前列腺炎Ⅰ号经验方治疗难治性Ⅲ型前列腺炎的疗效及安全性

Efficacy and safety of № I Empirical Prescription for Chronic Prostatitis in the treatment of type Ⅲ refractory chronic prostatitis

目的:观察经验方前列腺炎Ⅰ号治疗难治性Ⅲ型前列腺炎的疗效及安全性。方法:将53例Ⅲ型湿热瘀滞证难治性前列腺炎(RCP)患者随机分为治疗组和对照组。治疗组给予前列腺炎Ⅰ号1剂/d口服;对照组给予锯叶棕果实提取物(SPE)160 mg,2次/d,口服。分别于治疗前及治疗后4周、8周观察两组患者的NIH-CPSI评分、中医证候评分、尿动力学指标(最大尿流率、平均尿流率)和汉密尔顿抑郁量表和焦虑量表(HAMD、HAMA)评分。结果:治疗组25例、对照组23例患者完成临床观察。两组患者NIH-CPSI评分治疗前分别为(27.82±7.25)、(25.98±6.47)分,治疗8周后分别为(15.46±4.77)、(21.06±5.74)分。两组患者中医证候评分治疗前分别为(24.64±9.82)、(23.67±8.73)分,治疗4周后分别为(16.42±6.33)、(18.55±5.92)分,治疗8周后分别为(9.15±3.74)、(13.48±4.55)分。两组患者尿动力学指标(最大尿流率和平均尿流率)治疗前分别为(18.45±7.81)、(11.27±5.33)ml/s和(17.58±6.29)、(10.66±5.82)ml/s,治疗8周后分别为(23.44±8.73)、(16.51±7.36)ml/s和(21.26±8.32)、(13.44±6.16)ml/s。两组患者HAMD和HAMA评分治疗前分别为(22.74±6.37)、(21.37±7.15)分和(23.55±7.14)、(20.54±6.77)分,治疗4周后分别为(17.62±5.71)、(18.42±6.35)和(22.34±6.88)、(19.87±6.24),治疗8周后分别为(12.54±5.22)、(14.63±7.11)分和(21.62±5.63)、(19.42±7.04)分。以上数据显示,两组治疗前后各项指标(对照组HAMD和HAMA评分除外)均优于治疗前(P<0.05)。治疗组各治疗阶段评价指标改善程度均优于对照组(P<0.05)。两组患者治疗期间均未有明显不良反应发生。结论:前列腺炎Ⅰ号治疗Ⅲ型湿热瘀滞型RCP疗效确切、安全性好,具有较高的推广和应用价值。

Objective： To evaluate the efficiency and safety of № I Empirical Prescription for Chronic Prostatitis（ № I EPCP）in the treatment of type Ⅲ refractory chronic prostatitis. Methods： We randomly assigned 53 cases of type Ⅲ refractory chronic prostatitis with damp-heat and blood stasis to an experimental and a control group to receive № I EPCP at 1 dose per day and saw palmetto extract at 160 mg bid）,respectively,all for 8 weeks. Before and after 4 and 8 weeks of treatment,we obtained The National Institute of Health Chronic Prostatitis Symptom Index（ NIH-CPSI） scores,Traditional Chinese Medicine Syndrome Scores（ TCMSS）,maximum urinary flow rate（ Qmax）,average urinary flow rate（ Qavg）,Hamilton Depression Rating Scale（ HAMD） scores and Hamilton Anxiety Rating Scale（ HAMA） scores,and compared them between the two groups of patients. Results： Totally 48 of the patients completed the medication and follow-up,25 in the experimental and 23 in the control group. Compared with the baseline,the NIH-CPSI scores after 8 weeks of treatment were significantly decreased in the experimental（ 27. 82 ± 7. 25 vs 15. 46 ± 4. 77,P〈0. 05） and the control group（ 25. 98 ± 6. 47 vs 21. 06 ± 5. 74,P〈0. 05）,and so were the TCMSSs（ 24. 64 ± 9. 82 vs 16. 42 ± 6. 33 and9. 15 ± 3. 74,P〈0. 05,and 23. 67 ± 8. 73 vs 18. 55 ± 5. 92 and 13. 48 ± 4. 45,P〈0. 05）; the Qmax at 8 weeks were dramatically increased in the experimental group（ [18. 45 ± 7. 81] vs [23. 44 ± 8. 73] ml/s,P〈0. 05） and the control（ [17. 58± 6. 92] vs [21. 26 ± 8. 32]ml/s,P〈0. 05）,and so was the Qavg（ [11. 27 ± 5. 33]vs [16. 51 ± 7. 36]ml/s,P〈0. 05 and[10. 66 ± 5. 82]vs [13. 44 ± 6. 16] ml/s,P〈0. 05）; the HAMD scores were remarkably reduced in the experimental group（ 22. 74 ± 6. 37 vs 17. 62 ± 5. 71 and 12. 54 ± 5. 22,P〈0. 05） and the control（ 23. 55 ± 7. 14 vs 22. 34 ± 6. 88 and 21. 62 ±5. 63,P〈0. 05）,and so were the HAMA scores（ 21. 37 ± 7. 15 vs 18. 42 ± 6. 35 and 14. 63 ± 7. 11,P〈0. 05 and 20. 54 ±6. 77 vs 19. 87 ± 6. 24 and 19. 42 ± 7. 04,P〈0. 05）. No obvious adverse reactions were observed in either of the two groups during the medication. Conclusion： № I EPCP deserves promotion and clinical application for its definite effectiveness and safety in the treatment of type Ⅲ refractory chronic prostatitis with damp-heat and blood stasis.