Kishida T
Department of Obstetrics and Gynecology, Hokkaido University School of Medicine, Sapporo, Japan.
Hokkaido Igaku Zasshi. 1994 Jul;69(4):913-26.
In the diagnosis of premature rupture of the membranes (PROM) in the mid-trimester of pregnancy, it is often difficult to obtain reliable information from only an analysis of the amniotic fluid, especially in equivocal cases. In cases where we have not been able to obtain a definite diagnosis of PROM by conventional methods including amnioscopy, we have employed the intra-amniotic dye injection method (PSP method) by abdominal amniocentesis. We have established the method to be good for discrimination of high-leak and low-rupture PROM as well as the rupture of the pseudo-amniotic cavity, and have preliminarily reported on the clinical usefulness and safety of the PSP method since 1981. In this study, through examination of 64 equivocal PROM cases, we have investigated the clinical efficacy of the PSP method for cases in their 14th to 33rd week of gestation. The conventional methods showed a correct diagnostic rate of 63.9%-70.5%, in contrast the PSP method had a 100% rate. We have reconfirmed the clinical efficacy of the PSP method. The PSP method has been proven to be a reliable PROM diagnostic method, but employed for a selected doubtful cases. A non-invasive, reliable and rapid method which can be employed in a repeated manner as a bed-side examination, has been needed for many years. Amniotic fluid contains a high concentration of alpha-fetoprotein(AFP), especially in mid-trimester, and undetectable levels are determined in urine, vaginal fluid and seminal fluid. We have developed a new anti-AFP monoclonal antibody kit for PROM diagnosis. In the present study, we investigated the fundamental ability of AFP-test kit and the clinical efficacy of this kit for 71 cases in their 11th to 40th week of gestation with PROM or suspected PROM. The AFP-test kit method showed a correct diagnostic rate of 100%. The reaction time of this kit is approximately 3 minutes. It is a simple and non-invasive test which can be easily carried out repeatedly as a bed-side examination. This study has confirmed the high efficacy of the AFP-test kit as a method of PROM diagnosis.
在妊娠中期诊断胎膜早破（PROM）时，仅通过羊水分析往往难以获得可靠信息，尤其是在难以明确诊断的病例中。对于那些通过包括羊膜镜检查在内的传统方法仍无法明确诊断PROM的病例，我们采用了经腹羊膜腔穿刺的羊膜腔内染料注射法（PSP法）。我们已确定该方法有助于鉴别高渗漏型和低破裂型PROM以及假性羊膜腔破裂，并自1981年以来初步报道了PSP法的临床实用性和安全性。在本研究中，通过对64例可疑PROM病例的检查，我们调查了PSP法对妊娠14至33周病例的临床疗效。传统方法的正确诊断率为63.9% - 70.5%，相比之下，PSP法的诊断率为100%。我们再次证实了PSP法的临床疗效。PSP法已被证明是一种可靠的PROM诊断方法，但仅用于特定的可疑病例。多年来一直需要一种非侵入性、可靠且快速的方法，该方法可以作为床边检查反复使用。羊水中含有高浓度的甲胎蛋白（AFP），尤其是在妊娠中期，而在尿液、阴道分泌物和精液中检测不到AFP。我们开发了一种用于PROM诊断的新型抗AFP单克隆抗体试剂盒。在本研究中，我们调查了AFP检测试剂盒的基本性能以及该试剂盒对71例妊娠11至40周的PROM或疑似PROM病例的临床疗效。AFP检测试剂盒法的正确诊断率为100%。该试剂盒的反应时间约为3分钟。这是一种简单的非侵入性检测方法，可以很容易地作为床边检查反复进行。本研究证实了AFP检测试剂盒作为PROM诊断方法的高效性。
