输卵管通而不畅的HSG分级和中医综合治疗
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摘要
世界卫生组织统计我国不孕夫妇占已婚人群的10%左右。近年来随着性观念和环境的改变,不孕的发生率有逐年增加的趋势,其中,输卵管因素不孕为女性不孕的首要原因,约占67%。输输卵管阻塞直接导致不孕,已引起人们的重视,而输卵管通而不畅并未引起医生和患者的足够重视。但是输卵管通而不畅比输卵管阻塞危害更大,输卵管阻塞只是导致不孕,输卵管通而不畅不仅能导致不孕,而且还可以引起异位妊娠,是输卵管输卵管妊娠首位因素,输卵管妊娠约占异位妊娠95%。子宫输卵管造影检查(hysterosalpingography,HSG)已成为女性不孕输卵管首选的筛查方法。HSG诊断输卵管通畅、输卵管中远段阻塞和输卵管积水的诊断敏感度和特异度均较高,而且临床上都有较规范的诊断和治疗方案。目前输卵管通而不畅的HSG影像诊断过于简单,不能准确的反映输卵管的功能状态,致使一些只需要保守治疗患者进行了手术治疗,而且还有一些输卵管功能已丧失没有手术治疗意义的患者也进行了手术。对于通而不畅的输卵管,应该针对输卵管不同功能状态做出更合理诊疗决定,提高不孕患者正常宫内妊娠率,减少异位妊娠率。所以有必要对通而不畅的输卵管进行细化分级。我们通过观察分析HSG输卵管通畅度、柔软度、管腔黏膜、伞端状况、盆腔弥散相的影像学表现并与腹腔镜输卵管的诊疗结果对照,并随访12个月观察妊娠和输卵管通畅情况,将输卵管通而不畅功能损坏程度进行分级研究。
输卵管通而不畅的治疗要综合考虑简单、生殖力、成本效益和患者的依从性等因素。西医对输卵管通而不畅的非手术治疗除输卵管通液治疗外没有其它更好的方法。但是反复通液会破坏输卵管自身的蠕动能力和纤毛的摆动能力,每做一次通液还增加了一次感染的可能。腹腔镜等手术治疗不仅费用昂贵,而且有些手术的效果也不理想。中医治疗输卵管阻塞性不孕有多年经验,而且还取得不错的疗效。借鉴中医治疗输卵管阻塞性不孕经验进行中医综合治疗输卵管通而不畅研究,以期提高输卵管通而不畅患者的宫内妊娠率,降低输卵管妊娠率。
本研究分二部分进行：
一、输卵管通而不畅HSG分级
[目的]
研究输卵管通而不畅HSG分级方法及其临床意义。
[研究方法]
子宫输卵管造影诊断为输卵管通而不畅并妇科行腹腔镜手术后的472例不孕患者子宫输卵管的影像表现和腹腔镜诊疗结果对比分析,并随访12个月观察患者的妊娠情况和输卵管的通畅情况,将输卵管通而不畅按功能损坏程度进行分级。
规范的子宫输卵管造影检查
造影前肌肉注射硫酸阿托品0.5mg。造影剂为水性造影剂：泛影葡胺和欧乃派克。造影时在透视下全程动态观察、摄片。用20ml注射器吸取10ml造影剂,以260ml/小时的速度注射泵自动推注造影剂。注入造影剂前摄下腹部平片,然后再摄子宫颈管相、子宫相、输卵管充盈相、输卵管的粘膜相及弥散相共6张片。造影时主要观察子宫的位置、形态,有无畸形,宫腔有无充盈缺损,宫壁是否光滑等；输卵管的充盈显影速度,输卵管的形态、走行,输卵管有无蠕动及蠕动时输卵管管腔黏膜有无变化；造影剂由输卵管伞端弥散入盆腔的速度和形态,造影剂有无逆流到肌层、血管。
制定输卵管的评价标准：(1)输卵管通畅度的评价标准,(2)输卵管柔软度评价标准,(3)输卵管管腔黏膜的评价标准,(4)输卵管伞端状况评价标准,(5)盆腔弥散情况评价标准五个标准。
腹腔镜诊疗
腹腔镜对输卵管及盆腔情况进行观察,如有病灶做相应处理。手术结束前,进行输卵管通畅性检查并预防粘连处理。制定腹腔镜下输卵管通畅度判断标准、粘连紧密度和粘连的分度、输卵管积水评价标准、输卵管评分标准等。
影像阅片图片有两位副主任医师以上医师和一位主治医师三位医师共同阅片,影像诊断的最终结果得到三人的共同认可。图像的观察分析子宫颈、子宫、输卵管和盆腔等状况,观察输卵管通畅度、柔软度、管腔黏膜、伞端状况、盆腔弥散等情况,重点观察分析输卵管管腔黏膜、柔软度、伞端状况。
随访观察项目腹腔镜术后随访12个月,记录B型超声和β-hCG诊断宫内妊娠或异位妊娠情况；未妊娠者术后随访12个月再次复查子宫输卵管造影观察输卵管通畅情况。
统计学分析用SPSS13.0统计软件包进行分析,以P<0.05为有显著性意义。分类资料用χ2检验或精确概率法,组间的多重比较采用分割法,α’=0.05/4。
[结果]
Ⅰ级影像学表现：(1)输卵管通畅度：造影剂进入输卵管、从伞端溢出基本流畅；(2)柔软度：输卵管壁光滑、柔软,近呈自然流线型；输卵管的走行和位置有一定的变化；(3)管腔黏膜：黏膜形态、结构正常,有收缩和舒张的形态变化；(4)伞端状况：伞端有造影剂溢出,伞端显影清晰、自然、蠕动；(5)盆腔弥散：输卵管行程有少许造影剂残留影,盆腔内造影剂弥散尚均匀,近呈云雾状；
随访12个月Ⅰ级宫内妊娠84例,宫内正常妊娠率56.8%(84/148)；输卵管妊娠3例,输卵管妊娠率2.0%(3/148)。Ⅰ级61例未妊娠者122条输卵管中有120条输卵管仍通而不畅,通畅率98.4%(120/122)；有2条输卵管阻塞,阻塞率1.6%(2/122)。
Ⅱ级影像学表现(1)输卵管通畅度：造影剂进出输卵管稍显缓慢,双侧输卵管各部显影,有时需加压后造影剂才从伞端溢出；(2)柔软度：输卵管失去自然流线型,输卵管周围有静脉或淋巴逆流；(3)管腔黏膜：黏膜形态、结构尚清,较少有收缩和舒张的形态变化；(4)伞端状况：伞端造影剂溢出较少、显影欠佳；(5)盆腔弥散：输卵管行程有少许造影剂残留影,造影剂达到盆底,部分造影剂不均匀弥散、呈斑片状。
随访12个月Ⅱ级宫内妊娠31例,宫内正常妊娠率19.9%(31/156)；输卵管妊娠16例,输卵管妊娠率10.3%(16/156)。Ⅱ级119例未妊娠者238条输卵管中有194条输卵管仍通而不畅,通畅率81.5%(194/238)；有45条输卵管阻塞,输卵管阻塞率18.5%(44/238)。
Ⅲ级影像学表现(1)输卵管通畅度：输卵管充盈缓慢,双侧输卵管各部显影,密度不均,粗细不一,需加压后造影剂才从伞端溢出；(2)柔软度：管壁形态不规则、增厚或呈僵直状；输卵管的走行和位置固定无变化；(3)管腔黏膜：黏膜结构不清、边缘毛糙,黏膜形态固定,不规则显影,憩室、窦道,黏膜数较少；(4)伞端状况：需加压后造影剂从伞端溢出,伞端形态僵硬、无明显蠕动；(5)盆腔弥散：输卵管行程有少许造影剂残留影,造影剂未达到盆底,不均匀弥散、部分呈团块状。
随访12个月Ⅲ级宫内妊娠23例,宫内正常妊娠率13.7%(23/168)；输卵管妊娠22例,输卵管妊娠率13.1%(22/168)。123例未妊娠者246条输卵管中有174条输卵管仍通而不畅,通畅率70.7%(174/246)；有72条输卵管阻塞,阻塞率29.3%(72/246)。
Ⅰ级和Ⅱ及Ⅲ级间宫内正常妊娠率和输卵管妊娠率比较P<0.05,两组间差异有统计学意义；Ⅱ级和Ⅲ级间宫内正常妊娠率13.7%(23/168)和输卵管妊娠率比较P>0.05,两组间差异没有统计学意义。Ⅰ级和Ⅱ及Ⅲ级间通而不畅率、阻塞率比较P<0.05,两组间差异有统计学意义；Ⅱ级和Ⅲ级间通而不畅率、阻塞率比较P>0.05,两组间差异没有统计学意义。
Ⅰ级影像表现提示输卵管部分黏膜早期的轻微功能性病变,输卵管功能尚好。Ⅱ级影像表现提示输卵管局部有轻度病变,输卵管的生殖功能轻度受损。Ⅲ级影像表现提示输卵管中、重度病变,输卵管的生殖功能受损。
[结论]
输卵管通而不畅的HSG的3级分级法可以显示输卵管的功能受损程度,能为临床医师制定诊疗方案提供较为客观、可靠的参考指标。
二输卵管通而不畅的中医综合治疗
[目的]
研究中医综合疗法治疗输卵管通而不畅的临床疗效。
[研究方法]
输卵管通而不畅就诊的不孕患者661例,按输卵管通而不畅的三级分类法分三个级别。三个级别每个级别内均分中医综合治疗组、西医治疗组和对照组三组。(1)中医治疗组给予个性化辩证施治的中药内服、外敷小腹的外敷方和灌肠方进行中医综合治疗。内服药、外敷方和灌肠方均是连续运用10天为1疗程,每疗程均是在月经干净2天后开始连续运用,连续运用3个疗程。(2)西医治疗组进行输卵管通液治疗。通液的混合溶液包括庆大霉素8万单位、地塞米松2.5mg、透明质酸酶1500U、0.5%利多卡因2ml。每月隔日1次,连续3次,为一疗程,连续运用3个疗程。(3)对照组未做任何治疗。
随访观察项目腹腔镜术后随访12个月,记录B型超声和β-hCG诊断宫内妊娠或异位妊娠情况；未妊娠者术后随访12个月再次复查子宫输卵管造影观察输卵管通畅情况。
统计学分析用SPSS13.0统计软件包进行分析,以P<0.05为有显著性意义。分类资料用χ2检验或精确概率法,组间的多重比较采用分割法,α'=0.05/4。
[结果]
Ⅰ级中医治疗组宫内妊娠78例,宫内正常妊娠率68.4%(78/114)；1例输卵管妊娠,输卵管妊娠率0.9%(1/114)。随访12个月输卵管通而不畅率100%,无输卵管阻塞。Ⅰ级西医治疗组宫内妊娠26例,宫内正常妊娠率54.2%(32/59)；输卵管妊娠2例,输卵管妊娠率3.3%(2/59)。随访12个月输卵管通而不畅率98.0%,输卵管阻塞率2.0%。Ⅰ级对照组宫内妊娠22例,宫内正常妊娠率53.7%(22/41)；输卵管妊娠2例,输卵管妊娠率4.9%(2/41)。随访12个月输卵管通而不畅率91.2%,输卵管阻塞率8.8%。
Ⅱ级中医治疗组宫内妊娠40例,宫内正常妊娠率31.7%(40/126)；输卵管妊娠3例,输卵管妊娠率2.4%(3/126)。随访12个月输卵管通而不畅率95.2%,输卵管阻塞率4.8%。Ⅱ级西医治疗组宫内妊娠15例,宫内正常妊娠率22.1%(15/68)；输卵管妊娠6例,输卵管妊娠率8.8%(6/68)。随访12个月输卵管通而不畅率80.9%,输卵管阻塞率19.1%。Ⅱ级对照组宫内妊娠6例,宫内正常妊娠率17.1%(6/35)；输卵管妊娠4例,输卵管妊娠率11.4%(4/35)。随访12个月输卵管通而不畅率78.0%,输卵管阻塞率22.0%。
Ⅲ级中医治疗组宫内妊娠24例,宫内正常妊娠率20.2%(24/119)；输卵管妊娠3例,输卵管妊娠率2.5%(3/119)。随访12个月输卵管通而不畅率93.5%,输卵管阻塞率6.5%。Ⅲ级西医治疗组宫内妊娠9例,宫内正常妊娠率13.4%(9/67)；输卵管妊娠8例,输卵管妊娠率11.9%(8/67)。随访12个月输卵管通而不畅率72.0%,输卵管阻塞率28.0%。Ⅲ级对照组宫内妊娠4例,宫内正常妊娠率12.5%(4/32)；输卵管妊娠5例,输卵管妊娠率15.6%(5/32)。随访12个月输卵管通而不畅率65.2%,输卵管阻塞率34.8%。
Ⅰ级和Ⅱ级、Ⅰ级和Ⅲ级级间中医治疗组、西医治疗组和对照组间宫内妊娠率、输卵管妊娠率、输卵管通而不畅率和输卵管阻塞率两两比较P<0.05,两组间差异有统计学意义。Ⅱ级和Ⅲ级级间中医治疗组、西医治疗组和对照组间宫内妊娠率、输卵管妊娠率、输卵管通而不畅率和输卵管阻塞率两两比较P>0.05,两组间差异无统计学意义。Ⅰ级、Ⅱ级和Ⅲ级三级内各中医治疗组和西医治疗组、各中医治疗组和对照组间宫内宫内妊娠率、输卵管妊娠率、输卵管通而不畅率和输卵管阻塞率两两比较P<0.05,两组间差异有统计学意义。Ⅰ级、Ⅱ级和Ⅲ级三级内个西医治疗组和各对照组间宫内妊娠率、输卵管妊娠率、输卵管通而不畅率和输卵管阻塞率两两比较P>0.05,两组间差异无统计学意义。
中医综合治疗Ⅰ级输卵管通而不畅有很好疗效,不建议手术治疗。Ⅱ级输卵管通而不畅中医综合治疗有一定疗效。Ⅲ级输卵管通而不畅中医综合治疗疗效稍差。中医综合治疗可以缩短疗程,提高疗效,提高不孕患者正常宫内妊娠率和输卵管的通畅率,减低输卵管妊娠率和阻塞率。
[结论]
中医综合治疗可以提高各级输卵管通而不畅不孕者宫内妊娠率和输卵管的通畅率,降低输卵管妊娠率和阻塞率。
World Health Organization (WHO)statistics about10%of couples experience infertility in China. In recent years, along with sex concept and the environment change, the rate of infertility has increased year by year.Tubal factor infertility accounts about67%of female infertility.Oviduct blockag has attracted people's attention by leading to infertility. Incomplete patency oviduct can not only lead to infertility, but also can cause ectopic pregnancy. Tubal ectopic pregnancy accounts about95%ectopic pregnancy. Hysterosalpingography (HSG) has become the preferred method for screening of female infertility fallopian tube. At present, tubal and HSG imaging diagnosis of incomplete patency oviduct is too simple, does not accurately reflect the tubal function. Some patients were unfitly treated by operation. Diagnosis of incomplete patency oviduct should reflect the different function of fallopian tube for making more reasonable treatment decisions, improving the normal intrauterine pregnancy rate of infertility patients, reduce the ectopic pregnancy rate. We observed through analysis of HSG tubal pliability, intratubal mucosa, patency and adhesion in distal or pelvic and compare with the results of laparoscopic of incomplete patency oviduct.
The treatment of incomplete patency oviduct should consider the simple, fecundity, cost-effective and patient compliance and other factors. But repeatedly pass solution will destroy the ability to swing tubal peristaltic and cilia, every time the chance of infection do a pass liquid. Laparoscopic surgical treatment is not only expensive, but some of the effect of surgery is not ideal. TCM Tubal Infertility has many years of experience, but also made a good effect. TCM Comprehensive treatment of incomplete patency oviduct can improve intrauterine pregnancy, reduce tubal pregnancy rate.
This study is divided into two parts:
These grades of HSG of incomplete patency oviduct
[Objective]
To research the grade method of HSG of incomplete patency oviduct and its clinical significance.
[Method]
472patients with infertility induced by incomplete patency oviduct were divided into three grades according to hysterosalpingography diagnosis and laparoscopic diagnosis.The patients were regularly followed up to observe the patient's pregnancy ratio and tubal patency ratio for12months.
Standard of hysterosalpingography
Hysterosalpingography begin after30minutes injection of atropine sulfate0.5mg. HSG was done by real-time dynamic with automatic injection system. Six films was radiographied at before the injection of contrast agent KUB, cervical canal phase, the uterus phase, tubal filling phase, the tubal mucosal phase and dispersed phase.
Tubal evaluation criteria:(1) the standards of tubal patency,(2)the criteria of tubal pliability,(3) the criteria of tubal lumen mucosa, and (4) the criteria of tubal fimbria status,(5) the criteria of pelvic diffuse.
Laparoscopic diagnosis and treatment Tubal and pelvic were observed and treated by the laparoscopic.Tubal patency checking and prevention of adhesions processing were done by laparoscopic. Laparoscopic tubal patency,indexing adhesions tightness and adhesions, hydrosalpinx evaluation, tubal ratings standards. Image diagnosis Image reports were written by three advanced radiologists, and the final results of the diagnostic imaging has been a common recognition. The observation and analysis of the image of the cervix, uterus, fallopian tubes and pelvic condition, tubal patency, softness, lumen mucosa umbrella side conditions, pelvic dispersion, tubal lumen mucosa, softness, umbrella-side situation were the keys.
The follow-up observation patients were followed up for12months, recording diagnosis of intrauterine pregnancy or ectopic pregnancy; while non-pregnant patients were followed up for tubal patency.
Statistical analysis SPSS13.0statistical package for analysis, significant at P<0.05. Segment information using χ2test or Fisher's exact. Between the two groups for multiple comparisons using the split method.
[Results]
Manifestation of Imaging of the grade Ⅰ:(1) tubal patency:contrast agent enter and outflow smoothly the fallopian tube;(2) tubal pliability:tubal wall smooth, pliability, natural streamlined;(3) lumen mucosa:natural change morphology mucosal;(4) fimbria status:natural peristaltic umbrella;(5) pelvic dispersion:a little residual contrast agent shadow on the tubal trip, evenly cloudy contrast agent dispersion.followed up for12months intrauterine normal pregnancy rate of56.8%(84/148), tubal pregnancy rate of2.0%(3/148). tubal patency rate of98.4%(120/122), blocking rate of1.6%(2/122).
Manifestation of Imaging of the grade Ⅱ:(1) tubal patency:contrast agent enter and outflow slowly the fallopian tube,sometimes pressure fallopian tube contrast agent outflowing from the umbrella;(2)tubal pliability:loss of natural streamlined, peritubal venous or lymphatic countercurrent;(3) lumen mucosa:mucosal morphology, less the morphological changes;(4) fimbria status:a few contrast overflow agents;(5) pelvic dispersion:little residual contrast agent shadow on the tubal trip, contrast agent reaches the pelvic floor, uneven the contrast agent dispersion.followed up for12months intrauterine normal pregnancy rate of19.9%(31/156), tubal pregnancy rate of10.3%(6/156). tubal patency rate of81.5%(194/238), blocking rate of18.5%(44/238).
Manifestation of Imaging of the grade Ⅲ:(1) tubal patency:tubal filling slowly, varying thickness,contrast agent required pressure overflowing from the umbrella;(2)tubal pliability:wall irregular thickening stiff like; position fixed;(3) lumen mucosa:mucosal structure is unclear, rough edges, fixed mucosal morphology, irregular development, diverticulum, sinus, mucosal number less;(4) fimbria Status: need pressure from the umbrella side overflow, the umbrella end morphology stiff;(5) pelvic dispersion:tubal stroke have little residual contrast agent shadow on the tubal trip, contrast agent did not reach the basin bottom, unevenly dispersed, some lumps. followed up for12months intrauterine normal pregnancy rate of13.7%(23/168), tubal pregnancy rate of13.1%(22/168) tubal patency rate of70.7%(174/246), blocking rate of18.5%29.3%(72/246).
Ⅰ and Ⅱ, Ⅰ and Ⅲ grade intrauterine normal pregnancy rate and tubal pregnancy, P<0.0125, a statistically significant difference between the two groups; Ⅱ and Ⅲ the intrauterine normal pregnancy rate and tubal pregnancy rate, P>0.0125, no statistically significant difference between the two groups. Ⅰ and Ⅱ, Ⅰ and Ⅲ grade blocking rate, P<0.0125, a statistically significant difference between the two groups; Ⅱ and grade Ⅲ P>0.0125, the difference between the two groups was not statistically significant.
Grade Ⅰ display slight early mucous functional lesions, good tubal function.Grade Ⅱ display tubal local mild disease, mild impairment of reproductive function of the fallopian tubes.Grade Ⅲ display oviduct severe disease, damage to the reproductive function of the fallopian tube.
[Conclusion]
The grades method of HSG of incomplete patency oviduct can show tubal dysfunction state and provide an important reference for clinical development of treatment programs.
The comprehensive therapy of traditional Chinese Medicine of incomplete patency oviduct
[Objective]
The clinical efficacy of comprehensive therapy of TCM for incomplete patency oviduct.
[Research methods]
661patients with incomplete patency oviduct infertility were divided into three levels according to classification tubal passable. Each grade of the three levels were divided into integrated TCM treatment group, western medicine treatment group and the control group.(1) the comprehensive treatment TCM group were received treatment of Chinese herbs by oral,enema and external application. Each month continuous use for10days as a course of treatment, continuous use of the three courses.(2) Western medicine treatment group Perfuse the mixed the drugs, including gentamicin80,000units, dexamethasone2.5mg hyaluronidase1500U, lidocaine. Monthly three times in a row as a course, continuous use of the three courses.(3) the control group without any treatment.
The follow-up12months, recording intrauterine pregnancy, ectopic pregnancy, tubal patency.
Statistical analysis SPSS13.0statistical package for analysis, significant at P<0.05. Segment information using χ2test or Fisher's exact. Between the two groups for multiple comparisons using the split method.
[Results]
The grade Ⅰ intrauterine pregnancy TCM group78cases, intrauterine normal pregnancy rate was68.4%(78/114); cases of tubal pregnancy,tubal pregnancy rate was0.9%(1/114). Follow-up of12months tubal patencyr rate of100%, no tubal reobstruction. Western medicine treatment of intrauterine pregnancy the intrauterine normal pregnancy rate was54.2%(32/59); tubal pregnancy rate was3.3%(2/59). Follow-up of12months tubal tubal patencyr rate of98.0%, tubal reocclusion rate of2.0%. control group of intrauterine pregnancy of intrauterine normal pregnancy rate of53.7%(22/41); tubal pregnancy rate was4.9%(2/41). Follow-up of12months tubal patency of91.2%, tubal reocclusion rate of8.8%.
The grade Ⅱ TCM treatment group intrauterine intrauterine normal pregnancy rate of31.7%(40/126); tubal pregnancy rate was2.4%(3/126). Follow-up of12months tubal poor rate of95.2%, tubal reocclusion rate of4.8%. Western medicine treatment group intrauterine normal pregnancy rate of22.1%(15/68); tubal pregnancy six cases, tubal pregnancy rate of8.8%(6/68). tubal patency rate of80.9%, tubal reocclusion rate of19.1%. control group intrauterine normal pregnancy rate was17.1%(6/35); tubal pregnancy rate was11.4%(4/35), tubal patency rate of78.0%, tubal reocclusion rate of22.0%.
The grade Ⅲ TCM group intrauterine normal pregnancy rate was20.2%(24/119), tubal pregnancy rate was2.5%(3/119). Follow-up of12months tubal patency rate of93.5%, tubal reocclusion rate of6.5%. Western medicine treatment the intrauterine normal pregnancy rate of13.4%(9/67), tubal pregnancy rate was11.9%(8/67), tubal patency rate of72.0%, tubal reocclusion rate of28.0%. control group of intrauterine pregnancy rate was12.5%(4/32), tubal pregnancy rate was15.6%(5/32), tubal patency rate of65.2%, tubal reocclusion rate of34.8%.
Ⅰ and Ⅱ grade intrauterine pregnancy rate, tubal pregnancy rate, tubal poor rate and tubal occlusion rate of TCM group and Western medicine treatment group and the control group Ⅲ grade level pairwise comparisons (P<0.05), The difference between the two groups is statistically significant. Grade Ⅱ and Ⅲ grade TCM group and Western medicine treatment group and the control group compared intrauterine pregnancy rate, tubal pregnancy rate, tubal poor rate and tubal occlusion rate twenty-two P>0.05, no statistical difference between the two groups significance. Ⅰ, Ⅱ and Ⅲ grade three within TCM group and Western medicine treatment group, TCM group and the control group of intrauterine intrauterine pregnancy, tubal pregnancy rate, tubal poor rate and tubal reocclusion rate twenty-two comparison P<0.05, significant difference between the two groups. Grade Ⅰ, Ⅱ stage and grade Ⅲ three intrauterine pregnancy, tubal pregnancy rate, tubal poor rate and tubal occlusion rate within Western medicine treatment group and the control group pairwise comparisons P>0.05, between the two groups was not statistically significance.
Chinese medicine treatment of grade Ⅰ tubal passable have a good effect, does not recommend surgery. Grade Ⅱ tubal poor comprehensive treatment of traditional Chinese medicine has a certain effect. Ⅲ level tubal passable TCM treatment less efficacy. Integrated TCM treatment can shorten the course of treatment, improve efficacy, improve infertility patients with normal intrauterine pregnancy and tubal patency rates, reduce tubal pregnancy rate and reocclusion rate.
[Conclusion]
Integrated TCM treatment can improve all grades of incomplete patency oviduct patient's intrauterine pregnancy and tubal patency rate, reduce tubal pregnancy rate and blocking rate.
输卵管通而不畅的治疗要综合考虑简单、生殖力、成本效益和患者的依从性等因素。西医对输卵管通而不畅的非手术治疗除输卵管通液治疗外没有其它更好的方法。但是反复通液会破坏输卵管自身的蠕动能力和纤毛的摆动能力,每做一次通液还增加了一次感染的可能。腹腔镜等手术治疗不仅费用昂贵,而且有些手术的效果也不理想。中医治疗输卵管阻塞性不孕有多年经验,而且还取得不错的疗效。借鉴中医治疗输卵管阻塞性不孕经验进行中医综合治疗输卵管通而不畅研究,以期提高输卵管通而不畅患者的宫内妊娠率,降低输卵管妊娠率。
本研究分二部分进行：
一、输卵管通而不畅HSG分级
[目的]
研究输卵管通而不畅HSG分级方法及其临床意义。
[研究方法]
子宫输卵管造影诊断为输卵管通而不畅并妇科行腹腔镜手术后的472例不孕患者子宫输卵管的影像表现和腹腔镜诊疗结果对比分析,并随访12个月观察患者的妊娠情况和输卵管的通畅情况,将输卵管通而不畅按功能损坏程度进行分级。
规范的子宫输卵管造影检查
造影前肌肉注射硫酸阿托品0.5mg。造影剂为水性造影剂：泛影葡胺和欧乃派克。造影时在透视下全程动态观察、摄片。用20ml注射器吸取10ml造影剂,以260ml/小时的速度注射泵自动推注造影剂。注入造影剂前摄下腹部平片,然后再摄子宫颈管相、子宫相、输卵管充盈相、输卵管的粘膜相及弥散相共6张片。造影时主要观察子宫的位置、形态,有无畸形,宫腔有无充盈缺损,宫壁是否光滑等；输卵管的充盈显影速度,输卵管的形态、走行,输卵管有无蠕动及蠕动时输卵管管腔黏膜有无变化；造影剂由输卵管伞端弥散入盆腔的速度和形态,造影剂有无逆流到肌层、血管。
制定输卵管的评价标准：(1)输卵管通畅度的评价标准,(2)输卵管柔软度评价标准,(3)输卵管管腔黏膜的评价标准,(4)输卵管伞端状况评价标准,(5)盆腔弥散情况评价标准五个标准。
腹腔镜诊疗
腹腔镜对输卵管及盆腔情况进行观察,如有病灶做相应处理。手术结束前,进行输卵管通畅性检查并预防粘连处理。制定腹腔镜下输卵管通畅度判断标准、粘连紧密度和粘连的分度、输卵管积水评价标准、输卵管评分标准等。
影像阅片图片有两位副主任医师以上医师和一位主治医师三位医师共同阅片,影像诊断的最终结果得到三人的共同认可。图像的观察分析子宫颈、子宫、输卵管和盆腔等状况,观察输卵管通畅度、柔软度、管腔黏膜、伞端状况、盆腔弥散等情况,重点观察分析输卵管管腔黏膜、柔软度、伞端状况。
随访观察项目腹腔镜术后随访12个月,记录B型超声和β-hCG诊断宫内妊娠或异位妊娠情况；未妊娠者术后随访12个月再次复查子宫输卵管造影观察输卵管通畅情况。
统计学分析用SPSS13.0统计软件包进行分析,以P<0.05为有显著性意义。分类资料用χ2检验或精确概率法,组间的多重比较采用分割法,α’=0.05/4。
[结果]
Ⅰ级影像学表现：(1)输卵管通畅度：造影剂进入输卵管、从伞端溢出基本流畅；(2)柔软度：输卵管壁光滑、柔软,近呈自然流线型；输卵管的走行和位置有一定的变化；(3)管腔黏膜：黏膜形态、结构正常,有收缩和舒张的形态变化；(4)伞端状况：伞端有造影剂溢出,伞端显影清晰、自然、蠕动；(5)盆腔弥散：输卵管行程有少许造影剂残留影,盆腔内造影剂弥散尚均匀,近呈云雾状；
随访12个月Ⅰ级宫内妊娠84例,宫内正常妊娠率56.8%(84/148)；输卵管妊娠3例,输卵管妊娠率2.0%(3/148)。Ⅰ级61例未妊娠者122条输卵管中有120条输卵管仍通而不畅,通畅率98.4%(120/122)；有2条输卵管阻塞,阻塞率1.6%(2/122)。
Ⅱ级影像学表现(1)输卵管通畅度：造影剂进出输卵管稍显缓慢,双侧输卵管各部显影,有时需加压后造影剂才从伞端溢出；(2)柔软度：输卵管失去自然流线型,输卵管周围有静脉或淋巴逆流；(3)管腔黏膜：黏膜形态、结构尚清,较少有收缩和舒张的形态变化；(4)伞端状况：伞端造影剂溢出较少、显影欠佳；(5)盆腔弥散：输卵管行程有少许造影剂残留影,造影剂达到盆底,部分造影剂不均匀弥散、呈斑片状。
随访12个月Ⅱ级宫内妊娠31例,宫内正常妊娠率19.9%(31/156)；输卵管妊娠16例,输卵管妊娠率10.3%(16/156)。Ⅱ级119例未妊娠者238条输卵管中有194条输卵管仍通而不畅,通畅率81.5%(194/238)；有45条输卵管阻塞,输卵管阻塞率18.5%(44/238)。
Ⅲ级影像学表现(1)输卵管通畅度：输卵管充盈缓慢,双侧输卵管各部显影,密度不均,粗细不一,需加压后造影剂才从伞端溢出；(2)柔软度：管壁形态不规则、增厚或呈僵直状；输卵管的走行和位置固定无变化；(3)管腔黏膜：黏膜结构不清、边缘毛糙,黏膜形态固定,不规则显影,憩室、窦道,黏膜数较少；(4)伞端状况：需加压后造影剂从伞端溢出,伞端形态僵硬、无明显蠕动；(5)盆腔弥散：输卵管行程有少许造影剂残留影,造影剂未达到盆底,不均匀弥散、部分呈团块状。
随访12个月Ⅲ级宫内妊娠23例,宫内正常妊娠率13.7%(23/168)；输卵管妊娠22例,输卵管妊娠率13.1%(22/168)。123例未妊娠者246条输卵管中有174条输卵管仍通而不畅,通畅率70.7%(174/246)；有72条输卵管阻塞,阻塞率29.3%(72/246)。
Ⅰ级和Ⅱ及Ⅲ级间宫内正常妊娠率和输卵管妊娠率比较P<0.05,两组间差异有统计学意义；Ⅱ级和Ⅲ级间宫内正常妊娠率13.7%(23/168)和输卵管妊娠率比较P>0.05,两组间差异没有统计学意义。Ⅰ级和Ⅱ及Ⅲ级间通而不畅率、阻塞率比较P<0.05,两组间差异有统计学意义；Ⅱ级和Ⅲ级间通而不畅率、阻塞率比较P>0.05,两组间差异没有统计学意义。
Ⅰ级影像表现提示输卵管部分黏膜早期的轻微功能性病变,输卵管功能尚好。Ⅱ级影像表现提示输卵管局部有轻度病变,输卵管的生殖功能轻度受损。Ⅲ级影像表现提示输卵管中、重度病变,输卵管的生殖功能受损。
[结论]
输卵管通而不畅的HSG的3级分级法可以显示输卵管的功能受损程度,能为临床医师制定诊疗方案提供较为客观、可靠的参考指标。
二输卵管通而不畅的中医综合治疗
[目的]
研究中医综合疗法治疗输卵管通而不畅的临床疗效。
[研究方法]
输卵管通而不畅就诊的不孕患者661例,按输卵管通而不畅的三级分类法分三个级别。三个级别每个级别内均分中医综合治疗组、西医治疗组和对照组三组。(1)中医治疗组给予个性化辩证施治的中药内服、外敷小腹的外敷方和灌肠方进行中医综合治疗。内服药、外敷方和灌肠方均是连续运用10天为1疗程,每疗程均是在月经干净2天后开始连续运用,连续运用3个疗程。(2)西医治疗组进行输卵管通液治疗。通液的混合溶液包括庆大霉素8万单位、地塞米松2.5mg、透明质酸酶1500U、0.5%利多卡因2ml。每月隔日1次,连续3次,为一疗程,连续运用3个疗程。(3)对照组未做任何治疗。
随访观察项目腹腔镜术后随访12个月,记录B型超声和β-hCG诊断宫内妊娠或异位妊娠情况；未妊娠者术后随访12个月再次复查子宫输卵管造影观察输卵管通畅情况。
统计学分析用SPSS13.0统计软件包进行分析,以P<0.05为有显著性意义。分类资料用χ2检验或精确概率法,组间的多重比较采用分割法,α'=0.05/4。
[结果]
Ⅰ级中医治疗组宫内妊娠78例,宫内正常妊娠率68.4%(78/114)；1例输卵管妊娠,输卵管妊娠率0.9%(1/114)。随访12个月输卵管通而不畅率100%,无输卵管阻塞。Ⅰ级西医治疗组宫内妊娠26例,宫内正常妊娠率54.2%(32/59)；输卵管妊娠2例,输卵管妊娠率3.3%(2/59)。随访12个月输卵管通而不畅率98.0%,输卵管阻塞率2.0%。Ⅰ级对照组宫内妊娠22例,宫内正常妊娠率53.7%(22/41)；输卵管妊娠2例,输卵管妊娠率4.9%(2/41)。随访12个月输卵管通而不畅率91.2%,输卵管阻塞率8.8%。
Ⅱ级中医治疗组宫内妊娠40例,宫内正常妊娠率31.7%(40/126)；输卵管妊娠3例,输卵管妊娠率2.4%(3/126)。随访12个月输卵管通而不畅率95.2%,输卵管阻塞率4.8%。Ⅱ级西医治疗组宫内妊娠15例,宫内正常妊娠率22.1%(15/68)；输卵管妊娠6例,输卵管妊娠率8.8%(6/68)。随访12个月输卵管通而不畅率80.9%,输卵管阻塞率19.1%。Ⅱ级对照组宫内妊娠6例,宫内正常妊娠率17.1%(6/35)；输卵管妊娠4例,输卵管妊娠率11.4%(4/35)。随访12个月输卵管通而不畅率78.0%,输卵管阻塞率22.0%。
Ⅲ级中医治疗组宫内妊娠24例,宫内正常妊娠率20.2%(24/119)；输卵管妊娠3例,输卵管妊娠率2.5%(3/119)。随访12个月输卵管通而不畅率93.5%,输卵管阻塞率6.5%。Ⅲ级西医治疗组宫内妊娠9例,宫内正常妊娠率13.4%(9/67)；输卵管妊娠8例,输卵管妊娠率11.9%(8/67)。随访12个月输卵管通而不畅率72.0%,输卵管阻塞率28.0%。Ⅲ级对照组宫内妊娠4例,宫内正常妊娠率12.5%(4/32)；输卵管妊娠5例,输卵管妊娠率15.6%(5/32)。随访12个月输卵管通而不畅率65.2%,输卵管阻塞率34.8%。
Ⅰ级和Ⅱ级、Ⅰ级和Ⅲ级级间中医治疗组、西医治疗组和对照组间宫内妊娠率、输卵管妊娠率、输卵管通而不畅率和输卵管阻塞率两两比较P<0.05,两组间差异有统计学意义。Ⅱ级和Ⅲ级级间中医治疗组、西医治疗组和对照组间宫内妊娠率、输卵管妊娠率、输卵管通而不畅率和输卵管阻塞率两两比较P>0.05,两组间差异无统计学意义。Ⅰ级、Ⅱ级和Ⅲ级三级内各中医治疗组和西医治疗组、各中医治疗组和对照组间宫内宫内妊娠率、输卵管妊娠率、输卵管通而不畅率和输卵管阻塞率两两比较P<0.05,两组间差异有统计学意义。Ⅰ级、Ⅱ级和Ⅲ级三级内个西医治疗组和各对照组间宫内妊娠率、输卵管妊娠率、输卵管通而不畅率和输卵管阻塞率两两比较P>0.05,两组间差异无统计学意义。
中医综合治疗Ⅰ级输卵管通而不畅有很好疗效,不建议手术治疗。Ⅱ级输卵管通而不畅中医综合治疗有一定疗效。Ⅲ级输卵管通而不畅中医综合治疗疗效稍差。中医综合治疗可以缩短疗程,提高疗效,提高不孕患者正常宫内妊娠率和输卵管的通畅率,减低输卵管妊娠率和阻塞率。
[结论]
中医综合治疗可以提高各级输卵管通而不畅不孕者宫内妊娠率和输卵管的通畅率,降低输卵管妊娠率和阻塞率。
World Health Organization (WHO)statistics about10%of couples experience infertility in China. In recent years, along with sex concept and the environment change, the rate of infertility has increased year by year.Tubal factor infertility accounts about67%of female infertility.Oviduct blockag has attracted people's attention by leading to infertility. Incomplete patency oviduct can not only lead to infertility, but also can cause ectopic pregnancy. Tubal ectopic pregnancy accounts about95%ectopic pregnancy. Hysterosalpingography (HSG) has become the preferred method for screening of female infertility fallopian tube. At present, tubal and HSG imaging diagnosis of incomplete patency oviduct is too simple, does not accurately reflect the tubal function. Some patients were unfitly treated by operation. Diagnosis of incomplete patency oviduct should reflect the different function of fallopian tube for making more reasonable treatment decisions, improving the normal intrauterine pregnancy rate of infertility patients, reduce the ectopic pregnancy rate. We observed through analysis of HSG tubal pliability, intratubal mucosa, patency and adhesion in distal or pelvic and compare with the results of laparoscopic of incomplete patency oviduct.
The treatment of incomplete patency oviduct should consider the simple, fecundity, cost-effective and patient compliance and other factors. But repeatedly pass solution will destroy the ability to swing tubal peristaltic and cilia, every time the chance of infection do a pass liquid. Laparoscopic surgical treatment is not only expensive, but some of the effect of surgery is not ideal. TCM Tubal Infertility has many years of experience, but also made a good effect. TCM Comprehensive treatment of incomplete patency oviduct can improve intrauterine pregnancy, reduce tubal pregnancy rate.
This study is divided into two parts:
These grades of HSG of incomplete patency oviduct
[Objective]
To research the grade method of HSG of incomplete patency oviduct and its clinical significance.
[Method]
472patients with infertility induced by incomplete patency oviduct were divided into three grades according to hysterosalpingography diagnosis and laparoscopic diagnosis.The patients were regularly followed up to observe the patient's pregnancy ratio and tubal patency ratio for12months.
Standard of hysterosalpingography
Hysterosalpingography begin after30minutes injection of atropine sulfate0.5mg. HSG was done by real-time dynamic with automatic injection system. Six films was radiographied at before the injection of contrast agent KUB, cervical canal phase, the uterus phase, tubal filling phase, the tubal mucosal phase and dispersed phase.
Tubal evaluation criteria:(1) the standards of tubal patency,(2)the criteria of tubal pliability,(3) the criteria of tubal lumen mucosa, and (4) the criteria of tubal fimbria status,(5) the criteria of pelvic diffuse.
Laparoscopic diagnosis and treatment Tubal and pelvic were observed and treated by the laparoscopic.Tubal patency checking and prevention of adhesions processing were done by laparoscopic. Laparoscopic tubal patency,indexing adhesions tightness and adhesions, hydrosalpinx evaluation, tubal ratings standards. Image diagnosis Image reports were written by three advanced radiologists, and the final results of the diagnostic imaging has been a common recognition. The observation and analysis of the image of the cervix, uterus, fallopian tubes and pelvic condition, tubal patency, softness, lumen mucosa umbrella side conditions, pelvic dispersion, tubal lumen mucosa, softness, umbrella-side situation were the keys.
The follow-up observation patients were followed up for12months, recording diagnosis of intrauterine pregnancy or ectopic pregnancy; while non-pregnant patients were followed up for tubal patency.
Statistical analysis SPSS13.0statistical package for analysis, significant at P<0.05. Segment information using χ2test or Fisher's exact. Between the two groups for multiple comparisons using the split method.
[Results]
Manifestation of Imaging of the grade Ⅰ:(1) tubal patency:contrast agent enter and outflow smoothly the fallopian tube;(2) tubal pliability:tubal wall smooth, pliability, natural streamlined;(3) lumen mucosa:natural change morphology mucosal;(4) fimbria status:natural peristaltic umbrella;(5) pelvic dispersion:a little residual contrast agent shadow on the tubal trip, evenly cloudy contrast agent dispersion.followed up for12months intrauterine normal pregnancy rate of56.8%(84/148), tubal pregnancy rate of2.0%(3/148). tubal patency rate of98.4%(120/122), blocking rate of1.6%(2/122).
Manifestation of Imaging of the grade Ⅱ:(1) tubal patency:contrast agent enter and outflow slowly the fallopian tube,sometimes pressure fallopian tube contrast agent outflowing from the umbrella;(2)tubal pliability:loss of natural streamlined, peritubal venous or lymphatic countercurrent;(3) lumen mucosa:mucosal morphology, less the morphological changes;(4) fimbria status:a few contrast overflow agents;(5) pelvic dispersion:little residual contrast agent shadow on the tubal trip, contrast agent reaches the pelvic floor, uneven the contrast agent dispersion.followed up for12months intrauterine normal pregnancy rate of19.9%(31/156), tubal pregnancy rate of10.3%(6/156). tubal patency rate of81.5%(194/238), blocking rate of18.5%(44/238).
Manifestation of Imaging of the grade Ⅲ:(1) tubal patency:tubal filling slowly, varying thickness,contrast agent required pressure overflowing from the umbrella;(2)tubal pliability:wall irregular thickening stiff like; position fixed;(3) lumen mucosa:mucosal structure is unclear, rough edges, fixed mucosal morphology, irregular development, diverticulum, sinus, mucosal number less;(4) fimbria Status: need pressure from the umbrella side overflow, the umbrella end morphology stiff;(5) pelvic dispersion:tubal stroke have little residual contrast agent shadow on the tubal trip, contrast agent did not reach the basin bottom, unevenly dispersed, some lumps. followed up for12months intrauterine normal pregnancy rate of13.7%(23/168), tubal pregnancy rate of13.1%(22/168) tubal patency rate of70.7%(174/246), blocking rate of18.5%29.3%(72/246).
Ⅰ and Ⅱ, Ⅰ and Ⅲ grade intrauterine normal pregnancy rate and tubal pregnancy, P<0.0125, a statistically significant difference between the two groups; Ⅱ and Ⅲ the intrauterine normal pregnancy rate and tubal pregnancy rate, P>0.0125, no statistically significant difference between the two groups. Ⅰ and Ⅱ, Ⅰ and Ⅲ grade blocking rate, P<0.0125, a statistically significant difference between the two groups; Ⅱ and grade Ⅲ P>0.0125, the difference between the two groups was not statistically significant.
Grade Ⅰ display slight early mucous functional lesions, good tubal function.Grade Ⅱ display tubal local mild disease, mild impairment of reproductive function of the fallopian tubes.Grade Ⅲ display oviduct severe disease, damage to the reproductive function of the fallopian tube.
[Conclusion]
The grades method of HSG of incomplete patency oviduct can show tubal dysfunction state and provide an important reference for clinical development of treatment programs.
The comprehensive therapy of traditional Chinese Medicine of incomplete patency oviduct
[Objective]
The clinical efficacy of comprehensive therapy of TCM for incomplete patency oviduct.
[Research methods]
661patients with incomplete patency oviduct infertility were divided into three levels according to classification tubal passable. Each grade of the three levels were divided into integrated TCM treatment group, western medicine treatment group and the control group.(1) the comprehensive treatment TCM group were received treatment of Chinese herbs by oral,enema and external application. Each month continuous use for10days as a course of treatment, continuous use of the three courses.(2) Western medicine treatment group Perfuse the mixed the drugs, including gentamicin80,000units, dexamethasone2.5mg hyaluronidase1500U, lidocaine. Monthly three times in a row as a course, continuous use of the three courses.(3) the control group without any treatment.
The follow-up12months, recording intrauterine pregnancy, ectopic pregnancy, tubal patency.
Statistical analysis SPSS13.0statistical package for analysis, significant at P<0.05. Segment information using χ2test or Fisher's exact. Between the two groups for multiple comparisons using the split method.
[Results]
The grade Ⅰ intrauterine pregnancy TCM group78cases, intrauterine normal pregnancy rate was68.4%(78/114); cases of tubal pregnancy,tubal pregnancy rate was0.9%(1/114). Follow-up of12months tubal patencyr rate of100%, no tubal reobstruction. Western medicine treatment of intrauterine pregnancy the intrauterine normal pregnancy rate was54.2%(32/59); tubal pregnancy rate was3.3%(2/59). Follow-up of12months tubal tubal patencyr rate of98.0%, tubal reocclusion rate of2.0%. control group of intrauterine pregnancy of intrauterine normal pregnancy rate of53.7%(22/41); tubal pregnancy rate was4.9%(2/41). Follow-up of12months tubal patency of91.2%, tubal reocclusion rate of8.8%.
The grade Ⅱ TCM treatment group intrauterine intrauterine normal pregnancy rate of31.7%(40/126); tubal pregnancy rate was2.4%(3/126). Follow-up of12months tubal poor rate of95.2%, tubal reocclusion rate of4.8%. Western medicine treatment group intrauterine normal pregnancy rate of22.1%(15/68); tubal pregnancy six cases, tubal pregnancy rate of8.8%(6/68). tubal patency rate of80.9%, tubal reocclusion rate of19.1%. control group intrauterine normal pregnancy rate was17.1%(6/35); tubal pregnancy rate was11.4%(4/35), tubal patency rate of78.0%, tubal reocclusion rate of22.0%.
The grade Ⅲ TCM group intrauterine normal pregnancy rate was20.2%(24/119), tubal pregnancy rate was2.5%(3/119). Follow-up of12months tubal patency rate of93.5%, tubal reocclusion rate of6.5%. Western medicine treatment the intrauterine normal pregnancy rate of13.4%(9/67), tubal pregnancy rate was11.9%(8/67), tubal patency rate of72.0%, tubal reocclusion rate of28.0%. control group of intrauterine pregnancy rate was12.5%(4/32), tubal pregnancy rate was15.6%(5/32), tubal patency rate of65.2%, tubal reocclusion rate of34.8%.
Ⅰ and Ⅱ grade intrauterine pregnancy rate, tubal pregnancy rate, tubal poor rate and tubal occlusion rate of TCM group and Western medicine treatment group and the control group Ⅲ grade level pairwise comparisons (P<0.05), The difference between the two groups is statistically significant. Grade Ⅱ and Ⅲ grade TCM group and Western medicine treatment group and the control group compared intrauterine pregnancy rate, tubal pregnancy rate, tubal poor rate and tubal occlusion rate twenty-two P>0.05, no statistical difference between the two groups significance. Ⅰ, Ⅱ and Ⅲ grade three within TCM group and Western medicine treatment group, TCM group and the control group of intrauterine intrauterine pregnancy, tubal pregnancy rate, tubal poor rate and tubal reocclusion rate twenty-two comparison P<0.05, significant difference between the two groups. Grade Ⅰ, Ⅱ stage and grade Ⅲ three intrauterine pregnancy, tubal pregnancy rate, tubal poor rate and tubal occlusion rate within Western medicine treatment group and the control group pairwise comparisons P>0.05, between the two groups was not statistically significance.
Chinese medicine treatment of grade Ⅰ tubal passable have a good effect, does not recommend surgery. Grade Ⅱ tubal poor comprehensive treatment of traditional Chinese medicine has a certain effect. Ⅲ level tubal passable TCM treatment less efficacy. Integrated TCM treatment can shorten the course of treatment, improve efficacy, improve infertility patients with normal intrauterine pregnancy and tubal patency rates, reduce tubal pregnancy rate and reocclusion rate.
[Conclusion]
Integrated TCM treatment can improve all grades of incomplete patency oviduct patient's intrauterine pregnancy and tubal patency rate, reduce tubal pregnancy rate and blocking rate.
引文
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