| 1 BackgroundOf cancer patients with somatic pain is a subjective experience, by primary or secondary tumors invaded the bone and caused deep tissue, often shown as a dull pain, severe pain, and some patients may be accompanied by pressure and locating better. Is one of the most difficult pain to control in clinical. Currently there are certain limitations in using single modern medical therapy in the treatment of cancerous somatic pain, and there are varying degrees of adverse reactions, indication selection also has limitations, such as pain treatment opioid of choice, its obvious side effects limit its use. Therefore, looking for a safe, effective, green therapy of traditional Chinese medicine has a positive meaning to improve the quality of life of tumor patients suffered pain, extend lifetime and even tumours clinical as a whole. Chinese medicine with little toxicity and side effects but rich treatment. It can effectively relief pain and reduce opioid adverse reactions at the same time. This important method is safe and effective in the treatment of cancer pain.2 ObjectivesBy designing a prospective controlled clinical studies, evaluat the clinical efficacy and safety of Yishen Gukang Formula on Cancerous somatic pain, confirmed it’clinical efficacy on Cancerous somatic pain and clinical opioid dose can reduce and mitigate its adverse effects.3 MethodsUsed prospective and self-control method,65 cases with moderate to severe cancerous somatic pain and meet the inclusion criteria included into the stdy.From 1th day to 7th day oral OxyContin 10mg q12h,or increased dose titration according to the pain scores;between the 8th day to 14th day based on oxycodone hydrochloride oral medicine decoction (Yishen Gukang Formula),potion everyday,100ml/times,twice a day,14 days for a course of treatment. Efficacy was evaluated after the end of treatment of 7th and 14th days4 Results4.1 Statistical description65 effective cases included in this study, in which 38 male cases and 27 female cases,the average age was 67.70±15.12. Cancer species included 28 lung cancer cases, and 11 prostate cancer cases, and 7 breast cancer cases and 4 colorectal cancer cases and so on. Pain location more distributed in waist (23.08%), and abdominal (20%), and chest stalking department (15.39%), part patients (13.85%) with more than two place. Paints were all the heavy degrees pain. NRS score was 4.82±1.12 and KPS score was54.92±13.48, most patients needed care; Of the TCM syndromes,22 cases (33.85%) belonged to deficiency of kidney-yin and 19 cases (29.23%) blood stasis, and 24 cases (36.92%) belonged to both of them.4.2 Clinical efficacyAfter the 1th week of treatment the total effective rate was 86.3% and 53.9% of the efficiency. After the 2nd week of treatment the total effective rate was 93.8% and 66.2% of the efficiency, there was a statistically significant difference (P<0.05).4.3 Numberical rating scaleThe NRS score of Patients into groups of the 1th day was 4.82±1.12, after the lth week of treatment, the 7th day was 2.77±0.66, and there was significant difference between them, after 2nd week treated with adding Yishen Gukang Formula, the NRS score of 14th day wsa 1.97±0.81, and the difference was significant compared with the 7th day (P<0.01).4.4 Opoiods dosageThe 1th day’s basis opioid doseage (mg) was 56.23±8.71,and 54.85±6.84 of the 7th day, no statistical difference between them. The 14th day’s opioid doseage was 43.08.±10.8,with significant difference compared with the 7th day. The total doseage of the 1th week was significantly different compared with the 2nd week (P<0.01).4.5 Breakthrough painBreakthrough pain of the 1th week occurred (2.51±0.55)times, and 2nd week was 1.91±0.41, there was significant difference between them(P＜0.01).4.6 Pain affects scoresThe pain effects total score of the 1th day was 50.23±7.19,7th day for 48.45± 3.73,the difference between them with no statistics meaning (P>0.05). Individual compared in the sleep aspects, differences had statistics meaning (P<0.05).14th day’s total score was 45.17±3.98, with significantly differences compared with 7th day’s(P<0.01).There was statistics differences between Individual compared in the daily activities, mood, sleep, the life enjoy aspects (P＜0.05). Particularly with regard to sleep have significantly differentce (P＜0.01).4.7 Karnofsky performance statusThe KPS score of Patients in 1th day was 54.92±13.48,and the 7th day was 58.31 ±13.06, no statistical difference between them (P>0.05). The 14th day was 60.77± 14.82, no statistically significant difference with the 7th day, but a significant difference compared with the 1th day, 1th week and 2nd week in KPS scores improveing rate also no statistically significant difference (P>0.05).5 Conclusions5.1 In patients with moderate to severe cancerous somatic pain, based on opioids effectively controling pain, combined with Yishen Gukang Formula may further relieve pain and also reduce the breakthrough pain episodes.5.2 In patients with moderate to severe cancerous somatic pain, use Yishen Gukang Formula can reduce the consumption of opioids.5.3 In patients with moderate to severe cancerous somatic pain, Yishen Gukang Formula in treatment of cancer pain can be significantly reduced pain affects Rating, improving the negative impact of pain on patients, in particular, can improve the patient’s daily activities, mood, sleep, and enjoy life.5.4 Yishen Gukang Formula oral use with no systemic side effects,because of reducing the consumption of opiates, to a certain extent improve the adverse reactions caused by the heavy use of opioids. |
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