预约演示
更新于：2026-02-26
Piperaquine tetraphosphate/Artenimol
双氢青蒿素哌喹
更新于：2026-02-26
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2004-12-07), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
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结构/序列
分子式C44H59Cl2N6O9P |
InChIKeyUFVOQOAYNGAGOD-DFJWQXRPSA-N |
CAS号1042021-16-8 |
关联
148
项与 双氢青蒿素哌喹 相关的临床试验NCT07322068
Perennial Malaria Chemoprevention in the Malaria Vaccine Era
NCT07246525
Cluster Randomized Trial of Intermittent Preventive Treatment of Malaria in School-age Children to Improve the Health of Students and Decrease Community Transmission
NCT07021430
Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy: a Pilot Randomized Controlled Trial
100 项与 双氢青蒿素哌喹 相关的临床结果
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100 项与 双氢青蒿素哌喹 相关的转化医学
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100 项与 双氢青蒿素哌喹 相关的专利（医药）
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117
项与 双氢青蒿素哌喹 相关的文献（医药）2026-01-07AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
Treatment Efficacy of Dihydroartemisinin–Piperaquine for Uncomplicated Plasmodium falciparum and Plasmodium vivax Malaria in Timika, Papua, Indonesia
Article
作者: Indrawanti, Ratni ; Poespoprodjo, Jeanne Rini ; Hafidz, Firdaus ; Noviyanti, Rintis ; Ramli, Muhammad Syawal Satria ; Kenangalem, Enny ; Trianty, Leily ; Simatupang, Minerva ; Ubra, Reynold R. ; Puspitasari, Agatha Mia ; Hill, Jenny ; Prayoga, Pak ; Candrawati, Freis ; Kambuaya, Noy Norman
ABSTRACT.:
Dihydroartemisinin–piperaquine (DP), the first-line treatment for uncomplicated malaria in Timika, Papua, Indonesia, has also been used for intermittent preventive treatment in pregnancy (IPTp-DP) since February 2022. Concerns about the potential emergence of drug resistance associated with this dual policy prompted the present study, which was conducted to assess DP efficacy in treating uncomplicated
Plasmodium falciparum
(
P. falciparum
) and
Plasmodium vivax
(
P. vivax
) malaria in the general population 15 months after IPTp-DP was introduced. Between May and December 2023, the current study recruited 75
P. falciparum
and 75
P. vivax
malaria patients, who received supervised DP treatment for 3 days. Clinical and laboratory data were collected daily (on days 1, 2, 3, and 7) and then weekly for 6 weeks. Molecular analysis was performed to detect genetic markers of
P. falciparum
resistance to DP and distinguish between recrudescence and reinfection. A total of 68
P. falciparum
and 58
P. vivax
patients completed their day 42 follow-up. The cumulative risk of same-species recurrence by day 42 was 1.5% (95% CI: 0–7.9%) in
P. falciparum
patients (polymerase chain reaction-adjusted) and 5.2% (95% CI: 1.1–14.1%) for
P. vivax
patients (unadjusted). No patients exhibited parasitemia on day 3. No
P. falciparum
isolates carried
kelch 13
gene mutations or exhibited increased
plasmepsin
2–3 copy numbers on either day 0 (0/75) or at recurrence (0/2). At the current level of IPTp-DP coverage (824 doses administered), there was no evidence of high treatment failure rates or the selection of resistant parasites in patients with uncomplicated malaria treated with DP. Continuous monitoring of DP efficacy remains crucial for both treatment and chemoprevention.
2026-01-02INTERNATIONAL JOURNAL OF EPIDEMIOLOGY
Impact of intermittent preventive treatment of malaria in pregnancy with sulfadoxine–pyrimethamine on sexually transmitted and reproductive tract infections: results from a randomized trial in Uganda
Article
作者: Nakalembe, Miriam ; Clark, Tamara D ; Aguti, Miriam ; Benjamin-Chung, Jade ; Kamya, Moses R ; Dela Cruz, Erin J ; Rosenthal, Philip J ; Dorsey, Grant ; Ategeka, John ; Odongo, Bakar ; Roh, Michelle E ; Kizza, Jimmy ; Gaw, Stephanie L ; Kakuru, Abel ; Opira, Bishop ; Olwoch, Peter ; Adrama, Harriet ; Ozarslan, Nida
Abstract:
Background:
In sub-Saharan Africa, sexually transmitted and reproductive tract infections (STIs/RTIs) are important but underdiagnosed risk factors for adverse pregnancy outcomes. Sulfadoxine–pyrimethamine (SP), used for the intermittent preventive treatment of malaria in pregnancy (IPTp), may reduce the STI/RTI burden due to its antimicrobial activity. We assessed the impact of IPTp regimens on STI/RTI prevalence and evaluated associations between STIs/RTIs and adverse birth outcomes.
Methods:
We conducted a secondary analysis of a randomized–controlled trial comparing monthly IPTp with SP, dihydroartemisinin–piperaquine (DP), or DP+SP among pregnant women in Uganda. Vaginal swabs collected at or near delivery were tested for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Group B Streptococcus (GBS) by using GeneXpert; bacterial vaginosis was assessed by using Nugent scoring. Log-binomial regression was used to compare STI/RTI prevalence between IPTp arms; IPTp-DP served as the reference arm. Multivariable Poisson regression with robust standard errors was used to evaluate associations between infections and preterm delivery, term low birthweight (LBW), overall LBW, and small-for-gestational age.
Results:
Among the 2265 participants assessed, the IPTp-SP arm had an 80% [95% confidence interval (CI): 67%–88%] lower prevalence of C. trachomatis (2.5% vs 12.4%) and a 35% (95% CI: 1%–57%) lower prevalence of GBS (7.7% vs 11.7%) at delivery compared with the IPTp-DP arm. Chlamydia trachomatis was associated with increased preterm delivery [prevalence ratio (PR) = 1.86, 95% CI: 1.07–3.25] and GBS was associated with increased term LBW (PR = 2.08, 95% CI: 1.06–4.08).
Conclusion:
Monthly IPTp-SP may reduce the risk of adverse birth outcomes through its activity against C. trachomatis and GBS, highlighting its potential non-malarial benefits.
2026-01-01LANCET INFECTIOUS DISEASES
Efficacies of artemether–lumefantrine, artesunate–amodiaquine, dihydroartemisinin–piperaquine, and artesunate–pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in children aged 6 months to 10 years in Uganda: a randomised, open-label, phase 4 clinical trial
Article
作者: Appiah, Grace ; Nsobya, Sam L ; Kamya, Moses R ; Orena, Stephen ; Opigo, Jimmy ; Moriarty, Leah F ; Ebong, Chris ; Agaba, Bosco ; Tukwasibwe, Stephen ; Mugwanya, Edward ; Kyabayinze, Daniel ; Yeka, Adoke ; Nankabirwa, Joaniter I ; Okitwi, Martin ; Rosenthal, Philip J ; Sebikaari, Gloria ; Condo, Patrick M ; Rutazana, Damian ; Asua, Victor ; Binagwa, Benjamin ; Kiggundu, Moses ; Conrad, Melissa D ; Babirye, Shakira
BACKGROUND:
Anti-malarial artemisinin-based combination therapies (ACTs) might be losing efficacy in east Africa, with the spread of artemisinin partial resistance and reduced partner drug activity. Our trial aimed to measure the efficacies of artemether-lumefantrine, artesunate-amodiaquine, dihydroartemisinin-piperaquine, and artesunate-pyronaridine in three sites in Uganda.
METHODS:
This randomised, open-label, phase 4 clinical trial was carried out at three sites in the Agago, Arua, and Busia districts of Uganda. Children aged 6 months to 10 years with uncomplicated Plasmodium falciparum malaria were randomly assigned to receive either artemether-lumefantrine (20 mg artemether; 120 mg lumefantrine; twice a day for 3 days) in all sites or dihydroartemisinin-piperaquine (40 mg dihydroartemisinin and 320 mg piperaquine, once a day for 3 days) in Agago, artesunate-amodiaquine (25 mg artesunate and 67·5 mg amodiaquine for children <9 kg or 50 mg artesunate and 135 mg amodiaquine for children ≥9 kg, once a day for 3 days) in Busia; and artesunate-pyronaridine (60 mg artesunate and 180 mg pyronaridine for children >15 kg or 20 mg artesunate and 60 mg pyronaridine for children <15 kg, once a day for 3 days) in Arua, with follow-up to 42 days. Participants were not blinded to group assignments; however, investigators and those assessing outcome were masked. The primary outcome was parasitaemia, assessed by microscopy, either uncorrected or PCR-corrected to distinguish recrudescence from new infection. All participants who received the treatment per protocol and were not lost to follow-up were included in the primary outcome. All participants who were randomly allocated to treatment groups were included in the safety analyses. This study is registered with the Pan African Clinical Trials Registry, number PACTR202301796134887, and is complete.
FINDINGS:
Between Nov 7, 2022, and March 24, 2023, 808 participants (437 [54%] female) were enrolled and assigned to treatment groups; 15 (2%) were lost to follow-up and 793 (98%) completed follow-up. The uncorrected adequate clinical and parasitological response for artemether-lumefantrine was 87 (51·8%; 95% CI 44·0-59·5) of 168 participants in Arua, 88 (51·8%; 44·0-59·4) of 170 and Busia, and 131 (79·4%; 72·3-85·1) of 165 in Agago. This response for artemether-lumefantrine was lower than that of the other ACTs at all sites: 97 (98·0%; 92·2-99·6) of 99 for dihydroartemisinin-piperaquine in Agago, 95 (99·0%; 93·5-99·9) of 96 for artesunate-amodiaquine in Busia, and 73 (73·7%; 63·8-81·8) of 99 for artesunate-pyronaridine in Arua. PCR-corrected 28-day efficacies were 88 (81·5%; 72·6-88·1) of 108 for artemether-lumefantrine and 95 (100%; 95·2-100·0) of 95 for artesunate-amodiaquine in Busia; 131 (97·0%; 92·1-99·0) of 135 for artemether-lumefantrine and 97 (100%; 95·3-100·0) of 97 for dihydroartemisinin-piperaquine in Agago; and 87 (82·1%; 73·2-88·6) of 106 for artemether-lumefantrine and 73 (92·4%; 83·6-96·9) of 79 for artesunate-pyronaridine in Arua. All regimens were well tolerated. The most common adverse events were upper respiratory tract infection, diarrhoea, and anaemia. None of the reported adverse events were attributed to the study drugs. There were two serious adverse events, both cases of severe malaria in Arua, one in each of the treatment groups. Parasite clearance half-lives were prolonged with parasites carrying the PfK13 Cys469Tyr (median 4·2 h; IQR 3·4-4·9) and Ala675Val (4·9 h; 3·4-5·7) mutations compared with wild-type parasites (2·8 h; 2·3-3·6; p<0·0001).
INTERPRETATION:
Artemether-lumefantrine was associated with a higher risk of recurrent malaria than other antimalarial combinations tested, and K13 mutations were associated with delayed parasite clearance. Changes in first-line therapy for uncomplicated malaria must be considered in response to suboptimal efficacy of artemether-lumefantrine.
FUNDING:
US President's Malaria Initiative, US Agency for International Development, through the Uganda Malaria Reduction Activity and the National Institutes of Health (AI075045 and AI117001).
TRANSLATION:
For the Swahili translation of the abstract see Supplementary Materials section.
100 项与 双氢青蒿素哌喹 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 恶性疟 | 中国 | 2004-12-07 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 间日疟原虫感染 | 临床3期 | 巴西 | - | 2018-07-05 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 3,732 | 觸憲衊壓網醖製繭糧願(醖顧壓糧蓋選築鏇遞糧) = 夢網廠願壓鬱廠蓋網獵 淵鹹蓋獵選衊製鏇憲艱 (壓範蓋簾醖鑰衊壓簾製, 62.7 ~ 100) 更多 | 积极 | 2025-12-01 | |||
临床3期 | 2,757 | (SP + DP placebo every 4 weeks) | 糧膚顧鹹簾遞鹽鹹糧鬱 = 憲衊繭觸鹽糧壓蓋鹽廠 夢餘膚繭獵襯顧夢蓋鏇 (廠鑰膚襯壓衊簾廠範鑰, 窪構範積構鹽鏇遞顧獵 ~ 遞齋醖構醖蓋獵壓製鹽) 更多 | - | 2025-11-06 | ||
(DP + SP placebo every 4 weeks) | 糧膚顧鹹簾遞鹽鹹糧鬱 = 窪蓋夢糧夢選構鏇顧顧 夢餘膚繭獵襯顧夢蓋鏇 (廠鑰膚襯壓衊簾廠範鑰, 齋壓鏇築顧選選壓襯構 ~ 鑰鏇願壓窪範簾壓選壓) 更多 | ||||||
临床3期 | 2,757 | 齋遞齋憲襯襯憲鹹鹽艱(壓鏇獵鏇鬱襯淵淵廠簾) = 顧艱繭壓獵鑰範遞觸構 繭鏇膚網遞鹹積選夢鏇 (淵願積顧衊鹹簾築觸膚 ) 更多 | 不佳 | 2025-09-18 | |||
齋遞齋憲襯襯憲鹹鹽艱(壓鏇獵鏇鬱襯淵淵廠簾) = 顧鑰製範觸艱壓獵淵選 繭鏇膚網遞鹹積選夢鏇 (淵願積顧衊鹹簾築觸膚 ) 更多 | |||||||
N/A | 828 | 築顧顧膚繭製築膚齋蓋(獵膚網膚觸膚願選憲獵) = 窪鑰窪範廠淵壓遞鑰鹽 齋蓋選膚蓋範獵淵窪衊 (餘窪蓋願窪齋廠憲繭構, 94.4 ~ 100) | 积极 | 2025-07-14 | |||
築顧顧膚繭製築膚齋蓋(獵膚網膚觸膚願選憲獵) = 餘夢鑰醖鬱顧觸選蓋積 齋蓋選膚蓋範獵淵窪衊 (餘窪蓋願窪齋廠憲繭構, 96.2 ~ 100) 更多 | |||||||
临床4期 | 194 | (HIV-infected Children on EFV-based ART (E3)) | 憲構艱觸遞構蓋夢鏇範(網鹽夢鹽範艱餘夢鏇憲) = 願顧衊襯鏇蓋衊餘選範 窪醖選廠遞觸築鹽壓遞 (壓壓襯遞餘範鏇蓋獵窪, 膚憲範獵網憲積鏇齋鹽 ~ 鹹顧鑰鬱糧積願艱網製) 更多 | - | 2025-03-14 | ||
(HIV-infected Children on DTG-based ART (D3)) | 憲構艱觸遞構蓋夢鏇範(網鹽夢鹽範艱餘夢鏇憲) = 鬱鏇糧鹹鹹淵構獵蓋繭 窪醖選廠遞觸築鹽壓遞 (壓壓襯遞餘範鏇蓋獵窪, 鑰襯築廠積窪餘憲鬱遞 ~ 選觸餘製淵糧繭製網糧) 更多 | ||||||
临床3期 | 666 | IPTp with dihydroartemisinin-piperaquine + co-trimoxazole | 艱積廠觸鹽襯顧襯顧鹽(製鏇餘願觸鹹遞顧糧網) = reported in less than 4% of participants 選願壓窪繭鹽鏇糧簾憲 (衊獵鬱築襯網鹽選鹹淵 ) 更多 | 积极 | 2024-05-01 | ||
Placebo + co-trimoxazole | |||||||
临床4期 | 246 | (Proguanil Oral Tablet) | 夢鏇壓顧窪遞獵糧簾簾 = 淵醖獵淵蓋糧鹽積餘鑰 衊顧構壓簾製鏇製網夢 (醖築醖獵膚鬱醖獵顧顧, 簾積簾積糧襯鹹齋築選 ~ 獵夢獵蓋憲遞醖淵壓築) 更多 | - | 2024-03-27 | ||
(Sulfadoxine/Pyrimethanine-Amodiaquine) | 夢鏇壓顧窪遞獵糧簾簾 = 顧選範構願淵鹽網觸憲 衊顧構壓簾製鏇製網夢 (醖築醖獵膚鬱醖獵顧顧, 鬱遞醖壓淵選獵選鹹築 ~ 鹽糧蓋築蓋廠壓製餘醖) 更多 | ||||||
临床3期 | 780 | (Dihydroartemisinin-piperaquine) | 顧築構憲壓顧鹹壓衊獵 = 選獵膚鬱繭餘鬱膚鑰襯 淵膚觸積艱構醖淵窪壓 (選鏇構醖憲蓋壓觸簾膚, 願蓋廠鏇壓淵醖顧鏇廠 ~ 網顧簾築網願糧製壓網) 更多 | - | 2024-03-21 | ||
(Combination of Amodiaquine +Sulfadoxine-pyrimethamine) | 顧築構憲壓顧鹹壓衊獵 = 膚鏇遞醖衊夢製襯網餘 淵膚觸積艱構醖淵窪壓 (選鏇構醖憲蓋壓觸簾膚, 齋廠餘鑰製鬱醖廠夢積 ~ 醖繭鏇網選窪窪顧製網) 更多 | ||||||
临床3期 | 疟疾 HIV | 895 | 鹹艱鏇遞製鹹簾顧窪簾(選艱繭繭鹹構範鬱顧顧) = 憲遞獵顧鬱積選憲簾齋 積網鏇鹽憲願醖糧鬱壓 (艱鑰繭鹹憲簾蓋餘壓鹽 ) 更多 | 积极 | 2024-01-01 | ||
Co-trimoxazole plus placebo | 鹹艱鏇遞製鹹簾顧窪簾(選艱繭繭鹹構範鬱顧顧) = 顧窪簾築廠餘憲簾繭築 積網鏇鹽憲願醖糧鬱壓 (艱鑰繭鹹憲簾蓋餘壓鹽 ) 更多 | ||||||
临床3期 | - | 782 | Dihydroartemisinin-piperaquine (DHA-PQ) | 餘窪網選醖願顧醖艱糧(窪製顧鹹鹽憲網窪構鏇) = Nine women given DHA-PQ had grade 3-4 cardiac adverse events 糧範艱積艱蓋繭遞願選 (齋顧鑰鬱選觸壓繭觸艱 ) | - | 2021-12-02 |
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