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A Contractual Study on the Clinical Trial of Medicine (의약품 임상시험의 계약적 일고찰)

  • Song, Young-Min
    • The Korean Society of Law and Medicine
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    • v.12 no.1
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    • pp.257-285
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    • 2011
  • This thesis has studied about the legal characteristic of injection of the trial drug, the position of the pharmaceutical firm as a contractor of the clinical trial, the possibility of compulsory performance of consistent injection of the trial drug, and the damage claim caused in the process of the clinical trial from the viewpoint of protecting the trial subject in the clinical trial. According to court's judgement in the United States, the lawsuit of the trial subject, although the trial subject had expected consistent injections, was dismissed because there was no direct contract between pharmaceutical and trial subject. However, Helsinki Declaration prescribe the medical research as follows. 'All patients who participated in the research should be able to use the best precaution, diagnosis, and treatment proved by the final outcome of the research'. The trial subject is entitled to demand only the pharmaceutical firm which developed and provided the trial drug, and the pharmaceutical firm has the obligation to supply the trial drug to the trial subject. Therefore, it would be not enough to protect the trial subject if the pharmaceutical firm which makes the trial drug is ruled out. In addition, especially, in case the trial drug has a constant effect with the aim of treatment, if the injection of the trial drug is suddenly stopped, the trial subject would not have the benefit of treatment by the trial drug. In this case, the best remedy against the damage is to urge a constant injection of the trial drug. Thus, in certain case, it is reasonable to consider that the pharmaceutical firm has the obligation to supply the trial drug to the trial subject constantly, and it is also necessary to compel it through effective means in case the pharmaceutical firm do not fulfill its obligation to supply the trial drug. However, as an essential prerequisite for the assertion mentioned above, it should be judged under the principle of good faith considering the concrete situation, that is, what roles the pharmaceutical firm has played.

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A Systematic Review of Placenta Pharmacopuncture for Neuropsychiatric Diseases in Practice (자하거 약침의 신경정신과 임상 응용에 관한 체계적 문헌 고찰)

  • Shin, Haegue;Lee, Jae-Hyok;Kang, Hyung Won
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.2
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    • pp.157-180
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    • 2022
  • Objectives: To perform a systematic review of placenta pharmacopuncture for treating neuropsychiatric diseases, focusing on its efficacy and the safety so that evidence on its clinical use could be obtained, thus contributing to further studies. Methods: Through Korean, English, and Chinese databases (OASIS, Korean TK, KISS, RISS, ScienceON, Pubmed, Cochrane, EMBASE, CINAHL, AMED, CNKI, and Wanfang), combinations of keywords (placenta, pharmacopuncture, etc.) were used to select clinical studies published until January 2021 about placenta pharmacopuncture for neuropsychiatric diseases. Interventions included combined treatments. Study design included cases studies, series, and clinical trials. Cohort studies, literature reviews, in vitro and animal experiments were excluded. The primary outcomes involved measurements of symptoms, Visual Analogue Scale, or questionnaires. Data extracted from databases were imported to Endnote X7 to remove duplicates. The quality of the literature was assessed based on CAse REports Guidelines and Cochrane's Risk of Bias (ROB). Results: Twenty-one studies were selected, including ten case reports, three case series, two one-armed clinical trials, one non-randomized clinical trial, and five randomized clinical trials. There were six studies on sleep disorders, five studies on stroke sequela, two on mood disorders, two on enuresis, two on Guillain-Barré syndrome, two on multiple sclerosis, one on neurocognitive disorder, and one on vertigo. The most frequent combined treatment was acupuncture in both the experimental group (n=10) and the control group (n=3). Acupoints were ST36, SP6, BL23, CV4, GB20, GV20, N-HN54, and so on. All studies reported improvement of symptoms. The quality of case studies was relatively high. Assessment of ROBs resulted in low risks. Conclusions: Placenta pharmacopuncture is effective for neuropsychiatric diseases such as sleep disorders, mood disorders, enuresis, and neurocognitive disorders. Regarding insomnia, several studies have reported significant improvements with placenta pharmacopuncture. There was no adverse event associated with placenta pharmacopuncture.

Intermediate-Term Clinical Outcomes after Autologous Osteochondral Transplantation for Lateral Osteochondral Lesions of the Talus (외측 거골 골연골 병변에 대한 자가 골연골 이식술 후의 중기 추시 임상결과)

  • Sung-Hoo Kim;Byung-Ki Cho
    • Journal of Korean Foot and Ankle Society
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    • v.27 no.4
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    • pp.137-143
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    • 2023
  • Purpose: Autologous osteochondral transplantation (AOT) is indicated for patients with a large osteochondral lesion of the talus (OLT), accompanying subchondral cyst, and the failure of bone marrow stimulation (BMS) procedures. Despite the many reports on the clinical results of surgical treatment for medial osteochondral lesions, those of lateral lesions are rare. This paper reports the intermediate-term clinical outcomes after AOT for lateral OLTs. Materials and Methods: Twenty-one patients with lateral OLTs were followed up for at least three years after AOT. The clinical evaluations comprised the Foot and Ankle Outcome Score (FAOS) and Foot and Ankle Ability Measure (FAAM). The radiographic assessment included the irregularity of the articular surface (subchondral plate), the progression of degenerative arthritis, and the changes in talar tilt angle and anterior talar translation. Results: The mean FAOS and FAAM scores improved significantly from 42.1 to 89.5 and 39.5 to 90.6 points, respectively, at the final follow-up (p<0.001). The radiological evaluation revealed two cases (9.5%) of articular step-off ≥2 mm and 1 case (4.8%) of progressive arthritis. The mean talar tilt angle and anterior talar translation improved significantly. As postoperative complications, there was one case of a local wound problem, one case of superficial peroneal nerve injury, and one case of donor site morbidity. At a mean follow-up of 62.3 months, no patient showed a recurrence of instability or required reoperation for OLT. Conclusion: AOT for the lateral OLTs demonstrated satisfactory intermediate-term clinical outcomes, including daily and sports activity abilities. Most OLT could be accessed through lateral ligament division and capsulotomy, and the incidence of iatrogenic complications, such as recurrent sprains or chronic instability, was minimal. AOT appears to be an effective and relatively safe treatment for patients with large lateral osteochondral lesions unresponsive to conservative therapy, with subchondral cysts, or with failed primary BMS.

Primary Non-clear-cell Adenocarcinoma of the Vagina -Report of a Case- (질에 발생한 원발성 비투명세포선암 -1예 보고-)

  • Jee, M.K.;Choi, Y.I.;Yang, K.W.;Kim, B.K.;Kim, S.M.
    • The Korean Journal of Cytopathology
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    • v.1 no.1
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    • pp.103-110
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    • 1990
  • A case of primary non-clear-cell adenocarcinoma of the vagina is reported occurring in a 65-year-old woman without exposure to diethylstilbestrol (DES) in utero. The adenocarcinoma did not appear to be associated with vaginal adenosis. It lacked clear cell component and interestingly composed of columnar epithelial cells of endocervical-type. Cytologically round to oval nuclei revealed one or more small nucleoli and fine granular chromatin pattern. Cytoplasm was plump, faintly basophilic and homogeneously stained. Histologically well differentiated columnar epithelial cells were arranged on trabecular pattern mainly, and also occasional glandular lumina and small solid sheets were found. Mitoses were hardly found.

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Travelers' malaria among foreigners at the Hospital for Tropical Diseases, Bangkok, Thailand - a 6-year review (2000-2005)

  • Piyaphanee Watcharapong;Krudsood Srivicha;Silachamroon Udomsak;Pornpininworakij Karnchana;Danwiwatdecha Phatcharee;Chamnachanan Supat;Wilairatana Polrat;Looareesuwan Sornchai
    • Parasites, Hosts and Diseases
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    • v.44 no.3
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    • pp.229-232
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    • 2006
  • We retrospectively examined the charts of travelers admitted to the Hospital for Tropical Diseases, Bangkok, Thailand, with malaria during the years 2000-2005. Twenty-one cases of malaria were identified, of which 12 (57%) were Plasmodium vivax infections and 9 (43%) were P. falciparum infections. There was one mixed case with vivax and falciparum infection. Only 1 P. falciparum case had complications. All cases were successfully treated with standard antimalarial drugs. Only 3 of the 21 cases were thought to be acquired in Thailand, the rest were regarded to be imported.

Fine Needle Aspiration Cytology of Papillary Carcinoma of the Thyroid with Numerous Multinucleated Giant Cells (다수의 다핵 거대세포를 동반한 갑상선 유두상 암종의 세침흡인 세포학적 소견)

  • Kim, Kyung-Mi;Lee, Kyo-Young;Kang, Chang-Suk;Shim, Sang-In;Kim, Sun-Moo
    • The Korean Journal of Cytopathology
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    • v.4 no.1
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    • pp.62-65
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    • 1993
  • An unusual case of papillary carcinoma of the thyroid revealing numerous multinucleated giant cells in the aspiration biopsy cytology is reported. Papillary carcinoma is the most common malignant neoplasm of the thyroid and is frequently diagnosed by aspiration biopsy cytology. Recently, we experienced a case of papillary carcinoma with many multinucleated giant cells in a 55-year-old woman. The cytologic features are described.

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A clinical case of bovine anemia due to Theileria orientalis group in a non-grazed dairy cow in the upper part of South Korea

  • Espiritu, Hector M.;Lee, Hee-Woon;Lee, Sang-Suk;Cho, Yong-Il
    • Korean Journal of Veterinary Research
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    • v.61 no.4
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    • pp.33.1-33.5
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    • 2021
  • This study reports the detection and genotyping of the first clinical case of bovine anemia due to Theileria orientalis group (BATOG) in non-grazed dairy cow in upper South Korea. Blood and serum tests revealed anemia and hyperbilirubinemia from animal showing clinical symptoms, and later confirmed as piroplasmosis-positive. Follow-up surveillance on the herd revealed 2 asymptomatic cows with anemia. The three animals were confirmed theileriosis-positive and genotyping revealed the clinical and one of the asymptomatic cases have Chitose, while the other has Ikeda genotype. Clinical BATOG cases were rarely reported worldwide, and asymptomatic animals left untreated could serve as parasite reservoir.

Comprehensive Korean Medicine Treatment for Benign Essential Blepharospasm in a Patient Responding Poorly to Botulinum Toxin Treatment

  • Ha, Seojung;Kim, Sung A;Lee, Suji;Choi, Sungwoon;Lee, Sanghoon
    • Journal of Acupuncture Research
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    • v.39 no.1
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    • pp.49-52
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    • 2022
  • Benign essential blepharospasm (BEB) is a condition/disease which involves involuntary muscle contractions causing the eye to repetitively close, making it impossible for the patient to perform daily activities. This study reports Korean medicine treatment of a rare case BEB in a 34-year-old male patient whose symptoms showed minimal improvement following botulinum toxin injection (the standard treatment). Acupuncture, pharmacopuncture, and herbal medicine treatment for 11 days resulted in clinical improvement for all symptoms as assessed by using the Jankovic Rating Scale, Blepharospasm Disability Index, numerical rating scale, duration of spasms lasting more than 1 hour per day, and number of spasms lasting less than 1 minute per day. This case report suggests that comprehensive Korean medicine treatment could be a treatment option for BEB in patients who do not respond well to botulinum toxin injection.

Duplication of the ovarian vein: comprehensive review and case illustration

  • Edward C. Muo;Joe Iwanaga;Lukasz Olewnik;Aaron S. Dumont;R. Shane Tubbs
    • Anatomy and Cell Biology
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    • v.55 no.2
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    • pp.251-254
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    • 2022
  • Variations of the ovarian veins can impact imaging diagnosis, surgical procedures of the region, and can be related to clinical findings such as compression of the ureter. Therefore, a good working knowledge of such variants is important to the clinician who interprets imaging of the posterior abdominopelvic region of women and surgeons who operate in this region. Herein, we present a comprehensive review of duplicated ovarian veins and provide a case illustration.

A Case Report of HBeAg Seroconversion in Chronic Viral Hepatitis B (만성 바이러스성 B형 간염 환자에서 HBeAg이 혈청전환된 1례)

  • Choi, Eun-sol;Kim, Ha-yeon;Bae, Jung-han;Jang, Eun-gyeong;Kim, Young-chul;Lee, Jang-hoon
    • The Journal of Internal Korean Medicine
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    • v.37 no.3
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    • pp.529-538
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    • 2016
  • Objectives: The purpose of this case study is to report the efficacy and safety of treatment with Korean medicine of a patient with HBeAg-positive chronic viral hepatitis B.Methods: The patient took Korean medicine (mainly Injinchunggan-tang-gamibang) from July 20th, 2010, to March 14th, 2016, without any antiviral or interferon therapy. Changes to laboratory records, abdomen ultrasonography, and clinical symptoms were reviewed.Results: The laboratory records showed that AST, ALT, and HBV DNA had decreased to normal ranges, and HBeAg showed seroconversion. Clinical symptoms also improved after taking Korean medicine.Conclusion: The results suggest that treatment with Korean medicine and without antiviral or interferon therapy could be effective for HBeAg-positive chronic hepatitis B.