前列腺癌大分割调强放疗副反应初步分析

Objective To analyze the acute and late toxicities in patients with prostate cancer trea-ted with hypofractionated intensity-modulated radiotherapy (IMRT). Methods Between June 2006 and June 2008, 37 patients with prostate cancer were treated with hypofractionated IMRT. The clinical target vol-ume (CTV) was the prostate, seminal vesicles and pelvic lymph nodes in 24 patients, the prostate and semi-hal vesicles in 12, and only the tumor bed in 1. The dose per fraction was 2.3 - 2.8 Gy, with 2.7 Gy in 26 patients. The minimal dose was 62.5-75.0 Gy to the prostate and seminal vesicles, and 50 Gy to the pelvic lymph nodes. Results The median follow-up was 14 months. None of the patients experienced grade 4 a-cute gastro-intestinal (GI) toxicity. Grade 1, 2 and 3 acute GI toxicity occurred in 24.3%, 35.1% and 2.7% of the patients, respectively. The rectal V50>27% and V55>20% were highly significantly associat-ed with grade ≥1 acute GI toxicity. Grade 1,2 and 3 acute genitourinary (GU) toxicity occurred in 68%, 0% and 3% of the patients, respectively. The bladder V50> 10% was significantly associated with grade ≥1 acute GU toxicity. The incidence of late GI toxicity was low. No grade ≥3 late GI toxicity was observed. The incidence of late grade 1 and 2 GI toxicity was 24% and 5%, respectively. The rectal V65> 10% was highly significantly associated with grade ≥1 late GI toxicity. No late grade 4 GU toxicity was observed. The incidence of grade 1, 2 and 3 late GU toxicity was 49%, 11% and 3%, respectively. Grade ≥2 late GU toxicity was correlated with V40, V50 and mean dose of the bladder. Conclusions Acute and late toxicity of hypofractionated IMRT is acceptable in patients with prostate cancer.     

脑转移瘤立体定向放疗分次间和分次内摆位误差及残余误差分析

目的 分析脑转移患者立体定向放疗ExacTrac X线图像,计算分次间和分次内摆位误差及残余误差,分析进行逐弧位置验证的必要性。方法 通过对过去2年在本中心采用头部立体定向放疗的脑转移瘤病例的回顾性分析,配准其数字重建图像和ExacTrac正交kV级验证图像,计算患者3个方向的平移误差和旋转误差。数据包含分次间摆位误差、分次内摆位误差和残余误差。结果 75例116个病灶进行了337次头部立体定向放疗。分次间、分次内平移摆位误差分别为左右方向x (0.93±0.86)、(0.15±0.59) mm,头脚方向y (1.83±1.27)、(0.25±0.73) mm,腹背方向z (0.96±0.80)、(0.14±0.56) mm;分次间、分次内旋转摆位误差分别为矢状面Rx (0.65°±0.62°)、(0.19°±0.40°),横断面Ry (0.97°±0.94°)、(0.13°±0.25°),冠状面Rz (0.92°±0.71°)、(0.10°±0.29°)。残余平移误差左右、头脚、腹背方向分别为(0.06±0.23)、(0.08±0.24)、(0.08±0.22) mm;残余旋转误差矢状面、横断面、冠状面分别为(0.12°±0.27°)、(0.09°±0.18°)、(0.06°±0.19°)。337次分次间摆位误差99.1%超过误差阈值(0.7 mm,0.7°)需要至少校正1次;1 006组分次内摆位误差33.6%在治疗床转到位验证无需误差校正,66.4%需要校正至少1次。结论 头部立体定向放疗患者要重视分次间摆位误差和分次内摆位误差,进行逐弧体位验证是非常必要的。     

早期结外鼻型NK/T细胞淋巴瘤疗后远期复发因素分析

目的 分析Ⅰ_E~Ⅱ_E期上呼吸消化道NK/T细胞淋巴瘤(UADT-NKTCL)经治疗后无瘤生存超过5年患者的远期复发率及危险因素。
方法 1983-2007年共114例Ⅰ_E~Ⅱ_E期UADT-NKTCL患者疗后5年内无瘤生存,其中32例单纯放疗、80例化放疗、2例单纯化疗。采用Kaplan-Meier方法计算复发率并Logrank检验及危险因素的单因素分析,Cox模型进行多因素分析。
结果随访率100%,随访时间满10年者79例。全组5年后复发12例(10.5%),复发中位时间8.2年(5.1~23.1年)。复发者中50%出现局部区域复发而无远处器官或淋巴结受累。全组10年肿瘤特异生存率和累积远期复发率分别为92.2%和8.4%。单因素分析显示初诊时有全身症状、ECOG评分≥2分、单纯化疗、初治时放疗剂量<50 Gy是远期复发因素(χ²=4.00~11.14,P=0.004~0.045),多因素分析显示初诊存在全身症状是远期复发危险因素[HR=4.74(95%CI=1.33~16.94),χ²=5.73,P=0.017]。
结论 早期UADT-NKTCL疗后5年内无瘤生存者仍有部分会出现复发。初诊时全身症状是UADT-NKTCL远期复发的独立危险因素。     

前列腺癌大分割调强放疗副反应初步分析

Objective To analyze the acute and late toxicities in patients with prostate cancer trea-ted with hypofractionated intensity-modulated radiotherapy (IMRT). Methods Between June 2006 and June 2008, 37 patients with prostate cancer were treated with hypofractionated IMRT. The clinical target vol-ume (CTV) was the prostate, seminal vesicles and pelvic lymph nodes in 24 patients, the prostate and semi-hal vesicles in 12, and only the tumor bed in 1. The dose per fraction was 2.3 - 2.8 Gy, with 2.7 Gy in 26 patients. The minimal dose was 62.5-75.0 Gy to the prostate and seminal vesicles, and 50 Gy to the pelvic lymph nodes. Results The median follow-up was 14 months. None of the patients experienced grade 4 a-cute gastro-intestinal (GI) toxicity. Grade 1, 2 and 3 acute GI toxicity occurred in 24.3%, 35.1% and 2.7% of the patients, respectively. The rectal V50>27% and V55>20% were highly significantly associat-ed with grade ≥1 acute GI toxicity. Grade 1,2 and 3 acute genitourinary (GU) toxicity occurred in 68%, 0% and 3% of the patients, respectively. The bladder V50> 10% was significantly associated with grade ≥1 acute GU toxicity. The incidence of late GI toxicity was low. No grade ≥3 late GI toxicity was observed. The incidence of late grade 1 and 2 GI toxicity was 24% and 5%, respectively. The rectal V65> 10% was highly significantly associated with grade ≥1 late GI toxicity. No late grade 4 GU toxicity was observed. The incidence of grade 1, 2 and 3 late GU toxicity was 49%, 11% and 3%, respectively. Grade ≥2 late GU toxicity was correlated with V40, V50 and mean dose of the bladder. Conclusions Acute and late toxicity of hypofractionated IMRT is acceptable in patients with prostate cancer.     

前列腺癌大分割调强放疗副反应初步分析

Objective To analyze the acute and late toxicities in patients with prostate cancer trea-ted with hypofractionated intensity-modulated radiotherapy (IMRT). Methods Between June 2006 and June 2008, 37 patients with prostate cancer were treated with hypofractionated IMRT. The clinical target vol-ume (CTV) was the prostate, seminal vesicles and pelvic lymph nodes in 24 patients, the prostate and semi-hal vesicles in 12, and only the tumor bed in 1. The dose per fraction was 2.3 - 2.8 Gy, with 2.7 Gy in 26 patients. The minimal dose was 62.5-75.0 Gy to the prostate and seminal vesicles, and 50 Gy to the pelvic lymph nodes. Results The median follow-up was 14 months. None of the patients experienced grade 4 a-cute gastro-intestinal (GI) toxicity. Grade 1, 2 and 3 acute GI toxicity occurred in 24.3%, 35.1% and 2.7% of the patients, respectively. The rectal V50>27% and V55>20% were highly significantly associat-ed with grade ≥1 acute GI toxicity. Grade 1,2 and 3 acute genitourinary (GU) toxicity occurred in 68%, 0% and 3% of the patients, respectively. The bladder V50> 10% was significantly associated with grade ≥1 acute GU toxicity. The incidence of late GI toxicity was low. No grade ≥3 late GI toxicity was observed. The incidence of late grade 1 and 2 GI toxicity was 24% and 5%, respectively. The rectal V65> 10% was highly significantly associated with grade ≥1 late GI toxicity. No late grade 4 GU toxicity was observed. The incidence of grade 1, 2 and 3 late GU toxicity was 49%, 11% and 3%, respectively. Grade ≥2 late GU toxicity was correlated with V40, V50 and mean dose of the bladder. Conclusions Acute and late toxicity of hypofractionated IMRT is acceptable in patients with prostate cancer.     

头颈部黏膜恶性黑色素瘤手术联合放疗的预后分析

目的 探讨头颈部黏膜恶性黑色素瘤手术联合放疗的综合治疗模式的效果和失败模式,并分析影响预后的因素。方法 回顾分析1982-2017年收治的194例无远处转移的头颈部黏膜恶性黑色素瘤患者的病历资料。分析综合治疗模式的效果、失败模式及预后影响因素。结果 全组患者5年总生存、无局部复发生存、无区域复发生存和无远处转移生存率分别为41.4%、57.8%、76.5%和46.5%。194例患者中治疗失败141例,失败率为74.6%,其中首次失败为远处转移的患者占40%(56/141),首次失败为局部失败的患者占37%(52/141),首次失败为区域失败的患者占15%(21/141),同时合并远处转移和局部失败的患者占5%(7/141),同时合并局部失败和区域失败的患者占3%(5/141)。Cox多因素结果显示手术切缘和联合放疗是影响局部控制的独立预后因素(P=0.001、P=0.000)。结论 头颈部黏膜恶性黑色素瘤手术联合放疗的综合治疗模式可以获得较好的局部控制率,远处转移仍是其主要失败模式。     

前列腺癌大分割调强放疗副反应初步分析

Objective To analyze the acute and late toxicities in patients with prostate cancer trea-ted with hypofractionated intensity-modulated radiotherapy (IMRT). Methods Between June 2006 and June 2008, 37 patients with prostate cancer were treated with hypofractionated IMRT. The clinical target vol-ume (CTV) was the prostate, seminal vesicles and pelvic lymph nodes in 24 patients, the prostate and semi-hal vesicles in 12, and only the tumor bed in 1. The dose per fraction was 2.3 - 2.8 Gy, with 2.7 Gy in 26 patients. The minimal dose was 62.5-75.0 Gy to the prostate and seminal vesicles, and 50 Gy to the pelvic lymph nodes. Results The median follow-up was 14 months. None of the patients experienced grade 4 a-cute gastro-intestinal (GI) toxicity. Grade 1, 2 and 3 acute GI toxicity occurred in 24.3%, 35.1% and 2.7% of the patients, respectively. The rectal V50>27% and V55>20% were highly significantly associat-ed with grade ≥1 acute GI toxicity. Grade 1,2 and 3 acute genitourinary (GU) toxicity occurred in 68%, 0% and 3% of the patients, respectively. The bladder V50> 10% was significantly associated with grade ≥1 acute GU toxicity. The incidence of late GI toxicity was low. No grade ≥3 late GI toxicity was observed. The incidence of late grade 1 and 2 GI toxicity was 24% and 5%, respectively. The rectal V65> 10% was highly significantly associated with grade ≥1 late GI toxicity. No late grade 4 GU toxicity was observed. The incidence of grade 1, 2 and 3 late GU toxicity was 49%, 11% and 3%, respectively. Grade ≥2 late GU toxicity was correlated with V40, V50 and mean dose of the bladder. Conclusions Acute and late toxicity of hypofractionated IMRT is acceptable in patients with prostate cancer.     

前列腺癌大分割调强放疗副反应初步分析

Objective To analyze the acute and late toxicities in patients with prostate cancer trea-ted with hypofractionated intensity-modulated radiotherapy (IMRT). Methods Between June 2006 and June 2008, 37 patients with prostate cancer were treated with hypofractionated IMRT. The clinical target vol-ume (CTV) was the prostate, seminal vesicles and pelvic lymph nodes in 24 patients, the prostate and semi-hal vesicles in 12, and only the tumor bed in 1. The dose per fraction was 2.3 - 2.8 Gy, with 2.7 Gy in 26 patients. The minimal dose was 62.5-75.0 Gy to the prostate and seminal vesicles, and 50 Gy to the pelvic lymph nodes. Results The median follow-up was 14 months. None of the patients experienced grade 4 a-cute gastro-intestinal (GI) toxicity. Grade 1, 2 and 3 acute GI toxicity occurred in 24.3%, 35.1% and 2.7% of the patients, respectively. The rectal V50>27% and V55>20% were highly significantly associat-ed with grade ≥1 acute GI toxicity. Grade 1,2 and 3 acute genitourinary (GU) toxicity occurred in 68%, 0% and 3% of the patients, respectively. The bladder V50> 10% was significantly associated with grade ≥1 acute GU toxicity. The incidence of late GI toxicity was low. No grade ≥3 late GI toxicity was observed. The incidence of late grade 1 and 2 GI toxicity was 24% and 5%, respectively. The rectal V65> 10% was highly significantly associated with grade ≥1 late GI toxicity. No late grade 4 GU toxicity was observed. The incidence of grade 1, 2 and 3 late GU toxicity was 49%, 11% and 3%, respectively. Grade ≥2 late GU toxicity was correlated with V40, V50 and mean dose of the bladder. Conclusions Acute and late toxicity of hypofractionated IMRT is acceptable in patients with prostate cancer.     

前列腺癌大分割调强放疗副反应初步分析

目的 分析前列腺癌大分割照射患者的早期和晚期副反应,初步探讨副反应的影响因素.方法 2006-2008年间37例前列腺痛患者接受大分割调强放疗(IMRT).13例临床靶体积(CTV)包括前列腺±精囊或术后瘤床,24例包括前列腺、精囊(或术后瘤床)和盆腔淋巴引流区.分次照射剂量为2.3～2.8 Gy(2.7 Gy占26例).95%PTV处方剂量前列腺精囊为62.5～75.0 Gy,盆腔为50.0 Gy.结果 全组中位随访时间为14个月.早期胃肠反应发生率0级38%,1级2,4%,2级35%,3级3%;直肠V50>27%与V55>20%的≥1级早期直肠反应发生率不同(P<0.05).早期泌尿系统反应发生率0级30%,1级68%,2级0和3级3%;膀胱V60<10%与V60>10%的≥1级泌尿系统反应发生率也不同(X2=6.02,P=0.038).晚期直肠反应发生率0级70%,1级24%,2级5%,无3、4级反应;直肠V65<10%与V65>10%的≥1级晚期胃肠反应发生率不同(X2=5.58,P=0.020).晚期泌尿系统反应发生率0级38%,1级49%,2级11%,3级3%,无4级反应;膀胱平均剂量>40Gy、V40>32%与V50>29%的≥2级晚期泌尿系统反应发生率均不同.结论 前列腺癌大分割IMRT初步研究结果 显示急件和晚期副反应均在可接受范围内.     

医疗器械职业化专业化检查员培训体系分析及建设研究

医疗器械职业化专业化检查员队伍能力的提升,事关医疗器械监管事业健康发展。目前,我国医疗器械检查员的培训体系已不能满足医疗器械行业蓬勃发展的要求。本文围绕我国职业化专业化医疗器械检查员培训体系展开研究,介绍了发达国家或地区医疗器械检查员制度及检查员培训经验,分析了我国医疗器械检查员制度的进展及培训存在的问题、岗位胜任能力,并在此基础上构建我国医疗器械检查员培训体系,以期为完善我国职业化专业化医疗器械检查员队伍建设提供参考借鉴。