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【商业翻译】医师报约稿:HPV Vaccine Protects Against

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HPV Vaccine Protects Against Vulvar and Vaginal Cancers

Roxanne Nelson


May 18, 2007 — Results suggest that the human papillomavirus (HPV) vaccine (Gardasil; Merck and Co, Whitehouse Station, New Jersey) can protect against vulval and vaginal cancer, although the incidence is rare, but increasing. These data have come soon after other recently published studies confirming the efficacy of the vaccine in protecting against cervical cancer and also showing efficacy in protecting against anogential disease.

The current study, in the May 19 issue of The Lancet, shows that the prophylactic administration of the vaccine was effective in preventing high-grade vulval and vaginal lesions associated with HPV strains 16 or 18. These results were seen in women who were naive to these HPV strains prior to vaccination, and the maximum effect of the vaccine is expected in girls who are immunized prior to exposure to HPV.

"Vulvar cancer is a rare cancer, but the incidence is rising and there is no screening program for it," study author Marc Steben, MD, from the Institut National de Santé Publique du Québec, told Medscape in an interview. "We're seeing increasing rates, especially in younger women. In younger women, it is usually associated with HPV, but we found that we can prevent up to 90% of all vulval cancer by using this vaccine."

In the current article, the researchers analyzed the data from 3 randomized trials that involved 18,174 women between the ages of 16 to 26 years, who resided in 24 countries across Europe, Asia, and the Americas. The participants were randomly assigned to receive the vaccine or placebo and were followed up for an average of 3 years. The researchers combined an analysis of the 3 trials to assess the vaccine's effect on the rates of high-grade vulval and vaginal lesions associated with HPV types 16 and 18. They also evaluated the overall effect of the vaccine on these lesions whether or not HPV DNA was identified in the lesion.

The vaccine was 100% effective in preventing against vulval intraepithelial neoplasia grade 2-3 (VIN2-3) and vaginal intraepithelial neoplasia grade 2-3 (VaIN2-3) associated with HPV strains 16 and 18 in women without previous exposure to these HPV types and who remained naive throughout the completion of the vaccination program. It was 97% effective in preventing VIN2-3 and VaIN2-3 associated with HPV16 or HPV18 in women who were naive to exposure at the time of first vaccination.

Efficacy was lower in the intent-to-treat population, which included women who may have been previously exposed to HPV16 or HPV18 or who already had a vulval or vaginal HPV-related disease before vaccination. Within this cohort, vaccine efficacy against VIN2-3 or VaIN2-3 associated with either of these 2 HPV types was 71%. The researchers also reported a 49% efficacy rate against all VIN2-3 or VaIN2-3 whether or not HPV DNA was detected in the lesion.

Vulvar cancer is a rare disease, but its treatment can have a significant impact on quality of life, self-image, and sexual functioning, Dr. Steben told Medscape. "The treatment of choice is surgery, and can involve the destruction of very sensitive tissue. Adequate margins are sometimes impossible to achieve and it can be very mutilating."

Vulval intraepithelial neoplasia has a high invasive potential and a high rate of recurrence. Women face a significant risk of developing invasive vulval cancer, even after receiving treatment, Dr. Steben explained.

The true incidence of vaginal intraepithelial neoplasia is unknown, but rates of vulval carcinoma in situ have been rising and increased more than 400% in the United States between 1973 and 2000. During that same time, the incidence of invasive vulval cancer rose by 20%. The overall global rate of vulval carcinoma in situ has been increasing and appears to be primarily associated with HPV16 and HPV18.

Another of the study authors, Diane M. Harper, MD, MPH, from Dartmouth Medical School in Hanover, New Hampshire, told Medscape that more high-grade cases of vulval disease were seen in the study because more women received biopsies. "The fact that we had to combine all Gardasil trials for over 18,000 women-years of history to show 80 cases of VIN2-3 shows that the prevalence is really quite small."

Most cases are still seen in women older than 40 years, and in this study, they were 15 to 26 years old, so the natural history of VIN2-3 lesions in such a young person is not really known, she said. "As the trial data are carried out for more years, we will have an idea of how many cases the placebo and vaccinated arms continue to show."

The duration of protection from the vaccine is still not known, but long-term follow-up is planned in northern Europe, where women will be followed up for at least 10 years, Dr. Harper added.

HPV Vaccine Is Effective but Remains Controversial

Gardasil was approved for use in the United States in June 2006. The published clinical data show that it is effective, but the product has become highly controversial. One of the major points of contention has centered on the proposition in the United States to make the vaccine mandatory for preteen girls, as it is effective only when administered to women who are not infected with HPV.

Many conservative groups oppose making it mandatory, citing fears that it could send a subtle message condoning promiscuous sexual activity. Taking a more scientific view, many experts also point out that new vaccines are generally rolled out gradually, and mandatory use is only endorsed after several years of experience demonstrate that the new products are safe and effective.

Others point out that the overall prevalence of HPV types associated with cervical cancer is relatively low in the United States and that HPV is not a contagious disease like the measles or influenza and is only acquired through sexual activity. Therefore, it is not something that children can catch from each other in the classroom. The vaccine is also expensive, and some public health officials question if the money could be better spent on more pressing issues. Finally, lobbying by the maker of the vaccine to make it mandatory only served to increase the controversy and give the public an unfavorable view of the vaccine.

"The effect of the vaccine does not depend on whether or not the woman has been sexually active," Dr. Harper told Medscape. "What matters is whether or not the woman is currently infected with an HPV infection of the type 6, 11, 16 or 18 at the time of first vaccination. It's very useful for any woman regardless of sexual activity, as long as they are not infected with those virus types at the time of first vaccination."

Lancet. 2007;369:1693-1702.
本人已认领该文编译,48小时后若未提交译文,请其他战友自由认领。
请参考e, but increasing. These data have come soon after other recently published studies confirming the efficacy of the vaccine in protecting against cervical cancer and also showing efficacy in protecting against anogential disease.
2007年5月18日-研究结果表明人乳头状瘤病毒(HPV)疫苗有助于预防女性外阴和阴道癌。尽管这种癌症发生率极低,但正不断增加。在最近证实HPV疫苗有助于保护子宫颈癌并对粘膜疾病同样有所保护的论文发表不久,我们获得了这些数据。
The current study, in the May 19 issue of The Lancet, shows that the prophylactic administration of the vaccine was effective in preventing high-grade vulval and vaginal lesions associated with HPV strains 16 or 18. These results were seen in women who were naive to these HPV strains prior to vaccination, and the maximum effect of the vaccine is expected in girls who are immunized prior to exposure to HPV.
在5月19日该期的The Lancet发表的研究表明预防注射疫苗能够有效阻止与HPV 16或HPV 18有关的高度外阴和阴道损伤。这些结果来自于那些首次接种疫苗前未接触HPV毒株的女性,可以预期在女性接触HPV前接种疫苗将能发挥最大效用。
"Vulvar cancer is a rare cancer, but the incidence is rising and there is no screening program for it," study author Marc Steben, MD, from the Institut National de Santé Publique du Québec, told Medscape in an interview. "We're seeing increasing rates, especially in younger women. In younger women, it is usually associated with HPV, but we found that we can prevent up to 90% of all vulval cancer by using this vaccine."
外阴癌是一种罕见癌症,但是发病率正不断上升,并且没有相关的筛选程序。de Santé Publique du Québec国家研究所,医学博士,研究作者Marc Steben在一次采访中对Medscape说。我们注意到增加速度,尤其年轻女性。在年轻女性中,外阴癌常与HPV有关,但我们发现可以通过HPV疫苗来预防90%的所有外阴癌。
In the current article, the researchers analyzed the data from 3 randomized trials that involved 18,174 women between the ages of 16 to 26 years, who resided in 24 countries across Europe, Asia, and the Americas. The participants were randomly assigned to receive the vaccine or placebo and were followed up for an average of 3 years. The researchers combined an analysis of the 3 trials to assess the vaccine's effect on the rates of high-grade vulval and vaginal lesions associated with HPV types 16 and 18. They also evaluated the overall effect of the vaccine on these lesions whether or not HPV DNA was identified in the lesion.
在这篇文章中,研究者分析了对18,174名女性进行3 项随机实验的数据,这些女性年龄均在16至24 岁之间,居住在欧洲,亚洲和美洲的24个国家。参与者按照随机设计接受疫苗或者安慰剂,并进行平均3年的随访。研究者整合了3个实验的分析来评估疫苗对与HPV16和HPV18有关的高度外阴和阴道损伤疗效。他们同样评估了疫苗对所有损伤的整体疗效,而不论损伤中是否存在HPV DNA。
The vaccine was 100% effective in preventing against vulval intraepithelial neoplasia grade 2-3 (VIN2-3) and vaginal intraepithelial neoplasia grade 2-3 (VaIN2-3) associated with HPV strains 16 and 18 in women without previous exposure to these HPV types and who remained naive throughout the completion of the vaccination program. It was 97% effective in preventing VIN2-3 and VaIN2-3 associated with HPV16 or HPV18 in women who were naive to exposure at the time of first vaccination.
对最初没有接触并在疫苗接种后仍没有接触HPV的女性,疫苗能100%有效预防与HPV株16和HPV18有关的2-3 级外阴上皮内瘤变(VIN2-3)和2-3级阴道上皮内瘤变(VaIN2-3)。对首次接种前未接触HPV 的女性,疫苗能97%有效预防与HPV16和HPV18有关的VIN2-3和VaIN2-3。
Efficacy was lower in the intent-to-treat population, which included women who may have been previously exposed to HPV16 or HPV18 or who already had a vulval or vaginal HPV-related disease before vaccination. Within this cohort, vaccine efficacy against VIN2-3 or VaIN2-3 associated with either of these 2 HPV types was 71%. The researchers also reported a 49% efficacy rate against all VIN2-3 or VaIN2-3 whether or not HPV DNA was detected in the lesion.
但有效性在意向治疗人群中有所下降,这些人群包括接种疫苗前可能已经接触HPV 16或者HPV 18的女性以及已经具有与HPV有关的外阴或阴道疾病的女性。根据这种分类,疫苗预防与任一两种HPV类型相关的VIN2-3 或者VaIN2-3疾病效率未71%。研究者还发现疫苗对所有VIN2-3 或VaIN2-3疾病的预防效率为49%,不论损伤处是否发现HPV DNA。
Vulvar cancer is a rare disease, but its treatment can have a significant impact on quality of life, self-image, and sexual functioning, Dr. Steben told Medscape. "The treatment of choice is surgery, and can involve the destruction of very sensitive tissue. Adequate margins are sometimes impossible to achieve and it can be very mutilating."
外阴癌是一种很罕见的疾病,但是它的治疗对于生活质量,个人形象以及性功能都有重要影响。Steben博士告诉Medscape。治疗的选择通常是手术,常常会破坏敏感组织。有时很难留下足够的外缘,从而使外阴极不完整。
Vulval intraepithelial neoplasia has a high invasive potential and a high rate of recurrence. Women face a significant risk of developing invasive vulval cancer, even after receiving treatment, Dr. Steben explained.
外阴上皮内瘤变具有很高的侵袭能力并且复发率高。女性常面临发展成侵袭性外阴癌的高风险,即使在接受治疗后。Steben博士解释说。
The true incidence of vaginal intraepithelial neoplasia is unknown, but rates of vulval carcinoma in situ have been rising and increased more than 400% in the United States between 1973 and 2000. During that same time, the incidence of invasive vulval cancer rose by 20%. The overall global rate of vulval carcinoma in situ has been increasing and appears to be primarily associated with HPV16 and HPV18.
真正的外阴上皮内瘤变发病率仍不清楚,但是在1973至2000年,美国原位外阴癌发病率上升并增加了超过400%。同时,侵袭性外阴癌发病率增加了20%。全球原位外阴癌发病率增加,可能主要与HPV16 和HPV 18有关。
Another of the study authors, Diane M. Harper, MD, MPH, from Dartmouth Medical School in Hanover, New Hampshire, told Medscape that more high-grade cases of vulval disease were seen in the study because more women received biopsies. "The fact that we had to combine all Gardasil trials for over 18,000 women-years of history to show 80 cases of VIN2-3 shows that the prevalence is really quite small."
美国新罕布什尔州汉诺威Dartmouth医学院,医学博士,公共卫生学硕士,本文另一个研究作者Diane M. Harpe告诉Medscape,在研究中发现较多的高级外阴疾病是因为越来越多的女性接受活检。事实是在我们整合多年超过18,000女性的Gardasil检测结果仅发现80例VIN2-3,这说明患病率实际非常低。
Most cases are still seen in women older than 40 years, and in this study, they were 15 to 26 years old, so the natural history of VIN2-3 lesions in such a young person is not really known, she said. "As the trial data are carried out for more years, we will have an idea of how many cases the placebo and vaccinated arms continue to show."
大部分的病例常发生在年龄大于40岁的女性,而本研究中女性都在15至26岁,因此在这些年轻人群中VIN2-3损伤病史仍不清楚,她说。由于实验数据已经收集多年,对于安慰剂组和疫苗组将可能出现的病例数,我们心中有数。
The duration of protection from the vaccine is still not known, but long-term follow-up is planned in northern Europe, where women will be followed up for at least 10 years, Dr. Harper added.
疫苗保护期限仍不清楚,但是在北欧已经进行长期随访,在那里女性将被随访至少10年。Harper博士补充说。
HPV Vaccine Is Effective but Remains Controversial
HPV疫苗有效但仍有争议
Gardasil was approved for use in the United States in June 2006. The published clinical data show that it is effective, but the product has become highly controversial. One of the major points of contention has centered on the proposition in the United States to make the vaccine mandatory for preteen girls, as it is effective only when administered to women who are not infected with HPV.
Gardasil在2006年6月被美国批准使用。公布的临床数据证实其有效,但是该产品存在高度争议。由于疫苗仅对未感染HPV的女性注射有效,一个争议的主要观点集中在,美国政府对青春期以前女性强制进行疫苗注射的提议。
Many conservative groups oppose making it mandatory, citing fears that it could send a subtle message condoning promiscuous sexual activity. Taking a more scientific view, many experts also point out that new vaccines are generally rolled out gradually, and mandatory use is only endorsed after several years of experience demonstrate that the new products are safe and effective.
许多保守组织反对强制性注射,担心这是对乱性行为传递宽恕信号。出于更科学的观点,许多专家同样指出新疫苗注射应该逐步慢慢进行,强制注射应该在几年使用后新产品安全有效性得到证实才能进行。
Others point out that the overall prevalence of HPV types associated with cervical cancer is relatively low in the United States and that HPV is not a contagious disease like the measles or influenza and is only acquired through sexual activity. Therefore, it is not something that children can catch from each other in the classroom. The vaccine is also expensive, and some public health officials question if the money could be better spent on more pressing issues. Finally, lobbying by the maker of the vaccine to make it mandatory only served to increase the controversy and give the public an unfavorable view of the vaccine.
其他人指出在美国所有HPV类型与子宫颈癌患病率相对低,并且HPV并不是象麻疹或者流感样的传染性疾病,仅仅通过性活动传播。因此它并不是一种儿童可在课堂从其他儿童传染的疾病。疫苗还很昂贵,一些公共健康官员质疑钱应该花在其他更迫切的问题上。最终,疫苗制造商游说议员强制注射疫苗仅增加了争议并使公众对该疫苗产生恶感。
"The effect of the vaccine does not depend on whether or not the woman has been sexually active," Dr. Harper told Medscape. "What matters is whether or not the woman is currently infected with an HPV infection of the type 6, 11, 16 or 18 at the time of first vaccination. It's very useful for any woman regardless of sexual activity, as long as they are not infected with those virus types at the time of first vaccination."
疫苗的有效性不在于女性性生活是否活跃,Harper博士告诉Medscape。关键在于女性在首次注射疫苗时是否感染了6,11,16或18 型HPV病毒。不管性生活这对于任何女性有十分有用,只要她们在首次注射疫苗时没有感染这些类型病毒。

编译
研究结果表明人乳头状瘤病毒(HPV)疫苗有助于预防女性外阴和阴道癌。(Lancet. 2007;369:1693-1702.)
外阴癌是一种罕见癌症,但是发病率正不断上升,并且没有相关的筛选程序。在最近证实HPV疫苗有助于保护子宫颈癌并对粘膜疾病同样有所保护的论文发表不久,我们获得了这些数据。分析结果表明预防注射疫苗能够有效阻止与HPV 16或HPV 18有关的高度外阴和阴道损伤。这些结果来自于那些首次接种疫苗前未接触HPV毒株的女性,可以预期在女性接触HPV前接种疫苗将能发挥最大效用。我们注意到外阴癌增加速度,尤其年轻女性。在年轻女性中,外阴癌常与HPV有关,但我们发现可以通过HPV疫苗来预防90%的所有外阴癌。
在这项研究中,研究者分析了对18,174名女性进行3 项随机实验的数据。这些女性年龄均在16至24 岁之间,居住在欧洲,亚洲和美洲的24个国家。参与者按照随机设计接受疫苗或者安慰剂,并进行平均3年的随访。研究者整合了3个实验的分析来评估疫苗对与HPV16和HPV18有关的高度外阴和阴道损伤疗效。他们同样评估了疫苗对所有损伤的整体疗效,而不论损伤中是否存在HPV DNA。对最初没有接触并在疫苗接种后仍没有接触HPV的女性,疫苗能100%有效预防与HPV株16和HPV18有关的2-3 级外阴上皮内瘤变(VIN2-3)和2-3级阴道上皮内瘤变(VaIN2-3)。对首次接种前未接触HPV 的女性,疫苗能97%有效预防与HPV16和HPV18有关的VIN2-3和VaIN2-3。但有效性在意向治疗人群中有所下降,这些人群包括接种疫苗前可能已经接触HPV 16或者HPV 18的女性以及已经具有与HPV有关的外阴或阴道疾病的女性。根据这种分类,疫苗预防与任一两种HPV类型相关的VIN2-3 或者VaIN2-3疾病效率未71%。研究者还发现疫苗对所有VIN2-3 或VaIN2-3疾病的预防效率为49%,不论损伤处是否发现HPV DNA。
外阴癌是一种很罕见的疾病,但是它的治疗对于生活质量,个人形象以及性功能都有重要影响。治疗的选择通常是手术,常常会破坏敏感组织。有时很难留下足够的外缘,从而使外阴极不完整。外阴上皮内瘤变具有很高的侵袭能力并且复发率高。女性常面临发展成侵袭性外阴癌的高风险,即使在接受治疗后。
真正的外阴上皮内瘤变发病率仍不清楚,但是在1973至2000年,美国原位外阴癌发病率上升并增加了超过400%。同时,侵袭性外阴癌发病率增加了20%。全球原位外阴癌发病率增加,可能主要与HPV16 和HPV 18有关。在研究中发现较多的高级外阴疾病是因为越来越多的女性接受活检。事实是在我们整合多年超过18,000女性的Gardasil检测结果仅发现80例VIN2-3,这说明患病率实际非常低。大部分的病例常发生在年龄大于40岁的女性,而本研究中女性都在15至26岁,因此在这些年轻人群中VIN2-3损伤病史仍不清楚。由于实验数据已经收集多年,对于安慰剂组和疫苗组将可能出现的病例数,我们心中有数。疫苗保护期限仍不清楚,但是在北欧已经进行长期随访,在那里女性将被随访至少10年。
HPV疫苗有效但仍有争议
Gardasil在2006年6月被美国批准使用。公布的临床数据证实其有效,但是该产品存在高度争议。由于疫苗仅对未感染HPV的女性注射有效,一个争议的主要观点集中在,美国政府对青春期以前女性强制进行疫苗注射的提议。
许多保守组织反对强制性注射,担心这是对乱性行为传递宽恕信号。
出于更科学的观点,许多专家同样指出新疫苗注射应该逐步慢慢进行,强制注射应该在几年使用后新产品安全有效性得到证实才能进行。
其他人指出在美国所有HPV类型与子宫颈癌患病率相对低,并且HPV并不是象麻疹或者流感样的传染性疾病,仅仅通过性活动传播。因此它并不是一种儿童可在课堂从其他儿童传染的疾病。疫苗还很昂贵,一些公共健康官员质疑钱应该花在其他更迫切的问题上。
最终,疫苗制造商游说议员强制注射疫苗仅增加了争议并使公众对该疫苗产生恶感。
疫苗的有效性不在于女性性生活是否活跃,关键在于女性在首次注射疫苗时是否感染了6,11,16或18 型HPV病毒。不管性生活这对于任何女性有十分有用,只要她们在首次注射疫苗时没有感染这些类型病毒。(丁香)

我也来写几句:
1,HPV为人乳头状瘤病毒,“在5月19日该期的The Lancet发表的研究表明预防注射疫苗能够有效阻止与HPV 16或HPV 18有关的高度外阴和阴道损伤。这些结果来自于那些首次接种疫苗前未接触HPV菌株的女性,....”称其为菌株应该不妥,可改为毒株。

2,They also evaluated the overall effect of the vaccine on these lesions whether or not HPV DNA was identified in the lesion.
他们同样评估了疫苗对所有损伤的整体疗效,而不论损伤中是否存在HPV DNA。

我认为是以损伤组织的是否存在HPV DNA作为疫苗保护性的评价指标,所以翻译为“通过检测损伤组织中是否存在HPV DNA ,他们同样评估了疫苗对损伤的整体保护性。”

3,"As the trial data are carried out for more years, we will have an idea of how many cases the placebo and vaccinated arms continue to show."
由于实验数据已经收集多年,我们对如何持续展现安慰剂和疫苗组有一些想法。

由于实验数据已经收集多年,对于安慰剂组和疫苗组将可能出现的病例数,我们心中有数。

ldguan wrote:
谢谢dang1555提供链接

HPV Vaccine Protects Against Vulvar and Vaginal Cancers
HPV疫苗有助于预防女性外阴和阴道癌
Roxanne Nelson
May 18, 2007 — Results suggest that the human papillomavirus (HPV) vaccine (Gardasil; Merck and Co, Whitehouse Station, New Jersey) can protect against vulval and vaginal cancer, although the incidence is rare, but increasing. These data have come soon after other recently published studies confirming the efficacy of the vaccine in protecting against cervical cancer and also showing efficacy in protecting against anogential disease.
wuxiaocheng wrote:
我也来写几句:
1,HPV为人乳头状瘤病毒,“在5月19日该期的The Lancet发表的研究表明预防注射疫苗能够有效阻止与HPV 16或HPV 18有关的高度外阴和阴道损伤。这些结果来自于那些首次接种疫苗前未接触HPV菌株的女性,....”称其为菌株应该不妥,可改为毒株。

2,They also evaluated the overall effect of the vaccine on these lesions whether or not HPV DNA was identified in the lesion.
他们同样评估了疫苗对所有损伤的整体疗效,而不论损伤中是否存在HPV DNA。

我认为是以损伤组织的是否存在HPV DNA作为疫苗保护性的评价指标,所以翻译为“通过检测损伤组织中是否存在HPV DNA ,他们同样评估了疫苗对损伤的整体保护性。”

3,"As the trial data are carried out for more years, we will have an idea of how many cases the placebo and vaccinated arms continue to show."
由于实验数据已经收集多年,我们对如何持续展现安慰剂和疫苗组有一些想法。

由于实验数据已经收集多年,对于安慰剂组和疫苗组将可能出现的病例数,我们心中有数。

ldguan wrote:
谢谢dang1555提供链接

HPV Vaccine Protects Against Vulvar and Vaginal Cancers
HPV疫苗有助于预防女性外阴和阴道癌
Roxanne Nelson
May 18, 2007 — Results suggest that the human papillomavirus (HPV) vaccine (Gardasil; Merck and Co, Whitehouse Station, New Jersey) can protect against vulval and vaginal cancer, although the incidence is rare, but increasing. These data have come soon after other recently published studies confirming the efficacy of the vaccine in protecting against cervical cancer and also showing efficacy in protecting against anogential disease.

谢谢指正
不过第二句的翻译我还是认为有些不妥,可参见http://www.....cn/bbs/post/view?bid=116&id=9078061&tpg=1&ppg=1&sty=1&age=0#9078061。
ldguan wrote:
谢谢指正
不过第二句的翻译我还是认为有些不妥,可参见http://www.....cn/bbs/post/view?bid=116&id=9078061&tpg=1&ppg=1&sty=1&age=0#9078061。


谢谢ldguan,向你学习。
“The vaccine was 49% (18–69) effective against all VIN2–3 or VaIN2–3, irrespective of whether or not HPV DNA was detected in the lesion.”
第二句是我理解错了,谢谢提供链接
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