聚焦超声治疗子宫颈上皮内瘤样变的临床初期研究
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摘要
目的:本研究通过聚焦超声与高频电熨治疗子宫颈上皮内瘤样变(CIN)Ⅰ级合并高危型人乳头瘤病毒(HR-HPV)感染及对照组自然消退情况的临床对比研究,探讨聚焦超声治疗CINⅠ合并HR-HPV感染的有效性及安全性。
方法:采取非随机同期对照研究方法收集2008年6月至2009年10月确诊为CINⅠ合并HR-HPV感染的患者共140例,其中超声治疗组38例,电熨治疗组57例,对照组45例。超声治疗组采用重庆海扶技术有限公司研制的CZF型超声波治疗仪(海极星)治疗,电熨治疗组采用美国WALLACH公司研制的Quantum 2000型高频电波刀(LEEP刀)球形电极治疗。观察并比较三组随访6个月及12月后的CINⅠ及HR-HPV感染的消退情况。比较两治疗组的手术时间、术中疼痛程度、术中出血量及术后阴道排液、流血情况及宫颈恢复程度等。
结果:超声治疗组治疗后6个月随访CINⅠ的治愈率为81.58%,电熨治疗组84.21%,对照组37.78%。随访至12个月后超声治疗组患者CINⅠ的治愈率为86.21%,电熨治疗组为86.48%;对照组仅46.88%。两次随访中三组患者CINⅠ的治愈率均具显著统计学差异(均P﹤0.01),两治疗组的治愈率均显著高于对照组的自然消退率;但两组治疗组间的治疗效果无统计学差异(P﹥0.05)。
超声治疗组随访6个月后HR-HPV的治愈率为78.96%,电熨治疗组为73.69%,对照组33.33%。随访至12个月后超声治疗组HR-HPV的治愈率为82.67%,电熨治疗组81.11%,对照组为50.00%。三组患者HR-HPV的消退率无论是随访6个月或12个月均有显著统计学差异(P﹤0.01)。两治疗组的治愈率显著高于对照组的自然消失率;其中超声治疗组的消退率稍高于电熨治疗组,但二者无统计学差异(P﹥0.05)。
超声治疗组的平均手术时间为(3.78±1.45)分,电熨治疗组(5.23±1.91)分,前者明显短于后者(P﹤0.01);术中疼痛指数两治疗组分别为(4.01±1.58)及(4.99±1.35),超声治疗组明显低于电熨治疗组(P﹤0.01)。术后超声治疗组出现大量阴道排液的患者占47.36%,电熨治疗组为73.68%;出现阴道流血的人数超声治疗组占21.05%,电熨组为42.11%。两治疗组间术后的大量阴道排液及阴道流血人数均具有统计学差异(P﹤0.05);治疗后2月随访宫颈修复情况,超声治疗组宫颈完全光滑的患者比例占89.47%,电熨治疗组为89.48%,二者无统计学差异(P﹥0.05)。
结论:
聚焦超声治疗CINⅠ及HR-HPV与电熨治疗的疗效相近,但术中、术后的并发症较电熨治疗组明显减少。聚焦超声治疗低级别宫颈上皮内瘤样变及高危型人乳头瘤病毒感染是一种有效、安全的治疗方法。
Objective:
To investigate the healing rates and complications of focused ultrasound and electrocoagulation therapy for the cervical intraepithelial neoplasia gradeⅠ(CINⅠ) associated with high risk human papilloma virus (HR-HPV) infection, comparing with the control group. To explore the efficacy and safety of focused ultrasound therapy on CINⅠassociated with HR-HPV infection.
Method:
140 patients with CINⅠassociated with HR-HPV infection who visited out-patient clinic from June 2008 to October 2009 were enrolled in the study.38 patients were assigned to focused ultrasound group,57 patients to electrocoagulation group and 45 patients to control group. In focused ultrasound group, the patient were treated by the ultrasound therapeutic device (Seapostar○R), which was developed by the Chongqing Haifu(HIFU) Technology,Co.Ltd, China.In electrocoagulation group, the patients were treated by the Loop electrosurgical therapeutic device (Quantum 2000) with ball electrode, which was developed by the WALLACH Company. At 6 months and 12 months’follow-up visit, the healing rates of CINⅠand HPV infection were studied in three groups. Average operation time, pain intensity index, vaginal discharge, vaginal bleeding and cervical recuperation were compared in two therapy groups.
Result:
At 6 months’follow-up visit, the healing rate of CINⅠin ultrasound group was 81.58%,compared with 84.21% in electrocoagulation group, 37.78% in control group,respectively. At 12 months’follow-up visit, the healing rate of CINⅠwas 86.21% in focused ultrasound group ,electrocoagulation group was 86.48% , however control group was 46.88%.There was highly significant difference in three groups(P﹤0.01), the healing rates of two therapy groups were significantly higher than that of control group, however it was not statistical significant difference between the focused ultrasound group and electrocoagulation group (P> 0.05).
At 6 months’follow-up visit, the negative rate of HR-HPV was 78.96% in focused ultrasound group, compared with 73.69% in electrocoagulation group and 33.33% in control group,respectively. At 12 months’follow-up visit, the healing rate of HR-HPV was 82.76% in focused ultrasound group,hower electrocoagulation group was 81.11%, control group was 50.00%.There was highly significant statistical difference in the three groups(P﹤0.01)not only in the 6months but also 12months;the healing rates of two therapy groups were obviously higher than control group, however it was insignificant difference between the focused ultrasound group and electrocoagulation group (P> 0.05).
Compared with two therapy groups during operation, the average operation time of focused ultrasound group was 3.78±1.45 minutes, electrocoagulation group was 5.23±1.91 minutes, the former is obviously shorter than the latter(P﹤0.01); pain intensity index of two group were 4.01±1.58 and 4.99±1.35, the focused ultrasound group was lower than the other group(P﹤0.01). After treatment, vaginal discharge in focused ultrasound group patients was 47.36%, the other group was 73.68%, and vaginal bleeding in two therapy groups were 21.05% and 42.11%.The rates of vaginal discharge and bleeding in focused ultrasound group were significantly lower than those of electrocoagulation group (P<0.05), however the cervical recuperation of two groups were not significant difference in 2 months later. (P﹥0.05).
Conclusion:
The healing rates of focused ultrasound group on CIN I and HR-HPV infection were similar to those of electrocoagulation group, but focused ultrasound therapy was less side reaction and complications than electrocoagulation treatment. It is an effective and safe way in the treatment of patient with CIN I associated with HR-HPV infection.
方法:采取非随机同期对照研究方法收集2008年6月至2009年10月确诊为CINⅠ合并HR-HPV感染的患者共140例,其中超声治疗组38例,电熨治疗组57例,对照组45例。超声治疗组采用重庆海扶技术有限公司研制的CZF型超声波治疗仪(海极星)治疗,电熨治疗组采用美国WALLACH公司研制的Quantum 2000型高频电波刀(LEEP刀)球形电极治疗。观察并比较三组随访6个月及12月后的CINⅠ及HR-HPV感染的消退情况。比较两治疗组的手术时间、术中疼痛程度、术中出血量及术后阴道排液、流血情况及宫颈恢复程度等。
结果:超声治疗组治疗后6个月随访CINⅠ的治愈率为81.58%,电熨治疗组84.21%,对照组37.78%。随访至12个月后超声治疗组患者CINⅠ的治愈率为86.21%,电熨治疗组为86.48%;对照组仅46.88%。两次随访中三组患者CINⅠ的治愈率均具显著统计学差异(均P﹤0.01),两治疗组的治愈率均显著高于对照组的自然消退率;但两组治疗组间的治疗效果无统计学差异(P﹥0.05)。
超声治疗组随访6个月后HR-HPV的治愈率为78.96%,电熨治疗组为73.69%,对照组33.33%。随访至12个月后超声治疗组HR-HPV的治愈率为82.67%,电熨治疗组81.11%,对照组为50.00%。三组患者HR-HPV的消退率无论是随访6个月或12个月均有显著统计学差异(P﹤0.01)。两治疗组的治愈率显著高于对照组的自然消失率;其中超声治疗组的消退率稍高于电熨治疗组,但二者无统计学差异(P﹥0.05)。
超声治疗组的平均手术时间为(3.78±1.45)分,电熨治疗组(5.23±1.91)分,前者明显短于后者(P﹤0.01);术中疼痛指数两治疗组分别为(4.01±1.58)及(4.99±1.35),超声治疗组明显低于电熨治疗组(P﹤0.01)。术后超声治疗组出现大量阴道排液的患者占47.36%,电熨治疗组为73.68%;出现阴道流血的人数超声治疗组占21.05%,电熨组为42.11%。两治疗组间术后的大量阴道排液及阴道流血人数均具有统计学差异(P﹤0.05);治疗后2月随访宫颈修复情况,超声治疗组宫颈完全光滑的患者比例占89.47%,电熨治疗组为89.48%,二者无统计学差异(P﹥0.05)。
结论:
聚焦超声治疗CINⅠ及HR-HPV与电熨治疗的疗效相近,但术中、术后的并发症较电熨治疗组明显减少。聚焦超声治疗低级别宫颈上皮内瘤样变及高危型人乳头瘤病毒感染是一种有效、安全的治疗方法。
Objective:
To investigate the healing rates and complications of focused ultrasound and electrocoagulation therapy for the cervical intraepithelial neoplasia gradeⅠ(CINⅠ) associated with high risk human papilloma virus (HR-HPV) infection, comparing with the control group. To explore the efficacy and safety of focused ultrasound therapy on CINⅠassociated with HR-HPV infection.
Method:
140 patients with CINⅠassociated with HR-HPV infection who visited out-patient clinic from June 2008 to October 2009 were enrolled in the study.38 patients were assigned to focused ultrasound group,57 patients to electrocoagulation group and 45 patients to control group. In focused ultrasound group, the patient were treated by the ultrasound therapeutic device (Seapostar○R), which was developed by the Chongqing Haifu(HIFU) Technology,Co.Ltd, China.In electrocoagulation group, the patients were treated by the Loop electrosurgical therapeutic device (Quantum 2000) with ball electrode, which was developed by the WALLACH Company. At 6 months and 12 months’follow-up visit, the healing rates of CINⅠand HPV infection were studied in three groups. Average operation time, pain intensity index, vaginal discharge, vaginal bleeding and cervical recuperation were compared in two therapy groups.
Result:
At 6 months’follow-up visit, the healing rate of CINⅠin ultrasound group was 81.58%,compared with 84.21% in electrocoagulation group, 37.78% in control group,respectively. At 12 months’follow-up visit, the healing rate of CINⅠwas 86.21% in focused ultrasound group ,electrocoagulation group was 86.48% , however control group was 46.88%.There was highly significant difference in three groups(P﹤0.01), the healing rates of two therapy groups were significantly higher than that of control group, however it was not statistical significant difference between the focused ultrasound group and electrocoagulation group (P> 0.05).
At 6 months’follow-up visit, the negative rate of HR-HPV was 78.96% in focused ultrasound group, compared with 73.69% in electrocoagulation group and 33.33% in control group,respectively. At 12 months’follow-up visit, the healing rate of HR-HPV was 82.76% in focused ultrasound group,hower electrocoagulation group was 81.11%, control group was 50.00%.There was highly significant statistical difference in the three groups(P﹤0.01)not only in the 6months but also 12months;the healing rates of two therapy groups were obviously higher than control group, however it was insignificant difference between the focused ultrasound group and electrocoagulation group (P> 0.05).
Compared with two therapy groups during operation, the average operation time of focused ultrasound group was 3.78±1.45 minutes, electrocoagulation group was 5.23±1.91 minutes, the former is obviously shorter than the latter(P﹤0.01); pain intensity index of two group were 4.01±1.58 and 4.99±1.35, the focused ultrasound group was lower than the other group(P﹤0.01). After treatment, vaginal discharge in focused ultrasound group patients was 47.36%, the other group was 73.68%, and vaginal bleeding in two therapy groups were 21.05% and 42.11%.The rates of vaginal discharge and bleeding in focused ultrasound group were significantly lower than those of electrocoagulation group (P<0.05), however the cervical recuperation of two groups were not significant difference in 2 months later. (P﹥0.05).
Conclusion:
The healing rates of focused ultrasound group on CIN I and HR-HPV infection were similar to those of electrocoagulation group, but focused ultrasound therapy was less side reaction and complications than electrocoagulation treatment. It is an effective and safe way in the treatment of patient with CIN I associated with HR-HPV infection.
引文
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