【作者】 何志华；

【导师】 魏品康；

【作者基本信息】 第二军医大学 ， 中西医结合临床， 2012， 硕士

【摘要】 研究目的：设计随机对照试验，通过与黛力新对照，运用卡氏功能状态量表(KPS)、抑郁自评量表（SDS）、汉密尔顿抑郁量表（HAMD17）、汉密尔顿焦虑量表（HAMA）、抗抑郁剂副反应量表（SERS）等作为检测工具，观察白龙解郁颗粒治疗肿瘤患者抑郁发作的疗效、副反应及复发情况，客观评价白龙解郁颗粒治疗肿瘤患者抑郁症状的疗效。研究方法：在2010年9月至2011年12月就诊与我科门诊及病房的肿瘤患者中，经过纳入和排除标准，排除不符合本次试验的病例，对患者或家属进行知情告知的前提下，采用随机对照试验的方法，将纳入的样本分为白龙解郁组和黛力新组，白龙解郁组服用白龙解郁颗粒：12g/次，早晚餐后口服；黛力新组服用黛力新片：10.5mg/次，早中餐后口服，疗程为8周，随访4周。于治疗前及治疗结束时进行血常规、肝肾功能、心电图等常规检查；治疗前与8周时运用KPS量表观测患者生活质量；在用药前及用药后2、4、8周时用HAMD17、HAMA等量表评定疗效；治疗前和8周时用SERS副反应量表记录不良反应；从8周起定时随访至12周，运用SDS量表评测抑郁症复发情况。最后，运用Epidata软件进行数据的录入，SPSS18.0统计软件进行数据的统计分析。研究结果：1.8周治疗后，两组患者KPS量表评分分值明显增加，与本组治疗前相比，差别有统计学意义(P＜0.05)，但两组间并无明显差别(P>0.05)；2．两组HAMD17评分在各时间点与基线比较均显著下降，8周末白龙解郁组的治疗有效率为93％(30/32)；黛力新组为90％(29/32），与本组治疗前相比有统计学意义（P＜0.05)，两组间比较无统计学意义（P＞0.05)，黛力新组2周末起评分有显著下降，白龙解郁颗粒组治疗4周末起评分有显著下降；3.在HAMA量表中，两组评分在各时间点与基线比较均显著下降，2周以后，两组与治疗前相比就有统计学意义（P＜0.05)，4周时，白龙解郁组评分即有明显下降，4周、8周后两组间相比也有统计学意义（P＜0.01)；4．8周时，两组SERS副反应量表分值与治疗前比较均有统计学意义（P＜0.05)，同时，两组间的比较亦有统计学意义（P＜0.01)；5．8周至12周随访发现，白龙解郁颗粒组复发情况均好于黛力新组。研究结论：1.白龙解郁颗粒与黛力新均能提高肿瘤伴发抑郁症患者的生活质量，在治疗抑郁症上两者疗效相当，2.治疗伴随的焦虑症方面白龙解郁颗粒疗效优于黛力新，3.同时副反应、复发情况均优于黛力新。更多还原

【Abstract】 Objective：To comparatively observe the curative effect, adverse reaction and relapserates of Bailong Jieyu Granules and Deanxit on patients with cancer-related depression in arandomized trial. The scales of KPS、SDS、HAMD17、HAMA and SERS have been usedas a detection tool. So the curative effect of Bailong Jieyu Granules can be objectivelyevaluated.Methods：From September2010to December2011,64patients have been selectedfrom out patients and in patients in our hospital with into and exclusion standards. Thegroup of Bailong Jieyu takes away32patients and Deanxit group with another32patients.Before treatment and8weeks, the routine blood, hepatic/renal function and ECG havebeen checked. Before the drug and2,4,8weeks, the scales of KPS, HAMD17, HAMA,SERS have been used to record reactions. From8to12weeks, use SDS to compare twosets of the relapse rates. At last, use Epidata software to import the data, and SPAA18.0software to analyze.Results：1. In the8weekend, the two groups’ scores of KPS is more than before.1. Two groups’ scores of HAMD17, HAMA in different time points compared withbaseline are decreased significantly. In the HAMD17, scores of Deanxit group down sig-nificantly2weekend, Bailong Jieyu’s has dropped significantly4weekend. The curativeeffect of two groups in8weekend has no significant differences. In the HAMA, BailongJieyu’s score is obviously less than Deanxit’s in4weekend and8weekend.2. The scores of SERS with Bailong Jieyu group is less than Deanxit’s, and adversereaction is lower than Deanxit’s.3.8to12weeks that followed, Bailong Jieyu group significantly less than Deanxitgroup in average recurrence.Conclusion：Traditional Chinese medicine(Bailong Jieyu Granules) has significanteffect in the treatment of cancer-related depression, at the same time compared with the Western medicine Deanxit, and has fewer side effects, fewer recurrence.更多还原