| 1. Objective:1.1 Through simulating the common dosage clinically and studying the stability of compatibility of medicines used in sacral injection, to overcome the blindness and subjectivity in clinical operation, therefore provide theoretical support for safe compatibility for clinical use; The reason for complication in sacral injection are excessive local anesthetic use, too much drugs being used together, unfamiliarity with anatomy, over depth puncture, and et al, therefore reducing the incidence rate of complication in sacral injection.1.2 Glucocorticoid is (one of) the most commonly used drugs in sacral injection, and also the biggest reason for complication by excessive use. Glucocorticoid have the effects of promotion Na+absorption and elimination of K+,but excessive use can lead to hypokalemia. The excessive use of hormone or intense irritant drugs will probably cause hyperosmolarity or intraspinal irritation, or chemical irritation, dehydration, degeneration and even irreversible damage to nerve root, or prostatic hyperplasia, allergic dermatitis, hepatomegaly, asthma and et al. To study the stability of glucocorticoid in sacral injection is very important in standardization of drug compatibility.1.3 Sacral injection is developed from anesthesiology, and it is widely accepted that the mechanism of sacral injection in treatment of lumbar disc herniation (LDH) is blocking the conductive pathway of pain directly, blocking the stimulus to nerve roots of chemical factors, eliminating oedema and inhibiting adherence when glucocorticoid being injected into epidural space. Some people arbitrarily increase the dosage of glucocorticoid or local anesthetic in order to increase clinical effect, and some people consider high dose isotonic solution injecting will produce impact force and pressure in epidural space and may noninvasively detach adhesion, remove oppressed nerve root and serves as so-called "liquid knife", even some person allege that Chinese materia medica preparation including Dansen injection, Honghua injection and et al have a better effect than glucocorticoid in sacral injection, and Chinese materia medica preparation can replace glucocorticoid completely. The clinical effect of sacral injection on lumbar disc herniation is being studied in this article to explore the reliable curative effects of each drug injected into sacral.2. Methods:2.1 The medicines used in sacral injection is divided into essential medicines group(dexamethasone and 2% lidocaine or 2% procaine), western medicine group(drugs of essential medicines group add B vitamins, sodium bicarbonate injection and et al), Chinese medicine group(drugs of essential medicines group add Dansen injection, Honghua injection and et al), Chinese-Western medicine combined group(drugs of essential medicines group add Western medicine and Chinese materia medica preparation), and is divided into 13 groups further more. Compound medicines of each group were kept at room temperature respectively, and then observation on the changes in appearance, pH value,insoluble particles and UV absorbance at 0min,30min,1.0h,2.0h,4.0h respectively. The detailed detection method and judgment standard can be found in the People's Republic of China pharmacopoeia,2005,(part two), appendixâ…£A,â…¥H, IXC.2.2 Through studying prednisoloneacetate in preliminary experiment, it was found that the suspension can easily affect observation on particulate matter counting. Considering quite a few groups, fixed-dose dexamethason was made to study compatible stability of drugs in Reference to commonly used drugs recipes used in sacral injection, the glucocorticoid used in sacral injection is divided into 7 groups according to the different doses of corticosteroids, different dosage forms and the compatibility of Chinese and Western medicines. Compound medicines of each group was observed on the changes in appearance, pH value and UV absorbance at Omin,30min,1.0h,2.0h,4.0h at the ambient temperature respectively, and then glucocorticoid contents were determined by high performance liquid chromatography(HPLC).2.3 To divide 90 lumbar disc protrusion patients into 6 groups at random, they are normal saline injection group(group A),low dose hexadecadrol injection group(group B, hexadecadrol 5mg,high dose hexadecadrol injection group(group C, hexadecadrol 20mg),low dose triamcinolone acetonide injection group(group D, triamcinolone 5mg),high dose triamcinolone acetonide injection group(group E, triamcinolone 20mg) and DanShen injection group(group F, DanShen injection 5mg), each one has 15 patients, and there were no significant (statistic) differences among each groups on gender, age, course of the disease and prolapsed lumbar discs (P<0.05).All the patients received 20ml sacral injection and were accessed by M-JOA and VAS before injection,after injection immediately,1 week and 2 week after injection.3. Results:3.1 No significant changes were found for the mixture within 4h in appearance, pH value and UV absorbance; Except the particles of 5 simple compatibility groups in essential medicines group, western medicine group, Chinese medicine group reaching the standard(China Pharmacopoeia.2005 edition), the particles in the 8 other mixtures failed to meet the standard.3.2 Visible yellow-white precipitates appeared in the groups of Chinese-Western medicine combined group.(Immediately appeared large when hexadecadrol add DanShen injection and Honghua injection; Immediately appeared a little when DanShen injection or Honghua injection add respectively western medicine group, but increased as time followed) The other groups have no color or precipitate.3.3 No significant changes were found for the mixture within 4h in appearance, pH value, UV absorbance and high performance liquid chromatogram(HPLC), except large dose of triamcinolone group and Chinese-Western medicine combined group with large number of visible white or brown precipitate respectively.3.4 Being used in confecting triamcinolone and having a bigger perfect chromatographic peak, carbinol is suited to confect triamcinolone. To inject durgs separately after 0min,30min,1h,2h,4h, and the mean is 99.85%, RSD=0.92% (n=5), it shown that the compatibility is stable in 4h, but triamcinolone can be seen after 24h in the compatibility of a small amount of decomposition occurs.3.5 Their M-JOA and VAS scores are not of statistic significant difference before injection (P>0.05); their VAS scores immediately after injection are significantly lower than before injection (P<0.05), but the M-JOA scores have no significant difference before and immediately after injection (P>0.05); The M-JOA and VAS score of hexadecadrol and triamcinolone acetonide injection groups are significantly lower than normal saline and DanShen groups after injection (P<0.01), the M-JOA and VAS score of groups of different dose glucocorticoid injections, normal saline and DanShen groups have no significant (statistic) difference (P> 0.05).3.6 The M-JOA and VAS score of triamcinolone acetonide group are significantly lower than hexadecadrol group 1 week after injection(P<0.05), but the M-JOA and VAS score of triamcinolone acetonide group and hexadecadrol group have no significantly difference 2 week after injection (P>0.05).The recovery rate of all groups are excellent especially glucocorticoid groups according to Lumber spine M-JOA standard, and it shown that most of patients have a good curative effect, the function of lumbar vertebra and ADL improved as well.4. Conclusions: 4.1 For the medicines used in sacral injection, the simpler in compatibility, the more stable; whether western medicine or Chinese medicine, they all decrease in stability with drug increasing, furthermore, both Western medicine and Chinese medicine can not be used together.4.2 We should strictly follow the principle of the lowest effective concentration and low-dose administration in sacral injection therapy, but should not increase (their) dosage blindly.4.3 With the dose of glucocorticoid suspension increasing, its compatibility decreases in sacral injection. Both water ague glucocorticoid and triamcinolone acetonide acetate injection can not be mixed with Chinese medicine. Because the composition of Chinese herbs is complicated, it is hard to select one which is of specific, long-lasting effect but without side effect, which deserves our researches4.4 Glucocorticoid is stable in 4h, and it is better to use the fresh one.4.5 Traditional Chinese medicine preparation got the same effect as normal saline injection in sacral injection therapy treating lumbar disc protrusion, and Chinese materia medica preparation play an additional role in sacral injection. There are many Chinese materia medica preparations that were used in sacral injection, but we found it immature in our study.4.6 Glucocorticoid plays an important role in sacral injection, but there have no significant correlation between clinical effect and dosage. Considering the danger of injection into vascular and adhesion caused by crystallization, it must be start from low dose and agent priority.
|
PDF Full Text Request