Quinacrine Non-surgical Method of Voluntary Female Sterilization: Current News  
 
   
  

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GENERAL ARTICLES (continued)

Interview with Elton Kessel at Agra meeting.
E. Kessel. Newsletter report of the 11th Indian Conference on Family Welfare and Voluntary Sterilisation and Family Welfare of India, Oct. 30 1996; p. 2.
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Summary: No country has successfully reduced population growth below 1% without widespread use of sterilization. There is a great unmet need in India that the quinacrine method could satisfy. It is easy to provide in rural areas, safer than surgery and very inexpensive. Each country must conduct its own risk-benefit analysis to arrive at decision for its use. It could have a very favorable impact on the health of Indian women.

100,000 Quinacrine Sterilizations.
E. Kessel (Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon. Acta Obstetricia et Gynecologica Scandinavica 1997; Vol 76: Sup. 167:4 p.16 (Abstract).
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Summary: 100,000 quinacrine non-surgical female sterilizations have been completed over the past decade involving transcervical insertion of quinacrine (252 mg) as pellets by one, two or three monthly insertions. No deaths have been reported and serious complications are far fewer than for surgical sterilization. Side-effects are mild and transient Efficacy has improved from 3 pregnancy failures per 100 women at one year to approximately 1 by improved insertion technique and use of an additional contraceptive for 3 months. Efficacy is increased by repeat insertions or higher dose, which however extends damage to the tube beyond the intramural segment. Long-term follow-up of early cases in Chile shows no increased risk of cancer for this method. It is decreased by presence of blood in the uterine cavity. The main advantage of quinacrine sterilization is its ability to raise contraceptive prevalence and thereby reduce maternal mortality and morbidity, especially in rural and urban slum areas of developing countries. It should be made available as an option to well informed women everywhere as an economical and safe permanent family planning method.

Quinacrine sterilization: an assessment of risks for ectopic pregnancy, birth defects and cancer. .
E. Kessel. Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon, USA,. Advances in Contraception 1998; 14:81-90.
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Summary: Efficacy is presently estimated at 1 pregnancy failure per 100 women at 2 years. Early complications are lower for QS than surgical sterilization and this is also true for risk of ectopic pregnancy with newer insertion protocols. The risk of birth defects is very low, when estimated from a model with reasonable assumptions for probability of insertion in a pregnant uterus or within 30 days of conception, probability of such exposed pregnancy being carried to term, and probability of quinacrine exposure to the fetus causing a birth defect. Although quinacrine is a mutagen it is unlikely to be a carcinogen. Concentrations of quinacrine in the uterus after transcervical insertion are higher than for oral administration for only a matter of a few hours, although this brief exposure is adequate to cause injury to the tubal epithelium, leading to inflammation and an occluding scar. Oral administration of quinacrine is accepted as non-carcinogenic. Each site of use of QS must make its own risk/benefit assessment. The benefits of any contraceptive that can raise contraceptive prevalence is greatest for developing countries.

Quinacrine hydrochloride: future research.
T.M. King, N.H. Dubin, D.A. Blake, T.H. Parmley (The Johns Hopkins University School of Medicine, Baltimore, Maryland).. In: Female Transcervical Sterilization: Zatuchni GI, Shelton JD, Goldsmith A, Sciarra JJ. eds., Philadelphia, Harper and Row 1983; p 138.
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Summary: Further research on quinacrine is needed. Such research might include the following: (1) Development of a timed release system for quinacrine to give a rate of release that would ensure low plasma levels of this agent, even if it is accidentally placed in the peritoneal cavity, while at the same time yielding high efficacy in causing tubal occlusion. (2) Determination of the tubal occlusion efficacy of nonmutagenic drugs chemically related to quinacrine. (3) Continued testing of alternative drugs with potentially better therapeutic indices for their ability to cause tubal occlusion. (4) More precise definition of the process by which quinacrine results in decreased fertility. (5) Determination of the mechanism by which quinacrine causes tubal closure. (6) On development of improved drug and/or delivery systems, institution of clinical trials, so that such a sterilization technique would ultimately become available.

Quinacrine Pellet Non-Surgical Female Sterilization: A Non-Governmental Service Initiative In South India.
P. Kini (Chip Trust, 3004, 12 'A' Main, HAL II Stage, Bangalore - 560008. INDIA), S. Bhateja (Dr. Sita Bateja Nursing Home, Langford Garden, Bangalore -560025. INDIA), Rajgopal. K (Dept. of OB/GYN, Kasturba Medical College, Mangalore -575 001. INDIA). Acta Obstetricia et Gynecologica Scandinavica 1997; Vol 76: Sup. 167:4 p.58 (Abstract).
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Summary: There is considerable unmet need for female sterilization in South India, much of which could be supplied by the private sector if there were a safe, inexpensive and effective non-surgical method. The quinacrine pellet method is the leading candidate for this purpose with an international experience of over 100,000 cases. The method involves transcervical insertion of quinacrine pellets totaling 252 mg in the proliferative phase of 2 consecutive menstrual cycles using a modified IUCD inserter. Any clinician experienced in IUCD insertion and sterilization counseling should be able to provide this method. It is not yet approved for introduction in the government family planning programme but a group of gynaecologists, general practitioners and medical college clinics in South India decided to encourage its use in pilot studies. Lectures were given at medical society meetings where an excellent training video concerning counseling and proper insertions technique was shown. Some postgraduate students conducted clinical trials as part of their doctoral thesis. Local State governments gave informal support but would not officially endorse the method without central government approval. The method is now spreading in private practices of gynaecologists and general practitioners in South India. With increasing usage of the method it should become a viable commercial option for marketing in the private sector, which could increase contraceptive prevalence with no burden to the government.

Sterilization without surgery: Special Report.
M. Klitsch, Assoc. Editor (Alan Guttmacher Institute). International Family Planning Perspectives 1982; 8:101-104.
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Summary: For about two decades, investigators around the world have been trying to develop a safe, 95% effective method of nonsurgical female sterilization that could be performed under local anesthesia on an outpatient basis by nonphysicians, preferably after only a brief training period. Such a method has been called vital for meeting the worldwide demand for voluntary sterilization, since it is projected that around 180 million men and women will be seeking sterilizations over the next 20 years. Researchers have experimented with various chemical sterilants -- phenol-based compounds, quinacrine and methylcyanoacrylate -- and with silicone rubber delivered by a variety of techniques. However, the goal remains elusive, in that either failure rates have exceeded 5%, the method's safety cannot be assured, the procedure is too complex or the method requires too many administrations. This is the conclusion to be drawn from the International Workshop on Nonsurgical Methods for Female Tubal Occlusion, a three-day workshop held in Chicago in June 1982, by the Program for Applied Research in Fertility Regulation. The article gives a detailed description of the methods.

Sterilisation by quinacrine comes under fire in India.
S. Kumar. Lancet 1997; 349:1460.
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Summary: Sterilization by quinacrine is an unauthorized technique in India, according to the writer. Several critics of the method plan to take doctors throughout the country to court for conducting clinical trials. Supporters of the method accuse their critics of indulging in sensationalism. Despite 100,000 sterilizations there have been no casualties. The critics contend that it has a high potential for abuse. Reference is made to A Yellow Haze, a film dealing with such abuse. No legal action has been initiated so far.

Nonsurgical female sterilization.
L.E. Laufe (Duke University Medical Center, Durham, North Carolina); L.P. Cole (International Fertility Research Program, Research Triangle Park, North Carolina). International Journal of Gynaecology and Obstetrics 1980; 18:333-9.
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Summary: The development of a safe, effective nonsurgical method of female sterilization that can be performed by paramedical personnel remains a high priority. The method should have a blind delivery system and require only one application. Methyl cyanoacrylate and quinacrine hydrochloride are the two most promising chemical agents. Quinacrine has evolved from instillations of a solution to the development of pellets to the use of an IUD vector. By using an IUD vector to deliver the quinacrine, tubal occlusion can be achieved with a reduction in total dosage and with one insertion instead of the three necessary with the solution and pellet methods.

Post-Congress symposium on nonsurgical female sterilization, Bandung, September 15, 1991.
Staff article. MCI newsletter January 1992; No. 19 p. 2.
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Summary: Cosponsored by Mother and Child International (MCI) and the International Federation for Family Health (IFFH). Key researchers of the quinacrine sterilization method were present, including its developer, Dr. J. Zipper (Chile), who reported on 2000 cases, Dr. D. T. Hieu (Vietnam) 12,000 cases, Dr. B. Mullick (India) 9000 cases, and Dr. A. Bashir (Pakistan) 2700. Among those, there was not a single serious complication and no mortality, demonstrating relative safety of the method. There were discussions of attempts to improve the process. Mumford spoke of demand for female surgical sterilization that cannot be met. Kessel emphasized this method's importance in saving women's lives by avoiding high risk pregnancies. Dr. V. Frey, Secretary General of MCI stated that although MCI had financed the method for several years hoping that it could contribute to solution of too rapid population growth in developing countries, the organization no longer had the means to do so. He also expressed the opinion that other organizations involved in family planning and population activities should financially assist such studies. In a late press release, confirmation was received that the Government of India had decided to initiate a clinical trial of the method.

Sterilization needs in the 1990s: the case for quinacrine nonsurgical female sterilization.
S.D. Mumford (Center for Research on Population and Security, Research Triangle Park, North Carolina); E. Kessel (Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon). American Journal of Obstetrics and Gynecology 1992; 167:1203-7.
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Summary: Much evidence suggests that demand for sterilization is a function of supply of surgical sterilization services in less-developed countries. If such services were greatly expanded, the number of procedures performed would grow dramatically. While the prevalence of sterilization is estimated to increase from 23.5% to 28.8% of married women of reproductive age in the 1990s, there will actually be 106,432,000 more couples of reproductive age at the end of this decade than at its beginning who use either no method or a far less effective method with much lower continuation rates than sterilization--nearly a 20% increase. To achieve a mean sterilization prevalence of 47% of married women of reproductive age in the less-developed world, as now seen in the Republic of Korea and Puerto Rico, the number of sterilizations would need to be more than double the current projection for the 1990s: 328,429,000 rather than 159,000,000. The quinacrine pellet method for nonsurgical female sterilization offers hope that this enormous shortfall in sterilization services can be overcome in this decade.

Quinacrine pellets: an examination of nonsurgical sterilization.
C. Pies (Department of Health science, San José State University, San José, California); M. Potts, B. Young (School of Public Health, University of California at Berkeley). International Family Planning Perspectives 1994; 20:137-141.
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Summary: The quinacrine method of nonsurgical female sterilization has been studied for over a quarter of a century, but knowledge of its recent availability has aroused significant interest and concern. In the early 1970s, some attention to this method was generated by the shift from a liquid "slurry" method to slow-release pellets, although by that time many commentators saw the method as having an unacceptably high failure rate and as presenting serious risks. Findings from field studies in 1989-1992 in Vietnam have captured the attention of women's health activists and advocates, contraceptive researchers, policymakers, family planning providers and others affected by the development and use of this nonsurgical procedure. Of particular interest is the scientific rigor with which the field trials have been conducted, and the potential short-term and long-term health effects associated with the use of quinacrine pellets.

Quinacrine sterilization: a middle road.
Potts M, Benagiano G.. Contraception 2001; Nov;64(5):275-6.
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Summary: Malcolm Potts, MB, PhD, Bixby Professor of Population & Family Planning, School of Public Health University of California at Berkeley and Giuseppe Benagiano, M.D., Secretary General, International Federation of Gynecology and Obstetrics and former Director of the WHO Special Programme of Research, Development and Research Training in Human Reproduction (HRP) discuss issues surrounding research on the method.

Female sterilization using pharmacologically active agents.
R.M. Richart (Columbia University College of Physicians and Surgeons, New York, New York). In: Research Frontiers in Fertility Regulation: Zatuchni GI, Labbok M, Sciarra JJ, eds., Hagerstown, Harper and Row 1980; p. 262.
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Summary: In the 1960s, the major problem in developing a simple technique for outpatient female sterilization was thought to be a delivery system. A number of effective alternate systems for the delivery of pharmacologically active agents to the Fallopian tube, either blindly or under direct vision, have been developed. The present need is to integrate the delivery system with a safe, effective agent which will be delivered consistently to the Fallopian tubes and, once delivered, will consistently produce tubal closure. Although the closure rates being reported by all investigators studying a chemical approach to female sterilization are higher than those previously reported, no one system is clearly superior to any other at the present time. Further work is needed to increase the closure rates to even higher levels, to simplify the delivery systems, and to determine which agents will be acceptable for clinical use.

Sterilization using chemical agents.
R. M. Richart.. In: New Trends in Female Sterilization: D. A. F. van Lith, L. G. Keith, E. V. van Hall eds., Chicago 1980; Chap. 14, pp. 150-53.
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Summary: Present research efforts to develop a safe and effective nonsurgical means of blocking the Fallopian tubes are described. Quinacrine method is discussed in detail, reporting the work of Zipper and his associates in its development since the 1970s.

Female sterilization using chemical agents.
R.M. Richart (Columbia University College of Physicians and Surgeons and The Sloane Hospital for Women New York, New York). Research Frontiers in Fertility Regulation 1981; 1:1-12.
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Summary: The only two chemical agents for tubal closure that have been tested clinically and appear to have minimal side effects are quinacrine and MCA. Both have been applied in a variety of settings, both produce roughly comparable closure rates, and both appear to be candidates, with modifications in the delivery system or the ability to monitor tubal penetration, for a clinically useful outpatient-based sterilization technique for women. The delivery systems appear to be relatively simple and easy to use. The efficacy must be increased in order to have the greatest utility without requiring multiple applications, and a substantial number of women must be followed for a significant period of time to determine that there are no undesirable long-term sequelae with these systems. If these goals can be met, it is probable that tubal blockage can be accomplished using a safe, rapid and relatively inexpensive outpatient procedure.

The use of chemical agents in female sterilization.
R.M. Richart (Columbia-Presbyterian Medical Center, New York, New York). In: Female Transcervical Sterilization: Zatuchni GI, Shelton JD, Goldsmith A, Sciarra JJ, eds., Philadelphia, Harper and Row 1983; p 24.
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Summary: By the early 1960s, systematic studies directed toward a chemical cauterization technique were undertaken. Large numbers of chemical agents from virtually every class of compound that might be appropriate candidates for this procedure were screened, but most were found wanting. At present, only three chemical agents are actively being pursued in clinical trials: quinacrine, phenol, and methyl cyanoacrylate. The efficacy of these three compounds is comparable, but they differ significantly in their modes of delivery. The phenol-based system apparently requires a high degree of skill in blindly placing a cannula at the tubal ostium. It is not clear to what degree this skill is transferable to large numbers of operators. The quinacrine investigators have yet to settle on a delivery mode, but the newer approaches to delivery, using IUD vectors or slow-release pellets, will provide great simplicity if the experiments produce acceptable closure rates. The FEMCEPT system is more complex in its engineering and is a more expensive delivery system than a reusable cannula or an IUD vector, but it has produced increasingly satisfactory bilateral closure rates, and the delivery technique appears to be readily transferable, since most of the fourteen investigators who have used the system obtain comparable closure rates.

Discussion: Feasibility and acceptability of transcervical sterilization .
J.J. Sciarra, moderator. In: Female Transcervical Sterilization: Zatuchni GI, Shelton JD, Goldsmith A, Sciarra JJ, eds., Philadelphia, Harper and Row 1983; p 56-59.
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Transcervical quinacrine sterilization: clinical experience.
D.C. Sokal, J. Zipper, T. King.. International Journal of Gynecology and Obstetrics 1995; 51 Suppl:S59-S69.
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Summary: The objective was to review the use of quinacrine pellets for nonsurgical female sterilization. The transcervical insertion of quinacrine pellets has been under study for over 15 years. It could potentially expand access to sterilization services, because it is relatively simple to administer, with the use of a modified IUD inserter, and is inexpensive. Published and unpublished data are reviewed. Results were that the short-term safety of transcervical quinacrine appears to be better than surgical sterilization, but it is less effective, especially among women under 35, and there are virtually no data on its reversibility. Thus, it is probably most appropriate for older women, aged 35 and over, but it could be an option for others where access to surgical sterilization is limited. The authors concluded that the use of quinacrine pellets for female sterilization needs to be reviewed by appropriate regulatory authorities, especially with regard to long-term safety issues, and additional clinical studies are needed to better define a standardized regimen.

Quinacrine for female sterilization.
S. R.. Current Science (India) 1994; 67:631-2.
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Summary: According to experts, quinacrine seems to offer the best balance between safety and efficiency. Between 50,000 and 100,000 women in various developing countries have been treated with quinacrine with practically no harmful effects -- short term or long term. Detailed experiments show that cancer risk is also minimal. Contraceptive techniques developed by rich countries (and often sold by multinationals) are often tested in poor countries and these are extremely expensive. One wonders whether poorer countries should wait for the tests rich countries insist upon, but are not willing to pay for, or should they continue with their search for inexpensive but effective ways of birth control.

Delivery systems for applying quinacrine as a tubal closing agent.
R.G. Wheeler (International Fertility Research Program, Research Triangle Park, North Carolina). In: Female Transcervical Sterilization: Zatuchni GI, Shelton JD, Goldsmith A, Sciarra JJ, eds., Philadelphia, Harper and Row 1983; p 105.
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Summary: The use of quinacrine hydrochloride as an effective chemical agent for transcervical female sterilization has been established primarily through the pioneering work of Jaime Zipper. Current research is concerned with making the method commercially available through the development of dosage forms that will enhance the acceptance of the method and through toxicology of related studies that will document the safety of quinacrine chemical sterilization (QCS). Kessel and Mumford estimate that only one fourth to one third of the potential demand for sterilization in developing countries, excluding China, can be met by surgical sterilization in the 1980s and that quinacrine methods offer the best hope of meeting the demand. Although clinical application and dosage form development for QCS are in an advanced stage, its pharmacology is less understood. Basic research on the pharmacokinetics of intrauterine quinacrine, uterine fluid exchange, cervical discharge, and duration of quinacrine concentration effects on tubal occlusion would provide a rational basis for selecting an optimum dosage form. It is likely that clinical QCS will continue to be developed outside the United States where surgery is physically and financially out of reach of those most in need of sterilization.

The development of new technologies for female sterilization: conclusions and recommendations for research.
E.W. Wilson (Puketona Road, Paihia, New Zealand). International Journal of Gynecology and Obstetrics 1995; 51 Suppl:S71-S74.
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Summary: The conclusions and recommendations for research made during the consultation on the development of new technologies for female sterilization are presented. The participants in the consultation agreed that there was no single new method of female sterilization ready for introduction into service programs, but that there were several approaches with the potential to improve existing methods, or to provide new methods for tubal occlusion. A number of areas for future research were recommended including: additional operational research on existing abdominal approaches to tubal occlusion; further research into the physiology and pharmacology of the Fallopian tube; chemical occlusion using a transcervical approach with balloon pumps; techniques for endometrial ablation as sterilization methods; transcervical Fallopian tube cannulation; the use of quinacrine and other chemicals, such as elemental iodine, as tubal sclerosants, provided that these substances meet modern toxicological requirements.

QUINACRINE AS AN ANTIMALARIAL

The suppression of malaria.
B.M. Baker. In: Internal Medicine in World War II: Vol II: Infectious Diseases: Coates JB, Havens WP, eds., Medical Department, Department of the Army Washington, D.C. 1963; p 465.
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Summary: Parasite surveys were correlated with malaria rates under suppression, Atabrine discipline and determination of Atabrine plasma levels. The conclusion drawn was that when the suppressive dose of Atabrine [quinacrine hydrochloride] is 0.5 gm. twice weekly, protection is afforded roughly 98 percent of troops even though engaged in combat in a highly malarious area. An important result of Atabrine suppressive therapy not generally appreciated goes more fundamentally beyond postponing the evil day of clinical attacks until suppression is withdrawn. Atabrine in suppressive doses faithfully taken not only kills the gametocytes of P. vivax but prevents the development of P. vivax and P. falciparum gametocytes. Epidemics of malaria result from the availability of nonimmune susceptibles, anopheles mosquitoes, and gametocyte carriers. The latter can be controlled by Atabrine suppression and the relation of this control to outbreaks of malaria in troops was clearly demonstrated by observations in the Southwest Pacific.

Treatment of Malaria.
P.H. Long.. In: Internal Medicine in World War II: Vol II: Infectious Diseases: Coates JB, Havens WP, eds., Washington, D.C. Medical Department, Department of the Army 1963; p 493.
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Summary: After some experiment with various drug combinations, on 14 September 1943, Circular Letter No. 34, Office of the Surgeon, Headquarters, NATOUSA, advocated the Atabrine [quinacrine hydrochloride] schedule: 0.2 gm. of the drug every 6 hours for five doses followed by 0.1 gm. three times a day for 6 days. In Circular Letter No. 10, dated 15 February 1944, it was recommended that for third and subsequent relapses quinine be used in a dosage of 1.0 gm. three times a day for 3 days and then 0.3 gm. three times a day for 10 days. Circular Letter No. 41, dated 29 July 1944, rescinded Circular Letter No. 10 in view of the fact that the use of quinine in the therapy of relapsing malaria had shown no advantages over the use of Atabrine. Atabrine: This therapeutic Atabrine dosage scheme was found to be safe, effective, and productive of results equally as good as those obtained with quinine. Formerly, it had been observed that Atabrine did not effect a temperature drop as promptly as did quinine. At that time it was not the practice to administer loading doses of Atabrine during the first day or two of treatment. This objection was largely eliminated after it was found that the plasma concentration of the drug was a measure of its therapeutic effectiveness and that effective levels were more rapidly attained when larger doses were given at the start of a therapeutic regimen.

Clinical trials of antimalarial drugs.
H. Most.. In: Internal Medicine in World War II: Volume II: Infectious Diseases: Coates JB, Havens WP, eds., Washington, D.C. Medical Department, Department of the Army 1963; p 525.
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Summary: Penicillin was of no value. Cinchona alkaloids were as effective, but more toxic than quinine. Quinacrine hydrochloride (atabrine) was highly effective, with satisfactory general properties. After experiments with other dosages, results of clinical trials of quinacrine 2.8 gm in 7 days were excellent. Toxicity studies were conducted during and after World War II. An experimental approach to the chemotherapy of malaria led to a rational use of quinacrine for effective treatment of attacks and for suppression. Development of chemical methods for estimating quinacrine in biological fluids and tissues resulted in a better understanding of the limitations of treatment and suppressive schedules in use before and early in World War II. Clinical and field studies carried out on a large scale demonstrated that quinacrine if properly used was superior to totaquine or its component alkaloids for treatment or suppression of malaria due to P. vivax or P. falciparum. Quinacrine produced more prompt control of fever, symptoms, and parasitemia; was less toxic; and provided a longer interval to relapse than quinine, sulfonamides, or heavy metals. Quinacrine was shown to induce definitive cure in falciparum infections and to provide effective suppression of relapsing malaria when priming initial doses were followed by daily doses of 0.1 gm. Failures in suppression (breakthroughs) were shown mainly due to poor discipline and failure to take the drug. Parenteral use of quinacrine was found effective in severe falciparum infections, but no conclusive comparative study was reported between quinine and quinacrine given parenterally. Toxic reactions known before the war were encountered, these consisting of minor gastrointestinal symptoms and toxic psychoses. In addition, prolonged quinacrine ingestion produced edema of the cornea in some cases, and in a large number of cases, the following reactions were described: (1) Ochronosis-like pigmentation of skin, mucous membranes, and cartilage (possibly with hepatitis), (2) urticaria and, more significantly, a dermatitis complex (atypical lichen planus and/or eczematoid dermatitis), and (3) aplastic anemia. It was shown that long-continued suppression produced these reactions in only a small proportion of men taking the drug and that on the whole no significant disturbances in organ function resulted. The proper use of quinacrine made possible effective military operations in highly malarious areas.

The pharmacological basis for the rational use of atabrine in the treatment of malaria.
J.A. Shannon, D.P. Earle, JR., B.B. Brodie, J.V. Taggart, R.W. Berliner. Journal of Pharmacological Experimental Therapy 1944; Vol. 81:307-30.
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The Chemotherapy of Protozoan Diseases.
E. A. Steck (Division of Medicinal Chemistry). Walter Reed Army Institute of Research 1972; p. 3.121.
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The Chemotherapy of Protozoan Diseases.
E. A. Steck (Division of Medicinal Chemistry). Walter Reed Army Institute of Research 1972; p. 23.162-23.176.
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