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Tropical Medicine and International Health. 2004 Feb; 9(2):192-199.The World Health Organization (WHO) is promoting artemether-lumefantrine for treating uncomplicated malaria. The objective of this review is to summarize available evidence of its effects compared with other antimalarial regimens. We sought randomized and quasi-randomized studies comparing artemether-lumefantrine with any other antimalarial drug regimen. Databases searched were MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. Conference proceedings and reference article lists were searched and malaria researchers and the drug manufacturer were contacted. Two reviewers independently applied inclusion criteria and extracted data. Six trials (1698 participants) studied the four-dose regimen. Fever and parasite clearance tended to be shorter with artemether-lumefantrine, but parasitological failure on day 28 was more common with artemether-lumefantrine in comparison with mefloquine (one trial, n = 233), halofantrine (one trial, n = 86) and mefloquine-artesunate (one trial, n = 537); but less common with chloroquine (two trials, n = 378). For the six-dose regimen, two studies compared artemether-lumefantrine with mefloquine-artesunate, but there was insufficient data to demonstrate any meaningful comparative effects for day 28 parasitaemia, and no difference in parasite or fever clearance time was detected. There were 11 parasitological failures with artemether-lumefantrine and none with mefloquine-artesunate. There is no evidence to demonstrate the four-dose regimen of artemether-lumefantrine results in a higher cure rate than other antimalarial regimens against which it has been tested, apart from chloroquine in areas with high chloroquine resistance. Artemether-lumefantrine has potential advantages over non-artemisinin regimens because of the faster clearance time and gametocyte clearance. There is insufficient evidence about the six-dose regimen to know whether it is less or more effective than current antimalarial drug regimens. (author's)
Practical aspects of in vivo antimalarial drug efficacy testing in The Americas. [Aspectos prácticos de las pruebas de eficacia in vivo de la medicación antipalúdica realizadas en las Américas]
American Journal of Tropical Medicine and Hygiene. 2003; 68(4):391-397.The World Health Organization (WHO) has developed guidelines for in vivo antimalarial drug efficacy testing for Plasmodium falciparum and Plasmodium vivax in areas with low-to-moderate transmission, such as the Americas. These guidelines are used widely by ministries of health and national malaria control programs to assess the efficacy of their first-line and second-line drugs for the treatment of malaria and to provide the information necessary to update national malaria treatment policies. Following the WHO guidelines, we have conducted in vivo efficacy trials with a variety of drugs and drug combinations against P. falciparum and P. vivax at 13 sites in Peru, Bolivia, and Ecuador. Based on these experiences, we have identified several modifications that we believe should be made in the WHO recommendations to make them more suitable to the relatively low levels of P. falciparum transmission in the Americas and to the logistic challenges of carrying out such studies in sparsely populated areas, such as the Amazon Basin. These include changes in inclusion and exclusion criteria, in enrollment and follow-up procedures, and in the measurement of study outcomes. (author's)
DOTS versus self administered therapy (SAT) for patients of pulmonary tuberculosis: a randomised trial at a tertiary care hospital.
Indian Journal of Medical Sciences. 2002 Jan; 56(1):19-21.Tuberculosis is a major public health problem in India, and it is being made worse by poor adherence to and frequent interruption of antitubercular treatment. Directly observed therapy short course (DOTS), is one of the key elements in the WHO global tuberculosis control programme strategy and has been widely publicized as a breakthrough and strongly promoted globally by WHO. However little or no randomised data exists of comparison between DOTS versus self administered therapy (SAT). The present study is an effort in this direction to compare adherence and outcome after random allocation of patients to directly observed therapy (DOTS) or self administered therapy (SAT). (author's)
A dose escalation study of docetaxel and oxaliplatin combination in patients with metastatic breast and non-small cell lung cancer.
Anticancer Research. 2003 Jan-Feb; 23(1B):785-791.Objectives: To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of docetaxel in combination with oxaliplatin (L-OHP) as first-line treatment of patients with advanced breast (ABC) and non-small cell lung cancer (NSCLC). Patients and methods: Fifty-two patients (26 with NSCLC and 26 with ABC), who had not received prior chemotherapy for metastatic disease, were enrolled. The patients' median age was 64 years, and 42 (71%) had a performance status (WHO) 0-1. Docetaxel was given as a 1-hour infusion after standard premedication on day 1 and L-OHP as a 2 to 6-hour infusion on day 2 every 3 weeks. Doses were escalated at increments of 10mg/m2. Results: The DLT1 was reached at the doses of docetaxel 75mg/m2 and L-OHP 80mg/m2. The addition of rhG-CSF permitted further dose escalation (DLT2: docetaxel 90mg/m2 and L-OHP 130mg/m2). The dose-limiting events were grade 4 neutropenia, febrile neutropenia, grades 3 or 4 diarrhea and grade 3 fatigue. Out of 239 delivered cycles, grades 3 or 4 neutropenia occurred in 22 (9%) cycles with 5 (2%) neutropenic febrile episodes. There was one septic death. Grades 3 or 4 fatigue was observed in seven (13%) patients and grades 3-4 diarrhea in five (10%). Out of 42 patients evaluable for response, seven (27%) patients with ABC and five (19%) patients with NSCLC experienced a partial response. Conclusion: The combination of docetaxel and oxaliplatin is a feasible and well-tolerated regimen. The recommended doses for future phase II studies are 75mg/m2 for docetaxel on day 1 and 70mg/m2 for L-OHP on day 2 without rhG-CSF support and 85mg/m2 and 130mg/m2, respectively, with rhG-CSF support. (author's)
Lancet. 1999 Jul 10; 354(9173):158-9.The International Child Health Group of the Royal College of Pediatrics and Child Health is displeased with the UNAIDS, UNICEF, and WHO policy statement endorsing the artificial feeding of infants. The statement holds that with nutritionally adequate breast milk substitutes safely prepared and fed to the infants of mothers with HIV infection, the infants are at less risk of morbidity and mortality than if they were breast-fed. This global policy has more potential to harm than help, for women in extremely poor and unsuitable settings may wrongly decide to adopt bottlefeeding. The better strategy is to promote exclusive breast-feeding for 4-6 months. Efforts should also be made to reduce the vertical transmission of HIV by increasing the use of short-course zidovudine wherever feasible. Further efforts should be made to address the factors which contribute to HIV infection and prevent social and economic development.
TDR NEWS. 1996 Mar; (49):1-2.A UNDP/World Bank/WHO Special Program for Research and Training in Tropical Diseases (TDR) expert meeting has concluded that the means already exist with which to eliminate 4 of the 8 diseases which TDR originally identified as public health problems. Elimination in this case refers to reducing the number of cases of disease to a small and routinely manageable number. The diseases capable of being eliminated with existing tools are leprosy, onchocerciasis, lymphatic filariasis, and Chagas disease. Leprosy can be eliminated through the use of multidrug therapy, onchocerciasis through the administration of ivermectin, lymphatic filariasis through the use of DEC and ivermectin, and Chagas disease through the rational use of insecticides and the control of blood banks. Malaria, schistosomiasis, leishmaniasis, and African trypanosomiasis, however, must await better tools before their elimination can be attempted. TDR's role in identifying how to eliminate each of these diseases is described. Meeting attendees identified additional avenues of operational research upon which TDR should embark.
SCIENCE. 1998 Feb 27; 279(5355):1299.A US-funded, placebo-controlled clinical trial in Thailand has found that a brief, relatively inexpensive course of the antiretroviral drug AZT given during the final weeks of pregnancy can reduce the transmission of HIV from mothers to their newborn infants. Plans are now being developed to make the therapy available to thousands of HIV-infected women in the developing world. Main findings of the Thai study were released on February 18, 1998. Researchers conducted the trial to assess whether the provision of AZT orally to pregnant HIV-infected women for 4 weeks before going into labor would reduce the amount of HIV they passed onto their children. AZT was already known to be effective in reducing HIV transmission when given in a more complex and expensive regimen, but the short regimen costs only one-tenth that of standard treatment. In order to obtain clear results, half of the women received AZT and the other half a sugar tablet placebo. Preliminary data indicate that the level of HIV transmission fell from 18.6% in the placebo group to 9.2% in the AZT test group. The short-course AZT regimen therefore proved to be well tolerated and effective in women who did not breast-feed. Despite critics' complaints that the placebo-controlled nature of the trial was both unethical and unnecessary, evaluation of the therapy against a placebo enhanced the statistical power of the study, yielded rapid results, gave health officials confidence to recommend the broad use of the therapy, and fostered the recommendation that other placebo-controlled trials be changed.
SCIENCE. 1990 Oct 12; 250:200.Researchers in Kenya claim that small doses (100 unites) of oral alpha interferon depressed symptoms in AIDS patients and, in 10% of patients, all signs of HIV infection disappeared. President apap Moi promotes these findings. AIDS patients from other African countries and the US have since gone to Kenya seeking treatment. Yet the Western biomedical establishment is not showing much enthusiasm, not even the man who introduced the notion of using low dose oral alpha interferon to treat AIDS to the principal investigator. WHO has supported a sequence of rapid test of alpha interferon in other African countries. Experts at WHO headquarters believe alpha interferon is unproven as an AIDS drug and requires more study. Both the Kenyan study and the WHO studies were uncontrolled studies. Further the patients in the studies received different formulations of alpha interferon. WHO now calls for properly controlled formulations of alpha interferon. WHO now calls for properly controlled clinical trials. In New York City and Amarillo, Texas, 2 such small trials are indeed occurring. So far, however, preliminary data do not indicate changes in T cell counts. Thus alpha interferon has not caused improvement in immune status. US National Institute of Allergy and Infectious Diseases researchers have injected large doses of recombinant forms of alpha interferon in asymptomatic HIV infected subjects and viral production slowed down. In fact, the risk of developing opportunistic infections decreased. A phase III clinical trial of injectable alpha interferon alone and with the nucleoside analogs AZT and ddI is under way. Further millions of units of injectable alpha interferon is now used to treat people with Kaposi's sarcoma and genital warts. Kenyan officials are so confident of alpha interferon's ability to treat AIDS that it plans on mass producing it and patent the formulation. Yet a US veterinarian in Texas already has several patents on it.