明胶海绵栓塞子宫肌瘤对卵巢功能的影响及与PVA疗效对比
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摘要
目的:对比明胶海绵(Gelform)微粒与聚乙烯醇(PVA)颗粒栓塞子宫肌瘤疗效差异及观察明胶海绵微粒用于子宫动脉栓塞术(UAE)后对卵巢功能的影响。
方法:本研究对吉林大学中日联谊医院介入病房2002年至2008年105例以明胶海绵微粒为栓塞剂行UAE治疗的子宫肌瘤患者中完成随访的68例(A组)及吉林省人民医院截止2008年的35例以PVA颗粒行UAE治疗子宫肌瘤中完成随访的26例(B组)的临床资料进行回顾性分析。经统计学分析两组病例一般资料无明显差异(P>0.05)。栓塞材料中A组用明胶海绵微粒(直径500~700μm)为术前自制,高压灭菌后备用,B组用PVA颗粒(直径500μm)为市售。所有病例于UAE前和术后1、3、6个月行超声检查,部分病例同时行MRI检查。影像学检查的同时随访临床症状和月经规律的变化。明胶海绵微粒对卵巢功能的影响选择A组的15例分别于UAE前和术后1个月、3个月于月经中期采血行雌二醇(E2)、孕酮(PROG)、卵泡刺激素(FSH)、黄体生成素(LH)监测。所有数据均采用x±s形式表示,栓塞后综合征发生时间、程度的差异及肌瘤体积的变化均采用双因素方差分析,对于卵巢内分泌功能的影响的数据采用单因素方差分析。
结果:腹痛一般出现于术中～术后1d ,术后当天出现不同程度下腹阵痛及腰骶部坠胀痛,疼痛持续时间1～5d不等,A组为(0.5±1.17) d,B组为(1.80±1.21) d ,疼痛程度为Ⅰ～Ⅲ度,A组患者在疼痛的时间和程度上与B组有显著性差异(P <0.05);两组肌瘤体积均缩小(A组53%、B组54% ),子宫体积均缩小(A组44%、B组47% ),术后超声检查也显示同样结果。UAE术后6个月,所有病例肌瘤直径均缩小超过50%,个别病例肌瘤与子宫界限不清。B超或MRI检查显示,肌瘤体积平均缩小53 %,子宫体积平均缩小43 %;A组的15例患者中,术后1个月PROG、LH略有下降,FSH、E2略上升,而3个月各项指标均正常,分别与其自身UAE前比较,差异均无显著性(P>0.05见表)。1例46岁患者术后1个月出现月经絮乱,3个月恢复正常。
结论:PVA和明胶海绵微粒都是UAE治疗子宫肌瘤的有效栓塞剂,明胶海绵微粒栓塞后引起的副反应及并发症较PVA颗粒轻,两者在临床上的治疗作用无明显差异,单独采用明胶海绵微粒栓塞子宫动脉治疗症状性子宫肌瘤具有良好的近、中期疗效,但其远期疗效尚待进一步观察。明胶海绵颗粒行UAE对45岁以下的妇女卵巢功能没有明显影响,对45岁以上及45岁妇女长期是否有影响尚需大样本统计。明胶海绵微粒作为UAE的栓塞剂以其价格低廉、制作方便、安全有效等特点,有利于临床进一步推广应用。
Uterine myoma is one of the most common diseases among the pregnant women. At home and abroad, it takes the operation as treatment, it is widely expanded by interventional treatment. With the feature of easy operation, small wound, few complications, it is a good way of treating uterine myoma by TUAE through catheter, there is no uniform standard of embolization materials, it is willing to be observing and contradistinguishing through a large of cases.
It is well-known that the most effective embolization material is PVA particles recently, but the price of PVA particles is so high, they are easlily blocking the vascular because of the adhesion of particles, patients feel obviously paining after operation, it is unfavorable to widely used. This research is on comparing of the effort of treating uterine myoma between gelatin sponge particle and PVA particles through TUAE treatment. It is a discussion that it is possible to use gelatin sponge particle instead of PVA particles or not. It is a good way of observing the influence to ovary function by gelatin sponge particle using in arteria uterina embolism technique.
Gelfoam particles as the theory of treating womb cancer
Gelfoam paricles is not the prominent suppository .It is protein glue ,made of much amono acid of non tioxic ,non antigen interventional embolic is from bad necrotizing arteris and it caused acute inflamation and foreign body reaction, gelfoam particles is the function of space truss, promote thrombosis, womb cancer is for the both side of womb artry feeding. The feeding arteries is made of two classes, one is spreeding and bending the well vessels that made of the cancer feedings. It supples blood from the tumor center, the gelfoam particles can be grided and ptomoted blood and it can supple the blood. It isn't usual to have chemotherapy routinely after surgery for early stage womb cancer. The other is the round of canser which could be supplied blood from small artery in the round vascular of canser. They are formed rich vascular of canser by the two kinds of vascular in canser. We have made the turbid liquid of gelatin sponge particle, the particles are relatively uniform, the diameter is between 500μm and 700μm, it can reach the surface of vascular in canser, it is uneasy to be absorbed, it is ensured the effect of the peripheral embolization.
TUAE treatment as the theory of treating womb cancer:①The bilateral uterine artery embolization could directly block the supply of the blood of womb cancer, the leiomyoma cells are low in blood, oxygen, died , absorbed, shrinked the volume and disappeared;②It could block the estrogen into the canser by supplying blood, the degree of estrogen is obviously reduced, it not easy to form a new canser;③The supply of blood is obviously reduced, the growth of endometrial has be controled, the quantity and time of menstruation is obviously reduced, anemia could be improved and restored;④The womb is contained three arteris of blood suppliment (womb artery, ovarian artery and vagina artery) and collateral circulation, the bilateral uterine artery embolization could directly effect the womb cancer by the supply of blood, it couldn’t make the death of womb because of lowing in blood, it maintains the normal physiological functions. It could block the supply of blood to canser when most of the embolization is accumulated in the canser. The normal womb couldn’t die because of the supply of blood through the pelvic blood vessels.
Material and Method:
The research has analysed the clinical materials which are 68 examples of patients (Team A) who are treated by using gelatin sponge particle as TUAE treatment in Sino-Japanese Friendship Hospital Of Jilin University from 2002 to 2008 and 35 examples of patients (Team B) who are treated by using PVA particle as TUAE treatment in the People Hospital until 2008. The age of Team A is between 34-44 years old, average is 39 years old. There are 63 examples of single tumor, the maximum diameter of tumor is 150mm,and there are 6 examples of cancer-prone, 4 tmor at most, the maximum diameter of tumor is 43-95mm; The age of Team B is between 34-44 years old, average is 38 years old. There are 24 examples of single tumor, the maximum diameter of tumor is 130mm,and there are 2 examples of cancer-prone, 4 tmor at most, the maximum diameter of tumor is 45-100mm. There is no obvious difference between the material of two teams according to statistics(P>0.05).
It is used cardiovascular imaging system produced in the USA, Model name:INNOUA2000. Input power is 1KVA, the maximum power is 11KW, the focus size is 0.3/0,6/1,2. The catheter is uterine artery catheter cobra produced by Cook American Company.(REF: HNBR5. 0-35-90-P-NS- RUCC. or cobra catheter).
Surgical methods: The patients should be supine, the puncture point is the most obvious agency which is femoral artery from 1 centimeter of right groin, it also could choose the uterine artery when there is something wrong with puncture point. Anaesthetizing firstly, then piercing of Seldinger, placing the catheter after success. It could use high-pressure syringe, the flow is 4ml/s, total is 8-10ml, pressure is 300-500kPa, there are 2 pictures per second, it could observe the number and size of leiomyoma and the situation of blood supplyment,etc.
ALL of the pacients are cured by TUAE treatment, there is no complications, the success rate of technique is 100%. The gelatin sponge particle (the diameter is 500-700μm)of Team A is made by ourselves before operation, with high-temperature sterilization, the PVA particle (the diameter is 500μm) of Team B is sold in the market.
Phantom study revisitation : All of the patients should be examined by ultrasound before TUAE treatment and 1 month, two monthes ,three months after operation, part of the patients should be examined by MRI, with observing the change of clinical symptoms and menstrual. Estradiol and progesterone have reduced slightly among 15 patients after 1 month of the operation, FSH and LH have increased slightly, each target has appeared normally in 3 months, emission immunity designated object is I 125, the box is provided by Shanghai Biological Production, there is no obvious influence to the function of ovary according to statistics before and after TUAE treatment, with observing the change of clinical symptoms and menstrual. The pain could be divided into several standard according to VRS and observe whether heat or not. 4 Result: the success rate of technique is 100% between Team A and Team B. Abdominal pain is usually happen 1 day after the operation. Pain is continuing 1-5days, A team is (1.5+1.17)days, B team is (1.80-1.21)days, the degree of the pain is I-III ( the patients of I degree are treated by yin duo, the patients of II degree are treated by The strong pain decides, the patients of the III degree are treated by Du Lengding. The time and degree of the pain is obviously different between the patients of A and B team. (P<0.05) The two teams have never appeared obviously different in heating, disgusting, vomit and other responses after the operation such as irregular vagina bleeding, lower limb asthenia and waist acid.(P>0.05) The volume of myoma has obviously different in the first month (P<0.05), but the volume of myoma has reduced less than 20%, there is no clinical meaning. The volume of myoma has no obviously different in the third and sixth month. LH and progesterone have reduced slightly among 15 patients after 1 month of the operation, FSH and Estradiol have increased slightly, each target has appeared normally in 3 months, comparing the UAE of their own before, there is no obviously different (P>0.05) One of the 46-year-old patient has appeared menstruation disorder after 1 month of the operation, he has restored normally in the third month.
Conclusion: It is a treatment method of PVA particle and gelatin sponge particle using in arteria uterina as UAE micro creates, the curative effect is reliable, the security is high, it could retain the womb completely, there is no influence to live and birth later, it is one of the treatment method to instead of the operation of fibroid gradually, there in no obviously different between them, it is feasible to be the material of involvement embolism using gelatin sponge particle, there is no obvious influence to the function of ovary among the women of 45 years old. With the features of low price, easy operation,and reliable effect, gelatin sponge particle could promote widely as a method of UAE.
方法:本研究对吉林大学中日联谊医院介入病房2002年至2008年105例以明胶海绵微粒为栓塞剂行UAE治疗的子宫肌瘤患者中完成随访的68例(A组)及吉林省人民医院截止2008年的35例以PVA颗粒行UAE治疗子宫肌瘤中完成随访的26例(B组)的临床资料进行回顾性分析。经统计学分析两组病例一般资料无明显差异(P>0.05)。栓塞材料中A组用明胶海绵微粒(直径500~700μm)为术前自制,高压灭菌后备用,B组用PVA颗粒(直径500μm)为市售。所有病例于UAE前和术后1、3、6个月行超声检查,部分病例同时行MRI检查。影像学检查的同时随访临床症状和月经规律的变化。明胶海绵微粒对卵巢功能的影响选择A组的15例分别于UAE前和术后1个月、3个月于月经中期采血行雌二醇(E2)、孕酮(PROG)、卵泡刺激素(FSH)、黄体生成素(LH)监测。所有数据均采用x±s形式表示,栓塞后综合征发生时间、程度的差异及肌瘤体积的变化均采用双因素方差分析,对于卵巢内分泌功能的影响的数据采用单因素方差分析。
结果:腹痛一般出现于术中～术后1d ,术后当天出现不同程度下腹阵痛及腰骶部坠胀痛,疼痛持续时间1～5d不等,A组为(0.5±1.17) d,B组为(1.80±1.21) d ,疼痛程度为Ⅰ～Ⅲ度,A组患者在疼痛的时间和程度上与B组有显著性差异(P <0.05);两组肌瘤体积均缩小(A组53%、B组54% ),子宫体积均缩小(A组44%、B组47% ),术后超声检查也显示同样结果。UAE术后6个月,所有病例肌瘤直径均缩小超过50%,个别病例肌瘤与子宫界限不清。B超或MRI检查显示,肌瘤体积平均缩小53 %,子宫体积平均缩小43 %;A组的15例患者中,术后1个月PROG、LH略有下降,FSH、E2略上升,而3个月各项指标均正常,分别与其自身UAE前比较,差异均无显著性(P>0.05见表)。1例46岁患者术后1个月出现月经絮乱,3个月恢复正常。
结论:PVA和明胶海绵微粒都是UAE治疗子宫肌瘤的有效栓塞剂,明胶海绵微粒栓塞后引起的副反应及并发症较PVA颗粒轻,两者在临床上的治疗作用无明显差异,单独采用明胶海绵微粒栓塞子宫动脉治疗症状性子宫肌瘤具有良好的近、中期疗效,但其远期疗效尚待进一步观察。明胶海绵颗粒行UAE对45岁以下的妇女卵巢功能没有明显影响,对45岁以上及45岁妇女长期是否有影响尚需大样本统计。明胶海绵微粒作为UAE的栓塞剂以其价格低廉、制作方便、安全有效等特点,有利于临床进一步推广应用。
Uterine myoma is one of the most common diseases among the pregnant women. At home and abroad, it takes the operation as treatment, it is widely expanded by interventional treatment. With the feature of easy operation, small wound, few complications, it is a good way of treating uterine myoma by TUAE through catheter, there is no uniform standard of embolization materials, it is willing to be observing and contradistinguishing through a large of cases.
It is well-known that the most effective embolization material is PVA particles recently, but the price of PVA particles is so high, they are easlily blocking the vascular because of the adhesion of particles, patients feel obviously paining after operation, it is unfavorable to widely used. This research is on comparing of the effort of treating uterine myoma between gelatin sponge particle and PVA particles through TUAE treatment. It is a discussion that it is possible to use gelatin sponge particle instead of PVA particles or not. It is a good way of observing the influence to ovary function by gelatin sponge particle using in arteria uterina embolism technique.
Gelfoam particles as the theory of treating womb cancer
Gelfoam paricles is not the prominent suppository .It is protein glue ,made of much amono acid of non tioxic ,non antigen interventional embolic is from bad necrotizing arteris and it caused acute inflamation and foreign body reaction, gelfoam particles is the function of space truss, promote thrombosis, womb cancer is for the both side of womb artry feeding. The feeding arteries is made of two classes, one is spreeding and bending the well vessels that made of the cancer feedings. It supples blood from the tumor center, the gelfoam particles can be grided and ptomoted blood and it can supple the blood. It isn't usual to have chemotherapy routinely after surgery for early stage womb cancer. The other is the round of canser which could be supplied blood from small artery in the round vascular of canser. They are formed rich vascular of canser by the two kinds of vascular in canser. We have made the turbid liquid of gelatin sponge particle, the particles are relatively uniform, the diameter is between 500μm and 700μm, it can reach the surface of vascular in canser, it is uneasy to be absorbed, it is ensured the effect of the peripheral embolization.
TUAE treatment as the theory of treating womb cancer:①The bilateral uterine artery embolization could directly block the supply of the blood of womb cancer, the leiomyoma cells are low in blood, oxygen, died , absorbed, shrinked the volume and disappeared;②It could block the estrogen into the canser by supplying blood, the degree of estrogen is obviously reduced, it not easy to form a new canser;③The supply of blood is obviously reduced, the growth of endometrial has be controled, the quantity and time of menstruation is obviously reduced, anemia could be improved and restored;④The womb is contained three arteris of blood suppliment (womb artery, ovarian artery and vagina artery) and collateral circulation, the bilateral uterine artery embolization could directly effect the womb cancer by the supply of blood, it couldn’t make the death of womb because of lowing in blood, it maintains the normal physiological functions. It could block the supply of blood to canser when most of the embolization is accumulated in the canser. The normal womb couldn’t die because of the supply of blood through the pelvic blood vessels.
Material and Method:
The research has analysed the clinical materials which are 68 examples of patients (Team A) who are treated by using gelatin sponge particle as TUAE treatment in Sino-Japanese Friendship Hospital Of Jilin University from 2002 to 2008 and 35 examples of patients (Team B) who are treated by using PVA particle as TUAE treatment in the People Hospital until 2008. The age of Team A is between 34-44 years old, average is 39 years old. There are 63 examples of single tumor, the maximum diameter of tumor is 150mm,and there are 6 examples of cancer-prone, 4 tmor at most, the maximum diameter of tumor is 43-95mm; The age of Team B is between 34-44 years old, average is 38 years old. There are 24 examples of single tumor, the maximum diameter of tumor is 130mm,and there are 2 examples of cancer-prone, 4 tmor at most, the maximum diameter of tumor is 45-100mm. There is no obvious difference between the material of two teams according to statistics(P>0.05).
It is used cardiovascular imaging system produced in the USA, Model name:INNOUA2000. Input power is 1KVA, the maximum power is 11KW, the focus size is 0.3/0,6/1,2. The catheter is uterine artery catheter cobra produced by Cook American Company.(REF: HNBR5. 0-35-90-P-NS- RUCC. or cobra catheter).
Surgical methods: The patients should be supine, the puncture point is the most obvious agency which is femoral artery from 1 centimeter of right groin, it also could choose the uterine artery when there is something wrong with puncture point. Anaesthetizing firstly, then piercing of Seldinger, placing the catheter after success. It could use high-pressure syringe, the flow is 4ml/s, total is 8-10ml, pressure is 300-500kPa, there are 2 pictures per second, it could observe the number and size of leiomyoma and the situation of blood supplyment,etc.
ALL of the pacients are cured by TUAE treatment, there is no complications, the success rate of technique is 100%. The gelatin sponge particle (the diameter is 500-700μm)of Team A is made by ourselves before operation, with high-temperature sterilization, the PVA particle (the diameter is 500μm) of Team B is sold in the market.
Phantom study revisitation : All of the patients should be examined by ultrasound before TUAE treatment and 1 month, two monthes ,three months after operation, part of the patients should be examined by MRI, with observing the change of clinical symptoms and menstrual. Estradiol and progesterone have reduced slightly among 15 patients after 1 month of the operation, FSH and LH have increased slightly, each target has appeared normally in 3 months, emission immunity designated object is I 125, the box is provided by Shanghai Biological Production, there is no obvious influence to the function of ovary according to statistics before and after TUAE treatment, with observing the change of clinical symptoms and menstrual. The pain could be divided into several standard according to VRS and observe whether heat or not. 4 Result: the success rate of technique is 100% between Team A and Team B. Abdominal pain is usually happen 1 day after the operation. Pain is continuing 1-5days, A team is (1.5+1.17)days, B team is (1.80-1.21)days, the degree of the pain is I-III ( the patients of I degree are treated by yin duo, the patients of II degree are treated by The strong pain decides, the patients of the III degree are treated by Du Lengding. The time and degree of the pain is obviously different between the patients of A and B team. (P<0.05) The two teams have never appeared obviously different in heating, disgusting, vomit and other responses after the operation such as irregular vagina bleeding, lower limb asthenia and waist acid.(P>0.05) The volume of myoma has obviously different in the first month (P<0.05), but the volume of myoma has reduced less than 20%, there is no clinical meaning. The volume of myoma has no obviously different in the third and sixth month. LH and progesterone have reduced slightly among 15 patients after 1 month of the operation, FSH and Estradiol have increased slightly, each target has appeared normally in 3 months, comparing the UAE of their own before, there is no obviously different (P>0.05) One of the 46-year-old patient has appeared menstruation disorder after 1 month of the operation, he has restored normally in the third month.
Conclusion: It is a treatment method of PVA particle and gelatin sponge particle using in arteria uterina as UAE micro creates, the curative effect is reliable, the security is high, it could retain the womb completely, there is no influence to live and birth later, it is one of the treatment method to instead of the operation of fibroid gradually, there in no obviously different between them, it is feasible to be the material of involvement embolism using gelatin sponge particle, there is no obvious influence to the function of ovary among the women of 45 years old. With the features of low price, easy operation,and reliable effect, gelatin sponge particle could promote widely as a method of UAE.
引文
[1]乐杰.妇产科学[M] .第6版.北京:人民卫生出版社,2004 ,293- 296.
[2]乐杰.妇产科学北京.人民卫生出版社, 2004: 295-297.
[3]何桂,杨学荣.腹腔镜手术与开腹手术治疗子宫肌瘤的比较分析[J] .局部解剖学杂志,2004 ,13 (6) :3882 - 3891.
[4]Worthington2Kitsch RL, Popky GL, Hutchins FL. Uterine arterialembolizition for the management of leiomyomas: quality of life as2sessment and clinical response [J]. Radiology, 1998, 20 ( 8 ) :625-629.
[5]肖风华,章汉旺.垂体后叶素在腹腔镜下子宫肌瘤剔除术中的应用[J] .第四军医大学学报,2006 ,27 (2) :178.
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[7]Sikin GP , Englander M, Stainken BF , et al Embolic agents used for uterine fibroid embolization[J] . AJR ,2000 ,175 :767 - 773.
[8]Ravina JH ,Herbreteau D , Ciraru-Vigneron N , et al . Arterial Embolization to Treat Uterine Myomata [J] . Lancet , 1995 ,346 ( 3) :671-672.
[9]Bradley E ,Reidyl ,Forman R ,et al . Transcatheter Uterine Artery Embolization to Treat Large Uterine Fibroids [J] . Br J Obstet Gynaecol ,1998 ,105(2) :235-240.
[10]郭文波,杨建勇,陈伟,等.子宫动脉栓塞治疗子宫肌瘤和子宫腺肌症若干问题初探.放射学实践,2001 ,16 :243-246.
[11]张朝佑,主编.人体解剖学.第2版.北京:人民卫生出版社,1998.566-567.
[12]Razavi MK,Wolanske KA, Hwang GL, et al. Angiographic classification of ovarian artery-to-uterine artery anastomoses:initial obesevations in uterine fibroid embolization. Radiology 2002,224:707-712.
[13]Kim HS, Tsai J,Lee JM, et al. Effects of utero-ovarian anastomoses on basal follicle-stimulating hormone level change after uterine artery embolization with tris-acryl gelatin microspheres. J Vasc Interv Radiol,2006,17:965-971.
[14]Payne JF, Robboy SJ, Haney AF. Embolic microspheres within ovarian arterial vasculature after uterine artery embolization. Obstet Gynecol, 2002,100: 883-886
[15]Spies JB ,Antoinette RR , Gonsalves SM , et al . Ovarian Function after Uterine Artery Embolization for Leiomyomata : Assessment with Use of Serum Follicle Stimulating Hormone Assay [J] .JVIR ,2001 ,12 (4) :437-442.
[16]Spies JB ,Antoinette RR , Gonsalves SM , et al . Ovarian Function after Uterine Artery Embolization for Leiomyomata : Assessment with Use of Serum Follicle Stimulating Hormone Assay [J] .JVIR ,2001 ,12 (4) :437-442
[17]Kim HS, Tsai J,Lee JM, et al. Effects of utero-ovarian anastomoses on basal follicle-stimulating hormone level change after uterine artery embolization with tris-acryl gelatin microspheres. J Vasc Interv Radiol,2006,17:965-971.
[18]Sikin GP , Englander M, Stainken BF , et al Embolic agents used for uterine fibroid embolization[J] . AJR ,2000 ,175 :767 - 773.
[19]乐杰.妇产科学北京.人民卫生出版社, 2004: 295-297.
[20]何桂,杨学荣.腹腔镜手术与开腹手术治疗子宫肌瘤的比较分析[J] .局部解剖学杂志,2004 ,13 (6) :3882 - 3891.
[21]李谨,卢青.经腹全子宫切除术236例近远期并发症分析[J].中国实用妇科与产科杂志, 2003, 19 (1) : 53255.
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