Girard P M, Goldschmidt E, Vittecoq D, Massip P, Gastiaburu J, Meyohas M C, Coulaud J P, Schally A V
Centres Hospitaliers Universitaires Bichat-Claude-Bernard, Necker, St Antoine, Paris, France.
AIDS. 1992 Jul;6(7):715-8. doi: 10.1097/00002030-199207000-00015.
To evaluate the efficacy and tolerance of vapreotide, a new somatostatin analogue, in the treatment of refractory AIDS-related diarrhoea.
An open, non-comparative pilot trial.
The trial was conducted in 10 medical centres in France.
PATIENTS, PARTICIPANTS: Thirty-four AIDS patients with chronic diarrhoea unresponsive to conventional antidiarrhoeal therapy were enrolled. Cryptosporidiosis was diagnosed in 21 out of 30 evaluable patients. Mean number of stools prior to therapy was 10.1 +/- 4.9 per day (range, 3-20 stools per day).
After initial baseline studies, patients received subcutaneous vapreotide at escalating doses of 400 (23 patients) or 500 micrograms (seven patients), between two and six times daily.
Efficacy was assessed after 14 days of therapy, when it was found to be effective. Responders were offered the opportunity to continue receiving therapy.
Four patients demonstrated a complete response and 12 a partial response with greater than 50% reduction in daily stool emission. Fourteen patients did not respond to doses up to 2400 micrograms/day. Patients with conditions other than cryptosporidiosis had a significantly higher probability of response (P = 0.013), as did those with milder diarrhoea (less than 10 stools per day). Median duration of response was 1.5 months (range, 0.5-5 months); relapse occurred in five out of eight responders despite maintenance therapy. Toxicity was minimal.
We conclude that AIDS patients with diarrhoea not caused by Cryptosporidium may benefit from vapreotide therapy.
评估新型生长抑素类似物伐普肽治疗难治性艾滋病相关腹泻的疗效和耐受性。
一项开放、非对照的试点试验。
该试验在法国的10个医疗中心进行。
患者、参与者：纳入34例对传统止泻治疗无反应的慢性腹泻艾滋病患者。30例可评估患者中有21例诊断为隐孢子虫病。治疗前平均每日排便次数为10.1±4.9次（范围为每日3 - 20次）。
在进行初始基线研究后，患者接受皮下注射伐普肽，剂量逐步递增至400μg（23例患者）或500μg（7例患者），每日注射2至6次。
治疗14天后评估疗效，若发现有效，则让有反应者继续接受治疗。
4例患者完全缓解，12例部分缓解，每日排便次数减少超过50%。14例患者对每日高达2400μg的剂量无反应。非隐孢子虫病患者的反应概率显著更高（P = 0.013），腹泻较轻（每日少于10次）的患者也是如此。反应的中位持续时间为1.5个月（范围为0.5 - 5个月）；8例有反应者中有5例尽管接受维持治疗仍复发。毒性极小。
我们得出结论，非隐孢子虫引起腹泻的艾滋病患者可能从伐普肽治疗中获益。
