Bath F J, Bong J, Perkins W, Williams H C
Faculty of Medicine and Health Science., School of Nursing, Mansfield Education Centre, Kings Mill Centre, Mansfield Road, Sutton-in -Ashfield, Nottingham, UK, NG17 4JL.
Cochrane Database Syst Rev. 2003(2):CD003412. doi: 10.1002/14651858.CD003412.
Basal cell carcinoma (BCC) is the most common skin malignancy in humans. BCCs are defined as slow-growing, locally invasive, malignant (but not life threatening), epidermal skin tumours which mainly affect white skinned people. The first line treatment is usually surgical excision, but numerous alternatives are available.
To assess the effects of treatments for basal cell carcinoma.
We searched the Cochrane Database of Systematic Reviews (2002 issue 1) and Cochrane Controlled Trials Register (2002 issue 1), the Cochrane Skin Group Specialised Register (January 2002), MEDLINE (from 1966-2002), EMBASE (from 1980-2002), the Mega Register of Controlled trials and the National Research Register (2002 issue 1). In addition the cited references of all trials identified and key review articles were searched. Pharmaceutical companies were contacted where appropriate for reviews or unpublished trials.
Inclusion criteria were adults with one or more histologically proven, primary basal cell carcinoma. The primary outcome measure was recurrence at 3- 5 years, measured clinically. The secondary outcome included early treatment failure within 6 months, measured histologically. Adverse effect of treatment was evaluated by reviewing aesthetic appearance (to patient and blinded observer) and pain during and after treatment.
Study selection and assessment of methodological quality were carried out by two independent reviewers.
19 studies (13 published and 6 abstracts) were identified which include 7 broad therapeutic categories. Only one RCT of surgery versus radiotherapy had primary outcome data at four years, which showed that there were significantly more persistent tumours and recurrences, measured histologically, in the radiotherapy group as compared to the surgery group, which translates to an odds ratio of 0.09 (95%CI, 0.01 to 0.67) in favour of surgery. Cryotherapy, although convenient and less expensive than surgery, showed no significant difference in recurrences at one year, measured clinically, when compared to surgery, OR 0.23 (0.01 to 6.78). However when radiotherapy was compared to cryotherapy there were significantly more recurrences at one year, measured histologically, in the cryotherapy group, this translates to an odds ratio of 14.80 (95%CI, 3.17 to 69) in favour of radiotherapy. Preliminary studies suggest a high success rate (87-88%) for imiquimod in the treatment of superficial BCC using a once-daily regimen for 6 weeks and a useful (76%) treatment response when treating nodular BCC for 12 weeks, when measured histologically. However this cream has not been compared to surgery.
REVIEWER'S CONCLUSIONS: There has been very little good quality research on efficacy of the treatment modalities used. Most of the trials have looked only at BCCs in low risk areas. Surgery and radiotherapy appear to be the most effective treatments with surgery showing the lowest failure rates. Other treatments might have some use but few have been compared to surgery. Imiquimod emerged as a possible new treatment although it has not been compared to surgery or any other modality.
基底细胞癌(BCC)是人类最常见的皮肤恶性肿瘤。BCC被定义为生长缓慢、局部浸润性的恶性(但不危及生命)表皮皮肤肿瘤,主要影响白种人。一线治疗通常是手术切除,但也有许多其他选择。
评估基底细胞癌治疗方法的效果。
我们检索了Cochrane系统评价数据库(2002年第1期)和Cochrane对照试验注册库(2002年第1期)、Cochrane皮肤组专业注册库(2002年1月)、MEDLINE(1966 - 2002年)、EMBASE(1980 - 2002年)、大型对照试验注册库和国家研究注册库(2002年第1期)。此外,还检索了所有已识别试验的参考文献和关键综述文章。在适当情况下联系制药公司获取综述或未发表的试验。
入选标准为患有一处或多处经组织学证实的原发性基底细胞癌的成年人。主要结局指标是3至5年的复发率,通过临床测量。次要结局包括6个月内的早期治疗失败,通过组织学测量。通过评估美观程度(对患者和盲法观察者)以及治疗期间和治疗后的疼痛来评价治疗的不良反应。
由两名独立的评价者进行研究选择和方法学质量评估。
共识别出涉及7种广泛治疗类别的19项研究(13项已发表研究和6篇摘要)。仅有一项手术与放疗对比的随机对照试验有4年的主要结局数据,该数据显示,从组织学测量来看,放疗组的持续性肿瘤和复发明显多于手术组,这意味着支持手术的优势比为0.09(95%可信区间,0.01至0.67)。冷冻疗法虽然方便且比手术便宜,但与手术相比,临床测量的1年复发率无显著差异,优势比为0.23(0.01至6.78)。然而,当放疗与冷冻疗法对比时,从组织学测量来看,冷冻疗法组1年的复发明显更多,这意味着支持放疗的优势比为14.80(95%可信区间,3.17至69)。初步研究表明,咪喹莫特治疗浅表性BCC采用每日一次方案治疗6周的成功率较高(87 - 88%),治疗结节性BCC 12周时的治疗有效率为76%(通过组织学测量)。然而,该乳膏尚未与手术进行对比。
关于所使用治疗方式疗效的高质量研究非常少。大多数试验仅观察了低风险区域的BCC。手术和放疗似乎是最有效的治疗方法,手术显示出最低的失败率。其他治疗方法可能有一定作用,但很少与手术进行对比。咪喹莫特成为一种可能的新治疗方法,尽管它尚未与手术或任何其他治疗方式进行对比。