Real world analysis on renal impairment of elemene emulsion injection based on propensity score matching

Objective:To explore the main factors of renal function injury caused by the combination of elemene emulsion injection in the real world.Methods:Based on the hospital information system medical database constructed by the Institute of Clinical Basic Medicine of Chinese Academy of Traditional Chinese Medicine,taking the patient information of elemene emulsion injection used in 21 top three hospitals in China as the research object,the nested case control study method was used to compare the combined medication of patients with renal function injury group and control group,The main factors that may lead to renal function injury were screened by MCP variable selection method,and the above main factors were further analyzed by classical logistic regression and propensity score logistic regression method.Results:The analysis found that the combined use of potassium chloride within 7 d before the use of elemene emulsion injection or the combined use of furosemide during the use of elemene emulsion injection may be the main factor leading to renal function injury.Conclusion:The combination of elemene emulsion injection and the above main factors that may lead to renal injury should be avoided.If it must be used,clinical monitoring should be strengthened,and abnormal reactions should be treated immediately.The results of this study have certain clinical significance,and the clinical mechanism can be further studied and explored in the future.

Clinical Study on TACE Combined with Elemene Injection and Cinobufagin Injection Respectively for Middle and Advanced Primary Hepatic Carcinoma

Objective: To observe and compare the differences in the clinical effect and the incidences of adverse reactions oftranscatheter arterial chemoembolization(TACE) combined with elemene injection and cinobufagin injection respectively for middleand advanced primary hepatic carcinoma. Methods: A total of 104 cases of patients with middle and advanced primary hepaticcarcinoma who were treated in the oncology department from August 2018 to January 2020 were included as the study objects, andwere randomly divided into two groups according to different treatment regimens, 52 cases in each group. Both groups were treatedwith TACE once;the cinobufagin injection group was given intravenous infusion with 500 mL of 5% glucose injection and 10 mLof cinobufagin injection once a day. The elemene injection group was given intravenous infusion with elemene injection of 0.4 geach time and once a day. Both groups were treated for two courses, 15 days of continuous treatment with a rest of 15 days beingone course. The clinical effect, the changes in the indexes of liver function including alanine amino transferase(ALT), aspartatetransaminase(AST) and total bilirubin(TBil), the scores of alpha-fetoprotein(AFP) and Karnofsky (KPS) and tumor volumes aswell as the difference in the incidences of adverse reactions between the two groups were observed and compared. Results: Thetotal clinical effective rate was 88.46% in the elemene injection group and 71.15% in the cinobufagin injection group, and thedifference was significant(P<0.05). After treatment, the levels of ALT, AST and TBil in serum in the two groups were significantlydecreased when compared with those before treatment, differences being significant(P<0.05). There was no significant differencebeing found in the comparison of the levels of ALT, AST and TBil in serum between the two groups (P>0.05). After treatment, thedecrease of AFP, tumor volume and the increase of KPS scores in the elemene injection group were significantly more than thosein the cinobufagin injection group, differences being significant (P<0.01). During treatment, there was no significant differencebeing found in the comparison of the total incidences of adverse reactions between the two groups(P>0.05). The adverse reactionsin the cinobufagin injection group were mainly nausea and vomiting, with higher incidence than that in the elemene injection group,the difference being significant (P<0.05). The adverse reactions in the elemene injection group were mainly pain at the injectionsite, with higher incidence than that in the cinobufagin injection group, the difference being significant (P<0.05). Conclusion: Thetherapy of elemene injection combined with TACE for middle and advanced primary hepatic carcinoma has better clinical effect thanthat of cinobufagin injection, but the occ.

The effect of beta-elemene on alpha-tubulin polymerization in human hepatoma HepG2 cells

Objective： To investigate the impact of beta-elemene injection on the growth and alpha-tubule of human hepatocarcinoma HepG2 cells. Methods： Cell proliferation was assessed by MTT assay. Cell cycle distribution was detected by flow cytometry （FCM）. The mRNA expression of alpha-tubulin was measured by RT-PCR. Western blot analysis was used to determine protein expression of alpha-tubulin and the polymerization of tubulin. Results： Beta-elemene injection inhibited HepG2 cells proliferation in a dose- and time-dependent manner; FCM analysis indicated beta-elemene injection induced cell cycle arrested at S phase. RT-PCR and western- blot analysis showed that beta-elemene injection down-regulated alpha-tublin at both mRNA and protein levels, presenting a dose-dependent manner. Moreover, beta-elemene injection reduced the polymerization of microtubules in a dose-dependent manner. Conclusions： Beta-elemene injection can inhibit the proliferation of hepatoma HepG2 cells and induce cell apoptosis, the mechanism might be partly related to the down-regulation of alpha-tubulin and inhibition of microtubular polymerization.

Elemene Emulsion Injection Administration Reduces Neuropathic Pain by Inhibiting Astrocytic NDRG2 Expression within Spinal Dorsal Horn

Objective To investigate the mechanisms underlying elemene-induced analgesia in rats with spared nerve injury(SNI).Methods Sixty-five rats were equally divided into 5 groups using a random number table:naive group,sham group,SNI group,SNI+elemene(40 mg·kg−1·d−1)group and naive+elemene(40 mg·kg−1·d−1)group.An SNI rat model was established and the intervention were given respectively for 14 consecutive days.Von Frey filament tests and elevated plus-maze(EPM)tests were used to evaluate the effect of elemene on the mechanical threshold and anxiety,respectively.Immunoblotting and immunostaining were used to measure the expression of glial fibrillary acidic protein(GFAP)and NMYC downstream-regulated gene 2(NDRG2)within the lumbar spinal dorsal horn(SDH).Results The SNI rat model exhibited a significant decrease in paw withdrawal threshold and exploratory behaviour in the EPM(P<0.05).Consecutive administration of elemene alleviated SNI-induced mechanical allodynia and anxiety in rats(P<0.05).Immunohistochemical data showed that elemene decreased SNI-induced upregulation of NDRG2 within the SDH(P<0.05).Double immunofluorescent staining data further showed that elemene decreased SNI-induced upregulation of the number of GFAP immunoreactive(-ir),NDRG-ir,and GFAP/NDRG2 double-labelled cells within the SDH(P<0.05).Immunoblotting data showed that elemene decreased SNI-induced upregulation of GFAP and NDRG2 within the SDH(P<0.05).Conclusion Elemene possibly alleviated neuropathic pain by downregulating the expression of NDRG2 in spinal astrocytes in a rat model of SNI.

Systematic Review of β-Elemene Injection as Adjunctive Treatment for Lung Cancer

Objective： To evaluate the effectiveness and safety of βelemene Injection as an adjunctive treatment for lung cancer by systematic review. Methods： We retrieved randomized controlled clinical trials related to the use of β elemene Injection as an adjunctive treatment for lung cancer from Chinese Biomedical （CBMweb）, Chinese Medical Current Content （CMCC）, China National Knowledge Infrastructure （CNKI）, Chinalnfo, Cochrane Central Register of Controlled Trials; MEDLINE, EMBASE, OVID and TCMLARS. We also referred to an unpublished conference proceeding titled Clinical Use and Basic： Elemene Injection. We then divided the studies into nonsmall cell lung cancer （NSCLC） and small cell lung cancer （SCLC） subgroups by RevMan 5.1 software. Results： A total of 21 source documents （1,467 patients） matched prespecified criteria for determining the effectiveness and safety of β elemene Injection as an adjunctive treatment for lung cancer. Five studies involving 285 NSCLC patients reported a higher 24month survival rate （39.09%） with the adjunctive treatment than with chemotherapy alone （26.17%; RR, 1.51; 95% CI, 1.03 to 2.21）. Four studies involving 445 patients reported that the increased probability for improved performance status for patients treated with elemenebased combinations was higher than that of patients treated with chemotherapy alone （RR, 1.82; 95% CI, 1.45 to 2.29）. The results from a subgroup analysis on 12 studies involving 974 NSCLC patients and 9 studies involving 593 patients with both SCLC and NSCLC showed that the tumor control rate for NSCLC improved more in the elemenebased combinations treatment group （78.70%） than in the chemotherapy alone control group （71.31%; RR, 1.06; 95% CI, 1.00 to 1.12）. The tumor response rate for NSCLC also improved more among patients treated with elemene based combinations （50.71%） than among patients treated with chemotherapy alone （38.04%; RR, 1.34; 95%CI, 1.17 to 1.54）. In addition, the main adverse reaction to βelemene Injection was phlebitis, but usually only to a mild degree. An Egger＇s test showed no publication bias in our study （P=0.7030）. Conclusions： The effectiveness of chemotherapy for the treatment of lung cancer may improve when combined with β elemene injection as an adjunctive treatment. The combined treatment can result in an improved quality of life and prolonged survival. However, these results require confirmation by rigorously controlled trials.

榄香烯注射液联合一线化疗方案治疗非小细胞肺癌的疗效及安全性

目的探讨榄香烯注射液联合吉西他滨+顺铂(一线化疗方案)治疗非小细胞肺癌(NSCLC)的疗效及安全性。方法根据治疗方法的不同将78例NSCLC患者分为观察组和对照组,每组39例,对照组患者接受吉西他滨+顺铂治疗,观察组患者在对照组的基础上联合榄香烯注射液治疗。比较两组患者的临床疗效、免疫功能指标[CD3^(+)、自然杀伤(NK)细胞、CD4^(+)/CD8^(+)]、生活质量[卡氏功能状态(KPS)评分]及不良反应发生情况。结果观察组患者的总有效率高于对照组,差异有统计学意义(P﹤0.05)。治疗后,两组患者CD3^(+)、NK细胞、CD4^(+)/CD8^(+)均低于本组治疗前,KPS评分均高于本组治疗前,观察组患者CD3^(+)、NK细胞、CD4^(+)/CD8^(+)、KPS评分均高于对照组,差异均有统计学意义(P﹤0.05)。两组患者各不良反应发生率比较,差异均无统计学意义(P﹥0.05)。结论榄香烯注射液联合吉西他滨+顺铂治疗NSCLC患者,可提高治疗效果、免疫功能及生活质量,并且不会增加不良反应。

榄香烯乳状注射液粒度测定方法的研究

目的:用激光散射法测定榄香烯乳状注射液粒度分布,考察不同试验条件对结果的影响。方法:将摸索出的榄香烯乳状注射液粒度测定的方法-测定条件:遮光率5%~10%,吸收率0.0001~0.1,折射率1.52~1.54;搅拌转速800~1600 r·min^(-1),平衡时间0.5~1 min进行方法学验证,取3批榄香烯乳状注射液,在Bettersize2600激光粒度分布仪(湿法)上进行测定。结果:3批样品测定结果:d(0.1)、d(0.5)、d(0.9)、d(0.99)分别为252、251、213,354、351、316 nm,543、532、476 nm,979、953、887 nm。结论:本试验方法可用于测定榄香烯乳状注射液的粒度分布,结果重现性好。

HAIC联合动脉灌注榄香烯注射液治疗进展期肝癌临床研究

目的探讨肝动脉灌注化疗术(HAIC)联合动脉灌注榄香烯注射液治疗进展期肝癌患者的临床疗效。方法选取2021年4月至2022年1月江门市五邑中医院收治的80例进展期肝癌患者展开研究,按随机数表法分为观察组和对照组各40例。两组患者均接受HAIC治疗,对照组患者药物为奥沙利铂、氟尿嘧啶,观察组患者则在对照组治疗的基础上联合榄香烯注射液动脉灌注,两组患者均以3周为一个治疗周期,连续治疗6周。比较两组患者治疗6周后的临床疗效,比较两组患者随访2年的总生存期(OS)、无进展生存期(PFS),同时比较两组患者治疗期间的不良反应发生率。结果观察组患者的客观缓解率(ORR)为47.50%,明显高于对照组的25.00%,差异有统计学意义(P<0.05),但观察组和对照组患者的疾病控制率(DCR)分别为75.00%、60.00%,差异无统计学意义(P>0.05);随访2年显示,观察组患者的OS、PFS分别为(16.12±3.69)个月、(14.60±3.30)个月,明显长于对照组的(13.44±3.71)个月、(11.27±3.08)个月,差异均有统计学意义(P<0.05);观察组患者转氨酶升高、骨髓抑制、发热、恶心呕吐、腹泻、血液系统毒性、疼痛的发生率分别为50.00%、20.00%、17.50%、75.00%、35.00%、40.00%、37.50%,对照组分别为40.00%、25.00%、17.50%、67.50%、40.00%、42.50%、35.00%,差异均无统计学意义(P>0.05)。结论HAIC联合动脉灌注榄香烯注射液治疗进展期肝癌可提高患者的ORR,延长OS、PFS,具有临床应用价值。

中药榄香烯乳注射液治疗恶性脑肿瘤40例临床研究

目的 :探讨榄香烯乳注射液治疗恶性脑肿瘤的疗效。方法 :总结分析我院 1994年 1月～1998年 5月间 ,采用榄香烯乳注射液治疗 4 0例恶性脑肿瘤患者 (治疗组 )的疗效。 4 0例中原发性脑肿瘤 2 9例 ,脑转移瘤 11例。采用榄香烯乳注射液 0 4～ 1 2 g/d ,6～ 12 g/疗程 ,共用 2～ 6个疗程 ,每疗程间隔 1～1 5个月。经皮颈总动脉穿刺或插管 ,注射泵注入 ;静脉滴药或 (和 )经泵静脉持续灌注。根据治疗前后肿瘤体积变化、平均生存期、体能状态评分评价疗效。对照组 2 9例 ,原发性脑肿瘤 2 2例 ,脑转移瘤 7例 ;采用化疗方法 ,2～ 3个疗程 ,每疗程间隔 1～ 1 5个月。结果 :( 1)治疗组治疗前后肿瘤平均体积 (cm3)变化 =6 70- 2 67=4 0 3(t =3 0 2 ,P <0 0 1) ,治疗前后肿瘤体积平均缩小 61%。 ( 2 )治疗组CR 4例 ,PR 2 6例 ,CR +PR 30例 ,总有效率 75 0 % ( 95%可信区间± 13 4 % )。对照组 2 9例 ,CR 2例 ,PR 10例 ,总有效率 4 1 4 %( 95%可信区间± 17 9% ,χ2 =3 867,P <0 0 5)。 ( 3)治疗组治疗前后KPS平均记分差为 94 7- 88 2 =6 5分 (t =3 5313,P <0 0 1)。 ( 4 )治疗组平均生存期 2 5 4个月 ,对照组生存期 17 4个月 ,两组比较差异有显著性意义 (t=3 74 ,P <0 0 1)。结论

榄香烯乳注射液联合放疗治疗肺癌脑转移的临床观察

目的探讨榄香烯乳注射液联合放疗治疗肺癌脑转移的疗效及安全性。方法 48例肺癌脑转移患者分为放射治疗组26例(单放组)和榄香烯乳联合放疗治疗组22例(联合组),比较两组的有效率、中位生存期、1年生存率以及不良反应。结果单放组和联合组的有效率(CR+PR)分别为23.0%和54.5%(P<0.05),中位生存期分别为10.9个月和15.0个月(P<0.05)。主要不良反应包括:放疗后脑组织水肿症状和骨髓抑制,联合组发生白细胞减少低于单放组。结论榄香烯乳注射液联合放疗治疗肺癌脑转移效果优于单纯放射治疗,提高了患者生存质量,延长了生存期。

榄香烯注射液联合放疗与TP方案联合放疗治疗食管癌的比较研究

目的比较榄香烯注射液联合放疗与TP方案(紫杉醇+奈达铂)联合放疗治疗食管癌的临床疗效和不良反应。方法将2006年12月至2009年12月期间收治的125例初诊食管癌患者随机分成3组:单纯放疗组(RT组,n=45)、榄香烯注射液+放疗组(RT+E组,n=42)和TP方案+放疗组(RT+TP组,n=38)。放疗采用常规四野放疗或三维适形放疗,2Gy/次,5次/周,放射总剂量60～66Gy;榄香烯400mg/d静滴,d1～d21;紫杉醇150mg/m2静滴,d1;奈达铂50mg/d静滴,d1～d3。RT+TP组患者先行1个周期TP方案化疗后完善相关检查,无放疗禁忌证再行放疗;于放疗过程中前4周每周测定白细胞数量,并分析各组白细胞数量变化;3组患者放疗结束时,评价毒副反应及近期疗效;对患者进行随访,分别计算1、2、3年生存率并绘制生存曲线。结果 RT组、RT+E组及RT+TP组的有效率分别为84.4%、90.5%和92.1%,放射性食管炎的发生率分别为66.7%、61.9%和60.5%,放射性肺炎的发生率分别为24.4%、31.0%和28.9%,骨髓抑制的发生率均为100.0%,上述组间差异均无统计学意义(P>0.05)。从放疗开始后第1～4周,RT+E组白细胞数量与RT组和RT+TP组比较,差异有统计学意义(P<0.05)。RT组、RT+E组及RT+TP组的1年生存率为60.0%、73.8%、78.9%,2年生存率为40.0%、54.8%、60.5%,3年生存率为28.9%、33.3%、44.7%,组间差异无统计学意义(P>0.05)。结论榄香烯注射液联合放疗与TP方案联合放疗治疗食管癌的近期疗效相当,且两药均不增加放疗的毒副反应,放疗过程中联合使用榄香烯注射液可维持患者的白细胞数量。

胸腔注射榄香烯致严重不良反应7例病例系列分析

背景与目的恶性胸腔积液(malignant pleural effusion,MPE)指胸膜原发恶性肿瘤或其他部位恶性肿瘤转移至胸膜引起的胸腔积液。胸腔内注射榄香烯对MPE有良好的治疗效果,在临床中应用较普遍,同时存在一些不良反应,但文献缺乏对严重不良反应的报道及处理。本研究旨在观察榄香烯注射液治疗恶性胸腔积液导致不良反应发生情况,探讨严重不良反应发生原因和应对方案。方法回顾性分析14例胸腔注射榄香烯病例,对其中7例发生严重不良反应病例进行详细报道。结果榄香烯注射液胸腔注射所致严重不良反应主要表现为剧烈胸痛、呼吸困难、喘憋、意识模糊和凝血功能障碍,经临床对症治疗后均可缓解。结论胸腔注射榄香烯榄香烯对MPE有一定治疗价值,使用时应严格把握适应证、筛选患者、严密监测。

榄香烯注射液治疗肺癌的有效性与安全性评价

目的评价榄香烯注射液治疗肺癌的有效性与安全性.方法检索MEDLINE(1966～2004.7)、中国生物医学文献数据库(1978.1～2004.5)、中国期刊全文数据库(1994～2004)、万方数据库(1980～2004)和重庆维普信息数据库(1989～2004),同时从参考文献中追溯文献,并收集未发表的文献.纳入榄香烯注射液治疗肺癌的随机对照试验.使用国际Cochrane中心推荐的方法进行文献质量评价,并用RevMan4.2软件进行统计分析.结果共纳入17篇研究,且均为低质量研究.1项研究显示,榄香烯+西艾克+顺铂的疗效优于西艾克+顺铂;榄香烯+化疗(足叶乙甙+顺铂)与单用化疗比较的4个研究的合并分析结果显示,常规化疗基础上加用榄香烯可以改善其临床疗效[RR合并=1.62,95%CI (1.29,2.03)];单独使用榄香烯与使用环磷酰胺+阿霉素+顺铂相比的2项研究的合并分析结果显示,两者疗效差异无统计学意义[RR合并=0.81,95%CI (0.44,1.49)];此外,10项单独研究的结果均显示,单独使用榄香烯注射液或榄香烯注射液+常规方案治疗肺癌与常规治疗相比,两者疗效无统计学差异.3篇单个研究显示,常规治疗+榄香烯组与常规治疗组相比,其1年及以上的生存率无统计学差异.14篇单个研究结果表明,使用榄香烯可能减少由常规治疗引起的副反应例数.结论目前收集到的榄香烯注射液治疗肺癌的临床试验质量较低,各种治疗方案纳入研究数量少,尚不能根据纳入研究获得榄香烯治疗肺癌的近期及远期疗效与安全性的证据,尚需设计严密、实施科学的大样本研究进一步证实其临床疗效.

不同中药注射剂辅助治疗肝癌的有效性与经济学评价

目的:比较不同中药注射剂辅助治疗肝癌的成本-效果。方法:将2011年1月—2012年3月我院150例晚期肝癌患者以随机抽样法分为5组,即艾迪注射液组、康莱特注射液组、榄香烯注射液组、消癌平注射液组与对照组,每组各30例。所有患者均给予丝裂霉素、吡柔比星、顺铂的介入治疗。除对照组外,其他4组患者分别辅以上述4种不同中药注射剂予以治疗,运用药物经济学方法评价5组的成本-效果。结果:艾迪注射液组、康莱特注射液组、榄香烯注射液组与消癌平注射液组成本-效果比分别为113.05、185.14、183.83、184.95,对照组为125.84,艾迪注射液组成本-效果比明显低于其他3组中药注射剂组,组间比较差异有统计学意义(P<0.05)。艾迪注射液组、康莱特注射液组、榄香烯注射液组与消癌平注射液组治疗3个月后疾病控制率分别为89.64%、84.62%、89.64%、80.77%,均高于对照组的57.68%,组间比较差异有统计学意义(P<0.05)。结论:4种中药注射剂辅助治疗肝癌均优于对照组,艾迪注射液组经济学成本优于其他3组中药注射剂组。晚期肝癌患者在介入治疗基础上辅以艾迪注射液是较为经济的治疗方案。

榄香烯联合紫杉醇抗Lewis肺癌血管生成的研究

目的研究榄香烯注射液联合紫杉醇注射液对Lewis肺癌小鼠肿瘤血管生成的影响。方法以C57BL/6雄性小鼠皮下接种构建Lewis肺癌小鼠模型。将50只Lewis肺癌小鼠随机分为A、B、C、D、E 5组,A组予生理盐水对照,B组予紫杉醇,C组予榄香烯低剂量+紫杉醇,D组予榄香烯高剂量+紫杉醇,E组予榄香烯高剂量。2周后摘除眼球取血,并处死动物,切除瘤灶,称瘤质量,计算抑瘤率,应用免疫组化染色检测移植肿瘤组织中CD34和血管内皮生长因子(VEGF)受体1(VEGFR1)、VEGF受体2(VEGFR2)的表达;用ELISA法测定小鼠血清血管内皮生长因子浓度。结果与A组比较,B、C、D、E组抑瘤率、微血管密度、VEGF受体1和2表达、血清VEGF浓度均有显著性差异(P<0.05或0.01),且D组与B、C、E组在抑瘤率、微血管密度、VEGFR1及VEGFR2表达、血清VEGF浓度比较也均有显著差别(P<0.05或0.01)。结论①榄香烯有抗肿瘤血管生成和肿瘤生长的作用。②榄香烯可增强紫杉醇抗肿瘤血管生成和肿瘤生长的效应。③榄香烯可能通过降低Lewis肺癌血管内皮生长因子的生成、抑制瘤体血管内皮生长因子受体的表达而抑制肿瘤血管生成及肿瘤的生长。

榄香烯注射液联合放疗对肺癌患者近期疗效及血清MMP含量影响的研究

目的分析榄香烯注射液联合放疗对肺癌患者近期疗效及血清MMP含量影响。方法选择在该院接受住院治疗的肺癌患者作为研究对象,随机分为单纯接受放疗的对照组、接受榄香烯注射液联合放疗的观察组,比较两组患者的治疗效果、血清MMP含量及T细胞亚群水平等差异。结果 1观察组患者接受治疗后的CR和PR率明显高于对照组,SD和PD率明显高于对照组(P<0.05);2观察组患者接受治疗后的血清MMP-2及MMP-9水平均显著低于对照组患者(P<0.05);3观察组患者接受治疗后的CD4+和CD4+/CD8+水平高于对照组,CD8+水平低于对照组(P<0.05)。结论榄香烯注射液联合放疗可以有效提高肺癌患者的治疗后完全缓解率及部分缓解率,降低血清MMP含量,提升患者免疫水平。

榄香烯注射液联合化疗对晚期非小细胞肺癌患者免疫功能及疗效的影响

目的探讨榄香烯注射液联合化疗对晚期非小细胞肺癌患者免疫功能、生活质量及疗效的影响。方法选取本院2016年4月至2017年1月收治的晚期非小细胞肺癌患者58例,随机分成单纯化疗组(n=29)和联合用药组(n=29),单纯化疗组中分别有16、8和5例接受TP、GP和PC方案,联合用药组分别有15、10和4例接受TP、GP和PC方案,联合用药组在化疗基础上联合榄香烯注射液治疗。2个周期后采用RECIST 1.1版标准评价近期疗效,采用流式细胞仪检测治疗前及2个周期治疗后T细胞亚群(CD4^+、CD8^+和CD4^+/CD8^+)及NK细胞水平以评价免疫功能,同时评估治疗前后的KPS评分。结果全组58例均可评价疗效,共完成297个周期化疗,中位化疗周期数5个。58例患者获CR 1例、PR 31例、SD 13例和PD 13例,总有效率(RR)和疾病控制率(DCR)分别为55.2%和77.6%。联合用药组29例中获CR 1例、PR 17例、SD 6例和PD 5例,RR和DCR分别为62.1%和82.8%,而单纯化疗组29例中未有获CR者,PR 14例、SD 7例和PD 8例,RR和DCR分别为48.3%和72.4%,两组差异无统计学意义(P>0.05)。两组治疗前外周血T淋巴细胞亚群(CD4^+、CD8^+、CD4^+/CD8^+)及NK细胞水平的差异无统计学意义(P>0.05);单纯化疗组治疗前后以上指标的差异亦无统计学意义(P>0.05)。联合用药组治疗后外周血CD4^+、CD4^+/CD8^+及NK细胞水平分别(41.97±8.14)%、1.76±1.71和(17.38±7.41)%,较单纯化疗组明显升高(P<0.05),CD8^+水平为(24.07±5.20)%,较单纯化疗组明显下降(P<0.05);联合用药组治疗后KPS评分为(82.07±4.91)分,高于单纯化疗组的(74.83±5.74)分,差异有统计学意义(P<0.05)。结论榄香烯注射液联合化疗治疗晚期非小细胞肺癌可以改善患者的免疫功能及生活质量,值得在临床推广。

榄香烯同步放化疗治疗鼻咽癌疗效及对患者免疫功能的影响

目的探讨榄香烯同步放化疗治疗鼻咽癌疗效及对患者免疫功能的影响。方法采用随机数字法将92例鼻咽癌患者分为对照组(调强放疗+氟尿嘧啶+顺铂)和观察组(调强放疗+氟尿嘧啶+顺铂+静脉滴注榄香烯注射液500 mg/d)。评价两组患者近期疗效,外周血淋巴T细胞亚群水平变化,并记录评估不良反应发生情况。结果92例患者均顺利完成了所有治疗。对照组总有效率(71.74%)与观察组(82.61%)相比,差异有统计学意义(P<0.05);外周血淋巴细胞亚群CD8^+水平观察组(34.37±1.97)与对照组(31.35±2.39)相比明显升高(P<0.05),CD4^+/CD8^+比例观察组(0.98±0.18)与对照组(1.37±0.03)相比显著下调(P<0.05)。观察组患者生存质量(60.3±5.3)与对照组(57.2±7.4)相比差异有统计学意义(P<0.05);观察组在血液学毒性、皮肤反应Ⅲ~Ⅳ级发生率方面均较对照组有所降低,在消化道反应Ⅲ~Ⅳ级发生率显著低于对照组(P<0.05)。结论榄香烯同步放化疗可提高鼻咽癌患者的生存质量,降低不良反应发生率,同时能获得较好的预后。

榄香烯注射液联合化疗治疗NSCLC临床疗效的Meta分析

目的:从循证医学的角度系统评价榄香烯注射液联合化疗治疗非小细胞肺癌的疗效和不良反应,为临床应用提供依据。方法:搜集榄香烯注射液联合化疗治疗非小细胞肺癌的临床试验,运用Cochrane图书馆系统评价方法,对纳入研究进行质量评价和Meta分析。结果:Meta分析结果提示榄香烯注射液联合化疗在近期疗效、Karnofsky评分改善方面均优于单纯使用化疗。近期有效率比较OR值为1.77,95%CI为1.21-2.59;Karnofsky评分改善率比较OR值为1.95,95%CI为1.09-3.50。榄香烯注射液联合化疗时,Ⅱ度和Ⅱ度以上贫血及消化道不良反应的发生率也较单用化疗低,但白细胞降低未见差异。贫血比较OR值为0.56,95%CI为0.34-0.94。消化道反应比较OR值为0.54,95%CI为0.31-0.93。白细胞下降比较OR值为0.74,95%CI为0.46-1.20。结论榄香烯注射液联合化疗治疗非小细胞肺癌取得较单纯化疗更好的效果和更低的不良反应发生率。但由于纳入的研究方法学质量低,存在发生偏倚的可能性,需更多设计合理的高质量临床试验加以验证。

榄香烯注射液联合TACE治疗原发性肝癌的疗效与安全性的Meta分析

目的:采用Meta分析方法对榄香烯注射液联合经导管肝动脉化学栓塞术(TACE)治疗原发性肝癌的疗效与安全性进行系统评价。方法:检索Pubmed、EMbase、Cochrane Library、中国知网CNKI全文数据库、维普数据库、万方数据库和中国生物医学文献数据库,查找自建库至2016年1月公开发表的研究榄香烯注射液联合TACE治疗原发性肝癌的临床随机对照试验。按照纳入与排除标准选择文献,质量评估,资料提取,采用Rev Man 5.2软件进行Meta分析。结果:共纳入6篇中文RCT文献,均为高质量研究。Meta分析结果显示,榄香烯注射液联合TACE组治疗原发性肝癌的近期有效率[OR=2.68,95%CI(1.63,4.40),P<0.000 1]、近期缓解率[OR=2.52,95%CI(1.25,5.08),P=0.010]高于单纯TACE组;而胃肠道反应[OR=1.16,95%CI(0.55,2.46),P=0.69]、骨髓抑制[OR=0.66,95%CI(0.32,1.36),P=0.26]在两组中无明显统计学差异。结论:榄香烯注射液可以提高TACE对原发性肝癌的疗效,且安全性较好。