• 제목/요약/키워드: Non-inferiority

검색결과 39건 처리시간 0.026초

Is conventional radiofrequency ablation of the superolateral branch, one of the three genicular nerves targeted as standard, necessary or not? A non-inferiority randomized controlled trial

  • Osman Albayrak;Canan Sanal Toprak;Osman Hakan Gunduz;Savas Sencan
    • The Korean Journal of Pain
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    • 제37권3호
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    • pp.264-274
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    • 2024
  • Background: Radiofrequency ablation is an effective treatment modality in the symptomatic treatment of knee osteoarthritis. Our aim was to compare the efficacy of radiofrequency ablation of the superomedial and inferomedial genicular nerves (2 branches) with the superolateral, superomedial, and inferomedial genicular nerves (3 branches) and to show whether the 2-branch procedure is inferior to the 3-branch procedure. Methods: This study is a prospective, randomized, single-blind clinical study. Eligible participants were randomized into 2 groups: group A, which applied the procedure to the superomedial and inferomedial genicular nerves, and group B, which applied it to the superomedial, superolateral and inferomedial genicular nerves. Pain was evaluated with the numerical rating scale, quality of life with the Short Form-36 (SF-36), and disability with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index before, and at 1 and 3 months after the procedure. Results: A total of 41 patients were included. There were no differences between the groups except for the SF-36 physical health sub-score at baseline. A significant improvement was seen in the numeric rating scale (NRS) score, SF-36 sub-scores, WOMAC Index total, as well as pain and physical function scores in both groups, though no significant difference was detected between the groups during follow-up. Conclusions: Although we were unable to establish the noninferiority of conventional radiofrequency ablation (CRFA) applied to 2 branches to CRFA applied to 3 branches, in this trial, significant and similar improvement was observed in NRS, WOMAC total, pain, and physical function and SF-36 scores in both groups.

Effectiveness of Short-Course Antibiotic Treatment in Uncomplicated, Non-Bacteremic Pediatric Urinary Tract Infections: A Rapid Systematic Review

  • Han Ho Kim;Young June Choe
    • Pediatric Infection and Vaccine
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    • 제30권2호
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    • pp.55-61
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    • 2023
  • 목적: 소아에서 요로감염은 높은 질병부담을 갖는다. 본 연구의 목적은 합병증이 없고 균혈증이 없는 소아 요로감염에서 단기 항생제 요법이 기존의 표준치료 방법과 비교해 비열등한지 평가하고자 한다. 방법: PubMed, Embase 및 Cochrane 데이터베이스에서 2021년 4월까지 출간된 연구에 대한 신속 체계적 문헌고찰(Rapid Systematic Review)을 시행했다. 비교군으로는 소아 요로감염 환자를 대상으로 단기 항생제 치료(≤4일)를 한 군과 표준 항생제 치료(≥5-7일)를 한 군 간의 임상결과를 비교한 연구를 선정하였다. 결과: 신속 체계적 문헌고찰 결과, 단기 치료 방법은 표준 치료 방법에 비해 비열등한 치료 효과를 가지며, 임상 완치율 및 재발률이 유사한 것으로 측정되었다. 단기 치료와 표준 치료 방법의 임상적 치료율을 비교한 10개의 연구 모두 유사한 결과를 보고하였다. 신장 합병증을 평가를 한 연구는 단기 치료 방법이 표준 치료 방법과 비교해 비열등하지 않음을 보여주었다. 요로감염 재발에 대해서는 10개 중 8개의 연구에서 단기 치료와 표준 치료 방법 간 결과에 유의미한 차이가 없다고 보고하였다. 결론: 본 연구를 통해 결과는 균혈증이 없는 소아 요로감염 환자에서 단기 치료 방법이 표준 치료 방법에 준하는 효과성을 나타났었다. 본 연구결과를 바탕으로 일부 선택된 환자에 대한 치료 의사결정 시 참고할 수 있을 것이다.

SonazoidTM versus SonoVue® for Diagnosing Hepatocellular Carcinoma Using Contrast-Enhanced Ultrasound in At-Risk Individuals: A Prospective, Single-Center, Intraindividual, Noninferiority Study

  • Hyo-Jin Kang;Jeong Min Lee;Jeong Hee Yoon;Jeongin Yoo;Yunhee Choi;Ijin Joo;Joon Koo Han
    • Korean Journal of Radiology
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    • 제23권11호
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    • pp.1067-1077
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    • 2022
  • Objective: To determine whether Sonazoid-enhanced ultrasound (SZUS) was noninferior to SonoVue-enhanced ultrasound (SVUS) in diagnosing hepatocellular carcinoma (HCC) using the same diagnostic criteria. Materials and Methods: This prospective, single-center, noninferiority study (NCT04847726) enrolled 105 at-risk participants (71 male; mean age ± standard deviation, 63 ± 11 years; range, 26-86 years) with treatment-naïve solid hepatic nodules (≥ 1 cm). All participants underwent same-day SZUS (experimental method) and SVUS (control method) for one representative nodule per participant. Images were interpreted by three readers (the operator and two independent readers). All malignancies were diagnosed histopathologically, while the benignity of other lesions was confirmed by follow-up stability or pathology. The primary endpoint was per-lesion diagnostic accuracy for HCC pooled across three readers using the conventional contrast-enhanced ultrasound diagnostic criteria, including arterial phase hyperenhancement followed by mild (assessed within 2 minutes after contrast injection) and late (≥ 60 seconds with a delay of 5 minutes) washout. The noninferiority delta was -10%p. Furthermore, different time delays were compared as washout criteria in SZUS, including delays of 2, 5, and > 10 minutes. Results: A total of 105 lesions (HCCs [n = 61], non-HCC malignancies [n = 19], and benign [n = 25]) were evaluated. Using the 5-minutes washout criterion, per-lesion accuracy of SZUS pooled across the three readers (72.4%; 95% confidence interval [CI], 64.1%-79.3%) was noninferior to that of SVUS (71.4%; 95% CI, 63.1%-78.6%), meeting the statistical criterion for non-inferiority (difference of 0.95%p; 95% CI, -3.8%p-5.7%p). The arterial phase hyperenhancement combined with the 5-minutes washout criterion showed the same sensitivity as that of the > 10-minutes criterion (59.0% vs. 59.0%, p = 0.989), and the specificities were not significantly different (90.9% vs. 86.4%, p = 0.072). Conclusion: SZUS was noninferior to SVUS for diagnosing HCC in at-risk patients using the same diagnostic criteria. No significant improvement in HCC diagnosis was observed by extending the washout time delay from 5 to 10 minutes.

생체판의 제작 및 실험 (A Study on the Manufacture of the Artificial Cardiac Tissue Valve)

  • 김형묵;송요준;손광현
    • Journal of Chest Surgery
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    • 제12권4호
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    • pp.383-394
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    • 1979
  • Treatment of valvular heart disease with valve replacement has been one of the most popular procedures in cardiac surgery recently. Although, first effort was directed toward the prosthetic valve, it soon became popular that bioprosthesis, the valvular xenograft, was prefered in the majority cases. Valvular xenograft has some superiority to the artificial prosthetic valve in some points of thromboembolism and hemolytic anemia, and it also has some inferiority of durability, immunologic reaction and resistance to Infection. Tremendous efforts were made to cover the inferiority with several methods of collection, preservation, and valve mounting of the porcine valve or pericardium of the calf, and also with surgical technique of the valvular xenograft replacement. Auther has collected 320 porcine aortic valves immediately after slaughter, and aortic cusps were coapted with cotton balls in the Valsalva sinuses to protect valve deformity after immersion in the Hanks' solution, and oxidation, cross-linking and reduction procedures were completed after the proposal of Carpentier in 1972. Well preserved aortic valves were suture mounted in the hand-made tissue valve frame of 19, 21, and 23 mm J.d., and also in the prosthetic vascular segment of 19 mm Ld. with 4-0 nylon sutures after careful trimming of the aortic valves. Completed valves were evaluated with bacteriologic culture, pressure tolerance test with tolerane gauge, valve durability test in the saline glycerine mixed solution with tolerance test machine in the speed of 300 rpm, and again with pathologic changes to obtain following results: 1. Bacteriologic culture of the valve tissue in five different preservation method for two weeks revealed excellent and satisfactory result in view of sterilization including 0.65% glutaraldehyde preservation group for one week bacteriologic culture except one tissue with Citobacter freundii in 75% ethanol preserved group. 2. Pressure tolerance test was done with an apparatus composed of V-connected manometer and pressure applicator. Tolerable limit of pressure was recorded when central leaking jet of saline was observed. Average pressure tolerated in each group was 168 mmHg in glutaraldehyde, 128 mmHg in formaldehyde, 92 mmHg in Dakin's solution, 48 mmHg in ethylene oxide gas, and 26 mmHg in ethanol preserved group in relation to the control group of Ringer's 90 mmHg respectively. 3. Prolonged durability test was performed in the group of frame mounted xenograft tissue valve with 300 up-and-down motion tolerance test machine/min. There were no specific valve deformity or wearing in both 19, 21, and 23 mm valves at the end of 3 months (actually 15 months), and another 3 months durability test revealed minimal valve leakage during pressure tolerance test due to contraction deformity of the non-coronary cusp at the end of 6 months (actually 30 months) in the largest 23 mm group. 4. Histopathologic observation was focussed in three view points, endothelial cell lining, collagen and elastic fiber destructions in each preservation methods and long durable valvular tolerance test group. Endothel ial cell lining and collagen fiber were well preserved in the glutaraldehyde and formaldehyde treated group with minimal destruction of elastic fiber. In long durable tolerance test group revealed complete destruction of the endothelial cell lining with minimal destruction of the collagen and elastic fiber in 3 month and 6 month group in relation to the time and severity. In conclusion, porcine xenograft treated after the proposal of Carpentier in 1972 and preserved in the glutaraldehyde solution was the best method of collection, preservation and valve mounting. Pressure tolerance and valve motion tolerance test, also, revealed most satisfactory results in the glutaraldehyde preserved group.

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마리화나 남용환자의 역동적인 발달요인과 문제해결 (Dynamic Developmental Factors and their Problem Solving of Patients that Abuse Marihuana)

  • 원정숙
    • 대한간호학회지
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    • 제4권3호
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    • pp.105-116
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    • 1974
  • This study was made on patients who were Hospitalized due to sickness caused by the abuse of marihuana at the Psychiatric Section of a hospital during the period from Feb. to Oct., 1974. The following conclusion was obtained by reviewing the literature with respect to the nursing, and problem solving of those patients. 1. It appears that marihuana is a comparatively mild intoxicant in ordinary preparation without causing physical dependence or tolerance. 2. According to the status of men who are marihuana smokers, approximately 20% of them were college students, those preparing to retake college entrance examinations, non-employed and pharmacists. The men belong mostly to the middle foreigner′s mistress of higher, income bracket, and in the case of women, most of the smokers were US. servicemen entertainers. 3. Dynamic developmental factors: Case 1. : The patient had a characteristic, hysterical and emotionally unitable character, and was of low intelligence, In addition, to this already existing problem, the added uses of marihuana caused a mental illness to develope. Case 2 : The character, was reserved and introspective, her creative power and sentiment was fading and his ability of self-control was weakened. She used the smoking of marihuana to get rid of her own feeling of inferiority complex and tensions coming from interpersonal relationships. Case 3 : The patient was unconditionally resistive to the authoritativeness of superiors and irresponsible in his relationship with women, in his attitude concerning sex in general. He smoked marihuana because he felt become peace-loving and get enchanted experience through smoking it. 4. The points of issue appearing from the above case; (1) Movement of anti-social feelings against the "established system" by the youngsters. (2) Family problem. (3) Shamelessness, loss of motivation, disorderly attitude toward the sex, (4) Worries concerning the future. (5) Lack of knowledge concerning smoking of cigarette and marihuana. Chronic use of marihuana made, those youngman who had originally been ambitions to achieve something in life, lazy, inefficient, unable to make long-term plans, are such weak mined persons that they did not try to overcome problems when encountered. This will pose a great and important question in the mental health of the society, 5. Treatment and Problem sieving According to the literature, we will have to place importance upon hospitalized treatment The phases of treatment were divided into five parts. (1) Prehospital phase (2) Withdrawal Phase (3) Rehabilitation phase (4) Transitional phase (5) After-care phase The experiments have proved that there was much progress in the recovery of patients through environment therapy, supportive therapy and group psychotherapy. This was the above mentioned 5 phases of treating process in accordance with the weekly schedule of the hospital. It was thought that the patients would require prolonged after care management even after they were released from the hospital and that they will also require periodic visit, to the hospital and doctor′s interview with their family. In conclusion, the question of the young generation and marihuana smoking is becoming a great social problem in which their resistances to the "established system" and society is growing in the from of antiestablishment movements. In our country, the smoking of marihuana is gradually developing, therefore, I think, that it would be a very fortunate thing for us, if this report could be helpful for the motivation of further study on the questions of the young generation and its problems.

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Preoperative Prediction for Early Recurrence Can Be as Accurate as Postoperative Assessment in Single Hepatocellular Carcinoma Patients

  • Dong Ik Cha;Kyung Mi Jang;Seong Hyun Kim;Young Kon Kim;Honsoul Kim;Soo Hyun Ahn
    • Korean Journal of Radiology
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    • 제21권4호
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    • pp.402-412
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    • 2020
  • Objective: To evaluate the performance of predicting early recurrence using preoperative factors only in comparison with using both pre-/postoperative factors. Materials and Methods: We retrospectively reviewed 549 patients who had undergone curative resection for single hepatcellular carcinoma (HCC) within Milan criteria. Multivariable analysis was performed to identify pre-/postoperative high-risk factors of early recurrence after hepatic resection for HCC. Two prediction models for early HCC recurrence determined by stepwise variable selection methods based on Akaike information criterion were built, either based on preoperative factors alone or both pre-/postoperative factors. Area under the curve (AUC) for each receiver operating characteristic curve of the two models was calculated, and the two curves were compared for non-inferiority testing. The predictive models of early HCC recurrence were internally validated by bootstrap resampling method. Results: Multivariable analysis on preoperative factors alone identified aspartate aminotransferase/platelet ratio index (OR, 1.632; 95% CI, 1.056-2.522; p = 0.027), tumor size (OR, 1.025; 95% CI, 0.002-1.049; p = 0.031), arterial rim enhancement of the tumor (OR, 2.350; 95% CI, 1.297-4.260; p = 0.005), and presence of nonhypervascular hepatobiliary hypointense nodules (OR, 1.983; 95% CI, 1.049-3.750; p = 0.035) on gadoxetic acid-enhanced magnetic resonance imaging as significant factors. After adding postoperative histopathologic factors, presence of microvascular invasion (OR, 1.868; 95% CI, 1.155-3.022; p = 0.011) became an additional significant factor, while tumor size became insignificant (p = 0.119). Comparison of the AUCs of the two models showed that the prediction model built on preoperative factors alone was not inferior to that including both pre-/postoperative factors {AUC for preoperative factors only, 0.673 (95% confidence interval [CI], 0.623-0.723) vs. AUC after adding postoperative factors, 0.691 (95% CI, 0.639-0.744); p = 0.0013}. Bootstrap resampling method showed that both the models were valid. Conclusion: Risk stratification solely based on preoperative imaging and laboratory factors was not inferior to that based on postoperative histopathologic risk factors in predicting early recurrence after curative resection in within Milan criteria single HCC patients.

한국의 건강한 영아를 대상으로 DTPa-IPV 혼합백신을 접종한 경우와 DTPa 백신과 IPV 백신을 각각 투여하였을 경우의 면역원성, 반응원성 및 안전성 (Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants)

  • 김창휘;차성호;신손문;김천수;최영륜;홍영진;최명재;김광남;허재균;조대선;김성신;이상락;송은송;;옥진주;;;김정수
    • Pediatric Infection and Vaccine
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    • 제17권2호
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    • pp.156-168
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    • 2010
  • 목적 : 디프테리아, 파상풍, 백일해 및 불활화 폴리오 백신인 GlaxoSmithKline Biologicals의 $Infanrix^{TM}$-IPV(DTPa-IPV)를 접종시, 시판되고 있는 DTPa 백신과 IPV 백신을 각각 다른 부위에 동시 접종 했을 때(DTPa+IPV)와의 면역원성과 반응원성을 비교하기 위하여 본 연구를 시행하였다. 방법 : 생후 8-12주의 영아 458명을 무작위 배정하여, 각각 2, 4, 6개월에 DTPa-IPV 혹은 DTPa+IPV를 3회 기초접종 하였다. 면역반응을 확인하기 위하여 백신접종 전과 후에 채혈을 하였다. 반응원성은 각 백신 접종 후 작성된 증상기록카드를 통하여 평가하였다. 결과 : 3차 백신접종 한달 후에, 항-디프테리아, 항-파상풍 그리고 항-폴리오바이러스 type 1, 2, 3에 대한 혈청 방어율(seroprotection rate)은 ${\geq}99.5%$였고, 두군 모두 백일해 항원에 대한 백신 반응률(vaccine res-ponse rates)은 적어도 98.6% 이상이었다. 두 군간의 비 열등성은 사전 정의된 통계적 기준에 따라 보여주었다. 국소증상과 전신증상 발생률은 두 군 모두 비슷하게 보고되었고, grade 3의 증상이 DTPa-IPV 투여군에서 4.3%, DTPa+IPV 투여군에서는 4.5%로 보고되었다. 두 건의 중대한 이상반응(모두 발열)이 DTPa-IPV 투여 후에 보고되었고, 백신과의 연관성이 있는 것으로 간주되었다. 두 명의 영아는 모두 회복되었다. 결론 : DTPa-IPV 혼합백신은 한국의 소아들에게 기초접종으로 3회 투여시 충분한 면역반응을 보였고, 내약성이 우수했다. DTPa-IPV는 한국 예방접종 스케줄에 편입되어, 기초 접종을 완료하기 위한 접종 회수를 줄일 수 있다.

한의 진단의 추론형식과 실재성 (Inferential Structure and Reality Problem in Diagnosis of Oriental Medicine)

  • 박경모;최승훈;안규석
    • 제3의학
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    • 제2권1호
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    • pp.55-84
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    • 1997
  • Inferential structure and reality problem is a serious issue to O.M.(oriental medicine). The study will analyze this issue through a philosophical and historical comparative study of W.M.M(Western modern medicine) and O.M. First, I presuppose some basic ideas. The first is the division of the 'the philosophy of medicine' and 'the medicine itself'. Second, there is a 'visibility' that discriminate between 'the abstractive concept' and 'the concrete object' in diagnostic terminology. The third is the separation of disease, the entity and disease, the phenomenon. Finally, the distinction between the cause of disease and the nature of disease. Through these basic concepts, this study will analyze O.M's diagnostic methodology, 'Pattern identification of the S.A.S(sign and symptom)'. The results are follows: 1. O.M's views disease as a phenomenon. So, the S.A.S, which is visible, is the disease itself. Tough the analysis and inference of the S.A.S, 證(zheng) the essence is derived. 2. 證(zheng) can be considered as 'the abstractive concept' reflecting the essence of a disease. 3. 證(zheng) is not arrived through causal sequence reasoning but rather by analogical reasoning. 4. 證(zheng) is 'the non-random correlative combination of S.A.S', pattern. These patterns secure the abstractive deduction in reality. that is, The causality, the positivism, the view of disease as entity, and anatomical knowledge are the traits peculiar to W.M.M. But, these properties can not be applied universally to every medical systems. Also, these properties do not indicate the superiority or inferiority of any medical system. 5. 證(zheng) summarizes the patients condition simultaneously with the S.A.S. However, 證(zheng) doesn't necessarily indicate the knowledge about the actual internal organ. That is, Early in O.M.'s history, the diagnostic terminologies including 證(zheng) were analogical reflections of a naive knowledge of internal organs and external environmental factors. Later, the naive knowledge in 證(zheng) changed int new nature, an abstractive concept. The confusion of the concept of disease, the indiscriminate acceptance of Western anatomical knowledge, and the O.M.'s theoretical evolution et are the challenge facing modern O.M. To find solutions, this study looks at the sequence of the birth of W.M.M. and then compares it's system with the O.M. system. The confusion of the concept of disease, the indiscriminate acceptance of Western anatomical knowledge, and the O.M.'s theoretical evolution et are the challenge facing modern O.M. To find solutions, this study looks at the sequence of the birth of W.M.M. and then compares it's system with the O.M. system. It is recommended that O.M. diagnostics should pay close attention to the ambiguity of the diagnostic methodology in order to further development. At present time, the concept and the system peculiar to O.M. can not be explained by common language. but O.M.'s practitioner can not persist in this manner an: longer. Along with the internal development of O.M., the adjustment of O.M.'s diagnostic terminology needs to be adopted.

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Pasteurella multocida에 대(對)한 간이적혈구(簡易赤血球) 응집반응(凝集反應)과 적혈구(赤血球)의 안정화(安定化)에 관(關)한 연구(硏究) (Studies on the Simplified Hemagglutination Reaction to Pasteurella multocida and the Stabilization of Erythrocytes)

  • 이학철;정영건;김교준
    • 대한수의학회지
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    • 제10권1호
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    • pp.11-23
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    • 1970
  • Recently Carter(1952) reported the capsule antigens of Pasteurella multocida could be divided into four serological types A,B,C and D by means of precipitation tests. Subsequently he showed that the most sensitive for identification of these types involved the use of capsule substance adsorbed by erythrocytes in hemagglutination test. It may be somewhat difficult to conduct the hemagglutination test in small laboratory, because relatively large amounts of antisera and erythrocytes of the human O type are required for the test. A simple method for serological typing of P. multocida was the slide agglutination test employed by Little et al. (1943) and Namioka et al. (1962), but this method is still in controversy. The author tried adapting Carter's hemagglutination method to the slide method so called "micromethod technique", and studied on the stabilization of erythrocytes for use of slide hemagglutination to P. multocida although many invesigators reported the stabilization of erythrocytes. The results obtained are summarized as follows: 1. A simplified method (slide method) for capsule typing of the organism was developed by adapting Carter's hemagglutination reaction(tube method). Antibody-containing serum can be diluted serially on Boerner's microtest slide with capillary or serological pipetts with a considerable accuracy. The slide reaction can be carried out with case on the slide by adding $0.05m{\ell}$ of antigen-sensitized erythrocytes suspension diluted to one percent on $0.05m{\ell}$ of serially diluted antibody-containing sera, and the final result can be read after 60 minutes at the room temperature ($15^{\circ}C$). 2. It is difficult to determine superiority of inferiority between the slide method and the tube method on the pattern of the reaction of hemagglutination. 3. The pH range of 6.6 to 8.3 is optimal for the slide hemagglutination reaction. 4. The antigen-sensitization against erythrocytes at $37^{\circ}C$ is optimal for the slide hemagglutination. 5. Both the doses and concentration of antigen do not influence the antigen-adsorbing capacity of erythrocytes. 6. The reduction of antigen-sensitizing hours does not influence the antigen-adsorbing capacity of erythrocytes even 30 minutes. 7. The tannic acid treatment against formalinized and non-formalinized erythrocytes showed no effect on the reaction of hemagglutination. 8. The erythrocytes preserved at $4^{\circ}C$ in the ACD solution do not decrease the reactivity on the reaction of hemagglutination for 60 days, while they begin slight hemolysis 30 days after preserving. 9. The stable preparation of erythrocytes can be obtained by treating the cells at $37^{\circ}C$ for 20 hours with from 4 to 8 percent of formalin in saline or buffer. These cells can be preserved at $4^{\circ}C$ for more than 8 months experimented without hemolysis. With low concentration of formalin, the cells were not sufficiently stabilized resulting in the hemolysis after short period of preservation at $4^{\circ}C$. 10. The erythrocytes treated with 16 percent of formalin remain constantly or increase the reactivity for the reaction of hemagglutination. On the contrary, the cells treated with I to 8 percent of formalin decrease the reactivity. 11. There is no difference between nontreated fresh erythrocytes and the erythrocytes preserved in the ACD solution on the reactivity against the hemagglutination, and the erythrocytes treated with 16 percent of formalin showed the reactivity of higher level than that of the above two kinds of erythrocytes. 12. There is no difference between the saline and the isotonic buffer solution on the reaction of hemagglutination.

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