Kelly P, Buve A
Monze District Hospital, Zambia.
AIDS. 1993 Jan;7(1):91-3. doi: 10.1097/00002030-199301000-00014.
To determine whether combined chemotherapy with tinidazole, thiabendazole and cotrimoxazole is more effective than placebo in treatment of AIDS diarrhoea in Zambia.
Single-blind prospective comparison in consecutive patients, randomized alternately to placebo or chemotherapy.
A district hospital in Zambia.
Sixty-four HIV-seropositive patients with chronic diarrhoea were considered for inclusion in the study. Of these, 25 patients were not eligible for randomization (in 13 cases because of spontaneous remission); 11 were randomized, but excluded from the analysis (seven failed to attend for a scheduled visit and four died), leaving 28 patients who completed the study.
Proportion of diarrhoea-free days in the 7 days following treatment, as determined by daily stool counts.
There were 38 diarrhoea-free days out of 89 (43%) in the placebo group, and 39 out of 72 (54%) in the chemotherapy group; this difference was not statistically significant.
The high level of spontaneous remission probably indicates a natural fluctuation in stool frequency and demonstrates the need for placebo-controlled studies in any assessment of therapy for AIDS diarrhoea. Our findings do not allow us to conclude that the chemotherapy used is ineffective, since the number of patients was low, but will help in our understanding of the natural history of the disorder and the design of future studies.
确定替硝唑、噻苯达唑和复方新诺明联合化疗在赞比亚治疗艾滋病腹泻方面是否比安慰剂更有效。
对连续患者进行单盲前瞻性比较，交替随机分为安慰剂组或化疗组。
赞比亚的一家地区医院。
64名慢性腹泻的HIV血清阳性患者被纳入本研究。其中，25名患者不符合随机分组条件（13例是因为自发缓解）；11名患者被随机分组，但被排除在分析之外（7例未按计划就诊，4例死亡），剩下28名患者完成了研究。
通过每日粪便计数确定治疗后7天内无腹泻天数的比例。
安慰剂组89天中有38天无腹泻（43%），化疗组72天中有39天无腹泻（54%）；这种差异无统计学意义。
自发缓解率高可能表明粪便频率存在自然波动，并表明在对艾滋病腹泻治疗的任何评估中都需要进行安慰剂对照研究。我们的研究结果不能让我们得出所用化疗无效的结论，因为患者数量较少，但将有助于我们了解该疾病的自然史和未来研究的设计。
