equivalent(0.50mmPb, 0.35mmPb, 0.25mmPb) measured transmitted dose rate and shielding rate, uniformity under fluoroscopy and general radiography using to fluoroscopy system and digital radiography system, x-ray multifunction meter. The shielding rate measurement results, 0.5mmPb apron was Shielding rate of apron of a I company(fluoroscopy : 97.96%) was the best under six companies, and shielding rate of apron of a J company(fluoroscopy : 96.25%) was worst. 0.35mmPb Apron was Shielding rate of a I company(fluoroscopy : 96.79%) was the best under the three companies, and shielding rate of an H company(fluoroscopy : 95.81%) was the worst. 0.25mmPb Apron was Shielding rate of X company apron(fluoroscopy : 90.908%) was better than H company apron(fluoroscopy : 88.82%) than two companies. The uniformity measurement results, 0.5mmPb Aprons of X company(fluoroscopy : 0.13) and I company(fluoroscopy : 0.19) was the best under the six companies, and J company apron(fluoroscopy : 0.45) was the worst. 0.35mmPb. Along a manufacturer and lead equivalent performance of apron protection is distinguished certainly. Therefore, a patient, guardian or a person engaged in radiation related industry shall enforce experiment of a lot of ways defined or evaluation so that the maximum reduces radiation exposure. Buy the apron that protective performance is good, It will be performed through experiment and evaluation.

Temporal Variations of Cerebrovascular Diseases in a University Hospital (일개 대학병원을 대상으로 한 뇌혈관질환의 시간적 변동양상)

  • Lee, Mi-Yon;Lee, Sang-Bock;Lee, Jun-Hang;Lee, Sam-Yul;Lee, Tae-Soo;Jin, Gye-Hwan
    • Journal of the Korean Society of Radiology
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    • 제1권1호
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    • pp.17-23
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    • 2007
  • Background: Cerebrovascular diseases are known to show different patterns of incidence among regions and races. Therefore, it is very important to determine the incidence pattern of a specific area in order to diagnose, treat and prevent cerebrovascular diseases. The objective of the present study is to analyze quantitatively the incidence ratios of hemorrhagic and ischemic cerebrovascular diseases by season, by gender and by age. Methods: The subjects of this study were 1603 patients hospitalized for hemorrhagic or ischemic cerebrovascular diseases at the Department of Neurosurgery or the Department of Neurology of a University Hospital. Statistical analysis of data used Excel 2003 of Microsoft, and t-test was conducted using ORIGIN 6.0 of MICROCAL. Results: In the subjects, the incidence ratios of hemorrhagic and ischemic cerebrovascular diseases for four years, the period of this research, were 38.55% and 61.45%, respectively. The mean and standard deviation of age when hemorrhagic cerebrovascular diseases occurred were 58.20 and 12.60, respectively, and the percentages of subjects in their 40s, 50s, 60s and 70s were all around 20%. On the contrary, the mean and standard deviation of age when ischemic cerebrovascular diseases occurred were 65.01 and 13.59, respectively. The average age of patients with ischemic cerebrovascular diseases was older than that of patients with hemorrhagic brain diseases, and the percentages of those in their 60s, 70s and 80s were 15.53%, 37.06% and 27.72%, respectively. The season when hemorrhagic cerebrovascular diseases appeared most frequently was winter, which was followed by summer, spring and autumn. The season when hemorrhagic cerebrovascular diseases appeared most frequently was spring, which was followed by summer, winter and autumn. Conclusions: In this study, the incidence rates of hemorrhagic and ischemic cerebrovascular diseases were 38.55% and 61.45%, showing the rising percentage of ischemic cerebrovascular diseases. For making adequate prevention and disease control plans, it is considered necessary to make a long-term epidemiological investigation of cerebrovascular diseases.

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Effect of Biozyme on Alcohol Metabolism

  • Park, Seung-Hee;Nam, Suk-Woo;Sungpil Yoon;Minsik Son;Nam, Tae-Kyun;Seo, Dong-Wan;Sungyoul Hong;Lee, Hyang-Woo
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 한국응용약물학회 1995년도 춘계학술대회
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    • pp.91-91
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    • 1995
  • 에탄올에 의한 급성독성은 에탄올, 아세트알데히드 및 에탄을 대사산물의 변형생성물질 등에 기인하므로 알콜 섭취 후 혈중 에탄을 농도 및 아세트알데히드의 농도를 낮추는 것은 음주에 의한 급성 중독상태에 머무는 시간을 단축시키는데 중요하다. 본 실험에서는 Bacillus subtilis natto sp.를 식물 추출액을 배지로 하여 배양한 후 단백 분해효소로 고분자물질을 절단하여 얻은 발효액인 바이오짐(상품명: Biozyme)을 주성분으로 한 '비지니스(조선무약합자회사)' 의 인체 혈중 알콜대사 촉진작용을 검색하였으며, 비지니스 및 바이오짐이 랫드의 에탄을 대사에 미치는 효과를 검토하여 다음과 같은 결과를 얻었다. 인체 혈중 알콜대사 촉진작용을 검색하기 위해 알콜 섭취 전과 후의 혈중 에탄올 농도를 비교하였는데, 대조군에 비해 비지니스 투여군이 30분 후부터 2시간 후까지 혈청 알콜농도가 낮게 나타났다. 대조군의 혈청 알콜농도를 100으로 하였을 때 알콜 투여 30분, 60분, 90분, 120분 경과 후 시험군은 각각 대조군의 84.3%, 89,0%, 85.9%, 75.8%를 나타내어 평균 16% 정도 낮았다. 시험군의 AUC는 대조군의 AUC의 89%로 비지니스 투여군에서 혈액내 알콜의 제거가 빠르게 진전된다는 것을 보여주었다. 또한, 랫드의 에탄을 대사에 미치는 효과를 알아보고자 바이오짐 및 비지니스 투여 후 채혈하여 혈중 에탄을 및 아세트알데히드 농도를 측정하였다. 비즈니스 투여시 혈중 알콜 농도는 알콜 투여 60분 경과후 가장 큰 감소 효과(대조군:83.70$\pm$11.80mg/이, 시험군:45.12$\pm$6.63mg/d1, 47% 감소)를 나타내었으며, 시험군의 AUC는 대조군에 비해 30% 감소하였다. 혈중 아세트알데히드 농도는 투여 60분 후 비지니스 투여군(4.56$\pm$0.51nmol/$m\ell$)이 대조군(6.45$\pm$0.64nmo1/$m\ell$)에 비해 유의성 있는 감소(29%)를 나타내었으며, 시험군의 AUC는 대조군에 비해 35% 감소하였다. 바이오짐 투여시 혈중 에탄을 농도가 알콜 투여 2시간 경과 후 가장 큰 감소 효과(대조군:49.10$\pm$5.20mg/dl, 시험군:25.90$\pm$7.16mg/d1, 47% 감소)를 나타내었으며, 시험군의 AUC는 대조군에 비해 39% 감소하였고, 혈중 아세트알데히드의 농도는 투여 60분후 시험군(3.96$\pm$0.07nmo1/$m\ell$)이 대조군(6.45$\pm$0,64nmo1/$m\ell$)에 비해 유의성 있는 감소(39%)를 나타내었으며, 시험군의 AUC는 대조군에 비해 48% 감소하였다 한편, 시험관내 에탄올 대사 효소에 대한 바이오짐의 효과를 검색해본 결과 바이오짐(2.0 $\mu\textrm{g}$/assay)에 의해 Aldehyde dehydrogenase(1.5unit/assay)의 활성이 14% 증가되었다. 본 연구의 결과로 볼 때, 비지니스 및 바이오짐은 음주 후 상승된 혈중 에탄을 농도 및 아세트알데히드의 농도를 현저히 감소시키는 효과가 있었다.

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The effects of gamma irradiation on the survival and development of Clonorchis sinensis metacercariae (감마선 조사가 흰쥐에서의 간흡충 생존 및 발육에 미치는 영향)

  • 이순형;박양희
    • Parasites, Hosts and Diseases
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    • 제27권3호
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    • pp.187-196
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    • 1989
  • The effects of gamma irradiation on the survival and development of C. sinensis metacercariae were studied to evaluate the feasibility of irradiation as a control measure for clonorchiasis. Pseudorasbora parve were collected at an endemic river of clonorchiasis and were used for irradiation of the fluke in three schemes. The first (Scheme 1) was irradiation of the isolated metacercariae from the fish followed by infection to experimental rats. The second (Scheme 2) was irradiation of the fish, and then the metacercariae were isolated and in(ected to rats. The third (Scheme 3) was irradiation on the rat livers after infection with normal metacercariae. Irradiation doses varied from 5 to 100 Gy for Schemes 1 and 2, and 10 to 25 Gy for Scheme 3. The rats were sacrificed 2 to 6 weeks after infection. In Scheme 1, the metacercariae irradiated at 50 Gy failed to survive in the rats after 2 or 6 weeks. However, 1 to 44% of the metacercariae irradiated at 5∼30 Gy survived. The estimated LD50 of Scheme 1 was 16.5 Gy. The flukes irradiated in Scheme 2 survived better than those in Scheme 1. The average worm recovery rate in 50 Gy was 28%(7∼39% individually). Increasing the dose up to 100 Gy brought a remarkably low survival rate of an average 1%(0∼3% individually). The LD50 of Scheme 2 was 47.5 Gy. Worm recovery rates in the 10 Gy group of Scheme 3 were 21∼39%, and those in the 25 Gy group were 2% and 34%. Although the metacercariae were irradiated, all of the recovered worms were morphologically normal. Only the worms irradiated with 10 Gy or 25 Gy after 9 days from infection in Scheme 3 showed underdeveloped testes and seminal receptacle. The present results suggest that irradiation of the fish by 100 Gy could be adopted as a control measure for clonorchiasis.

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Histological and Histochemical Studies on the Epididymal Region and Deferent Ducts of the Drakes by the Age in Weeks (오리 부고환(副睾丸) 및 정관(精管)의 주령별(週齡別) 조직학적(組織學的) 및 조직화학적(組織化學的) 연구(硏究))

  • Lee, Jae-Hong;Ha, Chang-Su
    • Korean Journal of Veterinary Research
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    • 제23권2호
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    • pp.137-148
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    • 1983
  • This study was made for the better information of the male reproductive system on the meat-type drake, Cherry Belly X White Golden. The epithelium of ductules of epididymal region and deferent duct were observed histologically and histochemically with the progress of their development. India-ink absorbability on the luminal epithelium was also investigated after the administration of India-ink. The results are as follows; 1. Rete testis and various round ductules in immature form appeared in epididymis within 6 weeks after hatching, and simple cuboidal and simple columnar epithelium were found in the epithelia of the ductules within 8 weeks after hatching. Larger ductules were found on epididymal surface which was in the developing stage near to the immature efferent ductule. From 10th to 20th week, various ductules appeared in epididymis, and developing form of efferent ductules were much more increased on epididymal surface. The luminal epithelium of the ductules were composed of ciliated simple columnar and pseudostratified ciliated columnar cells. At the same time, deferent duct appeared. From the 21th week, various ductules in epididymis became abruptly matured. Lumen of rete testis was lined by simple squamous or simple cuboidal epithelium, and that of efferent ductules, having many folds and being larger than any others were lined by pseudostratified ciliated columnar epithelium in which ciliated columnar cells, non-ciliated cells(clear cells) and basal cells were noted. Connecting tubules of star shaped lumen were composed of pseudostratified ciliated columnar epithelium in which ciliated columnar cells, nonciliated cells, and basal cells were observed. The luminal surface of epididymal ducts was smooth and has thick pseudostratified columnar epithelium which was composed of high columnar cells and basal cells. From 26th week after hatching, sperm pooling was started in various ductules. 2. From 4th to 10th week, simple cuboidal epithelium of deferent duct transformed to simple columnar epithelium with the progress of aging. At the basement of epithelium, clear round cells were noted. From 12th to 20th week, high columnar cells with enlongated nucleus were noted on the luminal border of deferent ducts, forming folds of pseuclostratified columnar epithelium. From 20th week, the deferent duct started to have septa in it's lumen and composed mainly of pseudostratified columnar epithelium, and round cells disappeared. From 20th week, the lumen diameter of deferent duct became wider with the progress of aging, but there was no difference among the values of lumen diameter in upper, middle, and lower part of deferent ducts. At 26th week, the pooling period of sperms in deferent ducts, the lumen diameter became rapidly widen, especially in the lower part of deferent ducts. Thickness of muscular layer of ductus deferens showed gradual growth within 24 weeks but did abrupt thickening from 26th week. 3. Saliva resistant PAS granules were dotted on the top of nucleus in efferent ductules epithelium but the amount of the granules were little in the connecting ductules's epithelium. The granules reactive to acid phosphatase were abundant in the some epithelial cells of efferent ductules and connecting ductules, especially above the nucleus of cells. The granules reactive to alkaline phosphatase were noted on the luminal border of efferent ductules. Parts of free border of efferent ductules and middle portion of deferent ducts were stained slightly by alcian blue technique. India ink granules were found mainly in the epithelium of efferent ductules but were few in that of connecting ductules.

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Immunohistochemical study of the gastrointestinal endocrine cells in the Mongolian Gerbils, Meriones unguiculatus (몽골리안 저빌(Meriones unguiculatus)의 위장관 내분비 세포에 대한 면역조직화학적 연구)

  • Lee, Jae-hyun;Lee, Hyeung-sik;Ku, Sae-kwang;Park, Ki-dae;Kim, Kil-soo
    • Korean Journal of Veterinary Research
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    • 제40권4호
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    • pp.653-660
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    • 2000
  • In order to study the regional distribution and relative frequency of the immunoreactive endocrine cells in the gastrointestinal tract of the Mongolian gerbil, Meriones unguiculatus, the gastrointestinal tract was divided into 9 portions (cardia, fundus, pylorus, duodenum, jejunum, ileum, cecum, colon and rectum) and immunostained by immunohistochemical (PAP) method using 8 types of specific antisera against cholecystokinin (CCK)-8, gastrin, secretin, pancreatic polypeptide(PP), somatostatin, serotonin, glucagon and insulin. CCK-8-, gastrin-, somatostatin- and serotonin-immunoreactive cells were demonstrated in this study. These immunoreactive cells were found in the gastric gland regions of the pylorus or between parietal and chief cells of the fundus with round to spherical shaped, and in the interepithelial regions of the intestinal tract with spherical to spindle shaped except for jejunum where some of immunoreactive cells were also observed in the intestinal glands with round to spherical shaped. CCK-8-immunoreactive cells were restricted to the pylorus and duodenum with numerous and a few frequency, respectively. Gastrin-immunoreactive cells were restricted to the pylorus with numerous frequency. Similar to those of gastrin-immunoreactive cells, somatostatin-immunoreactive cells were restricted to pylorus with moderate frequency. Serotonin-immunoreactive cells were detected throughout whole gastrointestinal tract except for cardia and cecum with moderate or numerous frequency. However, no secretin-, PP-, glucagon- and insulin-immunoreactive cells were observed in this study. From these results, the appearance type, regional distribution and relative frequency of immunoreactive endocrine cells in the gastrointestinal tract of the Mongolian gerbils were somewhat lowered or restricted compared to those of other mammals and these differences were might be caused by feeding habits and species specification.

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Determination of Critical Duration of Weed Competition of Two Rice Cultivars under Different Seasonal Transplantings (수도(水稻) 이품종(異品種)의 작기이동(作期移動)에 따른 제초시기(除草時期) 결정(決定)에 관한 연구(硏究))

  • Guh, J.O.;Lee, K.S.;Kwon, S.L.;Heu, S.M.
    • Korean Journal of Weed Science
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    • 제3권2호
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    • pp.166-173
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    • 1983
  • To investigate the varietal differences of weed competitive functions under the three different seasons of transplanting, rice cultivars Milyang 23 and Sadominori were used with seven weeding methods, namely, weedy check, weed-free, once weeding at 3, 6, 9, 12 weeks after transplanting, and two times weeding at 3 and 9 weeks after transplanting, respectively. As a result, weeding stages and times for the proper weeding efficacies and reasonable rice productivities by respective weed group and total weed flora were estimated. Also, the constructive characteristics for yield formations under the different competitive conditions as affected by various cropping patterns were discussed.

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Effects of Spray Methods and Ammonium Sulfate and Potassium Chloride on Enhancing Phytotoxicity of Glyphosate (제초제(除草劑)의 살초효과(殺草效果) 증진(增進)을 위한 살포방법(撒布方法)과 황산암모늄 및 염화칼리의 첨가처리효과(添加處理效果))

  • Pyon, Jong-Yeong;Kim, Young-Rae
    • Korean Journal of Weed Science
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    • 제3권2호
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    • pp.190-198
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    • 1983
  • To examine the possibility of enhancing activity of foliar applied herbicides by spray methods and additives, field experiments were conducted to evaluate the effects of surfactant, spray volume, and additions of ammonium sulfate or potassium chloride to glyphosate on toxicity to Digitaria sanguinalis or Artemisia princeps. Glyphosate toxicity increased as spray volume was decreased from 120 1/10a to 40 and 80 1/10a. Additions of surfactant in the spray solution increased toxicity of glyphosate to D. sanguinalis and usually more pronounced effect was obtained at glyphosate 30.5g a.i./10a. Additions of 1 and 5% (w/v) ammonium sulfate to glyphosate increased toxicity to A. princeps at glyphosate 30.5 and 61.5g a.i./10a. 10% ammonium slufate, however, had no effect or were antagonistic. Additions of potassium chloride at 1,2 and 3% (w/v) were also very effective to increase herbicidal activity to A. princeps at glyphosate at 30.5 and 61.0g a.i/10a. These results suggest that the practices for enhancement of herbicidal activity by improvement of spray method and additions of ammonium sulfate or potassium chloride to glyphosate can be employed to use lower herbicide levels while giving the same degree of weed control in orchards and non-crop lands.

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Intra- and Inter-specific Competition of Bulrush(Scirpus juncoides Roxb.) (올챙고랭이(Scirpus juncoides Roxb.)의 종내(種內) 및 종간경합(種間競合)에 관한 연구(硏究))

  • Guh, J.O.;Huh, S.M.
    • Korean Journal of Weed Science
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    • 제9권2호
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    • pp.168-173
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    • 1989
  • In the characteristics of intra-specific competition according to bulrush density, the intra-specific competition in plant height began at 5 and 15% per pot in mixed culture and bulrush monoculture, respectively. The intra-specific competition in the shoot began at 5 plants per pot in both mixed culture and bulrush monoculture. The competition in dry matter weight began at 15 plants per pot in monoculture, and at 10 plants in mixed culture. On the rice density, the plant height, and numbers of shoot and dry matter weight in rice were rapidly increased up to 2.6, and 2.5 plants per pot, respectively, And then the increments were slow, The critical intra-specific competition of bulrush with rice was 2.5 to 3 plants per pot in their traits of rice, and especially the number of shoots and dry matter weights per pot showed significant decrements. In the different transplanting time in rice, the plant heights in both rice and bulrush elongated longer in mixed culture than in monoculture. The plant height of bulrush became shorter but the height of rice longer with late transplanting. The ratio of shoot number in rice to the number in bulrush was about 1 : 3 in all plots, and shoot numbers became less by late transplanting. The dry matter weight in both species were decreased by late transplanting, and the decrements were more prominent in bulrush than in rice.

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