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1.
《中国皮肤性病学杂志》2015,(12)
目的系统评价特比萘芬与伊曲康唑治疗趾甲真菌病的复发率。方法计算机检索Cochrane图书馆,Pub Med,EMBASE,CBMdisc,CNKI和万方数据库,搜索特比萘芬与伊曲康唑治疗趾甲真菌病的真菌学复发率的临床随机对照试验(RCTs),治疗组采用特比萘芬治疗,对照组采用伊曲康唑治疗。检索时间截至2014年5月。由两名研究者共同独立提取资料并评估纳入研究质量。采用Stata9.0软件对试验数据进行统计分析。结果两个亚组共纳入7篇文章包括11个RCT,共包括347例患者,治疗组216例,对照组131例。高质量文章1篇。亚组一即短期(随访时间≤1年)的真菌学复发率包括4个RCT;亚组二即长期(随访时间1年)的真菌学复发率包括7个RCT。Meta分析结果显示,特比萘芬与伊曲康唑治疗趾甲真菌病的真菌学复发率的差异有统计学意义,亚组一RR合并=0.33,95%CI 0.15~0.73,亚组二RR合并=0.51,95%CI 0.37~0.72。结论现有临床证据表明,特比萘芬治疗趾甲真菌病真菌学治愈后的真菌学复发率低于伊曲康唑,但临床应用的确切疗效尚需更多的RCT证实。 相似文献
2.
目的比较特比萘芬与伊曲康唑、氟康唑、灰黄霉素治疗甲癣疗效的差异。方法检索Medline文献数据库,查找所有比较特比萘芬与伊曲康唑、氟康唑、灰黄霉素治疗甲癣的双盲随机对照试验的文献,找出这4种药物治疗甲癣的真菌学治愈率并对其进行汇总,得出合并后真菌学治愈率的比值比(OR)及其95%可信区间(CI)。结果①有6篇比较特比萘芬与伊曲康唑、1篇特比萘芬与氟康唑、2篇特比萘芬与灰黄霉素治疗甲癣的双盲随机对照试验文献被纳入。②特比萘芬250mg/d连续疗法优于伊曲康唑400mg/d冲击疗法[OR=5.01,95%CI(3.42~7.33)]和伊曲康唑200mg/d连续疗法[OR=2.58,95%CI(1.91~3.49)]。特比萘芬的疗效亦优于氟康唑(P<0.001)和灰黄霉素[OR=3.46,95%CI(1.89~6.31)]。结论特比萘芬治疗甲癣的疗效优于伊曲康唑、氟康唑和灰黄霉素。 相似文献
3.
目的评价甲真菌病临床评分指数(SCIO)指导伊曲康唑冲击和特比萘芬连续疗法治疗甲真菌病的疗效、安全性及费用疗效比。方法制定SCIO评分体系,对200例甲真菌病患者的靶甲进行SCIO评分,根据SCIO积分范围随机分为2组,分别给予伊曲康唑冲击治疗和特比萘芬连续治疗。结果2种药物均有较好的抗真菌疗效。伊曲康唑组和特比萘芬组近、中、远期临床和真菌学疗效差异均无统计学意义(P>0.05),伊曲康唑组远期复发率4.26%,特比萘芬组尚未观察到复发病例。伊曲康唑组不良事件发生率为23%,特比萘芬组为21%(P>0.05)。Ⅱ度患者伊曲康唑组费用疗效比低于特比萘芬组,Ⅲ度和Ⅳ度患者特比萘芬组费用疗效比低于伊曲康唑组,但差异均无统计学意义(P>0.05)。结论SCIO具有一定的科学性和实用性,指导伊曲康唑冲击和特比萘芬连续疗法治疗甲真菌病显示同样有效且安全。 相似文献
4.
伊曲康唑和特比萘芬序贯疗法治疗甲真菌病的临床观察 总被引:7,自引:0,他引:7
目前,治疗甲真菌病国内外大多采用伊曲康唑间歇冲击疗法或特比萘芬短程连续疗法。随着对甲真菌病治疗要求的不断提高以及要求治疗的人数不断增多,寻求更有效、更经济的治疗甲真菌病的手段已成为必然。近两年来国外已有报道用伊曲康唑和特比萘芬序贯疗法来治疗甲真菌病,而国内少见报道。为了研究伊曲康唑和特比萘芬序贯疗法治疗甲真菌病的疗效及安全性,笔者从2001年4月~2002年9月用此疗法共治疗了26例甲真菌病患者,并与伊曲康唑间歇冲击疗法以及特比萘芬短程连续疗法作对照,现将临床观察报告如下。 相似文献
5.
马洁浩 《国际皮肤性病学杂志》1999,(5)
目前系统治疗甲真菌病的药物主要为特比萘芬和伊曲康唑。特比萘芬的治疗方法为连续给药12周,而伊曲康唑则为连续给药12周,或间歇疗法,即每4周给药1周,共12~16周,目前广泛使用后者治疗甲真菌病,并称与二药的连续用药法疗效相似。为比较连续使用特比萘芬与间歇使用伊曲康唑治疗趾甲真菌病的疗效 相似文献
6.
目的:采用间接比较的方法综合评价特比萘芬仿制药与原研药治疗甲真菌病的临床疗效和安全性。方法 :检索PubMed、EMbase、Cochrane Library、中国知网(CNKI)、万方和维普数据库中收录的特比萘芬仿制药及原研药分别与伊曲康唑比较治疗甲真菌病的随机对照试验(RCT),检索时限从建库至2018年6月。在提取资料和质量评价后,采用RevMan5.2和ITC软件对纳入的研究分别进行Meta分析和间接比较,并用GRADEpro软件评价证据质量。结果:共纳入8个RCT,合计914例患者。分析结果显示疗效方面,特比萘芬仿制药对比原研药治疗甲癣的有效率[RR=0.95,95%CI(0.84,1.07),P=0.96,证据质量:极低]、痊愈率[RR=1.06,95%CI(0.81,1.38),P=0.77,证据质量:极低]差异均无统计学意义;安全性方面,两者比较不良反应发生率[RR=1.58,95%CI(0.77,3.26),P=0.83,证据质量:极低]差异无统计学意义。结论:目前的研究在实施、报道方面存在诸多问题,结合证据质量,尚不能确定特比萘芬仿制药和原研药在治疗甲真菌的疗效和安... 相似文献
7.
伊曲康唑和特比萘芬联合治疗趾甲真菌病 总被引:4,自引:0,他引:4
为研究伊曲康唑及特比萘芬平行冲击治疗甲真菌病的疗效及药物经济学评估。甲真菌病患者随机分为治疗组46例服用伊曲康唑200mg 特比萘芬250mg,每日1次,连用7d,停药21d为1个疗程,共3个疗程;对照组45例采用伊曲康唑冲击疗法,共3个疗程。结果:两组近远期治愈率、有效率、真菌学治愈率,均无显著差异;临床治愈者24个月内,复发或再感染率分别为治疗组10.81%、对照组30.30%,P<0.05,有显著性差异;治疗组费用-效果比低于对照组,每治愈1例分别需人民币1093.56元和1357.36元。伊曲康唑及特比萘芬平行冲击治疗甲真菌病疗效确切、安全性好和复发率低,且较单一口服药物治疗具有更好的效价比。 相似文献
8.
目的观察伊曲康唑和特比萘芬序贯疗法治疗甲真菌病的临床疗效及安全性。方法对照组采用伊曲康唑冲击治疗(每日中晚餐各口服伊曲康唑200mg,连用1周,停用3周为一个疗程),指甲真菌病治疗2个疗程,趾甲真菌病治疗3个疗程。观察组指甲真菌病先用伊曲康唑冲击治疗1个疗程,随后应用盐酸特比萘芬冲击疗法(每日中晚餐各口服特比萘芬250mg,连用1周,停药3周),趾甲真菌病还需再重复伊曲康唑冲击治疗1个疗程。两组治疗结束后3、6月时各复诊一次,观察不良反应发生情况。结果观察组治疗3个月后的有效率显著高于对照组(P0.05),经6个月治疗后,2组有效率与治疗3个月后有效率相比均略有提高,但差异无统计学意义(P0.05),观察组有效率高于对照组,但无显著性差异(P0.05)。复发率观察显著低于对照组(P0.05)。结论伊曲康唑和特比萘芬序贯疗法治疗甲真菌病疗效确切,复发率与不良反应较少,值得临床推广应用。 相似文献
9.
目的探讨特比萘芬间歇疗法在治疗老年人甲真菌病中的疗效和安全性。方法采用随机双盲方法,将老年人甲真菌病患者分为2组。特比萘芬间歇疗法组:特比萘芬250mg,1次/d,连续4周,停药4周,再予连续4周;特比萘芬持续疗法组:特比萘芬250mg,次1/d,连续12周。在服药后第12周、24周、36周、48周、72周进行回访,观察疗效和不良反应。结果在72周时,特比萘芬间歇疗法组与持续疗法组的临床有效率为79.17%和81.82%;真菌清除率为83.33%和90.91%。在不同的观察时间,两组的临床有效率和真菌清除率相比较,差异均无统计学意义(P均>0.05)。结论在治疗老年人甲真菌病中,特比萘芬间歇疗法可以达到与特比萘芬持续疗法类似的疗效和安全性。 相似文献
10.
韦无边 《岭南皮肤性病科杂志》2007,14(6):358-359
目的:探讨序贯疗法治疗甲真菌病的安全性、依从性和疗效.方法:甲真菌病患者先服伊曲康唑1周,停3周为1个疗程,接着服特比萘芬1周,停3周为1个疗程.指甲真菌病服2个疗程,趾甲真菌病服3个疗程.结果:指甲真菌病有效率100%,趾甲真菌病有效率90.91%.结论:伊曲康唑与特比萘序贯疗法治疗甲真菌病安全有效,依从性好. 相似文献
11.
Abstract As the most frequently used systemic antifungal agents for onychomycosis, terbinafine and itraconazole have both proved to have the conditions of recurrence in various degrees during follow-up period after end of therapy; very little is known about their comparative recurrences after long-term follow-up. We conducted a meta-analysis of available trials to compare the long-term recurrences of toenail onychomycosis after successful treatment with terbinafine versus itraconazole. Meta-analysis was performed by the Review Manager version 5.0.25. Risk ratio and 95% confidence intervals were calculated by the fixed effect model. Five trials and total 251 eligible patients were included in this meta-analysis. The combined risk ratio of the meta-analysis comparing terbinafine with itraconazole for mycological recurrence rate was 0.44 (95% CI 0.29-0.66), which suggests that itraconazole therapy is more likely to produce mycological recurrence compared with terbinafine therapy. 相似文献
12.
An open randomized comparative study of oral itraconazole pulse and terbinafine pulse in the treatment of onychomycosis 总被引:1,自引:0,他引:1
Mishra M Panda P Tripathy S Sengupta S Mishra K 《Indian journal of dermatology, venereology and leprology》2005,71(4):262-266
BACKGROUND: Onychomycosis is a recalcitrant disease of the nails caused by dermatophytes, yeasts, and molds. AIMS: To compare the clinical efficacy of oral itraconazole pulse therapy and oral terbinafine pulse therapy in onychomycosis. METHODS: A randomized single-blind clinical comparative study was undertaken on 120 patients of onychomycosis during the period March 1999-February 2002. Sixty patients were randomly assigned to receive oral itraconazole 100 mg, two capsules twice daily for seven days a month and the other group of sixty patients received oral terbinafine 250 mg, one tablet twice daily for seven days every month. Four such monthly pulses were administered for each drug. The patients were evaluated at 4-weekly intervals till sixteen weeks and then at 24, 36 and 48 weeks. RESULTS: We observed a clinical cure rate of 82% and mycological cure rate of 90% in the group of patients treated with itraconazole while the group with terbinafine showed clinical and mycological cure rates of 79% and 87% respectively. This difference was not statistically significant. CONCLUSIONS: Both oral itraconazole and terbinafine are effective in the treatment of onychomycosis when administered in the pulse dosage form. Terbinafine is more cost effective while itraconazole has a broader spectrum of antimycotic activity. 相似文献
13.
AK Gupta†‡ MD Gover‡ CW Lynde§ 《Journal of the European Academy of Dermatology and Venereology》2006,20(10):1188-1193
BACKGROUND: Oral terbinafine and oral itraconazole are two of the most common agents used for the treatment of toenail dermatophyte onychomycosis. Despite the fact that diabetic patients are more likely to have onychomycosis than normal individuals are, there is little research into the efficacy of standard oral regimens of terbinafine and itraconazole for onychomycosis in the diabetic population. STUDY DESIGN: We present a prospective, randomized, single-blind, parallel group, comparator-controlled, multi-centre study designed to assess the efficacy of the pulse itraconazole (200 mg twice daily, 1 week on, 3 weeks off, for 12 weeks) vs. continuous terbinafine (250 mg once daily for 12 weeks) oral therapies in the treatment of dermatophyte toenail distal and lateral subungual onychomycosis (DLSO) in the diabetic population. EFFICACY PARAMETERS: Primary efficacy measures included mycological cure rate (negative KOH and culture) and effective cure (mycological cure plus nail plate involvement of 10% or less) at Week 48. RESULTS: At Week 48, mycological cure was attained by 88.2% (30 of 34) and 79.3% (23 of 29) of patients in the itraconazole and terbinafine groups, respectively (P not significant). Effective cure (mycological cure with 相似文献
14.
Pietro Nenoff Constanze Krüger Uwe Paasch Gabriele Ginter‐Hanselmayer 《Journal der Deutschen Dermatologischen Gesellschaft》2015,13(5):387-411
Treatment of dermatophyte infections is based on the clinical picture and mycological detection of the causative pathogen. Based on the appropriate indication, onychomycosis can be treated topically using an antimycotic nail lacquer. Atraumatic nail abrasion with 40 % urea ointment has a beneficial effect on healing. Continuous treatment of onychomycosis with terbinafine represents the most effective systemic therapy. Terbinafine or itraconazole are the safest and most effective antimycotic agents for the treatment of onychomycosis in children. For laser therapy of onychomycosis, only a few studies on clinical efficacy are available. Regarding tinea capitis, targeted species‐specific therapy of dermatophytosis of the scalp is currently recommended. Terbinafine, yet also itraconazole and fluconazole, are effective in tinea capitis caused by Trichophyton species. Microsporum infections of the scalp are preferably treated with griseofulvin, alternatively with itraconazole or fluconazole. Terbinafine is less effective. Candidal intertrigo are topically treated with nystatin, but azoles or ciclopirox olamine are also suitable candidates. Systemically, fluconazole or itraconazole are used. Topical and systemic antimycotics are equivalent forms of therapy in acute vulvovaginal mycosis. Fluconazole is the drug of choice in chronic recurrent vulvovaginal mycosis caused by Candida albicans. Ketoconazole shows very good efficacy in tinea versicolor. With respect to systemic treatment of severe and widespread tinea versicolor, itraconazole is the drug of choice. 相似文献
15.
Single-blind, randomized, prospective study on terbinafine and itraconazole for treatment of dermatophyte toenail onychomycosis in the elderly 总被引:5,自引:0,他引:5
BACKGROUND: The 2 most common agents used to treat dermatophyte onychomycosis of the toe are terbinafine (continuous) and itraconazole (pulse). Although comparative studies have been performed evaluating the efficacy of these 2 agents in adults, no such studies have been reported specifically in the elderly subset. OBJECTIVE: This prospective, randomized, single-blind, non--industry-sponsored, comparative study evaluated the efficacy and safety of terbinafine (continuous) and itraconazole (pulse) therapies in the treatment of dermatophyte onychomycosis of the toe in the elderly population. METHODS: Elderly patients (> or =60 years old) with dermatophyte onychomycosis of at least 1 great toe were randomly assigned to receive either terbinafine 250 mg/day for 12 weeks or itraconazole (pulse) 200 mg twice a day for 1 week, given for 3 pulses. At month 6 from the start of therapy, if there was less than 50% reduction in the affected nail plate area compared with baseline, or if there was less than 3 mm outgrowth of unaffected nail plate as measured in midline, then patients who had been administered terbinafine (continuous) therapy were given an extra 4 weeks of the drug (total of 16 weeks of therapy), and those who had received itraconazole (pulse) therapy were given an extra pulse (fourth pulse). Patients were evaluated at 1.5, 3, 6, 12, and 18 months from the start of therapy. The efficacy measures included mycologic cure rate and clinical efficacy (mycologic cure plus clinical cure or clinical improvement so that 10% or less of nail plate was clinically involved). RESULTS: There were 101 elderly patients enrolled in the study with 50 and 51 patients receiving terbinafine and itraconazole, respectively. The terbinafine group consisted of 28 men and 22 women, age (mean +/- standard error [SE]) 68.0 +/- 0.9 years, duration of onychomycosis (mean +/- SE) 18.2 +/- 1.4 years, number of nails involved (mean +/- SE) 5.5 +/- 0.5, and percent baseline nail plate area involved (mean +/- SE) 67.5% +/- 4.2%. The corresponding figures for the itraconazole (pulse) group were 24 men and 27 women, age (mean +/- SE) 68.8 +/- 0.8 years, duration of onychomycosis (mean +/- SE) 16.1 +/- 1.7 years, number of nails involved (mean +/- SE) 6.0 +/- 0.7, and percent baseline nail plate area involved (mean +/- SE) 74.9% +/- 3.8%, respectively, with no significant difference between the groups. At month 6, the number of patients that required an extra 4 weeks of terbinafine in the allylamine group or an extra itraconazole pulse in the triazole group was 13 of 50 and 23 of 51, respectively. The mycologic cure rate and clinical efficacy at 18 months from the start of therapy for the terbinafine group were 64.0% and 62.0%, respectively. The corresponding figures for the itraconazole (pulse) group were 62.7% and 60.8%, respectively, with no significant difference between the 2 groups. There were no dropouts during therapy. For both groups the drug appeared safe with no significant adverse events (AEs) or clinically significant laboratory abnormalities. All the AEs were mild and transient. There was high compliance with both regimens. CONCLUSIONS: In the elderly, for the treatment of dermatophyte toe onychomycosis, both terbinafine (continuous) and itraconazole (pulse) therapies are effective, safe, and associated with high compliance. 相似文献
16.
BACKGROUND: The prevalence of onychomycosis is higher in certain high-risk populations, such as the immunocompromised, diabetics and human immunodeficiency virus (HIV)-positive patients. These patients can also develop onychomycosis due to nondermatophyte fungi. Although the efficacy of terbinafine is well demonstrated in the treatment of conventional dermatophyte nail infection, there are few data on the efficacy of terbinafine in high-risk patient groups or in nondermatophyte fungi, which can be difficult to treat. OBJECTIVES: To review previously published data regarding the safety and efficacy of terbinafine in special patient populations, such as those with diabetes mellitus or HIV infection, those receiving immunosuppressive therapy, and patients with onychomycosis due to nondermatophyte fungi. METHODS: A Medline literature search up to October 2002 was performed in order to identify relevant studies. Pertinent abstracts presented at international meetings were also included. Cure rates (per-protocol and intention-to-treat) were extracted or calculated. All available safety data were also collated. RESULTS: Terbinafine was highly effective and well tolerated in patients with diabetes mellitus. Mycological cure rates of 62-78% were achieved in three studies, which is comparable with the efficacy in nondiabetic populations. Mycological cure rates of 64-91% were achieved in subsets of diabetic patients with Candida-positive nail cultures. The efficacy of terbinafine in patients receiving immunosuppressive therapy was also similar to that reported in immunocompetent patients. Levels of ciclosporin in the blood clearly decreased, with little clinical consequence; however, consideration should be given to the monitoring of ciclosporin levels in patients concomitantly receiving immunosuppressive therapy and terbinafine. Two small studies reported that terbinafine was also effective in treating onychomycosis in HIV-positive patients. Terbinafine was also effective and well tolerated in the treatment of nondermatophyte onychomycosis. CONCLUSIONS: This review suggests that terbinafine is a safe and effective treatment for onychomycosis in high-risk populations. However, the majority of these studies only included small numbers of patients and larger clinical trials are needed, especially in patients with HIV infection. 相似文献
17.
Terbinafine, an orally and topically active antimycotic agent, inhibits the biosynthesis of the principal sterol in fungi, ergosterol, at the level of squalene epoxidase. Squalene epoxidase inhibition results in ergosterol-depleted fungal cell membranes (fungistatic effect) and the toxic accumulation of intracellular squalene (fungicidal effect). Terbinafine has demonstrated excellent fungicidal activity against the dermatophytes and variable activity against yeasts and non-dermatophyte molds in vitro. Following oral administration, terbinafine is rapidly absorbed and widely distributed to body tissues including the poorly perfused nail matrix. Nail terbinafine concentrations are detected within 1 week after starting therapy and persist for at least 30 weeks after the completion of treatment. Randomized, double-blind trials showed oral terbinafine 250 mg/day for 12 or 16 weeks was more efficacious than itraconazole, fluconazole and griseofulvin in dermatophyte onychomycosis of the toenails. In particular, at 72 weeks' follow-up, the multicenter, multinational, L.I.ON. (Lamisil vs Itraconazole in ONychomycosis) study found that mycologic cure rates (76 vs 38% of patients after 12 weeks' treatment; 81 vs 49% of recipients after 16 weeks' therapy) and complete cure rates were approximately twice as high after terbinafine treatment than after itraconazole (3 or 4 cycles of 400 mg/day for 1 week repeated every 4 weeks) in patients with toenail mycosis. Furthermore, the L.I.ON. Icelandic Extension study demonstrated that terbinafine was more clinically effective than intermittent itraconazole to a statistically significant extent at 5-year follow-up. Terbinafine produced a superior complete cure rate (35 vs 14%), mycologic cure rate (46 vs 13%) and clinical cure rate (42 vs 18%) to that of itraconazole. The mycologic and clinical relapse rates were 23% and 21% in the terbinafine group, respectively, compared with 53% and 48% in the itraconazole group. In comparative clinical trials, oral terbinafine had a better tolerability profile than griseofulvin and a comparable profile to that of itraconazole or fluconazole. Post marketing surveillance confirmed terbinafine's good tolerability profile. Adverse events were experienced by 10.5% of terbinafine recipients, with gastrointestinal complaints being the most common. Unlike the azoles, terbinafine has a low potential for drug-drug interactions. Most pharmacoeconomic evaluations have shown that the greater clinical effectiveness of oral terbinafine in dermatophyte onychomycosis translates into a cost-effectiveness ratio superior to that of itraconazole, fluconazole and griseofulvin. CONCLUSION: Oral terbinafine has demonstrated greater effectiveness than itraconazole, fluconazole and griseofulvin in randomized trials involving patients with onychomycosis caused by dermatophytes. The drug is generally well tolerated and has a low potential for drug interactions. Therefore, terbinafine is the treatment of choice for dermatophyte onychomycosis. 相似文献
18.
Background:
Toenail onychomycosis is a challenge for clinicians to treat. While both Itraconazole and terbinafine have proven to be effective against onychomycosis, very little is known about their comparative efficacy in achieving mycological and clinical cure.Aim:
The purpose of this meta-analysis is to compare the efficacy of continuous terbinafine with intermittent itraconazole in the treatment of toenail onychomycosis.Material and Methods:
all RCTs comparing continuous terbinafine with intermittent itraconazole were identified from PUBMED and BIDS electronic database.Results:
analysis of total eight trials including 1181 patients state that treatment with continuous terbinafine is more likely to produce mycological and clinical cure compared to intermittent itraconazole with odds ratio 2.3(95% CI, 1.7 to 3.0 P<0.0001)Conclusion:
though both itraconazole and terbinafine are well tolerated and highly effective drugs, continuous terbinafine is more effective than intermittent itraconazole at achieving mycological cure of toenail onychomycosis 相似文献19.
口服特比萘芬治疗甲真菌病83例疗效观察 总被引:2,自引:0,他引:2
王新华 《中国皮肤性病学杂志》2009,23(8)
目的了解特比萘芬治疗甲真菌病的疗效和安全性。方法将2005年5月~2008年10月就诊的159例甲真菌病随机分为两组,治疗组83例,口服特比萘芬250mg,1次/d,连续服药;对照组76例口服伊曲康唑200mg,2次/d,冲击治疗,连用1周,停药3周为1个疗程,共3~4个疗程。结果治疗组和对照组停药时痊愈率分别为63.86%和50.00%,有效率分别为83.13%和69.74%,真菌学痊愈率分别为79.52%和65.79%;停药后16周痊愈率分别为84.34%和75.00%,有效率分别为97.60%和94.74%,真菌学痊愈率分别为93.98%和88.16%。不良反应发生率分别为9.64%和9.2%。两组在停药时及停药后16周痊愈率、有效率和真菌学治愈率,差异均无显著意义(P均>0.05);不良反应发生率差异也无显著性意义(P>0.05)。结论特比萘芬治疗甲真菌病疗效好,安全性高。 相似文献