| Background and ObjectiveEctopic pregnancy (EP) refers to that the fertilized egg implants outside the uterine cavity, but does not implant in normal endometrium successfully for some reasons. As a common clinical obstetric and gynecological acute abdomen, it can lead to infertility or even threaten life. Laparoscopy is the golden standard in the diagnosis of ectopic pregnancy. Due to the change of life style in recent years, the incidence of ectopic pregnancy among unmarried young women is on the rise; in terms of treatment, more and more patients are eager to preserve fertility, which leads to the situation where conservative treatment is receiving increasing attention. Conservative treatment consists of medicine conservative treatment and conservative operation treatment. So far, the commonly-used drugs in clinic are methotrexate (MTX), mifepristone,5-fluorouracil (5-Fu), traditional Chinese medicine preparation, etc. The medicine treatment of ectopic pregnancy in China mainly adopts the combined application of methotrexate (MTX) and mifepristone, for it not only has the advantages such as fast drug effect and high success rate, but also reduces the risk of the fallopian tube rupture and intraperitoneal hemorrhage. Conservative operation refers to that the operation only remove the product of conception but preserve the ipsilateral fallopian tube, which can retain the patients’reproductive function to the maximum. With such advantages as little trauma, rapid recovery after operation and less complications, as well as a clearer view during operation, laparoscopic operation is the preferred surgical method in the treatment of unruptured ectopic pregnancy. The clinical curative effect of conservative operation is superior to that of medication; however, the former method has the potential risk of postoperative rebleeding and persistent ectopic pregnancy (PEP) caused by the residual of trophoblast cells. It has been reported in the literature in China that laparoscopic operation combined with drug treatment has obvious advantages in the prevention of persistent ectopic pregnancy (PEP). This study is to adopt a combined method-preoperative drug application (intramuscular injection of methotrexate and oral mifepristone) plus laparoscopic conservative surgery-to treat the unruptured ectopic pregnancy, and thus to observe the value of this combined method in the treatment of ectopic pregnancy.Materials and Methods1We collect the clinical data of160unruptured ectopic pregnancy cases (in which the patients demand to preserve the reproductive function and accord with conservative treatment conditions) treated in the First Affiliated Hospital of Zhengzhou University from Jan.2008to Apr.2011.The selected conditions are as followa, firstly, the good ordinary circumstances, stable vital signs and no obvious signs of internal hemorrhage; secondly, no drug treatment contraindications; thirdly, the adnexal masses diameter≤4cm; the last,the serum beta-human chorinic gonadotropin (β-HCG)<2000U/L.Based on the results of preoperative gynecological ultrasonography and the postoperative pathology, all of the patients are confirmed as ectopic pregnancy in the fimbrial end、the isthmic section or the ampullary section(normally the interstitial tubal pregnancy are not treated by laparoscopic conservative surgery).We handed over the condition toward the patients and signed the relevant agreement with the patients according to whether premedication. According to the preoperative medication, the groups were as follows:40cases among them who undergo the laparoscopic conservative surgery directly were taken as group A, in which the patients received no drug treatment before operation;group B (40cases), in which the patients were treated with intramuscular injection of methotrexate (50mg/m2)before operation; group C (40cases), in which the patients were treated with oral mifepristone(50mg each time,twice-daily for three days) before operation; group D (40cases), in which the patients were treated with intramuscular injection of methotrexate(50mg/m2)and oral mifepristone(50mg each time,twice-daily for three days) before operation. All of the patients in the four groups share the same data concerning their age, height, weight and marital status, days of menolipsis, symptoms of abdominal pain, days of virginal bleeding, size of abdominal mass, and blood β-HCG value (P＞0.05). The difference of the size of abdominal mass and blood P-HCG value about before and after treatment among the groups which adopted preoperative medication were not statistically significant (P＞0.05),which makes the research results comparable. All of the patients were given blood routine examination, hepatorenal function examination, serum beta-human chorinic gonadotropin (β-HCG) examination, ultrasound examination and general physical examination. The operation time and intraoperative bleeding volume were recorded, and the recovery condition of blood β-HCG value and the condition of the tubal recanalization and intrauterine pregnancy were inquired about by way of telephone. The patients in the drug treatment groups also received regular examination of the liver and kidney function, so that the circumstances of the adverse drug reaction could be known and timely symptomatic treatment could be offered.2Statistical analysis:All clinical data are analyzed by the SPSS17.0statistical software; measurement data are analyzed by one-way variance; pairwise comparison between groups adopts LSD-t test; and categorical data are analyzed by chi-square test. Categorical datas are analysed by chi-square test, calibration of the chi-square test or four table’s exact probabilities.And P＜0.05is considered statistically significantly. Results1The data of operation time and intraoperative bleeding volume of patients in four groupsThe operation time and the intraoperative bleeding volume in group A are (57.3±17.4) min and (46.0±21.2) ml, while the operation time and the intraoperative bleeding volume in groups with preoperative drug application are lesser, among which the data of group D are significantly lesser, which are (38.4±6.8) min and (20.1±6.9) ml. By means of one-way variance and LSD-t test in pairwise comparison between groups, it shows that there are significant differences between the analysis results of group A and those of group B, C, D.2The Duration of blood P-HCG value of patients in four groups decreasing to normal after surgeryAll of the patients were given serum beta-human chorinic gonadotropin (β-HCG) examination on admission. We monitor and follow up blood β-HCG level after surgery, and we record the duration of the serum β-HCG decreasing to normal. By means of one-way variance for comparison between groups, the results show that there is no significant difference among the four groups (F=0.76,P=0.5253＞0.05).3The salpingography results of patients in four groups after three or four months since operationThree or four months after operation, patients of A, B, C and D groups underwent fallopian tube radiography on the third to the seventh day after menstrual period, lost to follow up some patients.The analysis results show that there is no significant difference among the four groups concerning the tubal patency rate of the untreated side, while the fallopian tube radiographic results of the treated side are quite different. In group A, tubal patency rate is57.9%(23/38), peritubal adhesion rate is18.4%(7/38), and obstruction rate is23.7%(9/38); in group B, tubal patency rate is65.7%(23/35), peritubal adhesion rate is22.9%(8/35), and obstruction rate is11.4%(4/35); in group C, tubal patency rate is62.2%(23/37), peritubal adhesion rate is24.3%(9/37), and obstruction rate is13.5%(5/37); in group D, tubal patency rate is82.9%(29/35), peritubal adhesion rate is11.4%(4/35), and obstruction rate is5.7%(2/35). The differences among the four groups are statistically significant (P＜0.05). Evidently, the tubal patency rate in group D is greater than that in group A, B and C; and the obstruction rate in group D is lesser that that in group A, B and C.4The data of natural pregnancy of patients in four groups within2years after operationWe follow up all the patients in the past two years to know whether there is intrauterine pregnancy or ectopic pregnancy and the occurrence time. The data of intrauterine pregnancy of the patients in group D within2years after operation:72.5%(29/40) patients were pregnant within six months,87.5%(35/40) patients were pregnant within one year, and92.5%(37/40) patients were pregnant within two years. There are significant differences between group D and group A, B and C concerning the intrauterine pregnancy rate, infertility rate and reoccurrence rate of ectopic pregnancy within six months, one year and two years after treatment (P=0.000<0.05). It also shows that the postoperative intrauterine pregnancy rate of group D is obviously higher than that of group A, B and C. And obviously, the potential risk of recurrence of ectopic pregnancy after treatment increases gradually over the course of time.5The first intrauterine pregnancy time of patients in four groups after treatmentAll the patients were followed up to inquire about the first intrauterine pregnancy time after operation. In group D, the time is (10.6±3.1) m; in group A, the time is (15.1±5.6) m; In group B, the time is (13.1±4.2) m; in group C, the time is (13.7±3.5) m. By way of LSD-t test in pairwise comparison between groups, the results show that there are significant differences between group D and group A, B and C. Evidently, the first intrauterine pregnancy time of group D is much earlier.6Complications and adverse drug reactionsIn the groups with preoperative drug application, the symptom of gastrointestinal discomfort appeared among the majority of patients, one who was treated by MTX was found severe bone marrow transplantation,the white blood cell count droped to0.5×109/L,maybe the reason was that the dose is slightly larger,those who were treated in our hospital were found no serious complications, the white blood cell count of some patients decreased slightly. The patients recovered after receiving symptomatic treatment. There was no liver and kidney dysfunction among the patients in the weekly examination. The laparoscopic conservative surgery of all the patients was successful, and there was no conversion to laparotomy or occurrence of surgical complications. Although there were two cases of persistent ectopic pregnancy (PEP) in group A, they recovered by receiving drug therapy after surgery.ConclusionsPreoperative drug application combined with laparoscopic conservative surgery in the treatment of unruptured ectopic pregnancy who demand to preserve the reproductive function can achieve remarkable effect. Moreover, preoperative application of MTX and mifepristone can reserve the function of the diseased fallopian tube to the maximum and has momentous clinical value. |
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