摘要
目的系统评价口服普萘洛尔治疗国内婴幼儿体表性血管瘤的近期疗效和安全性。方法按Coehrane系统评价方法，电子检索中国生物医学文献数据库CBM（1978—2012．9），清华同方中国期刊全文数据库CNKI（1979—2012．9），重庆维普中文科技期刊数据库VIP（1989—2012．9），万方数据库（1998—2012．9），纳入国内已发表的关于口服普萘洛尔治疗婴幼儿体表血管瘤的临床随机对照试验，对纳入研究的方法学质量进行评价，提取有效数据，并用Cochrane协作网提供的RevMan5．0软件对数据进行统计学分析比数比（OR）、95％可信区间（CI），并对统计结果进行系统评价。结果最终共纳入6篇临床随机对照试验，共计416例患儿；全部试验的方法学质量评价为B～C级。4篇普萘洛尔与激素组比较结果：普萘洛尔组的疗效明显优于口服强的松组[OR=5．10，95％CI（2．44，10．65），P〈0．0001]；1篇普萘洛尔与放射性核素”sr敷贴联合应用，其疗效显著[OR=4．47，95％CI（1．73，11．51），P=0．002]。1篇普萘洛尔联合1064nmNd：YAG激光较单纯激光组的总显效率，其差异有显著的统计学意义[OR=4．00，95％CI（1．41，11．35）]；总效应量检验结果：尸=0．009。但总有效率的总效应量检验（P=0．61）差异无统计学意义。单纯普萘洛尔与单纯激光组比较的总有效率[OR=0．13，95％CI（0．02，0．67）]，其差异有统计学意义（P=0．02）；二者总显效率比较：OR=0．33，95％CI（0．10，1．09），P=0．07，其差异无明显的统计学意义。普萘洛尔治疗组的不良反应低于强的松组[OR=0．04，95％CI（0．01，0．14），P〈0．0001]；与放射核素组、激光组比较中，普萘洛尔的不良反应轻。结论口服普萘洛尔治疗体表性婴幼儿血管瘤的近期疗效明确，不良反应少，较之强的松、放射核素、激光组在疗效及安全性方面优越；普萘洛尔联合常规治疗可以明显提高疗效，缩短疗程，减少不良反应的发生。由于本研究纳入的文献质量偏低，样本数量少，还不能得出更可靠的结论，需要进一步开展高质量的随机对照研究加以证实。
Objective To evaluate the short-term efficacy and safety of the oral propranolol on the treat- ment of infantile superficial hemangiomas. Methods A Cochrane systematic review was carried out on the liter- atures which obtained by electronic retrieval in Chinese Biomedical Literature Database CBM （1978 -2012.9） ; Tsinghua Tongfang, China Academic Journal CKNI （1979 -2012.9） ; VIP Database for Chinese Technical Peri- odicals （1989- 2012.9） and Wanfang database （1998 -2012.9 ）. The language restrictions were applied for Chinese which had been published. As the search engine was performed to identify the Clinical Randomized Con- trolled trials （RCTs） that analyzed the efficacy and safety of the oral administration of propranolol in the infantile superficial heamangiomas were included. The quality of included studies was evaluated and a meta-analysis was performed using the RevMan 5.0 software. Results Six RCTs encompassing a total of 416 patients were includ- ed. The methodological quality of all the included trials was between B and C levels （ simple methods）. The re- sults of Meta-analysis indicated that the curative effect in the group treated with oral propranolol is obviously su- perior to the control group treated with oral prednisone in 4 studies [ OR =5.10, 95% CI （2.44, 10.65）, P〈 0. 0001 ]. In one trial, propranolol had been shown to have a significant effect by comparison with radionuclides ~Sr application [ OR =4.47, 95% CI （ 1.73, 11.51 ）, P=0.002]. As for the Meta-analysis in the comparison of propranolol and laser groups ： in the total significant efficiency [ OR = 4.00, 95% CI （ 1.41, 11.35 ） ]. The quantity inspection result of total effect is P= 0. 009. But in the total effective rate, the total effect quantity in- spection result is P= 0.61, and there is no statistical difference. When simple propranolol treatment group com- pared with simple laser treatment group, the total effective rate was statistically different [ OR = 0.13, 95% CI （0.02, 0. 67）, P=0.02]. Both on a comparison of the total significant efficiency was [ OR = 0.33, 95% CI （0.10, 1.09）, P= 0.07], and both of them showed no significant difference. And for adverse reactions, the result of the propranolol treatment group was inferior to the prednisone group [ OR= 0. 04, 95%CI （0.01,0.14）, P〈 0. 0001 ]. In the radionuclide group and laser group comparison, descriptive analysis showed that propranolol has less adverse reaction. Conclusion Oral administration of propranolol has definited effect and less adverse reactions compared with prednisone, the radionuclide, and laser in the treatment of in- fantile superficial haemangiomas. If the propranolol is combined with other conventional therapy, the curative effect can be more obviously improved and shortened the course of treatment as to minimize the incidence of ad- verse reactions to some extent. However, due to this study included poor quality and small sample size trials, further well-designed RCTs should be performed.
出处
《中国美容整形外科杂志》
CAS
2013年第5期281-285,共5页
Chinese Journal of Aesthetic and Plastic Surgery
关键词
婴幼儿血管瘤
普萘洛尔
系统评价
临床随机对照试验
Meta分析
Infantile hemangioma
Propranolol
Meta-analysis
Systematic review
Clinical ran- domized controlled trial
