[Tribendimidine enteric coated tablet in treatment of 1,292 cases with intestinal nematode infection--a phase IV clinical trial].
OBJECTIVE
To further evaluate the efficacy and safety of tribendimidine in treatment of adult patients with intestinal nematode infections.


METHODS
An open and multi-center clinical trial was conducted in the provinces of Hainan, Sichuan and Guizhou. A total of 1,292 infected cases aged 15-70 years were enrolled in the study. Modified Kato-Katz method was used to diagnose the cases with intestinal nematode infections and assess the efficacy 3-4 weeks post treatment. Patients with Ascaris lumbricoides infection were treated orally with tribendimidine enteric coated tablets at a single dose of 300 mg, while in the patients with Ancylostoma duodenale, mixed A. duodenale and A. lumbricoides, or with other helminth infections, a single dose of 400 mg was administered.


RESULTS
The cure rate and effective rate of the patients with Ancylostoma infection were 88.4% (1,009/1,141) and 99.1% (1,131/1,141), respectively, while in patients with A. lumbricoides infection, they were 95.0% (419/441) and 99.8% (440/441), respectively. The cure rate of tribendimidine enteric coated tablet given to patients with Trichuris trichiura infection at a single dose of 400 mg was 76.8% (109/142). The adverse effect induced by tribendimidine was light and transient with a rate of 3.3% (42/1,292). No apparent impact was seen on blood and urine routine examinations, hepatic and renal functions as well as ECG examination.


CONCLUSIONS
It is further confirmed that under the used dosage for expanding treatment in larger sample of patients with various ages and infected with Ancylostoma duodenale, A. lumbricoides and other helminths, tribendimidine enteric coated tablet is safe with satisfactory efficacy.
Zhang
Jian-Hui
JH
Shandong Xinhua Pharmaceutical Company Ltd, Zibo 255005, China.
Xiao
Shu-Hua
SH
Wu
Zhong-Xing
ZX
Qiu
Dong-Chuan
DC
Wang
Shi-Hai
SH
Wang
Shan-Qing
SQ
Wang
Chong
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D002681:China; D006801:Humans; D007411:Intestinal Diseases, Parasitic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009349:Nematode Infections / Q000188:drug therapy* / Q000469:parasitology; D010655:Phenylenediamines / Q000009:adverse effects / Q000627:therapeutic use*; D017168:Rhabditida / Q000187:drug effects; D013608:Tablets, Enteric-Coated; D016896:Treatment Outcome; D055815:Young Adult
D010655:Phenylenediamines; D013608:Tablets, Enteric-Coated; C056017:tribendimidine