The FLUSH trial--flushing with lipiodol for unexplained (and endometriosis-related) subfertility by hysterosalpingography: a randomized trial

BACKGROUND: To assess the effectiveness of flushing with the oil-soluble contrast medium lipiodol in women with unexplained infertility. METHODS: An open randomized controlled trial design in a single centre secondary and tertiary level infertility service setting. A total of 158 women with unexplained infertility were stratified into two populations: 96 women without confirmed endometriosis and 62 women with endometriosis who had normal Fallopian tubes and ovaries. Randomization was computer-generated, with allocation concealment by opaque sequentially numbered envelopes. Lipiodol flushing was tested versus no intervention. The main outcome measures were clinical pregnancy (assessed at 6 months following randomization) and live birth. RESULTS: Lipiodol flushing resulted in a significant increase in pregnancy [48.0 versus 10.8%, relative risk (RR) 4.44, 95% confidence interval (CI) 1.61-12.21] and live birth (40.0 versus 10.8%, RR 3.70, 95% CI 1.30-10.50) rates versus no intervention for women with endometriosis, although there was no significant difference in pregnancy (33.3 versus 20.8%, RR 1.60, 95% CI 0.81-3.16) or live birth (27.1 versus 14.6%, RR 1.86, 95% CI 0.81-4.25) rates for women with unexplained infertility without confirmed endometriosis. CONCLUSIONS: Lipiodol flushing is an effective treatment for couples with unexplained infertility (based on meta-analysis data), but is particularly effective for women with endometriosis who have normal Fallopian tubes and ovaries.     

富血性肿瘤平阳霉素碘油乳剂栓塞后的病理学研究

探讨富血管性肿瘤平阳霉素碘油乳剂(PIE)靶动脉栓塞后病理学特点及意义。材料与方法对12例PLE 栓塞后肿瘤手术标本多部位取材,观察瘤体病理变化。结果12例标本肿瘤血管血栓形成4例,增生狭窄3例。管壁坏 死残留轮廓5例。瘤组织均发生凝固性坏死,位于中心4例,边缘1例,中心及边缘均有7例。坏死率100％者1例,75％ ～99％8例,50％～74％者1例,25％～49％者2例。肿瘤周边坏死假包膜形成4例。结论PLE具有祛血管作用,可用于 富血管肿瘤经动脉栓塞治疗。     

复合栓塞剂治疗巨大肝海绵状血管瘤的临床价值

目的 评价平阳霉素、碘油、地塞米松混合乳剂对巨大肝海绵状血管瘤介入肝动脉栓塞的疗效.方法 通过对30例巨大肝海绵状血管瘤血管的栓塞治疗,观察其治疗前后的肿瘤大小变化、临床症状的缓解、生存时间、有无副作用.结果 30例病人治疗后症状缓解,肿瘤明显缩小,无严重并发症,生活质量明显改善.结论 复合栓塞剂治疗巨大肝海绵状血管瘤,疗效肯定,安全性好.     

肝动脉栓塞用吡柔比星-碘油微乳的组方筛选及细胞毒作用评价

 目的 研制肝动脉栓塞用吡柔比星-碘油微乳并对其体外抗肿瘤活性进行研究。 方法 采用伪三元相图法研究不同表面活性剂、助表面活性剂和K_m值形成微乳的能力及区域,优选微乳处方,制备吡柔比星-碘油微乳,并对微乳的物理性质、稳定性进行研究;采用MTT法对吡柔比星-碘油微乳体外抗肿瘤活性进行考察。结果 碘化油/大豆磷脂/无水乙醇/水形成的微乳粒径小、黏度低,初步稳定性实验表明,4 ℃下放置药物含量和粒径均无显著变化。MTT实验结果表明,吡柔比星-碘油微乳对人肝癌细胞有明显抑制作用,空白微乳对肝癌细胞HepG-2抑制作用弱。结论 吡柔比星-碘油微乳制备简单,工艺重复性良好,质量稳定,体外抗肿瘤活性较强,为肝动脉栓塞给药剂型的改进提供了依据。     

A novel irinotecan-lipiodol nanoemulsion for intravascular administration: pharmacokinetics and biodistribution in the normal and tumor bearing rat liver

Colorectal cancer is one of the most common cancers in the United States and treatment options are limited for patients who develop liver metastases. Several chemotherapeutic regimens have been used for transvascular liver-directed therapy in the treatment of colorectal liver metastases without clear evidence of superiority of one therapy over another. We describe the development of a novel nanoemulsion through combining irinotecan (IRI), a first line systemic agent used for the treatment of colon cancer, with lipiodol, an oily contrast medium derived from poppy seed oil, and evaluated its pharmacokinetic and biodistribution profile as a function of portal venous chemoembolization (PVCE) versus transarterial chemoembolization (TACE) delivery. The Tessari technique was used to create a stable emulsion (20 mg IRI mixed with 2 mL lipiodol) with resultant particle size ranging from 28.9 nm to 56.4 nm. Pharmacokinetic profile established through venous sampling in Buffalo rats demonstrate that the area under the curve (AUC_0−∞) of IRI was significantly less after PVCE with IRI-lipiodol as compared to IRI alone (131 vs. 316 µg*min/mL, p-value = .023), suggesting significantly higher amounts of IRI retention in the liver with the IRI-lipiodol nanoemulsion via first-pass extraction. Subseqent biodistribution studies in tumor-bearing WAG/Rjj rats revealed more IRI present in the tumor following TACE versus PVCE (29.19 ± 12.33 µg/g versus 3.42 ± 1.62; p-value = .0033) or IV (29.19 ± 12.33 µg/g versus 1.05 ± 0.47; p-value = .0035). The IRI-lipiodol nanoemulsion demonstrated an acceptable hepatotoxicity profile in all routes of administration. In conclusion, the IRI-lipiodol nanoemulsion via TACE showed promise and warrants further investigation as an option for the treatment of metastatic colorectal cancer.     

热碘油联合90Y瘤内注射治疗肝癌的实验研究

目的 探讨热碘油联合^90钇（^90Y）瘤内注射治疗肝癌的安全性和可行性。方法 将40只荷瘤昆明小鼠随机分为A、B、C、D组各10只。A组瘤内注射0．1ml热碘油与0．1ml（100μCi）^90Y混悬液,B组注射0．1ml热碘油;C组注射0．1ml（100μCi）^90Y;D组注射0．1ml生理盐水。A、C组注药后2h、3d、7d、10d、14d在γ相机和ECT扫描仪下观察放射性分布情况。各组在上述时间点抽血查肝、肾功能及血常规,并测肿瘤最大径a和最小径b,计算肿瘤体积及肿瘤生长率．同时取肿瘤组织作病理检查。结果 除肿瘤外,A、C组小鼠其他脏器内均未发现^90Y沉积．病理切片也未显示小鼠其他脏器因^90Y放射损伤所致的病理改变。A、B、C、D组小鼠肝、肾功能及血常规均无变化．未见有心、肺、脾、肾的病理改变及骨储抑制等。注药后第3天起,D组肿瘤生长迅速,生长率在3、7、10、14d时分别为13％、20％、29％、36％．与A组（分别为-11％、-19％、-29％、-38％）、B组（分别为-6％、-9％、-11％、-16％）、C组（分别为-1％、-3％、-6％、-9％）比较．差异均有显著性,P均〈0．01）各时间点A组生长率最低,与其他各组相比,差异有显著性,P均〈0．05）B组也低于C组,差异有显著性,P均〈0．05。D组在3～14d肿瘤坏死范围均未超过30％,A组肿瘤重度坏死率在3、7、10及14d时分别为58％、68％、77％及87％,与B、C、D组比较,差异有显著性,P均〈0．01;B、C、D组坏死率呈降低趋势,且组间差异有显著性,P均〈0．05。结论 热碘油联合^90Y瘤内注射治疗小鼠肝癌安全、有效。     

动脉造影灌注化疗栓塞在恶性骨肿瘤诊断及治疗中的价值

目的：探讨动脉造影灌注化疗栓塞在恶性骨肿瘤诊断及治疗中的价值。并同时为临床骨科择期保肢及截肢创造科学依据,提供有利条件,提高患者生存质量,延长患者生命。方法：将收治的15例恶性骨肿瘤患者行介入治疗,其中6例行单纯动脉造影灌注化疗,9例行动脉造影灌注化疗栓塞,其中6例患者介入术后1周后接受外科手术。观察术后病人临床症状和体征、定期随访。结果：恶性骨肿瘤供血动脉超选择性插管操作成功率100％,动脉造影病变范围明显大于X光、CT、MRI诊断范围,肿瘤血管消失,供血动脉闭塞,临床症状明显缓解,未出现严重的栓塞综合征反应及并发症。结论：动脉造影灌注化疗栓塞术是诊断及治疗恶性骨肿瘤的有效方法,诊断范围更明确,疗效显著,可作为恶性骨肿瘤诊断及术前新辅助化疗的一种可行性方式。     

The clinical efficacy of percutaneous ethanol-lipiodol injection (PEI) combined with high-intensity focused ultrasound (HIFU) for small hepatocellularcarcinoma in special or high-risk locations

Objective The objective of this study was to explore the short-term effects and postoperative complications of ultrasound-guided percutaneous ethanol-lipiodol injection (PEI) combined with high-intensity focused ultrasound (HIFU) for the treatment of small hepatocellular carcinoma in a special or high-risk location. Methods Forty patients with small liver cancer in a special or high-risk location were randomly divided into two groups: 20 patients were treated with PEI combined with HIFU (P + H group), and 20 patients were treated with HIFU alone (H group). There were no significant differences in average age, liver function, tumor location, tumor number, or tumor size between the two groups (P > 0.05). Results Significant differences were observed in ablation parameters between the two groups (P < 0.05). Under the same power, ablation rates of the P + H group were significantly higher than those in the H group, and postoperative complications in the P + H group were significantly lower than those in the H group (P < 0.05). Conclusion The combination of PEI and HIFU has better clinical value than HIFU alone for small-cell liver cancer in special or high-risk locations.     

肾癌介入治疗明胶海绵与碘油临床应用研究

目的对明胶海绵和碘油在肾癌介入治疗中的应用比较研究.方法搜集28例中晚期肾癌,其中肾癌26例,2例为肾转移癌,I期2例,Ⅱ期23例,Ⅲ期2例,Ⅳ期1例.选择性肾动脉插管造影确认肿瘤供血动脉,分别在肾动脉主干或超选择肿瘤血管支行明胶海绵与碘油化疗栓塞术治疗.结果明胶海绵栓塞组12例,均在肾动脉主干或超选择栓塞;碘油栓塞组26例,超选择栓塞14例,主干栓塞2例,副肾动脉栓塞2例.碘油栓塞组的有效率(CR PR)显著高于明胶海绵栓塞组织(68.8%:41.2%,P＜0.05).碘油栓塞组并发症发生率也显著高于明胶海绵组(25%:8.3%,P＜0.05),采用超选择性肿瘤血管内化疗栓塞者无并发症发生.结论碘油化疗栓塞治疗肾癌的近期疗效优于明胶海绵化疗栓塞术.明胶海绵化疗栓塞术较为安全,但疗效欠佳,肾癌治疗应采用两种栓塞剂同时应用,对大部分肿瘤组织坏死起到较好作用,疗效肯定,便于随访观察.