Qun Su and Yuhong Li CASE REPORT A 71-year-old man was admitted to the intensive care unit following consciousness disturbance for 5 hours. His initial Glasgow Coma Scale (GCS) score was 7. He had right hemiplegia and active pupils, 3 mm on the two sides. Head computed tomography (CT) on admission showed an intracerebral hemotoma in the left temporoparietal region causing marked midline shift to the right, and a tubular high- density area in the left temporal lobe (Fig. 1). Laboratory studies revealed prothrombin time (PT) was prolonged to 66 seconds with an international normalized ratio (INR) 5.08. Renal and liver function tests were normal. Chest X-ray revealed no abnormality. The patient received aortic valve and mitral valve repla- cement one year ago and his heart function restored to New York Heart Association Class I. He was receiving warfarin therapy after surgery. He was followed in the medical clinic every 4 weeks. His INR was mostly in the range of 1.8-2.2 (Fig. 2), except during the dose titration in the first month of warfarin therapy. During the medical clinical visit a half of year ago, the patient felt well and he stated that he was taking all of the prescribed drugs follow- ing medical advice. The INR value was 1.9 three month ago and 2.0 one month ago. The patient’s blood pressure has been well-controlled since he was diagnosed hyper- tension. When admitted to the intensive care unit (ICU), the patient’s wife stated that he only took the prescribed medications. There were no recent changes in the amount of vegetable (vitamin K) intake. On further questioning, however, the old lady said that the patient started to take a kind of Chinese herb called shengmai-yin (Kanghua pharma Inc., Jiaozuo, Henan, China), because he believed that shengmai-yin was helpful for his heart disease. He took it 10 mL daily beginning 7 days prior to admission. On admission to the ICU, vitamin K1 40 mg was adminis- tered first and the INR decreased to 1.67, PT to 19 seconds. Craniectomy was performed to remove the intracerebral hematoma under general anesthesia. He remained confused and restless for 2 days, but then showed progressive reco- very in a consciousness level as well as motor and verbal functions. The patient was discharged on warfarin dose 2.25 mg daily; his INR was 2.0. Lotensin 5 mg daily con- tinued. He was advised not to take shengmai-yin and other herbal medicines because of the risk of loss of anticoagula- tion control. After 6 months, he was able to walk by himself, without any bleeding complications and alterations in INR to a value > 3.0. DISCUSSION During the first year of warfarin therapy, this patient never had any bleeding complications and alterations in INR to a value > 5.0 until he took the Chinese herb, shengmai-yin. In the absence of other precipitating factors, the temporal relationship between shengmai-yin consumption and the onset of bleeding in the brain suggested that this herbal product was responsible for the loss of anticoagulation control. An objective causality assessment using the Drug Interaction Probability Scale (DIPS)5 revealed that the ob- served reaction was highly probable to be related to con- comitant use of warfarin and herbal product, shengmai-yin. Shengmai-yin is a popular Chinese combination herbal product, which was developed on the base of a thousand- year-old traditional Chinese medicine prescription, sheng- mai-san. Traditional Chinese theory believed that shengmai- yin has the effect of supplementing Qi and nourishing Yin, fu mai and improving peripheral circulation. Shengmai-san is commonly used for its effect on oxidative damage in Fig. 1. Preoperative computed tomography scans showing left frontoparietal hematoma with midline shift. Fig. 2. The INR values of the patient 6 months before (values with minus on hori- zontal ordinate), during, and 6 months after (values with plus on horizontal ordi- nate) administration of shengmai-yin. The arrow indicates that time when the patients began administration of shengmai-yin. INR, international normalized ratio. 794 Yonsei Med J http://www.eymj.org Volume 51 Number 5 September 2010