• 제목/요약/키워드: Controlled trial

검색결과 1,476건 처리시간 0.042초

천왕보심단(天王補心丹)∘쌀발효추출물(GABAːgamma-aminobutyric acid 30%) 복합물의 항(抗)스트레스에 대한 유효성 연구ː무작위 배정 및 이중맹검 (Study on the Anti-stress Effect of Chenwangbosim-Dan Extract∘Fermented Rice Extract (GABA ː gamma-aminobutyric acid 30%) Complex : A double-blind, randomized, placebo-controlled study)

  • 홍초영;서상권;나승곤;조호성;이미경;진무현;노석선;주영승
    • 대한본초학회지
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    • 제38권2호
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    • pp.1-7
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    • 2023
  • Objectives : From this study, we sight to identify Anti-stress effect of Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex Methods : In order to measure the degree of functional evaluation of tension relief due to stress, it was evaluated whether the psychological indicators VAS(Visual Analog Scale) and POMS(Profile Of Mood State) were improved. Which is generally used for stress measurement and has a high frequency of clinical use. All clinical trial subjects were required to take the drug once a day at 9 ± 30 min in the morning for 2 weeks. Results : After intake, the group that Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had a statistically significant improvement effect compared to before intake due to an improved 30.81% of the VAS scores. The POMS-T score improved 54.13%, the POMS-V score improved 117.5% and the POMS-F score improved 59%, which had a statistically significant effect compared to Placebo group (p<0.001). There is a significant difference between two group, so even considering the placebo effect, the anti stress effect was confirmed in the Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex intake group. Conclusions : The above results showed that the Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had an anti-stress effect. Therefore, it is expected to be developed as a safe and comfortable mental care health functional food that can reduce the risk of drug abuse.

항암제 유발 신경독성을 관리하는 한의학 및 보완대체요법들과 임상시험 현황 (The Present Clinical Studies of Oriental Medicine and CAM Therapies in Chemotherapy-induced Peripheral Neurotoxicity)

  • 박선주;고호연;한유진;고성규;김성훈
    • 대한본초학회지
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    • 제24권4호
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    • pp.205-213
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    • 2009
  • Objectives : Cancer incidence is increasing in all countries and chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing chemotherapeutic agents have been a clinically serious problems. So far therapeutic options for CIPN patients are limited and no confirmed methods have yet been established for dealing with peripheral neuropathy. Therefore this review is to provide an evidence-based summary of oriental medicine and CAM (complementary and alternative medicine) neuroprotective and treatment therapies which have gone through clinical trials. Methods : An overview of the domestic and international papers of adult clinical trials relating management of only CIPN symptoms through 1990 to present were searched by electronic databases. Search key words were chemotherapy-induced neurotoxicity, chemotherapy-induced peripheral neuropathy, chemotherapy toxicity & herb, chemotherapy toxicity & acupuncture, chemotherapy toxicity & CAM. Only English and Korean written papers were reviewed. Total 25 papers were reviewed in this study, 18 papers were retrieved by electronic search. Results : Clinical studies of managing CIPN were rare, two acupuncture clinical studies and four herb medicinal studies were found. Rest of 19 papers were about other CAM clinical studies. Total 25 papers were analyzed, and all interventions were focused on their pain control efficacy. Other 24 trials of potential therapies except one proved to be effective for CIPN, however some described to be inadequate positive or sufficient negative. Conclusions : As most of the studies were pilot studies, interventions for the prevention and treatment of CIPN have to go through prospective confirmatory studies, such as larger scale randomized, double-blinded, placebo controlled clinical trials must be done for the safe and effective use of proposed therapies. Also standard measurement scales have to be developed for the better clinical study of CIPN.

한랭 두드러기에 대한 한약 치료: 체계적 문헌 고찰 및 메타분석 (Herbal Medicine Treatment for Cold Urticaria: A Systematic Review and Meta-Analysis)

  • 김혜나;오정화;윤화정
    • 한방안이비인후피부과학회지
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    • 제36권4호
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    • pp.122-144
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    • 2023
  • Objectives : The purpose of this study is to evaluate the effects of herbal medicine treatment in patients with cold urticaria. Methods : We searched randomized controlled trials(RCTs) reporting the effects of herbal medicine for cold urticaria through domestic and international databases from their inception to September 2023. The results were summarized in tables. We assessed the risk of bias in included RCTs through Cochrane risk of bias tool and the data synthesis was conducted through RevMan version 5.4. Results : A total of 12 RCTs were included in this review and all trials compared herbal medicine alone treatment(treatment group) with western medicine alone treatment(control group). The total effective rate(TER) of treatment group was statistically higher than that of control group(RR: 1.49, 95% CI: 1.38 to 1.62, p<0.00001, I2=65%). On the other hand, when comparing except for 1 trial with different evaluation period, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.36, 95% CI: 1.26 to 1.47, p<0.00001, I2=0%). And when comparing 8 trials using the total symptom score(TSS) change index as an indicator of TER, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.38, 95% CI: 1.26 to 1.51, p<0.00001, I2=0%). The treatment group showed more statistically significant decrease compared to the control group in TSS(MD: -2.51, 95% CI: -2.63 to -2.40, p<0.00001, I2=99%). The relapse rate of treatment group was statistically lower than that of control group(RR: 0.19, 95% CI: 0.10 to 0.40, p<0.00001, I2=0%). Mild adverse events such as sleepiness, dizziness were reported in control group and gastric discomfort was reported in treatment group. In the risk of bias assessment, many cases were evaluated as 'Unclear risk'. Conclusions : This review found that herbal medicine alone treatment could more effective and safe than western medicine alone treatment for cold urticaria. But further well-designed researches are needed because of heterogeneity between trials and the quality of the included trials.

Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales

  • Hyuk Sung Kwon;Seong-Ho Koh;Seong Hye Choi;Jee Hyang Jeong;Hae Ri Na;Chan Nyoung Lee;YoungSoon Yang;Ae Young Lee;Jae-Hong Lee;Kyung Won Park;Hyun Jeong Han;Byeong C. Kim;Jinse Park;Jee-Young Lee;Kyu-Yong Lee;Sangjae Kim
    • 대한치매학회지
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    • 제22권3호
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    • pp.100-108
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    • 2023
  • Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

위암 수술 후 항암치료를 병행한 한의치료의 유효성 및 안전성: 체계적 문헌고찰 및 메타분석 프로토콜 (Efficacy and Safety of Combination Treatment of Traditional Korean Medicine after Gastric Cancer Surgery: A Systematic Review and Meta-analysis Protocol)

  • 김종희;곽은빈;박소정;김동현;김수담;박지혜;유화승
    • 대한한의학방제학회지
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    • 제31권4호
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    • pp.361-371
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    • 2023
  • Objectives : Gastric cancer is a malignant tumor of the digestive tract that not only has a high mortality rate, but also affects quality of life. In Traditional Korean Medicine, acupuncture and herbal medicines can increase the survival rate for Gastric cancer and improve the quality of life. Traditional Korean Medicine treatment played an important role when used alone or in combination with chemotherapy. However, there is still insufficient evidence to support the efficacy and safety of Traditional Korean Medicine in patients undergoing chemotherapy after surgery. Therefore, the purpose of this study is to systematically evaluate the effect of oriental medicine treatment on patients as a complementary therapy for Gastric cancer. Methods : 2 researchers will search using EMBASE, Pubmed, CNKI, Cochrane Library, CiNii, KMBASE, KISS, OASIS, RISS, ScienceON. The search period of the database is from inception until June 2022. This study will include a randomized controlled trial of GC for acupuncture and herbal treatment. Primary outcomes include anti-cancer effects. Secondary outcomes evaluate survival rates and improvements in quality of life. The data uses Review Manager Software 5.4. Results : This study will provide a systematic evaluation by synthesizing the anti-cancer effect, survival rate and quality of life of Gastric cancer when Traditional Korean Medicine is combined with chemotherapy. Conclusion : The conclusion of this study will provide a basis for determining whether Traditional Korean Medicine treatment for Gastric cancer treatment is an effective and safe treatment method in clinical practice.

Neuroimaging Assessment of the Therapeutic Mechanism of Acupuncture and Bee Venom Acupuncture in Patients with Idiopathic Parkinson's Disease: A Double-blind Randomized Controlled Trial

  • Young-Eun Lee;Seung-Yeon Cho;Han-Gyul Lee;Seungwon Kwon;Woo-Sang Jung;Sang-Kwan Moon;Jung-Mi Park;Chang-Nam Ko;Seong-Uk Park
    • 대한한의학회지
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    • 제44권4호
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    • pp.104-120
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    • 2023
  • Objectives: The purpose of this study was to explore the therapeutic mechanism of acupuncture and bee venom acupuncture (BVA) in patients with idiopathic Parkinson's disease (IPD) using positron emission tomography (PET) and arterial spin labeling (ASL). Methods: Patients with IPD who received a stable dose of anti-parkinsonian medication for at least 4 weeks were recruited and randomly divided into one of two groups: treatment and control. The treatment group (11 subjects) received acupuncture and BVA at acupoints, and the control group (9 subjects) received sham acupuncture and normal saline injections at non-acupoints, twice per week for 12 weeks. The patients were examined using PET and ASL at baseline and after the 12-week treatment. In addition, age- and sex-matched healthy subjects without neurological symptoms and history were recruited to compare ASL data of patients with IPD. Results: PET results revealed that striatal dopamine transporter binding increased in each group after 12 weeks. Although the change was larger in the treatment group, the difference was not statistically significant. In ASL results, the treatment group exhibited hyperperfusion in specific regions compared with the healthy control group. After 12 weeks' intervention, hyperperfusion regions were recovered only in the treatment group. In contrast, significant changes were not found in hyperperfusion regions in the control group after 12 weeks. Conclusions: Our findings suggest that the therapeutic mechanisms of acupuncture and BVA in IPD are different from placebo and operate by altering dopamine availability and recovering hyperactivity in cerebral blood flow.

Effect of cryoanesthesia and sweet tasting solution in reducing injection pain in pediatric patients aged 7-10 years: a randomized controlled trial

  • Shital Kiran Davangere Padmanabh;Vishakha Bhausaheb Gangurde;Vikram Jhamb;Nasrin Gori
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제24권1호
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    • pp.37-45
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    • 2024
  • Background: The delivery of profound local anesthetics helps children receive successful treatment by reducing fear, anxiety, and discomfort during dental procedures. Local anesthetic injections are the most anticipated stimuli in dental surgery. Children's perceptions of pain can be altered by applying cryotherapy to precool the oral mucosa or by diverting their minds through taste distractions before administering local anesthetic injections. This study aimed to evaluate the efficacy of cryoanesthesia and xylitol sweet-tasting solution at the injection site in 7-10-year-old children. Methods: A total of 42 participants, aged 7-10 years, who underwent dental treatment requiring local anesthesia, were enrolled in the study. The children were randomly divided into three groups. In group I, sterile water was held in the mouth for 2 minutes before anesthetic administration, similar to group II, and in group III, a xylitol sweet-tasting solution was used for 2 minutes before needle insertion. The analysis of pain perception was carried out based on the Visual Analog Scale (VAS) and the Sound, Eyes, and Motor (SEM) scale. For VAS analysis, a one-way analysis of variance (ANOVA) was performed for intergroup comparison, and a post hoc Tukey test was performed for subgroup analysis. For the categorical SEM scale, the Kruskal-Wallis test followed by the post hoc test was performed for intergroup comparison. Where a P value of <0.05 was considered statistically significant at 95% confidence intervals. Results: Cryoanesthesia significantly reduced pain scores on VAS (4.21 ± 1.42) when compared to those on VAS with xylitol sweet-tasting solution (5.50 ± 1.40) and that with sterile water (6.14 ± 2.47). Intergroup comparison of the VAS scores among the three groups was performed using one-way ANOVA, which demonstrated statistically significant differences (P value <0.026) on the VAS scale. Intergroup comparison of the SEM scale was performed using the Kruskal-Wallis test, followed by post hoc comparison, which exhibited statistically significant differences (P < 0.007) among the three groups for the SEM scale. Conclusion: Cryoanesthesia demonstrated higher efficacy in reducing injection pain than that exhibited by the xylitol sweet-tasting solution.

임신 중 벨 마비 한방치료에 대한 국내외 증례 연구 고찰 (A Review of Clinical Research Trends on Korean Medicine Treatment for Bell's Palsy during Pregnancy)

  • 김효정;안영태;현지수;최소연;김백준;이윤재
    • 대한한방부인과학회지
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    • 제37권3호
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    • pp.1-19
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    • 2024
  • Objectives: The purpose of this study is to analysis the clinical study trends on Korean Medicine treatment for Bell's palsy during pregnancy. Methods: Key words such as 'facial palsy', 'Bell's palsy, 'Korean medicine', 'herbal medicine', 'acupuncture', 'pregnancy' were searched through the 'RISS', 'OASIS', 'KISS', 'PubMed' and 'CNKI' databases. Results: Ten clinical studies with 107 patients were selected, and 1 randomized controlled trial and 9 case reports were included as the target studies. In the 9 case reports, the gestational age at the onset of facial palsy was most common in the third trimester (29-42 weeks) in 38 cases (56.7%). The most commonly used Korean medicine interventions were acupuncture, with the most frequently used acupoints being ST4, ST2, ST6, BL2, TE23, LI20, GB1, GB14, SI18, and CV24. The herbal medicine treatment most commonly utilized was Geumgwedanggwi-san (金匱當歸散), which is related to the principles of clearing heat, nourishing blood, and stabilizing the fetus (淸熱養血安胎). Among the 65 participants evaluated using the House-Brackmann facial nerve grading system, 81.5% showed complete recovery to grade 1, while 6% remained at grade 4 with no effect, indicating the efficacy of Korean medicine treatment for facial palsy during pregnancy. All the selected studies reported no abnormalities in the mothers or fetal growth, and all participants who had the reported delivery had full-term childbirth. Conclusions: The effect on Korean Medicine treatment for Bell's palsy during pregnancy had mostly positive results. However, further large, well-designed clinical trials are needed to establish the foundation of Korean Medicine treatment for Bell's palsy during pregnancy.

지속성 알레르기비염의 비폐색에 대한 침치료의 효과: 무작위배정 대조군 연구 (Effect of Acupuncture on Nasal Obstruction in Patients with Persistent Allergic Rhinitis: A Randomized Controlled Trial)

  • 조정효;홍권의;강위창;최선미;박양춘
    • Journal of Acupuncture Research
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    • 제22권6호
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    • pp.229-239
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    • 2005
  • 목적: 알레르기비염은 이환율이 높은 질환이다. 비폐색은 알레르기비염의 주요 증상으로 수면장애, 우울, 주의력 저하, 기억력 감퇴 등을 유발한다. 비염에 대한 침치료는 문헌에 언급되어 있고 임상에서 많이 사용되지만 잘 디자인된 임상연구는 많지 않다. 본 연구는 알레르기비염환자의 비폐색에 대한 침치료의 효과에 대해 알아보고자 하였다. 방법: 본 연구는 단일맹검, 무작위배정, 대조군연구로 치료혈은 영향(Il20), 상성(GV23), 합곡(IL4)으로 하였고, 유효성 평가는 음향비 강통기도검사를 통한 총비강용적, 총비강최소단면적의 변화로 하였다. 결과: 101명의 피험자가 연구를 종료하였으며 연령, 성별, 체중, 신장, 맥박, 호흡수, 지속성 비염의 중증도, 양성반응을 보인 항원의 수에서 대조군과 침치료군에서 차이는 없었다. 침치료군과 대조군 모두에서 치료직후 총비강용적이 유의성(침치료군: p=0.0007, 대조: p=0.0175)있게 증가하였고, 치료15 분후 침치료군에서 대조군에 비하여 증가된 총비강용적이 경계수준의 유의성(p=0.0871)으로 유지되었다. 침치료군과 대조군 모두에서 치료직후 총비강최소단면적이 유의성(침치료군: p<0.0001, 대조군: p=0.0005)있게 증가하였고, 치료15분후 침치료군에서 대조군에 비하여 증가된 총비강최소단면적이 경계수준의 유의성(p=0.0929)으로 유지되었다. 결론: 지속성 알레르기비염의 비폐색에 대한 침치료는 비강용적과 비강단면적을 증가시켜 비폐색을 완화시키는 효과가 있었으나 지속적인 효과에 대하여는 추가적 연구가 필요하다.

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만성 긴장성 두통 환자에 대한 사암침 치료효과의 Pilot 임상연구 (Effect of Sa-am Acupuncture Method for Chronic Tension-type Headache;A Randomized Controlled Trial)

  • 홍권의;박양춘;조정효;조현경;정인철;강위창;이상봉;최선미
    • Journal of Acupuncture Research
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    • 제24권1호
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    • pp.13-28
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    • 2007
  • Objectives : Clinical character of chronic tension-type headache is bilateral, moderate intensity, persistent and chronic, repeating disease and CTTH is a common prevalent disease, but pathophysiology and likely mechanism remain unclear. It impedes subjective quality of life. The purpose of this research is to examine the effect of sa-am acupuncture method for chronic tension-type headache. Methods : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture for the treatment of chronic tension-type headache. Volunteers who satisfied the requirements were enrolled in study. Evaluation of chronic tension-type headache was measured by VAS and Headache Disability Inventory(HDI), Six point Linkert Scale before and after treatments. Results : 26 subjects finished study. There were not difference between two groups on age, sex, weight, height, blood pressure, pulse, respiratory rate, Byeonjeung, sunrise of treatment. In change of VAS, there were not difference between two groups on before treatment. Before treatment per visit, VAS of 6th and 7th visit were significantly decreased in active acupuncture(each p=0.039, p=0.008) and were not decreased in sham acupuncture. In change of VAS on a withdrawing needling after treatment, VAS of 1st, 2nd, 6th and 7th visit were significantly decreased in active acupuncture (each p=0.001, 0.038, 0.035, 0.008) and VAS of 2nd, 4th and 5th, 6th visit were significantly decreased in sham acupuncture(each p=0.033, 0.032, 0.035, 0.031). In change of VAS on 2hrs after treatment, VAS of 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.014, 0.023, 0.027) and 5th visit were significantly decreased in sham acupuncture(each p=0.004, 0.009). In change of VAS on 4hrs after treatment, VAS of 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.018, 0.011, 0.015) and 5th, 6th visit were significantly decreased in sham acupuncture(each p=0.020, 0.015). In change of VAS on the next day after treatment, VAS of 3th and 4th and 5th, 6th visit were significantly decreased in active acupuncture(each p=0.032, 0.011, 0.005, 0.012) and 4th, 5th visit were significantly decreased in sham acupuncture(each p=0.001, 0.012). In change of VAS according to a current time(before treatment, after a withdrawing needling, 2hrs, 4hrs, the next day), total score of VAS was decreased more active acupuncture group than sham acupuncture group, but there were no statistical significance compared with sham acupuncture group. In change of HDI score, after treatment was decreased than before treatment in two group, but there were no statistical significance compared with two group. In change of Six point Linkert scale score, after treatment was decreased than before treatment in two group on 6th, 7th visit(active acupuncture 6th 7th each p=0.002, 0.003, sham acupuncture 6th 7th each 0.003, 0.009), but there were no statistical significance compared with tow group. Conclusion : Sa-am acupuncture treatment is effective to improve the symptoms and quality of life in patients with chronic tension-type headache.

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