“复方苯酚糊剂”配方改进——苯酚最佳含量研究

本研究把“复方苯酚糊剂”配方中苯酚含量从 35%降至25%和15%,进行动物和临床研究,观察输卵管组织变化,术后副反应和绝育效果.家兔实验发现,15%苯酚配方对输卵管粘膜破坏程度和组织反应比25%和35%苯酚配方明显轻.临床研究,15%组458例,25%组498例,随访二年.术后发热率,15%苯酚配方组仅3.7%,25%组 6.83%,有显著差异(P<0.05).腹痛发生率,15%配方组为10.26%,25%组38.35%,两组有显著差异(P<0.05),其他腰痛等副反应发生率都以15%配方组为低.15%和25%两组不同苯酚含量配方组的绝育效果无差异,分别为99.77和99.37.研究结果表明含15%苯酚的“复方苯酚糊剂”,副反应轻微而绝育效果满意,故可定为最佳配方.

输卵管注药绝育术副反应和并发症的近远期观察

采用多中心随机化临床试验,共接纳1705例合格受术对象,其中871例使用复方苯酚糊剂(PAP),834例使用显影苯酚胶浆(PM)。观察结果表明,术后发热率两组分别为8.0％和4.4％,组间差别有统计学意义。发热主要因药物反应所致。两组附件感染率分别为2.3‰和1.2‰。盆腔化学性腹膜炎发生率分别为1.1‰和2.4‰。未见子宫穿孔、盆腔脓肿和宫外孕。术后伴有轻度腹痛者分别占33.6％和30.8％,偶见重度者。腹痛与药物在卵管内充盈的长度和引起的组织反应范围明显有关。腰痛情况与腹痛相似。术后有症状者,多数在短时间内缓解,少数需对症治疗。术后,轻度子宫出血者两组分别为23.2％和18.0％。出血与术时取出节育器明显有关。本术对受术妇女月经无明显影响。五年随访做妇科检查和宫颈细胞学检查无阳性发现,也未查见与绝育药物主要成份有关的潜在疾患。研究表明,本术安全可靠。为进一步降低副反应和并发症的发生,研究机构应着重于现有药物配方的改进,并在保证效果的基础上,尽量减少阿的平含量。主管部门应重新估价这一技术,并加强施术管理和施术者培训,制定全国统一的操作规范,确保服务质量。本术现已得到广泛使用,有很大的发展前景,各界应予更大的关注。

Long-term Safety Observations on Side Effects and Com -plications of Non-surgical Sterilization by Chem ical In-stillation of the Fallopian Tubal

The present objective is to observe the side effects and complications of fem ale tubalsterilization by phenol-atabrinepaste (PAP) and phenolm ucilage (PM). 1 705 eligible w om en w ere divided random ly into tw o groups, 871 usinig PAP and 834 w om en using PM. Results: Thefeverratesw ere8.0and 4.4( P< 0.01 ) respec- tively in group PAP and group PM. Infection rates of the appendages w ere 2.3 and 1.2 respectively. The incidence of chem ical peritonitis, w ithin the lim its of pelvic cavity, w ere 1.1and 2.4respectively. Perforation of uterus, pelvic ab- scessand ectopicpregnancy w ere notfound during thisobservation. Slightabdom inal pain after the proceduresw ere 33.6and 30.8respectively. Slightvaginalbleed- ing after the procedure w as 23.2 and 18.0 respectively. Menstruation of the w om en w as not affected by the instillation. This five-year follow -up study neither show ed a positivePap testnor a potentialdeseasecaused by thesterilizing agents. This technique isa safe and efficientm ethod for fem ale sterilization.

输卵管粘堵绝育术插管失败的相关因素分析

目的探讨影响输卵管粘堵术插管失败的相关因素,更好地指导和帮助育龄妇女选择适合于自身的绝育方法。方法回顾分析本站7年来完成的输卵管粘堵术3780例,分析其年龄、孕产次、分娩方式、既往盆腹腔病史、手术时间、子宫位置、手术次数等因素与输卵管插管结局之间的关系。结果输卵管插管失败比例为4.9%(185/3780)。第2次输卵管粘堵术插管失败比例明显高于第1次,年龄≥35岁的妇女高于年龄<35岁者,孕产次≥4次者高于孕产次<4次者,有剖宫产史者高于无剖宫产史者,有妇科炎症史及盆腹腔手术史者高于既往身体健康者,产后4～6个月者高于产后7～12个月及非哺乳期月经后者,后倾后屈及前倾前屈位子宫者高于后倾位及水平位子宫者,差异均有统计学意义(P<0.01)。结论选择条件适宜的育龄妇女进行输卵管粘堵术,可有效降低失败比例。

A Five-year Follow-up Study on the Efficacy and Safety of Female Tubal Sterilization by Chemical Instillation

A multi center randomized clinical trial was adopted in the present study. 1705 eligible women with identical demographic and gynecological characteristics were divided into two groups: 871 using phenol atabrine paste (PAP) and 834 using phenol mucilage (PM). The five year follow up rates for the two groups were 97.5% and 98.1%, respectively. The multiple decrement life table analysis showed that there was a significant difference in the gross cumulative failure rates between the two groups. The 60th month gross cumulative failure rates for PAP group and PM group were 4.61% and 11.87%, respectively, thus indicating the efficacy of PAP to be significantly higher than that of PM. 97.7% users had cervical smear examinations, but no suspected cancer cells or cancer cells were found. Meanwhile, there was no known diseases related to the chemical reagent. This follow up study indicates that tubal sterilization by chemical instillation is a simple,safe and efficient female method. It suggested that this method would be introduced to a wider use on the basis of modification in the composition of chemical agents, standardized operational procedure, and improved administrative regulation in the use of this technology.

喹喃克林凝胶对大鼠子宫腔堵塞后解剖及组织病理学观察

目的:了解喹喃克林几丁糖凝胶一次性使用对大鼠子宫腔的堵塞作用及子宫组织病理改变。方法:将不同浓度的喹喃克林几丁糖凝胶注入大鼠子宫腔内,并以宫腔注入复方苯酚糊大鼠为对照,解剖和病理切片观察大鼠子宫腔纤维化增生情况及局部和周围组织器官反应变化。结果:大鼠子宫腔内一次性注入35%喹喃克林几丁糖凝胶,4周后宫腔完全被空泡化的基质细胞和成纤维细胞堵塞,6周后宫腔完全被肉芽组织堵塞,阻塞效果与复方苯酚糊组相同。病理解剖结果显示大鼠管腔无局部及邻近组织炎性反应。结论:一次性注入35%浓度的喹喃克林几丁糖凝胶对大鼠子宫腔有明显的阻塞作用,生殖管腔无炎性反应,可作为一种非手术绝育法继续研究。

对乙酰氨基酚及其水解产物在碳糊电极上的电化学行为及同时测定

目的:研究对乙酰氨基酚(ACOP)和对氨基酚(PAP)在碳糊电极上的电化学行为;建立同时测定ACOP和PAP含量的电化学分析新方法。方法:采用循环伏安法研究ACOP和PAP在碳糊电极上的电化学行为,以差示脉冲伏安(DPV)对两者含量进行测定。结果:在pH 6.0磷酸盐缓冲液(PBS)中,ACOP氧化峰电流与其浓度在5.0×10-7～1×10-4mol.L-1范围内呈良好的线性关系,PAP氧化峰电流与其浓度在1.0×10-7～1.0×10-4mol.L-1范围内呈良好的线性关系,检测限分别为1.0×10-7mol.L-1和5.0×10-8mol.L-1。结论:该电极可以对ACOP和PAP进行单独或同时的测定,并用于实际样品对乙酰氨基酚片中对乙酰氨基酚的含量检测。本法操作简单、快速、灵敏、准确,可为对乙酰氨基酚片药物质量的控制和检测提供了一种简便的方法。