壳聚糖与丹参混合液在输卵管介入再通术中的应用研究

Chitosan and Salvia injection in interventional fallopian tube recanalization

目的：研究在输卵管介入再通术中应用壳聚糖、丹参注射液及两者混合药物灌注的临床价值，探讨壳聚糖与丹参注射液混合剂防治输卵管术后再粘连、促进组织修复的协同作用的机理，寻求预防输卵管再粘连与提高宫内妊娠率更为有效的方法。方法将400例输卵管阻塞患者随机分为对照组（100例）、壳聚糖组（100例）、丹参组（100例）、壳聚糖与丹参混合液组（100例）。对照组只注入松解液作消炎治疗，壳聚糖组：注入松解液作消炎治疗后再注入壳聚糖预防输卵管再粘连。丹参组：在注入松解液后再注入丹参注射液。壳聚糖与丹参混合液组：则在注入松解液后再注入壳聚糖及丹参注射液的混合剂。术中观察输卵管阻塞的部位、介入再通率，术后3个月随访各组患者输卵管通水通畅率，术后12个月随访妊娠率。结果400例共计800条输卵管，其中峡部阻塞输卵管316条，间质部阻塞输卵管364条。（1）介入再通率：对照组、壳聚糖组、丹参组及壳聚糖与丹参混合液组输卵管介入再通率分别为94.1％（159/169），97.1％（170/175），96.5％（166/172）和98.2％（173/176），各组分别比较，差异均无统计学意义（P〉0.05）；（2）术后3个月输卵管通水通畅率：术后3个月输卵管通水通畅率壳聚糖与丹参混合液组（90.9％，160/176）、壳聚糖组（88％，154/175）、丹参组（85.2％，145/170）通畅率明显高于对照组（73.9％，125/169），差异有统计学意义（P〈0.05）；（3）再通术后12个月输卵管通畅率壳聚糖与丹参混合液组（78.7％）、壳聚糖组（74.0％）、丹参组（72.4％）通畅率明显高于对照组（33.5％），差异有统计学意义（P〈0.05）；术后12个月内妊娠率壳聚糖与丹参混合液组（54％，54/100）、壳聚糖组（52％，52/100）、丹参组（49％，49/100）高于对照组（14％，14/100）。结论壳聚糖、丹参注射液及两者的混合液能有效地减少输卵管介入再通术后输卵管再粘连的发生，提高妊娠率。壳聚糖与丹参混合液使用过程中及术后患者出现并发症少，在介入再通术中应用有其独特的优势。

Objective To investigate the clinical value of using the injection of Chitosan,Salvia injection,and Chitosan and Salvia in interventional fallopian tube recanalization（FTR）,and to determine the mechanism of Chitosan and Salvia injection in the prevention of postoperative recurrence of tubal adhesion and the promotion of tissue repair,for more effective method to prevent tubal adhesion and improve intrauterine pregnancy rate. Methods A total of 400 patients with tubal obstruction were randomly divided into the control group（n=100）,Chitosan group（n=100）,Salvia group（n=100）,and Chitosan and Salvia injection group（n=100）. The control group was injected with liquid-releasing agent for anti-inflammatory treatment. The Chitosan group was injected with liquid-releasing agent for anti-inflammatory treatment ,and then was injected with Chitosan to prevent tubal adhesion. The Salvia group was injected with liquid-releasing＆amp;nbsp;agent,and then was injected with Salvia. The Chitosan and Salvia injection group was injected with liquid-releasing agent,and then was injected with Chitosan and Salvia injection. The location of tubal obstruction and interventional FTR rate were determined during operation. The patency rate of hydrotubation in each group was followed up at 3 months after the operation. The pregnancy rate in each group was followed up at 12 months after the operation. Results There were 400 patients with a total of 800 fallopian tubes,including 316 tubal obstructions at isthmus portion and 364 tubal obstructions at interstitial portion.（1）Interventional FTR rate：The interventional FTR rate in the control group,Chitosan group,Salvia group,and Chitosan and Salvia injection group was 94.1%（159/169）,97.1%（170/175）,96.5%（166/172）and 98.2%（173/176）, respectively. There were no statistically significant differences among the groups（P〉0.05）.（2）The patency rate of hydrotubation at 3 months after the operation：The patency rate of hydrotubation at 3 months after the operation in the Chitosan and Salvia injection group（90.9%,160/176）,Chitosan group（88%,154/175） and Salvia group（85.2%,145/170）was significantly higher than that in the control group（73.9%,125/169）, respectively,and the difference was statistically significant（P〈0.05）.（3）The patency rate of hydrotubation at 12 months after the operation：The patency rate of hydrotubation at 12 months after the operation in the Chitosan and Salvia injection group（85.2%,150/176）,Chitosan group（81.7%,143/175）and Salvia group （80%138/172）was significantly higher than that in the control group（39%,66/169）,respectively,and the difference was statistically significant（P〈0.05）. The pregnancy rate at 12 months after the operation in the Chitosan and Salvia injection group（54%,54/100）,Chitosan group（52%,52/100）and Salvia group（49%, 49/100）was significantly higher than that in the control group（14%,14/100）. Conclusion Chitosan, Salvia injection,and Chitosan and Salvia injection can effectively reduce the recurrence of tubal adhesion after interventional FTR and increase the pregnancy rate. Using Chitosan and Salvia injection show less complication in patients during and after the operation,which has specific advantage in interventional FTR.