Belinson J., Qiao Y., Pretorius R., Zhang W., Keaton K., Elson P., Fischer C., Lorincz A., Zahniser D., Wilbur D., Pan Q., Li L., Biscotti C., Dawson A., Li A., Wu L., Ling Y., Ma C. P., Yang X. P.
Department of Gynecology & Obstetrics, The Cleveland Clinic Foundation, Cleveland, Ohio;Cancer Institute/Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China;Department of Gynecologic Oncology and Pelvic Surgery, Kaiser Permanente, Fontana, California;Department of Biostatistics, Cleveland Clinic Foundation, Cleveland, Ohio;Optical Biopsy Tech. LLC, Knoxville, Tennessee;Digene Corporation, Silver Spring, Maryland;Cytyc Corporation, Boxborough, Massachusetts;Neopath Inc., Redmond, Washington;Department of Anatomic Pathology, The Cleveland Clinic Foundation, Cleveland, Ohio;Cancer Hospital, Yangcheng County, Shanxi Province, People's Republic of China; and Women and Children Health Station, Xiangyuan County, Shanxi Province, People's Republic of China.
Int J Gynecol Cancer. 1999 Sep;9(5):411-417. doi: 10.1046/j.1525-1438.1999.99055.x.
For cervical cancer screening to be feasible in developing countries, it must be accurate, inexpensive, and easy to administer. We conducted a pilot study in rural Shanxi Province, People's Republic of China, to determine disease prevalence and study feasibility in preparation for a large-scale comparative trial of 6 screening tests. One-hundred and thirty-six nonpregnant women with no history of hysterectomy, pelvic radiation, or Papanicolaou tests were screened in a rural clinic. Ten percent of the women enrolled reported abnormal vaginal bleeding and 45% reported abnormal vaginal discharge. The tests were the Papanicolaou test (both conventional and ThinPrep), a self-administered swab test by Hybrid Capture II for high-risk human papillomavirus (HPV), a test for high-risk HPV from residual PreservCyt medium, fluorescence spectroscopy, and visual inspection of the cervix by a clinician. All women also underwent colposcopy and biopsies as the reference standard. Biopsies showed 12 of 136 women had >/= high-grade squamous intraepithelial lesions (HGSIL). Screening was completed in 5 half-day sessions, the procedures went smoothly, and local cooperation was enthusiastic. Disease prevalence in Xiangyuan and Yangcheng Counties, Shanxi Province, can be estimated at 8.8% (95% CI, 4.5% to 15.0%). Screening 1000-2000 patients would be sufficient to detect a 10% difference in accuracy between diagnostic tests. The proposed large-scale trial is feasible.
为使宫颈癌筛查在发展中国家可行，它必须准确、廉价且易于实施。我们在中国山西省农村地区进行了一项试点研究，以确定疾病患病率并研究可行性，为6种筛查试验的大规模对比试验做准备。在一家农村诊所对136名无子宫切除史、盆腔放疗史或巴氏试验史的非妊娠妇女进行了筛查。登记的妇女中有10%报告有异常阴道出血，45%报告有异常白带。这些试验包括巴氏试验（传统法和液基薄层制片法）、用第二代杂交捕获法进行的高危型人乳头瘤病毒（HPV）自我采样检测、对剩余的保存液基细胞学培养基进行的高危型HPV检测、荧光光谱检查以及临床医生对宫颈的目视检查。所有妇女还接受了阴道镜检查和活检作为参考标准。活检显示136名妇女中有12名患有≥高级别鳞状上皮内病变（HGSIL）。筛查在5个半天内完成，程序进展顺利，当地合作热情高涨。山西省乡宁县和阳城县的疾病患病率估计为8.8%（95%CI，4.5%至15.0%）。筛查1000 - 2000名患者足以检测出诊断试验之间10%的准确性差异。拟议的大规模试验是可行的。
