[An analysis of disease spectrum of patients admitted to the General Internal Medicine Unit at Peking Union Medical College Hospital from 2004 to 2008, and the value of general internal medicine unit in comprehensive hospitals].

OBJECTIVE: To analyze the disease spectrum of patients admitted to the General Internal Medicine Unit at Peking Union Medical College Hospital, which is the first academic division of general internal medicine in the department of medicine within Chinese medical colleges and universities, and the value of general internal medicine unit in comprehensive hospitals. METHODS: A retrospective data review of patients admitted to the General Internal Medicine Unit from 2004 to 2008 was conducted from hospital information system and partially by chart review manually. Analysis of disease spectrum was performed thereafter. RESULTS: A total of 2593 patients were included in our study. It consisted of 1075 men and 1518 women, with an average age of 45.1 years old. Forty point three percent of these patients were from Beijing, the local city, and the remaining 59.7% were from outside of Beijing. Sixty-four point nine percent (1683/2593) of these patients did not have a clear diagnosis on admission, including 758 fever of unknown origin (FUO) cases and 925 non-FUO cases. The final diagnostic rate of the FUO cases was 89.2% [676/758, with the first three leading causes as diseases of the musculoskeletal system and connective tissue (29.8%), certain infectious and parasitic diseases (26.3%), and neoplasm (14.5%)]. The final diagnostic rate of the 928 non-FUO cases was 86.8% (803/925), with the first three leading causes as musculoskeletal system and connective tissue (24.9%), neoplasm (15.5%), and diseases of blood and blood-forming organs (11.4%). Despite most diagnoses fitting into the above categories, the array of diseases was broad with as many as 550 discharge diagnoses from 2004 to 2008. CONCLUSIONS: During 2004 - 2008, there was a high proportion of cases that presented to the General Internal Medicine Unit at Peking Union Medical College Hospital with an unclear diagnosis, and the spectrum of diseases diagnosed was very broad. This kind of patient admitting model might not only benefit patients with no clear admission diagnosis and patients with multidisciplinary medical problems for whom it is usually difficult to be admitted by a specialty unit, but would also benefit medical students and residents by providing a good clinical medicine teaching base. These features show the value of general internal unit in comprehensive hospitals.

[A multi-center clinical trial of recombinant human thrombopoietin in chronic refractory idiopathic thrombocytopenic purpura].

OBJECTIVE: To evaluate the efficacy and safety of human recombinant thrombopoietin (rhTPO, a product of Sunshine Pharmaceutical Co Ltd, China) in chronic refractory idiopathic thrombocytopenic purpura. METHODS: Eighty-two patients with chronic refractory idiopathic purpura received daily subcutaneous administration of rhTPO at a dose of 1.0 micro g/kg for a maximum of 14 doses. RESULTS: After the beginning of treatment, the median platelet counts increased from 15.5 (6.0 - 24.0) x 10(9)/L to 27.5 (16.0-47.0) x 10(9)/L, 35.0 (20.5-78.0) x 10(9)/L and 77.0 (41.8-119.5) x 10(9)/L on the fifth, seventh and fifteenth day, respectively (P < 0.01). After the discontinuation of rhTPO administration, the platelet count decreased gradually. On the twenty-eighth day, the median platelet count was 76.5 (35-120.3) x 10(9)/L, which was still significantly higher than the level before the treatment (P < 0.01). The overall response rate was 85.3%. The rate in the group with remarkable response (platelet count > or = 100 x 10(9)/L without bleeding) was 58.5% and that in the good response group (platelet count > or = 50 x 10(9)/L or 30 x 10(9)/L higher than the count before the treatment, without bleeding) was 26.8%. Only 3 patients had mild clinical untoward reactions. Low titer (1:5) of anti-TPO antibody in serum was detected with ELISA in one of the sixteen patients who received the test on the twenty-first and twenty-eighth day. Neutralizing test using TPO-dependent cell line showed that the positive serum had no neutralizing activity on rhTPO. CONCLUSION: Consecutive subcutaneous injection of rhTPO for a maximum of 14 days was associated with a temporary elevation in platelet counts in patients with chronic refractory ITP with tolerable adverse effects.

[The clinical study of recombinant human thrombopoietin in the treatment of chemotherapy-induced severe thrombocytopenia].

OBJECTIVE: To evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) on chemotherapy-induced severe thrombocytopenia. METHODS: In this self-controlled multi-center clinical trial, 81 patients, 23 with solid tumor and 58 with leukemia with complete remission, with the platelet count < or = 20 x 10(9)/L after chemotherapy were given two cycles of the same chemotherapy. The first cycle was non- rhTPO-treated cycle as control, in the second cycle rhTPO of the dosage of 1.0 microg.kg(-1).d(-1) was administered subcutaneously 6-24 hours after the beginning of chemotherapy for at most 14 days. Laboratory tests including complete blood counts, urinalysis, serum chemistry, coagulant test, chest radiography, and electrocardiography were made. Serum samples were screened for anti-rhTPO antibodies. RESULTS: In rhTPO-treated cycle, the platelet count was higher [the mean minimal platelet count was 13 x 10(9)/L, significantly higher than that of the control cycle (12 x 10(9)/L, P = 0.002), the mean maximal platelet count was 186 x 10(9) cells/L, significantly higher than that of the control cycle (122 x 10(9)/L, P < 0.001)]. The duration of thrombocytopenia was shorter in the rhTPO-treated cycle than in the control cycle: days with platelet count <50 x 10(9)/L, days with platelet count recovered > or = 75 x 10(9)/L, and days with platelet count recovered > or = 100 x 10(9)/L were 11 days, 21 days, and 24 days respectively, all significantly shorter than those of the control cycle (13 days, 24 days, and 27 days respectively, P < 0.05, P < 0.001, and P < 0.001). The amount of needed platelet transfusion was 10 U in the rhTPO-treated cycle, both significantly less than those in the control cycle (12 U, P < 0.001). No effects of rhTPO on hemoglobin, white blood cells, hepatic function, kidney function and coagulant function were found. Transient low-titer antibody was developed in one patient. Side effects such as fever, knee arthralgia, dizziness, headache and chill were mild and tolerable. CONCLUSION: Administration of rhTPO after chemotherapy significantly reduces the degree and duration of thrombocytopenia and the need for platelet transfusions.

[A multi-center clinical trial of recombinant human thrombopoietin in the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumor].

OBJECTIVE: To assess the efficacy and safety of recombinant human thrombopoietin (rhTPO) on chemotherapy-induced thrombocytopenia in patients with solid tumor. METHODS: In this randomized crossover self-controlled multi-center clinical trial, 154 patients with solid tumor were randomly divided into two groups (group A 77 cases and group B 77 cases). All patients were given the same two cycles of chemotherapy. In group A, the first cycle was treated cycle, in which patients were given rhTPO, while the second cycle was non-treated cycle as a control. In group B, the first cycle was non-treated cycle as a control, while the second cycle was treated cycle. RhTPO 1.0 microg/(kg x d) was administered subcutaneously 6-24 hours after chemotherapy for the longest 14 days. Laboratory tests included complete blood counts, urinalysis, serum chemistry, coagulant test, chest radiography, and electrocardiogram. Serum samples were screened for anti-rhTPO antibodies. RESULTS: In both group A and group B, platelet decrease and duration had no significant difference between the treated cycle and non-treated cycle. Platelet count was higher in the treated cycle, than in the non-treated cycle: [minimal mean platelet count (64.4 +/- 45.4) x 10(9) cells/L and (52.4 +/- 30.9) x 10(9) cells/L (P=0.000), maximal mean platelet count (263.9 +/- 142.5) x 10(9) cells/L and (148.9 +/- 67.7) x 10(9) cells/L (P=0.000)]. Duration of thrombocytopenia was shorter in the treated cycle than in the non-treated cycle [days with platelet count < 50 x 10(9) cells/L, (2.5 +/- 3.9) and (3.7 +/- 5.7) (P=0.04); days with platelet count recovered > or = 75 x 10(9) cells/L, (10.3 +/- 8.7) and (14.0 +/- 8.9) (P=0.000), and days with platelet count recovered > or = 100 x 10(9) cells/L, (15.9 +/- 10.5) and (21.1 +/- 9.5) (P=0.000)]. The need for platelet transfusion was not significantly reduced in treated cycle. The effects of rhTPO on WBC, Hb, hepatic function, renal function, and coagulant function were not found. Transient low-titer non-neutralizing antibody was developed in one patient. Therapy with rhTPO was tolerated by all patients. Mild side effects were observed in individual patients, including fever, dizziness, and chill. Conclusion Administration of rhTPO after chemotherapy can significantly reduce the degree and duration of thrombocytopenia and promote platelet recovery. Therapy with rhTPO seems to be safe.

Double-blind, multicenter, active-controlled, randomized clinical trial to assess the safety and efficacy of orally administered nicorandil in patients with stable angina pectoris in China.

BACKGROUND: The efficacy and safety of nicorandil were evaluated in Chinese patients with stable angina pectoris (AP) in a double-blind, multicenter, active-controlled, randomized clinical trial. METHODS AND RESULTS: After a 2-week washout period, 232 patients with stable AP were randomized to receive either nicorandil (5 mg tid; 115 patients) or isosorbide mononitrate (ISMN: 20 mg bid; 117 patients) for 2 weeks. Exercise capacity, number of weekly anginal attacks, nitroglycerin (NTG) consumption, and safety were evaluated. Nicorandil and ISMN significantly prolonged the time to 1 mm ST-segment depression in an exercise tolerance test. Both drugs improved the total exercise time and the time to onset of chest pain. There was no significant difference between the 2 groups. Nicorandil significantly decreased the number of anginal attacks and NTG consumption. ISMN decreased the number of anginal attacks significantly; however, there was no significance in NTG consumption, and the ratio of anginal attack reduction was at least 50% was significantly higher with nicorandil. Nicorandil was well tolerated and there was no safety profile difference compared with ISMN. Thus, nicorandil may have equivalent or better antianginal effect than ISMN. CONCLUSIONS: Nicorandil is beneficial as treatment for AP.