Mutua Florence M, M'imunya James Machoki, Wiysonge Charles Shey
Department of Medical Microbiology, College of Health Sciences, University of Nairobi, Nairobi, Kenya.
Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007933. doi: 10.1002/14651858.CD007933.pub2.
Genital ulcer disease by virtue of disruption of the mucosal surfaces may enhance HIV acquisition. Genital ulcer disease treatment with resolution of the ulcers may therefore contribute in reducing the sexual acquisition of HIV.
To determine the effects of treatment of genital ulcer disease on sexual acquisition of HIV.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, LILACS, NLM Gateway, Web of Science, WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, and reference lists of relevant publications for eligible studies published between 1980 and August 2011.
Randomized controlled trials of any treatment intervention aimed at curing genital ulcer disease compared with an alternative treatment, placebo, or no treatment. We included only trials whose unit of randomization was the individual with confirmed genital ulcer.
We independently selected studies and extracted data in duplicate; resolving discrepancies by discussion, consensus, and arbitration by third review author. We expressed study results as risk ratios (RR) with 95% confidence intervals (CI).
There were three randomized controlled trials that met our inclusion criteria recruited HIV-negative participants with chancroid (two trials with 143 participants) and primary syphilis (one trial with 30 participants). The syphilis study, carried out in the US between 1995 and 1997, randomized participants to receive a single 2.0 g oral dose of azithromycin (11 participants); two 2.0 g oral doses of azithromycin administered six to eight days apart (eight participants); or benzathine penicillin G administered as either 2.4 million units intramuscular injection once or twice seven days apart (11 participants). No participant in the trial seroconverted during 12 months of follow-up. The chancroid trials, conducted in Kenya by 1990, found no significant differences in HIV seroconversion rates during four to 12 weeks of follow-up between 400 and 200 mg single oral doses of fleroxacin (one trial, 45 participants; RR 3.00; 95% CI 0.29 to 30.69), or between 400 mg fleroxacin and 800 mg sulfamethoxazole plus 160 mg trimethoprim (one trial, 98 participants; RR 0.33; 95% CI 0.04 to 3.09). Adverse events reported were mild to moderate in severity, and included Jarisch-Herxheimer reactions and gastrointestinal symptoms. The differences between the treatment arms in the incidence of adverse events were not significant. The quality of this evidence on the effectiveness of genital ulcer disease treatment in reducing sexual acquisition of HIV, according to GRADE methodology, is of very low quality.
AUTHORS' CONCLUSIONS: At present, there is insufficient evidence to determine whether curative treatment of genital ulcer disease would reduce the risk of HIV acquisition. The very low quality of the evidence implies that the true effect of genital ulcer disease treatment on sexual acquisition of HIV may be substantially different from the effect estimated from currently available data. However, genital ulcer diseases are public health problems in their own right and patients with these conditions should be treated appropriately; whether the treatment reduces the risk of HIV infection or not.
由于黏膜表面破损，生殖器溃疡疾病可能会增加感染艾滋病毒的风险。因此，治愈生殖器溃疡疾病可能有助于减少通过性行为感染艾滋病毒的几率。
确定生殖器溃疡疾病的治疗对通过性行为感染艾滋病毒的影响。
我们检索了Cochrane对照试验中心注册库（CENTRAL）、PubMed、EMBASE、拉丁美洲及加勒比地区卫生科学数据库（LILACS）、美国国立医学图书馆网关、科学引文索引（Web of Science）、世界卫生组织国际临床试验注册平台、美国国立医学图书馆临床试验数据库（ClinicalTrials.gov），以及1980年至2011年8月期间发表的相关出版物的参考文献列表，以查找符合条件的研究。
将任何旨在治愈生殖器溃疡疾病的治疗干预措施与替代治疗、安慰剂或不治疗进行比较的随机对照试验。我们仅纳入随机分组单位为确诊生殖器溃疡患者个体的试验。
我们独立选择研究并重复提取数据；通过讨论、达成共识以及由第三位审阅作者进行仲裁来解决分歧。我们将研究结果表示为风险比（RR）及95%置信区间（CI）。
有三项符合我们纳入标准的随机对照试验，招募了感染艾滋病毒阴性的软下疳患者（两项试验，共143名参与者）和一期梅毒患者（一项试验，30名参与者）。1995年至1997年在美国进行的梅毒研究中，参与者被随机分组，分别接受单次口服2.0克阿奇霉素（11名参与者）；相隔六至八天口服两次2.0克阿奇霉素（8名参与者）；或苄星青霉素G，分别为240万单位肌肉注射一次或相隔七天注射两次（11名参与者）。在12个月的随访期间，试验中没有参与者血清转化。1990年在肯尼亚进行的软下疳试验发现，在四至12周的随访期间，单次口服400毫克和200毫克氟罗沙星（一项试验，45名参与者；RR 3.00；95% CI 0.29至30.69）之间，或400毫克氟罗沙星与800毫克磺胺甲恶唑加160毫克甲氧苄啶（一项试验，98名参与者；RR 0.33；95% CI 0.04至3.09）之间，艾滋病毒血清转化率没有显著差异。报告的不良事件严重程度为轻度至中度，包括赫氏反应和胃肠道症状。各治疗组之间不良事件发生率的差异不显著。根据GRADE方法，关于生殖器溃疡疾病治疗在减少通过性行为感染艾滋病毒方面有效性的这一证据质量非常低。
目前，尚无足够证据确定生殖器溃疡疾病的治愈性治疗是否会降低感染艾滋病毒的风险。证据质量极低意味着生殖器溃疡疾病治疗对通过性行为感染艾滋病毒的实际效果可能与根据现有数据估计的效果有很大差异。然而，生殖器溃疡疾病本身就是公共卫生问题，患有这些疾病的患者应得到适当治疗；无论治疗是否能降低艾滋病毒感染风险。
