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Characteristics and Factors Associated with Adverse Cutaneous Drug Reactions Caused by Traditional, Complementary and Conventional Medicine in Malaysia

Original article

Abstrak

Ubatan tradisional boleh menyebabkan kesan sampingan pada kulit. Tujuan kajian ini adalah untuk mengkaji ciri-ciri kesan sampingan pada kulit yang disebabkan oleh ubatan tradisional dan dibandingkan ubatan konvensional. Satu kajian retrospektif telah dijalankan terhadap 134 kes yang dikenalpasti di Klinik Dermatologi di hospital tertiari Kuala Lumpur. Kebanyakan kes (82.1%) adalah disebabkan oleh ubat-ubatan konvensional manakala 17.9% adalah disebabkan oleh ubatan tradisional.  Kesan sampingan ubatan tradisional pada kulit yang paling lazim adalah Exfoliative Dermatitis (ED) dan Acute Generalized Exanthematous Pustulosis (AGEP) (kedua-duanya 16.7%) manakala ruam makulopapular adalah reaksi yang paling lazim bagi ubatan konvensional (25.5%). Jangkamasa mulanya reaksi kesan sampingan ubatan pada kulit disebabkan oleh ubatan tradisional adalah hampir 4 minggu (60.2%) manakala ubat konvensional adalah lebih awal (1 hingga 6 hari, 65.4%) (p<0.05). Kemungkinan munculnya kesan sampingan ubatan yang tertunggak (4 minggu) adalah 14 kali lebih kerap dengan ubatan tradisional berbanding dengan ubat konvensional (p<0.05). Kajian ini menunjukkan bahawa ED dan AGEP adalah kesan sampingan kulit yang paling lazim disebabkan oleh ubat tradisional manakala ruam makulopapular lebih kerap berlaku dengan ubatan konvensional. Walau bagaimanapun, kebanyakan kesan sampingan ini adalah pada tahap sederhana. Oleh sebab kesan sampingan ubatan tradisional sering muncul selepas jangkamasa yang lama, riwayat penggunaan ubatan tradisional seharusnya didapatkan secara rutin bagi pesakit yang mempunyai masalah kulit walaupun ubatan ini telah lama digunakan. Semua kes yang disyaki mempunyai kesan sampingan pada kulit disebabkan oleh ubatan tradisional haruslah dilaporkan kepada Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) supaya ubatan tradisional dapat dipantau dari semasa ke semasa untuk menjamin keselamatan pengguna.

Abstract

Traditional and Complimentary Medicines (TCMs) can potentially cause Adverse Cutaneous Drug Reactions (ACDRs). The aim of this study was to describe the characteristics of ACDRs due to TCMs and compare with those due to conventional medicine. This was a retrospective study with 134 cases being diagnosed with ACDR at the Dermatology Clinic of a tertiary hospital in Kuala Lumpur. Most (82.1%) ACDRs were caused by conventional drugs, while 17.9% were due to TCMs. Majority (70-75%) of the ACDRs were of mild to moderate severity. The most common ACDR to TCM was Exfoliative Dermatitis (ED) and Acute Generalized Exanthematous Pustulosis (AGEP) (both 16.7%) while maculopapular rash was the most common reaction for conventional medications (25.5%). The onset of adverse reaction to TCM was about 4 weeks (60.2%) while reactions due to conventional medication was earlier (1 to 6 days, 65.4%; p<0.05). The odds of developing delayed ACDR was 14 times more with TCM compared to conventional medicine (p<0.05). This study showed that ED and AGEP were the most common ACDR manifestations of TCM while macuplopapular rash was the most common manifestation of conventional medications. However, most of these reactions were of mild to moderate severity. ACDR due to TCM may manifest long after the initiation of these products and hence its use should be routinely inquired when patients present with skin problems. All suspected cases of ADRs to TCM should be reported to the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) for continuous pharmacovigilance of these products.