| BackgroundCancer pain is a universal problem which cancer patients must to face,especially for the cancer patients who have been in the middle-late stage.The incidence and degree of pain rise in a straight line accompanied by the proliferation,diffusion,transfer and infiltration of tumor cells.To control cancer pain is banking on the control of tumor entity and the application of analgesic drugs.The Chinese herbal medicine has been the extensive attention,because of its advantages that less side-effect,lower dependence and last longer when it is used to treat cancer pain.The compound Kushen injection is just one.It has been confirmed by laboratory and clinical trials that the compound Kushen injection has the precise therapeutic effect of cancer pain,also can reduce the occurrence of the adverse reactions when applied combined with western medicine.But there is no related research can provide reference that guiding which dose is the best for clinical treatment.ObjectiveTo provide the reference and instruction by exploring the therapeutic effect and safety of different doses of the compound Kushen injection for the treatment of cancer pain,which is based on the randomized,double-bind,parallel controlled clinical trial that to observe the therapeutic effect and safety of different doses of compound Kushen injection for the treatment of cancer pain.Methods1.Adopt randomized,double-blind,parallel controlled and multicentre clinical trial method.2. Set up three groups:control group (compound Kushen injection 12ml), experimental group 1 (compound Kushen injection 20ml), experimental group 2 (compound Kushen injection 40 ml).3.Control group:96 cases;Experimental group 1:96 cases;Experimental group 2:96 cases.Plan to enroll 288 cases.4.Main Outcome Measures:Analgesic effect(Pain relief,Pain Relief efficacy);Secondary Outcome Measures:Analgesic duration;Painless days;TCM syndrome effect;Physical condition effect(The change of life ECOG score can be lower,stability and higher).5.Recording the incidence of adverse events,serious adverse events and adverse reactions.6.Analysis by SAS 9.2 software.All statistical tests are two-sides, it will be considered statistical difference when P<0.5.Results1. It is no statistical differences for the NRS/VAS pain score among the three groups.NRS score of the three groups:control group:4.48±1.82; experimental group 1:4.70±1.82; experimental group2:4.42±1.73;VAS score of the three groups:control group:4.53±1.91; experimental group 1:4.82±1.80; experimental group 24.52±1.96.2.The pain relief effectiveness rate of NRS/VAS score of malignant tumor patients rise gradually with the increase of the dose of compound Kunshen injection, The pain relief effectiveness rate of NRS score(28d)(FAS):control group (12ml):44.8%;experimental group 1(20ml):51.1%;experimental group 2(40ml):53.4%, The pain relief effectiveness rate of VAS score(28d)(FAS):control group (12ml)1:52.9%;experimental group 1(20ml):56.0%;experimental group 2(40ml):64.0%. Although it is no statistical differences for the rate of three groups, the experimental group 2(40ml) is higher than that experimental group 1(20ml) and control group (12ml), experimental group 1(20ml) is higher than control group (12ml),after the treatment.3.The painless days of the three groups(28d)(FAS):experimental group 2(40ml) (1.73±5.00) is higher than experimental group 1(20ml) (0.73±2.63) and control group (12ml)(0.95±3.05),but it is no statistical differences for the three groups (P>0.05).The diachronic TCM syndrome curative effect of the three group(28d)(FAS):the total effective rate of experimental group 2(40ml)(35.2%) is higher than experimental group 1(20ml)(29.5%) and control group (12ml),(32.2%),but it is no statistical differences for the three groups (P>0.05).The diachronic analysis(14d,21d,28d)(FAS) of the physical condition effect among the three groups showed that it is no statistical differences (P>0.05),but the physical condition of experimental group 2(40ml)(Overall stability rate:98.9%) is better than control group (12ml)(Overall stability rate:95.4%) while at 28d.lt is no statistical differences (P>0.05) for the comparison of the analgesic duration among the three groups.4.The adverse event rate of control group (12ml) is 46.6%(41 cases,N=88);experimental group 1(20mI) is 48.9%(43 cases,N=88);experimental group 2(40ml) is 55.6%(50 cases,N=90),it is no statistical differences for the three groups (P>0.05).The adverse reaction rate of control group (12ml) is 5.7%(5 cases,N=88);experimental group 1(20ml) is 13.6%(12 cases,N=88);experimental group 2(40ml) is 26.7%(24 cases,N=90);The main adverse reaction is the digestive system,such as nausea and vomiting,the adverse reaction rate of experimental group 2(40ml) is higher than experimental group 1(20ml) and control group (12ml),the comparison among them is statistical differences (P<0.05),but patients can tolerate the adverse reactions, and the adverse reactions are improved and disappear after symptomatic treatment.The serious adverse events are 5 cases among three groups,and all had died,3 cases of control group (12ml) and 2 cases of experimental group 1(20ml),but it has nothing to do with the test drug(Compound Kunshen injection) after judgment.ConclusionThe Different doses of the compound Kushen injection can ease cancer pain in patients with cancer in varying degrees,there may be a dose-dependent,the adverse reaction can be tolerated. |
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