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1 CCMP91-RD-007 Survey of concurrent use of Chinese medicine and Western medicine in cental Taiwan % 1.8 G G % 48.2% 413

2 32.5% China Medical College Pei-Dawn Lee Chao Abstract After implementation of National Health Insurance in Taiwan, the convenience of the clinic-visit makes the utilization of health care increased for both Chinese and western medicine. People taking Chinese and western medicine at the same period increased, it is reasonable to propose that the adverse effects resulted from herb-drug interactions may increase too. Due to the lack of statistical social survey concerning this issue, we attempted to understand the habits, the probability and the styles of the concurrent use of Chinese and western medicines in Taiwan. This research used the structural questionnaire to survey the adult outpatient of a medical center in central Taiwan. Analysis of the relationships between sex, age, chronic disease and the concurrent use of Chinese-western medicine with Chi-square tests were carried out. The environmental and population characteristics as prognostic factor were analyzed with multiple logistic regression. A total of 1995 effective surveys were collected. The recovery rate was 91.68%. The patients with chronic nephritis have higher chance to take herb and western medicine concomitantly than other patients. Increment of one year in age showed increased probability by 1.8%. Among outpatients, 23.3% of western medicine clinic, 40.3% of Chinese medicine clinic and 48.2% of Chinese-western medicine joint clinic have experience of taking herbs and western medicine during the same day. 414

People taking Chinese and western medicine at the same period increased, it is reasonable to propose that the adverse effects resulted from herb-drug interactions may increase too.

3 In summary, 32.5% of the outpatients in a medical center located at central Taiwan have the experience of taking herbs and western medicine concurrently. Keywords herb-drug interactions adverse reaction interaction survey felodipine (1-7) nitrendipine (8, 9) nisoldipine (10) nifedipine (11) nimodipine (12) verapamil (13) cyclosporin (14-20) terfenadine (21-24) diazepam 25 carbamazepine 26 simvastatin 27 saquinavir 28 (29-31) St. John s wort ( ) cyclosporin (32-34) digoxin

4 1. 2. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) 416

5 417

6 GMP C

8 Excel SPSS 10.0 SAS 38 Agresti 39 Bellack & Herson 40 Krathwohl 41 Meyers 42 Hosmer Kappa statistics 3. (Chi-square tests) (Multiple Logistic Regression Analysis) % 420

41 Meyers 42 Hosmer 43 1. 2. Kappa statistics 3.

9 ( ) % % % 37% 15% 33.3% 58.6% 42.7% 34.3% 53.9% 27.3% 6.8% 5.3% 93.2% 6.8% ( ) 44.7 % 30.6% 49.9% 41.9% 8.2% D 76.1% 0.4% C-D A-B G 7% ( ) % 63.1 % 22 % 20.7 % 60.8% 27.5 % 12.5% 25.4% F p<0.001 odds ratio

10 % 19.8% 16.8% 14.8% ( ) 18.6 % 66.6 % 80.3 % 26.8% 7.8 % 38.2 % % 56.7 % 43.3 % 42.8 % 81.9 % 17.4% 39.9 % 83.1 % 53.3 % ( ) % % % 70.9% 42.5% 18.1% 16.5% % % 422

9 % 17.4% 39.9 % 83.1 % 53.3 % ( ) 1995 56.4% 957 79.

11 40% 25% (45%) 45.5% 26% 28.4% 62% ( ) 44.7% 42.7% (68.0%) 27.4% 85.6% ( ) ( ) 25.0% 58.6% (80.5%) 16.3% 53.1% 84.7% ( ) ( ) % % % 26.5%

12 13.5% % % % 35.8% 24.6% 20.8% ( ) 9.8% 19.1% 18.7% 18.1% % 66.4% % % ( ) % % % % % % 65.2% 37.0% % % % % % 12.5% % % % % ( ) (Multiple Logistic Regression Analysis) 1. (dependent variable) ( ) ( ) ( ( ) ) ( ) ( ( ) ( ) 424

2% 37.0% 76 11.7% 20 24.7% 18 22.2% 15 18.5% 42 58.3% 12.5% 36 46.2% 648 232 23.3% 337 40.3% 79 48.

13 ( ) (G G ( ) ) (independent variables) SAS logistic stepwise multiple logistic regression model G G p odds ratio % (confidence interval; CI) 1.934~ G G odds ratio % ~ ( ) 2. ( ) ( ( ) ) ( ( ) ) ( ) ( ( ) ( ) ( ) ( ) ( ) (G G ( ) ) (independent variables) SAS stepwise logistic multiple logistic regression model (prognostic factors) odds ratio (1/0.748) odds ratio ( ) (1/0.644) 1.7 ( ) 3. SAS stepwise logistic procedure multiple logistic regression model ( ) 425

( ) ( ( ) ) ( ( ) ) ( ) ( ( ) ( ) ( ) ( ) ( ) (G G ( ) ) (independent variables) SAS stepwise logistic multiple logistic regression

14 odds ratio 4.75 odds ratio ( ) 4. stepwise logistic procedure multiple logistic regression model ( ) odds ratio 1 odds ratio 1 ( ) % 23.2% 8.5% 43.5% odds ratio % CI 4.445~6.733 ( ) multiple logistic regression ( ) multiple logistic 426

) odds ratio 1 odds ratio 1 ( ) 5. 1995 24.8% 23.2% 8.5% 43.

15 regression SAS logistic procedure ( ) % 39.4% 90% (Probability; Entry Decision) (Overall) % 2.5% 427

16 (The Centers for Disease Control and Prevention; CDC) % (Complementray and alternative medicine) 10% % 51 50% G 428

17 A B C A B C A B 68.0% 80.5% A B C 70% 429

18 50% %

19 48.2% 40.3% 23.3% 431

20 1. Bailey DG, Spence JD, Munoz C, Arnold JM. Interaction of citrus juices with felodipine and nifedipine. Lancet , Bailey DG, Arnold JMO, Munoz C, and Spence JD. Grapefruit juice-felodipine interaction: mechanism, predictability and effect of naringin. Clin. Pharmacol. Ther. 53:637-42, Lundahl J, Regardh CG, Edgar B, and Johnsson G. Relationship between time of intake of grapefruit juice and its effect on pharmacokinetics and pharmacodynamics of felodipine in healthy subjects. Eur. J. Clin. Pharmacol , Bailey DG, Bend JR, Arnold JMO, Tran LT, and Spence JD.: Erythromycin-felodipine interaction: magnitude, mechanism and comparison with grapefruit juice. Clin. Pharmacol. Ther. 60:25-33, Bailey DG, Arnold JMO, Bend JR, Tran LT, and Spence JD.: Grapefruit juice-felodipine interaction: reproducibility and characterization with the extended release drug formulation. Br. J. Clin. Pharmacol. 40:135-40, Lundahl J, Regardh CG, Edgar B, and Johnson G.: Effects of grapefruit juice ingestion pharmacokinetics and haemodynamics of intravenously and orally administered felodipine in healthy men. Eur. J. Clin. Pharmacol. 52: , Lundahl J, Regardh CG, Edgar B, and Johnson G.: The interaction effect of grapefruit juice is maximal after the first glass. Eur. J. Clin. Pharmacol. 54:75-81, Bailey DG, Munoz C, Arnold JMO, Strong HA, and Spence JD.: rapefruit juice and naringin interaction with nitrendipine. Clin. Pharmacol. Ther. 51:156, Soons PA, Vogels BA, Roosemalen MC, Schoemaker HC, Uchida E, Edgar B, Lundahl J, Cohen AF, and Breimer DD.: Grapefruit juice and cimetidine inhibit stereoselective metabolism of nitrendipine in humans. Clin. Pharmacol. Ther. 432

Relationship between time of intake of grapefruit juice and its effect on pharmacokinetics and pharmacodynamics of felodipine in healthy subjects. Eur. J. Clin. Pharmacol. 49

21 50: , Bailey DG, Arnold JMO, Strong HA, Munoz C, and Spence JD.: Effect of grapefruit juice and naringin on nisoldipine pharmacokinetics. Clin. Pharmacol. Ther. 54:589-94, Rashid TJ, Martin U, Clarke H, Waller DG, Renwick AG, and George CF.: Factors affecting the absolute bioavailability of nifedipine. Br. J. Clin. Pharmacol. 40:51-8, Fuhr U, Maier-Bruggemann A, Blume H, Muck W, Unger S, Kuhlmann J, Huschka C, Zaigler M, Rietbrock S, and Staib AH.: Grapefruit juice increases oral nimodipine bioavailability. Int. J. Clin. Pharm. Th. 36: , Fuhr U. Harder S. Lopez-Rojas P.: Increase of verapamil concentrations in steady state by coadministration of grapefruit juice. Arch Pharmacol. 349 (Suppl.): R134, Ducharme MP, Warbasse LH, and Edwards DJ.: Disposition of intravenous and oral cyclosporine after administration with grapefruit juice. Clin. Pharmacol. Ther. 57:485-91, Herlitz H, Edgar B, Hedner T, and Lidman I.: Grapefruit juice: a possible source of variability in blood concentrations of cyclosporin A. Nephrol Dial Trans. 8:375, Hollander AA, MJ. Van-Rooij J, Lentjes GW, Arbouw F, Van-Bree JB, Schoemaker RC, Van-Es LA, Van-Der-Woude FJ, and Cohen AF.: The effect of grapefruit juice on cyclosporin and prednisolone metabolism in transplant patients. Clin. Phaemacol. Ther. 57:318-24, Proppe DG, Hoch OD, McLean AJ, and Visser KE.: Influence of chronic ingestion of grapefruit juice on steady-state blood concentrations of cyclosporin A in renal transplant patients with stable graft function. Br. J. Clin. Pharmacol. 39:337-8, Proppe D, Visser K, Bartels R, Hoch O, Meyer H, and Mclean AJ.: Grapefruit 433

22 juice selectively modifies cyclosporin A metabolic patterns in renal transplant patients. Clin Pharmacol Ther. 59:138, Ioannides-Demos LL, Christophidis N, Ryan P, Angelis P, Liolios L, and Mclean AJ.: Dosing implications of a clinical interaction between grapefruit juice and cyclosporine and metabolite concentrations in patients with autoimmune diseases. J. Rheumatol. 24:49-54, Brunner LJ, Munar MY, Vallian J, Wolfson M, Stennett DJ, Meyer MM, and Bennett WM.: Interaction between cyclosporine and grapefruit juice requires long-term ingestion in stable renal transplant recipients. Pharmacotherapy. 18:23-9, Benton RE, Honig PK, Zamani K, Cantilena LR, and Woosley RL.: Grapefruit juice alters terfenadine pharmacokinetics and pharmaco-dynamics, resulting in prolongation of repolarization on the electrocardiogram. Clin. Pharmacol. Ther. 59:383-8, Honig PK, Wortham DC, Lazarev A, and Cantilena LA.: Grapefruit juice alters the systemic bioavailability and cardiac repolarization of terfenadine in poor metabolizers of terfenadine. J. Clin. Pharmacol. 36:345-51, Clifford CP, Adams DA, Murray S, Taylor GW, Wilkins MR, Boobis AR, and Davies DS. The cardiac effect of terfenadine after inhibition of its metabolism by grapefruit juice. Eur. J. Clin. Pharmacol. 52:311-5, Rau SE, Bend JR, Arnold JMO, Tran LT, Spence JD, and Bailey DG. Grapefruit juice-terfenadine single-dose interaction: magnitude, mechanism, and relevance. Clin. Pharmacol. Ther. 61: 401-9, Ozdemir M, Aktan Y, Boydag BS, Cingi MI, and Musmul A.: Interaction between grapefruit juice and diazepam in humans. Eur. J. Drug Metab. Ph. 23:55-9, Garg SK, Kumar N, Bhargava VK, and Prabhakar SK.: Effect of grapefruit juice on carbamazepine bioavailability in patients with epilepsy. Clin. Pharmacol. Ther. 434

23 64:286-8, Lilja JJ, Kivisto KT, and Neuvonen PJ.: Grapefruit juice-simvastatin interaction: effect on serum concentrations of simvastatin, simvastatin acid, and HMG-Co-A reductase inhibitors. Clin. Pharmacol. Ther. 64:477-83, Kupferschmidt HH, Fattinger KE, Ha HR, Follath F, and Krahenbuhl S.: Grapefruit juice enhances the bioavailability of the HIV protease inhibitor saquinavir in man. Br. J. Clin. Pharm. 45:355-9, Fuhr U.: Drug interactions with grapefruit juice. Extent, probable mechanism and clinical relevance. Drug Safety. 18:251-72, Bailey DG, Munoz C, Arnold JMO, and Spence JD.: Grapefruit juice and drugs: how significant is the interaction? Clin. Pharmacokinet. 26:91-8, Ameer B, and Weintraub RA.: Drug interactions with grapefruit juice, Clin. Pharmacokinet. 33:103-21, Rey, J. M. and Walter, G. Hypericum perforatum in depression: pest or blessing. Medical j. of Australia. 169:583-6, Ruschitzka, F., Meier, P. J., Turina, M, et al. Acute heart transplant rejection due to St. John s wort. The Lancet, 355:548-9, Breidenbach, Th., Kliem, V., Burg, M. et al. Profound drop of cyclosporin A whole blood though levels caused by St. John s wort. Trasplantation. 69: Johne, A., Brockmoller, J., Bauer, S. et al. Interaction of St. John s wort with digoxin. Clinical Pharmacology and Therapeutics. 66: Adriane F. B., Herb-Drug interactions, The Lancet. 355:134-8, Yu-Chi Hou, Su-Lan Hsiu, Chih-Wan Tsao, Yao-Horng Wang, and Pei-Dawn L. Chao, Acute Intoxication of Cyclosporin Caused by Coadministration of Decoctions of the Fruits of Citrus aurantium and the Pericarps of Citrus grandis, Planta Medica, 66, (2000). 38. (1985). 435

24 39. Agresti, A.Categorical Data Analysis. John Wiley & Sons Inc.(1990). 40. Bellack,A.S.,& Herson, M. Research Methods In Clinical Psychology. Pergamon Press Inc. (1984). 41. Krathwohl,D.R.Social and Behavior Science Research. Jossey-Bass Publishers. (1985). 42. Megers,R.H. Classical and Modern Regression with Applications. PWS-Kent Publishing Company. (1990). 43. Hosmer, D.W, Lemeshow, S. Applied Logistic Regression. A wiley-interscience Publication. (1989) pp pp Straus, S. E. Herbal Medicines- What s in the Bottle? New England Medicine. 347(25): , de Semet, P. A. G. M. Herbal Remedies. New England Medicine. 347(25): 436

25 , Boston Collaborative Drug Surveillance. Adverse drug interactions. JAMA 220: , Borda, I. T., Slone, D., Jick, H. Assesment of adverse reactions within a drug surveillance program. JAMA 205: 645-7, Jankel, C. A., Fitterman, L. K. Epidemiology of drug-drug interactions as a cause of hospital admissions. Drug Saf 9: 51-59, Karas, S. Jr. The Potential for drug interactions. Ann Emerg Med 10: , Nics A. S., Spielberg, S. P. Principles of therapeutics. In: Hardman J. G., Limbird L. E., Molinoff P. B., Ruddon R. W., Gilman A. G., editors. Goodman and Gilman s: The pharmacological basis of therapeutic, 9 th ed. New York: McGraw-Hill, p Hansten, P. D. Clinical and pharmacoeconomic significance of metabolic drug interactions. In: Levy, R. H., Thummel, K. E., Trager W. F., Hansten, P. D., Eichelbaum, M. editors. Metabolic drug interactions. Philadelphia: Lippincott-Raven Publishers, pp , Klepser, T. B., Klepser M. E. Unsafe and potentially safe herbal therapies. Am J Health Syst Pharm. 56:125,

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28 84.90% 63.10% 12.10% 13.10% 15.30% 4.40% 1.60% 6.00% 8.00% 1.10% 0.80% 1.20% 440

29 35% 40.20% 40.90% 36% 34% 15.80% 441

30 (%) < >

31 (%) <20, ,000-50, , , , , , , >200,

32 39.2 % 60.8 % 2.5 % 10.0 % 25.4 % 19.5 % 27.5 % 15.1 % X 2 = P< OR= (CI: ) OR odds ratio CI confidence interval p <0.001 F= P< OR= (CI: ) OR odds ratio CI confidence interval p <

33 80.3 % 51.1 % 70.2 % 26.8 % 26.2 % 7.8 % 5.7 % 3.6 % 6.2 % 38.1 % 23.7 % 38.2 % 43.3 % 56.7 % 39.9 % 17.4 % 42.8 % 81.9 % 18.1 % 445

34 n=957 n= % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % 446

35 56.4 % 52.0 % 14.9 % 9.0 % 5.1 % 2.9 % 35.6 % 37.2 % 0.2 % 1.3 % 0.4 % 2.0 % 4.4 % 1.5 % 27.0 % 39.0 % 9.0 % 3.8 % 0.2 % 0.2 % 0.4 % 3.1 % 9.8 % 11.8 % 63.5 % 61.6% 26.7 % 26.7 % 447

36 (%) (%) (%)

37 (%) (%) (%)

38 (%) (%)

39 n (n=489) Prognostic factor B (SE) OR (95%CI) ( ) (1.008~1.028) G( ) ( ) (1.934~11.449) B regression coefficient SE standard error p <0.01 p <0.001 OR odds ratio CI confidence interval (n=820) Prognostic factor B SE OR 95%CI ( ) (0.1095) ~0.927 ( ) (0.1250) ~2.236 ( ) (0.1285) ~0.828 ( ) (0.1110) ~2.116 n B regression coefficient SE standard error p <0.01 OR odds ratio CI confidence interval p <

40 n (n=475) Prognostic factor B SE OR 95%CI (0.7424) ~ (0.4678) ~ B regression coefficient SE standard error p <0.05 OR odds ratio CI confidence interval (n=670) Prognostic factor B (SE) OR (95%CI) (0.1657) (0.514~0.986) (0.1475) (0.472~0.842) (0.3058) (1.029~3.437) (0.1671) (1.100~2.119) (0.2645) (1.273~3.608) (0.1834) (0.470~0.966) (0.2407) (1.306~3.367) (0.5578) (1.331~12.575) n B regression coefficient SE standard error p <0.05 OR odds ratio CI confidence interval p <

41 % % % % % % % % % (n=648) B (SE) OR (95%CI) (0.1430) (0.960~1.682) (0.1382) (1.045~1.796) N: p <0.05 p <0.05 (n=1054) B (SE) OR (95%CI) (0.1042) (1.320~1.985) (0.0973) (1.053~1.542) p <

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864 现代药物与临床 Drugs & Clinic 第 31 卷第 6 期 2016 年 6 月 of apoptosis related factors, decrease the incidence of adverse reactions, which is of great

864 现代药物与临床 Drugs & Clinic 第 31 卷第 6 期 2016 年 6 月 of apoptosis related factors, decrease the incidence of adverse reactions, which is of great 现代药物与临床 Drugs & Clinic 第 31 卷第 6 期 2016 年 6 月 863 曲妥珠单抗联合多西紫杉醇治疗 Her-2 阳性乳腺癌的临床研究 * 周永安, 刘训碧黄石市中心医院 ( 普爱院区 ) 乳腺肿瘤外科, 湖北黄石 435000 摘要 : 目的探析注射用曲

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穨1-18.doc