理肝抗癌合剂治疗中晚期肝癌24例临床观察
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摘要
目的:
观察研究理肝抗癌合剂治疗中晚期原发性肝癌(以下简称“肝癌”)的临床疗效及安全性。以探索一种经济安全,疗效可靠,适宜推广的治疗中晚期肝癌的经验方法。原发性肝细胞癌是我国高发而严重的一种癌症,预后差。理肝抗癌合剂是湖北省中医院沈忠源教授的经验方,根据24例患者的临床观察证实,该方具有较好的临床疗效。
方法:
所选46例临床患者均来源于湖北省中医院肝病中心门诊和病房,符合中晚期肝癌的诊断标准和中医肝郁脾虚气滞血瘀痰凝型,分为治疗组与对照组,治疗组24例,对照组22例。两组均给予低盐,低脂,高蛋白,清谈饮食,治疗组给予理肝抗癌合剂,每日一剂,每次300ml,分早晚两次服,疗程为3个月;对照组给予金龙胶囊口服,一次4粒,一日3次,1个月一疗程,连续观察3个疗程。在治疗过程中每3个月进行CT或B超测量瘤体大小,检测血清AFP水平、肝功能Child-pugh分级,症状积分,功能状态(Karnofsky评分),并随访,统计生存期,应用SPSS13.0软件包进行资料的统计,结合临床实际对统计结果进行分析。
结果:
1治疗后两组临床症状改善比较:治疗组和对照组有效率和稳定率分别为7 9.2%、45.2%和87.5%、54.5%,两组比较均有统计学意义(P值分别为0.018和0.013,均小于0.05)。
2治疗后两组肝功能生化指标有效率比较:ALT、AST治疗后有效率治疗组较对照组差异均非常显著(P＜0.01);GGT治疗后有效率治疗组较对照组有统计学差异(P＜0.05)。
3治疗前后瘤体稳定率比较:治疗组瘤体稳定率(PR%+CR%+NC%)为58.3%,对照组瘤体稳定率(PR%+CR%+NC%)为45.5%,两组治疗后瘤体变化无统计学差异(P=0.475)。
4两组治疗前后AFP变化比较:两组治疗前后AFP变化无统计学差异(P＞0.05)。
5两组治疗后卡氏变化比较:①在卡氏评分变化(CR+PR)比较上,3月、6月、12月P值均小于0.05两组有统计学意义;在18月、2年及2年后P值均大于0.05,两组无统计学差异。②卡氏评分(CR+PR+NC)比较,初次治疗后的3月、6月、12月、18月P值均小于0.05,有统计学意义;2年及2年后,P值均大于0.05,无统计学差异。
6平均生存时间和生存率治疗后比较:治疗组和对照组的平均生存时间分别为13.67月和10.17月,治疗组长于对照组,且P=0.01 3＜0.05。在12月、18月、2年、2年后各时点的生存率均无统计学差异(P值均大于0.05)。治疗组在实验结束时(2009年3月)还有3例存活,对照组在终点时有1例存活。
7安全性检测:两组患者治疗后血清安全检测无毒副作用,两组治疗过程中后未发现不良反应及毒副作用。
结论:
研究表明,与对照组相比,理肝抗癌合剂全程治疗原发性肝癌,从患者症状积分、肝功能生化指标、AFP、卡氏评分、生存期等方面比较,在改善患者的临床症状、提高生存质量,延长生存期方面,有着更好的效果,且其安全性能好,无毒副作用。
Objective:
Observe the effect and safety of LI GAN KANG AI HE JI to treat the mid-term and later period primary liver cancer(PLC) so as to search an easy economy safe effective method in treating that.PLC is a very common and serious disease in our country which is very hard to control.LI CAN KANG AI HE JI was an experience medicine which is professor Shen in the Chinese medicine hospital of Hubei, according to the clinical observation of 24 patients,it should be have better clinical effect.
46 cases chosen all from the liver disease center of Chinese medicine hospital in Hubei province,match the mid-term and later period of PLC diagnosis standard and the Chinese medicine Certificate type,was divided into two groups,low salt diet,low lipid lipoprotein,high protein diet:therapeutic group of LI GAN KANG AI HE JI,24 cases,routine medicine control group,22 cases. Therapeutic group was given LI GAN KANG AI HE JI,everyday 1,300 ml each time,treat the distance as three months.The medicine control group was given JING NONG JIAO NANG pills,4 pieces each time,3 times every day,1 month for the therapeutic period,and treat for 3 periods.Record mass variety by CT,MRI or BUS,symptoms, Karnofsky performance status(KPS),the children grade of liver function,serum level of AFP、GGT、TBIL,QOL(every3months).Using the software of SPSS13.0 to statistic the index above.Median survival times(MST),and the survival rate etc,to analyze the outcome according to clinical circumstances.
Result:
1 The symptom improving comparison of two groups after treatment:The effective rates and stable rates of treatment group and compared group were respectively:79.2%、45.2%and 87.5%、54.5%.Two sets of comparison had statistical significances(P were respectively 0.018 and 0.013,and were less than 0.05).
2 The comparison of liver function index' s effective rates after the treatment:There were obvious differences between treatment group and compared group which are treated by ALT,AST (P＜0.01);There was a statistical difference between treatment group and compared group which were treated by GGT(P＜0.05).
3 The comparison of mass stable rates in front and back the treatment:Mass stable rates of the treatment group(PR%+CR%+NC %) was 58.3%,mass stable rates of the compared group(PR%+CR %+NC%) was 45.5%,the change of mass had no statistical difference after the treatment(P=0.475)
4 The comparison of AFP change after the treatment:There was no statistical difference of AFP change in front and back the treatment(P＞0.05).
5 The comparison of Karnofsky performance status(KPS) after the treatment:①There was statistical difference of the effective rate of Karnofsky performance status(KPS) at the time points of 3m、6m、12m(P＜0.05).There was no statistical difference of the effective rate of Karnofsky performance status(KPS) at the time points of 18m、2y、after 2y(P＞0.05).②There was statistical difference of the stabilization rate of Karnofsky performance status(KPS) at the time points of 3m、6m、12m、18m(P＜0.05).There was no statistical difference of the effective rate of Karnofsky performance status(KPS) at the time points of 2y、after 2y(P＞0.05).
6 The comparison of average survival time and survival rates after the treatment:Average Survival time of treatment group and compared group were respectively 13.67m and 10.17m.Treatment group was longer than compared group,and there was statistical difference(P=0.013).There was no statistical difference of the survival rate at the time points of 12m、18m、2y、after 2y(P＞0.05).When the observation time was over in March 2009,there was 3 survivals in treatment group and 1 survival in compared group.
7 Safety:Two sets of sufferer empress the treatment has safety examination not poisonous side effect,two sets of treatment empress all good reaction and not poison effect.
Conclusion:
There search show that:Compare with compared group,the treatment group had better effects on Karnofsky performance status(KPS)、survival time,It matched ability to alleviate sufferer's symptom,instauration liver function,development exaltation life quality,its curative effect be accurate credibility,safety function good,not poisonous side effect.
观察研究理肝抗癌合剂治疗中晚期原发性肝癌(以下简称“肝癌”)的临床疗效及安全性。以探索一种经济安全,疗效可靠,适宜推广的治疗中晚期肝癌的经验方法。原发性肝细胞癌是我国高发而严重的一种癌症,预后差。理肝抗癌合剂是湖北省中医院沈忠源教授的经验方,根据24例患者的临床观察证实,该方具有较好的临床疗效。
方法:
所选46例临床患者均来源于湖北省中医院肝病中心门诊和病房,符合中晚期肝癌的诊断标准和中医肝郁脾虚气滞血瘀痰凝型,分为治疗组与对照组,治疗组24例,对照组22例。两组均给予低盐,低脂,高蛋白,清谈饮食,治疗组给予理肝抗癌合剂,每日一剂,每次300ml,分早晚两次服,疗程为3个月;对照组给予金龙胶囊口服,一次4粒,一日3次,1个月一疗程,连续观察3个疗程。在治疗过程中每3个月进行CT或B超测量瘤体大小,检测血清AFP水平、肝功能Child-pugh分级,症状积分,功能状态(Karnofsky评分),并随访,统计生存期,应用SPSS13.0软件包进行资料的统计,结合临床实际对统计结果进行分析。
结果:
1治疗后两组临床症状改善比较:治疗组和对照组有效率和稳定率分别为7 9.2%、45.2%和87.5%、54.5%,两组比较均有统计学意义(P值分别为0.018和0.013,均小于0.05)。
2治疗后两组肝功能生化指标有效率比较:ALT、AST治疗后有效率治疗组较对照组差异均非常显著(P＜0.01);GGT治疗后有效率治疗组较对照组有统计学差异(P＜0.05)。
3治疗前后瘤体稳定率比较:治疗组瘤体稳定率(PR%+CR%+NC%)为58.3%,对照组瘤体稳定率(PR%+CR%+NC%)为45.5%,两组治疗后瘤体变化无统计学差异(P=0.475)。
4两组治疗前后AFP变化比较:两组治疗前后AFP变化无统计学差异(P＞0.05)。
5两组治疗后卡氏变化比较:①在卡氏评分变化(CR+PR)比较上,3月、6月、12月P值均小于0.05两组有统计学意义;在18月、2年及2年后P值均大于0.05,两组无统计学差异。②卡氏评分(CR+PR+NC)比较,初次治疗后的3月、6月、12月、18月P值均小于0.05,有统计学意义;2年及2年后,P值均大于0.05,无统计学差异。
6平均生存时间和生存率治疗后比较:治疗组和对照组的平均生存时间分别为13.67月和10.17月,治疗组长于对照组,且P=0.01 3＜0.05。在12月、18月、2年、2年后各时点的生存率均无统计学差异(P值均大于0.05)。治疗组在实验结束时(2009年3月)还有3例存活,对照组在终点时有1例存活。
7安全性检测:两组患者治疗后血清安全检测无毒副作用,两组治疗过程中后未发现不良反应及毒副作用。
结论:
研究表明,与对照组相比,理肝抗癌合剂全程治疗原发性肝癌,从患者症状积分、肝功能生化指标、AFP、卡氏评分、生存期等方面比较,在改善患者的临床症状、提高生存质量,延长生存期方面,有着更好的效果,且其安全性能好,无毒副作用。
Objective:
Observe the effect and safety of LI GAN KANG AI HE JI to treat the mid-term and later period primary liver cancer(PLC) so as to search an easy economy safe effective method in treating that.PLC is a very common and serious disease in our country which is very hard to control.LI CAN KANG AI HE JI was an experience medicine which is professor Shen in the Chinese medicine hospital of Hubei, according to the clinical observation of 24 patients,it should be have better clinical effect.
46 cases chosen all from the liver disease center of Chinese medicine hospital in Hubei province,match the mid-term and later period of PLC diagnosis standard and the Chinese medicine Certificate type,was divided into two groups,low salt diet,low lipid lipoprotein,high protein diet:therapeutic group of LI GAN KANG AI HE JI,24 cases,routine medicine control group,22 cases. Therapeutic group was given LI GAN KANG AI HE JI,everyday 1,300 ml each time,treat the distance as three months.The medicine control group was given JING NONG JIAO NANG pills,4 pieces each time,3 times every day,1 month for the therapeutic period,and treat for 3 periods.Record mass variety by CT,MRI or BUS,symptoms, Karnofsky performance status(KPS),the children grade of liver function,serum level of AFP、GGT、TBIL,QOL(every3months).Using the software of SPSS13.0 to statistic the index above.Median survival times(MST),and the survival rate etc,to analyze the outcome according to clinical circumstances.
Result:
1 The symptom improving comparison of two groups after treatment:The effective rates and stable rates of treatment group and compared group were respectively:79.2%、45.2%and 87.5%、54.5%.Two sets of comparison had statistical significances(P were respectively 0.018 and 0.013,and were less than 0.05).
2 The comparison of liver function index' s effective rates after the treatment:There were obvious differences between treatment group and compared group which are treated by ALT,AST (P＜0.01);There was a statistical difference between treatment group and compared group which were treated by GGT(P＜0.05).
3 The comparison of mass stable rates in front and back the treatment:Mass stable rates of the treatment group(PR%+CR%+NC %) was 58.3%,mass stable rates of the compared group(PR%+CR %+NC%) was 45.5%,the change of mass had no statistical difference after the treatment(P=0.475)
4 The comparison of AFP change after the treatment:There was no statistical difference of AFP change in front and back the treatment(P＞0.05).
5 The comparison of Karnofsky performance status(KPS) after the treatment:①There was statistical difference of the effective rate of Karnofsky performance status(KPS) at the time points of 3m、6m、12m(P＜0.05).There was no statistical difference of the effective rate of Karnofsky performance status(KPS) at the time points of 18m、2y、after 2y(P＞0.05).②There was statistical difference of the stabilization rate of Karnofsky performance status(KPS) at the time points of 3m、6m、12m、18m(P＜0.05).There was no statistical difference of the effective rate of Karnofsky performance status(KPS) at the time points of 2y、after 2y(P＞0.05).
6 The comparison of average survival time and survival rates after the treatment:Average Survival time of treatment group and compared group were respectively 13.67m and 10.17m.Treatment group was longer than compared group,and there was statistical difference(P=0.013).There was no statistical difference of the survival rate at the time points of 12m、18m、2y、after 2y(P＞0.05).When the observation time was over in March 2009,there was 3 survivals in treatment group and 1 survival in compared group.
7 Safety:Two sets of sufferer empress the treatment has safety examination not poisonous side effect,two sets of treatment empress all good reaction and not poison effect.
Conclusion:
There search show that:Compare with compared group,the treatment group had better effects on Karnofsky performance status(KPS)、survival time,It matched ability to alleviate sufferer's symptom,instauration liver function,development exaltation life quality,its curative effect be accurate credibility,safety function good,not poisonous side effect.
引文
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