Clinical Observation on 150 Cases of MYCu Intrauterine Device
Clinical Observation on 150 Cases of MYCu Intrauterine Device
Ma Lan
［Abstract］Objective To observe the clinical effect of new-type MYCu intrauterine
Device (MYCu IUD). Methods 150 women without contraindication and voluntarily required MYCu IUD insertion were selected at the out-patient department of this hospital, conventionally inserted with MYCu IUD, and followed-up 1, 3, 6 and 12 months after operation. Results 12 months after insertion, the cumulative rate of pregnancy with IUD in situation was 0.67%, cumulative rate of expulsion was 0, and cumulative rate of removal for medical reason was 0.67%. The occurrence rate of abnormal menstruation was 10% 1 month after operation and decreased to 0.68% at 12-month follow-up visit. Conclusion With easy and convenient application, low rate of pregnancy with IUD in situation, low expulsion rate, low rate of removal for medical reason, high continuous application rate, and broad indication, MYCu IUD can meet the demand of most women of child-bearing age who require to inserting IUD for contraception and deserves broad promotion and application in clinical practice.
［Key words］Intrauterine Device ; MYCu IUD; Clinical Effect
As a safe, effective, convenient, economic, and reversible contraceptive device, intrauterine device (IUD) is the main contraceptive measure for women of child-bearing age in China. At present, there are about 70% women in China choose IUD insertion as contraception method, account for 80% of the total number of women who choose IUD for contraception in the world［1］. For IUD is different in material and style and is effected by individual factors, IUD expulsion, downward movement, IUD in-situ pregnancy, side effects, and removal for medical reasons, still puzzle the body and mind health of child-bearing-age women. AiMu brand MYCu IUD researched by China enjoy such features as safe and effective, low rate of pregnancy with IUD in situation, low expulsion rate, and low side effects. For further exploration, the result of follow-up at 12 month after insertion of 150 cases of MYCu IUD inserted by this hospital during August and December 2010 is reported as follows.
1. Data and methods
1.1 General data 150 subjects at the age of 20～40 years old, healthy, with regular menstruation, will to insert MYCu IUD as the unique method for contraception, and without contraindication were selected at the out-patient department of this hospital.
1.2 Methods MYCu IUD was inserted by qualified doctors with IUD-insertion training; with inserted specification selected in accordance with the length of uterine cavity; inserted strictly in accordance with operation routines; and the operated were told the matters need attention after operation. Subjects were followed up 1, 3, 6, and 12 months after operation, and be carefully asked whether had the following self-conscious symptoms: change in menstruation and abnormal vagina bleeding (both called abnormal menstruation), waist and abdomen pain, and increased leukorrhoea. Ultrasonic wave was used to check IUD’s position in the uterine cavity. MYCu IUD, with titanium–nickle shape memory alloy support, a surface area of 225mm2, and 25mg indomethacin, was researched and produced by Liaoning AiMu Medical Science & Technology Co., Ltd. Data was analyzed by SPSS 13.0 software, and termination rate adopted life table method.
2 Results
2.1 Clinical effect
In follow–up visits 1, 3, 6, and 12 months after insertion, the cumulative rate of pregnancy with IUD in situation was 0.67%, expulsion rate was 0, rate of removal for medical reasons was 0.67%, continuous application rate was 98.7%, and there was no postoperative complication occurred.
2.2 Adverse reaction The occurrence rate of adverse reaction after IUD insertion was low. In follow-up visit 1 month after insertion, the occurrence rate of menstruation change was high, but obviously decreased 3 months later, details see table 1.
Table 1 The adverse reaction circumstance of 150 cases of MYCu IUD application（case， %）
|
Item |
Abnormal menstruation n (%) |
Pain in waist and abdomen n (%) |
Increased leucorrhea n (%) |
|
1 month |
15(10) |
1(0.67) |
0(0) |
|
3 months |
6(4) |
0(0) |
0(0) |
|
6 months |
0(0) |
0(0) |
0(0) |
|
12 months |
1(0.68) |
1(0.68) |
1(0.68) |
3 Discussions
For copper IUD, copper ions have the function of killing sperm and poisoning embryo, the larger the surface area of copper, the better the contraceptive effect. The copper surface area of MYCu IUD is 225mm2. For copper grains are fixed at the end of the support’s arm, copper is delivered to the highest position in the uterus, and close to the “ pass” at the uterine horns in two sides, a zone with high density of copper ions is formed in this area. Besides, capillary copper tubes on two side-arms release copper ions, better exerts copper ions’ anti-fertility function at the high, middle and low places of the uterine cavity. In this observation, the cumulative rate of pregnancy with IUD in situation 12 months after insertion was only 0.67%, which proves that MYCu IUD enjoy the feature of low rate of pregnancy with IUD in situation.
MYCu IUD maintains the basic design concept of MCu IUD and MCu II IUD［2］. It applies Ti-Ni shape memory alloy wire to form completely open “V” shape in accordance with uterus shape and dynamic mechanism. Copper grains, fixed at the end of two arms, keep the deigned shape under human body temperature and do not deform, can contract and expand as the womb does, not easy to deform, move, and expulse［3］. In observation 12 months after insertion, no expulsion occurred.
For this observation, in followed-up visit 12 months after insertion, the occurrence rate of side effects was very low. Through analyzation, it was thought to be because silicone rubber tubes on two side arms of MYCu IUD contain 25mg indomethacin, which decreased the synthesis of prostgladin during early insertion, hence effectively decreased side effects of uterus bleeding and pain and the rate of removal for medical reasons［4］. What’s more, since MYCu IUD was without tail, the probability of retrograde infection caused by it was eliminated, and sexual discomfort brought by it was also extinguished.
MYCu IUD was inserted by means of withdrawal, which was easy and convenient. At removal, IUD-removal device was used to get it, which was also convenient and easy to master.
Observed for 12 months, MYCu IUD was easy and convenient to use, had low rate of pregnancy with IUD in situation, low expulsion rate, low removal rate for medical reasons, high continuous application rate, and broad indication. Therefore, it can meet the demand of most women of child-bearing age who require to inserting IUD for contraception and deserves promotion and broad application in clinical practice.
References
［1］Le Jie. Obstetric and Gynecology. The 7th edition. Beijing: People's Hygiene Press, 2008:364.
［2］Wang Yu, Zhang Shulan, Li Shuzhi, and so on. Study on the Clinical Application of 1000 Cases of “AiMu” Brand Functional Intrauterine Device of the Second Generation. Chinese Journal of Practical Gynecology and Obstetrics, 2010, 26(9)705-707.
［3］Li Shuzhi, Zuo Wenli, Wu Shuying and so on. A Random Contrast Study on MYCu Intrauterine Device Containing 25mg Indomethacin. Chinese Journal of General Practitioners, 2010, 9(11) 760-764.
［4］Zhuang Liuqi. A Study on Indomethacin-containing Intrauterine Device. Chinese Journal of Practical Gynecology and
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